Sinecod

Leaflet attached to the packaging: information for the user

Sinecod, 5 mg/ml, oral drops, solution

Butamirate citrate

Please read carefully 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 this patient leaflet or as directed by a doctor or pharmacist.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If after 7 days there is no improvement or the patient feels worse, a doctor should be consulted.

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 butamirate citrate. Butamirate citrate is a non-opioid cough medicine.
Sinecod in the form of oral drops 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 after 7 days there is no improvement or the patient feels worse and (or) the patient has a fever, rash, or persistent headache, a doctor should be consulted, who will consider performing additional tests to determine the possible cause.
If the cough persists for more than 7 days, a doctor should be consulted.
Due to the suppression of the cough reflex by butamirate citrate, expectorant medicines should be avoided (see section "Sinecod and other medicines").

Children

In children from 2 months to 2 years of age, Sinecod oral drops can only be used on the advice of a doctor.
Sinecod oral drops should not be used in children under 2 months of age.
The medicine should be stored in a place that is out of sight and reach of children.

Sinecod and other medicines

The doctor or pharmacist should be informed about all supplements and medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
Expectorant medicines should be avoided, as this may lead to the accumulation of secretions in the airways, which increases the risk of bronchospasm and respiratory tract infections.

Pregnancy and breastfeeding

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

Driving and using machines

Sinecod may rarely cause drowsiness. Therefore, caution should be exercised when driving or performing other activities that require increased attention (e.g., operating machines). Children using the medicine should avoid riding bicycles or scooters.

Sinecod contains:

• Sorbitol- 10 drops of the medicine contain 142 mg of sorbitol, 15 drops contain 213 mg of sorbitol, and 25 drops contain 355 mg of sorbitol. Sorbitol is a source of fructose. If the patient (or their child) has previously been diagnosed with intolerance to some sugars or has a rare genetic disorder, hereditary fructose intolerance, in which the patient's body does not break down fructose, the patient should consult a doctor before taking the medicine or giving it to their child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.
• Etanol (alcohol)- the medicine contains small amounts of ethanol (alcohol), i.e., 1.5 mg of ethanol in 10 drops, 2.25 mg of ethanol in 15 drops, and 3.75 mg of ethanol in 25 drops. The amount of alcohol in a dose of 10 drops 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 dose of 10 drops, 15 drops, and 25 drops, which means the medicine is considered "sodium-free".
• Benzoic acid- the medicine contains 0.57 mg of 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. In case of doubt, a doctor or pharmacist should be consulted.
The medicine should be used for the shortest period necessary to relieve symptoms.
Without consulting a doctor, the medicine should not be used for more than 7 days.
The medicine should be taken orally.
The usual dose is:
Children from 2 months to 1 year of age: 10 drops four times a day;
Children over 1 year of age to 3 years: 15 drops four times a day;
Children over 3 years of age: 25 drops four times a day.
In children from 2 months to 2 years of age, Sinecod oral drops can only be used on the advice of a doctor.
Sinecod oral drops should not be used in children under 2 months of age.

Using a higher dose of Sinecod than recommended

In case of using a higher dose of the medicine than recommended, the following symptoms may occur:
drowsiness, nausea, vomiting, diarrhea, dizziness, and decreased blood pressure.
In case of taking a higher dose of the medicine than recommended, a doctor should be consulted immediately.

Missing a dose of Sinecod

A double dose should not be taken to make up for a missed dose.
In case of any further doubts about using this medicine, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, this medicine 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.
If any side effects occur, including any side effects not listed in this leaflet, a doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be informed. 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sinecod

Store in a temperature not exceeding 30°C.
Store in the original packaging.
The medicine should be stored in a place that is out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste containers. A pharmacist should be asked 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 butamirate citrate. One ml of solution (20 drops) contains 5 mg of butamirate citrate.
• The other ingredients are: sorbitol 70% solution, sodium saccharin, vanillin, benzoic acid, ethanol 96% v/v, glycerol, sodium hydroxide 30% solution, purified water.

What Sinecod looks like and what the packaging contains

The packaging contains 20 ml of solution.

Marketing authorization holder:

Haleon Poland Sp. z o.o.
ul. Rzymowskiego 53
02-697 Warsaw
tel. 800 702 849

Importer:

Haleon Germany GmbH
Barthstraße 4
80339 Munich
Germany
Date of last update of the leaflet:November 2024