Metronidazol Ielfa

Leaflet attached to the packaging: patient information

Metronidazol Jelfa, 10 mg/g, gel

Metronidazole

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including all possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse.

Table of contents of the leaflet:

• 1. What is Metronidazol Jelfa gel and what is it used for
• 2. Important information before using Metronidazol Jelfa gel
• 3. How to use Metronidazol Jelfa gel
• 4. Possible side effects
• 5. How to store Metronidazol Jelfa gel
• 6. Contents of the packaging and other information

1. What is Metronidazol Jelfa gel and what is it used for

The active substance of Metronidazol Jelfa is metronidazole, in the form of a gel for topical use, with a bactericidal effect.
Metronidazol, when applied to the skin, acts on Gram-negative bacteria growing in relatively anaerobic conditions, of the genus: Bacteroides, Fusobacterium.

Indications for use

• Rosacea,
• Seborrhoeic dermatitis,
• Mixed bacterial skin infections of the face,
• Perioral dermatitis,
• Posterior rosacea.

2. Important information before using Metronidazol Jelfa gel

When not to use Metronidazol Jelfa gel

Warnings and precautions

Before starting to use Metronidazol Jelfa gel, you should discuss it with your doctor or pharmacist.
The medicine is intended for topical use on the skin only.
In case of irritation, you should consult a doctor – the doctor will decide whether to reduce the frequency of application or discontinue the use of Metronidazol Jelfa gel.
During treatment, you should avoid exposure to UV radiation (sunbathing, solarium, lamps emitting UV radiation).
Avoid contact of the medicine with the eyes and mucous membranes. Application of the medicine near the eye may cause conjunctival irritation and tearing. If the medicine gets into the eyes, they should be rinsed immediately with a large amount of cool water. If the eyes remain irritated, you should consult an ophthalmologist.
Metronidazol Jelfa gel should be used with caution in patients with abnormal blood counts (dyscrasia), including those that have occurred in the past.
The medicine should be used in accordance with the doctor's recommendations; do not use the medicine for longer than recommended by the doctor.
There is evidence suggesting that metronidazole has a carcinogenic effect in some animal species. However, there is no data on the carcinogenic effect of the medicine in humans.

Metronidazol Jelfa gel and alcohol

After consuming alcohol, reactions have been observed (including acute psychosis and confusion) similar to those that occurred when drinking alcohol while taking disulfiram - a medicine used to treat alcoholism.

Metronidazol Jelfa gel and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
No interactions have been reported between metronidazole in the form of a gel applied to the skin and other medicines; however, it should be taken into account that during oral administration of metronidazole, the following have been observed:

• enhancement of the effect of warfarin and coumarin (blood clotting inhibitors)
• and prolongation of prothrombin time (this is an indicator of blood clotting time).

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
The medicine may be used during pregnancy only if the doctor decides that it is absolutely necessary, as there is no data on the safety of topical metronidazole use in pregnant women, and metronidazole administered orally crosses the placental barrier and quickly penetrates the fetus.
Breastfeeding
If the doctor considers it necessary to use the medicine, they should recommend stopping breastfeeding.
Effect on fertility
There is no data describing the effect of metronidazole on fertility in humans.

Driving and using machines

Using Metronidazol Jelfa gel should not affect your ability to drive vehicles or operate machines.

Metronidazol Jelfa gel contains:

• methyl parahydroxybenzoate
• propyl parahydroxybenzoate
• propylene glycol
• ethanol.

Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (possible late reactions).
The medicine contains 150 mg of propylene glycol in 1 g of gel. Propylene glycol may cause skin irritation.
The medicine contains 150 mg of alcohol (ethanol) in 1 g of gel. The medicine may cause burning of damaged skin.

3. How to use Metronidazol Jelfa gel

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations.
In case of doubts, you should consult a doctor or pharmacist.
A thin layer of gel should be applied precisely to the skin lesions twice a day, in the morning and evening before sleep. Before applying, the skin should be washed with a mild cleansing agent. After applying the gel, the patient may use cosmetics that do not clog pores and do not have a drying effect.
The duration of treatment depends on the type of microorganism, location, and severity of the infection.
Usually, the medicine is used for 3 to 4 months. Do not exceed the recommended duration of treatment.
The doctor will recommend how long to use Metronidazol Jelfa gel. If no improvement occurs after 3-4 months, you should consult a doctor.

Use in children and adolescents

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

Using a higher dose of Metronidazol Jelfa gel than recommended

Overdose when using the medicine topically is extremely rare.
In case of accidental ingestion, gastric lavage is recommended. Then, it is suggested to administer activated charcoal, followed by a laxative based on salts. Therapy should include symptomatic and supportive treatment.
Metronidazole can be removed from the body through dialysis.

Missing a dose of Metronidazol Jelfa gel

Do not use a double dose to make up for a missed dose.

Stopping the use of Metronidazol Jelfa gel

In case of any doubts related to the use of this medicine, you should consult a doctor or pharmacist.
Do not stop using the medicine without consulting a doctor, as this may lead to worsening of skin symptoms.

In case of accidental ingestion of Metronidazol Jelfa gel

After accidental ingestion of the medicine, you should immediately consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using the medicine, side effects may occur with the following frequency:
Common side effects(may occur in up to 1 in 10 patients):
dryness of the skin, redness, itching, unpleasant sensations on the skin (burning, pain/burning),
skin irritation, exacerbation of rosacea.
Uncommon side effects(may occur in up to 1 in 100 patients):
decreased sensation, abnormal sensation, taste disorders (metallic taste), nausea.
Frequency not known(cannot be estimated from the available data): contact dermatitis.
If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse.
Reporting suspected side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Metronidazol Jelfa gel

Store in a temperature below 25°C. Do not freeze.
The shelf life after first opening the packaging is 1 month.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after: Expiry date.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Metronidazol Jelfa gel contains

The active substance of the medicine is metronidazole; 1 g of gel contains 10 mg of metronidazole.
The other ingredients are: propylene glycol, ethanol 96%, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, carbomer 980, tromethamine, purified water.

What Metronidazol Jelfa gel looks like and what the packaging contains

Metronidazol Jelfa is a colorless, transparent, and uniform gel.
The available packaging of the medicine is a tube containing 15 g of gel, placed in a cardboard box.

Marketing authorization holder

Bausch Health Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland

Manufacturer:

Przedsiębiorstwo Farmaceutyczne Jelfa SA
58-500 Jelenia Góra, ul. Wincentego Pola 21
phone: (075) 64-33-102
fax: (075) 752-44-55
e-mail: [email protected]
Date of last revision of the leaflet: