Hascosept lemon-honey flavour

Package leaflet: Information for the patient

Hascosept lemon-honey flavour
3 mg, hard pastilles
Benzydamini hydrochloridum
Please read this leaflet carefully before using this 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
a doctor, pharmacist, or nurse.

• Keep this leaflet so that you can read it again if necessary.
• 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 your condition worsens, consult a doctor.

Table of contents

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

1. What Hascosept lemon-honey flavour is and what it is used for

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

2. Important information before taking Hascosept lemon-honey flavour

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

Children
Due to its pharmaceutical form, Hascosept lemon-honey flavour should not be used in children under 6 years of age.

Hascosept lemon-honey flavour and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Interactions between Hascosept lemon-honey 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 have a baby, she should consult a doctor or pharmacist before using this medicine.
Hascosept lemon-honey flavour should not be used during pregnancy unless absolutely necessary and prescribed by a doctor. If use is necessary, the lowest possible dose should be used for the shortest possible duration.
Hascosept lemon-honey flavour should not be used during breastfeeding.

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

Hascosept lemon-honey 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 lemon-honey 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 daily.
The lozenge should be sucked slowly. Do not chew or swallow.
Do not exceed the recommended dose. Treatment should not last longer than 7 days.
Use in children
Due to the pharmaceutical form, Hascosept lemon-honey 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 adult supervision.
Accidental overdose of Hascosept lemon-honey flavour
If too many lozenges have been taken by accident, seek medical advice immediately, taking the medicine package with you. The doctor will initiate appropriate management.
Very rarely, symptoms of overdose (excitement, convulsions, sweating, incontinence, 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 lemon-honey flavour
Do not take 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Allergic reactions, which may be severe, are side effects with unknown frequency (frequency cannot be
estimated from available data).
You should immediately contact your doctor if you 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.

Uncommon side effects (occurring in less than 1 in 100 people): skin reactions due to hypersensitivity to light.
Rare side effects (occurring in less than 1 in 1,000 people): burning or dryness in the mouth. If these symptoms occur, they may be reduced by slowly drinking a glass of water in small sips.
Very rare side effects (occurring in less than 1 in 10,000 people): laryngospasm.
Side effects with unknown frequency (frequency cannot be estimated from 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, severe skin itching or raised lumps on the skin, swelling of the face, lips, tongue and (or) throat; such a reaction may be life-threatening,
• oral hypoaesthesia (localised loss of sensitivity of the oral mucosa).

Reporting of side effects
If any side effects occur, including any unlisted side effects not mentioned in this leaflet, inform your doctor, pharmacist or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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 authorisation holder.
Reporting side effects helps to provide more information on the safety of the medicine.

5. How to store Hascosept lemon-honey flavour

No special storage temperature requirements apply. Store in the blister pack inside the original outer packaging, to protect from light.
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. Such measures help protect the environment.

6. Contents of the packaging and other information

What Hascosept lemon-honey flavour contains

• The active substance is benzidamine hydrochloride. Each hard pastille contains 3 mg of benzidamine hydrochloride.
• The other ingredients are: isomalt (E 953), acesulfame potassium (E 950), citric acid monohydrate, levomenthol, lemon flavour, honey flavour, quinoline yellow (E 104).

What Hascosept lemon-honey flavour looks like and contents of the pack
Hascosept lemon-honey flavour is a yellow, round pastille with a lemon-honey taste.
Blister packs made of PVC/PVDC/Al in a cardboard box. One package 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]