Clotrimazolum Gsk

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

Clotrimazolum GSK (Clotrimazole GSK 100 mg), 100 mg, vaginal tablets

Clotrimazolum
Clotrimazolum GSK and Клотримазол GSK 100 mg are trade names of the same medicine
recorded in Polish and Bulgarian.

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their illness symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Clotrimazolum GSK and what is it used for
• 2. Important information before using Clotrimazolum GSK
• 3. How to use Clotrimazolum GSK
• 4. Possible side effects
• 5. How to store Clotrimazolum GSK
• 6. Contents of the pack and other information

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

Clotrimazole is a locally acting antifungal medicine from the imidazole derivative group.
The indication for using Clotrimazolum GSK in the form of vaginal tablets is:

• yeast infections of the vagina and vulva, including infections caused by microorganisms 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 at the same time.

• The medicine should not be used during menstruation to avoid washing out the tablet. Treatment should be completed before the start of menstrual bleeding.
• During treatment, do not use tampons, vaginal douches, spermicides, or other vaginal products.
• While using Clotrimazolum GSK, refrain from sexual intercourse due to the possibility of infecting your partner.
• If any of the following apply to the patient, they should tell their doctor:
• the patient has had more than two cases of vaginal candidiasis in the last 6 months,
• the patient has had a sexually transmitted disease or has had contact with a partner with such a disease,
• the patient is pregnant or thinks she may be pregnant,
• the patient is under 12 or over 60 years old,
• the patient has been diagnosed with hypersensitivity (allergy) to imidazole or other antifungal medicines used vaginally.

The doctor will assess whether the patient can be recommended to use Clotrimazolum GSK vaginal tablets.

• Treatment should be stopped and a doctor consulted if any of the following occur during treatment:
• irregular vaginal bleeding,
• abnormal vaginal bleeding or intermenstrual spotting,
• vaginal discharge with an unpleasant odor,
• ulceration of the vagina or vulva, 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,
• diarrhea,
• back pain,
• shoulder pain.

Clotrimazolum GSK and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

• Clotrimazole used locally on the mucous membranes of the external genital organs may damage mechanical contraceptives made of latex (condoms and diaphragms), thereby reducing their effectiveness. Therefore, during treatment with clotrimazole and for at least 5 days after its completion, other contraceptive methods should be used. Consult a doctor to choose another method of preventing pregnancy.
• Clotrimazole used vaginally at the same time as tacrolimus or sirolimus taken orally (medicines used after organ transplantation) may increase the concentration of tacrolimus or sirolimus in the blood. The doctor may recommend checking the tacrolimus concentration in the blood.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medicine. The doctor will weigh the benefits and risks to the mother and child associated with using Clotrimazolum GSK.
The ingredients of Clotrimazolum GSK may pass into breast milk. If a woman is breastfeeding, she should consult a doctor before using this medicine.

Driving and using machines

Clotrimazolum GSK has no influence or insignificant influence on the ability to drive and use machines.

3. How to use Clotrimazolum GSK

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
Recommended dose
Adults
2 times 1 tablet for 3 consecutive days or 1 tablet per day for 6 to 7 days.
Children
Do not use in children under 12 years old.
Method of administration
Clotrimazolum GSK tablets are used vaginally. The tablet should be inserted deep into the vagina (preferably at night).
If the infection involves the vulva and surrounding areas, the doctor may recommend using the medicine in the form of a cream at the same time.
Duration of treatment
If symptoms worsen or do not improve after 7 days of using the medicine, consult a doctor again.
Tablets can be used again if the yeast infection returns after 7 days. If the infection recurs more than twice in six months, a medical consultation is necessary.

Using a higher dose of Clotrimazolum GSK than recommended

In case of using a higher dose of the medicine than recommended or accidental oral ingestion, consult a doctor or pharmacist.

Missing a dose of Clotrimazolum GSK

Do not take a double dose to make up for a missed dose.

Stopping the use of Clotrimazolum GSK

Do not stop using the medicine even if the symptoms of the disease have disappeared. Stopping treatment may cause the infection to recur.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
With unknown frequency, the following may occur:

• hypersensitivity, anaphylactic reactions, angioedema, allergic reactions (such as: hives, shortness of breath, low blood pressure, fainting);
• rash;
• abdominal pain, nausea;
• discomfort in the genital area, redness, burning, itching, and pain in the vagina and vulva, shedding of the vaginal mucosa, vaginal bleeding, discharge;
• irritation, swelling, and pain at the site of administration.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Clotrimazolum GSK

Keep the medicine out of sight and reach of children.
Store in a temperature 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 given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Clotrimazolum GSK contains

The active substance of the medicine is clotrimazole.
One vaginal tablet contains 100 mg of clotrimazole.
The other ingredients are: lactose monohydrate, potato starch, adipic acid, sodium bicarbonate, 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, oval-shaped, biconvex vaginal tablet with a smooth surface.
Packaging: PVC/aluminum blister pack containing 6 vaginal tablets, in a cardboard box.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Bulgaria, the country of export: 20030630

Parallel import authorization number: 108/24

Date of leaflet approval: 13.03.2024

[Information about the trademark]