Prescription Only. Read this package insert carefully before use of this medication, It contains important information regarding your treatment. In case of any doubt or if you are uncertain about anything, ask your doctor or your pharmacist. Keep this package insert as you may need to read it again.
COMPOSITION AND PRESENTATION: Each beige color coated tablet contains drospirerione 3 mg, ethinyl estratisoi 30mcg. Expicients: corn starch, povidone, lactose monohydrate, croscarmiellose sodium, talc, magnesium stearate, hypromellose 2910, macrogol 6000, titanium dioxide, iron oxide yellow. Each white color coated tablet contains microcrystalline cellulose, sodium starch glycolate, lactose monOhydrate, talc, magnesium stearate, hypromellose 2910, macrogol 6000, titanium dioxide, iron oxide yellow.
INDICATIONS: Oral contraception.
CLASSIFICATION: Oral contraceptive.
DOSAGE AND ADMINISTRATION: This medication must be orally administered with a glass of water. Take 1 tablet a day, every day at the same time for 28 consecutive days, in the ,;40 order indicated on the plastic box and without omitting any tablet. The first beige tablet (tablet No. 1) must be taken on the first day of the menstrual cycle (first day of bleeding). It is very important to respect the order, taking always the beige color (active) tablets and, once these are finished, the white color tablets (inactive) (tablets No. 22-28). Always keep an extra package available, in order to ensure you will not miss the first tablet of the next cycle.
The risk of pregnancy increases if you forget to take the active tablets (beige color tablets).
In case you forget, follow the instructions of your doctor, or the following general recommendations:
• If you forget to take 1 active tablet, take it as soon as you remember, even if this means to take 2 tablets on the same day, and then take the next dose at the regular time. Use an additional non hormonal or mechanic (condom, diaphragm) for the next 7 days, together with the tablets.
• If you forget to take 2 consecutive active tablets during the first or second week, take 2 tablets each day for 2 consecutive days, at the regular time and then return to the normal program. In this case, the risk of ovulation is higher, so you must use another birth control method, non-hormonal or mechanic, for at least the next 7 days, together with the tablets.
• If you forget to take 2 consecutive active tablets during the third week, or if you forget to take 3 consecutive active tablets during the first 3 weeks, discard the rest of the package and start with a new one on the next day. Also, it is recommended to use another birth control method, non-hormonal or mechanic, as an alternative during the 7 days after forgetting the tablets. It is possible that you do not experience your menstrual period on that month, but if your menstrual period does not appear for 2 consecutive months, contact your doctor in order to detect a possible pregnancy
• Errors in the intake of inactive tablets (white tablets) are negligible provided that the first active tablet (beige tablet) of the next package is taken on the appropriate day.
Do not exceed recommended dosage.
CAUTIONS AND WARNINGS:
• Use an additional birth control method at least during the first 7 days of the first cycle of product administration. Some doctors recommend using an additional contraception method during the first 3 weeks of the first cycle, in order to ensure a better protection
• Use another form of birth control in case you forget several doses (See "Dosage & Administration"), or if you are taking medications that decrease the efficacy of contraceptives.
• Inform your doctor in case you are Pregnant or breast-feeding. In case of diagnosed or suspected pregnancy, therapy must be interrupted and the doctor must be informed. The use of this medication during breast-feeding is not recommended, since these hormones are excreted in the mother’s milk, which could cause adverse effects to the infant.
• Avoid smoking cigarettes while taking contraceptives, since tobacco increases the risk of serious adverse effects, especially if you are older than 35 years. Avoid prolonged exposure to solar light, since some people may develop photosensitivity during therapy. Inform your doctor in case you ever miss any menstrual Period, in order to determine the specific cause, among other things a possible pregnancy. The use of oral contraceptives does not protect you against HIV (AIDS) or against any other sexually transmitted disease.
• Inform your doctor in case you ever had allergic reactions to a treatment with drospirenone, ethinyl estradiol, other hormones or any other substance (food, colorants, preservatives, etc.) or other medications. Inform your doctor or dentist that you are taking this medication before undergoing any kind of surgery (including dental surgery) or any emergency treatment. Contact your ophthalmologist if you use contact lenses and you notice visual changes or ocular discomfort.
• Some women may experience sensitivity, swelling or mild bleeding of the gums, contact your dentist in case you experience any of the above. Regularly brushing your teeth may decrease these effects. If therapy causes nausea or stomach discomfort, take the tablets with the meals.
• Contact your doctor in case of any uncommon vaginal bleeding, either persistent or repeated, in order to discard a possible malignant origin.
• Contact your doctor in case of any uncommon vaginal bleeding, either persistent or repeated, in order to discard a possible malignant origin. Inform your doctor that you are taking this medication before undergoing laboratory tests. Inform your doctor in case of background, or if you have any of the following diseases Family background of breast cancer and benignant breast disease; biliar vesicle disease (especially biliar calculi); epilepsy, mental depression; migraine type headache; high blood cholesterol: high arterial Pressure: high levels of blood potassium; menstrual problems; tobacco addiction and those pathologies mentioned in the “Contra-Indications” section. It is recommended to use a non-hormonal additional contraceptive method in case of vomit or diarrhea, either during or shortly after taking the contraceptive. Visit your doctor regularly in order to check the progress of your treatment
CONTRAINDICATIONS: Do not use in the following cases: blood vessels disease, circulation problems, coagulation alterations, thrombosis (blood clots); cardiac disease; cerebral hemorrhage (apoplexy stroke); breast cancer, uterus cervix. endometriurn, uterus or other cancer related to hormones; serious hepatic disease (especially, benignant or malignant hepatic tumor); pregnancy jaundice background, or during the previous use of oral contraceptives (yellow color of skin and eyes); kidneys disease; adrena( gland disease; abnormal vaginal bleeding of unknown origin; diagnosed or suspected pregnancy; background of hyper sensitivity to drospirenone, ethinyl estradiol or other hormones.
• Interactions have been described with the following products: medications that increase the blood potassium level: nonsteroidal anti-inflammatory (such as ibuprofen, naproxen, ketoprofen); diuretics that cause potassium retention (such-4s spironolactone, triamterene, amiloride); potassium supplements; salt substitutes; ACE inhibitors (such as captopril. benalepril, isinopril, enalaphl); antagonists of angiotensine II receptors (such as candesartan, losartan, valsartan, telmisartan); heparin.
• Interactions with the following medications may also occur: antibiotics (such as ampicillin, tetracycline); barbiturates (such as phenobarbital); phenytoin; carbamazepine; griseofulvine; primidona; rifampin; phenylbutazone; warfarin; hydrocortisone; prednisolone; cyclosporine; clofibrate; theophylline; morphine; salicylic acid; temazepam; atorvastatin; acetaminophen; ascorbic acid; St. John's Worth.
Inform your doctor of any medications you are using.
• In case you experience the following adverse reactions, seek for medical care immediately. Stomach or abdominal ache; bloody cough; intense headache; motor coordination loss; vision loss or vision changes; chest, groin or legs pain (especially in the ankles); feeling of loss of air; speak difficulty; weakness, numbness or pain of arms and legs.
• In case you experience some of the following adverse reactions while under treatment with this medication, contact your doctor. Especially during the first three months of use of the oral contraceptive: Changes in the menstrual bleeding pattern or inter menstrual bleeding (decrease of bleeding during menstrual cycle; vaginal bleeding in between regular menstrual periods; prolonged bleeding during menstrual cycle; complete absence of menstrual bleeding for several months or occasional stop of menstruation on non-consecutive months). Headache of migraine type; increase of arterial pressure; vaginal infection; mental depression; swelling, pain or sensitivity in the upper abdominal area; stomach, side or abdominal ache and yellow pigmentation of skin and eyes, especially in tobacco smokers; breast tumors, in women with breast disease background.
• The use of this medication may cause the following effects that normally do not require medical care, unless they are too bothering or do not disappear during the course of treatment: Acne, generally less frequent after the 3 first months of use; swelling, pain and increase in breast sensitivity; dizziness; nausea; swelling of ankles and feet; brown spots on skin exposed: increase or loss of body and face hair; increase or decrease of sexual appetite; increase of skin sensitivity to solar light; weight gain or loss.
Inform your doctor of any adverse effect which occurs when using medications
OVERDOSE: If you suspect an overdose, seek for medical care immediately.
PRESENTATION: Packages with 28 coated tablets which include 21 beige color active coated tablets and 7 white color inactive coated tablets (placebo).
STORAGE CONDITIONS: Keep in its original package, in a fresh and dry place, away from the light.
SHELF-LIFE: 36 months. Do not use this medication after the expiry date printed on the labels.
QUALITY SPECIFICATIONS: Manufacturer's.
PRESCRIPTION ONLY. ONLY USE THIS MEDICATION ACCORDING TO A DOCTOR'S PRESCRIPTION. KEEP ALL MEDICINES OUT OF REACH OF CHILDREN. READ THE PACKAGE INSERT CAREFULLY BEFORE USE. FOR MORE INFORMATION CONTACT YOUR DOCTOR.
MANUFACTURER: Laboratorios Recalcine S.A., Carrascal No. 5670, Santiago, Chile. DISTRIBUTOR: vimedimex.