Clotrimazole Gine-Canesmed Vaginal Cream 20mg/g 20gr

 What Clotrimazole Gine-Canesmed is and what it is used for
Clotrimazole is an antifungal (medicine used to treat fungal infections).



This medicine is indicated for adults and adolescents aged 12 years and over for the treatment of:



Complicated vulvovaginal candidiasis (4 or more fungal infections in the last year or infections with severe symptoms or patients with a weakened immune system) and,
Uncomplicated vulvovaginal candidiasis (sporadically caused fungal infections or less than 4 infections in the last year or infections with mild to moderate symptoms).
2. What you need to know before you use Clotrimazole Gine-Canesmed
Do not use Clotrimazole Gine-Canesmed

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



Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Clotrimazole Gine-Canesmed.



Before using this medicine tell your doctor if you have problems with your immune system, for example if you are being treated with oral corticosteroids or have HIV infection, AIDS or diabetes.



If you experience fever (38ºC or more), pain in the abdomen or back, lower back pain, abundant watery vaginal discharge and/or nausea, you should consult your doctor to rule out another type of disease.



If an allergic reaction occurs during use, treatment should be stopped and you should see your doctor immediately. Signs of a serious allergic reaction include a raised, itchy rash, swelling, sometimes on the face or mouth, causing difficulty in breathing.



You should consult a doctor if symptoms worsen during treatment or persist after treatment is finished, or if you notice an increase in vaginal discharge or changes in its appearance or smell, or if you have vaginal bleeding.





Children and adolescents

This medicine is indicated for children over 12 years of age, see below How to use Clotrimazol Gine-Canesmed, for instructions on administration.



Use of Clotrimazol Gine-Canesmed with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, especially if you are taking tacrolimus or sirolimus (medicines used in transplant patients), so that your doctor can monitor you appropriately.



This medicine may reduce the effectiveness and safety of latex products such as condoms and diaphragms. This effect is temporary and only appears during treatment.



It is recommended to avoid sexual intercourse in case of vaginal infection and while using this medicine to prevent the partner from becoming infected.



Pregnancy and breast-feeding

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



Your doctor will weigh up the benefit of using the medicine against the risks to the baby. A



decision must be made whether to stop breast-feeding or to stop the treatment taking into account the benefit of breast-feeding for the child and the benefit of the treatment for the mother.



Driving and using machines

Clotrimazole Gine-Canesmed has no or negligible influence on the ability to drive and use machines.



Clotrimazole Gine-Canesmed contains cetostearyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains cetostearyl alcohol.



3. How to use Clotrimazole Gine-Canesmed
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Vaginal administration. Do not ingest.





The recommended dose is:

Adults and adolescents over 12 years of age



Complicated vulvovaginal candidiasis (4 or more fungal infections in the last year or infections with severe symptoms or patients with a weakened immune system): Apply one applicator load intravaginally (approx. 5 g) once daily, preferably at night, for 7-14 consecutive days.



Uncomplicated vulvovaginal candidiasis (fungal infections sporadically or less than 4 infections in the last year or infections with mild to moderate symptoms): Apply one applicator load intravaginally (approx. 5 g), once daily, preferably at night, for 3 consecutive days.





The cream should be introduced deeply into the vagina (see INSTRUCTIONS FOR USE OF THE APPLICATOR), with the patient lying on her back and with her legs slightly bent, preferably at night before going to bed.



INSTRUCTIONS FOR USE OF THE APPLICATOR

1. Remove the cap from the tube and attach the applicator.











2. By carefully pressing the tube, fill the applicator until the plunger has moved to the stop.







3. Separate the applicator from the tube and insert it as far as possible into the vagina (preferably with the patient lying on her back and with her legs slightly bent), emptying it by pressing on the plunger.







4. Remove the applicator and discard.























Pregnant women

In case of treatment during the last 4 or 6 weeks of pregnancy, the use of the applicator is not recommended. Therefore, the use of vaginal tablets instead of vaginal cream is recommended, as these can be introduced directly with the finger, after careful hand washing.



If the symptoms persist after finishing treatment or recur after two months or if you suffer from problems with your immune system, HIV infection, AIDS or diabetes, you should consult your doctor. You



should not use tampons, intravaginal douches, spermicides or other vaginal products while using this medicine.



It is not recommended to start treatment during menstruation. Treatment should be finished before the start of menstruation.



Contact with the eyes should be avoided, as it may cause stinging. If contact with the eyes accidentally occurs, wash with plenty of water and consult an ophthalmologist, if necessary.



If you use more Clotrimazole Gine-Canesmed than you should

Accidental ingestion may cause gastrointestinal discomfort and/or vomiting.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Poison Information Service. Telephone (91) 562 04 20 indicating the medicine and the amount ingested.



If you forget to use Clotrimazole Gine-Canesmed

If you forget to take a dose, wait until the next one. Do not take a double dose to make up for a forgotten dose.



If you stop taking Clotrimazole Gine-Canesmed

Continue using Clotrimazole Gine-Canesmed until you finish the treatment, even if you feel better. You need to use the full treatment to cure the infection. If you stop the treatment, the fungus may not have disappeared.



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



4. Possible side effects
Like all medicines, Clotrimazole Gine-Canesmed can cause side effects, although not everybody gets them.



Adverse reactions with a frequency of unknown (cannot be estimated from the available data) are:



Allergic reactions: syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure), difficulty breathing, urticaria (red, itchy raised welts).

Peeling, itching, rash, swelling, erythema, burning or irritation of the genital area, vaginal discomfort, pelvic pain and vaginal bleeding.

Abdominal pain.



These symptoms do not usually lead to discontinuation of treatment and are more frequent during the first few days of treatment.



Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Medicinal Products for Human Use: http://www.notificaram.es. By reporting side effects you can help provide more information on the safety of this medicine.



5. How to store Clotrimazol Gine-Canesmed
Keep this medicine out of the sight and reach of children.

It does not require any special storage conditions. Store in the original packaging.



Do not use Clotrimazol Gine-Canesmed after the expiry date which is stated on the carton after the abbreviation EXP. The expiry date refers to the last day of that month.



Medicines should not be disposed of via wastewater or household waste. Throw away any medicines you no longer use at the Sigre Point C:\Users\BevAZ\Desktop\SIMB SIGRE.jpg at your pharmacy. If in doubt, ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and additional information
What Clotrimazole Gine-Canesmed contains

The active ingredient is clotrimazole. Each gram of cream contains 20 mg of clotrimazole.
The other ingredients (excipients) are: sorbitan stearate type I, polysorbate 60, cetyl palmitate, cetostearyl alcohol, octyldodecanol, benzyl alcohol and purified water. What Clotrimazole Gine-Canesmed


looks like and contents of the pack

White cream.

It comes in a cardboard box containing an aluminium tube with a PE cap with 20 g of cream and 3 disposable PE/PP vaginal applicators.