PELOGEL

Patient Information Leaflet

PELOGEL
gel for application to the gums
Please read all of this leaflet carefully before using this medicine, because it
contains important information for you.
This medicine should always be used exactly as described in this patient leaflet, or
as directed by your doctor or pharmacist.

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement or if your condition worsens after 10–15 days, consult your doctor.

Contents of the leaflet:

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

1. What Pelogel is and what it is used for

Pelogel contains a concentrated aqueous extract of peat and peppermint oil. The gel is used as an adjunctive dental treatment following prior removal of dental calculus.
The biologically active components of peat, primarily humic acids (humic and fulvic acids), exhibit anti-inflammatory activity in diseases of the oral mucosa and periodontium. Moreover, these acids have an astringent effect on the mucous membranes.
Massaging the gums and simultaneously rubbing in the peat extract improves microcirculation in pathologically altered tissues, which facilitates the absorption of exudates and infiltrates at inflammatory sites.

Indications:
Pelogel is used as an adjunctive treatment in:

• Periodontitis (periodontosis),
• Gingivitis. The gel may be used after completion of primary treatment by a dentist.

2. Important information before using Pelogel

When not to use Pelogel:

• if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6),
• in acute inflammatory conditions of the periodontium, gums, and oral cavity.

Warnings and precautions
Before starting to use Pelogel, discuss it with your dentist or pharmacist.
Removal of supragingival calculus is also recommended.
If there is no improvement after 10–15 days, or if the patient feels worse, consult a doctor.
Children
There is a lack of data on the safety of using the medicine in this age group.
Therefore, the use of the medicine is not recommended in children.
Pelogel and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently using or has recently used, as well as any medicines the patient plans to use.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
Pelogel has no influence on the ability to drive or operate machinery.

3. How to use Pelogel?

This medicine should always be used exactly as described in the patient information leaflet or as advised by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Adults: The single dose is approximately 2.5 g (1/2 teaspoon). Using a soft toothbrush or fingertip, massage the gel into the gums for about 1 minute (2–3 times daily). After applying the product, do not eat or drink for about half an hour. Use for approximately 2–3 weeks.

If you use more medicine than recommended
Symptoms of overdose are unknown.

If you forget to use a dose of Pelogel
Apply the next dose as scheduled. Do not use a double amount to make up for a missed dose.

4. Possible adverse reactions

No adverse effects or worsening of disease symptoms have been observed. If any adverse symptoms occur, discontinue use of the medicine and inform your doctor.
Reporting of adverse reactions.
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
al. Jerozolimskie 181 C
02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Pelogel

Keep in a dry place and in a tightly closed container.
Pelogel should be stored in a place inaccessible and not visible to children.
Do not use Pelogel after the expiry date stated on the packaging.
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 Pelogel contains

• The active substance is aqueous bilberry extract.
• The excipients are: glycerol 85%, peppermint oil, ethyl parahydroxybenzoate, ethanol 96%, purified water, methylcellulose.

What Pelogel looks like and contents of the pack
An aluminium tube containing 40 g of Pelogel, placed in a cardboard box with an informational leaflet.
Marketing Authorisation Holder
Przedsiębiorstwo Farmaceutyczne Sulphur Zdrój Exim sp. z o.o.
28-100 Busko-Zdrój, ul. Bohaterów Warszawy 116a
tel/fax 041-378-78-93
e-mail: [email protected]
Manufacturer
Przedsiębiorstwo Farmaceutyczne Sulphur Zdrój Exim sp. z o.o.
28-100 Busko-Zdrój, ul. Bohaterów Warszawy 116a
tel/fax 041-378-78-93
e-mail: [email protected]