Uniben mint flavor

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 3 days or if your condition worsens, consult your doctor.

Contents of the leaflet

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

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

Uniben mint flavour contains the active substance benzydamine, which belongs to the group of indole-type non-steroidal anti-inflammatory drugs (NSAIDs) for local and general use.
Benzydamine has anti-inflammatory and analgesic properties and acts locally as an anaesthetic and antiseptic. The drug is well absorbed locally, achieving high concentrations in tissues affected by inflammation.
This is a pastille for sucking.
Uniben mint flavour is indicated for the treatment of discomfort and symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat in adults and children over 6 years of age.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before using Uniben mint flavour

When not to use Uniben mint flavour

• if the patient is allergic to benzidamine hydrochloride or any of the other ingredients of this medicine (listed in section 6),
• in patients with phenylketonuria, as the medicine contains aspartame, a source of phenylalanine.

Warnings and precautions
Before starting to use Uniben mint flavour, discuss this with your doctor or
pharmacist.

• Use of this medicine is not recommended if the patient is 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 bronchial asthma, as it may cause breathing difficulties.
• If symptoms of inflammation in the mouth, e.g. ulceration, do not begin to improve after 3 days of treatment, consult your doctor, as in some patients oral ulceration may be a sign of another, more serious disease.

Children and adolescents
Do not use in children under 6 years of age, as the medicine is in the form of hard pastilles and there is
a risk of choking.
In children aged 6 to 11 years, the medicine should be used under supervision of an adult.

Uniben mint flavour and other medicines
Tell your doctor or pharmacist if you are currently taking, have recently taken or plan to take any other medicines.
Interactions between Uniben mint flavour and other medicines have not been studied.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
Do not use Uniben mint flavour during pregnancy unless absolutely necessary and recommended by a doctor. If use is necessary, the lowest possible dose for the shortest possible duration should be used.
Uniben mint flavour should not be used during breastfeeding.

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

Uniben mint flavour contains isomalt (E 953), aspartame (E 951), quinoline yellow (E 104), d-limonene and citral
This medicine contains isomalt. If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.
This medicine contains 2.30 mg of aspartame in each hard pastille. Aspartame is a source of phenylalanine.
It may be harmful for patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
This medicine contains quinoline yellow, which may cause allergic reactions.
This medicine contains a flavouring containing d-limonene and citral. D-limonene and citral may cause allergic reactions.

3. How to use Uniben mint-flavoured lozenges

This medicine should always be used exactly as described in this patient information leaflet or as advised by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is
1 lozenge 3 times daily.
The lozenge should be sucked slowly. Do not swallow or chew. Do not exceed the recommended dose.
Continuous treatment should not exceed 7 days.
Use in children and adolescents
Do not use in children under 6 years of age, as the medicine is in the form of hard lozenges and there is a risk of choking.
In children aged 6 to 11 years, the medicine should be used under the supervision of an adult.
If you feel that the effect of the medicine is too strong or too weak, consult your doctor.
Taking more Uniben mint-flavoured lozenges than recommended
If too many lozenges are accidentally taken, contact a doctor immediately and bring the medicine packaging with you. The doctor will initiate appropriate management.
Very rarely, symptoms of overdose (agitation, convulsions, sweating, incontinence, tremor, vomiting) have been reported in children after ingestion of medicines containing benzidamine in doses approximately one hundred times higher than the dose contained in a single lozenge.
Missing a dose of Uniben mint-flavoured lozenges
Do not take a double dose to make up for a missed dose.
If it is almost time for the next dose according to the dosing schedule, do not take the missed dose.
If you have any further doubts about using 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 (may affect less than 1 in 100 people):
skin reactions due to photosensitivity.
Rare adverse reactions (may affect less than 1 in 1,000 people): burning or dryness in the mouth. If these symptoms occur, they may be relieved by slowly drinking a glass of water in small sips.
Very rare adverse reactions (may affect less 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 of the skin or raised skin rash (hives), 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 for Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Uniben smak miętowy

Keep the medicine out of the sight and reach of children.
Store below 25°C in the original packaging.
Do not use this medicine after the expiry date stated on the packaging. 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 package and other information

What Uniben mint flavour medicine contains

• The active substance is benzidamine hydrochloride. Each hard pastille contains 3 mg of benzidamine hydrochloride, equivalent to 2.68 mg of benzidamine.
• The other ingredients are: isomalt (E 953), levomenthol, aspartame (E 951), citric acid monohydrate (E 330), natural lemon flavour (WONF) (containing, among others, d-limonene and citral), peppermint essential oil with reduced menthol content, eucalyptus essential oil, quinoline yellow (E 104), indigo carmine (E 132).

What Uniben mint flavour medicine looks like and contents of the pack
The medicine is in the form of green, round hard pastilles approximately 18 mm in diameter,
approximately 8 mm thick, with a mint flavour.
The pastilles are packed in blisters made of colourless polyvinyl chloride film with polyvinylidene chloride and aluminium foil (PVC/PVDC/Al).
Each pack contains 10 pastilles (1 blister), 20 pastilles (2 blisters), or 30 pastilles (3 blisters), together with the patient information leaflet, in a cardboard box. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Zakłady Farmaceutyczne „UNIA” Spółdzielnia Pracy
ul. Chłodna 56/60
00-872 Warsaw
tel.: 22 620 90 81 ext. 190
fax: 22 654 92 40
e-mail: [email protected]
Manufacturer
Przedsiębiorstwo Produkcyjno-Handlowe „EWA” S.A.
ul. Zamkowy Folwark 9
63-700 Krotoszyn
The patient information leaflet for Uniben mint flavour is available in the Audio Leaflet system via the national, toll-free telephone number: 800 706 848.