Uniben smak citrinovi

Package Leaflet: Information for the User

Uniben Lemon Flavor

3 mg, Hard Tablets

Benzydamine Hydrochloride

Read the 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 patient leaflet or as directed by a doctor or pharmacist.

• Keep this 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 not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 3 days there is no improvement or the patient feels worse, they should contact a doctor.

Table of Contents of the Leaflet

• 1. What is Uniben Lemon Flavor and what is it used for
• 2. Important information before using Uniben Lemon Flavor
• 3. How to use Uniben Lemon Flavor
• 4. Possible side effects
• 5. How to store Uniben Lemon Flavor
• 6. Contents of the pack and other information

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

Uniben Lemon 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, local anesthetic, and antiseptic properties. The medicine is well absorbed locally, achieving high concentrations in inflamed tissues. Suck the tablet. Do not swallow or chew. Do not exceed the recommended dose. Continuous treatment should not exceed 7 days.

2. Important information before using Uniben Lemon Flavor

When not to use Uniben Lemon 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, a source of phenylalanine.

Warnings and precautions

Before starting to use Uniben Lemon Flavor, discuss it with a doctor or pharmacist.

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

Children and adolescents

Do not use in children under 6 years of age, as the medicine 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 Lemon Flavor and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. The interaction of Uniben Lemon 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 baby, they should consult a doctor or pharmacist before using this medicine. Uniben Lemon Flavor should not be used during pregnancy or breastfeeding.

Driving and using machines

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

Uniben Lemon 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, they should consult a doctor before taking the medicine. The medicine contains 2.10 mg of aspartame in each hard tablet. Aspartame is a source of phenylalanine and may be harmful to patients with phenylketonuria. The medicine contains quinoline yellow, which can cause allergic reactions. The medicine contains the flavoring substance with d-limonene and citral. D-limonene and citral can cause allergic reactions.

3. How to use Uniben Lemon Flavor

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist. The recommended dose is 1 tablet 3 times a day. Suck the tablet 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 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, they should consult a doctor.

Using a higher than recommended dose of Uniben Lemon Flavor

In case of accidental ingestion of too many tablets, the patient should immediately contact a doctor, taking the packaging of the medicine with them. The doctor will initiate appropriate treatment. Very rarely, symptoms of overdose (excitement, convulsions, sweating, clumsiness, trembling, 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 Uniben Lemon Flavor

Do not take a double dose to make up for a missed dose. If it is time for the next dose, do not take the missed dose. If the patient has any further doubts about using this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Uniben Lemon 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 (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 slowly drinking a glass of water 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,
• oral numbness (local loss of sensitivity of the oral mucosa).

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Post-Marketing Surveillance 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, phone: +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, you can help provide more information on the safety of this medicine.

5. How to store Uniben Lemon Flavor

Keep the medicine out of the sight and reach of children. Store in a temperature 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 month stated. Medicines should not be disposed of via wastewater or household waste. Ask a pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Uniben Lemon 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), lime oil, peppermint oil with reduced menthol content, quinoline yellow (E 104), indigo carmine (E 132).

What Uniben Lemon Flavor looks like and contents of the pack

The medicine is in the form of round, yellow, hard tablets with a diameter of about 18 mm, a thickness of about 8 mm, and a lemon flavor. The tablets are packaged in blisters made of colorless polyvinyl chloride film with diofan and aluminum foil (PVC/PVDC/Al). One pack contains 10 tablets (1 blister), 20 tablets (2 blisters), or 30 tablets (3 blisters) along with the patient information 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, phone: 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 Lemon Flavor leaflet is available in the Ulotka Audio system under the national, free phone number: 800 706 848.

Date of last revision of the leaflet: