CHOLINEX 2.5 mg/1.2 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Cholinex Intense
3. 5 mg + 1.2 mg, hard lozenges
   1. Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Cholinex Intense and what is it used for
5. 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, sucrose, inverted sugar
   9. Cholinex Intense contains propylene glycol
   10. Cholinex Intense contains sulfites
   11. Cholinex Intense contains flavoring substances
   12. Cholinex Intense contains benzyl alcohol
6. How to use Cholinex Intense
   1. Using a higher dose of Cholinex Intense than recommended
   2. Missing a dose of Cholinex Intense
7. Possible side effects
   1. Reporting side effects
8. How to store Cholinex Intense
9. Contents of the packaging and other information
   1. What Cholinex Intense contains
   2. What Cholinex Intense looks like and what the packaging contains
   3. Available packaging
   4. Marketing authorization holder
   5. Manufacturer
   6. Date of last revision of the leaflet:

Leaflet attached to the packaging: information for the user

Cholinex Intense

2.5 mg + 1.2 mg, hard lozenges

Hexylresorcinol + Benzalkonium chloride

Please read carefully the contents of the leaflet before using the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in the 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.

Table of contents of the leaflet

• 1. What is Cholinex Intense and what is it 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. Contents of the packaging and other information

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

Cholinex Intense hard lozenges contain locally acting anesthetic 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:

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

Benzalkonium chloride may cause local irritation.

Cholinex Intense contains glucose, sucrose, inverted sugar

If the patient has previously been found to have intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains 1.24 g of sucrose and 1.12 g of glucose per lozenge. This should be taken into account in patients with diabetes who take more than 4 lozenges per day.

Cholinex Intense contains propylene glycol

The medicine contains 3.4 mg of propylene glycol in each lozenge.

Cholinex Intense contains sulfites

The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.

Cholinex Intense contains flavoring substances

The medicine contains flavors (honey and lemon) with benzyl alcohol, benzyl benzoate, benzyl cinnamate, citral, citronellol, geraniol, and linalool, which may cause allergic reactions.

Cholinex Intense contains benzyl alcohol

The medicine contains 0.000069 mg of benzyl alcohol in each lozenge.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).
Benzyl alcohol may cause mild local irritation.

3. How to use Cholinex Intense

This medicine should always be used exactly as described in the patient information leaflet or as directed by the 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; no more than 8 lozenges per day.
Children from 7 to 12 years of age
Take one lozenge every three hours; no 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.
If a higher dose of the medicine than recommended is taken, 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 any side effects occur, including any side effects not listed in the 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, 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 the 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 specified month.
Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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 and liquid glucose (50:50), propylene glycol, levomenthol, lemon flavor 10748 (containing citronellol, geraniol, and linalool), honey flavor 510167E (containing benzyl alcohol, benzyl benzoate, benzyl cinnamate, citral, citronellol, geraniol, and propylene glycol), caramel (containing sulfites), beta-carotene 5% (containing inverted sugar, medium-chain triglycerides, beta-carotene E160a, sugar esters, DL-alpha-tocopherol, lecithins, palmitate of ascorbic acid, pectins).

What Cholinex Intense looks like and what the packaging contains

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

Available packaging

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

Marketing authorization holder

STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturer

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

Date of last revision of the leaflet:

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