Izovag
Poland
Table of Contents
Package leaflet: Information for the patient
Izovag, 10 mg/g, vaginal cream
Isoconazoli nitras
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as prescribed by the
physician or pharmacist.
- Keep this leaflet for future reference.
- If advice or further information is needed, consult a pharmacist.
- If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the physician or pharmacist. See section 4.
- If there is no improvement after 7 days of treatment, or if the patient feels worse, contact the physician.
Table of contents
- What Izovag is and what it is used for
- Important information before using Izovag
- How to use Izovag
- Possible side effects
- How to store Izovag
- Contents of the pack and other information
1. What Izovag is and what it is used for
Izovag contains the active substance - isoconazole nitrate.
Isoconazole nitrate belongs to a group of antifungal medicines used to treat fungal and mixed vaginal infections, including those involving Gram-positive bacteria.
If there is no improvement after 7 days of treatment, or if the patient feels worse, contact the physician.
2. Important information before using Izovag
When not to use Izovag
- if the patient is allergic to isocanozole nitrate or any of the other ingredients of this medicine (listed in section 6);
- if the patient is a child under 15 years of age, as the use of vaginal applicators is not recommended in this age group.
Warnings and precautions
Before starting treatment with Izovag vaginal cream, discuss this with your doctor or
pharmacist.
To treat external genital infections or for prophylactic treatment of the patient's partner, a cream containing isocanozole nitrate other than the vaginal cream Izovag is recommended. Izovag cream is not intended for use in men.
During the 7-day treatment cycle and for one week after its completion, vaginal irrigation (douching) should not be performed.
To prevent recurrence of infections, wearing cotton underwear changed daily for clean, washed and boiled ones is recommended.
Towels used by the patient should be boiled after each use.
In case of accidental contact of the vaginal cream with the eye, rinse immediately with a large amount of water.
The ingredients of the medicine may damage latex, reducing the effectiveness of mechanical contraceptive methods (i.e. condoms).
Additional precautions should be taken throughout the entire treatment period and for 5 days after application of the cream.
If there is no improvement after 7 days or if the patient feels worse, she should contact her doctor.
Izovag and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines she plans to take.
There are no data on interactions between Izovag and other medicines.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
The use of vaginal applicators during pregnancy is not recommended.
Breastfeeding
Women who are breastfeeding may use Izovag only if, in the opinion of the doctor, the benefits to the mother outweigh the potential risks to the child.
Effect on fertility
There are no data indicating that the use of Izovag affects fertility.
Driving and operating machinery
Izovag has no effect on the ability to drive vehicles or operate machinery.
Izovag contains cetostearyl alcohol
This medicine may cause local skin reactions (e.g. contact dermatitis).
3. How to use Izovag
This medicine should always be used exactly as directed by the physician. In case of doubt, consult
your doctor or pharmacist.
If there is no improvement after 7 days, or if the patient feels worse, medical advice should be sought.
Izovag is intended for vaginal use only.
It is recommended to use the cream once daily for 7 consecutive days. The package contains 7
applicators, each for a single dose.
The cream should be inserted into the vagina as deeply as possible. Use the applicator provided in
the package for administration.
It is recommended to apply the vaginal cream at night, before going to sleep.
The best position for administration is lying down (on the back).
Treatment should not be continued during menstruation.
Instructions for use:
- remove the cap from the tube, pierce the protective seal, then screw the applicator provided onto the tube in place of the cap
- fully pull out the plunger of the applicator
- squeeze the tube to fill the applicator with cream
- remove the applicator and replace the cap on the tube to protect it
- insert the applicator deeply into the vagina, then press the plunger completely to fully expel the cream.
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Use of a higher than recommended dose of Izovag
A single use of a higher than recommended dose of the medicine or even accidental swallowing
of the entire contents of the tube does not pose a risk of acute poisoning.
In case of any doubts, consult a doctor or pharmacist.
Missed dose of Izovag
Do not use a double dose to make up for a missed dose. If a dose is missed, apply the next dose as soon as possible, then continue treatment according to the instructions.
Discontinuation of Izovag
If you have any further doubts regarding the use of this medicine, please consult your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Very rarely, local reactions at the site of application may occur, such as: burning
and itching.
Allergic reactions are also possible, such as: rash, swelling, nausea,
shortness of breath, hypotension.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor, pharmacist, or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl
Adverse effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.
5. How to store Izovag medicine
There are no special storage requirements for this medicine.
Keep the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the stated month.
After opening the tube, the cream remains stable for 7 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of medicines no longer in use. This will help protect the environment.
6. Contents of the package and other information
What Izovag contains
- The active substance is isiconazole nitrate. 1 g of cream contains 10 mg of isiconazole nitrate.
- The other ingredients are: polysorbate 60, sorbitan stearate, cetostearyl alcohol, liquid paraffin, white soft paraffin, purified water.
What Izovag looks like and contents of the pack
Izovag is a white, homogeneous cream.
The medicine is packed in an aluminium tube coated with a double layer of epoxy-phenolic lacquer,
with a protective membrane, fitted with a cap made of HDPE and containing 7 vaginal applicators made of LDPE,
with a plunger made of HDPE, with a capacity of approximately 4.5 g, placed in a cardboard box.
The tube contains 40 g of vaginal cream.
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
Baletowa 30 Street
02-867 Warsaw
+48 22 855 40 93
Manufacturer
Laboratórios Basi - Indústria Farmacêutica, S.A.
Parque Industrial Manuel Lourenço Ferreira, Lotes 8, 15 e 16
3450-232 Mortágua
Portugal