SEPTOFAR 0.6 mg/1.2 mg Lozenge

Contents of the leaflet

1. Leaflet attached to the packaging: patient information
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
2. What is Septofar Mint and what is it used for
3. Important information before taking Septofar Mint
   1. When not to take Septofar Mint
   2. Warnings and precautions
   3. Children
   4. Septofar Mint and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Septofar Mint contains maltitol and isomalt
   8. Septofar Mint contains sodium
4. How to take Septofar Mint
   1. Adults
   2. Overdose of Septofar Mint
   3. Missed dose of Septofar Mint
5. Possible side effects
   1. Reporting side effects
6. How to store Septofar Mint
7. Package contents and other information
   1. What Septofar Mint contains
   2. What Septofar Mint looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 08/2024

Leaflet attached to the packaging: patient information

Septofar Mint, 0.6 mg + 1.2 mg, hard lozenges
Amylmetacresol + 2,4-Dichlorobenzyl alcohol

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

Table of contents of the leaflet

• 1. What is Septofar Mint and what is it used for
• 2. Important information before taking Septofar Mint
• 3. How to take Septofar Mint
• 4. Possible side effects
• 5. How to store Septofar Mint
• 6. Package contents and other information

1. What is Septofar Mint and what is it used for

Septofar Mint contains amylmetacresol and 2,4-dichlorobenzyl alcohol. These ingredients are mild antiseptics.
Septofar Mint is used to relieve throat pain symptoms. By sucking on the lozenge, the active ingredients can work directly on the site of discomfort, and the affected area can be moistened and soothed. These actions help to relieve pain and discomfort in the mouth and throat.
A doctor should be consulted if there is no improvement after 3 days of taking the medicine or if the patient feels worse.
This medicine is recommended for adults, adolescents, and children (over 6 years old).
The medicine should not be used in children under 6 years old.

2. Important information before taking Septofar Mint

When not to take Septofar Mint

• if the patient is allergic to amylmetacresol, 2,4-dichlorobenzyl alcohol, or any of the other ingredients of this medicine (listed in section 6).
• this medicine should not be used in children under 6 years old.

Warnings and precautions

A doctor or pharmacist should be consulted before taking Septofar Mint.
The medicine is intended for short-term treatment (long-term use may disrupt the balance of the normal mouth flora and increase the risk of overgrowth of pathogenic microflora).
A doctor should be consulted if the symptoms of the disease persist for more than 3 days, worsen, or if a fever or other symptoms occur (e.g., difficulty breathing, swelling in the throat area, difficulty swallowing, nausea, and vomiting).

Children

Septofar Mint should not be given to children under 6 years old.

Septofar Mint and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
No clinically significant interactions are known.

Pregnancy and breastfeeding

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.
The safety of using Septofar Mint during pregnancy and breastfeeding has not been established.
Therefore, Septofar Mint is not recommended during pregnancy or breastfeeding.

Driving and using machines

Septofar Mint has no influence or negligible influence on the ability to drive and use machines.

Septofar Mint contains maltitol and isomalt

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.
The medicine may have a mild laxative effect.
Caloric value: 2.3 kcal/g maltitol or isomalt.

Septofar Mint contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per hard lozenge, which means the medicine is considered "sodium-free".

3. How to take Septofar Mint

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, a doctor or pharmacist should be consulted.
This medicine is intended for adults, adolescents, and children over 6 years old.
Do not exceed the recommended dose.
Recommended dosage:

Adults

One lozenge as needed, every 2-3 hours. Maximum dose: 8 lozenges in 24 hours.
Adolescents and children over 6 years old:1 lozenge every 2-3 hours. Maximum dose: 4 lozenges in 24 hours.
Children under 6 years old:Septofar Mint should not be used in children under 6 years old.
Elderly:dose adjustment is not required.
Septofar Mint should be allowed to dissolve slowly in the mouth. Septofar Mint should not be swallowed, chewed, or bitten.
Lozenges should not be taken directly before or during meals. Do not eat or drink for at least 20 minutes after taking this medicine.
This medicine is intended for short-term treatment. A doctor should be consulted if symptoms persist for more than 3 days or if a fever or other symptoms occur (see section 2).

Overdose of Septofar Mint

In case of taking more than the recommended dose of Septofar Mint lozenges or if a child accidentally takes the medicine, a doctor should be consulted.
Overdose may cause gastrointestinal disorders.

Missed dose of Septofar Mint

A double dose should not be taken to make up for a missed dose. The medicine should be continued as directed.
If there are any further doubts about taking this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Septofar Mint can cause side effects, although not everybody gets them.
In case of hypersensitivity to the medicine, its use should be stopped, and a doctor or pharmacist should be consulted. If any side effects occur or any side effects not listed in this leaflet occur, a doctor or pharmacist should be informed.
Rare(may affect up to 1 in 1,000 people):

• hypersensitivity reactions, including rash, burning, itching, and swelling of the mouth or throat.

Frequency not known(the frequency of these side effects cannot be estimated from the available data):

• urticaria, angioedema,
• dyspnea,
• glossodynia and gastrointestinal disorders, such as dyspepsia, nausea.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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 Septofar Mint

The medicine should be stored out of the reach and sight of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Septofar Mint contains

• The active substance of the medicine is amylmetacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are: peppermint oil, star anise oil, levomenthol, indigocarmine (E 132), quinoline yellow (E 104), sodium saccharin (E 954), tartaric acid (E 334), isomalt (E 953), and maltitol (E 965).

What Septofar Mint looks like and contents of the pack

Septofar Mint, hard lozenges, are green, biconvex, round lozenges with a mint flavor and a diameter of 19 mm.
PVC/PVDC/Aluminum blister.
Each pack contains: 6, 8, 10, 12, 16, 20, 24, 30, 36, 40, 48 lozenges.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
Nové Město
110 00 Prague
Czech Republic
tel.: (+420) 516 770 199

Manufacturer:

LOZY’S PHARMACEUTICALS, S.L.
Campus Empresarial s/n, 31795 Lekaroz (Navarra)
Spain
Artesan Pharma GmbH & Co. KG
Wendlandstraße 1
29439 Lüchow
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet: 08/2024