CLOTRIMAZOL AL

CLOTRIMAZOLE AL 2% vaginal cream

Important notes (mandatory information)

Clotrimazole AL 2%. Areas of application: for discharge caused by fungi (mostly Candida), inflammation of the vagina caused by fungi and superinfections with bacteria sensitive to clotrimazole.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Clotrimazole AL 2%
Active ingredient: Clotrimazole 0.02 g/g vaginal cream

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve after 4 days, you must see a doctor.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

What this leaflet contains

1. WHAT IS CLOTRIMAZOLE AL 2% AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING CLOTRIMAZOLE AL 2%?
3. HOW TO USE CLOTRIMAZOLE AL 2%?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE CLOTRIMAZOLE AL 2%?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS CLOTRIMAZOLE AL 2% AND WHAT IS IT USED FOR?

Clotrimazole AL 2% is a medicine for the treatment of fungal infections of the vagina. The active ingredient clotrimazole inhibits the growth and reproduction of fungal cells such as yeasts and a number of other fungi and some bacteria. Clotrimazole AL 2% is used for discharge caused by fungi (mostly Candida), inflammation of the vagina caused by fungi and superinfections with bacteria sensitive to clotrimazole.

2. WHAT SHOULD YOU CONSIDER BEFORE USING CLOTRIMAZOLE AL 2% ?

Clotrimazole AL 2% must not be used if you are allergic to clotrimazole or any of the other ingredients of this medicine listed in section 6. In case of hypersensitivity to cetyl stearyl alcohol, it is recommended to use a dosage form without cetyl stearyl alcohol (e.g. vaginal tablets) instead of the vaginal cream.

Warnings and precautions

The following describes when you should only use the medicine under certain conditions and only with special caution. Please consult your doctor:

• if this is the first time you have had the condition.
• if you have had more than 4 such fungal infections in the past 12 months.

If you have a fever (temperature of 38°C or higher), lower abdominal pain, back pain, foul-smelling vaginal discharge, nausea, vaginal bleeding and/or associated with shoulder pain, you should consult a doctor. In case of simultaneous infection of the labia and adjacent areas, local treatment with a clotrimazole-containing cream for external use is indicated in addition to intravaginal treatment (combination therapy). The partner should also undergo local treatment if symptoms such as itching and inflammation are present. Tampons, douches, spermicides or other vaginal products should not be used during treatment. It is recommended to abstain from sexual intercourse in case of vaginal infections and as long as this product is used, as the partner may become infected.

Use of Clotrimazole AL 2%

together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If vaginal clotrimazole and oral tacrolimus (FK-506 immunosuppressant) are used at the same time, the tacrolimus and likewise sirolimus plasma levels may increase. Patients should therefore be carefully monitored for symptoms of tacrolimus or sirolimus overdose; if necessary, by determining the respective plasma concentration level. Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (nystatin, natamycin).

Which cosmetics should you avoid?
Deodorants or other intimate hygiene products should only be used on the affected skin areas after consulting your doctor, as a reduction in the effectiveness of Clotrimazole AL 2% cannot be ruled out.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

You can use Clotrimazole AL 2% during pregnancy, but only as directed by a doctor. During pregnancy, treatment should either be carried out with the vaginal cream by the doctor or with vaginal tablets without an applicator. As a precaution, clotrimazole should not be used in early pregnancy (1st - 3rd month).

Breast-feeding

You can use Clotrimazole AL 2% during breast-feeding as directed by your doctor.

Fertility

There are no studies on the effect of clotrimazole on human fertility.

Driving and using machines

No special precautions are required.

Clotrimazole AL 2%

contains cetyl stearyl alcohol

Cetyl stearyl alcohol can cause local skin irritation (e.g. contact dermatitis). When Clotrimazole AL 2% is used together with latex products (e.g. condoms, diaphragms), the excipients contained may reduce the functionality and thus impair the safety of these products. The effect is temporary and occurs only during treatment.

3. HOW TO USE CLOTRIMAZOLE AL 2% ?

Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The recommended dose is: 1 applicatorful (approx. 5 g vaginal cream) is emptied as deeply as possible into the vagina once a day in the evening on 3 consecutive days.

Method of administration

You should insert 1 applicatorful (approx. 5 g) as deeply as possible into the vagina once a day - in the evening - on 3 consecutive days and empty it as described below. The treatment should preferably not be carried out during menstruation or should be completed before it begins. If treatment is necessary during pregnancy as directed by your doctor, it should be carried out with vaginal tablets, as these can also be used without an applicator.

Using the vaginal cream with the disposable applicator

The plunger of the disposable applicator is pulled out to the stop. Open the tube, place the disposable applicator on the tube, press down firmly and fill it by carefully squeezing the tube. Remove the disposable applicator from the tube, insert it as deeply as possible into the vagina (preferably lying on your back) and empty it by pressing the plunger. A new disposable applicator should be used for each application and discarded after use.

Duration of use

A three-day course of treatment is usually sufficient to clear up a fungal infection. However, a second course of treatment may be given if necessary. In general, the signs of a vaginal infection caused by fungi (such as itching, discharge, burning) will improve significantly within the first 4 days of treatment. If there is no significant improvement in symptoms after 4 days, please contact your doctor.

If you forget to use Clotrimazole AL 2%

If you forget to use it in the evening, you can make up for it in the course of the following morning. Do not use a larger amount of vaginal cream the next time, but continue the treatment as recommended.

If you stop using Clotrimazole AL 2%

In order to achieve complete healing of the infection and to prevent a relapse, you should not stop or interrupt the treatment prematurely if possible. If you do so, the symptoms may recur because your fungal infection is probably not yet properly healed. You should not stop the treatment as soon as the symptoms subside, but continue it consistently for 3 days.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

The following side effects have been identified in the context of the use of clotrimazole after approval. Since these reactions were reported voluntarily by patient groups of uncertain size, it is not possible to estimate the frequency on the basis of the available data.

Significant side effects or signs to watch out for, and measures to be taken if affected

If you are affected by any of the following side effects, stop using Clotrimazole AL 2% and see your doctor as soon as possible.

Immune system disorders (frequency not known)

Allergic reactions (shortness of breath, fainting).

Reproductive system and breast disorders (frequency not known)

Rash, genital skin detachment, edema, discomfort, pelvic pain, vaginal bleeding.

Gastrointestinal disorders (frequency not known)

Lower abdominal pain.

Other possible side effects

Immune system disorders (frequency not known)

Allergic reactions (hives, hypotension).

Reproductive system and breast disorders (frequency not known)

Itching, burning, stinging, skin redness, skin irritation.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE CLOTRIMAZOLE AL 2% ?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and tube after "use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. After opening the tube, the contents should not be used for more than 3 days. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Clotrimazole AL 2%

contains

The active substance is: Clotrimazole. 1 g vaginal cream contains 0.02 g clotrimazole. The other ingredients are benzyl alcohol, cetyl stearyl alcohol (Ph. Eur.), hexadecyl palmitate, octyldodecanol (Ph. Eur.), polysorbate 60, sorbitan stearate, purified water.

What Clotrimazole AL 2%

looks like and contents of the pack

White to off-white homogeneous vaginal cream. Clotrimazole AL 2% is available in packs of 20 g vaginal cream and 3 applicators.

Pharmaceutical entrepreneur
Aliud Pharma GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

STADA Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This leaflet was last revised in December 2016.

Source: Information from the package leaflet
Status: 01/2018
Areas of application: for discharge caused by fungi (mostly Candida), inflammation of the vagina caused by fungi and superinfections with bacteria sensitive to clotrimazole.