Oruvail Gel
(Ketoprofen)

Prescription Settings Edit

Brand Name Choices

Oruvail 2.5%
Oruvail 2.5% Topical Gel

Manufactured by Sanofi Aventis

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Generic Choices

No generic medication is available for Oruvail Gel (Ketoprofen)

What Oruvail Gel is and what it is used for

What Oruvail Capsules are and how they work The name of your medicine is Oruvail 100mg or 200mg Prolonged-Release Capsules, Hard (called Oruvail Capsules in this lea et). Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-In ammatory Drugs’ (NSAID’s). It works by blocking chemicals in your body that normally cause in ammation.What Oruvail Capsules are used for Oruvail Capsules are used to treat the swelling, pain, heat, redness and sti ness in your joints and muscles in the following:
• Rheumatoid arthritis (in ammation of your joints)

How to take Oruvail Gel

Always take Oruvail Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food
• Do not crush or chew your capsules
• The dose will depend on your body weight and how severe your pain is
• If you feel the e_x005F_x001E_ect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• These are slow release capsules so you will feel the e_x005F_x001E_ects for up to 16 hours How much to take Adults The usual dose is one capsule each day. Children Oruvail Capsules are not recommended for children. The elderly You are more likely to get side e_x005F_x001E_ects while taking Oruvail Capsules. Your doctor may start you on the lowest strength If you take more Oruvail Capsules than you should If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following e_x005F_x001E_ects may happen, feeling drowsy, stomach pains, being sick, feeling faint due to low blood pressure, di_x005F_x001D_culty breathing, wheezing, tightness in the chest or blood in your stools. If you forget to take Oruvail Capsules If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten capsule. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side e_x005F_x001E_ects Like all medicines, Oruvail Capsules can cause side e_x005F_x001E_ects, although not everybody gets them. Stop taking and see your doctor or go to a hospital straight away if:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your stomach, with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut. Frequency not known
• You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may also have _x005F_x001F_u like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment
• You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems
• You get chest pain or a sudden severe headache. Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke
• You get swelling of your face, lips or throat which makes it di_x005F_x001D_cult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction
• You are vomiting blood, have severe stomach pains or pass dark, tarry stools Tell your doctor as soon as possible if you have any of the following side e_x005F_x001E_ects:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem
• You have pale skin and feel tired, faint or dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This may be a sign of liver problems. Frequency not known
• Worsening of your Crohn’s disease or colitis
• Skin reaction to light or sunlamps (photosensitivity)
• Hair loss
• You may get more infections more easily than usual. This could be because of a serious blood disorder.
• Fits
• Pain in your eyes Other side e_x005F_x001E_ects

Common (a_x005F_x001E_ects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain, these are reduced by taking the medicine with food
• Feeling sick (nausea) or being sick (vomiting)

Uncommon (a_x005F_x001E_ects less than 1 in 100 people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen arms or legs
• Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or unwell

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• In_x005F_x001F_amed mouth

Very rare (a_x005F_x001E_ects less than 1 in 10,000 people)
• Severe stomach or back pain. These could be signs of pancreatitis. Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stu_x005F_x001E_y nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there Blood tests The results of a blood test may show changes in the way your liver or kidney is working. These side e_x005F_x001E_ects may go away during treatment as your body gets used to the medicine. Reporting of side e_x005F_x001E_ects If you get any side e_x005F_x001E_ects, talk to your doctor, pharmacist or nurse. This includes any possible side e_x005F_x001E_ects not listed in this lea_x005F_x001F_et. You can also report side e_x005F_x001E_ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side e_x005F_x001E_ects you can help provide more information on the safety of this medicine. 5. How to store Oruvail Capsules Keep this medicine in a safe place where children cannot see or reach it. Do not take Oruvail Capsules after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store the blister packs in a dry place below 25°C. Keep the blister strip in the outer carton in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Oruvail Capsules contain
• Each of the 100mg capsule contains 100mg of the active substance, ketoprofen
• Each of the 200mg capsule contains 200mg of the active substance, ketoprofen The other ingredients are sugar spheres, colloidal anhydrous silica, shellac, ethylcellulose, talc, gelatine, titanium dioxide (E171). Oruvail 100mg Capsules also contain aerythrosine (E127) and patent blue V (E131). What Oruvail Capsules look like and contents of the pack
• Oruvail 100mg Capsules are half pink and half purple marked with Oruvail 100 in white. They are supplied in blister packs of 8, 28, 30 & 56 capsules
• Oruvail 200mg Capsules are half pink and half white marked Oruvail 200 in blue. They are supplied in blisters packs of 4, 8, 14, 28 & 56 capsules Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sano_x005F_x001C_, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 08453 727101 Email: [email protected]_x005F_x001C_.com Manufacturer FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avda. Leganés, 62, Alcorcón 28923 Madrid, Spain. This lea_x005F_x001F_et was last revised in 06/2017 © sanofi, 1982-2017 11503340-05 PACKAGE LEAFLET: INFORMATION FOR THE USER Oruvail® 100mg or 200mg Prolonged-Release Capsules, Hard Ketoprofen Is this lea_x005F_x001F_et hard to see or read? Phone 08453 727101 for help Read all of this lea_x005F_x001F_et carefully before you start taking this medicine
• Keep this lea_x005F_x001F_et. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side e_x005F_x001E_ects gets serious, or if you notice any side e_x005F_x001E_ects not listed in this lea_x005F_x001F_et, please tell your doctor or pharmacist. In this lea_x005F_x001F_et: 1. What Oruvail Capsules are and what they are used for 2. Before you take Oruvail Capsules 3. How to take Oruvail Capsules 4. Possible side e_x005F_x001E_ects 5. How to store Oruvail Capsules 6. Further information 1. What Oruvail Capsules are and what they are used for What Oruvail Capsules are and how they work The name of your medicine is Oruvail 100mg or 200mg Prolonged-Release Capsules, Hard (called Oruvail Capsules in this lea_x005F_x001F_et). Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-In_x005F_x001F_ammatory Drugs’ (NSAID’s). It works by blocking chemicals in your body that normally cause in_x005F_x001F_ammation. What Oruvail Capsules are used for Oruvail Capsules are used to treat the swelling, pain, heat, redness and sti_x005F_x001E_ness in your joints and muscles in the following:
• Rheumatoid arthritis (in_x005F_x001F_ammation of your joints)
• Osteoarthritis (where the cushioning (cartilage) between your bone joints is damaged)
• Pain due to problems with your spine (such as ankylosing spondilitis)
• Lower back pain
• Sprains and strains
• Painful periods
• Pain and in_x005F_x001F_ammation after an operation
• Other painful in_x005F_x001F_ammatory joint, tendon, nerve or muscle problems
• Gout (painful, red, swollen joints) 2. Before you take Oruvail Capsules Do not take this medicine and tell your doctor if:  You are allergic (hypersensitive) to:
•ketoprofen
•aspirin
•any other Non-Steroidal Anti-In_x005F_x001F_ammatory Drug (NSAID) such as ibuprofen or indometacin
•any of the other ingredients of Oruvail Capsules (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue  You have or have ever had an ulcer or bleed in your stomach or intestine (gut)  You have severe heart problems  You have severe liver or kidney problems  You bruise more easily than usual and have bleeding that lasts a long time  You are pregnant (see ‘Pregnancy and breast-feeding’ below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Oruvail Capsules. Take special care with Oruvail Capsules Check with your doctor or pharmacist before taking your medicine if:  You are asthmatic  You have ulcerative colitis or Crohn’s disease  You have a disease a_x005F_x001E_ecting the skin, joints or kidneys called ‘Systemic Lupus Erythematosus’ (SLE)  You are 65 years of age or older  You are planning to become pregnant or you have problems becoming pregnant. Oruvail Capsules may make it more di_x005F_x001D_cult to become pregnant.  You have heart problems, previous stroke or think that you might be at risk of these conditions (if you have high blood pressure, diabetes or high cholesterol or are a smoker). Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Your doctor may need to keep a close check on you or give you a shorter course of treatment if:  You have high cholesterol or blood fats  You are diabetic  You smoke  You have kidney or liver problems  You are taking water tablets (diuretics) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Oruvail Capsules can a_x005F_x001E_ect the way some other medicines work. Also some medicines can a_x005F_x001E_ect the way Oruvail Capsules work. In particular, tell your doctor if you are taking any of the following:
• Other Non-Steroidal Anti-In_x005F_x001F_ammatory Drugs such as aspirin or ibuprofen
• Water tablets (diuretics)
• Medicines for high blood pressure or heart failure
• Digoxin
•used for controlling heart rate or helping in heart failure
• Medicines to stop your blood clotting such as heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban or edoxaban
• Medicines to dissolve blood clots such as streptokinase, alteplase, reteplase or tenecteplase
• Medicines for infections (antibiotics) such as cipro_x005F_x001F_oxacin, levo_x005F_x001F_oxacin or o_x005F_x001F_oxacin
• Medicines for depression such as _x005F_x001F_uoxetine, sertraline, citalopram or paroxetine
• Corticosteroids
•used for in_x005F_x001F_ammation such as hydrocortisone, betamethasone or prednisolone
• Ciclosporin
•used after an organ transplantation to help prevent rejection
• Mifepristone – used to terminate a pregnancy. It is important that Oruvail Capsules are not taken for 8-12 days after taking Mifepristone
• Lithium – used for some types of mental illness
• Methotrexate – used for some types of cancer or psoriasis
• Pentoxifylline
•used to help poor blood circulation in limbs
• Tacrolimus
•used after an organ transplant
• Probenecid
•used for gout
• Zidovudine – used for HIV Pregnancy and breast-feeding Do not take this medicine if you are pregnant, might become pregnant, or think you may be pregnant. You should not breast-feed if you are using Oruvail Capsules. This is because small amounts may pass into mothers’ milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines You may feel sleepy, dizzy, faint, your eyesight may be a_x005F_x001E_ected or you may have a _x005F_x001C_t while taking this medicine. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Oruvail capsule Oruvail Capsules contain sugar. Take this into account if you have diabetes. 3. How to take Oruvail Capsules Always take Oruvail Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food
• Do not crush or chew your capsules
• The dose will depend on your body weight and how severe your pain is
• If you feel the e_x005F_x001E_ect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• These are slow release capsules so you will feel the e_x005F_x001E_ects for up to 16 hours How much to take Adults The usual dose is one capsule each day. Children Oruvail Capsules are not recommended for children. The elderly You are more likely to get side e_x005F_x001E_ects while taking Oruvail Capsules. Your doctor may start you on the lowest strength If you take more Oruvail Capsules than you should If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following e_x005F_x001E_ects may happen, feeling drowsy, stomach pains, being sick, feeling faint due to low blood pressure, di_x005F_x001D_culty breathing, wheezing, tightness in the chest or blood in your stools. If you forget to take Oruvail Capsules If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten capsule. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Oruvail Capsules can cause side e ects, although not everybody gets them. Stop taking and see your doctor or go to a hospital straight away if:

Rare (a ects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your stomach, with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut. Frequency not known
• You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may also have u like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment
• You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems
• You get chest pain or a sudden severe headache. Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke
• You get swelling of your face, lips or throat which makes it di cult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction
• You are vomiting blood, have severe stomach pains or pass dark, tarry stools Tell your doctor as soon as possible if you have any of the following side e ects:

Rare (a ects less than 1 in 1,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem
• You have pale skin and feel tired, faint or dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This may be a sign of liver problems. Frequency not known
• Worsening of your Crohn’s disease or colitis
• Skin reaction to light or sunlamps (photosensitivity)
• Hair loss
• You may get more infections more easily than usual. This could be because of a serious blood disorder.
• Fits
• Pain in your eyes Other side e ects

Common (a ects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain, these are reduced by taking the medicine with food
• Feeling sick (nausea) or being sick (vomiting)

Uncommon (a ects less than 1 in 100 people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen arms or legs
• Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or unwell

Rare (a ects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• In amed mouth

Very rare (a ects less than 1 in 10,000 people)
• Severe stomach or back pain. These could be signs of pancreatitis. Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stu y nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there Blood tests The results of a blood test may show changes in the way your liver or kidney is working. These side e ects may go away during treatment as your body gets used to the medicine. Reporting of side e ects If you get any side e ects, talk to your doctor, pharmacist or nurse. This includes any possible side e ects not listed in this lea et. You can also report side e ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side e ects you can help provide more information on the safety of this medicine. 5. How to store Oruvail Capsules Keep this medicine in a safe place where children cannot see or reach it. Do not take Oruvail Capsules after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store the blister packs in a dry place below 25°C. Keep the blister strip in the outer carton in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Oruvail Capsules contain
• Each of the 100mg capsule contains 100mg of the active substance, ketoprofen
• Each of the 200mg capsule contains 200mg of the active substance, ketoprofen The other ingredients are sugar spheres, colloidal anhydrous silica, shellac, ethylcellulose, talc, gelatine, titanium dioxide (E171). Oruvail 100mg Capsules also contain aerythrosine (E127) and patent blue V (E131). What Oruvail Capsules look like and contents of the pack
• Oruvail 100mg Capsules are half pink and half purple marked with Oruvail 100 in white. They are supplied in blister packs of 8, 28, 30 & 56 capsules
• Oruvail 200mg Capsules are half pink and half white marked Oruvail 200 in blue. They are supplied in blisters packs of 4, 8, 14, 28 & 56 capsules Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sano , One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 08453 727101 Email: [email protected] .com Manufacturer FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avda. Leganés, 62, Alcorcón 28923 Madrid, Spain. This lea et was last revised in 06/2017 © sanofi, 1982-2017 11503340-05 Artworks Department. Madrid. Spain SAP-/ID number: 11503340-05 Replace: 11503340-04 Version number: 01 Date: 23.06.2017 Country: UK Designer: M. Luz Peirotén Product Description: Oruvail 100/200 mg Technical drawing St: 678 Zt: 678-1 Dimensions: 145x210 (x2) Laetus number: 306 Folder nº: 2976983 Minimum point size: 9 COLOURS P. Re ex blue PACKAGE LEAFLET: INFORMATION FOR THE USER Oruvail® 100mg or 200mg Prolonged-Release Capsules, Hard Ketoprofen Is this lea et hard to see or read? Phone 08453 727101 for help Read all of this lea et carefully before you start taking this medicine
• Keep this lea et. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side e ects gets serious, or if you notice any side e ects not listed in this lea et, please tell your doctor or pharmacist. In this lea et: 1. What Oruvail Capsules are and what they are used for 2. Before you take Oruvail Capsules 3. How to take Oruvail Capsules 4. Possible side e ects 5. How to store Oruvail Capsules 6. Further information 1. What Oruvail Capsules are and what they are used for What Oruvail Capsules are and how they work The name of your medicine is Oruvail 100mg or 200mg Prolonged-Release Capsules, Hard (called Oruvail Capsules in this lea et). Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-In ammatory Drugs’ (NSAID’s). It works by blocking chemicals in your body that normally cause in ammation. What Oruvail Capsules are used for Oruvail Capsules are used to treat the swelling, pain, heat, redness and sti ness in your joints and muscles in the following:
• Rheumatoid arthritis (in ammation of your joints)
• Osteoarthritis (where the cushioning (cartilage) between your bone joints is damaged)
• Pain due to problems with your spine (such as ankylosing spondilitis)
• Lower back pain
• Sprains and strains
• Painful periods
• Pain and in ammation after an operation
• Other painful in ammatory joint, tendon, nerve or muscle problems
• Gout (painful, red, swollen joints) 2. Before you take Oruvail Capsules Do not take this medicine and tell your doctor if:  You are allergic (hypersensitive) to:
•ketoprofen
•aspirin
•any other Non-Steroidal Anti-In ammatory Drug (NSAID) such as ibuprofen or indometacin
•any of the other ingredients of Oruvail Capsules (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue  You have or have ever had an ulcer or bleed in your stomach or intestine (gut)  You have severe heart problems  You have severe liver or kidney problems  You bruise more easily than usual and have bleeding that lasts a long time  You are pregnant (see ‘Pregnancy and breast-feeding’ below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Oruvail Capsules. Take special care with Oruvail Capsules Check with your doctor or pharmacist before taking your medicine if:  You are asthmatic  You have ulcerative colitis or Crohn’s disease  You have a disease a ecting the skin, joints or kidneys called ‘Systemic Lupus Erythematosus’ (SLE)  You are 65 years of age or older  You are planning to become pregnant or you have problems becoming pregnant. Oruvail Capsules may make it more di cult to become pregnant.  You have heart problems, previous stroke or think that you might be at risk of these conditions (if you have high blood pressure, diabetes or high cholesterol or are a smoker). Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Your doctor may need to keep a close check on you or give you a shorter course of treatment if:  You have high cholesterol or blood fats  You are diabetic  You smoke  You have kidney or liver problems  You are taking water tablets (diuretics) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Oruvail Capsules can a ect the way some other medicines work. Also some medicines can a ect the way Oruvail Capsules work. In particular, tell your doctor if you are taking any of the following:
• Other Non-Steroidal Anti-In ammatory Drugs such as aspirin or ibuprofen
• Water tablets (diuretics)
• Medicines for high blood pressure or heart failure
• Digoxin
•used for controlling heart rate or helping in heart failure
• Medicines to stop your blood clotting such as heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban or edoxaban
• Medicines to dissolve blood clots such as streptokinase, alteplase, reteplase or tenecteplase
• Medicines for infections (antibiotics) such as cipro oxacin, levo oxacin or o oxacin
• Medicines for depression such as uoxetine, sertraline, citalopram or paroxetine
• Corticosteroids
•used for in ammation such as hydrocortisone, betamethasone or prednisolone
• Ciclosporin
•used after an organ transplantation to help prevent rejection
• Mifepristone – used to terminate a pregnancy. It is important that Oruvail Capsules are not taken for 8-12 days after taking Mifepristone
• Lithium – used for some types of mental illness
• Methotrexate – used for some types of cancer or psoriasis
• Pentoxifylline
•used to help poor blood circulation in limbs
• Tacrolimus
•used after an organ transplant
• Probenecid
•used for gout
• Zidovudine – used for HIV Pregnancy and breast-feeding Do not take this medicine if you are pregnant, might become pregnant, or think you may be pregnant. You should not breast-feed if you are using Oruvail Capsules. This is because small amounts may pass into mothers’ milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines You may feel sleepy, dizzy, faint, your eyesight may be a ected or you may have a t while taking this medicine. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Oruvail capsule Oruvail Capsules contain sugar. Take this into account if you have diabetes. 3. How to take Oruvail Capsules Always take Oruvail Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food
• Do not crush or chew your capsules
• The dose will depend on your body weight and how severe your pain is
• If you feel the e ect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• These are slow release capsules so you will feel the e ects for up to 16 hours How much to take Adults The usual dose is one capsule each day. Children Oruvail Capsules are not recommended for children. The elderly You are more likely to get side e ects while taking Oruvail Capsules. Your doctor may start you on the lowest strength If you take more Oruvail Capsules than you should If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following e ects may happen, feeling drowsy, stomach pains, being sick, feeling faint due to low blood pressure, di culty breathing, wheezing, tightness in the chest or blood in your stools. If you forget to take Oruvail Capsules If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten capsule. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side e ects Like all medicines, Oruvail Capsules can cause side e ects, although not everybody gets them. Stop taking and see your doctor or go to a hospital straight away if:

Rare (a ects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your stomach, with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut. Frequency not known
• You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may also have u like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment
• You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems
• You get chest pain or a sudden severe headache. Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke
• You get swelling of your face, lips or throat which makes it di cult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction
• You are vomiting blood, have severe stomach pains or pass dark, tarry stools Tell your doctor as soon as possible if you have any of the following side e ects:

Rare (a ects less than 1 in 1,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem
• You have pale skin and feel tired, faint or dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This may be a sign of liver problems. Frequency not known
• Worsening of your Crohn’s disease or colitis
• Skin reaction to light or sunlamps (photosensitivity)
• Hair loss
• You may get more infections more easily than usual. This could be because of a serious blood disorder.
• Fits
• Pain in your eyes Other side e ects

Common (a ects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain, these are reduced by taking the medicine with food
• Feeling sick (nausea) or being sick (vomiting)

Uncommon (a ects less than 1 in 100 people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen arms or legs
• Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or unwell

Rare (a ects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• In amed mouth

Very rare (a ects less than 1 in 10,000 people)
• Severe stomach or back pain. These could be signs of pancreatitis. Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stu y nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there Blood tests The results of a blood test may show changes in the way your liver or kidney is working. These side e ects may go away during treatment as your body gets used to the medicine. Reporting of side e ects If you get any side e ects, talk to your doctor, pharmacist or nurse. This includes any possible side e ects not listed in this lea et. You can also report side e ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side e ects you can help provide more information on the safety of this medicine.

How to Store Oruvail Gel

Like all medicines, Oruvail Capsules can cause side e_x005F_x001E_ects, although not everybody gets them. Stop taking and see your doctor or go to a hospital straight away if:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your stomach, with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut. Frequency not known
• You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may also have _x005F_x001F_u like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment
• You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems
• You get chest pain or a sudden severe headache. Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke
• You get swelling of your face, lips or throat which makes it di_x005F_x001D_cult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction
• You are vomiting blood, have severe stomach pains or pass dark, tarry stools Tell your doctor as soon as possible if you have any of the following side e_x005F_x001E_ects:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem
• You have pale skin and feel tired, faint or dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This may be a sign of liver problems. Frequency not known
• Worsening of your Crohn’s disease or colitis
• Skin reaction to light or sunlamps (photosensitivity)
• Hair loss
• You may get more infections more easily than usual. This could be because of a serious blood disorder.
• Fits
• Pain in your eyes Other side e_x005F_x001E_ects

Common (a_x005F_x001E_ects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain, these are reduced by taking the medicine with food
• Feeling sick (nausea) or being sick (vomiting)

Uncommon (a_x005F_x001E_ects less than 1 in 100 people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen arms or legs
• Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or unwell

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• In_x005F_x001F_amed mouth

Very rare (a_x005F_x001E_ects less than 1 in 10,000 people)
• Severe stomach or back pain. These could be signs of pancreatitis. Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stu_x005F_x001E_y nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there Blood tests The results of a blood test may show changes in the way your liver or kidney is working. These side e_x005F_x001E_ects may go away during treatment as your body gets used to the medicine. Reporting of side e_x005F_x001E_ects If you get any side e_x005F_x001E_ects, talk to your doctor, pharmacist or nurse. This includes any possible side e_x005F_x001E_ects not listed in this lea_x005F_x001F_et. You can also report side e_x005F_x001E_ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side e_x005F_x001E_ects you can help provide more information on the safety of this medicine. 5. How to store Oruvail Capsules Keep this medicine in a safe place where children cannot see or reach it. Do not take Oruvail Capsules after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month. Store the blister packs in a dry place below 25°C. Keep the blister strip in the outer carton in order to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. Further information What Oruvail Capsules contain
• Each of the 100mg capsule contains 100mg of the active substance, ketoprofen
• Each of the 200mg capsule contains 200mg of the active substance, ketoprofen The other ingredients are sugar spheres, colloidal anhydrous silica, shellac, ethylcellulose, talc, gelatine, titanium dioxide (E171). Oruvail 100mg Capsules also contain aerythrosine (E127) and patent blue V (E131). What Oruvail Capsules look like and contents of the pack
• Oruvail 100mg Capsules are half pink and half purple marked with Oruvail 100 in white. They are supplied in blister packs of 8, 28, 30 & 56 capsules
• Oruvail 200mg Capsules are half pink and half white marked Oruvail 200 in blue. They are supplied in blisters packs of 4, 8, 14, 28 & 56 capsules Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Sano_x005F_x001C_, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. Tel: 08453 727101 Email: [email protected]_x005F_x001C_.com Manufacturer FAMAR HEALTH CARE SERVICES MADRID, S.A.U., Avda. Leganés, 62, Alcorcón 28923 Madrid, Spain. This lea_x005F_x001F_et was last revised in 06/2017 © sanofi, 1982-2017 11503340-05 Artworks Department. Madrid. Spain SAP-/ID number: 11503340-05 Replace: 11503340-04 Version number: 01 Date: 23.06.2017 Country: UK Designer: M. Luz Peirotén Product Description: Oruvail 100/200 mg Technical drawing St: 678 Zt: 678-1 Dimensions: 145x210 (x2) Laetus number: 306 Folder nº: 2976983 Minimum point size: 9 COLOURS P. Re_x005F_x001F_ex blue PACKAGE LEAFLET: INFORMATION FOR THE USER Oruvail® 100mg or 200mg Prolonged-Release Capsules, Hard Ketoprofen Is this lea_x005F_x001F_et hard to see or read? Phone 08453 727101 for help Read all of this lea_x005F_x001F_et carefully before you start taking this medicine
• Keep this lea_x005F_x001F_et. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side e_x005F_x001E_ects gets serious, or if you notice any side e_x005F_x001E_ects not listed in this lea_x005F_x001F_et, please tell your doctor or pharmacist. In this lea_x005F_x001F_et: 1. What Oruvail Capsules are and what they are used for 2. Before you take Oruvail Capsules 3. How to take Oruvail Capsules 4. Possible side e_x005F_x001E_ects 5. How to store Oruvail Capsules 6. Further information 1. What Oruvail Capsules are and what they are used for What Oruvail Capsules are and how they work The name of your medicine is Oruvail 100mg or 200mg Prolonged-Release Capsules, Hard (called Oruvail Capsules in this lea_x005F_x001F_et). Oruvail Capsules contain a medicine called ketoprofen. This belongs to a group of medicines called ‘Non-Steroidal Anti-In_x005F_x001F_ammatory Drugs’ (NSAID’s). It works by blocking chemicals in your body that normally cause in_x005F_x001F_ammation. What Oruvail Capsules are used for Oruvail Capsules are used to treat the swelling, pain, heat, redness and sti_x005F_x001E_ness in your joints and muscles in the following:
• Rheumatoid arthritis (in_x005F_x001F_ammation of your joints)
• Osteoarthritis (where the cushioning (cartilage) between your bone joints is damaged)
• Pain due to problems with your spine (such as ankylosing spondilitis)
• Lower back pain
• Sprains and strains
• Painful periods
• Pain and in_x005F_x001F_ammation after an operation
• Other painful in_x005F_x001F_ammatory joint, tendon, nerve or muscle problems
• Gout (painful, red, swollen joints) 2. Before you take Oruvail Capsules Do not take this medicine and tell your doctor if:  You are allergic (hypersensitive) to:
•ketoprofen
•aspirin
•any other Non-Steroidal Anti-In_x005F_x001F_ammatory Drug (NSAID) such as ibuprofen or indometacin
•any of the other ingredients of Oruvail Capsules (listed in Section 6 below) Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue  You have or have ever had an ulcer or bleed in your stomach or intestine (gut)  You have severe heart problems  You have severe liver or kidney problems  You bruise more easily than usual and have bleeding that lasts a long time  You are pregnant (see ‘Pregnancy and breast-feeding’ below) Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Oruvail Capsules. Take special care with Oruvail Capsules Check with your doctor or pharmacist before taking your medicine if:  You are asthmatic  You have ulcerative colitis or Crohn’s disease  You have a disease a_x005F_x001E_ecting the skin, joints or kidneys called ‘Systemic Lupus Erythematosus’ (SLE)  You are 65 years of age or older  You are planning to become pregnant or you have problems becoming pregnant. Oruvail Capsules may make it more di_x005F_x001D_cult to become pregnant.  You have heart problems, previous stroke or think that you might be at risk of these conditions (if you have high blood pressure, diabetes or high cholesterol or are a smoker). Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Your doctor may need to keep a close check on you or give you a shorter course of treatment if:  You have high cholesterol or blood fats  You are diabetic  You smoke  You have kidney or liver problems  You are taking water tablets (diuretics) If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Oruvail Capsules. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Oruvail Capsules can a_x005F_x001E_ect the way some other medicines work. Also some medicines can a_x005F_x001E_ect the way Oruvail Capsules work. In particular, tell your doctor if you are taking any of the following:
• Other Non-Steroidal Anti-In_x005F_x001F_ammatory Drugs such as aspirin or ibuprofen
• Water tablets (diuretics)
• Medicines for high blood pressure or heart failure
• Digoxin
•used for controlling heart rate or helping in heart failure
• Medicines to stop your blood clotting such as heparin, warfarin, clopidogrel, ticlopidine, dabigatran, apixaban, rivaroxaban or edoxaban
• Medicines to dissolve blood clots such as streptokinase, alteplase, reteplase or tenecteplase
• Medicines for infections (antibiotics) such as cipro_x005F_x001F_oxacin, levo_x005F_x001F_oxacin or o_x005F_x001F_oxacin
• Medicines for depression such as _x005F_x001F_uoxetine, sertraline, citalopram or paroxetine
• Corticosteroids
•used for in_x005F_x001F_ammation such as hydrocortisone, betamethasone or prednisolone
• Ciclosporin
•used after an organ transplantation to help prevent rejection
• Mifepristone – used to terminate a pregnancy. It is important that Oruvail Capsules are not taken for 8-12 days after taking Mifepristone
• Lithium – used for some types of mental illness
• Methotrexate – used for some types of cancer or psoriasis
• Pentoxifylline
•used to help poor blood circulation in limbs
• Tacrolimus
•used after an organ transplant
• Probenecid
•used for gout
• Zidovudine – used for HIV Pregnancy and breast-feeding Do not take this medicine if you are pregnant, might become pregnant, or think you may be pregnant. You should not breast-feed if you are using Oruvail Capsules. This is because small amounts may pass into mothers’ milk. Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding. Driving and using machines You may feel sleepy, dizzy, faint, your eyesight may be a_x005F_x001E_ected or you may have a _x005F_x001C_t while taking this medicine. If this happens, do not drive or use any tools or machines. Important information about some of the ingredients of Oruvail capsule Oruvail Capsules contain sugar. Take this into account if you have diabetes. 3. How to take Oruvail Capsules Always take Oruvail Capsules exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Taking this medicine
• Take this medicine by mouth
• Swallow the capsules whole with a drink of water
• Take with or after food
• Do not crush or chew your capsules
• The dose will depend on your body weight and how severe your pain is
• If you feel the e_x005F_x001E_ect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor
• These are slow release capsules so you will feel the e_x005F_x001E_ects for up to 16 hours How much to take Adults The usual dose is one capsule each day. Children Oruvail Capsules are not recommended for children. The elderly You are more likely to get side e_x005F_x001E_ects while taking Oruvail Capsules. Your doctor may start you on the lowest strength If you take more Oruvail Capsules than you should If you take more capsules than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken. The following e_x005F_x001E_ects may happen, feeling drowsy, stomach pains, being sick, feeling faint due to low blood pressure, di_x005F_x001D_culty breathing, wheezing, tightness in the chest or blood in your stools. If you forget to take Oruvail Capsules If you forget a dose, take it as soon as you remember. However, if it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten capsule. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. Possible side e_x005F_x001E_ects Like all medicines, Oruvail Capsules can cause side e_x005F_x001E_ects, although not everybody gets them. Stop taking and see your doctor or go to a hospital straight away if:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• You have an asthma attack
• You have a burning, aching pain in your stomach, with an empty feeling and hunger. This may be caused by an ulcer in your stomach or gut. Frequency not known
• You get blistering, peeling or bleeding on any part of your skin with or without an itchy, lumpy rash. This includes your lips, eyes, mouth, nose, genitals, hands or feet. You may also have _x005F_x001F_u like symptoms at the same time. You may have a serious skin problem that needs urgent medical treatment
• You have blood in your urine, change in the amount of urine you produce or swelling especially of your legs, ankles or feet. This may be caused by serious kidney problems
• You get chest pain or a sudden severe headache. Medicines such as Oruvail Capsules may be associated with a small increased risk of heart attack (myocardial infarction) or stroke
• You get swelling of your face, lips or throat which makes it di_x005F_x001D_cult to swallow, breathe or you may have wheezing or tightness in the chest, as well as itching and rashes. This may mean you are having a severe allergic reaction
• You are vomiting blood, have severe stomach pains or pass dark, tarry stools Tell your doctor as soon as possible if you have any of the following side e_x005F_x001E_ects:

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on your skin (paraesthesia)
• You bruise more easily than usual or have bleeding that lasts a long time. This could be because of a serious blood problem
• You have pale skin and feel tired, faint or dizzy. You may have anaemia
• You have blurred eyesight
• Your eyes or skin go yellow (jaundice).This may be a sign of liver problems. Frequency not known
• Worsening of your Crohn’s disease or colitis
• Skin reaction to light or sunlamps (photosensitivity)
• Hair loss
• You may get more infections more easily than usual. This could be because of a serious blood disorder.
• Fits
• Pain in your eyes Other side e_x005F_x001E_ects

Common (a_x005F_x001E_ects less than 1 in 10 people)
• Indigestion, heartburn, stomach pain, these are reduced by taking the medicine with food
• Feeling sick (nausea) or being sick (vomiting)

Uncommon (a_x005F_x001E_ects less than 1 in 100 people)
• Constipation, diarrhoea or wind
• Rash and itching
• Water retention which may cause swollen arms or legs
• Headaches, feeling dizzy, feeling drowsy or sleepy, feeling tired or unwell

Rare (a_x005F_x001E_ects less than 1 in 1,000 people)
• Ringing in your ears (tinnitus)
• Weight gain
• In_x005F_x001F_amed mouth

Very rare (a_x005F_x001E_ects less than 1 in 10,000 people)
• Severe stomach or back pain. These could be signs of pancreatitis. Frequency not known
• Balance problems (vertigo), feeling dizzy
• Feeling sleepy or being unable to sleep, changes in mood
• High blood pressure
• Changes in the way things taste
• Runny nose, itching, sneezing and stu_x005F_x001E_y nose
• Flushing
• Depression
• Feeling confused
• You see or hear things that are not there Blood tests The results of a blood test may show changes in the way your liver or kidney is working. These side e_x005F_x001E_ects may go away during treatment as your body gets used to the medicine. Reporting of side e_x005F_x001E_ects If you get any side e_x005F_x001E_ects, talk to your doctor, pharmacist or nurse. This includes any possible side e_x005F_x001E_ects not listed in this lea_x005F_x001F_et. You can also report side e_x005F_x001E_ects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard By reporting side e_x005F_x001E_ects you can help provide more information on the safety of this medicine

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Medix Pharmacy is a fully licensed pharmacy in the United Kingdom who provides competitive pricing on brand and generic medications with international shipping.

We are regulated by a number of executive government agencies in the United Kingdom including the Medicines and Healthcare products Regulatory Agency and the GPhC to ensure we offer our customers the highest level of service and peace of mind knowing that the medicines that you receive are safe, effective and authentic.

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