Co-Cyprindiol 2000/35 Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
CAMILETTE®
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.
- Keep this leaflet. You may need to read it again.
- If you have any questions or need more advice, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects become severe, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
THIS LEAFLET CONTAINS
1. What Camilette is for
2. Before you take Camilette
3. How to take Camilette
4. Possible side effects
5. How to store Camilette
6. Further information
1. WHAT CAMILETTE IS FOR
Camilette 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 Camilette if your skin condition has not improved after use of other anti-acne treatments, including topical treatments and antibiotics.
2. BEFORE YOU TAKE CAMILETTE
It’s important that you understand the benefits and risks of taking Camilette before you start taking it, or when deciding whether to carry on taking it. Although Camilette is suitable for most women, it is not suitable for everyone.
Regular medical check-ups
Before you start taking Camilette your doctor will give you a check-up to ensure that it is suitable for you to take. You will also need to return for regular check-ups with your doctor whilst you are taking Camilette.
Do not take Camilette
Tell your doctor if any of the following conditions applies to you before starting to use Camilette. Your doctor may then advise you to use a different treatment if you:
• are using another hormonal contraceptive
• are allergic (hypersensitive) to ethinylestradiol, cyproterone acetate or any of the other ingredients in Camilette, (listed in section 6 of this leaflet)
• or a close family member, (parent or sibling), have ever had a blood clot form in the veins of the legs (deep vein thrombosis) or the lungs (pulmonary embolism) or any other part of the body
• 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)
• or a close family member, (parent or sibling), have ever had a heart attack or stroke
• or a close family member, (parent or sibling), 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)
• have problems with blood clotting (e.g. protein C deficiency)
• have (or have ever had) a migraine, with visual disturbances
• suffer from sickle cell anaemia (abnormal red blood cells)
• suffer from vaginal bleeding of unknown cause
• are pregnant or think you might be pregnant
• are breast-feeding
• have had any of the following conditions whilst pregnant:
- persistent itching
- a skin rash that develops into blisters
- jaundice (yellowing of the skin and whites of the eyes)
- hearing difficulties
• have, or have ever had, cancer of the breast or of the lining of the womb (endometrium)
• have, or have ever had, liver tumours
• suffer from a type of jaundice known as Dubin-Johnson syndrome or Rotor syndrome
• have severely altered liver function (your doctor can know this by performing a blood test)
If any of these occur whilst taking Camilette, stop taking Camilette and contact your doctor as soon as possible.
Camilette can make some conditions worse
Some of the conditions listed below can be made worse by taking Camilette; others may mean Camilette is less suitable for you. While you may still be able to take Camilette, you will need to take special care and have check-ups more often.
Tell your doctor if you suffer or have previously suffered from:
• problems with your heart or circulation, including high blood pressure (hypertension)
• problems with blood clotting
• varicose veins or inflamed veins (phlebitis)
• inflammation of the pancreas (pancreatitis)
• diabetes
• high levels of fat in your blood (hypertriglyceridemia)
• obesity (being severely overweight)
• muscle cramps or spasms caused by calcium deficiency (tetany)
• a disease of the nervous system such as multiple sclerosis or Sydenham’s chorea
• fits (epilepsy)
• breast problems
• benign tumours of the womb (uterine fibroids)
• an intolerance to contact lenses
• asthma
• migraines
• depression
• brown patches on your face or body (chloasma), (see ‘Camilette and sun-beds or sun-lamps’ below)
• any illness that is likely to worsened during pregnancy:
- yellowing of the skin and whites of the eyes (jaundice)
- persistent itching (pruritus)
- kidney or liver problems
- gallstones
- a disease causing inflammation of connective tissue (systemic lupus erythematosus)
- blister-like rash (herpes gestationis) whilst pregnant
- an inherited form of deafness (otosclerosis)
- sickle cell disease
- swelling of body parts (hereditary angioedema)
- an inherited metabolic disease called porphyria
Tell your doctor if any of these apply to you. Also tell them if you get any for the first time, if any get worse or come back while taking Camilette, as you may need to stop taking it.
Camilette and Sun-Beds or Sun-Lamps
Sun-lamps are used by some women for acne as well as to tan the skin. The use of sun-beds or sun-lamps and prolonged sunbathing should be avoided when you are taking Camilette, as they increase the chance of chloasma, a patchy discolouration of the skin.
When should you contact your doctor Stop taking tablets and contact your doctor immediately if you notice possible sign of a blood clot. The symptoms are described in section 2 ‘Blood clots (Thrombosis)’.
Camilette 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 Camilette 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 Camilette compared with women who do not take Camilette 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 developing a blood clot are only slightly increased by taking Camilette;
• In healthy women who are not taking Camilette, not on the Pill and are not pregnant, about 5 - 10 in 100,000 will have a blood clot each year.
• Of those women who are taking Camilette or the Pill, up to 40 in 100,000 will have a blood clot each year.
• Of those women who are pregnant, around 60 in 100,000 will have a blood clot each 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 Camilette 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 given birth
If this applies to you, it is important to tell your doctor that you are using Camilette, as the treatment may have to be stopped. Your doctor may tell you to stop using Camilette several weeks before surgery or while you are less mobile. Your doctor will also tell you when you can start using Camillete 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 Camilette 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 sickle cell disease
• if you have diabetes
• if you have the skin disease systemic lupus erythematosus
In extremely rare cases blood clots can develop in other places such as the liver, gut, kidney or eye.
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 Camilette.
Camilette and Cancer
Whilst Camilette offers protection against cancers of the ovary and lining of the womb (endometrium), there is a slightly increased risk of cancer of the neck of the womb (cervix) with long-term use. It is uncertain as to whether this increased risk is caused by the Camilette or due to other factors such as sexual behaviour.
You should go for regular cervical smear tests.
There is also a slightly increased risk of finding breast cancer in women using Camilette and other oral contraceptives when compared with women of the same age who have never taken them.
It is uncertain whether oral contraceptives cause the increased risk of breast cancer or whether women taking them are examined more often and so the breast cancer is detected earlier.
However, it has been shown that breast cancers diagnosed in women who take oral contraceptives are less likely to have spread to other parts of their bodies, than those in women who do not take them.
While breast cancer is rare in women under 40 years of age, the risk significantly increases with increasing age. Therefore, the risk of finding breast cancer in women who have taken oral contraceptives is affected by the age at which a woman stops taking them.
Once women stop taking oral contraceptives the additional risk of breast cancer reduces and within about 10 years is the same as for women who have never taken them.
Your chances of developing breast cancer are only slightly increased by taking Camilette;
• In those women who have never taken Camilette or the Pill, about 16 in 10,000 will have breast cancer by the time they are 35 years old.
• In those women who take Camilette or the Pill for 5 years in their early twenties, about 17 to 18 in 10,000 will have breast cancer by the time they are 35 years old.
• In those women who have never taken Camilette or the Pill, about 100 in 10,000 will have breast cancer by the time they are 45 years old.
• In those women who take Camilette or the Pill for 5 years in their early thirties, about 110 in 10,000 will have breast cancer by the time they are 45 years old.
You should regularly check your breasts for any changes.
In rare cases benign liver tumours, and even more rarely malignant liver tumours have been reported in women who have taken Camilette for a long time.
The symptoms of these cancers are described in section 4 of this leaflet. If you experience any of them, see a doctor as soon as possible. Do not take any more Camilette until your doctor says you can and use another method of contraception, such as condoms, in the meantime.
Taking other medicines
Always tell your doctor or pharmacist if you are intending to take or have recently taken any other medicine at the same time as taking Camilette, even those medicines that are bought without a prescription.
In particular, tell your doctor, pharmacist or dentist if you are given any of the following medicines as they may stop Camilette from working properly as a contraceptive:
• medicines used to treat epilepsy such as carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin and topiramate
• medicines used to treat HIV such as nelfinavir, nevirapine and ritonavir
• medicines for treating fungal infections such as griseofulvin, clotrimazole, ketoconazole and tioconazole
• antibiotic medicines, used to treat bacterial infections, such as tetracyclines, rifabutin and rifampicin
• the herbal remedy, St. John’s Wort
If you are relying on Camilette for contraception and need to take one of these medicines, you may need to use an alternative non-hormonal method of contraception for a while. Your doctor, pharmacist or dentist can tell you if this is necessary and for how long.
Camilette can also affect how well other medicines work. Your doctor may need to adjust the dose of your other medication. Always follow your doctor’s advice.
Operations and tests
If you are going to have an operation, tell your doctor you are taking Camilette. You may need to stop taking it 4-6 weeks before the surgery. After the operation you should not start taking Camilette again until your doctor advises you to, especially if you are not able to move around as usual.
Taking Camilette may also affect the results of some clinical tests. If you are going to have any tests, it is important to tell your doctor or nurse that you are taking Camilette.
Pregnancy and breast-feeding
Do not take Camilette whilst you are pregnant or breast-feeding. If you think you might be pregnant, stop taking Camilette and consult your doctor. Use another form of contraception, such as a condom, in the meanwhile.
Driving and using machines
Camilette has no known effect on the ability to drive or use machines.
Camilette contains lactose and sucrose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before using Camilette.
3. HOW TO TAKE CAMILETTE
Your doctor has chosen Camilette as a treatment for your acne and/or excessive hair growth. However, Camilette also has a contraceptive effect and so you must not take any other hormonal contraceptive at the same time.
It is important to follow the advice below if you are relying on Camilette for contraception. Check with your doctor if there is anything you are not sure of.
Duration of use
Your doctor will tell you how long you need to keep taking Camilette. Taking Camilette
Camilette comes in strips of 21 pills, each marked with a day of the week.
• Start by taking a pill marked with the correct day of the week.
• Take one pill each day, moving along the strip in a clock-wise direction, until you have finished all 21 pills on the strip.
• Try to take your pill at the same time every day.
• Swallow each pill whole, with water.
After you have taken all 21 pills in the strip, you have a seven day break when you take no pills.
Within a few days of taking the last pill from the strip, you will have a withdrawal bleed like a period. These bleeds should be regular, and will probably be lighter than your periods before. You don’t need to use extra contraception during the seven day break as you are very unlikely to become pregnant, as long as you have taken your pills correctly and start the next strip of pills on time.
Start taking your next strip of Camilette after the seven pill-free days (i.e. on the eighth day) - even if your bleed has not yet finished. As long as you take Camilette correctly, you will find each new strip of tablets begins on the same day of the week as the one before.
Always start the new strip on time if you are relying on this medicine as contraception.
Check with your doctor or pharmacist if you are not sure.
Your doctor should stop treating you with this medicine when your skin has completely cleared, or the amount of hair growth has decreased. However, you will be able to have further courses of treatment if your problem returns.
Starting Camilette
New users or starting Camilette after a break
It is best to take your first Camilette 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 Camilette from another contraceptive Pill
- If you are currently taking a 21-day Pill: finish your current pack of 21 day contraceptive pills and then start taking Camilette the next day. Do not leave a gap between packs. By starting in this way you will not have a period until after your first strip of Camilette but you will have contraceptive protection with your first pill.
- If you are taking a 28-day Pill: start taking Camilette the day after your last active pill. Do not leave a gap between packs. By starting in this way you will not have a period until after your first strip of Camilette but you will have contraceptive protection with your first pill.
- If you are taking a progestogen-only Pill (POP or mini Pill): start Camilette on the first day of your period, even if you have already taken a progestogen-only Pill on that day. You will have contraceptive cover straight away.
Starting Camilette 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 Camilette 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 Camilette after having a baby If you have just had a baby, your doctor may advise you that Camilette should be started 21 days after delivery, providing you are fully mobile. You do not have to wait for a period; however you will need to use another method of contraception, such as a condom, until you start Camilette and for the first 7 days of pill taking.
Do not take Camilette if you are breast-feeding
A missed pill
If you are less than 12 hours late with a pill:
Don’t worry. Your contraceptive protection should not be affected if you take the late pill straight away. Keep taking your remaining pills at the usual time. This may mean taking two pills in one day.
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. You should:
- take the most recently missed pill as soon as you remember. 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 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, such as condoms, for seven days after missing a pill.
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 have become pregnant. Contact your doctor or pharmacist for advice as soon as possible. You may need to consider emergency contraception.
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.
If you lose a pill:
You should take the last pill of the strip in place of the lost pill. Then take all the remaining 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.
If you are sick or have diarrhoea
If you are sick (vomit) or have diarrhoea, your body may not get its usual dose of hormones from that pill. You should continue to take a pill every day for the next seven days as usual, but you should also use another method of contraception. If you come to the end of a strip 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.
If your stomach upset carries on or gets worse, talk to your doctor. They may recommend another form of contraception.
Missed a period - could you be pregnant?
Occasionally, you may miss a period. This could mean that you are pregnant. You should do a pregnancy test before starting another strip. If you are pregnant, stop taking Camilette and see your doctor as soon as possible.
If you take more Camilette than you should
It is unlikely that taking more than one pill will do you any harm, but if you feel sick, vomit or have any vaginal bleeding contact your doctor straight away.
If you want to get pregnant
If you are planning a baby, it’s best to stop using Camilette and use another method of contraception until you have had a natural period. Your doctor or midwife relies on the date of your last natural period to tell you when the baby is due. You should be aware that when you stop taking Camilette, your periods may not return right away. However, it will not cause any harm if you get pregnant straight away. Your doctor should stop treating you with this medicine when your skin has completely cleared, or the amount of hair growth has decreased. However, you will be able to have further courses of treatment if your problem returns.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Camilette can cause side effects, although not everybody gets them.
If you get any of the following side effects, stop taking Camilette and tell your doctor immediately:
• Allergic reaction, the symptoms of which may include:
- swelling of the face, tongue or throat which may cause difficulty swallowing and breathing
- red, raised lumps (hives) and itching
• Severe depression, although this is not considered a direct side effect of Camilette, you should stop Camilette as a precaution and see your doctor straight away
• Blood clot, the signs of which include:
- a migraine for the first time or migraines that are unusually frequent or more severe than normal
- any sudden changes to your eyesight, hearing, speech, sense of smell, taste or touch
- pain or swelling in your leg
- pain and tightness in the chest
- shortness of breath
- coughing for no apparent reason or coughing up blood
- weakness or numbness in any part of your body
- dizziness or fainting
• Breast cancer, you should check your breasts and nipples every month for changes, and tell your doctor if you can see or feel anything odd, such as:
- dimpling of the skin
- changes in the nipple
- any lumps you can see or feel
• Cervical cancer, the symptoms of which include:
- an unpleasant smelling vaginal discharge
- unusual vaginal bleeding
- pelvic pain
- pain in and around the vagina during sex
• Liver problems, the signs of which include:
- pain in your stomach area
- yellowing of the skin or whites of the eyes (jaundice)
- inflammation of the liver (hepatitis) which may cause light pressure or pain below the right ribs
If you think you may have any of these, see a doctor straight away. You may need to stop taking Camilette. If you do need to stop taking Camilette, remember to use another method of contraceptive (e.g. condoms).
Common side effects (affects more than 1 in every 100 users)
• feeling sick (nausea), stomach ache
• putting on weight
• headaches
• depressive moods or mood swings
• sore or painful breasts
Uncommon side effects (affects more than 1 in every 1,000 users, but less than 1 in every 100 users)
• being sick (vomiting), diarrhoea
• fluid retention
• migraine
• loss of interest in sex
• breast enlargement
• skin rash, itching
Rare side effects (affects less than 1 in every 1,000 users)
• poor tolerance of contact lenses
• losing weight
• increase of interest in sex
• vaginal or breast discharge
• venous blood clot
Other reported side effects
• high levels of fat in your blood (hypertriglyceridemia)
• worsening of the movement disorder chorea
• chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis), symptoms of which may include abdominal pain and blood and/or mucus in your stools
• chloasma (yellow-brown patches on the skin). This may happen even if you have been using Camilette for a number of months. Chloasma may be reduced by avoiding too much sunlight and UV lamps
• bleeding and spotting between your periods can sometimes occur for the first few months, but this usually stops once your body has adjusted to Camilette. If it continues, becomes heavy or starts again, contact your doctor
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.
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.
By reporting side effects, you can help provide more information on the safety of this medicine.
Also tell your doctor if any of your existing conditions get worse whilst you are taking Camilette.
5. HOW TO STORE CAMILETTE
Keep all medicines out of the sight and reach of children.
Do not use Camilette after the expiry date which is stated on the carton and blister strips. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of any medicines you no longer require. These measures will help protect the environment.
6. FURTHER INFORMATION
What Camilette contains:
The active ingredients, (the ingredients which make the medicine work), in Camilette are cyproterone acetate and ethinylestradiol.
Each tablet contains 2 milligrams of cyproterone acetate and 35 micrograms of ethinylestradiol.
The other ingredients are; lactose, maize starch, povidone, talc, magnesium stearate (E 572), sucrose, macrogol 6000, calcium carbonate (E 170), titanium dioxide (E 171), glycerol, montan glycol wax, yellow ferric oxide pigment (E 172).
What Camilette looks like and contents of the pack
Camilette tablets are beige/pale yellow, round, sugar-coated tablets. Each box of Camilette contains three blister strips, each comprising of 21 tablets.
Marketing Authorisation Holder:
Chelonia Healthcare Limited,
11 Boumpoulinas, Nicosia, PC. 1060, Cyprus Manufacturer:
Haupt Pharma GmbH,
Schleebruggenkamp 15, D-48159 Munster, Germany For more information about this product, please contact the Marketing Authorisation Holder.
This leaflet was last revised in 10/2014.
CL0142/O/PIL-Br/CL1