UNIBEN 1.5 mg/ml Aerosol

Contents of the leaflet

1. Package Leaflet: Information for the User
2. UNIBEN
3. 5 mg/ml, oral spray
   1. Read all of this leaflet carefully before using this medicine because it contains important information for you.
   2. Table of Contents
4. What is Uniben and what is it used for
   1. Indications for Use
5. Important information before you use Uniben
   1. When not to use Uniben
   2. Warnings and Precautions
   3. Uniben and other medicines
   4. Pregnancy and Breastfeeding
   5. Driving and using machines
6. How to use Uniben
   1. Children under 6 years:
   2. Children from 6 to 12 years:
   3. Adolescents over 12 years and adults:
   4. Instructions for use:
   5. Overdose
   6. Missed dose
7. Possible side effects
   1. Reporting side effects
8. How to store Uniben
9. Contents of the pack and other information
   1. What Uniben contains
   2. What Uniben looks like and contents of the pack
   3. Marketing Authorisation Holder and Manufacturer
   4. Date of last revision of the leaflet

Package Leaflet: Information for the User

UNIBEN

1.5 mg/ml, oral spray

Benzydamine hydrochloride

Read all of this leaflet carefully before using this medicine because it contains important information for you.

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents

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

1. What is Uniben and what is it used for

Uniben contains the active substance benzydamine hydrochloride, which belongs to a group of non-steroidal anti-inflammatory drugs (NSAIDs). It has local anti-inflammatory, analgesic, anaesthetic, and antiseptic effects.

Indications for Use

Treatment of local symptoms associated with acute inflammatory conditions of the mouth and throat.

2. Important information before you use Uniben

When not to use Uniben

Warnings and Precautions

Long-term use of this medicine, especially if prolonged, may cause an allergic reaction. If there is no improvement after short-term use, you should consult your doctor.

Uniben and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, and about any medicines you plan to take.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and using machines

No effects on the ability to drive and use machines have been observed.

Uniben contains methyl parahydroxybenzoate (E 218), ethanol, benzyl alcohol, citral, citronellol, eugenol, geraniol, d-limonene, and linalol, and sodium

This medicine contains methyl parahydroxybenzoate and may cause allergic reactions.

This medicine contains 8.5 mg of ethanol (alcohol) in a single dose, which is equivalent to 50 mg/ml. The amount of alcohol in a single dose of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.

A small amount of alcohol in this medicine will not have noticeable effects.

This medicine contains a fragrant substance with benzyl alcohol, citral, citronellol, eugenol, geraniol, d-limonene, and linalol, which may cause allergic reactions.

This medicine contains 0.153 nanograms of benzyl alcohol in each dose, which is equivalent to 0.17 ml of the medicine. Benzyl alcohol may cause allergic reactions.

This medicine may cause mild local irritation.

This medicine contains less than 1 mmol (23 mg) of sodium per 0.17 ml dose, which is equivalent to one dose, and is therefore considered 'sodium-free'.

3. How to use Uniben

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

Children under 6 years:

1 dose of the medicine per 4 kg of body weight, used 2 to 6 times a day.

Children from 6 to 12 years:

4 doses of the medicine at a time, used 2 to 6 times a day.

Adolescents over 12 years and adults:

4 to 8 doses of the medicine at a time, used 2 to 6 times a day.

Warning:Uniben should not be used for more than 7 days, and any extension of use should be decided by your doctor.

Instructions for use:

When using the medicine for the first time, press the pump several times to fill the dosing chamber and achieve the correct spray.

• 1. Turn the tip of the dosing chamber to the position as shown in Fig. 1.
• 2. Direct the tip of the dosing chamber into the mouth - as shown in Fig. 2.
• 3. Press the dosing chamber firmly with your thumb or index finger. Repeat this action the appropriate number of times, according to the recommended dosage.

If you feel that the effect of the medicine is too strong or too weak, you should consult your doctor.

Overdose

There are no known cases of overdose with Uniben used locally.

Missed dose

If you miss a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These symptoms usually resolve on their own after discontinuation of the medicine.

Reporting side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

5. How to store Uniben

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original package.

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.

Uniben can be used for 6 months after the date of first opening, without exceeding the expiry date stated on the packaging.

In this window, you should write the date of first opening of the medicine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Uniben contains

The active substance is benzydamine hydrochloride (1 ml of the medicine contains 1.5 mg of benzydamine hydrochloride).

What Uniben looks like and contents of the pack

Uniben is an oral spray in a polyethylene bottle with a dosing pump and applicator, containing 30 ml of the medicine, in a cardboard box.

Marketing Authorisation Holder and Manufacturer

Zakłady Farmaceutyczne "UNIA" Spółdzielnia Pracy

ul. Chłodna 56/60

00-872 Warszawa

tel.: 22 620 90 81 wew. 190

faks: 22 654 92 40

e-mail: [email protected]

Date of last revision of the leaflet