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: Each ...

3. Pharmaceutical form

Vaginal tablet. Mycoril 100 mg vaginal tablets: White, bullet shaped tablets, embossed with Remedicas logo on one side. Mycoril 200 mg vaginal tablets: White, bullet shaped tablets, embossed ...

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. Alternatively, ...

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 applicable: ...

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 should be ...

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 limited ...

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 possible ...

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 Clotrimazole ...

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 clotrimazole ...

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 and ...

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

Mycoril 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 ...

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 2005 Date ...

10. Date of revision of the text

02/2021

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