Holinex

Package Leaflet: Information for the Patient

Cholinex

150 mg, Hard Lozenges

Choline Salicylate

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

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor, pharmacist, or nurse.

• 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, pharmacist, or nurse. See section 4.
• If after 1-2 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is Cholinex and what is it used for
• 2. Important information before taking Cholinex
• 3. How to take Cholinex
• 4. Possible side effects
• 5. How to store Cholinex
• 6. Contents of the pack and other information

1. What is Cholinex and what is it used for

The active substance of Cholinex lozenges, choline salicylate, acts locally:

• anti-inflammatory, reducing swelling and congestion of the oral and pharyngeal mucosa,
• analgesic,
• increasing saliva production, thus supporting anti-inflammatory action.

Indications for use of Cholinex:

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

The medication should be used in patients over 12 years of age.

2. Important information before taking Cholinex

When not to take Cholinex

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 medication (listed in section 6),
esophageal varices (due to the risk of bleeding),
The medication should not be used during breastfeeding.

Warnings and precautions

Before starting the medication, discuss it with your doctor if you have:

• gastrointestinal inflammatory conditions,
• gastric or duodenal ulcer disease,
• bronchial asthma,
• diabetes or a tendency to tooth decay - the medication contains sucrose,
• previously diagnosed intolerance to certain sugars - the medication contains glucose,
• if you intend to give the medication to a child - in children under 12 years of age, the use of the medication should be decided by a doctor due to the risk of Reye's syndrome.

Cholinex and other medications

Tell your doctor or pharmacist about all medications you are taking, have recently taken, or plan to take, including those available without a prescription.
There is a small possibility that the choline salicylate contained in the medication may:

• Weaken the effect of other non-steroidal anti-inflammatory drugs.
• Enhance the effect of sedatives, hypnotics, antidiabetic, and anticoagulant medications.
• Increase the risk of bleeding when taken with steroid and non-steroidal anti-inflammatory medications, anticoagulants, fibrinolytics, or medications that inhibit platelet aggregation.

Cholinex with food and drink

Cholinex can be taken independently of meals.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medication.
Do not take Cholinex during pregnancy.
The use of Cholinex during breastfeeding is decided by a doctor.

Driving and using machines

The medication does not affect the ability to drive or operate machinery.

Cholinex contains glucose and sucrose

Glucose

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking the medication.
The medication contains 1493 mg of glucose in one hard lozenge. This should be taken into account in patients with diabetes.
The glucose in the medication may harm teeth.

Sucrose

If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking the medication.
The medication contains 1848 mg of sucrose in one hard lozenge. This should be taken into account in patients with diabetes.
The medication may harm teeth.

3. How to take Cholinex

This medication should always be taken exactly as described in this patient leaflet or as advised by a doctor or pharmacist. In case of doubt, consult a doctor, pharmacist, or nurse.
Typically, the recommended dosage of Cholinex for adults and children over 12 years of age is:
Suck one lozenge 4 to 6 times a day (maximum 6 lozenges per day).
If throat pain does not improve within 1 to 2 days, contact your doctor.

Taking more than the recommended dose of Cholinex

In case of taking more than the recommended dose, consult a doctor or pharmacist.

Missing a dose of Cholinex

Continue taking the medication without increasing the next dose.
Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medications, Cholinex can cause side effects, although not everybody gets them.
Side effects are ranked according to frequency, using the following terms:
rare – occurring in less than 1 in 1,000 people but more than 1 in 10,000 people;
very rare – occurring in less than 1 in 10,000 people.
When taking salicylates orally, the following side effects may occur:
Rare:
allergic reactions - skin redness and rash, cough, feeling of nasal congestion, facial swelling, tongue, lip swelling, difficulty swallowing or breathing difficulties;
gastrointestinal mucosa damage (abdominal pain, vomiting, bleeding).
Very rare:
in children under 12 years of age, after oral administration of salicylates, Reye's syndrome may occur, which is characterized by: severe vomiting, consciousness disorders (drowsiness or agitation), coma with convulsions, abnormal breathing (deep inhalation and exhalation), low blood sugar levels (hypoglycemia), cyanosis, fatty liver, and liver enlargement (detected in biopsy).
If any of the side effects get worse or if you experience any side effects not listed in this leaflet, tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. 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.
Reporting side effects will help gather more information on the safety of the medication.

5. How to store Cholinex

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C. Protect from moisture.
Store in the original packaging.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
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. Contents of the pack and other information

What Cholinex contains

• The active substance of the medication is: choline salicylate. One lozenge contains 150 mg of choline salicylate.
• Other ingredients are: sucrose, liquid glucose, peppermint oil.

What Cholinex looks like and contents of the pack

Cholinex is a hard lozenge, flat cylindrical in shape, slightly convex on both sides, with a yellow-gold color and a minty smell.
One pack contains 8, 16, 24, or 32 lozenges.

Marketing Authorization 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

Date of last revision of the leaflet:

Detailed information about this medication is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products.