Metronidazol chema

Package leaflet: Information for the user

METRONIDAZOL CHEMA 100 mg/g, ointment
Metronidazolum
Please read the entire leaflet carefully before use, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

Metronidazol Chema ointment is used in dentistry.
It exhibits antibacterial and anti-inflammatory effects.
This medicine is used:

• in endodontic treatment of pulp necrosis;
• in advanced periodontitis unresponsive to routine treatment;
• in periodontal abscesses;
• in ulcerative gingivitis.

Metronidazole is a chemotherapeutic agent belonging to the 5-nitroimidazole derivatives group.
It exerts strong bactericidal activity against anaerobic bacteria: Gram-negative bacilli ( Bacteroides spp., including clindamycin-resistant strains, Fusobacterium spp. ), Gram-positive bacilli ( Eubacterium spp. ), Gram-positive rods (e.g. Clostridium spp. ), non-spore-forming Gram-positive cocci ( Peptostreptococcus ), and non-spore-forming Gram-negative cocci ( Veillonella ). It also demonstrates anti-inflammatory activity.
Resistance to the drug is rare.
When applied locally in endodontic treatment or to the oral mucosa, it may be absorbed to a small extent.

2. Information before using Metronidazol Chema

When not to use Metronidazol Chema

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

In the treatment of periodontal diseases:

• if the patient has been diagnosed with cachexia, especially in children and elderly individuals;
• during pregnancy and breastfeeding (it crosses the placenta and is excreted in breast milk).

In endodontic treatment, if the patient is not allergic to the active substance or to any of
the other ingredients of this medicine, there are no contraindications.
Warnings and precautions
Before starting to use Metronidazol Chema, consult with your doctor or
pharmacist.
Due to the frequent development of bacterial resistance, the medicine should be used for a short period only: 7 to 10
days.
Metronidazol Chema 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 take.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
There is a lack of information regarding harmful effects associated with the topical use of metronidazole
in the treatment of endodontic diseases and apical and marginal periodontal tissues in pregnant or
breastfeeding women. However, the use of this medicine is not recommended in women during pregnancy or
breastfeeding due to the possibility of its passage through the placenta and into the milk of nursing
women.
Driving and operating machinery
Metronidazol Chema has no effect or has a negligible effect on the ability to drive
and operate machinery.
Metronidazol Chema contains cetostearyl alcohol. Cetostearyl alcohol may
cause local skin reactions (e.g. contact dermatitis).

3. How to use Metronidazol Chema

• In the treatment of pulp gangrene, as a temporary dressing between visits: the ointment is introduced via a Lentulo spiral into the cleaned and dried canal. In acute conditions, the dressing is changed daily until the acute symptoms subside; in chronic conditions, the dressing may be left in place for 2–3 days (but no longer than 5 to 7 days);
• In the treatment of advanced periodontitis, as an adjunct to basic therapy (scaling): gently apply to the gums twice daily;
• In the treatment of periodontal abscesses: locally, after drainage of the abscess, apply the ointment into the pathological gingival pocket, followed by causal treatment;
• In ulcerative gingivitis: gently apply to the gums 2–3 times daily, and perform oral sanitation after 3 to 5 days.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
When administered locally in periodontal diseases, adverse reactions usually occur rarely;
gastrointestinal disturbances (nausea, vomiting, abdominal pain) are sometimes observed.
Reporting of 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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Metronidazol Chema

Keep the medicine out of the sight and reach of children.
Keep the tube tightly closed.
Store in a refrigerator (at a temperature of 2°C - 8°C). Do not freeze.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube and the cardboard box after "EXP". 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 in use. This will help protect the environment.

6. Contents of the package and other information

What Metronidazol Chema contains

• The active substance is metronidazole. 1 g of the ointment contains 100 mg of metronidazole.
• The other ingredients are: cetostearyl alcohol, polyethylene glycol 400, polyethylene glycol 4000.

What Metronidazol Chema looks like and contents of the pack
Metronidazol Chema is a homogeneous, translucent mass of white color with a pale yellow tint.
The packaging consists of a tube containing 5 g of ointment. The tube, together with the leaflet, is placed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
CHEMA-ELEKTROMET
Spółdzielnia Pracy
Przemysłowa Street 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: [email protected]