Hascosept

PATIENT LEAFLET: INFORMATION FOR THE USER

HASCOSEPT

( Benzydamine hydrochloride)

1.5 mg/g, solution for oral use Please read this leaflet carefully, as it contains important information for the patient.

This medicine is available without a prescription, so that you can treat certain conditions without the help of a doctor. However, to achieve good treatment results, you should use Hascosept carefully.

• - Keep this leaflet, you may need to read it again.
• - Ask your doctor or pharmacist if you need advice or more information.
• - If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Table of contents of the leaflet:

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

1. WHAT IS HASCOSEPT AND WHAT IS IT USED FOR

Hascosept contains the active substance benzydamine hydrochloride. It is a substance with anti-inflammatory and analgesic effects. When used locally, it has a numbing and disinfecting effect. Hascosept is used to treat symptoms (pain, redness, swelling, aphthae) associated with inflammation of the mouth and throat in bacterial and viral infections, in post-operative conditions in laryngology and dentistry.

2. IMPORTANT INFORMATION BEFORE USING HASCOSEPT

When not to use Hascosept

• -if you are hypersensitive to any of the ingredients of the medicine.

When to be cautious when using Hascosept

Using, especially long-term, local-acting medicines may cause an allergic reaction. In such a case, you should stop using Hascosept and consult a doctor.

Using Hascosept with other medicines

No interactions with other medicines are known. You should tell your doctor about all the medicines you have taken recently, including those that are available without a prescription.

Pregnancy and breastfeeding

Before using any medicine, you should consult a doctor or pharmacist.
The medicine should be used with caution during pregnancy and breastfeeding.

Driving and using machines

There are no studies on the effect of the medicine on the ability to drive vehicles and operate machinery.

Important information about some ingredients of Hascosept

The medicine contains small amounts of ethanol (alcohol) - less than 100 mg per dose.
Due to the presence of methyl parahydroxybenzoate, the medicine may cause allergic reactions (possible late reactions).

3. HOW TO USE HASCOSEPT

If you have any doubts about using the medicine, you should consult a doctor or pharmacist.
For oral use.
Turn the applicator tip to the horizontal position. Then, place the applicator in the mouth, direct the applicator outlet towards the inflammation site, and press the button firmly.
Children under 6 years: 1 dose of the medicine per 4 kg of body weight (each dose contains 0.14 ml of solution), 2 to 6 times a day.
Regardless of body weight, do not exceed 4 doses at a time.
Children from 6 to 12 years: 4 doses of the medicine, 2 to 6 times a day.
Children over 12 years and adults: 4 to 8 doses of the medicine, 2 to 6 times a day.
Do not use a higher dose than recommended.
Before the first use, press the pump button several times to achieve proper spraying.

Using a higher dose of Hascosept than recommended

The medicine, when used locally, practically does not act systemically, so the risk of overdose is minimal. If you have taken a higher dose than recommended or accidentally swallowed the medicine, you should immediately contact a doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Hascoseptcan cause side effects, although they may not occur in everyone.
Local side effects are usually transient, resolve on their own, and rarely require additional treatment.
Benzydamine, when used locally, is absorbed into the circulation in small amounts, and therefore systemic side effects are very rare.
Diluting the medicine usually eliminates these symptoms.
Side effects that occur very rarely (in less than 1 in 10,000 patients using the medicine; frequency cannot be determined based on available data):

• general disorders and administration site conditions: burning sensation of the oral mucosa
• gastrointestinal disorders: dryness of the mouth, nausea, and vomiting
• immune system disorders: allergic reaction (hypersensitivity), hypersensitivity reactions
• nervous system disorders: sensation disorders, numbness, dizziness, headaches
• skin and subcutaneous tissue disorders: rash. Severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, chest pain or tightness, and (or) feeling of dizziness or fainting, severe itching of the skin or hives, swelling of the face, lips, tongue, and (or) throat, which can be life-threatening. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE HASCOSEPT

Keep out of the reach and sight of children.
Do not use Hascosept after the expiry date stated on the carton.
Store in a closed, original package, at a temperature below 25°C.
Shelf life after first opening: 12 months.
Medicines should 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. OTHER INFORMATION

What Hascosept contains

100 g of solution contains:
active substance
Benzydamine hydrochloride 0.15 g
excipients
Patent blue E 131, quinoline yellow E 104, peppermint flavor, glycerol, ethanol 96%, saccharin, sodium hydrocarbonate, methyl parahydroxybenzoate, polysorbate 20, purified water.

What Hascosept looks like and what the pack contains

One pack of the medicine (polyethylene bottle with an atomizer and oral applicator) contains 30 g of solution.

Marketing authorisation holder and manufacturer

“HASCO-LEK” Pharmaceutical Company S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
tel. (071) 352 95 22
fax. (071) 352 76 36
Drug Information Department
tel. (022) 742 00 22

Date of leaflet approval: 11.2016