Septogard

Package leaflet: Information for the user

Septogard, 1.5 mg/ml, oral spray
Benzydamini hydrochloridum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please contact your pharmacist.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement or if you feel worse after 7 days, you should contact your doctor.

Leaflet contents

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

1. What Septogard is and what it is used for

Septogard contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Septogard relieves pain and inflammation (inflammatory condition). It is used in the treatment of various painful conditions of the mouth or throat, such as:

• Mouth ulcers
• Sore throat
• Pain inside the mouth or gums
• Toothache

2. Important information before using Septogard

When not to use Septogard:

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

Warnings and precautions
Before starting to use Septogard, consult a doctor, dentist, or
pharmacist:

• if the patient has previously suffered from asthma or allergic diseases;
• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). If in doubt whether any of the above points apply to the patient, consult a doctor, dentist, or pharmacist before using Septogard.

Septogard and other medicines
Inform your doctor, dentist, or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take, including those available without a prescription.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor, dentist, or pharmacist before using this medicine.

Driving and operating machinery
Septogard has no effect or has a negligible effect on the ability to drive and operate machinery.

Septogard contains alcohol (ethanol), methyl parahydroxybenzoate (E 218) and sodium

Methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).

Ethanol
This medicine contains 13.6 mg of alcohol (ethanol) in each single dose. The amount in one dose corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per dose containing 8 single doses, meaning the medicine is considered "sodium-free".

3. How to use Septogard

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor, dentist, or pharmacist. If in doubt, consult a doctor, dentist, or pharmacist.

Do not apply Septogard to the eyes or in the eye area. If the aerosol gets into the eyes, immediately rinse them with cold water.

The recommended dose is:

• Adults, adolescents, and elderly people: 4 to 8 sprays, 2 to 6 times daily, no more frequently than every 1.5 to 3 hours;
• Children (aged 6–12 years): 4 sprays, 2 to 6 times daily, no more frequently than every 1.5 to 3 hours;
• Children under 6 years of age: 1 spray per every 4 kg of body weight, up to a maximum of 4 sprays, 2 to 6 times daily, no more frequently than every 1.5 to 3 hours. Contact a doctor, dentist, or pharmacist if symptoms worsen or the patient's condition does not improve.

How to use the aerosol

1. The product requires attaching the aerosol applicator arm before use.
2. Hold the bottle upright during use.
3. Remove the protective cap ( Fig. 1 ).

4. Then attach the spray nozzle provided with the packaging ( Fig. 2 ). Press it firmly onto the aerosol pump.

5. At first use, point the applicator arm away from yourself and others. Then press the white pump button firmly several times until a mist appears at the tip of the applicator arm ( Fig. 3 ). The aerosol is now ready for use.

6. Direct the applicator arm toward the affected area of the throat or oral cavity and firmly press the white pump button. One press releases one dose of the medicine.
7. Apply the appropriate number of sprays as described above. Hold your breath while administering the dose. Afterwards, wipe the tip of the applicator arm with a disposable tissue. This will help keep the applicator arm clear.
8. If the aerosol becomes blocked or stops working properly, return it to the pharmacy. Do not insert anything into the applicator arm to unblock it. No additional cleaning is required during use.

This medicine should be taken after eating or drinking.

Use of more than the recommended dose of Septogard
If more than the recommended dose is taken or if a large amount of the medicine is accidentally swallowed, contact a doctor, dentist, or pharmacist immediately for advice.

Missed dose of Septogard
Do not use a double dose to make up for a missed dose.

If you have any further questions about the use of this medicine, consult a doctor, dentist, or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious. If any of the following adverse reactions occur,
discontinue use of this medicine immediately and contact your doctor or go to the nearest
emergency department:

• Severe allergic reactions, which may include symptoms such as difficulty breathing, chest pain or tightness in the chest, and (or) dizziness/fainting, severe skin itching or raised skin rashes, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening.

The following adverse reactions have also been reported in patients using Septogard
with the following frequency:
Not common (may occur in less than 1 in 100 people):

• Numbness and (or) burning sensation in the mouth and (or) throat

Very rare (may occur in less than 1 in 10,000 people):

• Breathing difficulties and wheezing
• Itching
• Skin rash
• Light sensitivity (skin becomes more sensitive to sunlight than usual, resulting in itchy, red, peeling rash, sometimes with blisters)

Frequency unknown (frequency cannot be determined from available data):

• Redness or swelling of the skin
• Allergic reaction (hypersensitivity)

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 Septogard

Keep this medicine out of sight and reach of children.
Store in the original packaging.
No special temperature storage requirements for this medicine.
Do not use this medicine after the expiry date stated on the bottle and the cardboard
package after EXP. The expiry date refers to the last day of the stated month.
Do not use the medicine for more than 12 months after first opening.
Medicines must not be disposed of via wastewater or household waste. Ask
your pharmacist how to dispose of medicines no longer required. Following this advice helps
protect the environment.

6. Contents of the package and other information

What Septogard contains

• The active substance is benzydamine hydrochloride (1.5 mg per 1 ml of solution). Each spray dose contains 0.225 mg of benzydamine hydrochloride.
• The other ingredients are: glycerol, ethanol (96%), methyl parahydroxybenzoate (E 218), sodium saccharin (E 954), sodium bicarbonate, polysorbate 20, mint flavour SC-5230-AT (maltodextrin and menthol), purified water.

What Septogard looks like and contents of the pack
Septogard is an oral spray. It is a clear, colourless liquid, supplied in a bottle with a metering pump and a protective cap. This ensures a measured amount of spray is delivered with each use.
Available pack sizes: bottles containing 15 ml or 30 ml of solution in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: [email protected]
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Septogard

Package leaflet: information for the user

Septogard, 1.5 mg/ml, oral spray
Benzydamini hydrochloridum
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has advised.

• Keep this leaflet. You may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse effects, including any possible side effects not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.
• If there is no improvement within 7 days, or if you feel worse, consult your doctor.

Leaflet contents

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

1. What Septogard is and what it is used for

Septogard contains the active substance benzydamine hydrochloride, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Septogard relieves pain and inflammation (inflammatory condition). It is used in the treatment of various painful disorders of the mouth or throat, such as:

• Mouth ulcers
• Sore throat
• Pain inside the mouth or gums
• Toothache

2. Important information before using Septogard

Do not use Septogard:

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

Warnings and precautions
Before using Septogard, consult your doctor, dentist or pharmacist:

• if you have previously suffered from asthma or allergic conditions;
• if you are allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs). If you are unsure whether any of the above applies to you, speak to your doctor, dentist or pharmacist before using Septogard.

Septogard with other medicines
Tell your doctor, dentist or pharmacist about all medicines you are taking, have recently taken or plan to take, including those available without a prescription.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor, dentist or pharmacist before using this medicine.
Driving and using machines
Septogard has no effect or a negligible effect on the ability to drive and operate machinery.
Septogard contains alcohol (ethanol), methyl parahydroxybenzoate (E 218) and sodium
Methyl parahydroxybenzoate (E 218)
This medicine may cause allergic reactions (including delayed-type reactions).
Ethanol
This medicine contains 13.6 mg of alcohol (ethanol) per single dose. The amount in one dose corresponds to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have any noticeable effects.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose containing 8 single doses, meaning the medicine is considered "sodium-free".

3. How to use Septogard

Always use this medicine exactly as described in this patient leaflet or as advised by your doctor, dentist or pharmacist. If in doubt, consult your doctor, dentist or pharmacist.
Do not use Septogard in or around the eyes. If the spray gets into the eyes, immediately rinse them with cold water.
Recommended dosage:

• Adults, adolescents and elderly patients: 4 to 8 spray doses, 2 to 6 times daily, no more frequently than every 1.5–3 hours;
• Children (aged 6–12 years): 4 spray doses, 2 to 6 times daily, no more frequently than every 1.5–3 hours;
• Children under 6 years of age: 1 spray dose per 4 kg body weight, up to a maximum of 4 doses, 2 to 6 times daily, no more frequently than every 1.5–3 hours.

Consult your doctor, dentist or pharmacist if symptoms worsen or do not improve.

How to use the spray

1. Lift the nozzle.
2. Place the nozzle in the mouth and direct the spray towards the inflamed area in the mouth or throat.
3. Press the knurled surface of the pump firmly with your finger until the dose is delivered. Repeat as necessary. Hold your breath while administering the spray.

Note: At first use, press the nozzle several times to prime the pump and ensure proper spray function.
This medicine should be used after eating or drinking.
If you use more Septogard than you should
If you use more than the recommended dose or accidentally swallow a large amount of the medicine, contact your doctor, dentist or pharmacist immediately for advice.
If you forget to use a dose of Septogard
Do not use a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, consult your doctor, dentist or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious. If you experience any of the following, stop using this medicine immediately and contact your doctor or go to the nearest emergency department:

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

The following side effects have also been reported by patients using Septogard, with the following frequency:
Not common (may affect less than 1 in 100 people):

• Numbness and (or) burning sensation in the mouth and (or) throat

Very rare (may affect less than 1 in 10,000 people):

• Difficulty breathing and wheezing
• Itching
• Skin rash
• Photosensitivity (skin becomes more sensitive to sunlight than usual, resulting in itchy, red, scaly rash, sometimes with blisters)

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

• Redness or swelling of the skin
• Allergic reaction (hypersensitivity)

Reporting of side effects
If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 Authorisation Holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Septogard

Keep this medicine out of sight and reach of children.
Store in the original packaging.
No special storage temperature requirements.
Do not use this medicine after the expiry date stated on the bottle and carton after EXP. The expiry date refers to the last day of the stated month.
Do not use this medicine for more than 12 months after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Septogard contains

• The active substance is benzydamine hydrochloride (1.5 mg per 1 ml of solution). Each spray dose contains 0.225 mg of benzydamine hydrochloride.
• The other ingredients are: glycerol, ethanol (96%), methyl parahydroxybenzoate (E 218), sodium saccharin (E 954), sodium bicarbonate, polysorbate 20, mint flavour SC-5230-AT (maltodextrin and menthol), purified water.

What Septogard looks like and contents of the pack
Septogard is an oral spray. It is a clear, colourless liquid, available in a bottle with a metering pump and nozzle, in a cardboard box. This ensures a measured amount of spray is delivered with each use.
Available pack sizes: bottles containing 15 ml or 30 ml of solution in a cardboard box.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer/Importer
Marketing Authorisation Holder
Farmak International Sp. z o.o.
ul. Koszykowa 65
00-667 Warsaw
tel. +48 22 822 93 06
e-mail: [email protected]
Importer
Farmak International Sp. z o.o.
ul. Chełmżyńska 249
04-458 Warsaw
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Poland: Septogard