Sahol zhel stomatologihni

Package Leaflet: Information for the Patient

SACHOL DENTAL GEL, (87.1 mg + 0.1 mg)/g, gel for oral and gingival use
and on gums
Choline salicylate + Cetalkonium chloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Leaflet:

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

1. What is Sachol dental gel and what is it used for

The medicine has: anti-inflammatory, analgesic, and local antiseptic effects. The effect of the medicine is the result of the action of its individual components. The main component of the medicine - choline salicylate has a local anti-inflammatory and slightly analgesic effect. Cetalkonium chloride enhances the analgesic and anti-inflammatory effects of the medicine. The preservatives present in the base: methyl parahydroxybenzoate and propyl parahydroxybenzoate in the concentrations contained in the medicine have an antiseptic effect.

Indications:

• inflammatory conditions of the oral mucosa,
• ulcers and erosions of the oral mucosa,
• gingivitis,
• periodontal diseases.

2. Important information before using Sachol dental gel

When not to use Sachol dental gel

• if the patient is allergic to choline salicylate, cetalkonium chloride, other salicylates, or any of the other components of this medicine (listed in section 6)
• if the patient is in the third trimester of pregnancy.

Warnings and precautions

Before starting to use Sachol dental gel, discuss it with your doctor, pharmacist, or nurse.
In the place of application of the medicine, short-term, transient burning may occur.

Children and adolescents

Do not use in children under 3 years of age.

Sachol dental gel and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.
When used locally in accordance with the recommended dosage, there is no risk of interactions.

Pregnancy, breastfeeding, and fertility

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.
Pregnancy
Use during pregnancy only on the advice of a doctor.
Do not use in the first and second trimester of pregnancy unless your doctor decides it is absolutely necessary.
If the use of Sachol dental gel is necessary during the first and second trimester of pregnancy, use the smallest possible dose for the shortest possible time.
Do not use in the third trimester of pregnancy.
Breastfeeding
Salicylate derivatives are excreted in breast milk and their use is not recommended during breastfeeding.

Driving and using machines

Sachol dental gel has no effect on the ability to drive and use machines.

Sachol dental gel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate

parahydroxybenzoate.
The medicine may cause allergic reactions (possible late reactions).

Sachol dental gel contains ethanol

This medicine contains approximately 0.1 g of alcohol (96% ethanol) per dose. The amount of alcohol in a dose of this medicine is equivalent to less than 2.5 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

3. How to use Sachol dental gel

This medicine should always be used exactly as described in the package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Recommended dose: apply 2 to 3 times a day.
Method of administration: apply a small amount of gel (about 1 centimeter long) to the affected area, gently rub for about 2 minutes.
For about half an hour after applying the gel, do not drink or eat anything.
After application, the gel remains on the surface of the oral mucosa for a few minutes.

Use in children and adolescents

Do not use in children under 3 years of age.
Use in children over 3 years of age only on the advice of a doctor.

Overdose of Sachol dental gel

Theoretically, it is not possible to overdose on the medicine. However, if this happens, rinse the mouth with plenty of water and possibly induce vomiting.
In case of hypersensitivity to salicylates, after overdosing on the gel and absorbing significant amounts of choline salicylate into the body, symptoms of general salicylate action may occur, such as: sweating, ringing in the ears, nausea, vomiting, dizziness, skin changes (flushing or urticaria). In this case, contact a doctor.

Missing a dose of Sachol dental gel

Do not use a double dose to make up for a missed dose of the medicine.
If you have any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
General disorders and administration site conditions:
short-term, transient burning may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. 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 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.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.

5. How to store Sachol dental gel

Store the medicine out of sight and reach of children.
Store at a temperature below 25°C. Do not freeze.
Shelf life:
6 months after first opening.
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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sachol dental gel contains

• The active substances of the medicine are: choline salicylate and cetalkonium chloride. 1 g of gel contains 87.1 mg of choline salicylate and 0.1 mg of cetalkonium chloride.
• The other ingredients of the medicine are: hydroxyethylcellulose, methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, star anise essential oil, 96% ethanol, purified water.

What Sachol dental gel looks like and contents of the pack

Sachol dental gel is a clear, colorless, uniform mass with the smell of star anise essential oil.
Aluminum tube with a membrane and an HDPE cap in a cardboard box.
Pack size: 10 g.

Marketing authorization holder

Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
customerservice.pharma.poland@bausch.com

Manufacturer

Przedsiębiorstwo Farmaceutyczne Jelfa SA
ul. Wincentego Pola 21, 58 – 500 Jelenia Góra
tel.: (075) 643-31-02
fax: (075) 752-44-55
e-mail: jelfa@jelfa.com.pl

Date of last revision of the leaflet: