Halset

Package Leaflet: Information for the User

HALSET, 1.5 mg, lozenges

Cetylpyridinium chloride

Read the leaflet carefully before taking the medicine, as it contains

important information for the patient.
This medicine should always be taken exactly as described in the patient leaflet or as directed by
a doctor or pharmacist.

• This 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 the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement or the patient feels worse after 3 days, they should contact their doctor.

Table of Contents of the Leaflet:

• 1. What is Halset and what is it used for
• 2. Important information before taking Halset
• 3. How to take Halset
• 4. Possible side effects
• 5. How to store Halset
• 6. Contents of the pack and other information

1. What is Halset and what is it used for

Halset contains cetylpyridinium chloride. The medicine acts locally as a disinfectant in inflammation of the
mouth and throat. It has a bactericidal effect on Gram-positive and Gram-negative bacteria and also acts on
some fungi. Halset does not contain sugar.

Indications for Use

Halset is used preventively and therapeutically for mild and moderate inflammatory conditions of the mouth and
throat.
If there is no improvement or the patient feels worse after 3 days, they should consult their doctor.

2. Important Information Before Taking Halset

When Not to Take 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).

Halset should not be used in children due to the risk of accidental choking on the lozenge.

Warnings and Precautions

Before starting to take Halset, the patient should discuss it with their doctor or pharmacist.

• if symptoms of an allergic reaction occur, such as a rash - the patient should contact their doctor,
• in cases of severe infections or sore throat with high fever, headache, nausea, vomiting, or if symptoms worsen or do not improve after three days, the patient should see their doctor.

Halset and Other Medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take, including those available without a prescription.

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 taking this medicine.

Driving and Using Machines

There is no data on the effect of the medicine on the ability to drive and use machines.

Halset Contains Sorbitol

One lozenge contains 742.35 mg of sorbitol. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking the medicine (see section When Not to Take Halset). The caloric value is 2.6 kcal/g sorbitol.

3. How to Take Halset

This medicine should always be taken exactly as described in the patient leaflet or as directed by
a doctor or pharmacist. In case of doubt, the patient should consult their doctor or pharmacist.
Halset lozenges should be taken orally.
The lozenge should be sucked slowly.
The recommended dose is:
Adults and adolescents:suck 1 lozenge every 1-2 hours (maximum 8 lozenges per day).

Use in Children

Children over 6 years of age:suck 1 lozenge every 2-3 hours (maximum 6 lozenges per day).

Halset should not be used in children under 6 years of age.

Taking More Than the Recommended Dose of Halset

Taking more Halset lozenges than recommended may cause irritation of the mucous membranes of the mouth, diarrhea (especially in children), nausea, vomiting.
In case of taking more than the recommended dose, the patient should consult their doctor or pharmacist.

Missing a Dose of Halset

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

Stopping Halset

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Rarely, allergic reactions (e.g., hives, rash), burning sensation in the mouth, nausea, and transient taste disturbances occur.

Reporting Side Effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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
e-mail: ndl@urpl.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 Halset

The medicine should be stored out of sight and reach of children.
The medicine should be stored at a temperature below 25°C.
The medicine should not be used after the expiry date stated on the carton. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. 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 Pack and Other Information

What Halset Contains

• The active substance is cetylpyridinium chloride monohydrate. One lozenge contains 1.5 mg of cetylpyridinium chloride monohydrate.
• The other ingredients are: 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 a smooth surface, rounded corners and edges, white, with a gloss, sweet, minty flavor, and menthol aroma.
Pack sizes: 6, 12, 18, or 24 lozenges.

Marketing Authorization Holder and Manufacturer

BIOFARM Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500
To obtain more detailed information, the patient should contact the local representative of the marketing authorization holder:
Poland
Biofarm Sp. z o.o.
ul. Wałbrzyska 13
60-198 Poznań
Poland
Tel. 061 66 51 500

Date of Approval of the Leaflet: