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   Fertomid: Manufacturers Information Sheet


Fertomid-25 Tablets
Fertomid-50 Tablets

Composition
Fertomid-25 Tablets
Each tablet contains Clomiphene Citrate BP 25 mg
Fertomid-50 Tablets
Each tablet contains Clomiphene Citrate BP 50 mg

Description
Clomiphene citrate is a nonsteroidal agent which stimulates ovulation in a high percentage of appropriately selected anovulatory women, and improves sperms count and motility in men by inhibition of the negative feedback to the hypothalamus and anterior pituitary. It has no progestational, androgenic, or antiandrogenic effects and does not appear to interfere with pituitaryadrenal or pituitary thyroid functions.

Indications
FEMALE INFERTILITY
Fertomid induces ovulation in selected anovulatory women. Fertomid can be used to make an irregularly ovulating woman ovulate regularly. The fertile period can be known in advance and coitus can thus be timed accordingly.
In women having a menstrual cycle with a short luteal phase, pregnancy does not occur in spite of ovulation and fertilisation. Fertomid rectifies this by increasing the levels of progesterone.
OTHER GYNAECOLOGICAL DISORDERS
Fertomid is useful in the treatment of oligomenorrhoea, dysfunctional uterine bleeding, amenorrhoea, post pill amenorrhoea, Stein Leventhal syndrome (polycystic ovarian diseases), and Chiari Frommel syndrome.
MALE INFERTILITY
Fertomid increases spermatogenesis and is useful in oligospermia and asthenospermia.

Dosage and Administration
Female Infertility
One tablet of Fertomid-50 daily for five days starting on the fifth day of the menstrual cycle. If ovulation does not appear to have occurred, a second course of two tablets of Fertomid-50 daily (in a single dose) for five days should be given starting from the fifth day of the next cycle.
A third treatment cycle may follow, with dosage regimens that are similar to the second.
An interval of 30 days should be maintained between consecutive courses.
In amenorrhoeic patients, the regimen is identical, but treatment can be started on any day.
Male infertility
A dose of one tablet of Fertomid-25 daily for 25 days followed by a rest period of five days for three months.

Contraindications
Liver disease or history of liver dysfunction, in those with abnormal bleeding ofundetermined origin, in patients with neoplastic diseases of the genital tract.
PREGNANCY
Because the drug may adversely affect the human foetus, it is absolutely contraindicated in pregnancy. To avoid inadvertent Fertomid administration during early pregnancy, the patient should be carefully monitored to determine if ovulation occurs. If pregnancy or the presence of an ovarian cyst is suspected, subsequent therapy should be delayed until a correct diagnosis has been made.

Warnings and Precautions
Long term cyclic therapy with Fertomid is not recommended.
MULTIPLE PREGNANCY
There is an increased chance of multiple pregnancy when conception occurs in relationship to Fertomid therapy.
OVARIAN CYST
Pelvic examination is necessary prior to start of and before each subsequent course of Fertomid. Fertomid should not be given in the presence of an ovarian cyst (including endometriosis involving the ovary).
OVARIAN ENLARGEMENT
Pelvic examination is advised before each course of Fertomid to exclude abnormal ovarian enlargement. Maximal enlargement of the ovary occurs several days after completion of the course. Patients who complain of pelvic pain should be examined with care. If ovarian enlargement occurs, subsequent courses of Fertomid should be postponed till the ovaries have returned to their pretreatment size. It is important that the lowest dose of Fertomid consistent with expectation of good results be used.
A lower dosage or a shorter duration of treatment is recommended in case unusual sensitivity to pituitary gonadotrophins is suspected as in some patients with polycystic ovaries.

Side Effects
Side effects are dose related. The most common side effects are abdominal discomfort (distension, bloating, pain or tenderness), ovarian enlargement and visual blurring. The vasomotor symptoms resembling menopausal hot flushes are usually severe and disappear soon after treatment is discontinued.
Rare instances of massive ovarian enlargement and rupture of luteal cyst with haemoperitoneum have been reported.
Other less frequently reported symptoms include nausea, vomiting, increased nervous tension, depression, fatigue, dizziness, insomnia, headache, breast tenderness, heavier menses, intermenstrual spotting, weight gain, urticaria, allergic dermatitis, increased urinary frequencies and moderate reversible hair loss. When given continuously for prolonged period, clomiphene citrate may interfere with cholesterol synthesis.

Presentation
Fertomid-25 Blister pack of 10 tablets
Fertomid-50 Blister pack of 10 tablets


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