Patient Information Leaflet

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

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The 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 or pharmacist. 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:

Candidal 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 simultaneously.

This medicine should not be used 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 use of Clotrimazolum GSK to prevent possible infection of the partner.
If the patient has any of the following conditions, she should inform her doctor:
more than two fungal vaginal infections occurred within the last 6 months,
the patient previously had a sexually transmitted disease or had contact with a partner who had such a disease,
the patient is pregnant or suspects she may be pregnant,
the patient is under 12 or over 60 years of age,
the patient has hypersensitivity (allergy) to imidazole or other antifungal medicines applied vaginally.

The doctor will assess whether use of Clotrimazolum GSK can be recommended for the patient.

Treatment should be discontinued and the patient should consult a doctor if any of 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 application,
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 mucous membranes of the external genital organs 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 serum tacrolimus levels.

Pregnancy and breastfeeding
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor before using this medicine. The doctor will weigh the benefit to the patient against the potential risk to the fetus associated with use of Clotrimazolum GSK.
Clotrimazolum GSK may be used during breastfeeding under medical supervision.

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
physician or pharmacist.
Recommended dose
Adults
2 tablets twice daily for 3 consecutive days, or 1 tablet daily for 6 to 7 days.
Children
Do not use in children under 12 years of age.
Method of administration
Clotrimazolum GSK is administered intravaginally. The tablet should be inserted deeply
into the vagina (preferably at bedtime).
If the infection involves the labia and surrounding areas, the physician may recommend
concomitant use of the medicine in cream form.
Duration of treatment
If symptoms worsen or do not improve after 7 days of using the medicine, consult a
physician again.
Tablets may be used again if the yeast infection recurs after 7 days. If infections recur
more frequently than twice within six months, medical consultation is required.
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 physician 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 stop using the medicine even if symptoms have resolved. Discontinuing treatment
may lead to recurrence of infection.
If you have any further questions regarding the use of this medicine, consult a
physician or pharmacist.

4. Possible adverse reactions

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

hypersensitivity, anaphylactic reactions, angioedema, allergic reactions (such as: urticaria, dyspnoea, hypotension, fainting);
rash, itching;
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 reactions
If any adverse symptoms occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department for Monitoring Adverse Reactions of Medicinal Products
at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to gather further information on the safety of the medicine.

5. How to store Clotrimazolum GSK

Keep this medicine out of 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 stated 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: lactose monohydrate, potato starch, adipic acid, sodium hydrogen carbonate, magnesium stearate, colloidal anhydrous silica, sodium lauryl sulphate.

What Clotrimazolum GSK looks like and contents of the pack
Clotrimazolum GSK 100 mg is a white, biconvex, smooth-surfaced, oval vaginal tablet.
Pack: PVC/Aluminium blister pack containing 6 vaginal tablets.

For more detailed information on the medicine, please contact the Marketing Authorisation Holder 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, Grunwaldzka 189, 60-322 Poznań, Poland

Parallel importer:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland

Marketing Authorisation number in Bulgaria, the country of export: 20030630
Parallel import authorisation number: 287/24