Tussicalin

Package Leaflet: Information for the User

Tussicalin, 1.5 mg/ml, Syrup

Butamirate Citrate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist.

• Keep this package leaflet, you may need to read it again.
• If you need advice or further information, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, tell your doctor or pharmacist. See section 4.
• If after 5 days (3 days in children) there is no improvement or the patient feels worse, contact a doctor.

Table of Contents of the Package Leaflet:

• 1. What is Tussicalin and what is it used for
• 2. Important information before taking Tussicalin
• 3. How to take Tussicalin
• 4. Possible side effects
• 5. How to store Tussicalin
• 6. Contents of the package and other information

1. What is Tussicalin and what is it used for

Tussicalin contains the active substance butamirate citrate, which belongs to the group of cough suppressants.
Tussicalin in the form of a syrup is used for the symptomatic treatment of dry, irritating cough of various origins.
This medicine can be used without consulting a doctor only for short-term treatment of acute cough, e.g. acute infection of the upper and lower respiratory tract, trachea, and bronchi. This medicine may be used for the treatment of chronic cough only on the advice of a doctor.
A doctor should be consulted if there is no improvement or the patient feels worse after 5 days of taking the medicine (after 3 days in children under 12 years of age).

2. Important information before taking Tussicalin

When not to take Tussicalin

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

Children

Tussicalin can be used by adults, adolescents, and children over 3 years of age.
Tussicalin should not be used in children under 3 years of age, as the measuring cup is not suitable for measuring the correct dose. For this age group, other pharmaceutical forms are more suitable.

Tussicalin and other medicines

The doctor or pharmacist should be informed about all medicines currently being taken or recently taken, as well as any medicines that the patient plans to take.
This medicine should not be taken at the same time as so-called "expectorant" medicines (which facilitate the discharge of mucus), as such a combination of these medicines may lead to the accumulation of secretions in the respiratory tract.

Pregnancy, breastfeeding, and fertility

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 taking this medicine.
If the patient is pregnant or breastfeeding, Tussicalin should not be taken unless advised by a doctor.

Driving and using machines

Tussicalin may rarely cause drowsiness in some people. In such cases, vehicles should not be driven or machines operated.
During treatment with Tussicalin, children should not ride bicycles or scooters.

Tussicalin contains propylene glycol

The medicine contains 50.75 mg of propylene glycol in 15 ml of syrup, which corresponds to 3.38 mg/ml.
The maximum recommended daily dose (60 ml) contains 203 mg of propylene glycol.

Tussicalin contains sorbitol

The medicine contains 6,750 mg of sorbitol in 15 ml of syrup, which corresponds to 450 mg/ml. The maximum recommended daily dose (60 ml) contains 27 g of sorbitol. Sorbitol is a source of fructose. If it has been previously determined that the patient has intolerance to some sugars or has been previously diagnosed with hereditary fructose intolerance, a rare genetic disorder 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 a child. Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Tussicalin contains sodium benzoate

The medicine contains 15 mg of sodium benzoate in 15 ml of syrup, which corresponds to 1 mg/ml. Sodium benzoate may increase the risk of jaundice (yellowing of the skin and whites of the eyes) in newborns (up to 4 weeks of life).

Tussicalin contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means the medicine is considered "sodium-free".

3. How to take Tussicalin

This medicine should always be taken exactly as described in this package leaflet or as directed by a doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.
Usually, the recommended dose is:

To measure the dose correctly, use the measuring cup provided. The measuring cup should be washed and dried after each use. Do not pour the syrup back into the bottle from the measuring cup.
Without consulting a doctor, Tussicalin should not be taken for more than 7 days.
If symptoms worsen or do not improve within 5 days (3 days in children under 12 years of age) and/or fever, rash, or persistent headache occur, consult a doctor.
In the case of chronic cough, the medicine can be taken only after the doctor's recommendation, who will determine the appropriate dose and duration of treatment.
Always use the smallest possible dose for the shortest time necessary to alleviate symptoms.
Do not exceed the recommended dose.

Overdose of Tussicalin

In case of taking a higher dose of the medicine than recommended, consult a doctor immediately.

Missed dose of Tussicalin

If a dose is missed, take it as soon as possible. Do not take a double dose to make up for the missed dose.
In case of further doubts about taking the medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Tussicalin can cause side effects, although not everybody gets them.
The following symptoms may occur in rare cases (may affect up to 1 in 1,000 people):

• drowsiness,
• nausea,
• diarrhea,
• skin rash (hives).

These side effects should disappear after reducing the dose or stopping treatment. If these symptoms persist, stop taking Tussicalin and consult a doctor or pharmacist.

Reporting side effects

If any side effects occur, including those not listed in this package leaflet, 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
Side effects can also be reported to the marketing authorization holder.

By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Tussicalin

Do not store above 25°C. Do not store in the refrigerator or freeze.
Shelf life after first opening: 6 months.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging, on the label, and on the carton, after EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer needed. This will help protect the environment.

6. Contents of the package and other information

What Tussicalin contains

• The active substance of Tussicalin is butamirate citrate. One ml of syrup contains 1.5 mg of butamirate citrate.
• The other ingredients are: sorbitol (E 420), glycerol, sucralose (E 955), sodium benzoate (E 211), citric acid monohydrate, caramel flavor (also containing propylene glycol (E 1520)), bitter chocolate flavor F 2428 (also containing propylene glycol (E 1520)), purified water.

What Tussicalin looks like and contents of the pack

Tussicalin syrup is a colorless or light yellow liquid.
Tussicalin syrup is packaged in glass or plastic bottles with a plastic cap, containing 100 ml or 200 ml. Each package includes a measuring cup with a scale of 5, 10, 15, 20, 25, and 30 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Dr.Max Pharma s.r.o.
Na Florenci 2116/15
110 00 Prague
Czech Republic
Manufacturer:
Balkanpharma Troyan AD
Krayrechna Str. 1
5600 Troyan
Bulgaria

This medicine is authorized in the Member States of the European Economic Area under the following names:

Czech Republic
Tussical
Poland
Tussicalin
Slovakia
Tussical

Date of last revision of the package leaflet: