CYBELLE Cyproterone Acetate / Ethinylestradiol 2mg / 35mcg Film-Coated Tablet 1's

Oral contraceptive. Treatment of severe acne which has not improved after the long-term use of oral antibiotics; excessive hair growth on the face and body (moderately severe hirsutism).
Although Cybelle also act as an oral contraceptive, it should not be used in women solely for contraception but should be reserved for those women requiring treatment for the androgen-dependent skin conditions described.

 

Always take Cybelle exactly as the doctor has told. The patient should check with the doctor or pharmacist if she is not sure. If the patient is relying on this medicine for contraception it is important to follow these instructions carefully.
When To Start Taking Cybelle: If the patient starts taking Cybelle or restart after a break, take the 1st tablet on the 1st day (day 1) of the patient's period. Start with a tablet labeled with the correct day of the week. It is allowed to start on day 2-5, but in the 1st cycle, additional contraceptive precautions will be required for the first 7 days of pill taking.
Taking the First Pack of Cybelle: After taking the 1st pill, take 1 tablet daily, following the direction of the arrows, until the patient has taken all the 21 pills in the pack. The patient should try to take the pill at the same time everyday eg, after breakfast and swallow whole with water if required. The patient will have contraceptive cover straight away if she starts in this way.
Seven Pill-Free Days: After taking all the 21 pills, stop taking a pill during 7 days. A few days after taking the last pill of the pack, the patient will have her period. The periods will be regular, probably lighter than before and almost always painless. The patient is less likely to experience premenstrual syndrome (PMS), and can continue without any contraceptive protection during these 7 days, provided the patient has taken the previous pack correctly and start the next pack on time.
Taking the Next Pack of Cybelle: Start taking the next pack of pills after the 7 pill-free days. Each new pack will begin on the same day of the week as the 1 before. The patient should take the pill on this day even if she still have period.
Changing From Another Type of Contraceptive: Twenty-One Day Pill, Patch or Vaginal Ring: Cybelle should be started the day after taking the last active tablet (or after removal of the patch or ring) from the previous course, without break or at the latest, after the usual tablet (patch/ring)-free period. Start with a pill labeled with the correct day of the week. Follow the instructions under Taking the First Pack of Cybelle as mentioned previously. The patient will have contraceptive cover straight away if she starts in this way. The patient may not have the period until the end of the 1st Cybelle pack and may have some bleeding on pill-taking days, but this is normal.
Everyday Combined Pill (28 Days Pill): Cybelle should be started after taking the last active pill from the everyday pill pack. If the patient is not sure which pills are the active ones, ask the doctor or pharmacist. Take the 1st Cybelle tablet the next day, without a break between packs. Start with a pill labeled with the correct day of the week. Take the remaining inactive tablets from the patient's old pill to pharmacist for disposal. Follow the instructions under Taking the Fist Pack of Cybelle as mentioned previously. The patient will have contraceptive cover straight away if she starts in this way. The patient may not have a period until the end of the 1st Cybelle pack, and may have some bleeding on pill-taking days, but this is normal.
Mini Pill [Progesterone-Only-Pill (POP), Injectables, Implants]: The change from POP can be done on any day (Take the remaining pills of POP to the pharmacist for disposal). The change from implants should start on the day of implant removal. The change from an injectable should start on the day when the next injection should have been given.
Start with a pill labeled with the correct day of the week. Follow the instructions under Taking the First Pack of Cybelle. In all cases, additional contraceptive precautions will be required for the first 7 days of pill taking.
Following Delivery or Second-Trimester Abortion: The doctor may advise the patient to start taking Cybelle 21-28 days after delivery. The patient do not have to wait for her period. Following the instructions under Taking the First Pack of Cybelle as mentioned previously. The patient will have contraceptive cover straight away if she start in this way.
If start of Cybelle use occur later, it is recommended to use additional contraceptive precautions for the first 7 days of pill taking. If a sexual intercourse has already taken place, the possibility of a pregnancy must be excluded before starting the 1st course, or patient should wait for the next menstruation.
The patient must not breastfeed if patient is taking Cybelle.
Starting Cybelle Following a Miscarriage or Abortion: The doctor may advise to take Cybelle straight away. Follow the instructions under Taking First Pack of Cybelle as mentioned previously. The patient will have contraceptive cover straight away if she start in the way.
While Taking Cybelle: The patient should expect to find the skin less greasy after a few weeks and see a clear improvement in the acne after about 3 months. If the patient is taking this medicine to treat excessive hair growth on the face and body, it may take several months before the patient can see a clear improvement. The delay is because this medicine treats the underlying cause of the acne and hair growth, and not the actual spots or hair the patient have at the time necessary.
Duration of Treatment: The duration of treatment depends on seriousness of the clinical picture; in general this can be several months. It is recommended to keep taking Cybelle for at least 3-4 more cycles after disappearance of symptoms.
The doctor will stop the treatment when the skin is completely clear or the hair growth has decreased. If the problem comes back, the patient can take further courses for as long as necessary.
Do not stop the treatment prematurely.
Missed Period: If the patient does not have the period in the 7 pill-free days, whether the patient has missed any pills or not, the patient should tell the doctor as soon as possible and do not start another pack until the doctor tells you to. In the meantime, the patient must use another form of contraception.
Unexpected Bleeding: Some women experience a little breakthrough bleeding or spotting while they are taking this medicine, but this will stop in 1 day or two. If the patient continues to take the pills as usual, the problem should disappear after 1st few packs. However, if the bleeding keeps returning, is annoying or long lasting, talk to the doctor. It can also be a sign that the patient is not taking the pill regularly enough, so try to take it at the same time everyday.
If the Patient Wants to Get Pregnant: The bleeding, which the patient has during the 7 pill-free days and after the last pack the patient takes, is not a true period. The doctor will use the date of the patient's last true period before she gets pregnant to predict when the baby is due. Therefore, if the patient stops taking Cybelle so she can have a baby, the patient should use another method of contraception until she has had a true period, but it is not harmful to the patient or to the baby if she gets pregnant straight away.
Stomach Upsets: If the patient is sick or has severe diarrhea, it may stop the patient's medicine from working properly. If the patient is ill in this way, carry on taking the pills as normal, but the patient must also use an additional nonhormonal method of contraception eg, a condom or a cap with spermicide, during the gastrointestinal upset and for 7 days following the upset. If the current pack runs out before these 7 days, start the next pack without taking a break. This may mean the patient does not have a period until after the end of the 2nd pack. If the patient does not have a period at the end of the 2nd pack, she must talk to the doctor before starting another pack. If the sickness or diarrhea continues for a long time, see the doctor who may consider another form of contraception for the patient.
If the patient feels the effect of Cybelle is too strong or too weak for the patient, talk to the doctor or pharmacist.
Missed Dose: If the patient missed 1 pill and was due to have taken it 12 hrs ago or less, take it immediately or as soon as it is remembered. Take the rest of the pills as normal and the contraceptive cover will not be affected.
If the patient is >12 hrs late in taking the pill or if she missed >1, the contraceptive protection may be reduced. Follow the instructions for the 7 day rule if it happens during the: First Week: The patient should take the last missed tablet as soon as remembered, even if this means to take 2 tablets at the same time. Hereafter, continue taking the tablet at the usual time. The patient should use a barrier method for the next 7 days. If intercourse has taken place during the previous 7 days, the possibility of pregnancy must be considered. There is a greater risk of pregnancy if more tablets are forgotten to be taken which are closer to the usual pill-free period.
Second Week: The patient should take the last forgotten tablet as soon as remembered, even if this means to take 2 tablets at the same time. Hereafter, continue to take the tablets at the usual time of the day. Provided that the tablets have been taken correctly during the 7 days preceding the forgotten tablet, it is not necessary to take further contraceptive measures. However, if this is not the case, or if >1 tablet has been forgotten, the patient should use another contraceptive method for 7 days.
Third Week: By following 1 of the following 2 alternatives, it is not necessary to take further contraceptive precautions, provided that all the tablets have been taken correctly during the 7 days preceding the forgotten tablet. If this is not the case, the patient should follow the 1st of the 2 alternatives and use another contraceptive method for the next 7 days.
1. The patient should take the last forgotten tablet as soon as remembered, even if this means that the patient have to take 2 tablets at the same time. Hereafter, continue to take the tablets at the usual time. Start the next blister pack immediately after taking the last tablet in the present blister pack ie, there should be no more pill-free interval between the blister packs. This may mean the patient does not have period until after the end of the 2nd pack and may have some bleeding on pill-taking days but this is normal. If the patient does not have a period at the end of the 2nd pack, the patient must talk to the doctor before starting another pack.
2. Stop taking tablets from the present blister pack. In this case the patient should have a period without tablets of up to 7 days, including the days that she forgot tablets and continue with the next blister pack hereafter.
The possibility of pregnancy must be considered, if there have been forgotten tablets in a course and menstruation has not occurred in the following tablet-free period.
If The Patient Lose A Pill: The easiest thing to do if this happens is to take the last pill of the pack in place of the lost one. Then continue to take the rest of the pills on the correct days. The patient's cycle will then finish a day earlier, but the patient will still have contraceptive cover. The patient will then start the next pack 1 day earlier than before. If the patient lose the entire pack halfway through, ask the doctor or pharmacist what to do.
A thorough general and gynecological examination (including the breast) must be carried out and the family medical history must be carefully researched before starting the treatment, which is subject to medical prescription only. Disorder of blood coagulation system must also be excluded where family member suffered at a young age from the formation of blood clots (eg, deep vein thrombosis, stroke and heart attack).
Pregnancy must be excluded.

 

Overdosage

May be taken with or without food.

If the patient is allergic (hypersensitive) to ethinylestradiol, cyproterone acetate or any ingredients of Cybelle.
Patients has or has ever had disorder affecting blood circulation, in particular, those conditions relating to thrombosis: Formation of a blood clot in the blood vessels of the legs (deep vein thrombosis), the lungs (pulmonary embolism), the heart (heart attack) or other parts of the body; stroke (caused by a blood clot or a rupture of a blood vessel in the brain); condition that may be a 1st sign of a heart attack (eg, angina pectoris or chest pain) or stroke (eg, transient ischemic attack or small reversible stroke), history of migraine accompanied by visual symptoms, speech disability, or weakness or numbness in any part of the body; diabetes mellitus with blood vessel damage; pancreatitis (an inflammation of pancreas) associated with high levels of fatty substances in the blood; jaundice (yellowing of the skin) or severe liver disease; cancer that may grow under the influence of sex hormones (eg, of the breast or genital organs); benign malignant liver tumor; unexplained vaginal bleeding.
If any of these conditions appear for the 1st time while using Cybelle, stop taking it at once and consult the doctor. In the meantime, use non-antiandrogen therapy measures.
Cybelle is not to be used by males.
Use in Pregnancy: Cybelle must not be used by women who are pregnant or who think they might be pregnant. If the patient suspects that she is pregnant while using Cybelle, the patient should consult the doctor as soon as possible.
Use in Lactation: Cybelle must not be used during breastfeeding.

Several situations are described where the patient should stop taking Cybelle or where the reliability of Cybelle may be decreased. In such situations, the patient should not have sex or should take extra non-antiandrogen therapy precautions eg, use a condom or another barrier method. Do not use rhythm or temperature methods. These methods can be unreliable because Cybelle alters the usual changes in temperature and cervical mucus that occur during the menstrual cycle.
Cybelle, like all contraceptive pills, does not protect against HIV infection (AIDS) or any other sexually transmitted disease.
The doctor should check the medical history and that of the family before the patient starts taking these tablets. The doctor will also take the blood pressure and may check the breasts, abdomen and pelvic organs if considered necessary. The patient may also need to have a cervical smear. The doctor should also make sure the patient is not pregnant.
If Cybelle is used in the presence of any of the conditions listed as follows, the patient may need to be kept under close observation. Therefore, if any of these apply to the patient, tell the doctor before starting to use Cybelle: Smoking; diabetes; overweight; high blood pressure; valve disorder of a certain heart rhythm disorder; inflammation of the veins (superficial phlebitis); varicose veins; family has had thrombosis, heart attack or stroke; migraine; epilepsy; patient or someone in the immediate family has or has had high levels of cholesterol or triglycerides (fatty substances); anyone in the patient's family has had breast cancer; liver or gall bladder disease; Crohn's disease or ulcerative colitis (chronic inflammatory bowel disease), polycystic ovary syndrome (a disorder of the ovaries that may cause infertility, sometimes combined with androgenic symptoms and an increased risk of thrombosis); systemic lupus erythematosus (a disease affecting the skin all over body); hemolytic uremic syndrome (a disorder of blood coagulation causing failure of the kidneys); sickle cell disease.
Condition that occurred for the 1st time or worsened during pregnancy or previous use of sex hormones (eg, hearing loss, a metabolic disease called porphyria, a skin disease called herpes, gestations, a neurological disease Sydenham's chorea).
Chloasma (yellowish-brown pigmentation patches on the skin, particularly on the face). If so, avoid too much exposure to the sun or ultraviolet radiation (eg, sun beds and prolonged sunbathing).
Suffering from hereditary angioedema. Exogenous estrogen can trigger or exacerbate symptoms of angioedema. Consult the doctor immediately in case of occurrence of symptoms of angioedema, including swelling of the face, tongue and/or pharynx, and/or difficulty swallowing or hives together with difficulty breathing.
If any of the previously mentioned conditions appear for the 1st time, recur or worsen while using Cybelle, the patient should contact the doctor. Remember to use another form of contraception eg, a condom, or a cap with spermicide if using Cybelle for oral contraceptive purposes.
If the patient suffers from hirsutism and it is only recently appeared or has lately intensified to a considerable extent, the patient must advise the doctor.
Thrombosis: A thrombosis is the formation of a blood clot, which may block a blood vessel.
A thrombosis sometimes occurs in the deep veins of the legs (deep vein thrombosis). If this blood clot breaks away from the veins where it is formed, it may reach and block the arteries of the lungs, causing a so-called "pulmonary embolism". Deep vein thrombosis is a rare occurrence. It can develop whether or not the patient is taking the pill. The risk for venous thromboembolism is highest during the 1st year a woman ever uses a combined oral contraceptive. It can also happen if the patient becomes pregnant. The risk is higher in pill users than in non-users, but not as high as the risk during pregnancy.
Blood clots can also occur very rarely in the blood vessels of the heart (causing a heart attack) or the brain (causing a stroke). Extremely rarely blood clots can occur in the liver, gut, kidney or eye.
Very occasionally thrombosis may cause serious permanent disabilities or may even be fatal.
Biochemical factors (hereditary or acquired) that may indicate a possible predisposition for blood clot formation include having activated protein C (APC) resistance, hyperhomocysteinemia, antithrombin-III deficiency, protein C and S deficiency, and antiphospholipid antibodies.
The risk of having a heart attack or stroke increases as the patient gets older. Smoking, obesity, heart or blood vessel diseases, high blood pressure, diabetes, migraines, major surgery or extended rest, varicose veins or a family history of blood clots, heart attacks or strokes, all increase the risk of developing blood clots. The patient's risk will also increase with age. It also increases the more the patient smokes.
When using Cybelle the patient should stop smoking, especially if the patient is older than about 35 years of age.
If the patient develops high blood pressure while using Cybelle, she may be told to stop using it.
The risk of having deep vein thrombosis is temporarily increased as a result of an operation or immobilization (eg, when the patient has plaster or sprints in the leg or legs). In women who use Cybelle, the risk may yet be higher. Tell the doctor that the patient is using Cybelle well in advance of any expected hospitalization or surgery. The doctor should tell the patient to stop taking Cybelle several weeks before surgery or at the time of immobilization. The doctor should also tell the patient when to start taking Cybelle again after she's back on her feet.
If the patient notices possible signs of a thrombosis, stop taking Cybelle and consult the doctor immediately.
Cancer: Breast cancer has been diagnosed slightly more often in women who use the pill than in women of the same age who do not use the pill. This slight increase in the numbers of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of the pill. It is not known whether the difference is caused by the pill. It may be that the women were examined more often, so that the breast cancer was noticed earlier.
In rare cases, benign liver tumors and even more rarely, malignant liver tumors have been reported in users of the pill. These tumors may lead to internal bleeding. Contact the doctor immediately if the patient has severe pain in the abdomen.
Cervical cancer has been reported to occur more often in women using the pill for a long time. This finding may not be caused by the pill but may be related to sexual behavior and other factors.
Regular Check-Ups: When the patient is using Cybelle, the doctor should tell the patient to return for regular check-ups.
Contact the doctor as soon as possible if any changes in patient's health especially involving any of the conditions mentioned previously, lump in the breast, using other medications (see Interactions), immobilized or are to have surgery (consult the doctor at least 4 weeks in advance), unusual heavy vaginal bleeding; forgot any of the first 7 tablets and had intercourse in the 7 days before; severe diarrhea; missed period twice in a row or suspect that the patient is pregnant (do not start the next pack until told to by the doctor).
Stop taking tablets and see the doctor immediately if the patient notice any possible signs of thrombosis, myocardial infarction or stroke eg, the following: Unusual cough; severe pain in the chest which may reach the left arm, breathlessness; any unusual, severe or prolonged headache or migraine attack; partial or complete loss of vision or double vision, slurring or speech disability; sudden changes to the hearing, sense of smell or taste; dizziness or fainting; weakness or numbness in any part of the body; severe pain in the abdomen; severe pain or swelling in either of the legs.
A thorough general and gynecological examination (including the breast) must be carried out and the family medical history must be carefully researched before starting the treatment, which is subject to medical prescription only. Disorder of blood coagulation system must also be excluded where family member suffered at a young age from the formation of blood clots (eg, deep vein thrombosis, stroke and heart attack).
Cybelle contains lactose. If the patient has intolerance to certain sugars, consult the doctor before taking this medication.
Effects on the Ability to Drive or Operate Machinery: It is unlikely that the patient will experience any side effects which will affect the ability to drive or operate machinery.

 

Use In Pregnancy & Lactation

Like all medicines, Cybelle can cause adverse effects although not everybody gets them. Cybelle is generally well tolerated.
If any of the adverse effects get serious, or if the patient notices any adverse effects not listed, please tell the doctor or pharmacist.
Serious reactions associated with the use of Cybelle, as well as the related symptoms are described in Precautions.
The following adverse effects have been reported by users of Cybelle, although they need not to be caused by Cybelle. These adverse effects may occur in the first few months that the patient is using Cybelle and usually lessen with time.
If the patient suffers from hereditary angioedema, exogenous estrogen can trigger or exacerbate symptoms of angioedema. (See table.)

 

Some medicines may stop Cybelle from working properly. These include medicine used for the treatment of epilepsy (eg, primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate), tuberculosis (eg, rifampicin, rifabutin) and HIV infection (nelfinavir, nevirapine, efavirenz); some antibiotics (eg, ampicillin, tetracyclines) and antifungal (griseofulvin) for some other infectious disease, and herbal medicines containing St. John's wort.
Cybelle may also interfere with the working of other medicines (eg, cyclosporine, lamotrigine).
Inform the doctor or pharmacist if the patient is taking or have recently taken any other medicines or herbal products, even those not prescribed. Also tell any other doctor or dentist who prescribes another medicine (or the dispensing pharmacist) that the patient uses Cybelle. The doctor or pharmacist can tell if the patient needs to take additional contraceptive precautions and if so, for how long.

Storage

Action

Oral Contraceptives / Acne Treatment Preparations