Package leaflet: Information for the user

Warning! Keep the leaflet. Information on the immediate packaging is in a foreign language.
Clotrimazolum GSK (Клотримазол GSK 100 mg), 100 mg, vaginal tablets
Clotrimazolum
Clotrimazolum GSK and Клотримазол GSK 100 mg are trade names of the same medicinal product written in Polish and Bulgarian.
Please read the leaflet carefully before use, as it contains important information for the patient.

Keep this leaflet for future reference.
Consult your doctor or pharmacist if you have any questions.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
If the patient experiences any adverse reactions, including those not listed in this leaflet, inform a doctor, pharmacist, or nurse. See section 4.

Table of contents

What Clotrimazolum GSK is and what it is used for
Important information before using Clotrimazolum GSK
How to use Clotrimazolum GSK
Possible side effects
How to store Clotrimazolum GSK
Contents of the pack and other information

1. What Clotrimazolum GSK is and what it is used for

Clotrimazole is a locally acting antifungal agent belonging to the imidazole derivatives group.
It acts against most pathogenic fungi.
The indication for use of Clotrimazolum GSK in the form of vaginal tablets is:

Fungal infections of the vagina and vulva, including infections caused by organisms resistant to nystatin.

2. Important information before using Clotrimazolum GSK

When not to use Clotrimazolum GSK

If the patient is allergic (hypersensitive) to clotrimazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Do not take orally. Avoid accidental contact of the medicine with the eyes.
All potentially infected areas should be treated simultaneously.

Do not use during menstruation to avoid washing out the tablet. Treatment should be completed before the onset of menstrual bleeding.
During treatment, do not use tampons, vaginal douches, spermicides, or other vaginal products.
Sexual intercourse should be avoided during treatment with Clotrimazolum GSK to prevent possible infection of the partner.
If any of the following apply to the patient, she should inform her doctor:
she has had more than two vaginal fungal infections within the last 6 months,
she has previously suffered from sexually transmitted infections or had contact with a partner who has such an infection,
she is pregnant or suspects she may be pregnant,
she is under 12 or over 60 years of age,
she has had hypersensitivity (allergy) to imidazole or other antifungal medicines used vaginally.

The doctor will assess whether it is appropriate to recommend the use of Clotrimazolum GSK vaginal tablets.

Treatment should be discontinued and the patient should consult a doctor if the following occur during treatment:
irregular vaginal bleeding,
abnormal vaginal bleeding or intermenstrual spotting,
vaginal discharge with an unpleasant odour,
vaginal or vulvar ulceration, blisters or sores,
lower abdominal pain or difficulty urinating,
redness, irritation or swelling at the site of administration,
fever above 38°C or chills,
nausea or vomiting,
diarrhoea,
back pain,
shoulder pain.

Clotrimazolum GSK and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.

Clotrimazole applied locally to the external genital mucous membranes may damage latex-based mechanical contraceptives (condoms and diaphragms), thereby reducing their effectiveness. Therefore, during treatment with clotrimazole and for at least 5 days after completion of treatment, alternative contraceptive methods should be used. Consult your doctor to choose another method of contraception.
Vaginal clotrimazole used concomitantly with oral tacrolimus or sirolimus (medicines used after organ transplantation) may increase serum concentrations of tacrolimus or sirolimus. The doctor may recommend monitoring blood serum levels of tacrolimus.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicine. The doctor will evaluate the benefit to the patient and the potential risk to the unborn child associated with the use of Clotrimazolum GSK.
The ingredients of Clotrimazolum GSK may pass into human milk. If a woman is breastfeeding, she should consult her doctor before using this medicine.

Driving and operating machinery
Clotrimazolum GSK has no effect or has a negligible effect on the ability to drive and operate machinery.

3. How to use Clotrimazolum GSK

This medicine should always be used as directed by a physician. In case of doubts, consult a doctor or pharmacist.
Recommended dose
Adults
2 tablets twice daily for 3 consecutive days or 1 tablet per day for 6 to 7 days.
Children
Do not use in children under 12 years of age.
Method of administration
Clotrimazolum GSK tablets are intended for vaginal use. The tablet should be inserted deeply into the vagina (preferably at bedtime).
If the infection involves the labia and adjacent areas, the doctor may recommend simultaneous use of the medicine in the form of a cream.
Duration of treatment
If symptoms worsen or do not improve after 7 days of treatment, consult a doctor again.
The tablets may be used again if the yeast infection returns after 7 days. If the infection recurs more frequently than twice within six months, medical consultation is necessary.
Use of a higher than recommended dose of Clotrimazolum GSK
In case of using a higher than recommended dose or accidental oral ingestion, contact a doctor or pharmacist.
Missed dose of Clotrimazolum GSK
Do not use a double dose to make up for a missed dose.
Discontinuation of Clotrimazolum GSK
Do not discontinue use of the medicine even if symptoms have subsided. Stopping treatment prematurely may cause recurrence of the infection.
In case of any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like any medicine, this medicine can cause adverse effects, although not everybody will experience them.
With unknown frequency, the following may occur:

hypersensitivity, anaphylactic reactions, angioedema, allergic reactions (such as: urticaria, dyspnoea, hypotension, fainting);
rash;
abdominal pain, nausea;
discomfort in the genital area, erythema, burning, itching and pain in the vagina and vulva, desquamation of the vaginal mucosa, vaginal bleeding, vaginal discharge;
irritation, swelling and pain at the site of administration.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, telephone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Clotrimazolum GSK

Keep the medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum GSK contains
The active substance is clotrimazole.
Each vaginal tablet contains 100 mg of clotrimazole.
The other ingredients are: monohydrate lactose, potato starch, adipic acid, sodium hydrogen carbonate, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulfate.

What Clotrimazolum GSK looks like and contents of the pack
Clotrimazolum GSK 100 mg is a white, biconvex, smooth-surfaced, oval-shaped vaginal tablet.
Pack: PVC/aluminium blister pack containing 6 vaginal tablets, in a cardboard box.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Bulgaria, the country of export:
GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
Ireland

Manufacturer:
Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań, Poland

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Bulgaria (country of export) marketing authorisation number: 20030630
Parallel import authorisation number: 108/24