Uniben smak miemtovi

Package Leaflet: Information for the User

Uniben Mint Flavor

3 mg, Hard Tablets

Benzydamine Hydrochloride

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

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist.

• This package leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including those not listed in this package leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

Table of Contents of the Package Leaflet

• 1. What is Uniben Mint Flavor and what is it used for
• 2. Important information before using Uniben Mint Flavor
• 3. How to use Uniben Mint Flavor
• 4. Possible side effects
• 5. How to store Uniben Mint Flavor
• 6. Package contents and other information

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

Uniben Mint Flavor contains the active substance benzydamine, which belongs to the indole, non-steroidal anti-inflammatory drugs (NSAIDs) for topical and systemic use. Benzydamine has anti-inflammatory, analgesic, and local anesthetic and antiseptic effects. The medicine is well absorbed locally, reaching high concentrations in inflamed tissues. It is a lozenge. The medicine is used to treat symptoms (pain, redness, swelling) associated with inflammatory conditions of the mouth and throat in adults and children over 6 years old. If there is no improvement or the patient feels worse after 3 days, a doctor should be consulted.

2. Important information before using Uniben Mint Flavor

When not to use Uniben Mint Flavor

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

Warnings and precautions

Before starting to use Uniben Mint Flavor, the doctor or pharmacist should be consulted.

• The medicine is not recommended for use in 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.
• If the symptoms of inflammation in the mouth, such as ulcers, do not start to improve after 3 days of using the medicine, a doctor should be consulted, as in some patients, mouth ulcers may be a sign of a more serious underlying condition.

Children and adolescents

The medicine should not be used in children under 6 years old, as it is in the form of hard tablets and there is a risk of choking. In children between 6 and 11 years old, the medicine should be used under adult supervision.

Uniben Mint Flavor and other medicines

The doctor or pharmacist should be informed about all medicines that the patient is currently using or has recently used, as well as any medicines that the patient plans to use. The interaction between Uniben Mint Flavor and other medicines has not been studied.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine. Uniben Mint Flavor should not be used during pregnancy or breastfeeding.

Driving and using machines

Local use of benzydamine in the recommended doses does not affect the ability to drive vehicles or operate machinery.

Uniben Mint Flavor contains isomalt (E 953), aspartame (E 951), quinoline yellow (E 104), d-limonene, and citral

The medicine contains isomalt. If the patient has previously been diagnosed with intolerance to some sugars, the patient should consult a doctor before taking the medicine. The medicine contains 2.30 mg of aspartame in each hard tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. The medicine contains quinoline yellow, which may cause allergic reactions. The medicine contains a flavoring substance with d-limonene and citral. D-limonene and citral may cause allergic reactions.

3. How to use Uniben Mint Flavor

This medicine should always be used exactly as described in this package leaflet for the patient or as directed by a doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted. The recommended dose is 1 tablet 3 times a day. The tablet should be sucked slowly. Do not swallow or chew. Do not use a higher dose than recommended. Continuous treatment should not exceed 7 days.

Use in children and adolescents

The medicine should not be used in children under 6 years old, as it is in the form of hard tablets and there is a risk of choking. In children between 6 and 11 years old, the medicine should be used under adult supervision. If the patient feels that the effect of the medicine is too strong or too weak, a doctor should be consulted.

Using a higher dose of Uniben Mint Flavor than recommended

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

Missing a dose of Uniben Mint Flavor

A double dose should not be used to make up for a missed dose. If it is time for the next dose according to the dosing schedule, the missed dose should not be taken. In case of any further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Uniben 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 doctor should be informed immediately 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.

Uncommonside effects (may affect up to 1 in 100 people): skin reactions due to hypersensitivity to light. Rareside effects (may affect up to 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 (may affect up to 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) 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,
• numbness of the mouth (local loss of sensitivity of the oral mucosa).

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, the doctor, pharmacist, or nurse should be informed. 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.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Uniben Mint Flavor

The medicine should be stored out of sight and reach of children. Store in a temperature below 25°C, in the original package. This medicine should not be used after the expiry date stated on the package. The expiry date refers to the last day of the month stated. Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Package contents and other information

What Uniben Mint Flavor contains

• The active substance of the medicine is benzydamine hydrochloride. One hard tablet contains 3 mg of benzydamine hydrochloride, which corresponds to 2.68 mg of benzydamine.
• The other ingredients are: isomalt (E 953), levomenthol, aspartame (E 951), citric acid monohydrate (E 330), natural lemon flavor (WONF) (contains, among others, d-limonene and citral), peppermint oil with reduced menthol content, eucalyptus oil, quinoline yellow (E 104), indigo carmine (E 132).

What Uniben Mint Flavor looks like and what the package contains

The medicine is in the form of round, green, mint-flavored hard tablets with a diameter of about 18 mm and a thickness of about 8 mm. The tablets are packaged in blisters made of colorless polyvinyl chloride film with a diofan and aluminum foil (PVC/PVDC/Al). One package contains 10 tablets (1 blister), 20 tablets (2 blisters), or 30 tablets (3 blisters) along with the package leaflet in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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 content of the Uniben Mint Flavor package leaflet is available in the Ulotka Audio system under the national, free phone number: 800 706 848.

Date of the last update of the package leaflet: