Septogard honey-orange flavour

Package leaflet: Information for the user

Septogard honey-orange flavour
3 mg, hard pastilles
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 it can be read again if necessary.
• If advice or further information is needed, please consult the pharmacist.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 3 days, or if the patient feels worse, medical advice should be sought from a doctor.

Contents of the leaflet

1. What Septogard honey-orange flavour is and what it is used for
2. What you need to know before taking Septogard honey-orange flavour
3. How to take Septogard honey-orange flavour
4. Possible side effects
5. How to store Septogard honey-orange flavour
6. Contents of the pack and other information

1. What Septogard honey-orange flavour is and what it is used for

Septogard honey-orange flavour contains benzydamine hydrochloride as the active substance.
This medicine is used for the 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 the patient feels worse, medical advice should be sought.

2. Important information before using Septogard honey-orange flavour

When not to use Septogard honey-orange flavour:

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

Warnings and precautions
Before starting to use 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 from the so-called non-steroidal anti-inflammatory drugs (NSAIDs) group,
• if after using the hard pastilles sore throat worsens or does not improve within 3 days, or fever, severe sore throat or other symptoms occur, medical advice should be sought.

Children
Due to the pharmaceutical form, this medicine should not be administered to children under 6 years of age.
Septogard honey-orange flavour and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Taking Septogard honey-orange 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 child, she should consult a doctor or pharmacist before using this medicine.
This medicine should not be used during pregnancy and breastfeeding.
Driving and operating machinery
Benzylamine hydrochloride has no effect or has negligible effect on the ability to drive or operate machinery.
This medicine contains isomalt, aspartame and carmine red
This medicine contains 3.409 mg of aspartame in each hard pastille.
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 improper excretion.
This medicine contains isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact a doctor before taking this medicine.
This medicine also contains carmine red, a dye which may cause allergic reactions.

3. How to use Septogard Honey-Orange 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.

Recommended dose:
Adults and children over 6 years of age: suck 1 lozenge slowly 3 times daily to relieve sore throat pain.

Do not exceed 3 lozenges per day.
Do not use this medicine 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 given under adult supervision.

Administration:
Slowly suck one lozenge until fully dissolved in the mouth. Do not swallow or chew the lozenge.

Overdose of Septogard Honey-Orange Flavour

In case of accidental ingestion of too many lozenges, contact a pharmacist, doctor or the nearest hospital emergency department immediately. Always bring the medicine packaging with you, regardless of whether any lozenges remain.

Very rarely, symptoms of overdose have been reported in children following oral administration of benzydamine at doses approximately 100 times higher than that contained in one lozenge: excitation, convulsions, sweating, ataxia, tremor and vomiting.

If you have any further questions 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 not everyone will experience them.
Uncommon (may occur in up to 1 in 100 patients):

• photosensitivity (causing rash or sunburn)

Rare (may occur in 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 this sensation.

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

• difficulty breathing or swallowing, 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 not known (frequency cannot be estimated from the available data):

• allergic reaction (hypersensitivity)
• severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, pain or tightness in the chest and (or) feeling dizzy/fainting, severe skin itching or raised skin lumps, 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 anaesthesia).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this 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 to provide more information on the safety of the medicine.

5. How to store the medicine Septogard honey-orange 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 packaging and
blister pack following the EXP marking. The expiry date refers to the last day of the stated month.
No special storage instructions 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. This will help protect the environment.

6. Contents of the pack and other information

What Septogard honey-orange flavour medicine contains
The active substance is benzidamine hydrochloride. One hard tablet contains 3 mg of benzidamine hydrochloride (equivalent to 2.68 mg of benzidamine).
The other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), peppermint essential oil, carmine red (E 124), orange flavour, honey flavour (containing propylene glycol (E 1520)).

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

Marketing Authorisation Holder
Farmak International Sp. z o.o.
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. Fabricii 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 medicine is authorised in the European Economic Area countries under the following names:
Spain: Propalgar 3mg pastillas para chupar
Czech Republic: Larymed pomeranč a med
Romania: Faringocalm Miere şi Portocală 3 mg pastile
Poland: Septogard smak miodowo-pomarańczowy