Septogard

Leaflet attached to the packaging: information for the user

Septogard, 1.5 mg/ml, mouthwash solution

Benzydamine hydrochloride

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

This medicine should always be used in accordance with the description in the patient leaflet 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 any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after 7 days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

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

1. What is Septogard and what is it used for

Septogard, containing the active substance benzydamine hydrochloride, belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Septogard has a pain-relieving and anti-inflammatory effect (at the site of inflammation). It is used to treat various painful conditions of the mouth or throat, such as:

• mouth ulcers,
• sore throat,
• pain after dental surgery.

2. Important information before using Septogard

When not to use Septogard:

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

Warnings and precautions

Before starting to use Septogard, the patient should consult their doctor or pharmacist:

• if the patient has or has had asthma or an allergy, which may increase the risk of bronchospasm or allergic reactions;
• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). If in doubt, the patient should consult their doctor, dentist, or pharmacist before using Septogard.

Care should be taken to avoid getting the mouthwash solution in the eyes. If it accidentally gets into the eyes, they should be rinsed immediately with cold water.

Septogard and other medicines

The patient should inform their doctor, dentist, or pharmacist about all medicines they are taking, have recently taken, or plan to take, including those available without a prescription.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor, dentist, or pharmacist before using Septogard.

What Septogard contains

• methyl parahydroxybenzoate (E218), which may cause allergic reactions (possible late reactions).
• 10.1% v/v ethanol (alcohol), i.e., up to 1.2 g per dose, equivalent to 30 ml of beer, 12.5 ml of wine per dose. Alcohol is harmful to individuals with alcohol dependence. This should be taken into account when using Septogard in pregnant or breastfeeding women, children, and high-risk groups, such as patients with liver disease or epilepsy.

3. How to use Septogard

This medicine should always be used in accordance with the recommendations of the doctor, dentist, or pharmacist. If in doubt, the patient should consult their doctor, dentist, or pharmacist. Septogard should not be used in the eyes or near the eyes. If the mouthwash solution gets into an eye, it should be rinsed immediately with cold water. Septogard should not be used for more than 7 days unless a doctor or dentist has recommended otherwise. Septogard is usually used undiluted, but if stinging occurs, it can be diluted with water. Septogard is intended for rinsing the mouth and throat according to the following instructions:

• adults, elderly, and children over 12 years:the usual dose is 15 ml (approximately 1 tablespoon) every 1.5-3 hours. Rinse the mouth or throat, then spit out the solution. Do not swallow. Measure the dose with the measuring cup provided with the packaging;
• children 12 years and under:children under 12 years should not use this medicine.

If symptoms worsen or the patient's condition does not improve, they should contact their doctor, dentist, or pharmacist.

Using more than the recommended dose of Septogard

In case of taking more than the recommended dose or accidental ingestion of a large amount of the medicine, the patient should immediately consult their doctor, dentist, or pharmacist for advice.

Missing a dose of Septogard

A double dose should not be used to make up for a missed dose. If the patient has any further doubts about using this medicine, they should consult their doctor, dentist, or pharmacist.

4. Possible side effects

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

Some side effects can be serious. If any of the following side effects occur, the patient should immediately seek medical attention

• severe allergic reactions, which may include difficulty breathing, chest pain or tightness, and (or) dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening.

Other side effects; if serious symptoms occur, the patient should inform their doctor

Uncommon (affects 1 in 1,000 people):

• numbness and (or) burning sensation in the mouth and (or) throat.

Rare (affects less than 1 in 10,000 people):

• breathing difficulties and wheezing,
• itching,
• skin rash,
• hypersensitivity reactions, which may be associated with itching, accompanied by a red, flaky rash, sometimes with blisters.

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

• redness or swelling of the skin,
• allergic reaction (hypersensitivity).

If the patient experiences a burning sensation while rinsing their mouth with the solution, the next dose may be diluted with water to reduce this effect.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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, e-mail: ndl@urpl.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

The medicine should be stored out of sight and reach of children. Store in the original packaging. There are no special precautions for storage. The medicine should not be used after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the month stated. After first opening, do not use for more than 12 months. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Package contents and other information

What Septogard contains

The active substance of Septogard is benzydamine hydrochloride (1.5 mg per 1 ml of the medicine). Each 15 ml of the solution contains 22.5 mg of benzydamine hydrochloride. The other ingredients are: glycerol, ethanol 96%, methyl parahydroxybenzoate (E218), sodium saccharin (E954), sodium bicarbonate, polysorbate 20, peppermint flavor SC-5230-AT (maltodextrin and menthol), quinoline yellow (E104), patent blue V (E131), purified water.

What Septogard looks like and what the pack contains

Septogard is a mouthwash solution. It is a clear, green solution with a characteristic peppermint flavor. It is available in a 100 ml bottle with a screw cap, a protective strip, and a measuring cup, in a carton.

Importer

Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
tel.: +48 22 822 93 06
e-mail: biuro@farmakinternational.pl

Marketing authorization holder

Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
Date of last revision of the leaflet:May 2025