CLOTRIMAZOLUM 100 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Clotrimazolum GSK, 100 mg, Vaginal Tablets
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
3. What is Clotrimazolum GSK and what is it used for
4. Important information before using Clotrimazolum GSK
   1. When not to use Clotrimazolum GSK
   2. Warnings and precautions
   3. Clotrimazolum GSK and other medicines
   4. Pregnancy and breastfeeding
   5. Driving and using machines
5. How to use Clotrimazolum GSK
   1. Using more than the recommended dose of Clotrimazolum GSK
   2. Missing a dose of Clotrimazolum GSK
   3. Stopping the use of Clotrimazolum GSK
6. Possible side effects
   1. Reporting side effects
7. How to store Clotrimazolum GSK
8. Contents of the pack and other information
   1. What Clotrimazolum GSK contains
   2. What Clotrimazolum GSK looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer
   5. Date of the last revision of the leaflet:

Package Leaflet: Information for the User

Clotrimazolum GSK, 100 mg, Vaginal Tablets

Clotrimazolum

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. 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.
It acts on most pathogenic fungi.
The indication for using Clotrimazolum GSK in the form of vaginal tablets is:

• vaginal and vulvar yeast infections, including infections caused by microorganisms resistant to nystatin.

2. Important information before using Clotrimazolum GSK

When not to use Clotrimazolum GSK

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

Warnings and precautions

Do not use 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, you should not use tampons, vaginal douches, spermicides, or other vaginal products.
• While using Clotrimazolum GSK, you should refrain from sexual intercourse due to the possibility of infecting your partner.
• If any of the following apply to you, tell your doctor:
• you have had more than two cases of vaginal yeast infections in the last six months,
• you have had a sexually transmitted disease or have had contact with a partner with such a disease,
• you are pregnant or think you may be pregnant,
• you are under 12 or over 60 years old,
• you have been diagnosed with hypersensitivity (allergy) to imidazole or other antifungal medicines used vaginally.

Your doctor will assess whether you can be recommended to use Clotrimazolum GSK vaginal tablets.

• Stop the treatment and consult your doctor if you experience any of the following 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 application site,
• 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, have recently taken, or might take.

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

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Your doctor will weigh the benefit for you and the risk for your baby of using Clotrimazolum GSK.
Clotrimazolum GSK can be used during breastfeeding under medical supervision.

Driving and using machines

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

3. How to use Clotrimazolum GSK

Always use this medicine exactly as your doctor has told you.
In case of doubt, consult your 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 of age.
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, your 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 your 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 more than the recommended dose of Clotrimazolum GSK

In case of using a higher dose than recommended or accidental oral ingestion, contact your doctor or pharmacist.

Missing a dose of Clotrimazolum GSK

Do not use 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 the treatment may cause the infection to recur.
If you have any further questions about the use of this medicine, ask your 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:

• anaphylactic reaction, angioedema, hypersensitivity (with symptoms such as: hives, shortness of breath, low blood pressure, fainting);
• rash, itching;
• 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 application site.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, please tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Clotrimazolum GSK

Keep the medicine out of the 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 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, oblong, biconvex vaginal tablet with a flat base and rounded edges on one side and a straight cut edge on the other.
Packaging: a blister pack made of colorless or white polyvinyl chloride film and aluminum foil (PVC/Aluminum) containing 6 vaginal tablets, in a cardboard box.

Marketing authorization holder

GSK PSC Poland sp. z o.o.
ul. Grunwaldzka 189
60-322 Poznań

Manufacturer

Delpharm Poznań Spółka Akcyjna
ul. Grunwaldzka 189
60-322 Poznań
To obtain more detailed information, please contact the representative of the marketing authorization holder:
GSK Services Sp. z o.o.
tel. (22) 576-90-00

Date of the last revision of the leaflet:

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