(Cyproterone Acetate/Ethinyl Estradiol)

Prescription Settings Edit

Brand Name Choices

Dianette 2/0.035mg
Dianette 2/0.035mg

Cyproterone Acetate/Ethinyl Estradiol

Manufactured by Bayer

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Generic Choices

Cyproterone Acetate/Ethinyl Estradiol 21 Day 2/0.035mg
Cyproterone Acetate/Ethinyl Estradiol 21 Day 2/0.035mg

Generic Equivalent of Diane-35 2/0.035mg

Manufactured by Various UK Generic Manufacturers (MHRA Approved)

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Cyproterone Acetate/Ethinyl Estradiol 21 Day 2/0.035mg
Cyproterone Acetate/Ethinyl Estradiol 21 Day 2/0.035mg

Marketed as Ran-Cyproterone/Ethinyl Estradiol in Canada

Generic Equivalent of Diane-35 2/0.035mg

Manufactured by Ranbaxy

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

More Generic Choices

What Diane-35 is and what it is used for

Dianette contains an oestrogen and an anti-androgen. Dianette is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate. You should only take Dianette if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics. If you are taking Dianette for skin treatment, you must not take any other hormonal contraceptive at the same time. When your skin condition has cleared up and you stop taking Dianette, you will need to go back to your original/preferred method of contraception.Treating skin conditions Androgens are hormones that stimulate hair growth and the grease glands in your skin. If you produce too much androgen, or if you are sensitive to the effect, the grease glands may produce too much sebum. This can block the grease glands, which can become infected and inflamed causing acne spots. Dianette stops the androgens affecting your skin and reduces the amount of androgens produced. Contraception Dianette is a 21-day Pill – you take one each day for 21 days, followed by 7 days when you take no pills.Dianette will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this. Dianette needs to be taken as directed to prevent pregnancy.

How to take Diane-35

Your doctor has chosen Dianette as a treatment for your acne or excessive hair growth on your face and body. However, Dianette also has a contraceptive effect, so it is important to follow the advice below if you are relying on Dianette for contraception. If you are only using Dianette for your acne or excessive hair growth, you can still follow this advice, but ask your doctor if you are unsure. Duration of use Your doctor will tell you how long you need to keep taking Dianette. How to take it Take Dianette every day for 21 days Dianette comes in strips of 21 pills, each marked with a day of the week.  Take your pill at the same time every day.  Start by taking a pill marked with the correct day of the week.  Follow the direction of the arrows on the strip. Take one pill each day, until you have finished all 21 pills.  Swallow each pill whole, with water if necessary. Do not chew the pill. Then have seven pill-free days After you have taken all 21 pills in the strip, you have seven days when you take no pills. Within a few days of taking the last pill from the strip, you should have a withdrawal bleed like a period. This bleed may not have finished when it is time to start your next strip of pills. If you are relying on this medicine to prevent pregnancy, always take Dianette as described here. You don’t need to use extra contraception during the seven pill-free days – as long as you have taken your pills correctly and start the next strip of pills on time. Check with your doctor if you are not sure. Start your next strip on day eight Start taking your next strip of Dianette after the seven pill-free days (on day eight) – even if you are still bleeding. So if you take the last pill of one pack on a Friday, you will take the first pill of your next pack on the Saturday of the following week. Always start the new strip on time. As long as you take Dianette correctly, you will always start each new strip on the same day of the week. Starting Dianette New users or starting Dianette after a break V034_1 11 It is best to take your first Dianette pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill. Changing to Dianette from another contraceptive Pill  If you are currently taking a 21-day Pill: start Dianette the next day after the end of the previous strip. You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Dianette.  If you are taking a 28-day Pill: start taking Dianette the day after your last active pill. You will have contraceptive protection with your first pill. You will not have a bleed until after your first strip of Dianette.  If you are taking a progestogen-only Pill (POP or ‘mini Pill’): start Dianette on the first day of bleeding, even if you have already taken the progestogen-only Pill for that day. You will have contraceptive cover straight away. Starting Dianette after a miscarriage or abortion If you have had a miscarriage or an abortion during the first three months of pregnancy, your doctor may tell you to start taking Dianette straight away. This means that you will have contraceptive protection with your first pill. If you have had a miscarriage or an abortion after the third month of pregnancy, ask your doctor for advice. You may need to use extra contraception, such as condoms, for a short time. Contraception after having a baby If you have just had a baby, your doctor may advise you that Dianette should be started 21 days after delivery provided that you are fully mobile. You do not have to wait for a period. You will need to use another method of contraception, such as a condom, until you start Dianette and for the first 7 days of pill taking. Do not take Dianette if you are breast-feeding A missed pill If you are less than 12 hours late with a pill, take it straight away. Keep taking your pills at the usual time. This may mean taking two pills in one day. Don’t worry – your contraceptive protection should not be reduced. If you are more than 12 hours late with a pill, or you have missed more than one pill, your contraceptive protection may be reduced.  Take the most recently missed pill as soon as you remember, even if it means taking two at once. Leave any earlier missed pills in the pack.  Continue to take a pill every day for the next seven days at your usual time.  If you come to the end of a strip of pills during these seven days, start the next strip without taking the usual seven day break. You probably won’t have a bleed until after you finish the second strip of pills, but don’t worry. If you finish the second strip of pills and don’t have a bleed, do a pregnancy test before starting another strip.  Use extra contraception for seven days after missing a pill, such as condoms. V034_1 12  If you have missed one or more pills from the first week of your strip (days 1 to 7) and you had sex in that week, you could become pregnant. Contact your doctor or pharmacist for advice as soon as possible. They may recommend you use emergency contraception. If you have missed any of the pills in a strip, and you do not bleed in the first pillfree break, you may be pregnant. Contact your doctor or do a pregnancy test yourself. If you start a new strip of pills late, or make your ‘week off’ longer than seven days, you may not be protected from pregnancy. If you had sex in the last seven days, ask your doctor or pharmacist for advice. You may need to consider emergency contraception. You should also use extra contraception, such as a condom, for seven days. A lost pill If you lose a pill, Either take the last pill of the strip in place of the lost pill. Then take all the other pills on their proper days. Your cycle will be one day shorter than normal, but your contraceptive protection won’t be affected. After your seven pill-free days you will have a new starting day, one day earlier than before. Or if you do not want to change the starting day of your cycle, take a pill from a spare strip if you have one. Then take all the other pills from your current strip as usual. You can then keep the opened spare strip in case you lose any more pills. If you are sick or have diarrhoea If you are sick (vomit) or have very bad diarrhoea, your body may not get its usual dose of hormones from that pill. If you are better within 12 hours of taking Dianette, follow the instructions in section 3.4 A lost pill, which describes how to take another pill. If you are still sick or have diarrhoea more than 12 hours after taking Dianette, see section 3.3, A missed pill. → Talk to your doctor if your stomach upset carries on or gets worse. He or she may recommend another form of contraception. Missed a period – could you be pregnant? Occasionally, you may miss a withdrawal bleed. This could mean that you are pregnant, but that is very unlikely if you have taken your pills correctly. Start your next strip at the normal time. If you think that you might have put yourself at risk of pregnancy (for example, by missing pills or taking other medicines), or if you miss a second bleed, you should do a pregnancy test. You can buy these from the chemist or get a free test at your doctors surgery. If you are pregnant, stop taking Dianette and see your doctor. Taking more than one pill should not cause harm It is unlikely that taking more than one pill will do you any harm, but you may feel sick, vomit or bleed from the vagina. Even girls who have not yet started to menstruate but V034_1 13 have accidentally taken this medicine may experience such bleeding. Talk to your doctor if you have any of these symptoms. When you want to get pregnant If you are planning a baby, it’s best to use another method of contraception after stopping Dianette until you have had a proper period. Your doctor or midwife relies on the date of your last natural period to tell you when your baby is due. However, it will not cause you or the baby any harm if you get pregnant straight away.

Possible side effects

Like all medicines, Dianette can cause side effects, although not everybody gets them. If you get any side effect, particularly if severe and persistent, or have any change to your health that you think may be due to Dianette, please talk to your doctor. An increased risk of blood clots in your veins (venous thromboembolism (VTE)) or blood clots in your arteries (arterial thromboembolism (ATE)) is present for all women taking combined hormonal contraceptives. For more detailed information on the different risks from taking combined hormonal contraceptives please see section 2 “What you need to know before you take Dianette”. The following is a list of the side effects that have been linked with the use of Dianette: 4.1 Serious side effects – see a doctor straight away Severe depression: Although, it is not considered a direct side effect of Dianette, some women have reported feeling depressed whilst taking Dianette. In very rare cases this has been associated with thoughts of ending their lives. If you develop severe depression, you should stop Dianette as a precaution, and see your doctor straight away. Signs of a blood clot:  an unusual sudden cough;  severe pain in the chest which may reach the left arm;  breathlessness;  any unusual, severe, or long-lasting headache or worsening of migraine;  partial or complete loss of vision, or double vision;  slurring or speech disability;  sudden changes to your hearing, sense of smell, or taste;  dizziness or fainting;  weakness or numbness in any part of your body;  severe pain in your abdomen;  severe pain or swelling in either of your legs. Signs of a severe allergic reaction or worsening of hereditary angioedema: V034_1 14  swelling of the hands, face, lips, mouth, tongue or throat. A swollen tongue/throat may lead to difficulty swallowing and breathing  a red bumpy rash (hives) and itching. Signs of breast cancer include:  dimpling of the skin  changes in the nipple  any lumps you can see or feel. Signs of cancer of the cervix include:  vaginal discharge that smells and/or contains blood  unusual vaginal bleeding  pelvic pain  painful sex. Signs of severe liver problems include:  severe pain in your stomach  yellow skin or eyes (jaundice)  inflammation of the liver (hepatitis)  your whole body starts itching. → If you think you may have any of these, see a doctor straight away. You may need to stop taking Dianette. 4.2 Less serious side effects

Common side effects (may affect up to 1 in 10 people)  feeling sick  stomach ache  putting on weight  headaches  depressive moods or mood swings  sore or painful breasts

Uncommon side effects (may affect up to 1 in 100 people)  being sick and stomach upsets  fluid retention  migraine  loss of interest in sex  breast enlargement  skin rash, which may be itchy

Rare side effects (may affect up to 1 in 1,000 people)  poor tolerance of contact lenses  losing weight  increase of interest in sex  vaginal or breast discharge V034_1 15  venous blood clot → Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Dianette. Also tell them if any existing conditions get worse while you are taking Dianette. 4.3 Bleeding between periods should not last long A few women have a little unexpected bleeding or spotting while they are taking Dianette, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Dianette as usual. The problem should disappear after the first few strips. You may also have unexpected bleeding if you are not taking your pills regularly, so try to take your pill at the same time every day. Also, unexpected bleeding can sometimes be caused by other medicines. → Make an appointment to see your doctor if you get breakthrough bleeding or spotting that:  carries on for more than the first few months  starts after you’ve been taking Dianette for a while  carries on even after you’ve stopped taking Dianette.

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Diane-35

Keep all medicines out of the reach and sight of children. Do not store above 25°C. Do not use Dianette after the expiry date shown on the strip. Do not throw away any medicines down a drain or into a bin. Ask your pharmacist what to do with any medicines you do not want. This will help to protect the environment.

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2 to 3 weeks on average

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