Package leaflet: Information for the user

Sachodent, 87.1 mg/g, gel for oral use
Cholini salicylas
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
the physician or pharmacist.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform a doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Table of contents

What Sachodent is and what it is used for
Important information before using Sachodent
How to use Sachodent
Possible side effects
How to store Sachodent
Contents of the pack and other information

1. What Sachodent is and what it is used for

Sachodent is a gel medicine used in the treatment of pain, inflammatory conditions, irritations,
injuries, or ulcers of the oral cavity.
Sachodent is indicated for use in adults and adolescents over 16 years of age.
Sachodent is rapidly absorbed through the mucous membrane and effectively relieves pain when applied to the affected area.
Pain relief occurs within 2–3 minutes after applying the gel to the painful site and lasts for 2–3 hours.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Sachodent

When not to use Sachodent

if the patient is allergic to choline salicylate or any of the other ingredients of this medicine (listed in section 6);
if the patient has ever previously experienced breathing difficulties (asthma, bronchospasm), urticaria, rhinitis, or facial or tongue swelling after taking or using medicines containing acetylsalicylic acid or other non-steroidal anti-inflammatory drugs;
in children and adolescents under 16 years of age in case of illness accompanied by fever.

Warnings and precautions
Before starting to use Sachodent, consult a doctor or pharmacist.
If the pain is severe and persistent, or if symptoms are accompanied by 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 must not be used in children and adolescents under 16 years of age with feverish illness due to the risk of Reye's syndrome. Reye's syndrome is a very rare, life-threatening condition affecting the brain and liver. It usually occurs after fever subsides. Symptoms of Reye's syndrome include persistent vomiting, headache, and disturbances of consciousness.
Sachodent and other medicines
Inform your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines planned for future use.
Salicylates may enhance the effect of anticoagulant (blood-thinning) medicines and may inhibit the action of drugs used in the treatment of gout (those increasing uric acid excretion).
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Sachodent should be used cautiously and only as directed by a doctor in pregnant women and during breastfeeding.
Sachodent is not recommended during the last three months of pregnancy. During the first six months of pregnancy, Sachodent should not be used unless necessary and specifically recommended by a doctor. If use is required, the lowest possible dose for the shortest possible duration should be administered.
Driving and operating machinery
Sachodent has no effect on the ability to drive or operate machinery.
Sachodent contains 96% ethanol
This medicine 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 medicine should always be used exactly as described in this patient information 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
Using a clean finger, apply a small amount—a gel strip approximately 0.5–1 cm in length or the volume of a pea—onto the affected area of the mucous membrane and gently massage. Do not exceed the amount of gel recommended for a single application. Apply 3–4 times daily.
If necessary, in case of severe pain, the dose may be repeated every 2–3 hours. Do not exceed the maximum of 8–10 applications per day.
The gel may be used before meals and before bedtime.
If there is no improvement after 7 days, or if symptoms worsen, consult a doctor. Without consulting a doctor, this medicine should not be used for longer than 7 days.
Use in children and adolescents under 16 years of age
This medicine is contraindicated for use in children and adolescents under 16 years of age—see section “Important information before using Sachodent”.
This medicine must not be used in children and adolescents under 16 years of age if they have a feverish illness.
Use of a higher than recommended dose of Sachodent
If a higher than recommended dose has been used, consult a doctor or pharmacist.
Salicylate overdose may occur during treatment with high doses or prolonged therapy. Symptoms of overdose include: headache, dizziness, tinnitus, hearing disturbances, confusion, drowsiness, excessive sweating, vomiting, diarrhoea, fever, and rapid breathing.
If you have any further doubts regarding the use of this medicine, consult a doctor or pharmacist.
Missed dose of Sachodent
Do not use a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Frequency not known (frequency cannot be determined from available data):

burning sensation of the mucous membrane.

The following adverse reactions are considered typical for the group of salicylates:
Frequency not known (frequency cannot be determined from available data):

bronchospasm manifesting as breathing difficulties, bronchial asthma;
gastric ulcer, duodenal ulcer;
Reye's syndrome (in children and adolescents under 16 years of age when used in febrile illness);
prolonged bleeding time.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a 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.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
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 Sachodent

Keep the medicine out of sight and reach of children.
Store below 25°C.
Shelf life after first opening of the tube: 2 years.
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 stated 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 will help protect
the environment.

6. Contents of the package and other information

What Sachodent contains

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

What Sachodent looks like and contents of the pack
Sachodent is a transparent, colourless to pale yellow, homogeneous gel with a characteristic
aniseed odour.
Packaging: an aluminium tube internally coated with epoxy-phenolic lacquer, with a nozzle
and a cap made of HDPE polyethylene, placed in a cardboard box.
Pack size: 10 g
Marketing Authorisation Holder
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Jesienna 9
80-298 Gdańsk
Poland
Tel.: +48 58 521 34 00
Manufacturer
ZIAJA Ltd Zakład Produkcji Leków sp. z o.o.
ul. Przemysłowa 12
83-050 Kolbudy
Poland
This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Sachodent
Czech Republic: Sachodent