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 the patient experiences any side effects, including any possible side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or the patient feels worse after 1-2 days, they should contact their 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. Package contents and other information

1. What is Cholinex and what is it used for

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

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

Indications for the use of Cholinex:

• inflammatory conditions of the oral and pharyngeal mucosa,
• throat pain and swelling accompanying inflammatory conditions,
• as a supportive medication for antibiotic therapy of oral and pharyngeal mucosa infections caused by certain microorganisms,
• in the treatment of inflammatory conditions of the gums and periodontal tissues.

2. Important information before taking Cholinex

When Not to Take Cholinex

If the patient has:

an allergy to the active substance, salicylates, other nonsteroidal anti-inflammatory drugs, or any of the other ingredients of this medication (listed in section 6), esophageal varices (due to the risk of bleeding), phenylketonuria.

Warnings and Precautions

Before starting to take the medication, the patient should discuss it with their doctor if they have:

• inflammatory conditions of the gastrointestinal tract,
• stomach or duodenal ulcers,
• asthma.

Cholinex and Other Medications

The patient should inform their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they 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 nonsteroidal anti-inflammatory drugs,
• enhance the effect of sedatives, hypnotics, antidiabetic, and anticoagulant medications,
• increase the risk of bleeding when administered with steroid and nonsteroid anti-inflammatory drugs, anticoagulants, fibrinolytics, or medications that inhibit platelet aggregation.

Cholinex with Food and Drink

Cholinex can be taken independently of meals.

Cholinex without sugar can be safely used by people with diabetes and those prone to tooth decay, as it does not contain sugar.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medication.

The use of Cholinex is not recommended during pregnancy.

The decision to use Cholinex during breastfeeding is made by the doctor.

Driving and Operating Machines

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

Cholinex Contains Aspartame (E 951), Isomalt, and Maltitol

Aspartame (E 951)

The medication contains 1.75 mg of aspartame in each hard lozenge.

Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Isomalt and Maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

The medication may have a mild laxative effect. The energy value is 2.3 kcal/g of isomalt and 2.3 kcal/g of maltitol.

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 doubts, the patient should consult their doctor, pharmacist, or nurse.

Typical dosing of Cholinex for adults and children over 12 years old:

Suck one lozenge 4 to 6 times a day (maximum 6 lozenges per day).

If throat pain does not subside within 1 to 2 days, the patient should contact their doctor.

Use in Children

Before administering the medication to children under 12 years old, the patient should consult their doctor due to the possibility of Reye's syndrome.

Overdose of Cholinex

In case of taking a higher dose than recommended, the patient should consult their doctor or pharmacist.

Missed Dose of Cholinex

The patient should continue taking the medication without increasing the next dose.

The patient should 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 their frequency of occurrence, 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 old, Reye's syndrome may occur after oral administration of salicylates, which is characterized by: severe vomiting, consciousness disorders (drowsiness or agitation), coma with convulsions, abnormal breathing (deep inhalation and exhalation), decreased blood sugar levels (hypoglycemia), cyanosis, fatty liver, and liver enlargement (detected in biopsy).

If any side effect worsens or if any side effects not mentioned in the leaflet occur, the patient should inform their doctor or pharmacist.

Reporting Side Effects

If side effects occur, including any side effects not listed in this leaflet, the patient should inform their 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, phone: +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

The medication should be stored 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 expiration date stated on the packaging. The expiration date is the last day of the specified month.

Medications should not be disposed of in the sewage system or household waste containers. The patient should ask their pharmacist what to do with unused medications. This will help protect the environment.

6. Package Contents 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 isomalt, liquid maltitol, aspartame (E951), acesulfame potassium, peppermint oil. The product does not contain sugar.

What Cholinex Looks Like and What the Package Contains

Cholinex is a flat cylindrical lozenge, glassy white to light yellow in color, and has a minty smell.

One package 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 Update of the Leaflet: