MYCORIL Vaginal tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Mycoril 100 mg vaginal tablets.
Mycoril 200 mg vaginal tablets.
Mycoril 500 mg vaginal tablets.
2. Qualitative and quantitative composition
Mycoril 100 mg vaginal tablets: Each vaginal tablet contains 100 mg clotrimazole.
Mycoril 200 mg vaginal tablets: Each vaginal tablet contains 200 mg clotrimazole.
Mycoril 500 mg vaginal tablets: E...
3. Pharmaceutical form
Vaginal tablet.
Mycoril 100 mg vaginal tablets:
White, bullet shaped tablets, embossed with Remedica's logo on one side.
Mycoril 200 mg vaginal tablets:
White, bullet shaped tablets, embosse...
4.1. Therapeutic indications
Mycoril is indicated for the treatment of candidal vaginitis.
4.2. Posology and method of administration
Posology
Adults and children of 12 years of age and older
Mycoril 100 mg vaginal tablets:
Insert one vaginal tablet daily, preferably at night, before going to bed, for six consecutive days. Alter...
4.3. Contraindications
Hypersensitivity to clotrimazole or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Medical advice should be sought if this is the first time the patient has experienced symptoms of candidal vaginitis.
Before using Mycoril, medical advice must be sought if any of the following are...
4.5. Interaction with other medicinal products and other forms of interaction
Laboratory tests have suggested that, when used together, this product may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. Patients shou...
4.6. Fertility, pregnancy and lactation
Fertility
No human studies of the effects of clotrimazole on fertility have been performed, however, animal studies have not demonstrated any effects of the drug on fertility.
Pregnancy
There are l...
4.7. Effects on ability to drive and use machines
The medication has no or negligible influence on the ability to drive or use machinery.
4.8. Undesirable effects
The following adverse reactions have been identified during post-approval use of clotrimazole. Because these reactions are reported voluntarily from a population of uncertain size, it is not always...
4.9. Overdose
In the event of accidental oral ingestion, routine measures such as gastric lavage should be performed only if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting).
5.1. Pharmacodynamic properties
Pharmacotherapeutic group:
Gynecological anti-infectives and antiseptics, Anti-infectives and antiseptics excl. combinations with corticosteroids
ATC code:
G01AF02
Mechanism of action
Clotrimazo...
5.2. Pharmacokinetic properties
Pharmacokinetic investigations after vaginal application have shown that only a small amount of clotrimazole (3-10% of the dose) is absorbed. Due to the rapid hepatic metabolism of absorbed clotrim...
5.3. Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction...
6.1. List of excipients
Calcium lactate pentahydrate
Lactose monohydrate
Maize starch
Lactic acid
Hypromellose
Cellulose, microcrystalline
Crospovidone
Silica, colloidal anhydrous
Magnesium stearate
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
M
ycoril 100 mg vaginal tablets:
Aluminium strips. The pack also contains an applicator. Pack-size of 6 vaginal tablets.
Mycoril 200 mg vaginal tablets:
Aluminium strips. The pack also contains a...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Mycoril 100 mg vaginal tablets: 14906
Mycoril 200 mg vaginal tablets: 19874
Mycoril 500 mg vaginal tablets: 17952
9. Date of first authorization / renewal of the authorization
Mycoril 100 mg vaginal tablets:
Date of first authorisation: 09 September 1994
Date of latest renewal: 01 September 2010
Mycoril 200 mg vaginal tablets:
Date of first authorisation: 13 December 20...
10. Date of revision of the text
02/2021
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