Patient Information Leaflet

HALSET, 1.5 mg, lozenges
Cetylpyridinium chloride
Please read this 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 patient leaflet or as directed by a
physician or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days, or if symptoms worsen, consult your doctor.

Table of contents:

What HALSET is and what it is used for
Important information before using HALSET
How to use HALSET
Possible side effects
How to store HALSET
Contents of the pack and other information

1. What HALSET is and what it is used for

HALSET contains cetylpyridinium chloride. HALSET exerts a local antiseptic action in inflammatory conditions of the oral cavity and throat. It has bactericidal activity against Gram-positive and Gram-negative bacteria and is also effective against certain fungi. HALSET does not contain sugar.
Indications
HALSET is indicated for prophylactic and therapeutic use in mild to moderate inflammatory conditions of the oral cavity and throat.
If there is no improvement after 3 days, or if symptoms worsen, consult a doctor.

2. Important information before using Halset

When not to use Halset

if the patient is allergic to cetylpyridinium chloride or any of the other ingredients of this medicine (listed in section 6);
if the patient has been diagnosed with fructose intolerance (a rare metabolic disorder).

Do not use in children due to the risk of accidental choking on the tablet.
Warnings and precautions
Before starting to use Halset, discuss this with your doctor or pharmacist.

if symptoms of an allergic reaction occur, such as rash – contact your doctor;
in case of severe infections or sore throat accompanied by high fever, headache, nausea, vomiting, or if symptoms worsen or do not improve after three days, consult a doctor.

Halset with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those obtained without a prescription.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
Driving and operating machinery
There are no data available on the influence of this medicine on the ability to drive or operate machinery.
Halset contains sorbitol.
One lozenge contains 742.35 mg of sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine (see section When not to use Halset). The caloric value of sorbitol is 2.6 kcal/g.

3. How to use Halset medicine

This medicine should always be used exactly as described in this patient leaflet, or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Halset tablets are for oral use.
Suck one tablet slowly.
Recommended dose:
Adults and adolescents: suck 1 tablet every 1-2 hours (maximum 8 tablets per day).
Use in children
Children over 6 years of age: suck 1 tablet every 2-3 hours (maximum 6 tablets per day).
Halset is not recommended for children under 6 years of age.
Use of a higher than recommended dose of Halset medicine
Using more Halset tablets than recommended may cause irritation of the oral mucosa, diarrhoea (especially in children), nausea, vomiting.
If you have taken more medicine than recommended, consult your doctor or pharmacist.
Missed dose of Halset medicine
Do not take a double dose to make up for a forgotten dose.
Stopping Halset medicine
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Allergic reactions (e.g. urticaria, rash) are rare, as well as burning sensation in the oral cavity,
nausea, and transient taste disturbances.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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
e-mail: [email protected]
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Halset

Keep this medicine out of sight and reach of children.
Store the medicine at a temperature below 25°C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Halset contains

The active substance is cetylpyridinium chloride monohydrate. Each lozenge contains 1.5 mg of cetylpyridinium chloride monohydrate.
Other ingredients: sorbitol, peppermint oil, menthol, magnesium stearate.

What Halset looks like and contents of the pack
Lozenges.
Halset lozenges are rectangular, flat on both sides, with smooth surface, rounded corners and edges, white in colour, with a slight sheen, sweet minty taste and menthol odour.
Pack sizes: 6, 12, 18 or 24 lozenges.

Marketing Authorisation Holder and Manufacturer
BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500

For further information, please contact the local representative of the Marketing Authorisation Holder:
Poland
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500