Grinazole

PATIENT LEAFLET: INFORMATION FOR THE USER

GRINAZOLE 100 mg/g

Metronidazole

Read the leaflet carefully before using the medicine, as it contains

important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult your doctor or dentist.
• This medicine has been prescribed specifically for you. 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 side effects, including any not listed in this leaflet, they should inform their doctor or dentist. See section 4.

Table of contents of the leaflet:

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

1. WHAT IS GRINAZOLE AND WHAT IS IT USED FOR

Grinazole is intended for local treatment of root canal infections of the tooth, following pulp necrosis and its complications.
The active substance of the medicine is metronidazole, used in local treatment of infections.
The medicine is intended for professional use by a dentist.

2. IMPORTANT INFORMATION BEFORE USING GRINAZOLE

When not to use Grinazole

If the patient is allergic to metronidazole or other imidazoles (substances with a structure similar to metronidazole), para-aminobenzoates, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before using the product, a medical history should be taken to check for any allergic reactions.

Grinazole and other medicines

Tell your doctor or dentist about all medicines you are taking, or have recently taken, and any medicines you plan to take.
There are no reports of interactions with Grinazole used locally in the treatment of root canal infections of the tooth.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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Pregnancy:
Caution should be exercised when administering the medicine to pregnant women.
Breastfeeding:
Metronidazole may cause a bitter taste in breast milk, which can cause vomiting in infants, combined with a reluctance to eat.
It is recommended to avoid using metronidazole during breastfeeding.
However, if metronidazole is necessary in the form of Grinazole in a breastfeeding woman, breastfeeding can be considered acceptable provided that the newborn is clinically monitored during the mother's treatment and for 2-3 days after its completion.

Driving and using machines

Grinazole does not affect the ability to drive vehicles or operate machinery.

Grinazole contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (possible late reactions).

3. HOW TO USE GRINAZOLE

Grinazole is used by the dentist during the treatment of root canal infections of the tooth.
The medicine is intended for use only in dental practice.
After cleaning the canal, if there are clinical symptoms of infection, Grinazole paste should be placed in the canal using mechanically driven instruments and closed with temporary cement.
Treatment should be completed 2-3 days later by removing the Grinazole paste from the canal and filling the canal in a standard manner.

Using more than the recommended dose of Grinazole

There are no reports of overdose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Grinazole can cause side effects, although not everybody gets them.
During the visit to the dentist's office, the dentist will carefully monitor the effects of Grinazole.
The frequency of possible side effects listed below is defined as:
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1000 people
Very rare: may affect up to 1 in 10,000 people
Not known: frequency cannot be estimated from the available data
Immune system disorders
Not known: hypersensitivity reactions
General disorders and administration site conditions
Not known: periapical irritation, causing exacerbation of symptoms of apical periodontitis.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or dentist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products,

• 2 - Al. Jerozolimskie 181 C, 02-222 Warsaw,

Tel.: + 48 22 49 21 301
Fax: + 48 22 40 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of the medicine.

5. HOW TO STORE GRINAZOLE

Store in a temperature below 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Grinazole contains

• The active substance is metronidazole.
• The other ingredients are: propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), glycerol monostearate, glycerol.

What Grinazole looks like and contents of the pack

Grinazole is a white to ivory-colored paste.
A multi-layer tube with HDPE (high-density polyethylene), closed with a white polypropylene cap, containing 4.5 g of paste.
The carton contains one tube.

Marketing authorization holder and manufacturer

SEPTODONT
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France
To obtain information about the medicine, contact the representative of the marketing authorization holder in Poland:
Septodont Polska sp. z o.o.
ul. Taneczna 18 A
02-829 Warsaw
Tel.: 22/ 545 89 50
Fax: 22/ 641 80 21
e-mail: sekretariat@septodont.com.pl
Date of last revision of the leaflet:

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