Package leaflet: Information for the patient

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!
Clotrimazolum GSK (Клотримазол 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 languages.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask 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 you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 medicine belonging to the imidazole derivatives group.
It acts against most pathogenic fungi.
The indication for Clotrimazolum GSK in the form of vaginal tablets is:

Vaginal and vulval candidiasis, 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.

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 the patient has any of the following conditions, she should inform her doctor:
experienced more than two vaginal fungal infections within the last 6 months,
had a sexually transmitted disease in the past or had contact with a partner who had such a disease,
is pregnant or suspects she may be pregnant,
is under 12 or over 60 years of age,
has 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.

Discontinue treatment and consult a doctor immediately if any of the following occur during treatment:
irregular vaginal bleeding,
abnormal vaginal bleeding or intermenstrual spotting,
vaginal discharge with an unpleasant odour,
ulceration of the vagina or vulva, 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 contraceptive devices (condoms and diaphragms), thereby reducing their effectiveness. Therefore, during treatment with clotrimazole and for at least 5 days after its completion, alternative contraceptive methods should be used. Consult your doctor to choose another method of contraception.
Vaginal use of clotrimazole together 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 a doctor before using this medicine. The doctor will evaluate the benefit to the patient and the potential risk to the fetus associated with the 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 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. If in doubt, 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 for vaginal use. The tablet should be inserted deep into the vagina (preferably at bedtime).
If the infection involves the labia and surrounding areas, the doctor may recommend simultaneous use of the medicine in cream form.
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 infections recur more 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 stop using the medicine even if symptoms have improved. Discontinuing treatment may lead to recurrence of infection.
If you have any further questions regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following may occur with unknown frequency:

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 application site.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration 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 adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store Clotrimazolum GSK

Keep the 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 specified month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices 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 is in the form of white, biconvex vaginal tablets with bevelled edges, elongated in shape, with one end rounded and the other end straight bevelled.
Pack: PVC/Aluminium blister pack containing 6 vaginal tablets, in a cardboard box.
For more detailed information, 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
ul. Grunwaldzka 189
60-322 Poznań
Poland

Parallel Importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation number in Bulgaria, the country of export: 20030630
Parallel Import Licence number: 23/25