Cybelle Special Precautions

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.