Marketing authorization number: Р N002501/01
Brand name: Mamoclam
INN: Laminaria thalli
Dosage form: 100 mg film-coated tablets
Each tablet contains:
100 mg of the active substance, the lipid complex named – “Clam”- obtained by saponification of
concentrate from dried Laminaria thalli (with 30% of long-chain fatty acids and 0.1% of iodine calculated with reference to dried basis ).
Excipients including microcrystalline cellulose, lactose, sucrose, potato starch, magnesium carbonate, calcium stearate, povidone, and Silicii dioxydum colloidale (aerosil).
Film coating ingredients including hypromellose, titanium dioxide, macrogolum 6000, and Copper Chlorophylls.
Description
Film-coated, round, biconvex, deep green to light green tablets. On the cut, tablets are light brown with spots of darker and lighter color and specific odor.
Therapeutic category
Plant-based drug for treatment of mastopathy.
ATC code: G02C
Pharmacological properties
Mamoclam has therapeutic effect in fibrocystic breast disease (mastopathy). It relieves signs of mastalgia and premenstrual syndrome, reduces breast cysts, and normalizes mammary epithelial cell proliferation.
Indications
Mamoclam is suitable for both single-agent therapy and combination therapy.
Contraindications:
Use during pregnancy and lactation
During pregnancy and lactation it is possible to use iodine in physiological doses only: no more than 250 mg per day
Posology and method of administration
Mamoclam should be taken orally before meals. Single dose - 1-2 tablets 2-3 times a day at regular intervals during the day (daily dose is 3-6 tablets). Length of treatment is 1-3 months.
If necessary, repeat the course after a break (from two weeks to three months).
Possible side effects
Mamoclam is usually well tolerated. Some patients may experience the following side effects:
Idiosyncratic drug reaction in the form of the skin itching, redness, and cutaneous eruption.
Gastrointestinal disorders: heartburn , flatulence, diarrhea
In prolonged use, iodism (including rhinitis, Quincke's edema, salivation, lacrimation, acne)
Interaction with other drugs
In applying Mamoclam at therapeutic doses body gets iodine in doses somewhat higher than the recommended dose of physiological trace element, in this connection, Mamoclam should not be used with drugs containing iodine
Overdose
Manifestations of overdosage have not been identified in the application of Mamoclam
Pharmaceutical form
100 mg; film-coated tablets.
Pack size: - bottle packed, available in packs of 20, 30 (orange glass bottle), 40 (polymer bottle).
- blister packed, available in packs of 10, 20.
A bottle or 2 or 4 blisters are packed in a secondary cardboard package with SoPC. The SoPC may be printed on a secondary package.
Storage conditions
Store in a dry place at temperature no higher than 25 ° C. Keep out of reach of children
Shelf life
2 years. Do not use this medicine after the expiry date, which is stated on the carton.
Conditions of supply of pharmacies
Without prescription.
Manufacturer / organization receiving claims
ZAO "Mega Farm"
Rusakovskaya St, 22. 107014, Moscow, Russia
Tel./fax (501) 443-95-71
Ordered by LTD «FITOLON-NAUKA»
Donskaya St, 19 - 4-H. 199178, Saint-Petersburg, Russia
Tel./fax (812) 337-50-70