Toselix forte

Package leaflet: Information for the patient

Toselix forte
1.5 mg/ml, syrup
Butamirati citras
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be taken exactly as described in this patient leaflet or as directed by
your doctor or pharmacist.

• Keep this leaflet, so that you can read it again if necessary.
• If you need advice or further information, please consult your pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.
• If there is no improvement after 5 to 7 days, or if your condition worsens, consult your doctor.

Table of contents

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

1. What Toselix forte is and what it is used for

Toselix forte contains the active substance butamirate citrate.
Butamirate citrate is a non-opioid antitussive agent.
The indication for Toselix forte syrup is the symptomatic treatment of acute, non-productive
(dry) cough.

2. Important information before using Toselix forte

When not to use Toselix forte

• if the patient is allergic to butamirate citrate or any of the other ingredients of this medicine (listed in section 6). Symptoms of allergy may include: urticaria (skin swelling with redness and itching), skin itching, swelling of lips, tongue, throat, and larynx.
• if the patient has phenylketonuria.

Warnings and precautions
Toselix forte should not be used in patients with respiratory centre dysfunction.
If cough persists for more than 5 to 7 days, consult a doctor.
Children
Toselix forte should not be used in children under 3 years of age.
Toselix forte and other medicines
Concurrent use of Toselix forte and expectorants (medicines that increase secretion production) should be avoided. This may lead to mucus accumulation in the airways, 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.
Toselix forte should be avoided during the first trimester of pregnancy. In the remaining months of pregnancy and during breastfeeding, Toselix forte may be used only if absolutely necessary and after consultation with a doctor.
Driving and operating machinery
Toselix forte may cause drowsiness; therefore, driving or operating machinery should be avoided if this effect occurs.
Toselix forte contains liquid maltitol, aspartame, methyl parahydroxybenzoate, and benzoic acid
Toselix forte contains 582.50 mg of liquid maltitol per 1 ml of syrup. If the patient has previously been diagnosed with intolerance to certain sugars, he or she should consult a doctor before taking this medicine. The medicine may have a mild laxative effect. Calorific value: 2.3 kcal/g of maltitol.
Toselix forte contains 2.91 mg of aspartame per 1 ml of syrup. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to impaired excretion.
Toselix forte also contains methyl parahydroxybenzoate. It may cause allergic reactions (including delayed-type reactions occurring several or even dozens of hours after exposure).
Toselix forte contains 0.70 mg of benzoic acid per 1 ml of syrup.
The medicine contains less than 1 mmol (23 mg) of sodium per 1 ml of syrup, i.e. the medicine is considered "sodium-free".

3. How to take Toselix forte

This medicine should always be taken exactly as described in this patient leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
Toselix forte should be taken orally.
Do not use Toselix forte for longer than 5 to 7 days without consulting a doctor.
A measuring cup with graduations to facilitate dosing is attached to the package. 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 of age: 15 ml of syrup three times a day.
Adults: 15 ml of syrup four times a day.
Toselix forte should not be used in children under 3 years of age.
If the effect of the medicine appears too strong or too weak, consult a doctor.

Taking more Toselix forte than recommended
If more medicine has been taken than recommended, inform a doctor or pharmacist immediately.
The following symptoms of overdose may occur:

• drowsiness, dizziness,
• nausea, vomiting, diarrhoea,
• hypotension.

Missed dose of Toselix forte
If a dose is missed, take it as soon as possible and continue treatment according to the recommendations.
Do not take a double dose to make up for a missed dose.
If there are any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Uncommon adverse effects (occurring in more than 1 in 1,000 and less than 1 in 100 people):

• dizziness.

Rare adverse effects (occurring in more than 1 in 10,000 and less than 1 in 1,000 people):

• drowsiness,
• nausea, diarrhoea,
• urticaria (skin swelling with redness and itching).

These symptoms usually resolve during treatment and rarely require dose reduction.
If the described allergic reactions or gastrointestinal disturbances do not resolve after dose reduction, treatment with the medicine should be discontinued.

Reporting of adverse effects

If any adverse effects occur, including any 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 at 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
Adverse effects may also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Toselix forte

Keep this medicine out of sight and reach of children.
Store below 25°C. Do not store in a refrigerator or freeze.
Do not use this medicine 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. This will help protect the environment.

6. Contents of the package and other information

What Toselix forte contains

• The active substance is butamirate citrate. 1 ml of syrup contains 1.5 mg of butamirate citrate.
• Other ingredients (excipients) are: liquid maltitol (E 965), sodium citrate, monohydrate citric acid, aspartame (E 951), methyl parahydroxybenzoate (E 218), benzoic acid (E 210), forest fruit flavour, purified water.

What the medicine looks like and contents of the pack
Toselix forte is a clear, transparent syrup with a forest fruit odour.
The medicine is packed in a brown glass type III bottle, closed with an aluminium cap,
with a sealing made of foamed polyethylene, and a tamper-evident ring, containing 150 ml of syrup,
placed in a cardboard box. A measuring cup made of polypropylene (PP) is included in the pack.
Marketing Authorisation Holder:
Zakład Farmaceutyczny ,,Amara” sp. z o.o.
Stacyjna 5 Street
30-851 Kraków
Tel. +48 12 657 40 40
[email protected]
Manufacturer:
Farmaceutyczna Spółdzielnia Pracy „GALENA”
Krucza 62 Street
53-411 Wrocław
Poland