País: Israel
Língua: inglês
Origem: Ministry of Health
CLOMIFENE CITRATE
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
G03GB02
TABLETS
CLOMIFENE CITRATE 50 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
CLOMIFENE
CLOMIFENE
In women : ovulatory failure in patients desiring pregnancy.
2011-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only IKACLOMIN ® 50 MG TABLETS ACTIVE INGREDIENT: CLOMIFENE CITRATE 50 MG Inactive and allergenic ingredients in the preparation - see section 6 “Further Information”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. The medicine was prescribed for the treatment of your ailment. Do not pass it on to others. It may harm them even if it seems to you that their ailment is similar. This medicine is not intended for children, adolescents, men or postmenopausal women. THIS PREPARATION SHOULD BE TAKEN ACCORDING TO THE RECOMMENDATION OF A SPECIALIST IN THE FIELD OF GYNECOLOGY OR ENDOCRINOLOGY. 1. WHAT IS THE MEDICINE INTENDED FOR? The medicine contains the active ingredient clomifene citrate. The substance belongs to a group of medicines called ovulation stimulants. It works by stimulating the ovaries to release the egg (ovulation). Ikaclomin is used to treat different types of infertility in women who do not ovulate properly. THERAPEUTIC GROUP Antiestrogen to treat infertility. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: You are allergic (sensitive) to the active ingredient or any of the other ingredients contained in the medicine (listed in section 6). Signs of the allergic reaction include: a rash, swelling or breathing difficulties, swelling of the lips, face, throat or tongue. You have or ever had liver diseases. You have unusual menstrual bleeding where the cause of bleeding is unknown. You have a type of cancer that worsens with use of hormones. You have an ovarian cyst. You are pregnant. Before taking the medicine, you should undergo a test to make sure that you are not pregnant. Do not use the medicine if any of the above conditions apply to you. SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFOR Leia o documento completo
Ikaclomin Tablets SPC KO 01.2018 IKACLOMIN TABLETS 1. NAME OF THE MEDICINAL PRODUCT Ikaclomin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Clomifene Citrate 50mg as the active ingredient. For a full list of excipients, see section 6.1 Each tablet contains: _Lactose content: 57.7 mg per tablet. _ _Sodium content: 0.24 mg-0.36 mg per tablet_ 3. PHARMACEUTICAL FORM Tablet White to slightly off white, 8.2 mm diameter, round, flat beveled edges tablet, engraved "S" on one side, scored on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In women: ovulatory failure in patients desiring pregnancy. Tablets are indicated only for patients on whom ovulatory dysfunction is demonstrated. Other causes of infertility must be excluded or adequately treated before giving Clomifene citrate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Physicians experienced in managing gynecological or endocrine disorders should supervise the workup and treatment of candidate female patients for clomifene citrate therapy. Patients should be selected for clomifene citrate therapy only after careful diagnostic evaluation (see indications). The plan of therapy should be outlined in advance. Route of Administration Oral Adults Only: The recommended dose for the first course of Clomifene citrate is 50mg (1 tablet) daily for 5 days. Therapy may be started at any time in the patient who has had no recent uterine bleeding. If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs before therapy, the regimen of 50mg daily for 5 days should be started on or about the fifth day of the cycle. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment. If ovulation appears not to have occurred after the first course of therapy, a _ _ _ _ _ _ Ikaclomin Tablets SPC KO 01.2018 second course of 100mg daily (two 50mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one. Leia o documento completo