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Cybelle

Cybelle Dosage/Direction for Use

cyproterone + ethinylestradiol

Manufacturer:

Laboratorios Leon Farma

Distributor:

Exeltis
Full Prescribing Info
Dosage/Direction for Use
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.
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