SACHOL DENTAL GEL

Package leaflet: Information for the patient

SACHOL DENTAL GEL, (87.1 mg + 0.1 mg)/g, gel for oral and gingival use
Choline salicylate + Cetylpyridinium chloride
Please read all of this 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 patient leaflet or as directed by a doctor, pharmacist, or nurse.

• 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 adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse, consult your doctor.

Contents of the leaflet:

1. What Sachol Dental Gel is and what it is 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 Sachol Dental Gel is and what it is used for

The product has local anti-inflammatory, analgesic, and antiseptic effects. These effects result from the action of its individual components. The main active ingredient, choline salicylate, exerts local anti-inflammatory and mild analgesic effects. Cetylpyridinium chloride enhances the analgesic and anti-inflammatory effects of the preparation. Methyl parahydroxybenzoate and propyl parahydroxybenzoate present in the base, at the concentrations contained in the product, exert antiseptic activity.

Indications:

• Inflammatory conditions of the oral mucosa,
• Erosions and ulcerations of the oral cavity,
• 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 ingredients 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, please discuss it with your doctor,
pharmacist, or nurse.
At the site of application, a short-lived, transient burning sensation 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 currently taking,
have recently taken, or plan to take.
When used locally according to the recommended dosage, there is no risk of
drug interactions.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have
a baby, you should consult your doctor or pharmacist before using this medicine.
Pregnancy
Use during pregnancy only on medical advice.
Do not use during the first and second trimesters of pregnancy unless your doctor decides it is absolutely necessary.
If use of Sachol dental gel is necessary during the first or second trimester of pregnancy,
the lowest possible dose should be used for the shortest possible duration.
Do not use during the third trimester of pregnancy.
Breastfeeding
Salicylic acid derivatives are excreted in human milk, and their use is not recommended
during breastfeeding.
Driving and operating machinery
Sachol dental gel has no effect on the ability to drive or operate machinery.
Sachol dental gel contains methyl parahydroxybenzoate and propyl parahydroxybenzoate.
The medicine may cause allergic reactions (delayed-type reactions are possible).
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 cause noticeable effects.

3. How to use Sachol dental gel

This medicine should always be used exactly as described in this patient information leaflet 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 daily.
Method of administration: apply a small amount of gel (approximately 1 centimeter in length) to the affected area and gently rub in for about 2 minutes.
For about half an hour after applying the gel, do not drink or eat any food.
After application, the gel remains on the surface of the oral mucosa for several minutes.

Use in children and adolescents
This medicine should not be used in children under 3 years of age.
Use in children over 3 years of age only on the advice of a doctor.

Use of a higher than recommended dose of Sachol dental gel
Overdose is theoretically not possible. However, if it occurs, rinse the mouth thoroughly with plenty of water and, if necessary, induce vomiting.
In case of hypersensitivity to salicylates, after overdosing and systemic absorption of significant amounts of choline salicylate, symptoms of general salicylate effects may occur, such as: sweating, tinnitus, nausea, vomiting, dizziness, skin reactions (flushing or urticaria). In such cases, contact a doctor.

Missed dose of Sachol dental gel
Do not use a double dose to make up for a missed dose.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
General disorders and administration site conditions:
transient, temporary burning sensation may occur.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor 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:
Al. Jerozolimskie 181C,
02-222 Warsaw,
tel.: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sachol dental gel

Keep the medicine out of sight and reach of children.
Store 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 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 packaging and other information

What the medicine Sachol dental gel contains

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

What the medicine Sachol dental gel looks like and contents of the pack
Sachol dental gel is a transparent, colourless, homogeneous mass with a characteristic aniseed odour.
Aluminium tube with a membrane and HDPE screw cap in a cardboard box.
Pack size: 10 g.
Marketing Authorisation Holder
Bausch + Lomb Ireland Limited
3013 Lake Drive
Citywest Business Campus
Dublin 24, D24PPT3
Ireland
[email protected]
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: [email protected]