Hascosept mint flavor

Package leaflet: Information for the user

Hascosept mint flavour
3 mg, hard lozenges
Benzydamini hydrochloridum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor, pharmacist, or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
• If there is no improvement after 3 days, or if you feel worse, you should contact your doctor.

Leaflet contents

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

1. What Hascosept mint flavour is and what it is used for

Hascosept mint flavour contains the active substance benzydamine, which belongs to the group of indole-type non-steroidal anti-inflammatory drugs (NSAIDs) for topical and general use.
Benzydamine has anti-inflammatory and analgesic properties and acts locally as a local anesthetic and antiseptic. When administered topically, the drug is well absorbed, achieving high concentrations in tissues affected by inflammation. Hascosept mint flavour is intended for the local treatment of symptoms of inflammation in the mouth and throat. Hascosept mint flavour is generally well tolerated.
Hascosept mint flavour is used to treat discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat. The medicine is intended to be sucked.
If there is no improvement after 3 days, or if you feel worse, you should consult your doctor.

2. Important information before taking Hascosept mint flavour

When not to take Hascosept mint flavour
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 treatment with Hascosept mint flavour, consult a doctor or pharmacist.
The use of this medicine is not recommended in patients who are allergic to acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine should be used with caution in patients who have experienced bronchial asthma, as it may cause breathing difficulties.
In some patients, ulceration of the mouth and throat may be a symptom of another serious underlying disease. If symptoms worsen or do not improve after 3 days of treatment, medical advice should be sought.

Children
Due to the pharmaceutical form, Hascosept mint flavour should not be used in children under 6 years of age.

Hascosept mint flavour and other medicines
Inform your doctor or pharmacist about any other medicines the patient is currently taking, has recently taken, or plans to take.
Interactions between Hascosept mint flavour and other medicines have not been studied.

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 mint flavour should not be used during pregnancy unless absolutely necessary and prescribed by a doctor. If use is required, the lowest possible dose should be administered for the shortest possible duration.
Hascosept mint flavour should not be used during breastfeeding.

Driving and operating machinery
Local application of benzydamine at recommended doses does not affect the ability to drive or operate machinery.

Hascosept mint flavour contains isomalt
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to take Hascosept mint flavour

This medicine should always be taken exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Adults and children over 6 years of age
The recommended dose is one lozenge three times a day.
The lozenge should be sucked slowly. Do not chew or swallow.
Do not exceed the recommended dose. Continuous treatment should not exceed 7 days.
Use in children
Due to the pharmaceutical form, Hascosept mint flavour should not be used in children under 6 years of age. In children aged 6 to 11 years, the medicine should be used under the supervision of an adult.
Accidental overdose of Hascosept mint flavour
If too many lozenges have been taken by mistake, seek medical advice immediately, taking the medicine pack with you. The doctor will initiate appropriate management.
Very rarely, symptoms of overdose (agitation, seizures, sweating, restlessness, tremor, vomiting) have been reported in children after ingestion of medicines containing benzydamine in doses approximately one hundred times higher than the dose contained in a single lozenge.
Missed dose of Hascosept mint flavour
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning 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.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data) are allergic reactions, which may be severe.
You should immediately inform your doctor if any of the following symptoms occur:

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

Uncommon adverse reactions (occurring in fewer than 1 in 100 people): skin reactions due to photosensitivity.
Rare adverse reactions (occurring in fewer than 1 in 1,000 people): burning or dryness in the mouth. If these symptoms occur, they may be reduced by drinking a glass of water slowly, in small sips.
Very rare adverse reactions (occurring in fewer than 1 in 10,000 people): laryngospasm.
Adverse reactions with unknown frequency (frequency cannot be estimated from the available data):

• premature closure of the ductus arteriosus in the fetus,
• allergic reaction (hypersensitivity),
• severe allergic reaction (anaphylactic shock) with symptoms such as: difficulty breathing, pain or tightness in the chest and (or) dizziness/fainting, intense itching or raised rash on the skin, swelling of the face, lips, tongue and (or) throat; such a reaction may be life-threatening,
• oral hypoaesthesia (localised loss of sensation in the oral mucosa).

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Hascosept mint flavour

There are no special storage temperature requirements for this medicine. Store in the blister
pack within the original outer packaging to protect from light.
Keep the medicine 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 stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect
the environment.

6. Contents of the packaging and other information

What Hascosept mint flavour contains

• The active substance is benzidamine hydrochloride. One hard pastille contains 3 mg of benzidamine hydrochloride.
• Other ingredients: isomalt (E 953), potassium acesulfame (E 950), citric acid monohydrate, levomenthol, mint flavour, quinoline yellow (E 104), patent blue V (E 131).

What Hascosept mint flavour looks like and contents of the pack
Hascosept mint flavour is a green, round pastille with a mint flavour.
Supplied in blisters made of PVC/PVDC/Al in a cardboard carton. One pack contains 8, 16, 24 or 32 pastilles.
Marketing Authorisation Holder and Manufacturer
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
ul. Żmigrodzka 242 E, 51-131 Wrocław
Medicinal product information
tel.: 22 742 00 22
e-mail: [email protected]