DIANE - 35 is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. These include patients with polycystic ovary syndrome, who require treatment for these symptoms. DIANE - 35 is a hormonal contraceptive (the “Pill”). Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate as well. You should only take DIANE - 35, if your doctor considers that other anti-acne treatments, including topical treatments and antibiotics, are inappropriate. Each of the 21 beige coated tablet contains the hormones ethinylestradiol and cyproterone acetate.
1. What DIANE - 35 is and what it is used for
2. What you need to know before you take DIANE - 35
General notes
Before you can begin taking DIANE - 35, your doctor will ask you some questions about your personal health history and that of your close relatives. The doctor will also measure your blood pressure and, depending upon your personal situation, may also carry out some other tests. In this leaflet, several situations are described where you should stop using DIANE - 35, or where the reliability of DIANE - 35 may be decreased. In such situations you should either not have sex or you should take extra non-hormonal contraceptive precautions, e.g. use a condom or another barrier method.
Do not use rhythm or temperature methods. These methods can be unreliable because DIANE - 35 alters the monthly changes of body temperature and cervical mucus. DIANE - 35 does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
Do not take DIANE - 35
Do not use DIANE - 35 if you have any of the conditions listed below. If any of these apply to you, tell your doctor before starting to use DIANE - 35
• if you are allergic (hypersensitive) to ethinylestradiol, cyproterone acetate or any of the other ingredients in DIANE - 35. This may cause, for example, itching, rash or swelling
• if you have (or have ever had) a blood clot in your leg (thrombosis), lung (pulmonary embolism) or other part of your body
• if you have (or have ever had) a heart attack or stroke
• if you have (or have ever had) a disease that may be an indicator of a heart attack in the future (e.g angina pectoris which cases severe pain in the chest) or ‘mini-stroke’ (transient ischaemic attack)
• if you have (or have ever had) a migraine, with visual disturbances, speech disability or weakness or numbness in part of your body.
• if you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions:
o diabetes affecting your blood vessels.
o very high blood pressure.
o a very high level of fat in your blood (cholesterol or triglycerides)
• if you have problems with blood clotting (e.g. protein C deficiency)
• if you have (or have ever had) liver disease (symptoms of which may be yellowing of the skin or itching over the whole body) and your liver is still not working normally
• if you are taking any antiviral medicines which contain ombitasvir, paritaprevir, or dasabuvir, or any combinations of these. These antiviral medicines are used to treat chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus).
• if you have (or have ever had) a cancer that may grow under the influence of sex hormones (e.g. of the breast or the genital organs)
• if you have (or have ever had) a benign or malignant tumour of the liver
• if you have any unexplained bleeding from the vagina
• if you are using another hormonal contraceptive
• if you are pregnant or think you might be pregnant
• if you are breast-feeding
If any of these conditions appear for the first time while using DIANE - 35, stop taking it at once and consult your doctor. In the meantime, use non-hormonal contraceptive measures. See also ‘General notes’. DIANE - 35 is not for use in men.
3. How to take DIANE - 35
DIANE - 35 is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. The dose regimen of DIANE - 35 is similar to the regimen of most of the usual contraceptive Pills. Thus, the same administration rules must be considered. The irregular intake of DIANE - 35 can lead to intermenstrual bleedings and could lessen the therapeutic and contraceptive reliability. The DIANE - 35 pack contains 28 tablets. Follow the direction of the arrows until all 28 tablets have been taken. Take your tablet at about the same time each day, with some liquid if necessary. Usually a period will start while you are taking tablets from the silver section (i.e. on day 2 - 3 after the last hormone-containing beige DIANE - 35 tablet). Do not leave a gap between packs, i.e. start taking your next pack on the day after you have finished the current one, even if your period continues. This means that you will always start new packs on the same day of the week, and also that you have your withdrawal bleed on about the same days every month.
When can you start with the first pack?
If you have not used a contraceptive with hormones during the previous month, wait for your next period to occur. Start with DIANE - 35 on the first day of the cycle (= 1st day of bleeding) from the silver section of the pack and select the right tablet for that day of the week (e.g. “M O” for Monday). During the first cycle, you must use extra protective measures (for example, a condom) for the first 14 days of DIANE - 35 use.
Changing from another combined hormonal contraceptive pill, or combined contraceptive vaginal ring or patch.
You can start taking DIANE - 35 the day after you take the last tablet from your present Pill pack (this means no tablet-free break). If your present Pill pack also contains hormone-free tablets you can start DIANE - 35 on the day after taking the last tablet containing hormones (if you are not sure which this is, ask your doctor or pharmacist). In case you have used a vaginal ring or transdermal patch, start using DIANE - 35 on the day of removal of the last ring or patch of a cycle pack. If you follow these instructions, it is not necessary to use an additional contraceptive method.
Changing from a progestogen-only method (progestogen-only pill, injection, implant or a progestogen-releasing intrauterine system ‘IUS’).
You may switch from the progestogen-only pill any day (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due) but in all of these cases you must use extra protective measures (for example, a condom) during the first 14 days of DIANE - 35 use.
After a miscarriage.
Follow the advice of your doctor, but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking.
After having a baby.
If you have just had a baby, your doctor may tell you to wait until after your first normal period before you start taking DIANE - 35. Sometimes it is possible to start sooner. Your doctor will advise you, but remember to use extra protective measures (for example, a condom) during the first cycle for the first 14 days of tablet-taking. If, after having a baby, you have had sex before starting DIANE - 35, be sure that you are not pregnant or wait until the next menstrual period. If you want to start DIANE - 35 after having a baby and are breastfeeding, discuss this first with your doctor.
If you take more DIANE - 35 than you should
There are no reports of serious harmful effects of taking too many DIANE - 35 tablets. If you take several hormone-containing tablets at once, you may feel sick or vomit or may bleed from the vagina. Even girls who have not yet started to menstruate but have accidentally taken this medicine may experience such bleeding.
4. Possible side effects
DIANE - 35 can have side effects. Not all side effects reported for DIANE - 35 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DIANE - 35, please consult your health care provider for advice.
Frequent side effects:
• nausea
• abdominal pain
• weight gain
• headache
• depressed or altered mood
• breast pain including breast tenderness
Less frequent side effects:
• vomiting
• diarrhoea
• fluid retention
• migraine
• reduced interest in sex or increased interest in sex
• breast enlargement
• vaginal discharge
• breast discharge
• rash
• urticaria (hives)
• erythema nodosum or multiforme (skin disorders)
• venous blood clot
• contact lens intolerance
• allergic reactions (hypersensitivity)
• weight loss
If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA via the “6.04 Adverse Drug reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DIANE - 35.
5. How to store DIANE - 35
Keep this medicine out of the sight and reach of children. Store at or below 30 °C. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).