Package leaflet: information for the user

Cholinex Intense
2.5 mg + 1.2 mg, hard pastilles
Hexylresorcinol + Benzalkonium chloride
Read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult a pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, 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 your condition worsens, consult a doctor.

Table of 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 pastilles contain hexylresorcinol, which acts locally as an anaesthetic and antibacterial agent, and benzalkonium chloride, which has antibacterial properties.
Cholinex Intense hard pastilles 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 your condition worsens, consult a doctor.

2. Important information before taking Cholinex Intense

When not to use Cholinex Intense:

if you are allergic (hypersensitive) 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, consult your doctor or pharmacist before using 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
Benzalkonium chloride may cause local irritation.
Cholinex Intense contains glucose, sucrose, and invert sugar
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
The medicine contains 1.24 g of sucrose and 1.12 g of glucose per pastille. This should be taken into account in diabetic patients taking more than 4 pastilles per day.
Cholinex Intense contains propylene glycol
The medicine contains 3.4 mg of propylene glycol in each pastille.
Cholinex Intense contains sulphites
The medicine may rarely cause severe hypersensitivity reactions and bronchospasm.
Cholinex Intense contains flavouring agents
The medicine contains flavours (honey and lemon) containing 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 pastille.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult a doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their bodies and cause adverse 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 this patient leaflet or as directed by a doctor, pharmacist, or nurse. If in doubt, consult a doctor, pharmacist, or nurse.
Allow the tablet to dissolve slowly in the mouth.

Adults (including elderly patients) and children over 12 years of age
Take one tablet every three hours; do not exceed 8 tablets in 24 hours.

Children aged 7 to 12 years
Take one tablet every three hours; do not exceed 4 tablets in 24 hours.

Cholinex Intense must not be given to children under 7 years of age.
Do not exceed the recommended dose. If symptoms persist, consult a doctor.
If you feel 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 discontinuation of the medicine, symptomatic treatment should be administered.
Following ingestion of an excessive dose, symptoms such as nausea, vomiting, diarrhoea, excessive sweating, and increased thirst related 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 at 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, additional information on the safety of the medicine can be collected.

5. How to store the medicine 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 package and other information

What Cholinex Intense contains

The active substances 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 and liquid glucose (50:50), propylene glycol, levomenthol, lemon flavour 10748 (containing, among others, citronellol, geraniol and linalool), honey flavour 510167E (containing, among others, benzyl alcohol, benzyl benzoate, benzyl cinnamate, citral, citronellol, geraniol and propylene glycol), caramel (containing sulphites), beta-carotene 5% (containing invert sugar, medium-chain triglycerides, beta-carotene E160a, sugar esters, Dl-alpha-tocopherol, lecithins, ascorbyl palmitate, pectin).

What Cholinex Intense looks like and contents of the pack
Cholinex Intense is a hard pastille, light yellow in colour, round and biconvex.
Pack sizes
10, 12, 16, 20 or 24 hard pastilles.
Marketing Authorisation Holder
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Manufacturer
Przedsiębiorstwo Produkcyjno-Handlowe „EWA” S.A. w Krotoszynie
ul. Zamkowy Folwark 9,
63-700 Krotoszyn
Poland
Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.