Septofar mint

Patient leaflet: information for the patient

Septofar Mint, 0.6 mg + 1.2 mg, hard pastilles
Amylmetacresolum + Alcohol 2,4-dichlorobenzylicus
Please read carefully the entire leaflet before using 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
the 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 adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days of treatment, or if your condition worsens, you should contact your doctor.

Table of contents of the leaflet

1. What is Septofar Mint and what it is used for
2. Important information before using Septofar Mint
3. How to use Septofar Mint
4. Possible side effects
5. How to store Septofar Mint
6. Contents of the pack and other information

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

Septofar Mint contains amylmetacresol and 2,4-dichlorobenzyl alcohol. These ingredients are
mild antiseptics.
Septofar Mint is used to relieve sore throat symptoms. By sucking the pastille, the active ingredients of the medicine can act directly at the site of discomfort, and may also help moisturise and soothe the affected area. These actions help to relieve pain and discomfort in the mouth and throat.
You should contact your doctor if there is no improvement after 3 days of using the medicine, or if your condition worsens.
This medicine is recommended for adults, adolescents and children (aged above 6 years).
Do not use this medicine in children under 6 years of age.

2. Important information before using Septofar Mięta

When not to use Septofar Mięta

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

Warnings and precautions
Consult a doctor or pharmacist before using Septofar Mięta.
This medicine is intended for short-term treatment only (with prolonged use, the balance of normal oral flora may be disturbed, and there is a risk of overgrowth of pathogenic microorganisms).
Contact a doctor if symptoms persist for more than 3 days, worsen, or if fever or symptoms other than sore throat occur (e.g. difficulty breathing, swelling around the throat area, difficulty swallowing, nausea and vomiting).
Children
Septofar Mięta must not be given to children under 6 years of age.
Septofar Mięta and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
No clinically significant interactions are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The safety of using Septofar Mięta during pregnancy and breastfeeding has not been established.
Therefore, Septofar Mięta is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
Septofar Mięta has no effect or has negligible effect on the ability to drive and operate machinery.
Septofar Mięta contains maltitol and isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before using this medicine.
The medicine may have a mild laxative effect.
Calorific value: 2.3 kcal/g of maltitol or isomalt.
Septofar Mięta contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per hard pastille, meaning the medicine is considered "sodium-free".

3. How to use Septofar Mięta

This medicine should always be used exactly as described in this patient leaflet, or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is intended for adults, adolescents, and children over 6 years of age.
Do not exceed the recommended dose.
Recommended dosage:
Adults
One tablet when needed, every 2–3 hours. Maximum dose: 8 tablets within 24 hours.
Adolescents and children over 6 years of age: 1 tablet every 2–3 hours. Maximum dose: 4 tablets within 24 hours.
Children under 6 years of age: Septofar Mięta must not be used in children under 6 years of age.
Elderly patients: dose adjustment is not required.
Septofar Mięta tablets should be slowly dissolved in the mouth. Do not swallow, chew, or crush the tablet.
Do not take the tablets immediately 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 only. Consult your doctor if symptoms persist for more than 3 days, or if fever or other symptoms besides sore throat occur (see section 2).
Taking more Septofar Mięta than recommended
If you take more tablets than recommended, or if a child accidentally swallows the medicine, contact your doctor immediately.
Overdose may cause gastrointestinal discomfort.
If you miss a dose of Septofar Mięta
Do not take a double dose to make up for a missed dose. Continue using the medicine as directed.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although they do not occur in everyone.
If hypersensitivity to the medicine occurs, discontinue use and consult a doctor or pharmacist.
If any adverse reactions occur, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Rare (may affect up to 1 in 1,000 patients):

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

Frequency not known (frequency cannot be estimated from the available data):

• urticaria, angioedema,
• dyspnoea,
• tongue pain (glossodynia) and gastrointestinal disorders such as dyspepsia, nausea.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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, 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.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Septofar Mięta

Keep this medicine out of the sight and reach 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 stated month.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist what to do with medicines no longer required. Proper disposal helps protect the environment.

6. Contents of the pack and other information

What Septofar Mięta contains

• The active substances are amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are: peppermint essential oil, star anise essential oil, levomenthol, indigo carmine dye (E 132), quinoline yellow (E 104), sodium saccharin (E 954), tartaric acid (E 334), isomalt (E 953) and maltitol (E 965).

What Septofar Mięta looks like and contents of the pack
Septofar Mięta, lozenges are green, circular, biconvex lozenges with a mint flavour, 19 mm in diameter.
PVC/PVDC/Aluminium blister packs.
Each pack contains: 6, 8, 10, 12, 16, 20, 24, 30, 36, 40 or 48 lozenges.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area under the following names: