MYCORIL Vaginal tablet Ref.[28282] Active ingredients: Clotrimazole

Source: Υπουργείο Υγείας (CY)  Revision Year: 2021  Publisher: Remedica Ltd, Aharnon Str., Limassol Industrial Estate, 3056 Limassol, Cyprus

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, two vaginal tablets can be inserted for three consecutive days.

Mycoril 200 mg vaginal tablets: one vaginal tablet should be inserted into the vagina daily, preferably at night, before going to bed, for three consecutive days.

Mycoril 500 mg vaginal tablets: one vaginal tablet should be inserted into the vagina, preferably at night before going to bed.

If symptoms persist for more than 7 days the patient may have a medical condition that requires treatment by a doctor.

The treatment can be repeated if necessary, however, recurrent infections may indicate an underlying medical cause. Patients should seek medical advice if symptoms return within 2 months.

If the labia and adjacent areas are simultaneously infected, local treatment with an external cream should also be given, in addition to the intravaginal treatment (combination treatment).

Mycoril vaginal tablets need moisture in the vagina in order to dissolve completely, otherwise undissolved pieces of the vaginal tablet might crumble out of the vagina. Pieces of undissolved vaginal tablet may be noticed by women who experience vaginal dryness. To help prevent this, it is important that the vaginal tablet is inserted as high as possible into the vagina at bedtime.

Treatment during the menstrual period should not be performed due to the risk of the vaginal tablet being washed out by the menstrual flow. The treatment should be finished before the onset of menstruation.

Do not use tampons, intravaginal douches, spermicides or other vaginal products while using this product.

Vaginal intercourse should be avoided in case of vaginal infection and while using this product because the partner could become infected.

Children under 12 years of age

As this product is administered with a vaginal applicator, paediatric usage is not recommended.

Method of administration

Mycoril vaginal tablets should be inserted into the vagina, as high as possible, using the applicator provided. This is best achieved when lying back with legs bent up.

Instructions for the use of the applicator (please see picture below):

  1. Remove the applicator from the packaging. Pull out the plunger (A) until it stops. Remove the vaginal tablet from the foil strip pack and place it firmly into the applicator (B).
  2. Insert the applicator containing the vaginal tablet carefully as deep as is comfortable into the vagina. This is best done when lying on your back with your knees bent up.
  3. Holding the applicator in place, slowly press the plunger until it stops; thereby the vaginal tablet is deposited into the vagina.
  4. Remove the applicator. After use, remove plunger A completely by pulling it out of the applicator B. Then wash it in warm (not boiling) soapy water, rinse and dry carefully.
  5. After completing the treatment, dispose of the applicator in a safe place, out of the reach of children. The applicator cannot be flushed down the toilet.

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).

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 an applicator. Pack-size of 3 vaginal tablets.

Mycoril 500 mg vaginal tablets: Aluminium strips. The pack also contains an applicator. Pack-size of 1 vaginal tablet.

6.6. Special precautions for disposal and other handling

No special requirements.

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.