Septogard smak citrinovi

Package Leaflet: Information for the User

Septogard Lemon Flavor

3 mg, Hard Lozenges

Benzydamine Hydrochloride

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet for the patient 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 those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 3 days there is no improvement or the patient feels worse, a doctor should be consulted.

Table of Contents of the Leaflet

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

1. What is Septogard Lemon Flavor and what is it used for

Septogard Lemon Flavor contains benzydamine hydrochloride as the active substance. This medicine is used for the symptomatic treatment of acute sore throat in adults and children over 6 years of age. If after 3 days there is no improvement or the patient feels worse, a doctor should be consulted.

2. Important information before using Septogard Lemon Flavor

When not to use Septogard Lemon Flavor:

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

Warnings and precautions

Before starting to use this medicine, the patient should discuss it with a doctor or pharmacist:

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

Children

Due to the pharmaceutical form, this medicine should not be given to children under 6 years of age.

Septogard Lemon Flavor and other medicines

The patient should tell the doctor or pharmacist about all medicines being taken currently or recently, as well as about medicines planned to be taken.

Taking Septogard Lemon Flavor with food and drink

Eating and drinking do not affect the treatment with this medicine.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using the medicine. This medicine should not be used during pregnancy and breastfeeding.

Driving and using machines

Benzydamine hydrochloride has no or negligible influence on the ability to drive and use machines.

This medicine contains isomalt and aspartame

This medicine contains 3.409 mg of aspartame in each lozenge. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. This medicine contains isomalt. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to use Septogard Lemon Flavor

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted. The recommended dose is: Adults and children over 6 years of age: suck 1 lozenge 3 times a day to relieve pain. Do not use more than 3 lozenges per day. This medicine should not be used for more than 7 days. If after 3 days there is no improvement or the patient feels worse or if fever, severe sore throat, or other symptoms occur, a doctor should be consulted. Children from 6 to 11 years of age: the medicine should be administered under adult supervision. Oropharyngeal administration: One lozenge should be sucked slowly until it dissolves in the mouth, without swallowing or chewing it.

Using a higher dose of Septogard Lemon Flavor than recommended

In case of accidental ingestion of too many lozenges, a pharmacist, doctor, or the nearest hospital emergency department should be contacted immediately. The medicine packaging should always be taken along, regardless of whether there are any lozenges left in it. Very rare cases of overdose symptoms have been reported in children: excitement, convulsions, sweating, ataxia, tremors, and vomiting after oral administration of benzydamine in doses about 100 times higher than that contained in a lozenge. In case of any further doubts about the use of this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Uncommon(may affect up to 1 in 100 people):

• increased sensitivity to sunlight (causing rash or sunburn)

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

• burning or dryness in the mouth. If this happens, a glass of water can be drunk to weaken this feeling.

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

• difficulty breathing or swallowing, rash, itching, hives, or swelling of the face, hands, and feet, eyes, lips, and (or) tongue, dizziness (angioedema)
• difficulty breathing (laryngospasm or bronchospasm)

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 pressure in the chest, and (or) feeling of dizziness/fainting, severe itching of the skin or protruding bumps on the skin, swelling of the face, lips, tongue, and (or) throat, which can be life-threatening. If any of these symptoms occur, medical advice should be sought immediately at the nearest hospital.
• local numbness of the oral mucosa (oral numbness).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, 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. By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Septogard Lemon Flavor

The medicine should be stored out of sight and reach of children. This medicine should not be used after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. There are no special precautions for storage. 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. Contents of the pack and other information

What Septogard Lemon Flavor contains

The active substance of the medicine is benzydamine hydrochloride. One lozenge contains 3 mg of benzydamine hydrochloride (which corresponds to 2.68 mg of benzydamine). The other ingredients of the medicine are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), lemon flavor, peppermint essential oil.

What Septogard Lemon Flavor looks like and contents of the pack

Round, yellow, lemon-flavored lozenges, 19 ± 1 mm in diameter. The lozenges are packaged in PVC/PVDC/Aluminum blisters. The pack contains 12, 20, or 24 lozenges. Not all pack sizes may be marketed.

Marketing authorization 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. Fabricii nr. 124 400632 Cluj Napoca Romania Pharmazet Group s.r.o. Třtinová 260/1 196 00 Praha 9 Czech Republic

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

Spain: IosBenc 3mg pastillas para chupar sabor limón Czech Republic: Larymed citron Romania: Faringocalm Lămâie 3 mg pastile Poland: Septogard smak cytrynowy

Date of last revision of the leaflet: