Supremin max

Package leaflet: Information for the user

Supremin MAX, 1.5 mg/ml, syrup
Butamirate citrate
Please read the entire leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by the
physician or pharmacist.

• Keep this leaflet for future reference.
• If advice or further information is needed, consult a pharmacist.
• If the patient experiences any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform a doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 7 days, or if the patient feels worse, consult a doctor.

Contents of the leaflet

1. What Supremin MAX is and what it is used for
2. Important information before taking Supremin MAX
3. How to use Supremin MAX
4. Possible side effects
5. How to store Supremin MAX
6. Contents of the package and other information

1. What Supremin MAX is and what it is used for

Supremin MAX contains the active substance butamirate citrate. It is a non-opioid antitussive agent.
Supremin MAX syrup is used for the symptomatic treatment of acute, dry cough.

2. Information before using Supremin MAX

When not to use Supremin MAX:

• if the patient is allergic to butamirate citrate or to any of the other ingredients of this medicine (listed in section 6).
• if the patient has symptoms of severe respiratory centre depression.
• during the first trimester of pregnancy (see section "Pregnancy and breastfeeding").

Warnings and precautions
Before starting to use Supremin MAX, consult your doctor or pharmacist.
Do not use this medicine for longer than 7 days without consulting a doctor.
Due to the cough-suppressant effect of butamirate citrate, concomitant use of expectorant medicines should be avoided (see section "Supremin MAX with other medicines").

Children and adolescents
Supremin MAX should not be used in children under 3 years of age.

Supremin MAX with other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
Concomitant use of expectorant medicines should be avoided, as this may lead to accumulation of secretions in the airways, increasing the risk of bronchospasm and respiratory tract infection.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Supremin MAX is contraindicated during the first trimester of pregnancy.

Driving and operating machinery
Supremin MAX may cause dizziness or drowsiness. Therefore, caution should be exercised when driving or operating machinery.

Supremin MAX contains sorbitol, glycerol, ethanol, sodium benzoate and sodium

Sorbitol
Supremin MAX contains 2.25 g of sorbitol in 5 ml of syrup.
Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or their child), or if hereditary fructose intolerance—a rare genetic disorder in which the patient's body cannot metabolize fructose—has been diagnosed, the patient should consult a doctor before taking the medicine or giving it to a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect. Calorific value: 2.6 kcal/g of sorbitol.

Glycerol
This medicine may cause headache, gastric disturbances and diarrhoea.

Ethanol
This medicine contains 7 mg of alcohol (ethanol) in 5 ml of syrup. The amount of alcohol in 5 ml of this medicine is equivalent to less than 0.2 ml of beer or 0.1 ml of wine. The maximum single dose used in adults (15 ml of syrup) contains 21 mg of ethanol, equivalent to 0.6 ml of beer or 0.3 ml of wine.
The small amount of alcohol in this medicine will not cause noticeable effects.

Sodium benzoate
The medicine contains 5 mg of sodium benzoate in 5 ml of syrup.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per 5 ml of syrup, meaning the medicine is considered "sodium-free".

3. How to use Supremin MAX

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
The medicine should be taken orally and not for longer than 7 days without consulting a doctor.
A measuring device is provided with the medicine package to help measure the correct amount of syrup. The dosing device should be washed and dried after each use.
Recommended dose:

• Children aged 3 to 6 years: 5 ml of syrup three times a day;
• Children aged 6 to 12 years: 10 ml of syrup three times a day;
• Adolescents over 12 years of age: 15 ml of syrup three times a day;
• Adults: 15 ml of syrup four times a day.

Supremin MAX should not be used in children under 3 years of age.
Use of a higher than recommended dose of Supremin MAX
If more medicine is taken than recommended, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhoea, dizziness, and low blood pressure.
If an overdose is taken, seek immediate medical advice.
Missed dose of Supremin MAX
Do not take a double dose to make up for a missed dose.
Stopping Supremin MAX treatment
If you have any further questions about the use of 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.
The following symptoms occur rarely (more frequently than in 1 out of 10,000, but less frequently than in 1 out of 1,000 patients taking the medicine): drowsiness, dizziness, nausea, diarrhoea, urticaria.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products 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 authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Supremin MAX

Keep this medicine out of sight and reach of children.
Store below 25 °C. Do not store in a refrigerator or freeze.
Do not use this medicine after the expiry date stated on the bottle after: Expiry (EXP). The expiry date refers to the last day of the stated month.
Shelf life after first opening: 2 years, but not beyond the expiry date indicated on the packaging.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the packaging and other information

What the medicine Supremin MAX contains

• The active substance is butamirate citrate. 1 ml of syrup contains 1.5 mg of butamirate citrate.
• The other ingredients (excipients) are: sodium benzoate (E 211), sorbitol liquid, non-crystallizing (E 420), glycerol, sodium saccharin (E 954), orange flavouring liquid (containing ethanol), citric acid monohydrate, sodium citrate, purified water.

What Supremin MAX looks like and contents of the pack
Supremin MAX is a clear syrup with an orange flavour and odour.
The packaging consists of a bottle made of brown polyethylene terephthalate (PET), closed with an aluminium cap with a polyethylene (PE) foam seal, containing 150 ml of syrup in a cardboard box. A dosing cup made of polypropylene (PP) with marked graduations is attached to the bottle.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva Pharmaceuticals Polska Sp. z o.o.
Emilii Plater 53 Street
00-113 Warsaw
Tel: (22) 345-93-00

Manufacturer
Polfarmex S.A
Józefów 9 Street
99-300 Kutno