Sinecod

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sinecod, 1.5 mg/ml, syrup

Butamirati citras

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist.
• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or additional information, you should consult a pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet:

• 1. What is Sinecod and what is it used for
• 2. Important information before using Sinecod
• 3. How to use Sinecod
• 4. Possible side effects
• 5. How to store Sinecod
• 6. Contents of the packaging and other information

1. What is Sinecod and what is it used for

Sinecod contains the active substance butamirati citras. Butamirati citras is a non-opioid cough medicine.
Sinecod syrup is used for the symptomatic treatment of coughs of various origins.

2. Important information before using Sinecod

When not to use Sinecod:

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

Warnings and precautions

If after 7 days there is no improvement or the patient feels worse and (or) the patient has a fever, rash, or persistent headache, they should contact their doctor, who will consider performing additional tests to determine the possible cause.
If the cough persists for more than 7 days, the patient should contact their doctor.
Due to the suppression of the cough reflex by butamirati citras, the patient should avoid taking expectorant medicines at the same time (see "Sinecod and other medicines").

Children

Sinecod syrup should not be used in children under 3 years of age.
The medicine should be stored in a place that is out of sight and reach of children.

Sinecod and other medicines

The patient should tell their doctor or pharmacist about all supplements, medicines, or products they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking expectorant medicines at the same time, as this may lead to the accumulation of secretions in the airways, increasing the risk of bronchospasm and respiratory tract infections.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.

Driving and using machines

Sinecod may rarely cause drowsiness. Therefore, the patient should be cautious while driving or performing other activities that require increased attention (e.g., operating machines). Children using 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 the patient has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, fructose malabsorption, they should consult their doctor before taking this medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.
• Etanol (alcohol)- the medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose, i.e., 11.88 mg of 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, or 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 have noticeable effects.
• Sodium- the medicine contains less than 1 mmol (23 mg) of sodium per ml, which means the medicine is considered "sodium-free".
• Benzoesowy acid- the medicine contains 5.75 mg of benzoesowy acid in 5 ml of syrup, 11.5 mg in 10 ml, and 17.25 mg in 15 ml.

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 you have any doubts, you should consult a doctor or pharmacist.
The medicine should be used for the shortest period necessary to alleviate the symptoms.
Without consulting a doctor, you should not use Sinecod for more than 7 days.
The medicine should be taken orally.
A measuring cup is included with the packaging to measure 5 ml, 10 ml, and 15 ml of syrup.
The measuring cup should be washed and dried after each use.
The usual dose is:
Children aged 3 to 6 years: 5 ml of syrup three times a day.
Children aged 6 to 12 years: 10 ml of syrup three times a day.
Adolescents over 12 years: 15 ml of syrup three times a day.
Adults: 15 ml of syrup four times a day.
Sinecod syrup should not be used in children under 3 years of age.

Using a higher dose of Sinecod than recommended

If a higher dose of the medicine is used than recommended, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhea, dizziness, and decreased blood pressure.
If a higher dose of the medicine is used than recommended, you should immediately consult a doctor.

Missing a dose of Sinecod

You should not take a double dose to make up for a missed dose.
If you have any further doubts about using this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Sinecod can cause side effects, although not everybody gets them.
Rarely (more often than 1 in 10,000, but less often than 1 in 1,000 patients using the medicine), the following symptoms occur:

• drowsiness,
• nausea,
• diarrhea,
• hives. These symptoms should disappear after reducing the dose or stopping the use of the medicine.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell 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.
By reporting side effects, you can help gather more information on the safety of this medicine.

5. How to store Sinecod

Do not store above 30°C.
The medicine should be stored in a place that is out of 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 month stated.
The medicine should be stored in its original packaging.
Do not pour the medicine from the measuring cup back into the bottle.
Discard the empty bottle or measuring cup in the trash.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sinecod contains

• The active substance of Sinecod is butamirati citras. One ml of syrup contains 1.5 mg of butamirati citras.
• The other ingredients of the medicine are: sorbitol solution (70% w/w), sodium saccharin, vanillin, benzoesowy acid, ethanol (94% w/w), glycerol, sodium hydroxide (30% w/w), purified water.

What Sinecod looks like and what the packaging contains

The packaging contains 200 ml of syrup.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization 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 by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Hungary, the country of export:OGYI-T-5302/02

Parallel import authorization number: 65/23 Date of approval of the leaflet: 05.04.2023

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