Sahodent

Package Leaflet: Information for the Patient

Sachodent, 87.1 mg/g, Gel for Oral Use

Choline Salicylate

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient.

This medication should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact a doctor.

Table of Contents of the Leaflet

• 1. What is Sachodent and What is it Used For
• 2. Important Information Before Using Sachodent
• 3. How to Use Sachodent
• 4. Possible Side Effects
• 5. How to Store Sachodent
• 6. Package Contents and Other Information

1. What is Sachodent and What is it Used For

Sachodent is a gel medication used to treat pain, inflammation, irritation, damage, or ulcers in the mouth.

Sachodent is indicated for use in adults and adolescents over 16 years of age.

Sachodent is quickly absorbed through the mucous membrane and effectively relieves pain after application to the affected area. Pain relief occurs within 2-3 minutes of applying the gel to the painful area and lasts for 2-3 hours.

If after 7 days there is no improvement or you feel worse, consult a doctor.

2. Important Information Before Using Sachodent

When Not to Use Sachodent

Warnings and Precautions

Before starting to use Sachodent, discuss it with your doctor or pharmacist.

If the pain is severe and persistent or if symptoms are accompanied by an elevated body temperature, contact a doctor.

Children and Adolescents Under 16 Years of Age

Sachodent is not indicated for use in children and adolescents under 16 years of age. Sachodent should not be used in children and adolescents under 16 years of age with a feverish illness, due to the risk of Reye's syndrome. Reye's syndrome is a very rare, life-threatening disease that affects the brain and liver, usually occurring after a fever has resolved. It is characterized by profuse vomiting, headache, and altered consciousness.

Sachodent and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take.

Salicylates may enhance the effect of blood-thinning medications (anticoagulants) and may inhibit the effect of medications used to treat gout (increasing uric acid excretion).

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 medication.

Sachodent should be used with caution and under medical supervision in pregnant and breastfeeding women.

During the last three months of pregnancy, the use of Sachodent is not recommended. During the first six months of pregnancy, Sachodent should not be used unless necessary and recommended by a doctor. If use is necessary, the smallest dose should be administered for the shortest duration.

Driving and Using Machines

Sachodent does not affect the ability to drive or operate machinery.

Sachodent Contains 96% Ethanol

This medication contains 363.7 mg of 96% ethanol per gram of gel. It may cause a burning sensation on damaged skin.

3. How to Use Sachodent

This medication should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose:

Adults and adolescents over 16 years of age:

Apply a small amount, a strip of gel about 0.5-1 cm long or the volume of a pea, to the affected area of the mucous membrane with a clean finger and gently massage. Do not exceed the recommended dose for a single application. Use 3-4 times a day.

If necessary, in case of severe pain, the dose can be repeated every 2-3 hours. Do not exceed the maximum number of 8-10 applications per day.

The gel can be used before meals and before bedtime.

If after 7 days there is no improvement or you feel worse, contact a doctor. Without consulting a doctor, the medication should not be used for more than 7 days.

Use in Children and Adolescents Under 16 Years of Age

This medication is contraindicated for use in children and adolescents under 16 years of age - see "Important Information Before Using Sachodent".

The medication should not be used in children and adolescents under 16 years of age with a feverish illness.

Overdose of Sachodent

In case of using a higher dose of the medication than recommended, consult a doctor or pharmacist.

Overdose of salicylates may occur during the use of high doses of the medication or prolonged treatment. Symptoms of overdose include: headaches and dizziness, tinnitus, hearing disturbances, confusion, drowsiness, increased sweating, vomiting, diarrhea, fever, rapid breathing.

If you have any further doubts about the use of this medication, consult a doctor or pharmacist.

Missing a Dose of Sachodent

Do not use a double dose to make up for a missed dose.

4. Possible Side Effects

Like all medications, Sachodent can cause side effects, although not everybody gets them.

Frequency not known (frequency cannot be estimated from the available data):

• mucous membrane burning sensation.

The following side effects are considered common for the group of salicylates:

Frequency not known (frequency cannot be estimated from the available data):

• bronchospasm manifesting as breathing difficulties, asthma;
• gastric ulcer, duodenal ulcer;
• Reye's syndrome (in children and adolescents under 16 years of age with a feverish illness);
• prolonged bleeding time.

Reporting Side Effects

If you experience any side effects, including those 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.: +48 22 49 21 301

Fax: +48 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 medication.

5. How to Store Sachodent

Keep the medication out of sight and reach of children.

Store in a temperature below 25°C.

Shelf life after first opening the tube: 2 years.

Do not use this medication after the expiry date stated on the packaging after "EXP".

The expiry date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Sachodent Contains

• The active substance of the medication is choline salicylate. 1 g of gel contains 87.1 mg of choline salicylate.
• Other ingredients are: 96% ethanol, glycerol (E 422), hypromellose 2910, sodium cyclamate, anise oil, levomenthol, purified water.

What Sachodent Looks Like and What the Package Contains

Sachodent is a clear, colorless to light yellow, homogeneous gel with a characteristic anise odor.

Package: aluminum tube internally coated with epoxy-phenolic varnish, with a nozzle and a polyethylene HDPE cap, placed in a cardboard box.

Package size: 10 g

Marketing Authorization Holder

ZIAJA Ltd Pharmaceutical Manufacturing Plant sp. z o.o.

ul. Jesienna 9

80-298 Gdańsk

Poland

Tel.: +48 58 521 34 00

Manufacturer

ZIAJA Ltd Pharmaceutical Manufacturing Plant sp. z o.o.

ul. Przemysłowa 12

83-050 Kolbudy

Poland

This Medication is Authorized for Use in the Member States of the European Economic Area Under the Following Names:

Poland: Sachodent

Czech Republic: Sachodent

Date of Last Update of the Leaflet:02/2025