Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sinecod, 5 mg/ml, oral drops, solution
Butamirati citras
Please read the entire leaflet carefully before using this 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 for future reference.
If advice or additional information is needed, please consult your pharmacist.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the physician or pharmacist. See section 4.
If there is no improvement after 7 days of treatment, or if the patient feels worse, consult a physician.

Table of contents:

What Sinecod is and what it is used for
What to know before using Sinecod
How to use 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 oral drops are 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, contact a doctor, who will consider performing additional tests to determine the possible cause.
If cough persists for more than 7 days, contact a doctor.
Due to the cough-suppressant effect of citric butamirate, concomitant use of expectorants should be avoided (see section "Sinecod and other medicines").

Children
Sinecod oral drops may be used in children from 2 months of age only on medical advice.
Sinecod oral drops must not be used in children under 2 months of age.
Keep the medicine out of sight and reach of children.

Sinecod and other medicines
Inform your doctor or pharmacist about all medicines and dietary supplements you are currently taking, have recently taken, or plan to take.
Concomitant use of expectorants should be avoided, 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 might 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 – 10 drops contain 142 mg sorbitol, 15 drops contain 213 mg sorbitol, 25 drops contain 355 mg sorbitol. Sorbitol is a source of fructose. If the patient (or his/her child) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot metabolize 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), i.e. 1.5 mg ethanol in 10 drops, 2.25 mg ethanol in 15 drops, and 3.75 mg ethanol in 25 drops. The amount of alcohol in a 10-drop 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 10-drop, 15-drop, and 25-drop dose, meaning the medicine is considered "sodium-free".
benzoic acid – the medicine contains 0.57 mg benzoic acid in 10 drops, 0.86 mg in 15 drops, and 1.44 mg in 25 drops.

3. How to use Sinecod

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.
The medicine should be used 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 usual dosage is:
Children from 2 months to under 1 year of age: 10 drops four times daily;
Children from 1 to 3 years of age: 15 drops four times daily;
Children over 3 years of age: 25 drops four times daily.
Sinecod drops may be used in children from 2 months to under 2 years of age only on a doctor's advice.
Sinecod oral drops must not be used in children below 2 months of age.
Use of more Sinecod than recommended
If more medicine than recommended has been taken, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhoea, dizziness and low blood pressure.
If you have taken more than the recommended dose, seek medical advice immediately.
If you forget to take Sinecod
Do not take a double dose to make up for a forgotten dose.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody gets them.
The following symptoms occur rarely (more frequently than in 1 out of 10,000, but less frequently than in 1 out of 1,000 patients taking the medicine):

drowsiness,
nausea,
diarrhoea,
urticaria.

These symptoms should resolve after dose reduction or discontinuation of the medicine.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sinecod

Store below 30°C. Keep in the original packaging to protect from heat.
Keep Sinecod out of sight and reach of children.
Do not use Sinecod after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices help protect the environment.

6. Contents of the packaging and other information

What Sinecod contains

The active substance is butamirate citrate. One ml of solution (22 drops) contains 5 mg of butamirate citrate.
Other ingredients are: sorbitol 70% solution, sodium saccharin, vanillin, benzoic acid, ethanol 94%, glycerol, sodium hydroxide 30% solution, purified water.

What Sinecod looks like and contents of the pack
The pack contains 20 ml of solution.
For more detailed 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:
InPharm Sp. z o.o.
Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, country of export: OGYI-T-5302/03
Parallel import authorization number: 164/20