Septofar honey and lemon

Package leaflet: information for the patient

Septofar Honey and Lemon, 0.6 mg + 1.2 mg, hard pastilles
Amylmetacresolum + Alcohol 2,4-dichlorobenzylicus
Please read this leaflet carefully 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 a doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, 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 of treatment, or if your condition worsens, consult your doctor.

Table of contents

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

1. What Septofar Honey and Lemon is and what it is used for

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

2. Information before using Septofar Honey and Lemon

When not to use Septofar Honey and Lemon

• 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 must not be used in children under 6 years of age.

Warnings and precautions
Consult a doctor or pharmacist before using Septofar Honey and Lemon.
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 flora).
Contact a doctor if symptoms persist for more than 3 days, worsen, or if fever occurs or symptoms other than sore throat appear (e.g. breathing difficulties, swelling around the throat, swallowing difficulties, nausea and vomiting).
Children
Septofar Honey and Lemon must not be given to children under 6 years of age.
Septofar Honey and Lemon with other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or plans to take.
No clinically significant interactions are known.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
The safety of using Septofar Honey and Lemon during pregnancy and breastfeeding has not been established.
Therefore, Septofar Honey and Lemon is not recommended during pregnancy or breastfeeding.
Driving and operating machinery
Septofar Honey and Lemon has no effect or has a negligible effect on the ability to drive and operate machinery.
Septofar Honey and Lemon contains maltitol and isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before using this medicine.
The medicine may have a mild laxative effect.
Energy value: 2.3 kcal/g of maltitol or isomalt.
Septofar Honey and Lemon contains sodium
The medicine contains less than 1 mmol (23 mg) of sodium per hard tablet, meaning the medicine is considered "sodium-free".
Septofar Honey and Lemon contains sunset yellow
The medicine may cause allergic reactions.

3. How to use Septofar Honey and Lemon

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 lozenge every 2–3 hours as needed. Maximum dose is 8 lozenges within 24 hours.
Adolescents and children over 6 years of age: One lozenge every 2–3 hours. Maximum dose is 4 lozenges within 24 hours.
Children under 6 years of age: Septofar Honey and Lemon must not be used in children under 6 years of age.
Elderly patients: No dose adjustment is required.

Septofar Honey and Lemon lozenges should be slowly dissolved in the mouth. Do not swallow, chew, or crush the lozenge.
Do not take the lozenges immediately before or during meals. Avoid eating or drinking 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 symptoms other than sore throat occur (see section 2).

Overdose of Septofar Honey and Lemon
If you take more than the recommended dose of Septofar Honey and Lemon lozenges, or if a child accidentally ingests the medicine, contact your doctor immediately.
Overdose may cause gastrointestinal discomfort.

Missed dose of Septofar Honey and Lemon
Do not take a double dose to make up for a missed dose. Continue treatment according to the recommended dosage.

If you have any further questions 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 not everyone experiences them.
If hypersensitivity to the medicine occurs, discontinue use and consult a doctor or pharmacist.
If any adverse reaction occurs, or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.

Rare (may affect no more than 1 in 1,000 patients):

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

Frequency not known (frequency of these adverse reactions cannot be determined from the available data):

• urticaria, angioedema,
• dyspnoea,
• tongue pain (glossodynia) and gastrointestinal disorders such as dyspepsia and 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 of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21301, 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 Septofar Honey and Lemon

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 on the blister after:
EXP. 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 properly dispose of medicines no longer required. These measures help protect
the environment.

6. Contents of the package and other information

What Septofar Honey and Lemon contains

• The active substances are amylometacresol 0.6 mg and 2,4-dichlorobenzyl alcohol 1.2 mg.
• The other ingredients are: peppermint essential oil, quinoline yellow (E 104), sodium saccharin (E 954), tartaric acid (E 334), orange yellow (E 110), lemon flavour, honey flavour, isomalt (E 953) and maltitol (E 965).

What Septofar Honey and Lemon looks like and contents of the pack
Septofar Honey and Lemon, pastilles are yellow, convex on both sides, round pastilles with a honey-lemon flavour and 19 mm in diameter.
PVC/PVDC/Aluminium blister.
Each pack contains: 6, 8, 10, 12, 16, 20, 24, 30, 36, 40, or 48 pastilles.
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, 31795 Lekaroz (Navarra)
Spain
Artesan Pharma GmbH & Co. KG
Wendlandstraße 1
29439 Lüchow
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following names: