Package leaflet: Information for the patient

Cholinex
150 mg, hard tablets
Choline salicylate
Please read carefully all the information in this leaflet before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a
physician, 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 after 1–2 days, or if you feel worse, contact your doctor.

Table of contents:

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

1. What Cholinex is and what it is used for

The active substance in Cholinex tablets – choline salicylate – acts locally:

anti-inflammatory, reducing swelling and congestion of the oral and pharyngeal mucosa,
analgesic (pain-relieving),
increases salivation, thereby enhancing the anti-inflammatory effect.

Indications for use of Cholinex:

inflammatory conditions of the oral and pharyngeal mucosa,
pain and swelling of the throat associated with inflammatory conditions,
as an adjunct to antibiotic therapy in infections of the oral and pharyngeal mucosa caused by certain microorganisms.

This medicine should be used in patients over 12 years of age.

2. Important information before using Cholinex

When not to use Cholinex
Do not use the medicine if the patient has:
hypersensitivity to the active substance - choline salicylate, other non-steroidal anti-inflammatory drugs, or
any of the other ingredients of this medicine listed in section 6,
oesophageal varices (due to risk of bleeding).
This medicine should not be used during breastfeeding.

Warnings and precautions
Before starting treatment, consult a doctor if the patient has:

gastrointestinal inflammatory conditions,
gastric or duodenal ulcer,
bronchial asthma,
diabetes or a tendency to dental caries - the medicine contains sucrose,
previously diagnosed intolerance to certain sugars - the medicine contains glucose,
if the medicine is to be given to a child - in children under 12 years of age, a doctor should decide on the use of the medicine due to the risk of Reye's syndrome.

Cholinex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available without a prescription.
There is a slight possibility that choline salicylate contained in the medicine may:

reduce the effectiveness of other non-steroidal anti-inflammatory drugs,
enhance the effect of sedatives, hypnotics, antidiabetic and anticoagulant medicines,
increase the risk of bleeding when administered together with corticosteroids and non-steroidal anti-inflammatory drugs, anticoagulants, fibrinolytics (clot-dissolving agents), or medicines inhibiting platelet aggregation (platelet clumping).

Cholinex with food and drink
Cholinex may be taken independently of meals.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Cholinex should not be used during pregnancy.
The decision on using Cholinex during breastfeeding is made by a doctor.

Driving and operating machinery
Cholinex does not affect the ability to drive or operate machinery.

Cholinex contains glucose and sucrose

Glucose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 1493 mg of glucose in one hard pastille. This should be taken into account in patients with diabetes.
Glucose contained in the medicine may have harmful effects on teeth.

Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains 1848 mg of sucrose in one hard pastille. This should be taken into account in patients with diabetes.
The medicine may have harmful effects on teeth.

3. How to use Cholinex

This medicine should always be taken exactly as described in this patient leaflet, or as directed by
your doctor or pharmacist. If in doubt, consult your doctor, pharmacist, or nurse.
The usual dosage of Cholinex for adults and children over 12 years of age is:
Suck one tablet 4 to 6 times daily (maximum 6 tablets per day).
If sore throat symptoms do not improve within 1 to 2 days, consult your doctor.
Taking more Cholinex than recommended
If you take more Cholinex than you should, consult your doctor or pharmacist.
If you forget to take Cholinex
Continue taking Cholinex as before, without increasing the next dose.
Do not take 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 everyone experiences them.
Adverse reactions are listed according to frequency of occurrence, using the following terms:
rare – occurring in fewer than 1 in 1,000 people but more than 1 in 10,000 people;
very rare – occurring in fewer than 1 in 10,000 people.

The following adverse reactions may occur during oral administration of salicylates:
Rare:
allergic reactions – skin redness and rash, cough, feeling of nasal congestion, swelling of the face, tongue or lips, difficulty swallowing or breathing difficulties;
gastrointestinal mucosal damage (abdominal pain, vomiting, bleeding).

Very rare:
in children under 12 years of age, Reye's syndrome may occur after oral use of salicylates, characterized by: sudden and severe vomiting, disturbances of consciousness (drowsiness or agitation), coma with convulsions, abnormal breathing (deep inhalations and exhalations), decreased blood sugar concentration (so-called hypoglycemia), cyanosis, fatty infiltration and enlargement of the liver (confirmed by biopsy).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 provide more information on the safety of this medicine.

5. How to store the medicine Cholinex

Keep the medicine out of sight and reach of children.
Store below 25°C. Protect from moisture.
Keep in the original packaging.
Do not use this medicine 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 what to do with medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Cholinex contains

The active substance is: choline salicylate. One tablet contains 150 mg of choline salicylate.
The other ingredients are: sucrose, liquid glucose, peppermint oil.

What Cholinex looks like and contents of the pack
Cholinex is in the form of tablets with the shape of a flat cylinder, slightly convex on both sides, yellowish-gold in colour and with a minty odour.
One pack contains 8, 16, 24 or 32 tablets.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Przedsiębiorstwo Produkcyjno-Handlowe „EWA” S.A.
ul. Zamkowy Folwark 9
63-700 Krotoszyn
Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.