SEPTOGARD 1.5 mg/5 mg Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Package Leaflet Contents
2. What Septogard Plus is and what it is used for
3. Important information before using Septogard Plus
   1. When not to use Septogard Plus:
   2. Warnings and precautions
   3. Children and adolescents
   4. Septogard Plus and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Septogard Plus contains macrogolglycerol hydroxystearate and sodium
4. How to use Septogard Plus
   1. Adults
   2. Use in children and adolescents
   3. Method of administration
   4. Duration of treatment
   5. Overdose of Septogard Plus
   6. Missed dose of Septogard Plus
5. Possible side effects
   1. Reporting side effects
6. How to store Septogard Plus
7. Package contents and other information
   1. What Septogard Plus contains
   2. What Septogard Plus looks like and contents of the pack
   3. Marketing authorization holder
   4. Importer
   5. This medicine is authorized in the Member States of the European Economic Area under the following names:
   6. Date of last revision of the package leaflet:

Package Leaflet: Information for the User

Septogard Plus, (1.5 mg + 5 mg)/ml, oral spray, solution
Benzydamine hydrochloride + Cetylpyridinium chloride

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 this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a doctor or pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

Package Leaflet Contents

• 1. What Septogard Plus is and what it is used for
• 2. Important information before using Septogard Plus
• 3. How to use Septogard Plus
• 4. Possible side effects
• 5. How to store Septogard Plus
• 6. Package contents and other information

1. What Septogard Plus is and what it is used for

Septogard Plus is an anti-inflammatory, analgesic, and antiseptic medicine for local use in the mouth. The oral spray disinfects the mouth and throat and reduces symptoms of throat inflammation, such as pain, redness, swelling, feeling of heat, and disturbance of function.

Septogard Plus is used in adults and adolescents over 12 years of age as an anti-inflammatory, analgesic, and antiseptic for the treatment of:

• irritation of the throat, mouth, and gums,
• inflammation of the gums and throat,
• before and after tooth removal.

If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

2. Important information before using Septogard Plus

When not to use Septogard Plus:

• if the patient is allergic (hypersensitive) to benzydamine hydrochloride, cetylpyridinium chloride, or any of the other ingredients of this medicine (listed in section 6);
• in children under 6 years of age, as this pharmaceutical form is not intended for this age group.

Warnings and precautions

Before starting to use Septogard Plus, the doctor or pharmacist should be consulted.

Septogard Plus should not be used for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, a doctor should be consulted.

The use of local medicines, especially for a longer period, may lead to irritation. In such cases, treatment should be discontinued.

Septogard Plus should not be used in combination with anionic compounds, such as those found in toothpastes, and it is not recommended to use the medicine directly before or after brushing teeth.

Direct contact between Septogard Plus and the eyes should be avoided.

This medicine should not be inhaled.

Children and adolescents

Septogard Plus should not be used in children under 6 years of age, as the oral spray is not intended for this age group.

Septogard Plus should not be used in children between 6 and 12 years of age unless a doctor recommends otherwise.

Septogard Plus and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Septogard Plus should not be used at the same time as other antiseptic products.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult a doctor or pharmacist before using this medicine.

Septogard Plus is not recommended during pregnancy.

Before using Septogard Plus during breastfeeding, the doctor should be consulted.

The doctor will decide whether to discontinue breastfeeding or stop treatment with Septogard Plus.

Driving and using machines

Septogard Plus has no or negligible influence on the ability to drive and use machines.

Septogard Plus contains macrogolglycerol hydroxystearate and sodium

Macrogolglycerol hydroxystearate may cause gastrointestinal disorders and diarrhea.

This medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is essentially 'sodium-free'.

3. How to use Septogard Plus

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

Adults

To obtain a single dose, the pump head of the spray should be pressed once or twice. The dose can be repeated every 2 hours, 3 to 5 times a day.

Use in children and adolescents

Adolescents over 12 years of age

To obtain a single dose, the pump head of the spray should be pressed once or twice. The dose can be repeated every 2 hours, 3 to 5 times a day.

Septogard Plus should not be used in children under 12 years of age.

The recommended dose should not be exceeded.

For optimal effect, it is not recommended to use the medicine directly before or after brushing teeth.

Method of administration

Before the first use of Septogard Plus, the pump head of the spray should be pressed at least 3-4 times until a uniform spray is obtained. If the medicine has not been used for a longer period (at least one week), the pump head of the spray should be pressed 1-2 times to obtain a uniform spray.

The mouth should be opened wide, the applicator directed towards the throat, and the pump head of the spray pressed 1-2 times.

During spraying, the breath should be held.

Duration of treatment

This medicine should not be used for more than 7 days. If symptoms worsen or do not improve after 3 days, or if other symptoms such as fever occur, a doctor should be consulted.

A doctor should be consulted if the condition is recurrent or if new changes in its characteristics are observed.

Overdose of Septogard Plus

In case of overdose or accidental ingestion of a large amount of the medicine, a doctor or pharmacist should be consulted immediately.

Missed dose of Septogard Plus

A double dose should not be used to make up for a missed dose.

If there are any further doubts about the use of the medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Septogard Plus can cause side effects, although not everybody gets them.

Rare (may affect up to 1 in 1000 people):

• hives, increased sensitivity of the skin to sunlight (phototoxicity),
• sudden, uncontrolled narrowing of the airways in the lungs (bronchospasm),
• burning sensation in the mouth.

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

• local irritation of the mouth.

Frequency not known (cannot be estimated from the available data):

• allergic reaction (hypersensitivity): severe allergic reaction (anaphylactic shock), which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, and which may be life-threatening,
• loss of sensation (numbness) of the oral mucosa.

These symptoms are usually temporary. However, if they occur, a doctor or pharmacist should be consulted.

By following the instructions in the package leaflet, the risk of side effects can be minimized.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the doctor or pharmacist should be informed.

Side effects can be reported directly to the Department of Monitoring 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, more information can be gathered on the safety of the medicine.

5. How to store Septogard Plus

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 packaging after 'EXP'. The expiry date refers to the last day of the month stated.

There are no special storage conditions for this medicine.

This medicine should not be used for more than 6 months after first opening. There are no special storage conditions after first opening.

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. Package contents and other information

What Septogard Plus contains

The active substances are benzydamine hydrochloride and cetylpyridinium chloride.

Each ml of the oral spray, solution contains 1.5 mg of benzydamine hydrochloride and 5 mg of cetylpyridinium chloride (as cetylpyridinium chloride monohydrate).

One spray contains 0.1 ml of the oral spray, solution, containing 0.15 mg of benzydamine hydrochloride and 0.5 mg of cetylpyridinium chloride (as cetylpyridinium chloride monohydrate).

The other ingredients are glycerol (E 422), sodium saccharin, macrogolglycerol hydroxystearate, peppermint flavor (contains: natural peppermint essential oil, natural peppermint extract, maltodextrin, menthofuran, pulegone, arabic gum (E 414)), and purified water.

What Septogard Plus looks like and contents of the pack

Septogard Plus is a clear, colorless solution.

A polyethylene (HDPE) bottle with a pump dispenser (PE/POM/EVA/stainless steel/aluminum/silicone emulsion) and an applicator (PP/HDPE): 30 ml of the oral spray, solution in a cardboard box.

Marketing authorization holder

Farmak International Sp. z o.o.

ul. Koszykowa 65

00-667 Warsaw

tel. +48 22 822 93 06

Importer

Symphar Sp. z o.o.

ul. Chełmżyńska 249

04-458 Warsaw

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

Lithuania: Benzydamine hydrochloride/Cetylpyridinium chloride Farmak 1.5 mg/5 mg/ml burnos gleivinės purškalas (tirpalas)

Poland: Septogard Plus

Date of last revision of the package leaflet:

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