Atussan

Package Leaflet: Information for the User

ATUSSAN, 1.5 mg/ml, syrup

Butamirate citrate

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

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this package 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 those not listed in this package leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Package Leaflet:

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

1. What is Atussan and what is it used for

Atussan contains the active substance butamirate citrate. It is a non-opioid cough medicine.

Indications:

• Symptomatic treatment of cough of various origins.

2. Important information before taking Atussan

When not to take Atussan:

Warnings and precautions

Before starting to take Atussan, the patient should discuss it with their doctor or pharmacist:

Atussan and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
They should avoid taking expectorant medicines(which increase the production of secretions) at the same time. This may cause secretions to accumulate in the airways. The risk of bronchospasm and respiratory tract infection will increase.

Atussan with food and drink

Atussan should be taken before a meal.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Atussan should be avoided in the first trimester of pregnancy. In the second and third trimesters, the medicine may be used if the doctor considers it absolutely necessary.
For safety reasons, butamirate citrate should not be used during breastfeeding.

Driving and using machines

Atussan may cause dizziness or drowsiness, so the patient should be cautious when driving or operating machinery.

Atussan contains sorbitol, glycerol, sodium benzoate, ethanol, and sodium

The medicine contains 450 mg of sorbitolper 1 ml of syrup. Sorbitol is a source of fructose. If the patient has been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, they should consult their doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. Energy value: 2.6 kcal/g of sorbitol.
Atussan also contains glycerol(0.25 g per 1 ml of syrup), which may cause headache, stomach upset, and diarrhea.
Atussan also contains sodium benzoate(E 211). The medicine contains 1 mg of benzoic acid salt per 1 ml of syrup.
Atussan contains small amounts of ethanolas part of the flavoring. This medicine contains 6.96 mg of alcohol (ethanol) per 5 ml of syrup. In the case of the maximum daily dose, the amount of alcohol is equivalent to:

• in children from 3 to 6 years - less than 1 ml of beer and less than 1 ml of wine,
• in children from 6 to 12 years - less than 2 ml of beer and less than 1 ml of wine,
• in adolescents over 12 years - less than 2 ml of beer and less than 1 ml of wine,
• in adults - less than 2 ml of beer and 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

This medicine contains less than 1 mmol (23 mg) of sodiumper 1 ml of syrup, which means the medicine is considered "sodium-free".

3. How to take Atussan

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist. Without consulting a doctor, Atussan should not be taken for more than 7 days.

Usual dose:

Children and adolescents
Adults
15 ml of syrup (22.5 mg of butamirate citrate) 4 times a day.

• Atussan should not be taken by children under 3 years of age.
• Atussan should be taken before a meal.

A measuring cup with a scale to facilitate dosing is attached to the packaging.

Overdose of Atussan

In case of taking a higher dose of the medicine than recommended, the patient should immediately inform their doctor or pharmacist.
The following overdose symptomsmay occur:

• drowsiness;
• vomiting, diarrhea, nausea;
• dizziness;
• hypotension.

Missed dose of Atussan

In case of missing a dose, the patient should take the dose as soon as possible and continue treatment as directed.
A double dose should not be taken to make up for a missed dose.

Stopping treatment with Atussan

In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Atussan can cause side effects, although not everybody gets them.
Rare side effects(more than 1 in 10,000 people and less than 1 in 1,000 people):

• drowsiness;
• nausea, diarrhea;
• hives.

Reporting side effects

If any side effects occur, including those not listed in the package leaflet, the patient should inform their doctor or pharmacist, or nurse. 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
Phone: 22 49-21-301,
Fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Atussan

The medicine should be stored out of sight and reach of children.
Store in a temperature below 25°C. Store in the original packaging.
Do not use this medicine after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Atussan contains

• The active substance of the medicine is butamirate citrate. 1 ml of syrup contains 1.5 mg of butamirate citrate.
• The other ingredients are: sodium benzoate (E 211), liquid, non-crystallizing sorbitol (E 420), glycerol (E 422), sodium saccharin, orange flavor liquid (contains, among others, ethanol), citric acid monohydrate, sodium citrate, purified water.

What Atussan looks like and contents of the pack

Atussan is a clear syrup with an orange flavor and smell.
A brown glass or polyethylene terephthalate (PET) bottle, closed with an aluminum or polyethylene (PE) cap, containing 100 ml or 150 ml or 200 ml of syrup, placed in a cardboard box. A measuring cup is attached to the packaging.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland (Poland)
Phone: (24) 357 44 44
Fax: (24) 357 45 45
e-mail: polfarmex@polfarmex.pl

Date of last revision of the package leaflet: