Toselix forte

Package Leaflet: Information for the Patient

Toselix Forte

1.5 mg/ml, Syrup

Butamirate Citrate

Read the Leaflet Carefully Before Taking the Medication, as it Contains

Important Information for the Patient.
This medication should always be taken exactly as described in this patient leaflet or as advised by your 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 ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 5 to 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Toselix Forte and What is it 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 is Toselix Forte and What is it Used For

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

2. Important Information Before Taking Toselix Forte

When Not to Take Toselix Forte

• if you are allergic to butamirate citrate or any of the other ingredients of this medication (listed in section 6). The symptoms of an allergic reaction may include: hives (skin swelling with redness and itching), itching, swelling of the lips, tongue, throat, and larynx.
• if you have phenylketonuria.

Warnings and Precautions

Toselix Forte should not be taken by people with respiratory function disorders.
If the cough persists for more than 5 to 7 days, you should contact your doctor.

Children

Toselix Forte should not be taken by children under 3 years of age.

Toselix Forte and Other Medications

You should avoid taking Toselix Forte and expectorant medications (which increase mucus production) at the same time. This may cause mucus to accumulate in the airways, increasing the risk of bronchospasm and respiratory tract infections.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you should ask your doctor or pharmacist for advice before taking this medication.
You should avoid taking Toselix Forte during the first trimester of pregnancy. In the other months of pregnancy and during breastfeeding, Toselix Forte may only be taken if absolutely necessary and after consulting a doctor.

Driving and Operating Machinery

Toselix Forte may cause drowsiness, so you should avoid driving or operating machinery if such symptoms occur.

Toselix Forte Contains Liquid Maltitol, Aspartame, Methyl Parahydroxybenzoate, and Benzoic Acid

Toselix Forte contains 582.50 mg of liquid maltitol in 1 ml of syrup. If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medication. The medication may have a mild laxative effect. The energy value is 2.3 kcal/g of maltitol.
Toselix Forte contains 2.91 mg of aspartame in 1 ml of syrup. Aspartame is a source of phenylalanine.
This may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper elimination.
Toselix Forte also contains methyl parahydroxybenzoate. This may cause allergic reactions (possible late reactions, i.e., occurring after several or several dozen hours).
Toselix Forte contains 0.70 mg of benzoic acid in 1 ml of syrup.
The medication contains less than 1 mmol (23 mg) of sodium in 1 ml of syrup, which means the medication is considered "sodium-free".

3. How to Take Toselix Forte

This medication should always be taken exactly as described in this patient leaflet or as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Toselix Forte should be taken orally.
Without consulting a doctor, you should not take Toselix Forte for more than 5 to 7 days.
A measuring cup with a scale is included with the packaging to facilitate dosing. 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.
Toselix Forte should not be taken by children under 3 years of age.
If you feel that the effect of the medication is too strong or too weak, you should consult your doctor.

Taking a Higher Dose of Toselix Forte Than Recommended

If you have taken more than the recommended dose of the medication, you should immediately tell your doctor or pharmacist.
The following symptoms of overdose may occur:

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

Missing a Dose of Toselix Forte

If you miss a dose, you should take it as soon as possible and continue treatment as recommended.
You should not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medication, you should ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everybody gets them.
Uncommon Side Effects(more than 1 in 1000 people and less than 1 in 100 people):

• dizziness.

Rare Side Effects(more than 1 in 10,000 people and less than 1 in 1000 people):

• drowsiness,
• nausea, diarrhea,
• hives (skin swelling with redness and itching).

These symptoms usually disappear during treatment and rarely require a reduction in the dose of the medication.
If the described allergic reactions or gastrointestinal disorders do not disappear after reducing the dose, you should stop taking the medication.

Reporting Side Effects

If you experience any side effects, including those 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
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 medication.

5. How to Store Toselix Forte

The medication should be stored out of sight and reach of children.
Store in a temperature below 25°C. Do not store in the refrigerator or freeze.
Do not use this medication after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medications should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the Pack and Other Information

What Toselix Forte Contains

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

What Toselix Forte Looks Like and What the Pack Contains

Toselix Forte is a clear, transparent syrup with a forest fruit flavor.
The packaging of the medication is a brown glass type III bottle, closed with an aluminum cap, with a PE foam seal, with a guarantee ring, containing 150 ml of syrup, placed in a cardboard box. A measuring cup made of PP is included with the packaging.

Marketing Authorization Holder:

Zakład Farmaceutyczny "Amara" sp. z o.o.
ul. Stacyjna 5
30-851 Kraków
Tel. +48 12 657 40 40
amara@amara.pl

Manufacturer:

Farmaceutyczna Spółdzielnia Pracy "GALENA"
ul. Krucza 62
53-411 Wrocław
Polska

Date of Last Revision of the Leaflet: