Supremin Max

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

Supremin MAX, 1.5 mg/ml, syrup

Butamirate citrate

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

This medicine should always be taken exactly as described in the 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 possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If after 5 to 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Supremin MAX and what is it used for
• 2. Important information before taking Supremin MAX
• 3. How to take Supremin MAX
• 4. Possible side effects
• 5. How to store Supremin MAX
• 6. Package contents and other information

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

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

2. Important information before taking Supremin MAX

When not to take Supremin MAX:

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

Warnings and precautions

Before starting Supremin MAX, the patient should discuss it with their doctor or pharmacist.
The medicine should not be taken for longer than 7 days without consulting a doctor.
Due to the suppression of the cough reflex by butamirate citrate, the patient should avoid taking expectorant medicines at the same time (see "Supremin MAX and other medicines").

Children and adolescents

Supremin MAX should not be taken by children under 3 years of age.

Supremin MAX and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
The patient should avoid taking expectorant medicines at the same time, as this may lead to a buildup of secretions in the airways, increasing the risk of bronchospasm and respiratory infection.

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.
Supremin MAX is contraindicated in the first trimester of pregnancy.

Driving and using machines

Supremin MAX may cause dizziness or drowsiness. Therefore, the patient should be cautious while 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 the patient has previously been diagnosed with intolerance to some sugars or has been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the patient's body does not break down fructose, 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 sorbitol.
Glycerol
The medicine may cause headache, stomach upset, and diarrhea.
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, which is equivalent to 0.6 ml of beer or 0.3 ml of wine.
A small amount of alcohol in this medicine will not have 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, which means the medicine is considered "sodium-free".

3. How to take Supremin MAX

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, the patient should consult their doctor or pharmacist.
The medicine should be taken orally, not for longer than 7 days without consulting a doctor.
A measuring cup is attached to the packaging, allowing the patient to measure the correct amount of syrup. The measuring cup should be washed and dried after each use.

Recommended dose:

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

Supremin MAX should not be taken by children under 3 years of age.

Taking a higher dose of Supremin MAX than recommended

In case of taking a higher dose of the medicine than recommended, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhea, dizziness, and decreased blood pressure.
In case of taking a higher dose of the medicine than recommended, the patient should immediately consult their doctor.

Missing a dose of Supremin MAX

The patient should not take a double dose to make up for a missed dose.

Stopping Supremin MAX

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Supremin MAX can cause side effects, although not everybody gets them.
Rarely (more often than 1 in 10,000, but less often than 1 in 1,000 patients taking the medicine), the following symptoms occur: drowsiness, dizziness, nausea, diarrhea, hives.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor or pharmacist. 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: +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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Supremin MAX

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

6. Package contents and other information

What Supremin MAX contains

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

What Supremin MAX looks like and what the package contains

Supremin MAX is a clear, orange-flavored and orange-scented syrup.
The packaging of the medicine is a brown polyethylene terephthalate (PET) bottle, closed with an aluminum cap with a foam polyethylene (PE) seal, containing 150 ml of syrup in a cardboard box. A measuring cup made of polypropylene (PP) with a marked scale is attached to the bottle.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53
00-113 Warsaw
Phone: (22) 345-93-00

Manufacturer

Polfarmex S.A
ul. Józefów 9
99-300 Kutno

Date of last update of the leaflet: