INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo MENOFLUSH TABLETS

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

MENOFLUSH TABLETS

COMPOSITION:
Each Menoflush tablet contains:
Ethinyl oestradiol         0,02 mg Vitamin B12         3 mcg
Vitamin A         4000 i.u. Vitamin C         50 mg
Vitamin B1         2 mg Nicotinamide         20 mg
Vitamin B2         1,5 mg Pyridoxine (B6)         1 mg

PHARMACOLOGICAL CLASSIFICATION:
21.8.1 Oestrogens

PHARMACOLOGICAL ACTION:
Ethinyl oestradiol
has a powerful oestrogenic action.
The multivitamins supplement the intake of food.

INDICATIONS:
Menopausal symptoms and senile changes in women.

CONTRA-INDICATIONS
Oestrogens should be avoided in pregnant women. Oestrogens are contra-indicated in patients with a family or personal history of malignant neoplastic disease of the breast or genital tract (unless indicated for the treatment of the neoplasm and in those patients with previous thrombo-embolic disorders; cardiovascular disease; thrombophlebitis; undiagnosed vaginal bleeding, herpes gestationis, or endometriosis; liver impairment or sickle-cell anaemia. Oestrogens may cause fluid retention, therefore must be used with care in patients with asthma, epilepsy, migraine, heart or kidney disease.
Use with care in patients with hypertension and hypercalcaemia and in disorders such as otosclerosis which are known to be subject to deterioration during pregnancy. It may precipitate porphyria in susceptible patients and may exacerbate diabetes mellitus. Use with care in women who are breast-feeding.

DOSAGE AND DIRECTIONS FOR USE:
Menoflush: If the uterus is intact:
1 or 2 tablets per day from day 1 to day 25.
Progestogen to be added from day 16 to day 25.
It there is no uterus, progestogen need not be added.
To be taken at the same time each day.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
It any abnormal or irregular uterine bleeding should occur, treatment should be stopped and the cause of the bleeding ascertained.
Ethinyl oestradiol may cause sodium and water retention with oedema, weight gain, tenderness and enlargement of the breasts, changes in libido, menstrual disorders and withdrawal bleeding, alterations in liver function, jaundice, gall-stones, depression, headache, migraine, dizziness, a decrease in glucose tolerance, and decrease in tolerance of contact lenses. It may cause hypercalcaemia when employed in metastatic malignant conditions. Most oestrogens produce dose-related nausea and vomiting and other gastro-intestinal disturbances. Skin reactions include chloasma or melasma, rashes, and urticaria. Erythema multiforme and erythema nodosum have been reported. Unopposed oestrogen therapy may cause endometrial proliferation and there is a risk of an increased incidence of endometrial hyperplasia and consequently carcinoma, especially in postmenopausal women. This association may be prevented if oestrogens are given cyclically with added progestogens.
Vitamin A: Excessive amounts of Vitamin A over long periods can lead to toxicity, known as hypervitaminosis A, which is characterised by fatigue, irritability, anorexia and loss of weight, vomiting and other gastro-intestinal disturbances, low-grade fever, hepatosplenomegaly, skin changes, alopecia, dry hair, cracking and bleeding lips, anaemia, headache, hypercalcaemia, subcutaneous swelling and pains in the bones and joints.
Vitamin B1: Adverse effects seldom occur following administration of thiamine.
Vitamin B2: No adverse effects have been reported with the use of riboflavine.
Vitamin C: Large doses are reported to cause diarrhoea and other gastro-intestinal disturbances. Ascorbic acid should be given with care to patients with hyperoxaluria.
Vitamin B12: Allergic hypersensitivity reactions have occurred rarely.
Nicotinamide: No adverse effects have been reported with the use of nicotinamide.
Pyridoxine (B6): Long-term administration of large doses in excess of 2 g of pyridoxine is associated with the development of severe peripheral neuropathies.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Following an overdose of Menoflush, the stomach may be emptied by gastric lavage and aspiration, the patient must be taken to the nearest hospital for symptomatic and supportive therapy.

CONDITIONS OF REGISTRATION:
Advertising to the professions only.

IDENTIFICATION:
Yellow sugar-coated tablets

PRESENTATION:
Packs of 30 and 100 tablets.

STORAGE INSTRUCTIONS:
Store in a cool, dry place below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
A/21.8.1/743

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmaceutical Enterprises (Pty) Ltd
Howard Studios, Howard Drive, Pinelands 7405

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
June 2000

Updated on this site: March 2004
Source: Pharmaceutical Industry

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