Septogard smak miodovo-pomaranihovi

Package Leaflet: Information for the User

Septogard Honey-Orange 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.

• Keep this leaflet, you may need to read it again.
• If you need advice or further information, consult a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

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

1. What is Septogard Honey-Orange Flavor and what is it used for

Septogard Honey-Orange Flavor 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 after 3 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Septogard Honey-Orange Flavor

When not to use Septogard Honey-Orange Flavor:

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

Warnings and precautions

Before taking this medicine, you should discuss it with your doctor or pharmacist:

• if you have been diagnosed with a disease called phenylketonuria,
• if you have asthma,
• if you are allergic to salicylates (e.g., acetylsalicylic acid and salicylic acid) or other non-steroidal anti-inflammatory drugs (NSAIDs),
• if after using the lozenges, the sore throat worsens or does not improve within 3 days, or if you develop a fever, severe sore throat, or other symptoms, you should contact your doctor.

Children

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

Septogard Honey-Orange Flavor and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.

Taking Septogard Honey-Orange Flavor with food and drink

Food and drink do not affect the treatment with this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this 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, aspartame, and carmoisine

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 you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
This medicine also contains carmoisine, a dye that can cause allergic reactions.

3. How to use Septogard Honey-Orange 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. If you are unsure, consult your doctor or pharmacist.
The recommended dose is:
Adults and children over 6 years of age: suck 1 lozenge 3 times a day to relieve pain.
Do not take 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 you feel worse or develop a fever, severe sore throat, or other symptoms, you should contact your doctor.
Children between 6 and 11 years of age: the medicine should be administered under adult supervision.
Sublingual administration:
One lozenge should be sucked slowly until it dissolves in the mouth, do not swallow or chew it.

Overdose of Septogard Honey-Orange Flavor

In case of accidental ingestion of too many lozenges, you should immediately contact a pharmacist, doctor, or the nearest hospital emergency department. Always take the medicine packaging with you, regardless of whether there are any lozenges left in it.
Very rarely, the following symptoms of overdose 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 one lozenge.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

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, you can drink a glass of water to weaken this feeling.

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

• difficulty breathing or swallowing, rash, itching, urticaria, 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, chest pain or tightness, and (or) feeling of dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, which may be life-threatening. If you experience any of these symptoms, you should immediately seek medical advice at the nearest hospital.
• local numbness of the oral mucosa (oral hypoesthesia).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance of Adverse Reactions to Medicinal Products 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Septogard Honey-Orange Flavor

Keep this medicine out of the sight and reach of children.
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 month.
There are no special storage precautions for this medicine.
Medicines should 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 Flavor contains

The active substance is benzydamine hydrochloride. One lozenge contains 3 mg of benzydamine hydrochloride (equivalent to 2.68 mg of benzydamine).
The other ingredients are: isomalt (E 953), citric acid monohydrate, aspartame (E 951), quinoline yellow (E 104), peppermint essential oil, carmoisine (E 124), orange flavor, honey flavor (contains propylene glycol (E 1520)).

What Septogard Honey-Orange Flavor looks like and contents of the pack

Round, orange lozenges, 19 ± 1 mm in diameter, with a honey-orange flavor.
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:
Propalgar 3mg pastillas para chupar
Czech Republic:
Larymed pomeranč a med
Romania:
Faringocalm Miere şi Portocală 3 mg pastile
Poland:
Septogard smak miodowo-pomarańczowy

Date of last revision of the leaflet: