Actusept

Leaflet attached to the packaging: information for the user

Actusept, 1.5 mg/ml, oral spray, 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 exactly as described in this 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 any side effects occur, including any possible side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement after 3 days or the patient feels worse, a doctor should be consulted.

Table of contents of the leaflet

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

1. What is Actusept and what is it used for

Actusept contains benzydamine, which belongs to a group of medicines called non-steroidal anti-inflammatory drugs. The medicine has local anti-inflammatory and analgesic effects and acts locally as an anesthetic on the oral mucosa.
Actusept is used for the local treatment of symptoms of inflammation in the mouth and throat, associated with pain (e.g., oral ulcers, sore throat, inflammation of the oral mucosa and gums). It is also used to relieve post-traumatic pain after oral or throat surgery (e.g., after tonsillectomy or dental surgery), or after the use of a nasogastric tube.
If there is no improvement after 3 days or the patient feels worse, a doctor should be consulted.

2. Important information before using Actusept

When not to use Actusept

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

Warnings and precautions

Before starting to use Actusept, the doctor or pharmacist should be consulted:

• if the patient is allergic to acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs), as the risk of an allergic reaction to benzydamine may be increased;
• if the patient has asthma or an allergy, which may lead to an increased risk of bronchospasm.

Gingivitis may be a symptom of a dental disease. A dentist should be consulted if the treatment is ineffective.
Contact between the medicine and the eyes should be avoided.

Actusept and other medicines

The doctor should be informed about all medicines currently being used or recently used by the patient, as well as any medicines the patient plans to use.
No effect of other medicines on Actusept or of Actusept on other medicines has been demonstrated.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Actusept can be used during pregnancy only if recommended by a doctor. Actusept can be used during breastfeeding only if recommended by a doctor, as it cannot be excluded that benzydamine passes into human milk.

Driving and using machines

The medicine has no or negligible influence on the ability to drive and use machines.

Actusept contains methyl parahydroxybenzoate (E 218), ethanol, and sodium

Methyl parahydroxybenzoate (E 218)

The medicine may cause allergic reactions (possible late reactions).

Etanol

This medicine contains 14.58 mg of alcohol (ethanol) in each spray. The amount of alcohol in one spray of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not have noticeable effects.

Sodium

The medicine contains less than 1 mmol (23 mg) of sodium per spray, which means the medicine is considered "sodium-free".

3. How to use Actusept

This medicine should always be used exactly as described in this leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.

Recommended dose

Adults and adolescents over 12 years of age

4 to 8 sprays, 2 to 6 times a day; no more often than every 1.5 to 3 hours.

Children from 6 to 12 years of age

4 sprays, 2 to 6 times a day; no more often than every 1.5 to 3 hours.

Children under 6 years of age

1 spray per 4 kg of body weight, up to a maximum of 4 sprays, 2 to 6 times a day; no more often than every 1.5 to 3 hours.
The medicine should not be used in children who are unable to hold their breath during spraying.

Elderly patients

The dosage is the same as for other adults.

Method of administration

The medicine should be used after meals and drinking.

How to use the spray

• 1. When using the spray, the bottle should be held upright.
• 2. Before the first use, the spray should be prepared. The spray nozzle should be pointed away from the face. The white actuator should be pressed firmly until a mist appears from the end of the spray nozzle. The spray is now ready for use.
• 3. The spray nozzle should be directed at the painful area of the mouth or throat and the actuator pressed again. One press of the actuator releases one spray.
• 4. After administering the required number of sprays, the end of the spray nozzle should be wiped with a disposable cloth. This helps maintain the patency of the nozzle.
• 5. The end of the spray nozzle should not be pushed with any object in case of blockage.
• 6. During administration, the breath should be held.

Duration of treatment:

A doctor should be consulted if symptoms worsen or do not improve after 3 days or if a fever occurs. The medicine should not be used for more than 7 days without consulting a doctor.

Use of a higher than recommended dose of Actusept

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

Missed dose of Actusept

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

• numbness or tingling in the mouth.

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

• difficulty breathing or swallowing (bronchospasm or laryngospasm)

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

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

Reporting side effects

If any side effects occur, including any possible side effects not listed in this leaflet, the doctor, pharmacist, or nurse 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Actusept

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the label and carton after "Expiry date (EXP)". The expiry date refers to the last day of the month.
The medicine should not be stored in a refrigerator or frozen.
After the first opening, the medicine should be stored at a temperature below 25°C.
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 used. This will help protect the environment.

6. Contents of the packaging and other information

What Actusept contains

• The active substance of the medicine is benzydamine hydrochloride. One milliliter of Actusept oral spray, solution, contains 1.5 mg of benzydamine hydrochloride. One spray (0.18 ml) of the spray contains 270 micrograms of benzydamine hydrochloride.
• The excipients are: sodium bicarbonate, polysorbate 20, absolute ethanol, methyl parahydroxybenzoate (E 218), sodium saccharin (E 954), glycerol, peppermint oil, purified water.

What Actusept looks like and what the pack contains
Actusept is a colorless, clear, transparent liquid with a minty smell, in an orange glass bottle (type III) with a pump spray nozzle (PP applicator, LDPE/PP tube), in a cardboard box.
Pack size: 30 ml

Marketing authorization holder and manufacturer

Marketing authorization holder

Dr. Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
tel.: (+420) 516 770 199

Manufacturer/Importer

Medis International a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic

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

Czech Republic:
Larymed
Poland:
Actusept
Romania:
Zotrina 1.5 mg/ml spray bucofaringian, soluţie
Slovakia:
Larynox

Date of last revision of the leaflet: