What is Canesten gyno cream and what is it used for?

Canesten Gyno cream is used for infections of the labia and for infections of the vagina, which are caused by certain types of fungi or yeast. You can recognize a (vulvo)vaginal yeast infection by itching, a burning sensation, red, swollen, painful labia and a white, lumpy, odorless discharge. Canesten Gyno cream inhibits the growth of the fungus, kills the fungus and thus quickly relieves the itching thanks to the active ingredient clotrimazole.

Consult your doctor if the symptoms persist or worsen after 7 days (you may then have a different type of vaginal infection).

How do you use this medicine?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are unsure about the correct use, contact your doctor or pharmacist.

Dosage and method of administration (adults and adolescents aged 16 years and over)

The vaginal cream can best be inserted in a supine position, with legs slightly raised and spread. In the evening before going to bed, insert the Canesten gyno cream as deeply as possible into the vagina, for six consecutive days.

Canesten gyno cream is administered as follows:

1. Open the tube by pushing the tube cap upside down through the aluminum seal.

2. Pull out the applicator rod as far as it will go.

3. Place the applicator on the tube, hold it firmly and fill it completely by gently squeezing the tube.

4. Remove the applicator from the tube, insert it as deeply into the vagina as possible (best when lying on your back) and empty it by pressing the stick.

5. Remove and discard the applicator.

Canesten gyno cream can also be used to prevent re-infection. Apply the cream thinly to the affected areas twice a day for about one week. When using Canesten gyno cream externally, this can be combined with an internally used
cream or tablet.

Have you used too much of this medicine?

There are no known cases of overdose when using Canesten gyno cream according to the instructions. Consult your doctor if the cream is accidentally taken orally. If in doubt, contact your doctor or pharmacist.

Did you forget to use this medicine?

In that case, you can use the normal dose at the next time. Do not use a double dose to make up for a forgotten dose.

Read the package leaflet before use

Read this entire leaflet carefully before you start taking this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or
as your doctor has told you.

Download the package insert

Warnings

When should you not use this medicine or should you be extra careful with it?

When should you not use this medicine?

• In case of burns.
• You are allergic to cetylstearyl alcohol or any of the other ingredients of this medicine (listed in section 6).
• Do not use Canesten gyno if you suffer from one or more of the following complaints:
  - pain in the lower abdomen or pain when urinating;
  - fever or chills;
  - irregular or abnormal bleeding;
  - sores or blisters in the genital area;
  - lower back pain;
  - nausea or vomiting;
  - diarrhea;
  - pus formation;
  - strong smelling discharge.
  In these cases a doctor should always be consulted.

When should you be extra careful with this medicine?

Consult your doctor if:

• the complaints have been observed more than three times in the past year;
• you have had a sexually transmitted disease in the past;
• your partner has a sexually transmitted disease;
• you are pregnant or suspect you are pregnant;
• you are under 16 years of age.

Age indication

Canesten gyno is suitable for adults and young adults aged 16 and over.

Use of Canesten gyno cream in combination with other medicines

There are no known interactions of Canesten gyno cream with other medicines.

Pregnancy, breastfeeding and fertility

• Pregnancy: Canesten gyno cream can, as far as is known, be used without any danger to the foetus at the recommended dosage during pregnancy, if necessary. During pregnancy, the use of the applicator should be avoided and administration of the vaginal tablets by hand is preferred. The vaginal tablet can be inserted by hand.

• Breastfeeding: Canesten gyno cream can be used during breastfeeding according to the general prescription.

• Fertility: There have been no studies in humans on the effects of clotrimazole on fertility, but animal studies have not shown an effect of the medicine on fertility. If you are pregnant, think you may be pregnant or are planning to have a baby, or are breast-feeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving ability and use of machines

Canesten gyno cream does not affect the reaction time.

Ingredients

What substances are in this product?

The active substance in this medicine is: 10 mg/gram clotrimazole. Other excipients in this medicine are: sorbitan stearate (E 491), polysorbate 60 (E 435), cetostearyl alcohol, cetyl palmitate, 2-octyldodecanol, benzyl alcohol, water.

Canesten gyno cream contains benzyl alcohol

This product contains 2 grams of benzyl alcohol in every 100 grams of cream, which is 20 mg/g of cream. Benzyl alcohol may cause mild local irritation. This product contains cetylstearyl alcohol. This may cause local skin reactions (e.g. contact dermatitis).

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects occur with unknown frequency
have been identified during the use of clotrimazole.

• Immune system disorders: hypersensitivity in severe cases leading to swelling of the lips, tongue and throat or anaphylactic reaction (may be accompanied by nausea, diarrhoea, low blood pressure, difficulty breathing, unconsciousness).
• Skin and subcutaneous tissue disorders: red skin, itchy rash, skin eruption, stinging/burning sensation of the skin.
• General disorders and administration site conditions: administration site irritation or reaction, fluid retention.
  When using the cream, the partner may experience irritation of the penis.
• Reproductive system and breast disorders: vaginal bleeding.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to any possible side effects not listed in this leaflet. You can also report side effects directly via www.lareb.nl. By reporting side effects you can help provide more information on the safety of this medicine.

How should you store this medicine?

Keep out of the sight and reach of children.
Keep this medicine in the original packaging, do not refrigerate or freeze.
Do not use this medicine after the expiry date which is stated on the carton and on the tube seal after 'Do not use after'. The expiry date refers to the last day of that month.
Shelf life: 3 months after opening.

Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of medicines that are no longer
are necessary. These measures will help protect the environment.

Specifications

• Dosage form: Cream
• Contents: 35 grams of cream and 6 applicators
• Delivery status: Pharmacy and Drugstore Only (UAD)
• Registration number: RVG - Register of Packaged Medicines 07856
  Main ingredients: CLOTRIMAZOL

License holder:

Bayer BV
Siriusdreef 36
2132 WT Hoofddorp (NL)

Manufacturer:

Kernpharma SL, Barcelona, Spain.
GP Grenzach Produktions GmbH, Grenzach-Wyhlen

View this medicine in the Medicines Information Bank