METAGYL Tablet (2022)
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Περιεχόμενα
1. Name of the medicinal product
Metagyl Tablets. Metagyl Forte Tablets.
2. Qualitative and quantitative composition
<b>Metagyl Tablets:</b> Each film coated tablet contains: Metronidazole 200 mg. <b>Metagyl Forte Tablets:</b> Each film coated tablet contains: Metronidazole 400 mg. Sugar Free.
3. Pharmaceutical form
<u>Metagyl Tablets:</u> Sky blue, round, biconvex film coated tablets. <u>Metagyl Forte Tablets:</u> Sky blue, round, biconvex film coated tablets.
4.1. Therapeutic indications
a) In the oral treatment of: urogenital trichomoniasis nonspecific vaginitis all forms of amoebiasis giardiasis acute ulcerative gingivitis (Vincents) acute pericoronitis b) Treatment of infections in ...
4.2. Posology and method of administration
The tablets should betaken with or afterfood. Immature children and babies weighing less than 10 kg should receive proportionally smalle doses, as advised by the physician. Children over 10 years may be ...
4.3. Contraindications
Hypersensitivityto metronidazole. Active organic disease of central nervous system including epilepsy. Blood dyscrasias or a history of blood dyscrasias. Severe hepatic function impairment. The safety ...
4.4. Special warnings and precautions for use
Patients should be advised not to take alcohol during metronidazole therapy and for at least one day afterwards because of the possibility of disulfiram-reaction. Precautions Metronidazole should be used ...
4.8. Undesirable effects
Following side-effects with metronidazole have been reported: <b>Gastrointestinal system</b> Dryness of mouth, unpleasant metallic taste, diarrhoea, loss of appetite, nausea or vomiting, stomach pain ...
4.9. Overdose
See side effects: Treatment is symptomatic and supportive.
5.1. Pharmacodynamic properties
<b>Pharmacological classification:</b> A 20.2 Antimicrobial (chemotherapeutic) agents other than antibiotics. Antibacterial Activity Metronidazole is active against protozoa including Entamoeba hintolytica. ...
6.1. List of excipients
Microcrystalline cellulose, maize starch, povidone K30, crospovidone, colloidal anhydrous silica, magnesium stearate, hydroxypropylmethyl cellulose, macrogol-400, brilliant blue lake, titanium dioxide, ...
6.4. Special precautions for storage
Keep in well closed in light-resistant containers, at or below 25°C. KEEP OUT OF REACH OF CHILDREN.
6.5. Nature and contents of container
<u>Metagyl Tablets:</u> Blisters and patient ready packs of 21s, 28s or 250s. HDPE Bottle of 1000s. <u>Metagyl Forte Tablets:</u> Blisters and patient ready packs of 55, 14s, 21s or 100s. HDPE Bottle of ...
7. Marketing authorization holder
Oethmaan Biosims (PTY) Ltd., 207A Sherwood House, Greenacres Office Park, c/o Victory and Rustenburg Roads, Victory Park, Johannesburg 2195
8. Marketing authorization number(s)
Metagyl Tablets: 32/20.2/0218 Metagyl Forte Tablets: 32/20.2/0219
9. Date of first authorization / renewal of the authorization
29 July 1998
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