SUPREMIN

Patient Information Leaflet

SUPREMIN
4 mg/5 ml, syrup
Butamirati citras
Please read the following carefully before using this medicine, as it contains important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by a physician or pharmacist.

• Keep this leaflet for future reference.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If your symptoms do not improve or worsen, contact your doctor.

Table of contents:

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

1. What Supremin is and what it is used for

Supremin syrup contains butamirate citrate as the active substance, a non-opioid antitussive agent. It reduces the frequency and intensity of cough by suppressing the cough reflex. In addition to its antitussive effect, butamirate produces slight bronchodilation.
Indications: treatment of acute, dry cough.

2. Important information before using Supremin

When not to use Supremin:

• if the patient is allergic to butamirate or any of the other ingredients of this medicine (listed in section 6),
• in patients with phenylketonuria.

Warnings and precautions
Supremin is not indicated for use in patients with symptoms of severe respiratory centre depression.
This medicine should not be used for longer than a few days.

Supremin with other medicines
Interactions between Supremin and other medicines are not known.

Supremin with food and drink
The medicine should be taken before meals.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Use of this medicine is not recommended during the first trimester of pregnancy.
During the second and third trimesters of pregnancy and during breastfeeding, the medicine should be used only if clearly necessary.

Driving and operating machinery
Caution is advised, as in rare cases, reduced ability to drive or operate machinery may occur.

The medicine contains aspartame, benzoic acid, methyl parahydroxybenzoate, liquid maltitol, propylene glycol, ethanol, benzyl alcohol (components of the caramel-orange flavour), and sodium.

Aspartame
The medicine contains 12.5 mg of aspartame in 5 ml of syrup. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion. See also section "When not to use Supremin".

Benzoic acid
The medicine contains 7.5 mg of benzoic acid in 5 ml of syrup.

Methyl parahydroxybenzoate
The medicine may cause allergic reactions (including delayed-type reactions).

Liquid maltitol
If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine. The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.

Propylene glycol
The medicine contains 9.2 mg of propylene glycol per 5 ml of syrup.

Ethanol
This medicine contains 6.2 mg of alcohol (ethanol) in 5 ml of syrup, equivalent to 0.16% v/v. The amount of alcohol in 5 ml of this medicine is equivalent to less than 0.2 ml of beer or 0.06 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.

Benzyl alcohol
The medicine contains 0.08 mg of benzyl alcohol per 5 ml of syrup.
Benzyl alcohol may cause allergic reactions.
Do not administer to young children (under 3 years of age) for longer than one week without medical or pharmacist advice.
Pregnant or breastfeeding women and patients with liver or kidney disease should consult a doctor before using this medicine, as larger amounts of benzyl alcohol may accumulate in their bodies and cause adverse effects (so-called metabolic acidosis).

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

This medicine should always be taken exactly as described in the patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Oral administration.
The medicine should be taken before meals.
A measuring spoon, capable of measuring 5 ml of syrup, is supplied with the medicine package.
Unless otherwise directed by a doctor, the usual dosage is as follows:

• children aged 2 to 6 years: 1 measuring spoon (4 mg) 3 times daily
• children aged 6 to 12 years: 2 measuring spoons (8 mg) 3 times daily
• children over 12 years: 3 measuring spoons (12 mg) 3 times daily
• adults: 3 measuring spoons (12 mg) 4 times daily

If the effect of the medicine appears too strong or too weak, consult a doctor.
Taking more medicine than recommended (Supremin overdose)
Symptoms of butamirate overdose include: drowsiness, vomiting, abdominal pain, diarrhoea, ataxia (impaired motor coordination), agitation, and low blood pressure. In case of overdose, seek immediate medical advice. The doctor may perform gastric lavage and administer activated charcoal and laxatives.
Missing a dose of Supremin
Take the missed dose as soon as remembered. If it is almost time for the next dose, take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
Adverse effects occur uncommonly (less frequently than in 1 in 100 people):
rash, nausea, diarrhoea, dizziness.
These symptoms usually resolve during treatment and rarely require dose reduction.
If the described allergic reactions or gastrointestinal disturbances do not resolve after dose reduction,
treatment with Supremin should be discontinued.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed
in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported
directly to the Department of Monitoring Adverse Drug Reactions of 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store the medicine Supremin

Keep the medicine out of sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the carton and bottle after: Expiry
date. The expiry date refers to the last day of the stated month.
Expiry date after first opening: 28 days.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Supremin contains

• The active substance is butamirate citrate. 5 ml (1 measuring spoon) of syrup contains 4 mg of butamirate citrate.
• The other ingredients are: methyl parahydroxybenzoate, benzoic acid, anhydrous citric acid, sodium citrate, liquid maltitol, aspartame, caramel-orange flavour (E 34493) (containing, among others, propylene glycol, ethanol, benzyl alcohol), purified water.

What Supremin looks like and contents of the pack
Syrop in a brown glass bottle with an aluminium cap or a polypropylene cap together with a measuring spoon made of polystyrene, in a cardboard box or in a brown glass bottle closed with a polyethylene cap made of HDPE (high-density polyethylene) and a tamper-evident ring made of PE (polyethylene), together with a measuring spoon made of polystyrene, in a cardboard box.
Bottle containing 200 ml of syrup in a cardboard box also containing a 5 ml measuring spoon.

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

Manufacturer:
Balkanpharma Troyan AD
1, Krayrechna Str.
5600 Troyan
Bulgaria