Package leaflet: information for the patient

Hascosept Forte
3 mg/ml, oral spray, solution
Benzydamini hydrochloridum
Please read this 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
the doctor or pharmacist.

Keep this leaflet for future reference.
If advice or further information is needed, consult a pharmacist.
If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

Table of contents

What Hascosept Forte is and what it is used for
What you need to know before using Hascosept Forte
How to use Hascosept Forte
Possible side effects
How to store Hascosept Forte
Contents of the pack and other information

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

The active substance in Hascosept Forte is benzydamine (in the form of benzydamine hydrochloride), a substance belonging to the group of non-steroidal anti-inflammatory drugs (NSAIDs).
Benzydamine has strong anti-inflammatory and analgesic properties and acts locally as a local anesthetic and antiseptic. Due to its excellent local absorption and high concentration achieved in inflamed tissues, symptoms quickly subside.
The medicine is generally well tolerated and is suitable for local treatment of inflammatory symptoms.
Indications
Treatment of symptoms (pain, redness, swelling, aphthae) associated with inflammatory conditions of the mouth and throat, namely:

in bacterial and viral infections,
in laryngitis,
in mucosal inflammation following radiotherapy,
in conditions following surgical procedures in otorhinolaryngology and dentistry, as well as after intubation.

If there is no improvement after 7 days, or if the patient feels worse, consult a doctor.

2. Important information before using Hascosept Forte

When not to use Hascosept Forte
If the patient is allergic to the active substance or to any of the other ingredients of this medicine
(listed in section 6).

Warnings and precautions
Before starting treatment with Hascosept Forte, consult a doctor or pharmacist.
Prolonged use, especially long-term, of locally acting medicinal products may cause an allergic
reaction. In such a case, discontinue use of the medicine and consult a doctor who will recommend
appropriate management.

Hascosept Forte and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently
taken, as well as any medicines planned for future use.
No interactions between Hascosept Forte and other medicines are known.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become
pregnant, she should consult a doctor or pharmacist before using this medicine.
Hascosept Forte should not be used during pregnancy unless absolutely necessary and
recommended by a doctor. If use is necessary, the lowest possible dose should be used for the
shortest possible duration.
Hascosept Forte may be used during breastfeeding only if recommended by a doctor, as penetration
of benzydamine into breast milk cannot be excluded.

Driving and operating machinery
Hascosept Forte has no influence on the ability to drive or operate machinery.

Hascosept Forte contains 96% ethanol
This medicine contains 14 mg of alcohol (ethanol) per single 0.14 ml dose of solution.
The amount of alcohol in a single dose 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

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
For application to the oral mucosa.
Before first use, press the pump button several times to ensure proper spray function.
Rotate the applicator tip to the horizontal position. Then place the applicator into the mouth, direct its nozzle toward the inflamed area, and firmly press the button.

Dosage
Adults: apply 2 to 6 times daily, 2–4 doses per application (one dose contains 0.14 ml of solution).
Do not exceed the recommended dose.
Continuous treatment should not exceed 7 days; any decision on extending treatment should be made by a doctor.

Use of a higher than recommended dose of Hascosept Forte
If more than the recommended dose is used or if a large amount of the medicine is accidentally swallowed, contact a doctor or pharmacist immediately. Bring this leaflet with you.

Missed dose of Hascosept Forte
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 your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur after using Hascosept Forte with the following frequency:
Uncommon (may occur in up to 1 in 100 patients):

Skin damage due to photosensitivity (phototoxic reactions).

Rare (may occur in up to 1 in 1,000 patients):

Burning or dryness in the mouth.

Very rare (may occur in up to 1 in 10,000 patients):

Laryngospasm, angioedema.

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

Allergic reaction (hypersensitivity),
Severe allergic reaction (anaphylactic shock), the symptoms of which may include difficulty breathing, pain or tightness in the chest, and (or) dizziness/fainting, intense itching of the skin or raised lumps on the skin, swelling of the face, lips, tongue, and (or) throat, which may potentially be life-threatening,
Nausea, vomiting, oral mucositis, dizziness, headache.

Local symptoms are related to the pharmacodynamic action of benzydamine, which, among other effects, exhibits local anaesthetic properties.
Local adverse reactions are usually transient, resolve spontaneously, and rarely require additional treatment.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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,
Phone: +48 22 4921301,
Fax: +48 22 4921309
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 Hascosept Forte

Store in a tightly closed, original container, at a temperature below 25°C.
After first opening the bottle, the medicine remains suitable for use for 1 year, provided it is 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Hascosept Forte contains

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

What Hascosept Forte looks like and contents of the pack
Hascosept Forte is a colourless solution with a characteristic peppermint odour.
One pack (a bottle made of high-density polyethylene (HDPE) with a spray pump and applicator) contains 30 ml of solution. The bottle is placed in a cardboard box.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, Żmigrodzka 242 E Street
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]