Metronidazole ziaja
PolandTable of Contents
Package leaflet: Information for the patient
Metronidazol Ziaja, 10 mg/g, gel
Metronidazolum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
- Keep this leaflet, so that you can read it again if necessary.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
- If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
Table of contents of the leaflet
- What Metronidazol Ziaja is and what it is used for
- Important information before using Metronidazol Ziaja
- How to use Metronidazol Ziaja
- Possible adverse reactions
- How to store Metronidazol Ziaja
- Contents of the packaging and other information
1. What Metronidazol Ziaja is and what it is used for
Metronidazol Ziaja in the form of a topical gel contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with bactericidal activity.
When applied to the skin, metronidazole acts against anaerobic Gram-negative bacteria of the genera: Bacteroides, Fusobacterium.
Indications:
- Rosacea,
- Seborrheic dermatitis,
- Mixed bacterial infections of the facial skin,
- Perioral dermatitis,
- Post-steroid rosacea.
2. Important information before using Metronidazol Ziaja
When not to use Metronidazol Ziaja
- if the patient is allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Metronidazol Ziaja, discuss this with your doctor or pharmacist.
Metronidazol Ziaja is intended for topical use only.
If skin irritation symptoms occur, contact your doctor, who may recommend less frequent application or temporary interruption of therapy.
During treatment, avoid exposure to UV radiation (sunlight, sunbeds, UV lamps).
Avoid contact of the medicine with eyes or mucous membranes. Applying the medicine near the eye may cause irritation of the conjunctiva and tearing. In case of accidental contact with eyes, rinse thoroughly with plenty of cool water. If eye irritation persists, consult an ophthalmologist.
Metronidazol Ziaja should be used with caution in patients with blood abnormalities (dyscrasia), including those occurring in the past. If the patient has any blood disorder, this should be reported to the doctor.
Do not use the medicine for longer than recommended by the doctor.
There is evidence suggesting that metronidazole has carcinogenic effects in certain animal species. However, there are no data regarding the carcinogenic potential of the medicine in humans.
Metronidazol Ziaja with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines planned for future use.
The risk of interactions with systemically acting medicines is unlikely due to minimal absorption of Metronidazol Ziaja following topical application.
However, it should be noted that when metronidazole was administered orally, an enhanced anticoagulant effect of warfarin and coumarin (medicines that inhibit blood clotting) and prolonged prothrombin time (a measure of blood clotting time) have been observed.
Metronidazol Ziaja and alcohol
Reactions similar to those observed when consuming alcohol during disulfiram treatment (a medicine used in alcoholism treatment) have been reported after alcohol consumption, including acute psychoses and confusion.
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
Metronidazol Ziaja may be used in pregnant women only if, in the opinion of the doctor, it is clearly necessary, as there are no data on the safety of topical metronidazole use in pregnant women. Orally administered metronidazole crosses the placental barrier and rapidly reaches the fetus.
Breastfeeding
Do not use the medicine during breastfeeding.
The doctor will decide whether to discontinue Metronidazol Ziaja or to stop breastfeeding.
Effect on fertility
There are no data describing the effect of metronidazole on fertility in humans.
Driving and operating machinery
Metronidazol Ziaja is unlikely to affect the ability to drive or operate machinery.
Metronidazol Ziaja contains:
- methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), therefore the medicine may cause allergic reactions (delayed-type reactions possible).
- 150 mg of 96% ethanol in each gram of gel, therefore the medicine may cause stinging of damaged skin. The medicine is flammable. Do not use near open flames, lit cigarettes, or certain devices (e.g. hair dryers).
- 150 mg of propylene glycol (E 1520) in each gram of gel, therefore the medicine may cause skin irritation.
3. How to use Metronidazol Ziaja
This medicine should always be used as directed by a physician or pharmacist. If in doubt,
consult a physician or pharmacist.
Metronidazol Ziaja is intended for topical application to the skin.
Apply a thin layer of gel to the affected skin areas twice daily (morning
and evening). Before application, cleanse the affected areas with a gentle cleansing agent.
After applying the medicine, patients should use only cosmetics that do not clog pores and do not have an astringent effect.
The duration of treatment depends on the type of microorganism, location, and severity of infection, and usually lasts
from 3 to 4 months. The treatment period should not be extended. However, if a clear improvement occurs, the treating physician may recommend continuing treatment with Metronidazol Ziaja
for an additional 3 or 4 months, depending on the severity of the lesions.
Your physician will advise how long Metronidazol Ziaja should be used. If no improvement is observed after 3 to 4 months, contact your physician.
Use in children
Metronidazol Ziaja is not recommended for use in children due to lack of data on safety and efficacy of the medicine.
Use of a higher than recommended dose of Metronidazol Ziaja
Overdose following topical application is unlikely.
If excessive amounts of the medicine need to be removed from the skin, wash the skin with large amounts of warm water.
In case of accidental ingestion, gastric lavage is recommended. Subsequently, activated charcoal should be administered, followed by a saline laxative. Treatment should include symptomatic and supportive measures.
Metronidazole can be removed from the body by dialysis.
In case of accidental ingestion, contact a physician, who will decide on appropriate treatment.
Missed dose of Metronidazol Ziaja
Do not apply a double dose to make up for a missed dose.
Discontinuation of Metronidazol Ziaja
Do not discontinue treatment earlier than advised without consulting a physician, as this may lead to worsening of skin symptoms.
If you have any further questions regarding the use of this medicine, consult your physician or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The adverse reactions listed below are categorized according to their frequency of occurrence:
Common adverse reactions (may occur in up to 1 in 10 patients):
dry skin, redness, itching, skin discomfort (burning, skin pain/stinging),
skin irritation, worsening of rosacea.
Uncommon adverse reactions (may occur in up to 1 in 100 patients):
reduced sensation, abnormal sensation, taste disturbances (metallic taste), nausea.
Frequency not known (cannot be estimated from available data): contact dermatitis.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions 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
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.
5. How to store Metronidazol Ziaja
Keep this medicine out of sight and reach of children.
Storage conditions before first opening of the tube: No special requirements for storage of the medicine.
Storage conditions after first opening of the tube: Store below 25°C.
Shelf-life after first opening of the tube: 3 years, but not beyond the expiry date stated on the packaging.
Do not use this medicine after the expiry date indicated on the carton and tube following "EXP".
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.
6. Contents of the pack and other information
What Metronidazol Ziaja contains
- The active substance is metronidazole; 1 g of gel contains 10 mg of metronidazole.
- The other ingredients are: ethanol 96%, carbomer 980, propylene glycol (E 1520), disodium edetate, methylparahydroxybenzoate (E 218), propylparahydroxybenzoate (E 216), triethanolamine, purified water.
What Metronidazol Ziaja looks like and contents of the pack
Metronidazol Ziaja is a transparent, colourless to pale yellow, homogeneous gel.
Pack: aluminium tube with a sealing membrane internally coated with epoxy-phenolic varnish, fitted with a HDPE cap with a plug seal, containing 15 g of gel, placed together with the package leaflet in a cardboard box.
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Tel.: +48 58 521 34 00
(logo of the marketing authorisation holder)
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy