Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
clomifene citrate, Quantity: 50 mg
Sanofi-Aventis Australia Pty Ltd
Tablet, uncoated
Excipient Ingredients: sucrose; lactose monohydrate; maize starch; magnesium stearate; pregelatinised maize starch; iron oxide yellow
Oral
10 tablets, 5 tablets
(S4) Prescription Only Medicine
INDICATIONS AS AT 1 JANUARY 1991: CLOMID is indicated for the treatment of ovarian failure in carefully selected infertile women who wish to become pregnant.
Visual Identification: Beige, round, flat faced bevel edged tablet with a score line on one side and "M" into two concentric circles engraved on the other side; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2019-08-08
CLOMID ® (CLO(H)-MID) _clomifene citrate (clom-i-feen sit-rate)_ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Clomid. It does not contain all the available information. It does not take the place of talking to your doctor. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Clomid against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CLOMID IS USED FOR About 20% of couples who experience difficulty in conceiving, do so because the woman's ovaries are not producing and releasing an egg each menstrual cycle (anovulation). Your doctor has prescribed Clomid to treat this. Clomid acts by causing a gland in the brain (the anterior pituitary) to release hormones which stimulate ovulation. It must be remembered that there are many causes of anovulation, so Clomid may not be effective in all cases. When taking Clomid there should be 28-32 days from the beginning of one period to the next. Your ovaries should release an egg 6-12 days after a course of Clomid. You should have intercourse around this time to maximise your chances of conception. If your period does not arrive after the 35th day there are two likely possibilities: • the dose of Clomid has not been sufficient to produce ovulation, or • you are pregnant If your period is overdue, contact your doctor/fertility unit and they will advise you what steps to take. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE CLOMID Your doctor will perform a pelvic examination on you before you begin to take Clomid. This is to check that you have no physical conditions which may stop you falling pregnant or which might indicate that Clomid is not a suitable drug for you. _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE CLOMID IF YOU HAVE AN ALLERGY TO CLOMID OR ANY OF THE INGREDIENTS LISTED AT THE END Read the complete document
clomid-ccdsv8-piv12-22dec20 Page 1 of 12 AUSTRALIAN PRODUCT INFORMATION – CLOMID (CLOMIFENE CITRATE) TABLETS 1 NAME OF THE MEDICINE Clomifene citrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Clomid tablet contains the active ingredient 50 mg clomifene citrate. Excipients with known effect: sugars (sucrose, lactose monohydrate). For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Tablet, 50 mg (beige, scored on one side and M into two concentric circles engraved on the other side). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Clomid is indicated for the treatment of ovulatory failure in carefully selected infertile women who wish to become pregnant. 4.2 DOSE AND METHOD OF ADMINISTRATION The recommended dose for the first course of Clomid is 50 mg (one tablet) daily for five days. When ovulation occurs at this dosage there is no advantage in increasing the dose in subsequent cycles of treatment. If ovulation occurs at this dosage but is not followed by pregnancy, subsequent courses for a total maximum of six cycles of Clomid treatment may be administered. If ovulation appears not to have occurred after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for five days should be given. Increase of the dosage or duration of therapy beyond 100 mg daily for five days should not be undertaken. If ovulatory menses do not occur, this dose may be repeated for two additional cycles but failure to induce ovulation after three consecutive cycles at this dosage should constitute an adequate therapeutic trial. If, however, ovulation does occur at this dosage but is not followed by pregnancy, subsequent courses for a total maximum of 6 cycles of Clomid treatment may be administered. Therapy may be started at any time in a patient who has had no recent uterine bleeding but if progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to clomid-ccdsv8-piv12-22dec20 Page 2 of 12 therapy, the co Read the complete document