Septogard lemon flavor

Package leaflet: Information for the user

Septogard lemon flavour
3 mg, hard tablets
Benzydamini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because 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 doctor 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 not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

Contents of the leaflet

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

1. What Septogard lemon flavour is and what it is used for

Septogard lemon flavour contains benzydamine hydrochloride as the active substance.
This medicine is used for local symptomatic treatment of acute sore throat in adults and children over 6 years of age.
If there is no improvement after 3 days, or if your condition worsens, consult your doctor.

2. Important information before using Septogard lemon flavour

When not to use Septogard lemon flavour:

• if the patient is allergic to benzidamine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with this medicine, consult a doctor or pharmacist:

• if the patient has been diagnosed with phenylketonuria,
• if the patient suffers or has suffered from asthma,
• if the patient is allergic to salicylates (e.g. acetylsalicylic acid and salicylic acid) or other medicines in the so-called non-steroidal anti-inflammatory drugs (NSAIDs) group,
• if after using the lozenges throat pain worsens or does not improve within 3 days, or if fever, severe sore throat or other symptoms occur, medical advice should be sought.

Children
Due to the pharmaceutical form, this medicine should not be given to children under 6 years of age.
Septogard lemon flavour and other medicines
Inform the doctor or pharmacist about all medicines currently taken or taken recently, as well as any medicines the patient plans to take.
Taking Septogard lemon flavour with food and drink
Food and drink do not affect treatment with this medicine.
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.
Septogard lemon flavour should not be used during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, the lowest possible dose for the shortest possible duration should be used.
This medicine should not be used during breastfeeding.
Driving and operating machinery
Benzidamine hydrochloride has no effect or has negligible effect on the ability to drive or operate machinery.
This medicine contains isomalt and aspartame
This medicine contains 3.409 mg of aspartame in each hard lozenge.
Aspartame is a source of phenylalanine. It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
This medicine contains isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Septogard lemon flavour

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years of age: suck one hard tablet three times a day to relieve pain.
Do not exceed three hard tablets per day.
This medicine should not be used for longer than 7 days.
If there is no improvement after 3 days, or if symptoms worsen, fever develops, severe sore throat or other symptoms occur, consult a doctor.
Children aged 6 to 11 years: the medicine should be administered under adult supervision.
Oropharyngeal administration:
Slowly suck one hard tablet until it dissolves in the mouth. Do not swallow or chew it.
Use of a higher than recommended dose of Septogard lemon flavour
In case of accidental ingestion of too many hard tablets, contact a pharmacist, doctor, or the nearest hospital emergency department immediately. Always take the medicine packaging with you, regardless of whether any hard tablets remain.
Very rarely, symptoms of overdose in children have been reported: excitation, convulsions, sweating, ataxia, tremor, and vomiting following oral administration of benzydamine at doses approximately 100 times higher than the amount contained in one hard tablet.
If you have any further doubts 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 they do not occur in everyone.
Not common (may affect up to 1 in 100 patients):

• photosensitivity (causing rash or sunburn)

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

• burning or dryness in the mouth. If this occurs, you may drink a glass of water to relieve the sensation.

Very rare (may affect up to 1 in 10,000 patients):

• breathing or swallowing difficulties, rash, itching, hives, or swelling of the face, hands and feet, eyes, lips and (or) tongue, dizziness (angioedema)
• breathing difficulties (laryngeal or bronchial spasm)

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

• allergic reaction (hypersensitivity)
• severe allergic reaction (anaphylactic shock) with symptoms such as: breathing difficulties, pain or tightness in the chest and (or) feeling dizzy/fainting, intense itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue and (or) throat, which may be life-threatening. If any of these symptoms occur, seek immediate medical advice at the nearest hospital.
• local loss of sensitivity of the oral mucosa (oral hypoesthesia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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, website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store the medicine Septogard lemon flavour

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and
blister after the label EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. Doing so helps protect
the environment.

6. Contents of the package and other information

What Septogard lemon flavour contains
The active substance is benzylamine hydrochloride. One hard tablet contains 3 mg of
benzylamine hydrochloride (equivalent to 2.68 mg of benzylamine).
Other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), lemon flavour, peppermint essential oil.

What Septogard lemon flavour looks like and contents of the pack
Yellow, round hard tablets with a lemon flavour, 19 ± 1 mm in diameter.
The hard tablets are packed in PVC/PVDC/Aluminium blisters.
The pack contains 12, 20 or 24 hard tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06

Manufacturer
Lozy’s Pharmaceuticals S.L.
Campus Empresarial
31795 Lekaroz (Navarra)
Spain

Infarmade S.L.
Calle De La Torre de los Herberos, 35
Polígono Industrial Carretera de la Isla
41703 Dos Hermanas (Sevilla)
Spain

Terapia SA
Str. Fabriciei nr. 124
400632 Cluj Napoca
Romania

Dr. Max Pharma s.r.o
Na Florenci 2116/15
Nové Město
110 00 Prague 1
Czech Republic

This medicinal product is authorised in the following names in the European Economic Area countries:
Czech Republic: Larymed citron
Romania: Faringocalm Lămâie 3 mg pastile
Poland: Septogard lemon flavour