Package leaflet: information for the patient

Cholinex
150 mg, hard pastilles
Choline salicylate
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your 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 side effects 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.

Contents of the leaflet:

What Cholinex is and what it is used for
What you need to know before taking Cholinex
How to take 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 of Cholinex pastilles – choline salicylate – acts locally:

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

Indications for 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,
in dental treatment of inflammatory conditions of the gums and periodontal tissues.

2. Important information before using Cholinex

When not to use Cholinex
Do not use this medicine if the patient has:
an allergy to the active substance, salicylates, 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),
phenylketonuria.

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

gastrointestinal inflammatory conditions,
gastric or duodenal ulcer disease,
bronchial asthma.

Cholinex and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient intends to take.
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 effects of sedatives, hypnotics, antidiabetic, and anticoagulant medicines,
increase the risk of bleeding when administered together with steroid or non-steroidal anti-inflammatory drugs, anticoagulants, fibrinolytics (clot-dissolving agents), or medicines inhibiting platelet aggregation (preventing blood platelets from clumping).

Cholinex with food and drink
Cholinex may be taken independently of meals.
Cholinex sugar-free may be safely used by people with diabetes or those prone to dental caries, as it does not contain sugar.

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

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

Cholinex contains aspartame (E 951), isomalt, and maltitol

Aspartame (E 951)
The medicine contains 1.75 mg of aspartame in each hard pastille.
Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.

Isomalt and maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine.
The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of isomalt. Calorific value: 2.3 kcal/g of maltitol.

3. How to use Cholinex

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

The usual dosage of Cholinex for adults and children aged 12 years and above 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 a doctor.

Use in children
Before using Cholinex in children under 12 years of age, consult a doctor due to the risk of Reye's syndrome.

Taking more Cholinex than recommended
If more medicine has been taken than recommended, consult a doctor or pharmacist immediately.

Missed dose of Cholinex
Continue treatment 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 everybody will experience 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 following oral administration of salicylates, which is characterized by: sudden and profuse vomiting, disturbances in consciousness (drowsiness or agitation), coma with convulsions, abnormal breathing (deep inhalations and exhalations), decreased blood sugar levels (so-called hypoglycemia), cyanosis, fatty infiltration and enlargement of the liver (detected during 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 to provide more information on the safety of this medicine.

5. How to store Cholinex

Keep this 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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Cholinex contains

The active substance is: choline salicylate. One tablet contains 150 mg of choline salicylate.
Other ingredients are: isomalt, liquid maltitol, aspartame (E951), acesulfame potassium, peppermint oil. The product does not contain sugar.

What Cholinex looks like and contents of the pack
Cholinex is in the form of tablets with a flat cylindrical shape, glassy white to pale yellow in colour, and with a mint flavour.
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
Poland