Summary of product characteristics (sopc)

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:

1. intolerance of drug components;
2. severe kidney diseases;
3. hyperthyroidism;
4. toxic adenoma of the thyroid gland, multinodular goiter;
5. furunculosis, chronic pyoderma;
6. hemorrhagic diathesis.

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