Hascosept smak miemtovi

Package Leaflet: Information for the Patient

Hascosept Mint Flavor

3 mg, hard tablets
Benzydamine Hydrochloride

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet for the patient or as advised by a doctor, pharmacist, or nurse.

• Keep this package leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet

• 1. What is Hascosept Mint Flavor and what is it used for
• 2. Important information before taking Hascosept Mint Flavor
• 3. How to take Hascosept Mint Flavor
• 4. Possible side effects
• 5. How to store Hascosept Mint Flavor
• 6. Contents of the package and other information

1. What is Hascosept Mint Flavor and what is it used for

Hascosept Mint Flavor contains the active substance benzydamine, which belongs to the group of indole non-steroidal anti-inflammatory drugs (NSAIDs) for topical and systemic use.
Benzydamine has anti-inflammatory, analgesic, and local anesthetic and antiseptic effects. After topical administration, the medicine is well absorbed, reaching high concentrations in the inflamed tissues. Hascosept Mint Flavor is intended for the local treatment of symptoms of oral cavity and throat inflammation. The medicine is generally well tolerated.
Hascosept Mint Flavor is used to treat discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the oral cavity and throat. The medicine is intended for sucking. If after 3 days there is no improvement or the patient feels worse, they should consult their doctor.

2. Important information before taking Hascosept Mint Flavor

When not to take Hascosept Mint Flavor

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

Warnings and precautions

Before starting to take Hascosept Mint Flavor, the patient should discuss it with their doctor or pharmacist.
The medicine is not recommended for patients who are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
The medicine should be used with caution in patients who have had asthma, as it may cause shortness of breath.
In some patients, oral and throat ulcers may be a symptom of another serious disease. If the symptoms worsen or do not improve after 3 days of taking the medicine, the patient should consult their doctor.

Children

Due to the pharmaceutical form of Hascosept Mint Flavor, it should not be used in children under 6 years of age.

Hascosept Mint Flavor and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The interaction of Hascosept Mint Flavor with other medicines has not been studied.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Hascosept Mint Flavor should not be used during pregnancy and breastfeeding.

Driving and using machines

Topical use of benzydamine in the recommended doses does not affect the ability to drive and use machines.

Hascosept Mint Flavor contains isomalt

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Hascosept Mint Flavor

This medicine should always be taken exactly as described in the package leaflet for the patient or as advised by a doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.

Adults and children over 6 years of age

The recommended dose is one tablet 3 times a day.
The tablet should be sucked slowly. Do not chew or swallow.
Do not take a higher dose than recommended. Continuous treatment should not exceed 7 days.

Use in children

Due to the pharmaceutical form of Hascosept Mint Flavor, it should not be used in children under 6 years of age. In children between 6 and 11 years of age, the medicine should be used under adult supervision.

Taking a higher dose of Hascosept Mint Flavor than recommended

In case of accidental ingestion of too many tablets, the patient should immediately consult their doctor, taking the package of the medicine with them. The doctor will take appropriate action.
Very rarely, symptoms of overdose (excitement, convulsions, sweating, clumsiness, tremors, vomiting) have been reported in children after ingestion of benzydamine-containing medicines in doses about 100 times higher than the dose contained in a single tablet.

Missing a dose of Hascosept Mint Flavor

The patient should not take a double dose to make up for a missed dose.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Hascosept Mint Flavor can cause side effects, although not everybody gets them.

Side effects of unknown frequency (frequency cannot be estimated from the available data) are allergic reactions, which can be severe.

The patient should immediately inform their doctor if they experience any of the following symptoms:

• sudden swelling of the mouth or throat,
• difficulty breathing,
• rash or itching, especially if it affects the whole body.

Uncommonside effects (occurring in less than 1 in 100 people): skin reactions due to hypersensitivity to light.
Rareside effects (occurring in less than 1 in 1,000 people): burning or dryness in the mouth. If these symptoms occur, they can be reduced by drinking a glass of water slowly, in small sips.
Very rareside effects (occurring in less than 1 in 10,000 people): laryngospasm.
Side effects of unknown frequency(frequency cannot be estimated from the available data):

• premature closure of the fetal ductus arteriosus,
• allergic reaction (hypersensitivity),
• 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; such a reaction can be life-threatening,
• oral mucosal numbness (local loss of sensitivity of the oral mucosa).

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in this package leaflet, they should inform their doctor, pharmacist, or nurse. 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.: 22 49 21 301, fax: 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 Hascosept Mint Flavor

There are no special recommendations for the storage temperature of the medicine. Store in a blister pack in the original outer packaging to protect from light.
The medicine should be stored out of 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. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Hascosept Mint Flavor contains

• The active substance of the medicine is benzydamine hydrochloride. One hard tablet contains 3 mg of benzydamine hydrochloride.
• The other ingredients are: isomalt (E 953), acesulfame potassium (E 950), citric acid monohydrate, levomenthol, peppermint flavor, quinoline yellow (E 104), patent blue V (E 131).

What Hascosept Mint Flavor looks like and what the package contains

Hascosept Mint Flavor is a green, round, mint-flavored tablet.
PVC/PVDC/Al blisters in a cardboard box. One package of the medicine contains 8, 16, 24, or 32 tablets.

Marketing authorization holder and manufacturer

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Medicine information
tel.: 22 742 00 22
e-mail: [email protected]

Date of the last update of the package leaflet: