Supremin

Package Leaflet: Information for the User

SUPREMIN

4 mg/5 ml, syrup

Butamirate citrate

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

This medicine should always be taken exactly as described in the package 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 there is no improvement or the patient feels worse, they should contact their doctor.

Table of Contents of the Leaflet:

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

Supremin syrup contains butamirate citrate as the active substance, which is a non-opioid cough medicine. It reduces the frequency and intensity of coughing by inhibiting the cough reflex. In addition to its anti-cough effect, butamirate slightly dilates the bronchi. Indications for use: acute, dry cough.

2. Important information before taking Supremin

When not to take 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 depression. The medicine should not be used for more than a few days.

Supremin and other medicines

No interactions with other medicines are known for Supremin.

Supremin with food and drink

The medicine should be taken before meals.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before taking this medicine. It is not recommended to use this medicine in the first trimester of pregnancy. In the second and third trimesters of pregnancy and during breastfeeding, the medicine may be used only if necessary.

Driving and using machines

Care should be taken as butamirate may cause drowsiness and affect the ability to drive or operate machinery.

The medicine contains aspartame, benzoic acid, methyl parahydroxybenzoate, liquid maltitol, propylene glycol, ethanol, benzyl alcohol (ingredients of the caramel-orange flavor) 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 its improper elimination. See also the section "When not to take 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 (possible late reactions).

Liquid maltitol

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine. The medicine may have a mild laxative effect. Caloric value: 2.3 kcal/g of maltitol.

Propylene glycol

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

Etanol

This medicine contains 6.2 mg of alcohol (ethanol) in 5 ml of syrup, which is 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 have 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 give to small children (under 3 years) for more than a week without consulting a doctor or pharmacist. Pregnant or breastfeeding women and patients with liver or kidney disease should consult their doctor before taking the medicine, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (metabolic acidosis).

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

This medicine should always be taken exactly as described in the package 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 is provided with the medicine packaging to measure 5 ml of syrup. If the doctor does not recommend special dosing, the medicine is usually taken:

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

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

Overdose of Supremin

Symptoms of butamirate overdose are: drowsiness, vomiting, abdominal pain, diarrhea, ataxia (coordination disorders), excitement, and decreased blood pressure. In case of overdose, seek medical attention immediately, as the doctor may perform gastric lavage, administer activated charcoal, and laxatives.

Missed dose of Supremin

Take the medicine as soon as you remember. If it is almost time for the next dose, take it at the scheduled time. Do not take a double dose to make up for the missed dose. If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Supremin can cause side effects, although not everybody gets them. Uncommon side effects (less than 1 in 100 people): rash, nausea, diarrhea, dizziness. These symptoms usually resolve during treatment and rarely require a dose reduction. If the described allergic reactions or gastrointestinal disorders do not resolve after reducing the dose, discontinue use of Supremin.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, inform your 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, Tel.: +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. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Supremin

Keep the medicine out of the sight and reach of children. Store in a temperature 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 month stated. Shelf life after first opening: 28 days. Medicines should 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 flavor (E 34493) (contains propylene glycol, ethanol, benzyl alcohol), purified water.

What Supremin looks like and contents of the pack

Syrup in a brown glass bottle with an aluminum or polypropylene cap and a measuring spoon made of polystyrene, in a cardboard box or a brown glass bottle closed with a polyethylene cap with HDPE (high-density polyethylene) and a guarantee ring made of PE (polyethylene), with a measuring spoon made of polystyrene, in a cardboard box. Bottle containing 200 ml of syrup in a cardboard box also containing a measuring spoon with a capacity of 5 ml.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: March 2022