Hascosept Forte

Leaflet attached to the packaging: patient information

Hascosept Forte

3 mg/ml, spray for oral use, 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 patient leaflet or as directed by your doctor or pharmacist.

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

Table of contents of the leaflet

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

1. What is Hascosept Forte and what is it used for

The active substance of Hascosept Forte is benzydamine (as benzydamine hydrochloride), a non-steroidal anti-inflammatory drug (NSAID). Benzydamine has strong anti-inflammatory and analgesic effects and acts locally as an anesthetic and antiseptic. Due to its good local absorption and high concentration in inflamed tissues, symptoms quickly subside. The medicine is generally well-tolerated and suitable for local treatment of inflammatory symptoms.

Indications for use

Treatment of symptoms (pain, redness, swelling, aphthae) associated with inflammation of the oral cavity and throat, i.e.:

• bacterial and viral infections,
• pharyngitis,
• mucositis after radiotherapy,
• post-operative conditions in laryngology and stomatology, as well as after intubation.

If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using Hascosept Forte

When not to use Hascosept Forte

If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting to use Hascosept Forte, discuss it with your doctor or pharmacist. The use of locally acting medicines, especially long-term, may cause an allergic reaction. In such a case, discontinue the medicine and consult your doctor, who will recommend appropriate action.

Hascosept Forte and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. There are no known interactions between Hascosept Forte and other medicines.

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. Your doctor will decide whether you can use the medicine during pregnancy or while breastfeeding.

Driving and using machines

The medicine does not affect the ability to drive or use machines.

Hascosept Forte contains ethanol 96%

The medicine contains 14 mg of alcohol (ethanol) in a single dose of 0.14 ml of solution. The amount of alcohol in a single dose 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 cause noticeable effects.

3. How to use Hascosept Forte

Always use this medicine exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. For use on the oral mucosa. Before the first use, press the pump several times to ensure proper spraying. Turn the applicator tip to the horizontal position. Then, place the applicator in the oral cavity, direct the outlet towards the inflamed area, and press the button firmly. Dosage Adults: use 2 to 6 times a day, 2-4 doses (one dose contains 0.14 ml of solution). Do not exceed the recommended dose. Continuous treatment should not exceed 7 days, and any extension should be decided by your doctor.

Using more than the recommended dose of Hascosept Forte

In case of using more than the recommended dose or accidental ingestion of a large amount of the medicine, contact your doctor or pharmacist immediately. Bring this leaflet with you.

Missing a dose of Hascosept Forte

Do not use a double dose to make up for a missed dose. If you have any further questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Hascosept Forte can cause side effects, although not everybody gets them. After using Hascosept Forte, the following side effects may occur with the following frequency:

Uncommon(may affect up to 1 in 100 people):

• skin damage due to hypersensitivity to light (phototoxic reactions).

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

• burning or dryness in the mouth.

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

• laryngospasm, angioedema.

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

• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock), 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, and which may be life-threatening.
• nausea, vomiting, numbness of the mouth, dizziness, headache.

Local symptoms are related to the pharmacodynamic effect of benzydamine, which, among other things, has a local anesthetic effect. Local side effects are usually transient, resolve on their own, and rarely require additional treatment. Reporting side effects If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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 Hascosept Forte

Store in a closed, original package, at a temperature below 25°C. After the first opening of the bottle, the medicine is suitable for use for 1 year, if stored at a temperature below 25°C. Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Hascosept Forte contains

• The active substance is benzydamine hydrochloride. 1 ml of solution contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: peppermint flavor (AR0960), glycerol (E 422), ethanol 96%, sodium saccharin (E 954), macrogol glycerol ricinoleate, purified water.

What Hascosept Forte looks like and what the package contains

Hascosept Forte is a colorless solution with a characteristic peppermint smell. One package of the medicine (a polyethylene (HDPE) bottle with a spray pump and applicator) contains 30 ml of solution. The bottle is placed in a cardboard box.

Marketing authorization holder and manufacturer

"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A. 51-131 Wrocław, ul. Żmigrodzka 242 E

Information about the medicine

tel.: 22 742 00 22 e-mail: informacjaoleku@hasco-lek.pl

Date of the last update of the leaflet: