GYNAZOL 20 mg. 5 g.

WHAT GYNAZOL AND WHAT IT IS USED
Gynazol 20 mg / g vaginal cream is indicated for the local treatment of vulvovaginal infections caused by Candida albicans.

2. BEFORE YOU TAKE Gynazol
Do not take Gynazol:
if you are hypersensitive (allergic) to butoconazole nitrate (butoconazole nitrate) or any of the other ingredients of Ginazol.
Taking other medicines or other products
Gynazol 20 mg / g vaginal cream contains mineral oil. Of mineral oil can soften latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore the use of these drugs is not recommended within 72 hours after Ginazol 20 mg / g vaginal cream.

special warnings
Gynazol 20 mg / g vaginal cream contains mineral oil. Of mineral oil can soften latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore the use of these drugs is not recommended within 72 hours (approximately 3 days) after administration of Gynazol 20 mg / g vaginal cream.
Recurrent vaginal fungal infections, and particularly difficult to treat may be early symptoms of infection with human immunodeficiency virus (HIV) in women who are at risk of AIDS.
After treatment with Gynazol 20 mg / g cream for vaginal period of three days it is not advisable to make a vaginal lavage or washing of the cream from the vagina due to prolonged action of the vaginal cream. For the same reason should be avoided sex life for three days after its application.

Precautions
If clinical symptoms persist, they should be retested for the exclusion of other disease agents and confirm the initial diagnosis and to exclude other conditions that may predispose a patient to recurrent vaginal fungal infections.

Pregnancy and lactation
Consult your doctor or pharmacist before using any medicine.
There are no adequate and well-controlled studies Ginazol 20 mg / g Vaginal Cream in pregnant women. Therefore, the use of Ginazol 20 mg / g vaginal cream during pregnancy is recommended only solution to the physician the potential benefit outweighs the potential risk to the fetus.
It is not known whether the active substance is excreted in human milk, therefore should be exercised caution when the drug is administered to nursing mothers. Breastfeeding is recommended only solution to the physician the potential benefit outweighs the potential risk to the baby.

Driving and using machines
Ginazol 20 mg / g vaginal cream not affect your ability to drive or operate machinery.

Important information about some of the ingredients of Ginazol
Gynazol 20 mg / g vaginal cream contains methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol.
Para-hydroxybenzoates may cause allergic reactions (redness, itching, rash), and propylene glycol can cause local irritation (redness, itching).

3. HOW TO TAKE Gynazol
Unit dose applicator filled with cream disposable contains approximately 5 g of vaginal cream.
The recommended dosage regimen is to implement a complete applicator cream into the vagina at any time of day (preferably in the evening).

Use of the filled applicator disposable
Step 1. Preparation of the applicator
Remove the foil and remove the filled applicator.
To be implemented, the applicator is made with an appropriate nozzle.
Do not remove the nozzle.
Do not use applicator if the nozzle is removed!
Do not heat the applicator before use.
While holding firmly applicator, pull the ring back to the full withdrawal of the piston.

Step 2. Enter the applicator
Gently insert the applicator as comfortable deep in the vagina.
Step 3. Application of the cream
Slowly push the plunger to remain cream into the vagina. Remove empty applicator from the vagina and discard.

Vaginal cream Ginazol need only be applied into the vagina. Do not place it in your mouth or swallow it. If this happens accidentally, contact your doctor immediately.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Gynazol 20 mg / g vaginal cream can have side effects.
Based on reports from controlled clinical studies and post-marketing surveillance most frequently reported complaints following adverse reactions (> = 5%), vaginal burning, itching, irritation and swelling, pain or cramps in the abdomen or pelvis, or a combination two or more symptoms.
Possible local adverse reactions Ginazol 20 mg / g vaginal cream are very similar to the clinical signs and symptoms of vulvovaginal fungal or yeast infection. If symptoms do not cease during the course of treatment, please contact your doctor as soon as possible.
In the application of any drug reactions may occur hypersensitivity allergic reactions. That is why you pay attention that if you experience any of the following symptoms of sensitivity to the drug as exfoliative dermatitis (redness or peeling) or urticaria (hives edematous), please call your doctor immediately.

If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE Gynazol
Keep out of reach of children.
Do not store above 30 ° C.
Do not use Gynazol after the expiry date stated on the label. The expiry date refers to the last day of that month.
Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION
What Gynazol 20 mg / g Vaginal Cream
Each filled applicator contains approximately 5 g vaginal cream. This amount of cream contains approximately 100 mg of butoconazole nitrate, which is an imidazole derivative with antifungal activity.
The active substance is butoconazole nitrate.
The other ingredients are: Sorbitol liquid (not crystallized); Mineral oil; Glyceryl monoisostearate; Polyglyceryl-3 oleate; Solid paraffin; Hydrophobic silica; Edetate disodium; Methyl parahydroxybenzoate; Propyl parahydroxybenzoate; propylene glycol; Purified water.

Looks Gynazol 20 mg / g vaginal cream and contents of the pack
White to off-white homogeneous soft cream free of foreign substances without evidence of phase separation and conforming to the model.
Ginazol cream is filled into applicator of polypropylene with natural color. Each full applicator is placed in a polystyrene container that is wrapped in laminated bag. The bag is placed in a folding carton.