Metronidazole jelfa
Poland
Table of Contents
P package leaflet: information for the patient
Metronidazol Jelfa, 10 mg/g, gel
Metronidazolum
Please read carefully the entire leaflet 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 doubts, please consult your doctor, pharmacist, or nurse.
- 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 the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Table of contents of the leaflet:
- What is Metronidazol Jelfa gel and what is it used for
- Important information before using Metronidazol Jelfa gel
- How to use Metronidazol Jelfa gel
- Possible side effects
- How to store Metronidazol Jelfa gel
- Contents of the packaging and other information
1. What is Metronidazol Jelfa gel and what is it used for
The active substance in Metronidazol Jelfa gel, a topical gel, is metronidazole with bactericidal activity.
After topical application to the skin, metronidazole acts against Gram-negative bacteria growing under relatively anaerobic conditions, from the genera: Bacteroides, Fusobacterium.
Indications
- Rosacea,
- Seborrheic dermatitis,
- Mixed bacterial infections of facial skin,
- Perioral dermatitis,
- Post-steroid rosacea.
2. Important information before using Metronidazol Jelfa gel
When not to use Metronidazol Jelfa gel
- if the patient is allergic to metronidazole or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Metronidazol Jelfa gel, discuss this with your doctor or pharmacist.
This medicine is intended for topical use on the skin only.
If irritation occurs, consult a doctor – the doctor will decide whether to reduce the frequency of application or discontinue treatment with Metronidazol Jelfa gel.
During treatment, avoid exposure to UV radiation (sunbathing, solariums, UV lamps).
Avoid contact of the medicine with eyes and mucous membranes. Application near the eye may cause irritation of the conjunctiva and tearing. If the medicine gets into the eyes, rinse immediately with a large amount of cool water. If eye irritation persists, consult an ophthalmologist.
Metronidazol Jelfa gel should be used with caution in patients with blood abnormalities (dyscrasias), including those occurring in the past.
The medicine should be used according to the doctor's instructions; do not use the medicine longer than recommended by the doctor.
There is evidence suggesting that metronidazole has carcinogenic effects in certain animal species. However, there are no data on the carcinogenic effects of the medicine in humans.
Metronidazol Jelfa gel and alcohol
Reactions similar to those observed when consuming alcohol during disulfiram therapy (a drug used in the treatment of alcoholism), including acute psychoses and confusion, have been reported after alcohol consumption.
Metronidazol Jelfa gel and other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to use.
No interactions have been reported between metronidazole in the form of a topical skin gel and other medicines. However, when metronidazole is administered orally, the following interactions have been observed:
- enhanced effect of warfarin and coumarin (medicines that inhibit blood clotting)
- and prolonged prothrombin time (a measure of blood clotting time).
Pregnancy, breastfeeding, and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
This medicine may be used during pregnancy only if the doctor decides it is absolutely 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
If the doctor considers the use of this medicine necessary, breastfeeding should be discontinued.
Effect on fertility
There are no data describing the effect of metronidazole on fertility in humans.
Driving and operating machinery
The use of Metronidazol Jelfa gel should not affect the ability to drive or operate machinery.
Metronidazol Jelfa gel contains:
- methyl parahydroxybenzoate
- propyl parahydroxybenzoate
- propylene glycol
- ethanol.
Methyl parahydroxybenzoate and propyl parahydroxybenzoate may cause allergic reactions (delayed-type reactions possible).
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 stinging on damaged skin.
3. How to use Metronidazol Jelfa gel
This medicine should always be used according to the instructions given by the doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
A thin layer of the gel should be carefully applied to the affected skin areas twice daily, in the morning and in the evening before bedtime. Before application, the skin should be washed with a mild cleansing agent. After applying the gel, the patient may use cosmetics that do not clog skin pores and do not have astringent properties.
The duration of treatment depends on the type of microorganism, the location and severity of the infection.
Usually, the medicine is used for 3 to 4 months. Do not exceed the duration of treatment recommended by the doctor.
Your doctor will advise how long you should use Metronidazol Jelfa gel. If there is no improvement after 3–4 months, consult your doctor.
Use in children and adolescents
Metronidazol Jelfa gel is not recommended for use in children due to lack of data on safety and efficacy.
Use of a higher than recommended dose of Metronidazol Jelfa gel
Overdose with topical application of the medicine is extremely rare.
If removal of excessive amounts of the medicine from the skin is necessary, wash the skin thoroughly with plenty of warm water. In case of accidental ingestion, gastric lavage is recommended. This should be followed by administration of activated charcoal and then a saline laxative. Treatment should include symptomatic and supportive measures.
Metronidazole can be removed from the body by dialysis.
Missed dose of Metronidazol Jelfa gel
Do not use a double dose to make up for a missed dose.
Stopping treatment with Metronidazol Jelfa gel
If you have any doubts regarding the use of this medicine, consult your doctor or pharmacist.
Do not stop using the medicine earlier than recommended and without consulting your doctor, as this may lead to a worsening of skin symptoms.
In case of accidental ingestion of Metronidazol Jelfa gel
If the medicine is accidentally ingested, seek medical advice immediately.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after using this medicine:
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 the available data): contact dermatitis.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse.
Reporting suspected adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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
Tel.: + 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 Jelfa gel
Store below 25°C. Do not freeze.
Shelf life after first opening of the container – 1 month.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Contents of the packaging and other information
What Metronidazol Jelfa gel contains
The active substance is metronidazole; 1 g of gel contains 10 mg of metronidazole.
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 contents of the pack
Metronidazol Jelfa is a colourless, transparent, and homogeneous gel.
The medicinal product is packed in a tube containing 15 g of gel, placed in a cardboard box.
Marketing Authorisation 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
tel.: (075) 64-33-102
fax: (075) 752-44-55
e-mail: [email protected]