Metronidazol Hema

Leaflet attached to the packaging: information for the user

METRONIDAZOLE

100 mg/g, ointment
(Metronidazolum)

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 you need to. If you have any doubts, consult your doctor or pharmacist. This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

What is Metronidazole and what is it used for
Important information before using Metronidazole
How to use Metronidazole

• 4. Possible side effects How to store Metronidazole Contents of the pack and other information

What is Metronidazole and what is it used for

Metronidazole
is an ointment used in dentistry.
It has antibacterial and anti-inflammatory effects.
The ointment is used:
in endodontic treatment of pulpitis;
in advanced cases of periodontitis that do not respond to routine treatment;
in periodontal abscesses;
in ulcerative gingivitis.
Metronidazole is a chemotherapeutic agent from the group of 5-nitroimidazole derivatives.
It has a strong bactericidal effect on anaerobic bacteria: Gram-negative rods ( Bacteroides spp.including strains resistant to clindamycin, Fusobacterium spp.), Gram-positive rods ( Eubacterium
spp.), Gram-positive bacilli (including Clostridium spp.), non-spore-forming Gram-positive cocci ( Peptostreptococcus) and non-spore-forming Gram-negative cocci ( Veillonella). It also has anti-inflammatory effects.
Resistance to the drug is rare.
When used locally in endodontic treatment and on the mucous membrane of the oral cavity, it may be absorbed to a small extent.

Important information before using Metronidazole

When not to use Metronidazole

In the treatment of periodontal diseases:
if the patient is allergic to metronidazole or any of the other ingredients of this medicine (listed in section 6);
if the patient has cachexia, especially in children and the elderly;
during pregnancy and breastfeeding (it passes through the placenta and into breast milk).
In endodontic treatment, there are no contraindications.

Warnings and precautions

Due to the frequent development of bacterial resistance, the product should be used for a short period: 7 to 10 days.

Metronidazole and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to have a child, consult your doctor or pharmacist before using this medicine.
There is no information on adverse effects during local use of metronidazole in the treatment of endodontic and periodontal diseases in pregnant or breastfeeding women. However, as a precaution, it is not recommended to use this medicine due to the possibility of its penetration through the placenta and into breast milk.

Driving and using machines

Metronidazole
does not affect the ability to drive and use machines.

How to use Metronidazole

• In the treatment of pulpitis, as a temporary filling between visits: the ointment is introduced into the cleaned and dried canal with a Lentulo needle. In case of acute condition, the dressing is changed daily until the exacerbation subsides, and in chronic conditions, the dressing is left for 2-3 days (but no longer than 5-7 days);
• in the treatment of advanced periodontitis as a supplement to basic treatment (scaling) - gently rub the gums 2 times a day;
• in the treatment of periodontal abscesses - locally, after drainage of the abscess, the ointment is introduced into the pathological gum pocket, and then causal treatment is started;
• in ulcerative gingivitis, gently rub the gums 2-3 times a day, and after 3-5 days, sanitize the oral cavity.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After local administration in periodontal diseases, they occur rarely; sometimes gastrointestinal disorders (nausea, vomiting, abdominal pain) are observed.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02-222 Warsaw
Phone: + 48 22 49-21-301
Fax: + 48 22 49-21-309
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

How to store Metronidazole

Store the tube tightly closed.
Store in the refrigerator (2°C - 8°C). Do not freeze.
The medicine should be stored out of sight and reach of children.
Pay attention to the expiry date of the medicine.
Do not use this medicine after the expiry date stated on the tube. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Metronidazole contains

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

What Metronidazole looks like and what the pack contains

Metronidazole
is a homogeneous, translucent mass of white color with a light yellow tint.
The packaging of the medicine is a tube containing 5g of ointment. The tube, along with the leaflet, is placed in a cardboard box.

Marketing authorization holder and manufacturer

CHEMA-ELEKTROMET
Cooperative
ul. Przemysłowa 9
35-105 Rzeszów
tel. 17 862 05 90
e-mail: chema@chema.rzeszow.pl

Date of last update of the leaflet: