CHOLINEX 2.5 mg/1.2 mg Lozenge

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Cholinex Intense
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
3. What Cholinex Intense is and what it is used for
4. Important information before using Cholinex Intense
   1. When not to use Cholinex Intense:
   2. Warnings and precautions
   3. Children
   4. Cholinex Intense and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Cholinex Intense contains benzalkonium chloride
   8. Cholinex Intense contains glucose and sucrose
   9. Cholinex Intense contains propylene glycol
   10. Cholinex Intense contains flavorings
   11. Cholinex Intense contains azo dyes (ponceau 4R and brilliant black)
   12. Cholinex Intense contains sulfites
   13. Cholinex Intense contains sodium
5. How to use Cholinex Intense
   1. Using a higher dose of Cholinex Intense than recommended
   2. Missing a dose of Cholinex Intense
6. Possible side effects
   1. Reporting side effects
7. How to store Cholinex Intense
8. Package contents and other information
   1. What Cholinex Intense contains
   2. What Cholinex Intense looks like and contents of the pack
   3. Available packs
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Cholinex Intense

2.5 mg + 1.2 mg, hard lozenges
Hexylresorcinol + Benzalkonium chloride

Read the package 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 package leaflet for the patient or as directed by a doctor, pharmacist, or nurse.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 7 days (in adults) or 3 days (in children) there is no improvement or the patient feels worse, they should contact their doctor.

Package Leaflet Contents

• 1. What Cholinex Intense is and what it is used for
• 2. Important information before using Cholinex Intense
• 3. How to use Cholinex Intense
• 4. Possible side effects
• 5. How to store Cholinex Intense
• 6. Package contents and other information

1. What Cholinex Intense is and what it is used for

Cholinex Intense hard lozenges contain locally acting anesthetizing and antibacterial hexylresorcinol and benzalkonium chloride with antibacterial action.
Cholinex Intense hard lozenges are used symptomatically for pain and inflammation of the throat.
If after 7 days (in adults) or 3 days (in children) there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before using Cholinex Intense

When not to use Cholinex Intense:

• if the patient is allergic to the active substances or any of the other ingredients of this medicine (listed in section 6)
• if the patient has been diagnosed with intolerance to certain sugars (glucose, sucrose, fructose).

Warnings and precautions

Before starting to use Cholinex Intense, the patient should discuss it with their doctor, pharmacist, or nurse.

Children

Cholinex Intense should not be given to children under 7 years of age.

Cholinex Intense and other medicines

No interaction of Cholinex Intense with other medicines has been found.

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 using this medicine.

Driving and using machines

No effect of Cholinex Intense on the ability to drive and use machines has been found.

Cholinex Intense contains benzalkonium chloride

The medicine contains 1.2 mg of benzalkonium chloride in each hard lozenge. Benzalkonium chloride may cause local irritation.

Cholinex Intense contains glucose and sucrose

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine.
The medicine contains 1.366 g of sucrose and 0.419 g of glucose per hard lozenge. This should be taken into account in patients with diabetes who take more than 2 lozenges per day.

Cholinex Intense contains propylene glycol

The medicine contains 10.68 mg of propylene glycol in each hard lozenge.

Cholinex Intense contains flavorings

The medicine contains flavor (blackcurrant) with d-limonene, d-dipentene, and linalool, which may cause allergic reactions.

Cholinex Intense contains azo dyes (ponceau 4R and brilliant black)

The medicine may cause allergic reactions.

Cholinex Intense contains sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Cholinex Intense contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per hard lozenge, which means the medicine is considered "sodium-free".

3. How to use Cholinex Intense

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor, pharmacist, or nurse. In case of doubt, the patient should consult their doctor, pharmacist, or nurse.
The lozenge should be sucked slowly.
Adults (including the elderly) and children over 12 years of age
Take one lozenge every three hours; do not take more than 8 lozenges per day.
Children from 7 to 12 years of age
Take one lozenge every three hours; do not take more than 4 lozenges per day.
Cholinex Intense should not be given to children under 7 years of age.
A higher dose than recommended should not be used. If symptoms persist, the patient should consult their doctor.
If the patient feels that the effect of Cholinex Intense is too strong or too weak, they should consult their doctor.

Using a higher dose of Cholinex Intense than recommended

Overdose of hexylresorcinol may cause stomach and intestinal irritation.
After discontinuing the medicine, symptomatic treatment should be applied.
After taking too high a dose of the medicine, nausea, vomiting, diarrhea, excessive sweating, and increased thirst associated with excessive consumption of levomenthol may occur.
In case of using a higher dose of the medicine than recommended, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Cholinex Intense

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, Cholinex Intense can cause side effects, although not everybody gets them.
Local irritation or inflammation in the mouth and throat may occur.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they 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, 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 to gather more information on the safety of this medicine.

5. How to store Cholinex Intense

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C.
The medicine should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cholinex Intense contains

• The active substances of the medicine are hexylresorcinol and benzalkonium chloride. One hard lozenge contains 2.5 mg of hexylresorcinol and 1.2 mg of benzalkonium chloride.
• The other ingredients are sucrose, liquid glucose, propylene glycol, citric acid monohydrate, levomenthol, blackcurrant flavor PHL-472549 (containing d-limonene, d-dipentene, linalool, propylene glycol, sulfites, glucose syrup, and sugar), ponceau 4R (E 124), brilliant black (E 151).

What Cholinex Intense looks like and contents of the pack

Cholinex Intense is a light purple, round, biconvex hard lozenge.

Available packs

10, 12, 16, 20, or 24 hard lozenges.

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
To obtain more detailed information on this medicine, the patient should contact the representative of the marketing authorization holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

Manufacturer

Przedsiębiorstwo Produkcyjno-Handlowe "EWA" S.A. in Krotoszyn
ul. Zamkowy Folwark 9
63-700 Krotoszyn

Date of last revision of the package leaflet:

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