Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sinecod, 1.5 mg/ml, syrup
Butamirate citrate
Please read this leaflet carefully before using the medicine, as 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 doctor or pharmacist.
Keep this leaflet, as you may need to read it again.
If you need advice or further information, consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement or if the patient feels worse after 7 days, consult a doctor.

Table of contents:

What Sinecod is and what it is used for
Important information before taking Sinecod
How to take Sinecod
Possible side effects
How to store Sinecod
Contents of the pack and other information

1. What Sinecod is and what it is used for

Sinecod contains the active substance butamirate citrate. Butamirate citrate is a non-opioid antitussive agent.
Sinecod syrup is used for the symptomatic treatment of cough of various origins.

2. Important information before using Sinecod

When not to use Sinecod:

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
If there is no improvement after 7 days, or if the patient feels worse and (or) develops fever, rash or persistent headache, consult a doctor who will consider performing additional tests to determine the possible cause.
If cough persists for more than 7 days, consult a doctor.
Due to the cough reflex suppression caused by butamirate citrate, concomitant use of expectorants should be avoided (see section "Sinecod with other medicines").

Children
Sinecod syrup should not be used in children under 3 years of age.
Keep this medicine out of sight and reach of children.

Sinecod with other medicines
Tell your doctor or pharmacist about all medicines and dietary supplements you are currently taking, have recently taken, or plan to take.
Avoid concomitant use of expectorant medicines, as this may lead to accumulation of respiratory secretions, 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 have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and operating machinery
Sinecod may rarely cause drowsiness. Therefore, caution should be exercised when driving or performing other activities requiring increased attention (e.g. operating machinery). Children taking this medicine should avoid riding bicycles or scooters.

Sinecod contains:

sorbitol – the medicine contains 284 mg of sorbitol per ml of syrup. Sorbitol is a source of fructose. If the patient (or his or her child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, 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.
ethanol (alcohol) – the medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose, i.e. 11.88 mg ethanol in 5 ml syrup, 23.76 mg in 10 ml, and 35.64 mg in 15 ml. The amount of alcohol in a 5 ml, 10 ml, and 15 ml dose is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medicine will not cause noticeable effects.
sodium – the medicine contains less than 1 millimole (23 mg) of sodium per ml, meaning the medicine is considered "sodium-free".
benzoic acid – the medicine contains 5.75 mg of benzoic acid in 5 ml syrup, 11.5 mg in 10 ml, and 17.25 mg in 15 ml.

3. How to take Sinecod

This medicine should always be taken exactly as described in this patient information leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine should be taken for the shortest duration necessary to relieve symptoms.
Do not use Sinecod for longer than 7 days without consulting a doctor.
This medicine is for oral use.
The medicine package includes a measuring device allowing measurement of 5 ml, 10 ml, and 15 ml of syrup.
The dosing device should be washed and dried after each use.
The usual dose is:
Children aged 3 to 6 years: 5 ml of syrup three times daily.
Children aged 6 to 12 years: 10 ml of syrup three times daily.
Adolescents over 12 years of age: 15 ml of syrup three times daily.
Adults: 15 ml of syrup four times daily.
Sinecod syrup should not be used in children under 3 years of age.
Taking more Sinecod than recommended
If more medicine is taken than recommended, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhoea, dizziness, and low blood pressure.
If an overdose occurs, seek immediate medical advice.
Missed dose of Sinecod
Do not take a double dose to make up for a missed dose.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.
The following symptoms occur rarely (more than 1 in 10,000 but less than 1 in 1,000 patients taking the medicine):

drowsiness,
nausea,
diarrhoea,
urticaria.
These symptoms should resolve after reducing the dose or discontinuing the medicine.

Reporting of adverse effects
If any adverse effects occur, including any 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sinecod medicine

Do not store above 30°C.
Keep the medicine in a place that is out of sight and out of reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Keep the medicine in its original packaging.
Do not pour the medicine from the measuring spoon back into the bottle.
Dispose of the empty bottle or measuring spoon in the trash.
Medicines must 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. Package contents and other information

What Sinecod contains

The active substance in Sinecod is citric acid butamirate. Each 1 ml of syrup contains 1.5 mg of butamirate citrate.
Other components of the medicine are: sorbitol solution (70% w/w), sodium saccharin, vanillin, benzoic acid, ethanol (94% w/w), glycerol, sodium hydroxide (30% w/w), purified water.

What Sinecod looks like and contents of the pack
The pack contains 200 ml of syrup.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Hungary, the country of export:
GlaxoSmithKline-Consumer Kft.
Csörsz utca 43.
1124 Budapest
Hungary
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing Authorisation Number in Hungary, the country of export: OGYI-T-5302/02
Parallel Import Authorisation Number: 65/23