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Acnocin 2000/35 Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SZ00000LT000

Acnocin® (Co-cyprindiol) 2000/35 Tablets


Cyproterone acetate/Ethinylestradiol

^ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor, pharmacist or nurse.

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4


What is in this leaflet:

1.    What Acnocin® is and what it is used for

2.    What you need to know before you take Acnocin®

3.    How to take Acnocin®

4.    Possible side effects

5.    How to store Acnocin®

6.    Contents of the pack and other information


A SANDOZ


1    What Acnocin® is and what it is used for


Acnocin® 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 Acnocin® if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics.


What you need to know before you take Acnocin®


It’s important that you understand the benefits and risks of taking Acnocin® before you start taking it, or when deciding whether to carry on taking it. Although Acnocin®is suitable for most healthy women it isn’t suitable for everyone.

^ Tell your doctor if you have any of the illnesses or risk factors mentioned in this leaflet.

Before you start taking Acnocin®

•    Your doctor will ask about you and your family’s medical problems and check your blood pressure and exclude the likelihood of you being pregnant. You may also need other checks, such as a breast examination, but only if these examinations are necessary for you or if you have any special concerns.

While you’re on Acnocin®

•    You will need regular check-ups with your doctor, usually when you need another prescription of Acnocin®.

•    You should go for regular cervical smear tests.

   Check your breasts and nipples every month for changes - tell your doctor if you can see or feel anything odd, such as lumps or dimpling of the skin.

•    If you need a blood test tell your doctor that you are taking Acnocin®, because this type of medicine can affect the results of some tests.

•    If you’re going to have an operation, make sure your doctor knows about it. You may need to stop taking Acnocin® about

4-6 weeks before the operation. This is to reduce the risk of a blood clot (see section 2.1). Your doctor will tell you when you can start taking Acnocin® again.

   If you need to stop taking Acnocin®, remember to use another contraceptive (e.g. condoms) if you are relying on Acnocin® for contraception.

Do not take Acnocin®

Tell your doctor if any of the following conditions applies to you before starting to use Acnocin®. Your doctor may then advise you to use a different treatment:

•    If you are using another hormonal contraceptive

•    If you are pregnant or might be pregnant

•    If you are breast-feeding

•    If you have or have ever had breast cancer or cancer of the womb

•    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 disease that may be an indicator of a heart attack in the future (e.g. angina pectoris which causes severe pain in the chest) or ‘mini-stroke’ (transient ischaemic attack)

•    If you have (or have ever had) a heart attack or stroke.

•    If you have a condition that may increase the risk of a blood clot in your arteries. This applies to the following conditions:

-    diabetes affecting your blood vessels

-    very high blood pressure

-    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) a migraine, with visual disturbances

•    If you have ever had a severe liver disease, and you have been told by your doctor that your liver test results are not yet back to normal

•    If you have ever had liver tumours

•    If you are allergic to Cyproterone acetate/ethinylestradiol or any of the ingredients of this medicine listed in section 6).

•    If you have any liver disease

•    If you have blood disease called porphyria

•    If you have abnormal bleeding from your vagina of unknown cause ^ If you suffer from any of these, or get them for the first time while taking Acnocin®, contact your doctor as soon as possible. Do not take Acnocin®. If needed, use another form of contraception.

Acnocin® is not for use in men.

Warnings and precautions

When should you contact your doctor

Stop taking tablets and contact your doctor immediately if you notice possible signs of a blood clot. The symptoms are described below in ‘Blood clots (Thrombosis)’ and in Section 4.

Acnocin® also works as an oral contraceptive. You and your doctor will have to consider all the things that would normally apply to the safe use of oral hormonal contraceptives.

Blood clots (thrombosis)

Taking Acnocin® may slightly increase your risk of having a blood clot (called a thrombosis). Your chances of having a blood clot are only increased slightly by taking Acnocin® compared with women who do not take Acnocin® or any contraceptive pill. A full recovery is not always made and in 1-2% of cases, can be fatal.

Blood clots in a vein

A blood clot in a vein (known as a ‘venous thrombosis’) can block the vein. This can happen in veins of the leg, the lung (a lung embolus), or any other organ.

Using a combined pill increases a woman’s risk of developing such clots compared with a woman not taking any combined pill. The risk of developing a blood clot in a vein is highest during the first year a woman uses the pill. The risk is not as high as the risk of developing a blood clot during pregnancy.

Your chances of having a blood clot are only increased slightly by taking cyproterone acetate/ethinylestradiol.

•    Of 100,000 women who are not taking cyproterone acetate/ethinylestradiol, not on the Pill and not pregnant, about 5 to 10 will have a blood clot in a year.

•    Of 100,000 women who take cyproterone acetate/ethinylestradiol or the Pill, up to 40 will have a blood clot in a year.

•    Of 100,000 women who are pregnant, around 60 will have a blood clot in a year

•    The risk of blood clots in a vein in users of a combined pill increases further:

•    with increasing age;

•    if you smoke.

When using a hormonal contraceptive like Acnocin® you are strongly advised to stop smoking, especially if you are older than 35 years;

•    if one of your close relatives has had a blood clot in the leg, lung or other organ at a young age;

•    if you are overweight;

•    if you must have an operation, or if you are off your feet for a long time because of an injury or illness, or you have your leg in a plaster cast;

•    if you have polycystic ovary syndrome;

•    if you have recently had a baby;

•    if you have certain rare medical conditions such as systemic lupus erythematosus, Crohn’s disease or ulcerative colitis;

•    if you have sickle cell disease.

If this applies to you, it is important to tell your doctor that you are using Acnocin®, as the treatment may have to be stopped. Your doctor may tell you to stop using Acnocin® several weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Acnocin® again after you are back on your feet.

Blood clots in an artery

A blood clot in an artery can cause serious problems. For example, a blood clot in an artery in the heart may cause a heart attack, or in the brain may cause a stroke.

The use of a combined pill has been connected with an increased risk of clots in the arteries. This risk increases further:

•    with increasing age;

•    if you smoke.

When using a hormonal contraceptive like Acnocin® you are strongly advised to stop smoking, especially if you are older than 35 years;

•    if you are overweight;

•    if you have high blood pressure;

•    if a close relative has had a heart attack or stroke at a young age;

•    if you have a high level of fat in your blood (cholesterol or triglycerides);

•    if you get migraines;

•    if you have a problem with your heart (valve disorder, disturbance of the rhythm);

•    if you have polycystic ovary syndrome;

•    if you have diabetes;

•    if you have certain rare medical conditions such as systemic lupus erythematosus;

•    if you have sickle cell disease.


Symptoms of blood clots

Stop taking tablets and see your doctor immediately if you notice possible signs of a blood clot, such as:

•    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.

Following a blood clot, recovery is not always complete. Rarely serious permanent disabilities may occur or the blood clot may even be fatal. Directly after giving birth, women are at an increased risk of blood clots so you should ask your doctor how soon after delivery you can start taking Acnocin®.

See a doctor straight away if you also develop severe depression, a severe allergic reaction, worsening of hereditary angioedema, signs of breast cancer or cervical cancer or signs of severe liver problems (symptoms and signs are described in section 4).

Cyproterone acetate/ethinylestradiol and cancer

While high dose COCs reduce your risk of cancer of the ovary and womb if used in the long term, it is not clear whether lower dose oestrogen-progestogen containing Pills like cyproterone acetate/ethinylestradiol also provide the same protective effects. However, it also seems that taking cyproterone acetate/ethinylestradiol slightly increases your risk of cancer of the cervix - although this may be due to having sex without a condom, rather than cyproterone acetate/ethinylestradiol All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take cyproterone acetate/ethinylestradiol or other oral contraceptives, as they slightly increase your risk of breast cancer. This risk goes up the longer you’re on cyproterone acetate/ethinylestradiol but returns to normal within about 10 years of stopping it. Because breast cancer is rare in women under the age of 40, the extra cases of breast cancer in current and recent cyproterone acetate/ethinylestradiol users is small. For example:

•    Of 10,000 women who have never taken cyproterone acetate/ethinylestradiol or the Pill, about 16 will have breast cancer by the time they are 35 years old.

•    Of 10,000 women who take cyproterone acetate/ethinylestradiol or the Pill for 5 years in their early twenties, about 17-18 will have breast cancer by the time they are 35 years old.

•    Of 10,000 women who have never taken cyproterone acetate/ethinylestradiol or the Pill, about 100 will have breast cancer by the time they are 45 years old.

•    Of 10,000 women who take cyproterone acetate/ethinylestradiol or the Pill for 5 years in their early thirties, about 110 will have breast cancer by the time they are 45 years old.

Your risk of breast cancer is higher:

•    if you have a close relative (mother, sister or grandmother) who has had breast cancer

•    if you are seriously overweight

^ See a doctor as soon as possible if you notice any changes in your breasts, such as dimpling of the skin, changes in the nipple or any lumps you can see or feel.

•    Taking cyproterone acetate/ethinylestradiol has also been linked to liver diseases, such as jaundice and non-cancer liver tumours, but this is rare. Very rarely cyproterone acetate/ethinylestradiol has also been linked with some forms of liver cancer in women who have taken it for a long time.

^ See a doctor as soon as possible if you get severe pain in your stomach, or yellow skin or eyes (jaundice). You may need to stop taking Acnocin®.

Malignant tumours may be life-threatening and, in some cases, may be fatal.

If you have hereditary angioedema.

Consult your doctor immediately if you experience symptoms of angioedema such as swollen face, tongue or throat, and/or difficulty swallowing, or hives, together with difficulty breathing. Products containing estrogens may induce or worsen symptoms of angioedema.

Make sure Acnocin® is OK for you

Acnocin® should not be taken by some women

^ Tell your doctor if you have any medical problems or illnesses.

Cyproterone acetate/ethinylestradiol can make some illnesses worse

Some of the conditions listed below can be made worse by taking cyproterone acetate/ethinylestradiol. Or they may mean it is less suitable for you. You may still be able to take Acnocin® but you need to take special care and have check-ups more often.

•    If you or your close family have ever had problems with your heart or circulation, such as high blood pressure

•    If you or your close family have ever had problems with blood clotting

•    If you have had migraines

•    If you are currently suffering from depression or have done so in the past

•    If you are overweight (obese)

•    If you have the inherited disease called porphyria

•    If you have diabetes

•    If you have a disease of the liver or the gallbladder

•    If you have epilepsy (see Acnocin® and using other medicines”)

•    If you have Crohn’s disease or inflammatory bowel disease

(ulcerative colitis)

•    If you have inflammation of the pancreas (pancreatitis), or a history or family history of high levels of fat in your blood (hypertriglyceridemia), as you may be at risk of developing pancreatitis

•    If you have brown patches on your face or body (chloasma)

(see below Acnocin® and sun-beds or sun-lamps’)

•    If you have any illness that worsened during pregnancy or previous use of the Pill or Acnocin® (see section 4)

^ Tell your doctor if any apply to you. Also tell them if you get any of these for the first time while taking Acnocin®, or if any get worse or come back, because you may need to stop taking it.

Other medicines and Acnocin®

If you ever need to take another medicine at the same time as taking Acnocin®, always tell your doctor, pharmacist or dentist that you’re taking Acnocin®. Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.

If you are taking Acnocin® for skin treatment, you must not take any other hormonal contraceptive at the same time.

Some medicines can stop Acnocin® from working properly - for example:

•    some medicines used to treat epilepsy

•    some medicines used to treat HIV

•    griseofulvin (an anti-fungal medicine), rifampicin

•    certain sedatives (called barbiturates)

•    St. John’s Wort (a herbal remedy).

If you do need to take one of these medicines, Acnocin® may not be suitable for you or you may need to use extra contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.

Acnocin® can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medicine.

In addition, cyproterone acetate/ethinylestradiol can also interfere with the results of some blood tests, so always tell your doctor that you are taking Acnocin® if you have a blood test.

Acnocin® with food and drink

There are no special instructions about food and drink while on Acnocin®.

Pregnancy and breast-feeding

Do not use Acnocin® if you are pregnant or are breast-feeding. If

you think you might be pregnant, do a pregnancy test to confirm that you are before you stop taking Acnocin®.

Driving and using machines

Acnocin® has no known effect on the ability to drive or use machines. Acnocin® contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before using Acnocin®.

Acnocin® and sun-beds or sun-lamps

Sun-lamps are used by some women for acne as well as to tan the skin. This is not a very useful treatment for acne. Do not use sun-beds or sun-lamps and avoid prolonged sunbathing if you are taking cyproterone acetate/ethinylestradiol. Their use increases the chance of chloasma, a patchy discolouration of the skin (as it does with ordinary oral contraceptives).


3    How to take Acnocin®


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor has chosen Acnocin® as a treatment for your acne or excessive hair growth on your face and body. However, Acnocin® also has a contraceptive effect, so it is important to follow the advice below if you are relying on Acnocin® for contraception.

If you are only using Acnocin® 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 Acnocin®.

The length of use depends on the severity of your symptoms and how they respond to treatment. In general, treatment should be carried out over several months. It is recommended to take Acnocin® for at least another 3 to 4 cycles after the signs have lessened. If the symptoms come back, weeks or months after stopping Acnocin®, treatment with Acnocin® may be re-started. However,), the increased risk of blood clots following a break of 4 or more weeks should be considered (see also the section Acnocin® and blood clots’).

How to take it

Take Acnocin® every day for 21 days

Acnocin® 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 Acnocin® 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 Acnocin® 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 Acnocin® correctly, you will always start each new strip on the same day of the week.

Starting Acnocin®

New users or starting Acnocin® after a break

It is best to take your first Acnocin® 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 Acnocin® from another contraceptive Pill

   If you are currently taking a 21-day Pill: start Acnocin® 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 Acnocin®.

   If you are taking a 28-day Pill: start taking Acnocin® 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 Acnocin®.

   If you are taking a progestogen-only Pill (POP or mini Pill ): start Acnocin® 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 Acnocin® 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 Acnocin® 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 Acnocin® 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 Acnocin® and for the first 7 days of pill taking.

Do not take Acnocin® if you are breast-feeding

If you forget to take Acnocin®

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.

•    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 pill-free 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 Acnocin®, follow the instructions in section 3. A lost pill, which describes how to take another pill.

If you are still sick or have diarrhoea more than 12 hours after taking Acnocin®, see section 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 Acnocin® and see your doctor.

If you take more Acnocin® than you should

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 have some vaginal 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 Acnocin® 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.

If you stop taking Acnocin®

You can stop taking Acnocin® whenever you want.

Ask your doctor for advice about other reliable methods of birth control if you do not want to become pregnant.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


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:

•    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 Acnocin®.

Less serious side effects

Common side effects (between 100 and 1000 in every 10,000 users may be affected)

   feeling sick

•    stomach ache

•    putting on weight

•    headaches

•    depressive moods or mood swings

   sore or painful breasts

Uncommon side effects (between 10 and 100 in every 10,000 users may be affected)

•    being sick and stomach upsets

•    fluid retention

•    migraine

•    loss of interest in sex

•    breast enlargement

•    skin rash, which may be itchy

Rare side effects (between 1 and 10 in every 10,000 users may be affected)

•    poor tolerance of contact lenses

•    losing weight

•    increase of interest in sex

•    vaginal or breast discharge

•    venous blood clot

   hypersensitivity (rash, itching, hives, difficulty breathing or swallowing, dizziness)

   erythema nodosum (rash with painful red lumps, pain in joints and muscles)

   erythema multiforme (rash, skin reddening, blistering of lips, eyes or mouth, skin peeling)

Frequency not known (cannot be estimated from the available data)

•    bleeding and spotting between your periods can sometimes occur for the first few months but this usually stops once your body has adjusted to Acnocin®. If it continues, becomes heavy or starts again, contact your doctor

•    chloasma (yellow brown patches on the skin). This may happen even if you have been using cyproterone acetate/ethinylestradiol for a number of months. Chloasma may be reduced by avoiding too much sunlight and/or UV lamps

•    occurence or deterioration of the movement disorder chorea

•    Crohn’s disease or ulcerative colitis.

•    Increase in blood pressure

•    Hypertrigliceridemia (high level of triglycerides in the blood) Conditions that may worsen during pregnancy or previous use of the Pill:

•    yellowing of the skin (jaundice)

•    persistent itching (pruritus)

•    kidney or liver problems

•    gall stones

•    certain rare medical conditions such as systemic lupus erythematosus

•    blister-like rash (herpes gestationis) whilst pregnant

•    an inherited form of deafness (otosclerosis)

•    a personal or family history of a form of sickle cell disease

•    swelling of body parts (hereditary angioedema)

•    an inherited disease called porphyria

•    cancer of the cervix

If you have hereditary angioedema medicines containing certain female sex hormones (estrogens) may induce or worsen the symptoms of angioedema (see section ”When to take special care with Acnocin®).

^ Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Acnocin®. Also tell them if any existing conditions get worse while you are taking Acnocin®.

Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking cyproterone acetate/ethinylestradiol, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Acnocin® 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 Acnocin® for a while

•    carries on even after you’ve stopped taking Acnocin®.

Reporting of side effects

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


5


How to store Acnocin®


Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, after EXP.

The expiry date refers to the last day of that month.

Store in the original package in order to protect from moisture Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.


6


Contents of the pack and other information


4 Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.

^ Tell your doctor or pharmacist if you are worried about any side effects which you think may be due to Acnocin®.

Serious side effects - see a doctor straight away

Severe depression:

Although, it is not considered a direct side effect of cyproterone acetate/ethinylestradiol, you should stop Acnocin® as a precaution, if you develop severe depression, and see your doctor straight away.


What Acnocin® contains

Each coated tablet contains 2 mg cyproterone acetate and 0.035 mg ethinylestradiol.

•    The active substances are cyproterone acetate and ethinylestradiol.

•    The other ingredients are:

Tablet core:

Lactose monohydrate Maize Starch Povidone K25 Talc

Magnesium Stearate (E572)

Tablet coating:

Sucrose,

Calcium Carbonate (E170)

Talc

Titanium Dioxide (E171)

Povidone K90

Polyethylene glycole 6000, Glycerol 85%

Iron Oxide yellow (E172)

Montan Glycol Wax

What Acnocin® looks like and contents of the pack

Acnocin® are yellow, biconvex, round sugar-coated tablets with a 5.6-5.8 mm nominal diameter.

The coated tablets are packed in plastic/aluminium blister each containing 21 coated tablets inserted into a carton. Each carton contains either 1, 3 or 6 blister strips.

Pack size

21,63, 126 tablets (in blisters of 21 tablets).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Sandoz Ltd.

Frimley Business Park,

Frimley,

Camberley,

Surrey,

GU16 7SR United Kingdom


This leaflet was last revised in 07/2016.


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