Patient leaflet - Co-cyprindiol 2000/35 coated tablets

1. What Co – Cyprindol is and what it is used for

Co – Cyprindiol contains an oestrogen and an anti-androgen. Co – Cyprindiol 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 Co – Cyprindiol if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics.

If you are taking Co – Cyprindiol 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 Co – Cyprindiol, 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 say produce too much sebum. This can block the grease glands, which can become infected and inflamed causing acne spots. Co – Cyprindiol stops the androgens affecting your skin and reduces the amount of androgens produced.

Contraception

Co – Cyprindiol is a 21-day Pill – you take one each day for 21 days, followed by 7 days when you take no pills.

Co – Cyprindiol will not protect you against sexually transmitted infections, such as Chlamydia or HIV. Only condoms can help to do this.

Co – Cyprindiol needs to be taken as directed to prevent pregnancy

2. What you need to know before you take Co – Cyprindiol

2.1. Before you take Co – Cyprindiol

It’s important that you understand the benefits and risks of taking Co – Cyprindiol before you start taking it, or when deciding whether to carry on taking it. Although Co – Cyprindiol 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 Co – Cyprindiol

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 Co – Cyprindiol

You will need regular check-ups with your doctor, usually when you
need another prescription of Co – Cyprindiol .
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 Co – Cyprindiol,
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 Co – Cyprindiol at least 4 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 Co – Cyprindiol again.
If you need to stop taking Co – Cyprindiol, remember to use another
contraceptive (e.g. condoms) if you are relying on Co – Cyprindiol for contraception.

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 in section 2 ‘Blood clots (Thrombosis)’ and in Section 4.

Co-cyprindiol 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 Co-cyprindiol 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 Co-cyprindiol compared with women who do not take Co-cyprindiol 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 Co – Cyprindiol.

Of 100,000 women who are not taking Co – Cyprindiol, 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 Co – Cyprindiol 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 Co-cyprindiol 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 Co-cyprindiol, as the treatment may have to be stopped. Your doctor may tell you to stop using Co-cyprindiol atleast 4 weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Co-cyprindiol 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 Co-cyprindiol 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;
PACKAGE LEAFLET: INFORMATION FOR THE USER
Co - Cyprindiol 2000/35 Coated Tablets
(cyproterone acetate / ethinylestradiol)
- 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 Co-cyprindiol.

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).

Co-cyprindiol 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 Co-cyprindiol also provide the same protective effects. However, it also seems that taking Co-cyprindiol slightly increases your risk of cancer of the cervix – although this may be due to having sex without a condom, rather than Co-cyprindiol. All women should have regular smear tests.

If you have breast cancer, or have had it in the past, you should not take Co-cyprindiol or other oral contraceptives, as they slightly increase your risk of breast cancer. This risk goes up the longer you’re on Co-cyprindiol, 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 Co-cyprindiol users is small. For example:

Of 10,000 women who have never taken Co-cyprindiol or the Pill, about 16 will have breast cancer by the time they are 35 years old.
Of 10,000 women who take Co-cyprindiol 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 Co-cyprindiol or the Pill, about 100 will have breast cancer by the time they are 45 years old.
Of 10,000 women who take Co-cyprindiol 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 Co-cyprindiol has also been linked to liver diseases, such as jaundice and noncancer liver tumours, but this is rare. Very rarely, Co-cyprindiol 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 Co-cyprindiol.

For high doses (25mg and above) of cyproterone acetate an increased risk of benign brain tumour (meningioma) has been reported. If you are diagnosed with meningioma, your doctor will stop all cyproterone containing products, including Co-cyprindiol as a precautionary measure (see section 2.2 ‘Make sure Co-cyprindiol is ok for you’)

2.2. Make sure Co – Cyprindiol is OK for you Co-cyprindiol should not be taken by some women

→ Tell your doctor if you have any medical problems or illnesses. Do not use Co-cyprindiol Tell your doctor if any of the following conditions applies to you before starting to use Co-cyprindiol. 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
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 ‘ministroke’ (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 have meningioma or have ever been diagnosed with a meningioma (a generally benign tumour of the tissue layer between the brain and the skull)
If you are allergic (hypersensitive) to any of the ingredients in
Co-cyprindiol.

→ If you suffer from any of these, or get them for the first time while taking Co-cyprindiol, contact your doctor as soon as possible. Do not take Co-cyprindiol. If needed, use another form of contraception.

Co-cyprindiol can make some illnesses worse

Some of the conditions listed below can be made worse by taking Co-cyprindiol. Or they may mean it is less suitable for you. You may still be able to take Co-cyprindiol 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 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 ‘Co-cyprindiol and sun-beds or sun-lamps’)
If you have any illness that worsened during pregnancy or previous use of the Pill or Co-cyprindiol (see section 4)
If you experience symptoms of angioedema such as swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing contact a doctor immediately. Products containing estrogens may cause or worsen the symptoms of hereditary and acquired angioedema.

Co-cyprindiol may increase the risk of gallstone formation and may worsen existing disease

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

Psychiatric disorders:

Some women using hormonal contraceptives including Co-cyprindiol have reported depression or depressed mood. Depression can be serious and may sometimes lead to suicidal thoughts. If you experience mood changes and depressive symptoms contact your doctor for further medical advice as soon as possible.

Taking other medicines

Always tell your doctor which medicines or herbal products you are already using. Also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that you take Co-cyprindiol. They can tell you if you need to take additional contraceptive precautions (for example condoms) and if so, for how long, or, whether the use of another medicine you need must be changed.

Also check the leaflets that come with all your medicines to see if they can be taken with hormonal contraceptives.

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

Some medicines:

can have an influence on the blood levels of Co-cyprindiol and
can make it less effective in preventing pregnancy, or
can cause unexpected bleeding

These include:

medicines used for the treatment of
- epilepsy (e.g. primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine)
- tuberculosis (e.g. rifampicin)
- HIV and Hepatitis C Virus infections (so-called protease inhibitors and nonnucleoside reverse transcriptase inhibitors, such as ritonavir, nevirapine, efavirenz)
- Fungal infections (e.g. griseofulvin, ketoconazole)
- arthritis, arthrosis (etoricoxib)
- high blood pressure in the blood vessels in the lungs (bosentan)
the herbal remedy St. John's wort

If you do need to take one of these medicines, Co-cyprindiol 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 Co - Cyprindiol Tabs_Package Leaflet

180 mm

how long.

Co-cyprindiol may influence the effect of other medicines, e.g.

medicines containing ciclosporin
the anti-epileptic lamotrigine (this could lead to an increased
frequency of seizures)
theophylline (used to treat breathing problems)
tizanidine (used to treat muscle pain and/or muscle cramps).

Your doctor may need to adjust the dose of your other medicine. In addition, Co-cyprindiol can also interfere with the results of some blood tests, so always tell your doctor that you are taking Co-cyprindiol if you have a blood test.

Do not use Co-cyprindiol if you have hepatitis C and are taking the medicinal products containing ombitasvir / paritaprevir / ritonavir, dasabuvir, glecaprevir/ pibrentasvir or sofosbuvir / velpatasvir / voxilaprevir as these products may cause increases in liver function blood test results (increase in ALT liver enzyme). Your doctor will prescribe another type of contraceptive prior to start of the treatment with these medicinal products. Co-cyprindiol can be restarted approximately 2 weeks after completion of treatment. See section ‘Do not use Co-cyprindiol …’.

Taking Co-cyprindiol with food and drink

There are no special instructions about food and drink while on Co-cyprindiol.

Pregnancy and breast-feeding

Do not use as Co – Cyprindiol 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 as Co – Cyprindiol.

Driving and using machines

There are no known effects of Co-cyprindiol on the ability to drive or use machines.

Co – Cyprindiol contains lactose and sucrose

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before using Co – Cyprindiol.

Co – Cyprindiol 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 Co – Cyprindiol. Their use increases the chance of chloasma, a patchy discolouration of the skin (as it does with ordinary oral contraceptives).

3. How to take Co-Cyprindiol

Always take Co – Cyprindiol exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. If you are relying on this medicine for contraception, it is important that you follow these instructions carefully.

Duration of use

Your doctor will tell you how long you need to keep taking Co – Cyprindiol.

How to take it

Take Co – Cyprindiol every day for 21 days

Co – Cyprindiol 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. Your seven pill-free days.

After you have taken all 21 tablets, you have 7 days when you take no tablets. A few days after you have taken the last pill from each pack, you will have 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 Co – Cyprindiol 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.

Taking your next pack of Co – Cyprindiol

Start taking your next strip of Co – Cyprindiol 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 Co – Cyprindiol correctly, you will always start each new strip on the same day of the week.

Starting Co – Cyprindiol

New users or starting Co – Cyprindiol after a break

It is best to take your first Co – Cyprindiol pill on the first day of your next period. By starting in this way, you will have contraceptive protection with your first pill.

Changing from another type of oral contraceptive

➔ If you are currently taking a 21-day Pill: start Co – Cyprindiol 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 Co – Cyprindiol.

➔ If you are taking a 28-day Pill: start taking Co – Cyprindiol 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 Co

Cyprindiol.

➔ If you are taking a progestogen-only Pill (POP or ‘mini Pill’): start Co

Cyprindiol 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 Co – Cyprindiol after a miscarriage or an 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 Co – Cyprindiol 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.

Starting Co – Cyprindiol after having a baby

If you have just had a baby, your doctor may advise you to start taking Co –Cyprindiol 21 days after delivery. You do not have to wait for a period. You will need to use another method of contraception until you start Co – Cyprindiol and for the first 7 days of pill taking. Follow the instructions as before (see “Taking your first pack of Co – Cyprindiol”). You must not breastfeed if you take Co –Cyprindiol.

Do not take Co – Cyprindiol 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.
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.

What should I do if I lose a pill? [A lost pill]

If you lose a pill, the easiest thing to do is to take the last pill of the pack in place of the lost pill. Then take all the pills on their proper days. Your cycle will be one day shorter than normal, but contraceptive protection will not be affected. After your 7 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.

What should I do if I have stomach upsets?

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 Co – Cyprindiol, follow the instructions in section, A lost pill, which describes how to take another pill.

If you are still sick or have diarrhoea more than 12 hours after taking Co – Cyprindiol, see section, 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 Co – Cyprindiol 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 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 Co – Cyprindiol 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.

4. Possible side effects

Like all medicines, Co-cyprindiol 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 Co-cyprindiol, 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 Co-cyprindiol”.

The following is a list of the side effects that have been linked with the use of Co-cyprindiol:

4.1 Serious side effects – see a doctor straight away

Severe depression:

Although, it is not considered a direct side effect of Co-cyprindiol, you should stop Co-cyprindiol as a precaution, if you develop severe depression, and see your doctor straight away. In very rare cases this has been associated with thoughts of ending their lives.

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.

Contact a doctor immediately if you experience any of the following symptoms of angioedema: swollen face, tongue and/or throat and/or difficulty swallowing or hives potentially with difficulty breathing (see also section “WHAT YOU NEED TO KNOW BEFORE YOU TAKE CO-CYPRINDIOL”).

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 difficultyswallowing 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 Co-cyprindiol.

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
venous blood clot

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

4.3 Bleeding between periods should not last long

A few women have a little unexpected bleeding or spotting while they are taking Co-cyprindiol, especially during the first few months. Normally, this bleeding is nothing to worry about and will stop after a day or two. Keep taking Co-cyprindiol 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 Co-cyprindiol for a while
carries on even after you’ve stopped taking Co-cyprindiol.

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.

5. How to store Co-Cyprindiol

Keep out of the reach and sight of children.

Do not store above 25°C

Store in the original package. Do not use Co – Cyprindiol after the expiry date which is stated on the carton and blister strip.

Medicines should not be disposed of via wasterwater 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 Co – Cyprindiol contains

The active substances are cyproterone acetate and ethinylestradiol The other ingredients are:

Tablet core: Lactose monohydrate, Maize starch, Povidone K25, Talcum, Magnesium stearate

Tablet coating: Sucrose, Calcium carbonate, Talcum, Titanium dioxie (E 171), Povidone K90, Macrogol 6000, Glycerol 85%, Iron oxide pigment, Montan glycol wax.

What Co – Cyprindiol Iooks like and contents of the pack.

Co – Cyprindiol tablets are round, yellow sugar-coated tablets. Each pack of Co– Cyprindiol contacts three blister strips each with 21 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

Strandhaven Limited T/A Somex Pharma,

High Road, Seven Kings, Ilford,

Essex, IG 8BS, UK

Manufacturer

Somex Pharma,

Ilford, Essex,

IG3 8RA, UK

Active substance	Ethinylestradiol
Pharmaceutical form	Round, biconvex, yellow sugar-coated tablets with a 5.7mm nominal diameter.
Excipients	Lactose monohydrate, maize starch, povidone K25, talcum, magnesium stearate, sucrose, calcium carbonate, polyethylene glycol 6000, Povidone K90 titanium dioxide (E 171), glycerol 85%, montan glycol wax, iron oxide pigment.
Shelf life	36 months
Storage	Store in the original package
Marketing authorisation	PL 15764/0011 (first authorised 28 August 2025)
Marketing authorisation holder	Strandhaven Limited

Co-cyprindiol 2000/35 coated tablets – patient leaflet, side effects, dosage