Grinazole

GRINAZOLE 100 mg/g
Metronidazolum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Contents of the leaflet:

1. What Grinazole is and what it is 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 GRINAZOLE IS AND WHAT IT IS USED FOR

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

2. IMPORTANT INFORMATION BEFORE USING GRINAZOLE

When not to use Grinazole
Do not use Grinazole if the patient is allergic to metronidazole or other imidazoles (substances structurally similar to metronidazole), para-aminobenzoic acid, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before using the product, a medical history regarding possible allergic reactions should be taken from the patient.

Grinazole and other medicines
Inform your doctor or dentist about all medicines the patient is currently taking or has recently used, as well as any medicines planned for future use.
There are no reported interactions when Grinazole is used locally in the treatment of infections in the tooth root canal.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

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Pregnancy:
Caution should be exercised when administering this medicine to pregnant women.

Breastfeeding:
Metronidazole may cause a bitter taste in breast milk, which may lead to vomiting and refusal to feed in infants.
The use of metronidazole during breastfeeding is generally not recommended.
However, if it is necessary to use metronidazole in the form of Grinazole in a breastfeeding woman, breastfeeding may be considered acceptable provided that the newborn is clinically monitored during maternal treatment and for 2–3 days after its completion.

Driving and operating machinery
Grinazole has no influence on the ability to drive motor vehicles or operate mechanical equipment.

Grinazole contains propyl parahydroxybenzoate (E216) and methyl parahydroxybenzoate (E218), which may cause allergic reactions (including delayed-type reactions).

3. HOW TO USE GRINAZOLE MEDICINAL PRODUCT

Grinazole medicinal product is used by a dentist during treatment of infections in the tooth root canal.
The product is intended exclusively for use in dental practice.
After cleaning the canal, if there are clinical signs of infection, Grinazole paste should be placed
into the canal using mechanically driven instruments and sealed with a temporary cement.
Complete the treatment 2-3 days later by removing the Grinazole paste from the canal and filling the canal
in a standard manner.
Use of a higher than recommended dose of Grinazole
Cases of overdose have not been reported.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During your dental visit, the dentist will carefully monitor the effect of the medicine Grinazole.
The frequency of possible adverse reactions listed below is defined as follows:
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 leading to exacerbation of symptoms of periodontitis.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your dentist or pharmacist.
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,

• 2 - Al. Jerozolimskie 181 C, 02-222 Warsaw,
  Tel.: + 48 22 49 21 301
  Fax: + 48 22 40 21 309
  e-mail: [email protected]
  Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. HOW TO STORE GRINAZOLE

Store below 25°C.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP. The expiry date refers to the last day of the specified 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 help protect the environment.

6. CONTENTS OF THE PACKAGE AND OTHER INFORMATION

What Grinazole contains

• The active substance is metronidazole.
• Other components of the medicine are: propyl parahydroxybenzoate (E216), methyl parahydroxybenzoate (E218), glycerol monostearate, glycerol.

What Grinazole looks like and contents of the pack
Grinazole is a paste, white in colour, gradually changing into ivory colour.
Multilayer tube made of HDPE (high-density polyethylene), closed with a white polypropylene cap, containing 4.5 g of paste.
The cardboard box contains one tube.

Marketing Authorisation Holder and Manufacturer
SEPTODONT
58, rue du Pont de Créteil
94100 Saint-Maur-des-Fossés
France

For information regarding the medicine, please contact the representative of the Marketing Authorisation 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: [email protected]

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