DESOGESTREL FILM-COAT TB 0.08 MG 28 UNITS CERAZETTE MERCK SHARP&DOHME

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DESOGESTREL FILM-COAT TB 0.08 MG 28 UNITS CERAZETTE MERCK SHARP&DOHME

Contents Desogestrel. Description The active substance is Desogestrel (75 microgram). Excipients/Inactive Ingredients: The other ingredients are: silica, colloidal anhydrous; all-rac-α-tocopherol; maize starch; povidone; stearic acid; hypromellose; macrogol 400; talc; titanium dioxide (E 171) and lactose monohydrate (see also Precautions). Indications/Uses Cerazette is used to prevent pregnancy. Cerazette contains a small amount of one type of female sex hormone, the progestogen desogestrel. For this reason Cerazette is called a progestogen-only-pill (POP), or a mini-pill. Contrary to combined pills, the POP or mini-pill do not contain an estrogen hormone next to the progestogen. Most POPs or mini-pills work primarily by preventing the sperm cells from entering the womb but, do not always prevent an egg cell from ripening, which is the primary action of combined pills. Cerazette is distinct from other mini-pills in having a dose that in most cases is high enough to prevent the egg cells from ripening. As a result, Cerazette provides high contraceptive efficacy. In contrast to the combined pill, Cerazette can be used by women who do not tolerate estrogens and by women who are breast feeding. A disadvantage is that vaginal bleeding may occur at irregular intervals during the use of Cerazette. The woman also may not have any bleeding at all. Dosage/Direction for Use The Cerazette pack contains 28 tablets. Arrows are printed on the front side of the pack, between the tablets. If the patient turns over the pack, and looks at the back side, she will see the days of the week printed on the foil. Each day corresponds to one tablet. Every time the patient starts a new pack of Cerazette, take a tablet from the top row. Don't start with just any tablet. For example if the patient starts on a Wednesday, she must take the tablet from the top row marked (at the back) with WED. Continue to take one tablet a day until the pack is empty, always following the direction indicated by the arrows. By looking at the back of the pack the patient can easily check if she has already taken the tablet on a particular day. Take the tablet each day at about the same time. Swallow the tablet whole, with water. The patient may have some bleeding during the use of Cerazette, but she must continue to take the tablets as normal. When a pack is empty, the patient must start with a new pack of Cerazette on the next day - thus without interruption and without waiting for a bleed. Starting on the First Pack of Cerazette: When no hormonal contraceptive has been used in the past month: Wait for the period to begin. On the first day of the period take the first Cerazette tablet. The patient needs not take extra contraceptive precautions. The patient may also start on days 2-5 of the cycle, but in that case make sure she also uses an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. When changing from a combined pill, vaginal ring, or transdermal patch: The patient can start taking Cerazette on the day after the patient takes the last tablet from the present Pill pack, or on the day of removal of the vaginal ring or patch (this means no tablet-, ring-, or patch-free break). If the present Pill pack also contains inactive tablets the patient can start Cerazette on the day after taking the last active tablet (if she is not sure which this is, ask the doctor or pharmacist). If the patient follows these instructions, she needs not take extra contraceptive precautions. The patient can also start at the latest the day following the tablet-, ring-, patch-free break, or placebo tablet interval, of the present contraceptive. If the patient follows these instructions, make sure she uses during the first cycle an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. When changing from another progestogen-only pill (mini-pill): The patient may stop taking it any day and start taking Cerazette right away. The patient needs not take extra contraceptive precautions. When changing from an injectable or implant or a progestogen-releasing intrauterine device (IUD): Start using Cerazette when the next injection is due or on the day that the implant or the IUD is removed. The patient needs not take extra contraceptive precautions. After having a baby: The patient can start Cerazette between 21 to 28 days after the birth of the baby. If the patient starts later, make sure she uses during the first cycle an additional contraceptive method (barrier method) for the first 7 days of tablet-taking. However, if intercourse has already occurred, pregnancy should be excluded before starting Cerazette use. Additional information for breast-feeding women can be found in Use in Pregnancy & Lactation. The doctor can also advise the patient. After a miscarriage or an abortion: The doctor will advise the patient. If the patient forgets to take Cerazette: If the patient is less than 12 hours late in taking a tablet, the reliability of Cerazette is maintained. Take the missed tablet as soon as remembered and take the next tablets at the usual times. If the patient is more than 12 hours late in taking any tablet, the reliability of Cerazette may be reduced. The more consecutive tablets missed the higher the risk that the contraceptive efficacy is decreased. Take the last missed tablet as soon as remembered and take the next tablets at the usual times. Use an additional contraceptive method (barrier method) too for the next 7 days of tablet-taking. If the patient missed one or more tablets in the first week of tablet-intake and had intercourse in the week before missing the tablets, there is a possibility of becoming pregnant. Ask the doctor for advice. If the patient suffers from gastro-intestinal disturbances (e.g., vomiting, severe diarrhea): Follow the advice for missed tablets as previously mentioned. If the patient vomits or uses medical charcoal within 3-4 hours after taking the Cerazette tablet or has severe diarrhea, the active ingredient may not have been completely absorbed. If the patient stops taking Cerazette: The patient can stop taking Cerazette whenever she wants. From the day she stops she is no longer protected against pregnancy. For any further questions on the use of this product, ask the doctor or pharmacist. Overdosage If the patient takes more Cerazette than she should: There have been no reports of serious harmful effects from taking too many Cerazette tablets at one time. Symptoms that may occur are nausea, vomiting, and in women or girls, slight vaginal bleeding. For more information ask the doctor for advice. Contraindications Do not take Cerazette: If the patient is allergic to any of the ingredients of Cerazette. If the patient is pregnant or thinks she might be pregnant. If the patient has a thrombosis. Thrombosis is the formation of a blood clot in a blood vessel (e.g. of the legs (deep venous thrombosis) or the lungs (pulmonary embolism)). If the patient has had jaundice (yellowing of the skin) or severe liver disease and the liver function is still not normal. If the patient has or is suspected to have a cancer that is sensitive to sex-steroids, such as certain types of breast cancer. If the patient has any unexplained vaginal bleeding. Tell the doctor before starting to use Cerazette if any of these conditions apply. The doctor may advise to use a non-hormonal method of birth control. Consult the doctor immediately if any of these conditions appear for the first time while using Cerazette. Warnings Seek immediate medical consultation for any disorders while taking medication. Contraindicated for individuals with venous thrombosis and hepatic disease. Special Precautions Cerazette, like all hormonal contraceptives, does not protect against HIV infection (AIDS) or any other sexually transmitted disease. Take special care with Cerazette: Tell the doctor before starting to use Cerazette if: the patient has ever had breast cancer; the patient has liver cancer, since a possible effect of Cerazette cannot be excluded; the patient has ever had a thrombosis; the patient has diabetes; the patient suffers from epilepsy (see Interactions); the patient suffers from tuberculosis (see Interactions); the patient has high blood pressure; the patient has or has had chloasma (yellowish-brown pigmentation patches on the skin, particularly of the face); if so, avoid too much exposure to the sun or ultraviolet radiation. When Cerazette is used in the presence of any of these conditions, the patient may need to be kept under close observation. The doctor can explain what to do. Decreased Bone Mass: Estrogens are important to maintain the strength of the bones. During the use of Cerazette, the concentration in the blood of the natural estrogen estradiol is comparable to the concentration seen in the first half of the natural cycle but is decreased in comparison with the second half of the natural cycle. It is not known whether this has an effect on the strength of the bones. Breast Cancer: Regularly check the breasts and contact the doctor as soon as possible if the patient feels any lump in the breasts. Breast cancer has been found slightly more often in women who take the Pill than in women of the same age who do not take the Pill. If women stop taking the Pill, the risk gradually decreases, so that 10 years after stopping the risk is the same as for women who have never taken the Pill. Breast cancer is rare under 40 years of age but the risk increases as the woman gets older. Therefore, the extra number of breast cancers diagnosed is higher if the age until which the woman continues to take the Pill is higher. How long she takes the Pill is less important. In every 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 20, there would be less than 1 extra case of breast cancer found up to 10 years after stopping, in addition to the 4 cases normally diagnosed in this age group. Likewise, in 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 30, there would be 5 extra cases in addition to the 44 cases normally diagnosed. In 10,000 women who take the Pill for up to 5 years but stop taking it by the age of 40, there would be 20 extra cases in addition to the 160 cases normally diagnosed. The risk of breast cancer in users of progestogen-only pills like Cerazette is believed to be similar to that in women who use the Pill, but the evidence is less conclusive. Breast cancers found in women who take the Pill, seem less likely to have spread than breast cancers found in women who do not take the Pill. It is not known whether the difference in breast cancer risk is caused by the Pill. It may be that the women were examined more often, so that the breast cancer is noticed earlier. Thrombosis: See the doctor immediately if the patient notices possible signs of a thrombosis (see also Patient Counselling Information). 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 venous thrombosis). If this 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". As a result, fatal situations may occur. Deep venous thrombosis is a rare occurrence. It can develop whether or not the patient is taking the Pill. It can also happen if the patient becomes pregnant. The risk is higher in Pill-users than in non-users. The risk with progestagen-only pills like Cerazette is believed to be lower than in users of Pills that also contain estrogens (combined Pills). Vaginal bleeding: Vaginal bleeding may occur at irregular intervals during the use of Cerazette. This may be just slight staining which may not even require a pad, or heavier bleeding, which looks rather like a scanty period and requires sanitary protection. The patient may also not have any bleeding at all. The irregular bleedings are not a sign that the contraceptive protection of Cerazette is decreased. In general, the patient needs not take any action; just continue to take Cerazette. If, however, bleeding is heavy or prolonged consult the doctor. Ovarian cysts: During the use of all low-dose hormonal contraceptives, small fluid-filled sacs may develop in the ovaries. These are called ovarian cysts. They usually disappear on their own. Sometimes they cause mild abdominal pain. Only rarely, they may lead to more serious problems. Important information about some of the ingredients of Cerazette: Cerazette contains lactose (milk sugar). Contact the doctor before taking Cerazette, if the patient has been told by the doctor that she has intolerance to some sugars. Driving and using machines: There are no indications of any effect of the use of Cerazette on alertness and concentration. Use In Pregnancy & Lactation Pregnancy: Do not use Cerazette if the patient is pregnant, or thinks she may be pregnant. Breast-feeding: Cerazette may be used while the patient is breast-feeding. Cerazette does not influence the production or the quality of breast milk. However, a small amount of the active substance of Cerazette passes over into the milk. The health of children breast-fed for 7 months whose mothers were using Cerazette has been studied up to 2,5 years of age. No effects on the growth and development of the children were observed. If the patient is breast feeding and wants to use Cerazette, contact the doctor. Side Effects Like all medicines, Cerazette can cause side effects, although not everybody gets them. Serious undesirable effects associated with the use of contraceptive Pills are described in Breast Cancer and Thrombosis under Precautions. Read Precautions for additional information and consult the doctor at once where appropriate. Apart from these side effects, breast secretion may occur. In addition, allergic reactions (hypersensitivity), including swelling of the face, lips, tongue, and/or throat causing difficulty in breathing or swallowing (angioedema and/or anaphylaxis) have been reported. If any of the side effects gets serious, or if the patient notices any side effects not listed, tell the doctor or pharmacist. Drug Interactions The patient should tell the doctor or pharmacist if she is taking or has recently taken any other medicines or herbal products, including medicines obtained without a prescription. The patient should also tell any other doctor or dentist who prescribes another medicine (or the pharmacist) that she uses Cerazette. Some medicines may stop Cerazette from working properly. These include medicines used for the treatment of: epilepsy (e.g., primidone, phenytoin, carbamazepine, oxcarbazepine, felbamate, topiramate and phenobarbital); tuberculosis (e.g., rifampicin, rifabutin); HIV infection (e.g., ritonavir, nelfinavir, nevirapine, efavirenz); Hepatitis C virus infection (e.g., boceprevir, telaprevir); other infectious diseases (e.g., griseofulvin); high blood pressure in the blood vessels of the lungs (bosentan); stomach upset (medical charcoal); depressive moods (the herbal remedy St. John's wort). If the patient is taking medicines or herbal products that might make Cerazette less effective, a barrier contraceptive method should also be used. Since the effect of another medicine on Cerazette may last up to 28 days after stopping the medicine, it is necessary to use the additional barrier contraceptive for that long. Cerazette may also interfere with how other medicines work, causing either an increase in effect (e.g., medicines containing ciclosporine) or a decrease in effect (e.g., lamotrigine). Storage Store between 2°C to 30°C in the original package, in order to protect from light and moisture. Patient Counseling Information Regular check-ups: When you are using Cerazette, your doctor will tell you to return for regular check-ups. In general, the frequency and nature of these check-ups will depend on your personal situation. Contact your doctor as soon as possible if: you have severe pain or swelling in either of your legs, unexplained pains in the chest, breathlessness, an unusual cough, especially when you cough up blood (possibly indicating a thrombosis); you have a sudden, severe stomachache or look jaundiced (possibly indicating liver problems); you feel a lump in your breast (possibly indicating breast cancer); you have a sudden or severe pain in the lower part of your belly or the stomach area (possibly indicating an ectopic pregnancy, this is a pregnancy outside the womb); you are to be immobilised or are to have surgery (consult your doctor at least four weeks in advance); you have unusual, heavy vaginal bleeding; you suspect that you are pregnant. MIMS Class Oral Contraceptives ATC Classification G03AC09 - desogestrel ; Belongs to the class of progestogens. Used as systemic contraceptives. Thai FDA Category D

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