Sinecod

Package Leaflet: Information for the User

Sinecod, 1.5 mg/ml, Syrup

Butamirate Citrate

Read the Leaflet Carefully Before Using the Medication, as it Contains Important Information for the Patient

This medication should always be used exactly as described in the patient leaflet or as advised 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 those not listed in this leaflet, the doctor or pharmacist should be informed. See section 4.
• If there is no improvement or the patient feels worse after 7 days, 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 pack 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 suppressant.

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 medication (listed in section 6).

Warnings and precautions

If there is no improvement or the patient feels worse after 7 days, and/or if the patient has a fever, rash, or persistent headache, a doctor should be consulted to consider 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, medications that induce coughing should be avoided (see "Sinecod and other medications").

Children

Sinecod syrup should not be used in children under 3 years of age.

The medication should be stored out of sight and reach of children.

Sinecod and other medications

The doctor or pharmacist should be informed about all supplements, medications, or planned medications.

Medications that induce coughing should be avoided, as they 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, breastfeeding, or planning to have a child, they should consult a doctor or pharmacist before using this medication.

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 this medication should avoid riding bicycles and scooters.

Sinecod contains:

• Sorbitol- the medication contains 284 mg of sorbitol per ml of syrup. 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 where the patient's body does not break down fructose, they should consult a doctor before taking the medication or giving it to their child. Sorbitol may cause gastrointestinal discomfort and have a mild laxative effect.
• Etanol (alcohol)- the medication contains small amounts of ethanol (alcohol), less than 100 mg per dose, i.e., 11.9 mg of ethanol in 5 ml of syrup, 23.7 mg in 10 ml, and 35.6 mg in 15 ml. The amount of alcohol in a 5 ml, 10 ml, or 15 ml dose of this medication is equivalent to less than 1 ml of beer or 1 ml of wine. The small amount of alcohol in this medication will not have noticeable effects.
• Sodium- the medication contains less than 1 mmol of sodium (23 mg) per dose, i.e., 1.55 mg of sodium in 5 ml of syrup, 3.1 mg in 10 ml, and 4.65 mg in 15 ml, which means the medication is considered "sodium-free".
• Benzoic acid- the medication 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

This medication should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist.

In case of doubt, a doctor or pharmacist should be consulted.

The medication should be used for the shortest period necessary to alleviate symptoms.

Without consulting a doctor, Sinecod should not be used for more than 7 days.

The medication should be taken orally.

A measuring cup is provided with the medication 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 medication is used than recommended, the following symptoms may occur:

drowsiness, nausea, vomiting, diarrhea, dizziness, and decreased blood pressure.

If a higher dose of the medication is used 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 medication, a doctor or pharmacist should be consulted.

4. Possible side effects

Like all medications, Sinecod can cause side effects, although not everybody gets them.

Rarely (more than 1 in 10,000, but less than 1 in 1,000 patients using the medication), the following symptoms may occur:

• drowsiness,
• nausea,
• diarrhea,
• hives. These symptoms should resolve after reducing the dose or discontinuing the medication.

If any side effects occur, including those not listed in the leaflet, a doctor or pharmacist should be consulted.

Reporting side effects

If any side effects occur, including those not listed in the leaflet, the doctor or pharmacist should be informed.

Side effects can be reported directly to the Department of Drug Safety Monitoring 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 gather more information on the safety of the medication.

5. How to store Sinecod

The medication should be stored at a temperature below 30°C.

The medication should be stored out of sight and reach of children.

The medication should not be used after the expiration date stated on the packaging.

The expiration date refers to the last day of the specified month.

The medication should be stored in its original packaging.

The medication should not be poured back into the bottle from the measuring cup.

The empty bottle or measuring cup should be disposed of in the trash.

Medications should not be disposed of in the sewage system or household waste containers.

A pharmacist should be asked how to dispose of unused medications.

This will help protect the environment.

6. Contents of the pack and other information

What Sinecod contains

• The active substance of Sinecod is butamirate citrate. One ml of syrup contains 1.5 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 pack contains

The pack contains 100 ml or 200 ml of syrup.

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 revision of the leaflet:November 2024