Metronidazol Ziaia

Package Leaflet: Information for the Patient

Metronidazol Ziaja, 10 mg/g, Gel

Metronidazole

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Metronidazol Ziaja and what is it used for
• 2. Important information before using Metronidazol Ziaja
• 3. How to use Metronidazol Ziaja
• 4. Possible side effects
• 5. How to store Metronidazol Ziaja
• 6. Package contents and other information

1. What is Metronidazol Ziaja and what is it used for

Metronidazol Ziaja, in the form of a gel for topical use, contains the active substance metronidazole.
Metronidazole is a nitroimidazole derivative with bactericidal action.
After topical application, metronidazole acts on Gram-negative bacteria growing in relatively anaerobic conditions, of the genus: Bacteroides, Fusobacterium.

Indications:

• -Rosacea,
• -Seborrhoeic dermatitis,
• -Mixed bacterial infections of the facial skin,
• -Perioral dermatitis,
• -Post-rosacea.

2. Important information before using Metronidazol Ziaja

When not to use Metronidazol Ziaja

• -if the patient is hypersensitive to metronidazole or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with Metronidazol Ziaja, the patient should discuss it with their doctor or pharmacist.
Metronidazol Ziaja is intended for topical use only.
In case of skin irritation symptoms, the patient should contact their doctor, who may recommend less frequent use of the medicine or temporary discontinuation of therapy.
During treatment, the patient should avoid exposure to UV radiation (sunlight, sunbeds, lamps emitting UV radiation).
The patient should avoid contact between the medicine and the eyes or mucous membranes. Applying the medicine near the eye may cause conjunctivitis and tearing. If the medicine accidentally comes into contact with the eyes, they should be rinsed with a large amount of cool water. If the eyes remain irritated, the patient should consult an ophthalmologist.
Metronidazol Ziaja should be used with caution in patients with abnormal blood counts (dyscrasia), including those that have occurred in the past. If the patient has any blood disease, they should inform their doctor.
The medicine should not be used for longer than recommended by the doctor.
There is evidence suggesting that metronidazole has carcinogenic effects in some animal species. However, there are no data on the carcinogenic effects of the medicine in humans.

Metronidazol Ziaja and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The risk of interactions with systemic medicines is low due to the low absorption of Metronidazol Ziaja after topical application.
However, it should be noted that during oral administration of metronidazole, an increase in the anticoagulant effect of warfarin and acenocoumarol (blood clotting inhibitors) and a prolongation of prothrombin time (a measure of blood clotting) have been observed.

Metronidazol Ziaja and alcohol

After consuming alcohol, reactions (including acute psychosis and confusion) similar to those that occur when drinking alcohol during treatment with disulfiram (a medicine used to treat alcoholism) have been observed.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
Pregnancy
Metronidazol Ziaja may be used in pregnant women only if, in the doctor's opinion, it is absolutely necessary, as there are no data on the safety of topical metronidazole in pregnant women, and metronidazole administered orally crosses the placental barrier and quickly reaches the fetus.
Breastfeeding
The medicine should not be used during breastfeeding.
The doctor will decide whether to stop using Metronidazol Ziaja or discontinue breastfeeding.
Fertility
There are no data on the effect of metronidazole on human fertility.

Driving and using machines

Metronidazol Ziaja is unlikely to affect the ability to drive or use machines.

What Metronidazol Ziaja contains

• methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216), so the medicine may cause allergic reactions (possible late reactions).
• 150 mg of ethanol 96% in each gram of gel, so the medicine may cause a burning sensation on damaged skin. The medicine is flammable. It should not be used near an open flame, a lit cigarette, or certain devices (e.g., hair dryers).
• 150 mg of propylene glycol (E 1520) in each gram of gel, so the medicine may cause skin irritation.

3. How to use Metronidazol Ziaja

This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Metronidazol Ziaja is intended for topical use on the skin.
A thin layer of the gel should be applied to the affected areas of the skin twice a day (morning and evening). Before use, the treated areas should be washed with a mild cleansing agent.
After applying the medicine, patients can use only cosmetics that do not clog pores and do not have a drying effect.
The treatment duration depends on the type of microorganism, location, and severity of the infection, and usually lasts from 3 to 4 months. The treatment period should not be extended. However, if significant improvement occurs, the treating doctor may recommend continuing the use of Metronidazol Ziaja for another 3 or 4 months, depending on the severity of the disease.
The doctor will recommend how long to use Metronidazol Ziaja. If no improvement occurs after 3 to 4 months, the doctor should be consulted.

Use in children

Metronidazol Ziaja is not indicated for use in children due to the lack of data on the safety and efficacy of the medicine.

Using more than the recommended dose of Metronidazol Ziaja

Overdose of the medicine after topical application is unlikely.
In case of accidental ingestion of the medicine, gastric lavage is recommended. Then, activated charcoal and a laxative based on salts should be administered. The therapy should include symptomatic and supportive treatment.
Metronidazole can be removed from the body through dialysis.
In case of accidental ingestion of the medicine, the doctor should be consulted, who will decide on the appropriate treatment.

Missing a dose of Metronidazol Ziaja

A double dose should not be used to make up for a missed dose.

Stopping the use of Metronidazol Ziaja

The use of the medicine should not be stopped without consulting the doctor, as this may lead to worsening of skin symptoms.
In case of any further doubts about the use of this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are listed with their frequency of occurrence:
Common side effects (may occur in up to 1 in 10 patients):
dry skin, redness, itching, skin discomfort (burning, skin pain/stinging), skin irritation, exacerbation of rosacea.
Uncommon side effects (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 the available data): contact dermatitis.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Aleje Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Metronidazol Ziaja

The medicine should be stored out of sight and reach of children.
Storage conditions before the first opening of the tube: No special storage precautions are required.
Storage conditions after the first opening of the tube: Store below 25°C.
Shelf life after the first opening of the tube: 3 years, but no longer than the expiry date stated on the packaging.
The medicine should not be used after the expiry date stated on the carton and tube after: "EXP".
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This will help protect the environment.

6. Package contents and other information

What Metronidazol Ziaja contains

• -The active substance of the medicine 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, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), tromethamine, purified water.

What Metronidazol Ziaja looks like and what the package contains

Metronidazol Ziaja is a transparent, colorless to light yellow, homogeneous gel.
Packaging: aluminum tube with a sealing membrane, internally coated with an epoxy-phenolic varnish, with an HDPE cap and a piercer, containing 15 g of gel, packaged with a leaflet in a cardboard box.

Marketing authorization holder

ZIAJA Ltd Pharmaceutical Works Ltd.
ul. Jesienna 9
80-298 Gdańsk
Phone: +48 58 521 34 00
(logo of the marketing authorization holder)

Manufacturer

ZIAJA Ltd Pharmaceutical Works Ltd.
ul. Przemysłowa 12
83-050 Kolbudy

Date of the last update of the leaflet: