PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Sinecod
1.5 mg/ml, syrup
Butamirati citras
Please read the entire 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
physician 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 adverse reactions not listed in this leaflet, inform the physician or pharmacist. See section 4.
If there is no improvement or if the patient feels worse after 7 days, consult a physician.

Table of contents of the leaflet:

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 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 longer than 7 days, consult a doctor.
Due to the cough reflex suppression caused by citric butamirate, concomitant use of expectorant medicines should be avoided (see section "Sinecod with other medicines").

Children

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

Sinecod with other medicines

Inform your doctor or pharmacist about all medicines and dietary supplements you are currently taking or have recently taken, as well as any medicines you plan to take.
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 have a child, 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 in each ml of syrup. Sorbitol is a source of fructose. If intolerance to certain sugars has previously been diagnosed in the patient (or his/her child), or if hereditary fructose intolerance—a rare genetic disorder in which the body cannot break down 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.
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 of 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 of this medicine 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 of syrup, 11.5 mg in 10 ml, and 17.25 mg in 15 ml.

3. How to use Sinecod medicine

This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
This medicine should be used for the shortest period necessary to relieve symptoms.
Do not use Sinecod medicine 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 syrup measuring 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.
Use of a higher than recommended dose of Sinecod
If a higher dose than recommended is used, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhoea, dizziness, and low blood pressure.
If a higher than recommended dose is used, consult a doctor immediately.
Missed dose of Sinecod
Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult a 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 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 reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for 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 reactions enables continuous monitoring of the benefit-risk balance of the medicine and 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 out of the sight and 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.
Store the medicine in its original packaging.
Do not pour the medicine from the measuring device back into the bottle.
Dispose of the empty bottle or measuring device in the bin.
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 Sinecod contains

The active substance in Sinecod is butamirate citrate. One ml of syrup contains 1.5 mg of butamirate citrate.
The other ingredients 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 further information, please contact the responsible entity or the parallel importer.
Responsible entity in Hungary, country of export:
Haleon Hungary Kft.
Csörsz u. 43.
1124 Budapest
Hungary
Manufacturer:
GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
Barthstrasse 4
80339 Munich
Germany
Haleon Germany GmbH
Barthstrasse 4
80339 Munich
Germany
Parallel importer:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3
91-342 Łódź
SHIRAZ PRODUCTIONS Sp. z o.o.
Tymiankowa 24/28
95-054 Ksawerów
Hungarian marketing authorization number: OGYI-T-5302/02
Parallel import authorization number: 192/23