Cetol

Each active tablet contains Cyproterone (Cetol) acetate 2 mg and ethinyloestradiol 35 mcg. It also contains the following excipients: Lactose, microcrystalline cellulose, povidone, croscarmellose sodium, magnesium stearate, opadry white, opadry buff, opaglos white, quinoline yellow and sucrose.

Each non-active tablet contains lactose 67 mg, microcrystalline cellulose and magnesium stearate.

Cetol is a calendar pack containing 21 small, yellow, active tablets and 7 large, white, non-active tablets.

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 Cetol 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.

Take Cetol tablets at about the same time each day as this will help prevent missing a dose.

To achieve effective clinical efficacy or contraception, Cetol is to be taken everyday. The same rules apply to taking Cetol as to the taking of any other contraceptive pill. Bleeding between one period and the next, and/or reduced therapeutic or contraceptive effectiveness can be caused by not taking Cetol regularly.

When Hormonal Contraception Has Not Been Used in the Past Month: Starting on the 1st day of the period, take Cetol for the corresponding day of the week in the red area of the calendar pack (eg, if the period starts on a Monday, take the 1st tablet from the spot marked Monday in the red section). Continue taking 1 tab daily until all tablets in the calendar pack have been taken. This includes all of the small yellow active tablets and the white non-active tablets. Start taking the next tablet from the next calendar pack on the day after the last tablet on the first calendar pack. Follow the arrows on the pack for the corresponding day of the week.

The patient must use an additional barrier contraceptive method eg, condoms or diaphragm for the first 14 days after starting the 1st pack of Cetol. Do not use rhythm, temperature or cervical mucous methods. Additional contraceptive methods are not required when starting the 2nd or subsequent packs after completing the 1st pack provided that Cetol has been taken on a regular daily basis ie, no tablets have been missed.

Changing from a Combined

Oral Contraceptive: Start Cetol the day after taking the last active tablet from the present pill pack (this means no tablet-free break). If not sure which tablets are active and non-active, ask a doctor or pharmacist.

Changing from a Pill Containing Only Progestogen (Minipill): Take the 1st active tablet of Cetol on the 1st day of bleeding even if the patient has already taken a progestogen-only pill on that day. The patient will not need additional contraceptive precautions. Discard all remaining progestogen-only tablets.

Changing from a Contraceptive Injection or Implant: Start Cetol on either the day the injection is due or the implant is removed. Use an additional barrier contraceptive method eg, condoms or diaphragm (but not rhythm, temperature or cervical mucous methods) for the first 14 days of Cetol if having intercourse.

After Giving Birth: It is recommended not to start Cetol until the 1st normal period begins. It is, however, possible to start sooner if advised to do so by a doctor. It is recommended not to take Cetol while breastfeeding without first seeking the doctor's advice.

After an Abortion or Miscarriage: Talk to a doctor.

In Case of Missed Doses: The risk of getting pregnant increases as the number of missed tablets increases. The risk of pregnancy is particularly high if the active tablets at the beginning or end of the pack are missed. If the patient has forgotten to take a tablet or tablets, the following instructions (also known as the "7-day rule") apply.

If the white non-active tablets are missed, do not worry. Take the next tablet on the indicated day as usual.

If the yellow active tablets are missed but taken within 12 hrs, the patient is still protected against pregnancy. Take the missed tablet and the next tablet at the usual time even if this means taking 2 tabs in 1 day.

If the yellow active tablet is missed for >12 hrs, protection against pregnancy is lost. Take the missed tablet immediately and the next tablet at the usual time even if this means taking 2 tabs on the same day. Extra barrier contraceptive methods will be required according to the 7-day rule. Information about the 7-day rule is given as follows.

If the missed tablet or tablets occurred in the 1st week of yellow active tablets from the pack, and there is intercourse in any of the 7 days preceding that week, the patient must seek advice from a doctor to exclude the possibility of pregnancy.

When the yellow active tablets are missed for a few days, see the doctor to exclude the possibility of pregnancy. Follow the 7-day rule after disposing of the missed tablets in the pill pack.

If extra contraceptive precautions are required, refrain from having intercourse or use a barrier contraceptive method eg, a cap with spermicide or condom.

Rhythm, temperature or cervical mucous methods must not be used since oral contraceptives alter normal menstrual cycles changes.

The 7-Day Rule: Do not stop taking Cetol.

Take the yellow active tablets for 7 consecutive days before effective contraception is achieved.

Refrain from intercourse or use barrier contraceptive methods while taking the 7 yellow active tablets.

If <7 yellow active tablets remain in the current blister strip, finish these and go straight onto the yellow active tablets of the next blister strip missing out the white inactive tablets. It is possible that the patient may not have a period until the end of the next blister strip, however, this will not cause harm.

If Vomiting Occurs Soon After Taking Cetol: Vomiting within 3-4 hrs after taking Cetol is similar to missing a tablet as it may mean that the amount of the active ingredients absorbed into the bloodstream is reduced. The patient should follow the same advice given for missed tablets.

Taking Other Medicines with Cetol: Some medicines can interfere with the beneficial clinical effect of Cetol. These drugs include phenytoin, barbiturates eg, primidone and phenobarbitone, antiepileptics eg, carbamazepine, oxcarbamazepine and antibiotics/antifungals eg, rifampicin, ampicillin, tetracyclines and griseofulvin. While taking these drugs and for the next 7 days, follow the advice given for missed tablets. Ask the doctor for advice about the length of time needed to use extra contraceptive precautions if on continuous medication or taking rifampicin.

Delaying a Period: When the active tablets in a blister strip are finished, start taking the yellow active tablets from a 2nd blister strip missing out the white non-active tablets of the 1st blister strip. Breakthrough bleeding or spotting may occur while taking the yellow active tablets from the 2nd blister strip.

Changing the Day a Period Starts: By taking Cetol as directed, the period will start on about the same day every 4 weeks. To change this, shorten (never lengthen) the number of days in which to take the white non-active tablets. If the number of days is shortened to ≤3 days, this may stop the bleeding during the break but breakthrough bleeding or spotting may occur while taking the yellow active tablets from the 2nd blister strip.

If Unexpected Bleeding Occurs: During the first few months of taking Cetol, spotting or breakthrough bleeding may occur in between periods. Continue to take Cetol as directed. Such spotting or breakthrough bleeding usually stops after about 3 cycles of taking Cetol. However, inform the doctor if bleeding continues, changes to heavy bleeding or starts again.

Duration of Treatment: The severity of the acne or hirsutism will determine how long the patient should remain on treatment. Several months are generally required with continuation for another 3-4 months after the acne or hirsutism is controlled. Further treatment with Cetol can be initiated if the conditions recur. It is likely that longer treatment will be required for polycystic ovary syndrome.

If the patient is allergic (hypersensitive) to Ethinylestradiol (Cetol), Cyproterone (Cetol) acetate or any ingredients of Cetol.

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 Cetol, stop taking it at once and consult the doctor. In the meantime, use non-antiandrogen therapy measures.

Cetol is not to be used by males.

Use in Pregnancy: Cetol 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 Cetol, the patient should consult the doctor as soon as possible.

Use in Lactation: Cetol must not be used during breastfeeding.

Some medicines may stop Cetol 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.

Cetol 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 Cetol. The doctor or pharmacist can tell if the patient needs to take additional contraceptive precautions and if so, for how long.

Like all medicines, Cetol can cause adverse effects although not everybody gets them. Cetol 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 Cetol, as well as the related symptoms are described in Precautions.

The following adverse effects have been reported by users of Cetol, although they need not to be caused by Cetol. These adverse effects may occur in the first few months that the patient is using Cetol and usually lessen with time.

If the patient suffers from hereditary angioedema, exogenous estrogen can trigger or exacerbate symptoms of angioedema.