Package leaflet: Information for the user

Cholinex Intense
2.5 mg + 1.2 mg, hard lozenges
Hexylresorcinol + Benzalkonium chloride
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has advised.

Keep this leaflet. You may need to read it again.
If you need advice or more information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist or nurse. See section 4.
If there is no improvement after 7 days (in adults) or 3 days (in children), or if you feel worse, please consult a doctor.

Contents of the leaflet

What Cholinex Intense is and what it is used for
Important information before taking Cholinex Intense
How to take Cholinex Intense
Possible side effects
How to store Cholinex Intense
Contents of the pack and other information

1. What Cholinex Intense is and what it is used for
Cholinex Intense hard lozenges contain hexylresorcinol, which acts locally as an anaesthetic and antibacterial agent, and benzalkonium chloride, which has antibacterial properties.
Cholinex Intense hard lozenges are used symptomatically for sore throat and throat inflammation.
If there is no improvement after 7 days (in adults) or 3 days (in children), or if you feel worse, you should consult a doctor.

2. Important information before taking Cholinex Intense

When not to take Cholinex Intense:

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

Warnings and precautions
Before starting treatment with Cholinex Intense, discuss it with your doctor, pharmacist or nurse.
Children
Do not give this medicine to children under 7 years of age.
Cholinex Intense and other medicines
No interactions between Cholinex Intense and other medicines have been reported.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor or pharmacist before taking this medicine.
Driving and operating machinery
Cholinex Intense has no known effect on the ability to drive or operate machinery.
Cholinex Intense contains benzalkonium chloride
This medicine contains 1.2 mg of benzalkonium chloride per hard lozenge. Benzalkonium chloride may cause local irritation.
Cholinex Intense contains glucose and sucrose
If you have been previously diagnosed with intolerance to certain sugars, you should consult your doctor before taking this 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 diabetic patients taking more than 2 lozenges per day.
Cholinex Intense contains propylene glycol
This medicine contains 10.68 mg of propylene glycol per hard lozenge.
Cholinex Intense contains flavouring agents
The medicine contains flavour (raspberry) containing d-limonene, d-dipentene and linalool, which may cause allergic reactions.
Cholinex Intense contains azo dyes (carmoisine and brilliant black)
The medicine may cause allergic reactions.
Cholinex Intense contains sulphites
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, meaning the medicine is considered "sodium-free".

3. How to take Cholinex Intense

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

Adults (including elderly people) and children over 12 years of age
Take one tablet every three hours; not more than 8 tablets per day.

Children aged 7 to 12 years
Take one tablet every three hours; not more than 4 tablets per day.

Do not give this medicine to children under 7 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
If you feel that the effect of Cholinex Intense is too strong or too weak, consult a doctor.

Taking more Cholinex Intense than recommended
Overdose of hexylresorcinol may cause irritation of the stomach and intestines.
After stopping the medicine, symptomatic treatment should be administered.
If an excessive dose is taken, nausea, vomiting, diarrhoea, profuse sweating, and increased thirst due to excessive intake of levomenthol may occur.
If you have taken more than the recommended dose, contact a doctor or pharmacist immediately.

If you forget to take Cholinex Intense
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 everyone will experience them.
Local irritation or inflammatory conditions in the oral cavity and throat may occur.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects 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 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.
Adverse reactions can also be reported to the marketing authorization holder.
By reporting adverse reactions, more information on the safety of this medicine can be collected.

5. How to store Cholinex Intense

Keep the medicine out of the sight and reach of children.
Store below 25°C.
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 how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cholinex Intense contains

The active substances in this medicine are: hexylresorcinol and benzalkonium chloride. Each hard pastille 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, raspberry flavour PHL-472549 (containing, among others, d-limonene, d-dipentene, linalool, propylene glycol, sulphites, glucose syrup and sugar), cochineal red (E 124), brilliant black (E 151).

What Cholinex Intense looks like and contents of the pack
Cholinex Intense is a medicine in the form of light violet, round, biconvex hard pastilles.
Pack sizes available
10, 12, 16, 20 or 24 hard pastilles.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
For further information about this medicine, please contact the representative of the Marketing Authorisation 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
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products