Description
Release form
Vaginal cream 2%.
20 g in aluminum tubes. The tube, along with disposable applicators (3 pcs.) For intravaginal administration and instructions for use, is placed in a cardboard pack.
Indications
Genital infections caused by yeast-like fungi of the genus Candida (candida vulvovaginitis).
If necessary, please consult your doctor before using the medicine.
Contraindications
Hypersensitivity to clotrimazole or other components of the drug, especially to cetostearyl alcohol
menstruation
I trimester of pregnancy.
Precautions
Breastfeeding Period.
Use during pregnancy and lactation
Use in the first trimester of pregnancy is contraindicated. The question of the advisability of using the drug in the II-III trimesters of pregnancy should be decided individually after consulting a doctor.
The use of the drug during breastfeeding is allowed only if, according to the doctor, the potential benefit of using the cream for the mother outweighs the possible risk to the baby.
Special instructions
Read the instructions for use carefully before you start using the drug. Save the instruction, it may be needed again. If you have any questions, consult your doctor.
The medicine you are treating is intended for you personally and should not be shared with others, as it can harm them even if you have the same symptoms as you.
If allergic reactions or irritation occur at the injection site, treatment is discontinued.
The drug can not be used during menstruation, it is advisable to start treatment after menstruation.
In case of simultaneous infection of the labia and adjacent areas (candida vulvitis), local treatment with clotrimazole should be additionally performed.
During pregnancy, vaginal cream treatment is carried out without an applicator.
To prevent infection, simultaneous treatment of sexual partners is necessary.
During treatment, it is recommended to refrain from sexual intercourse.
During treatment, it is recommended to use contraceptives. The risk of rupture of a condom or diaphragm increases with their simultaneous use with the use of the drug. You must use reliable methods of contraception.
Hygiene practices must be followed to prevent reinfection.
If the clinical signs of infection persist after treatment is completed, a repeated microbiological examination should be performed to confirm the diagnosis.
Effect on the ability to drive vehicles and mechanisms
The drug does not affect the ability to drive vehicles and engage in other potentially dangerous activities, requiring increased concentration of attention and speed of psychomotor reactions.
Composition of
100 g of cream contains:
Active ingredient: clotrimazole – 2.0 g
Excipients: sorbitan stearate – 2.0 g, cetyl palmitate – 3.0 g, cetostearyl alcohol [cetyl alcohol 60% and stearyl alcohol ] – 10.0 g, polysorbate-60 – 1.5 g, octyldodecanol – 13.5 g, benzyl alcohol – 1.0 g, purified water – 67.0 g.
Dosage and Administration
Topically. For intravaginal use only.
For 6 consecutive days, once a day in the evening before bedtime, enter the contents of the filled applicator (approximately 5 g) as deep as possible into the vagina, in the supine position, with slightly bent legs.
Using vaginal cream with a single-use applicator:
1. Open the tube and screw on the single-use applicator.
2. Gently squeezing the tube, fill the disposable applicator until the piston extrudes completely.
3. Unscrew the applicator from the tube. Insert the applicator as deep as possible into the vagina (preferably in the supine position) and squeeze out the contents of the applicator by pressing on the piston.
4. Remove the disposable applicator after use and discard.
Use the drug only according to the method of use and at the doses indicated in the instructions for use.
A second course of treatment is possible after consultation with your doctor.
If there is no improvement after treatment or if new symptoms appear, consult a doctor.
Side effects
According to the World Health Organization (WHO), adverse effects are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100,? 1/10), infrequently (? 1/1000,? 1/100), rarely (? 1/10000,? 1/1000) and very rarely (? 1/10000) the frequency is unknown (the frequency of occurrence of phenomena cannot be determined based on available data).
Immune system disorders:
frequency unknown: allergic reactions with symptoms such as urticaria, fainting, arterial hypotension, shortness of breath.
Disorders of the gastrointestinal tract:
frequency unknown: abdominal pain.
Disorders of the skin and subcutaneous tissue:
frequency unknown: in case of hypersensitivity to the active substance or another component of the drug, such as cetostearyl alcohol, allergic reactions can occur.
Disorders of the kidneys and urinary tract:
frequency unknown: rapid urination, intercurrent cystitis.
Genital disorders:
frequency unknown: itching, burning, hyperemia and swelling of the vaginal mucosa, ulceration of the vaginal mucosa, rash, pain in the pelvic area.
Other:
frequency unknown: headache, gastralgia.
If any of the side effects indicated in the instructions are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.
Drug interaction
When vaginally administered, clotrimazole reduces the activity of amphotericin B and other polyene antibiotics.
When used concomitantly with natamycin and nystatin, clotrimazole activity may decrease.
The simultaneous use of clotrimazole intravaginally and tacrolimus, sirolimus orally can lead to an increase in the concentration of the latter in blood plasma, therefore, patients should be monitored for the development of symptoms of their overdose, if necessary with a measurement of plasma concentrations.
Overdose
In case of overdose, the following symptoms are possible: dizziness, nausea, vomiting.
treatment. There is no specific antidote. In case of accidental ingestion, symptomatic treatment should be carried out.
Storage Conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
The Expiration of
is 3 years.
active substance
Clotrimazole
conditions granted through pharmacies
Without prescription
Dosage form
cream vaginal
