TOSSEVO 6 mg/ml SYRUP

Introduction

Leaflet: information for the patient

Tossevo6mg/ml syrup EFG

Levodropropizina

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 4 days.

Contents of the leaflet:

1. What is Tossevo and what is it used for
2. What you need to know before taking Tossevo
3. How to take Tossevo
4. Possible side effects
5. Storage of Tossevo
6. Package contents and additional information

1. What is Tossevo and what is it used for

This medication contains levodropropizina and belongs to the group of medications called antitussives.

Levodropropizina is indicated for:

Treatment of non-productive forms of cough, such as irritative or nervous cough in adults, adolescents, and children over 2 years old.

You should consult a doctor if your symptoms worsen or do not improve after 4 days.

2. What you need to know before taking Tossevo

Do not take Tossevo:

• If you are allergic to levodropropizina or any of the other components of this medication (listed in section 6).
• If you have excessive mucus secretion in the bronchi or have impaired mucus elimination function (Kartagener syndrome, bronchial ciliary dyskinesia).
• In pregnancy and lactation
• Children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before taking Tossevo.

The administration of this medication should be evaluated:

• If you have liver and kidney failure.
• If you are diabetic

Children

Do not administer to children under 2 years old.

Taking Tossevo with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

No interactions or incompatibilities with other medications have been observed. However, caution should be exercised when administering this medication concomitantly with anxiolytic medications (which reduce anxiety), such as benzodiazepines, especially in sensitive patients, as an increase in sedative effect may occur.

Using Tossevo with food

Since there is no information available on the effect of food on the absorption of the product, it should be taken outside of meals.

Pregnancy, lactation, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

This medication is not recommended during pregnancy or in women of childbearing age who are not using contraceptive methods.

Levodropropizina is excreted in breast milk, so its use is not recommended during the lactation period.

Driving and using machines

Since this product can rarely cause drowsiness, caution should be exercised when driving vehicles, operating hazardous machinery, and engaging in activities where lack of concentration and skill may pose a risk.

Tossevo containssucrose,methyl parahydroxybenzoateandpropyl parahydroxybenzoate

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Patients with diabetes mellitus should note that this medication contains 1.84 g of glucose per 10 ml of syrup (measured with the graduated measuring cup provided in the package).

It may cause tooth decay.

It may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).

3. How to take Tossevo

Follow the administration instructions of the medication contained in this leaflet or as indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.

Measure the amount of medication to be administered using the measuring cup provided with the package.

Once used, wash the measuring cup with water.

Do not administer with food.

Antitussives are symptomatic medications and should only be used while symptoms persist.

It is not advisable to use the medication for more than 7 days.

If the patient's symptoms worsen or persist after 4 days of treatment, the treatment should be discontinued and the patient's clinical situation evaluated.

The recommended dose is:

Adults

• 10 ml every 6-8 hours. Do not administer more than 3 times a day.

Use in children and adolescents

• Children under 2 years old: Should not take this medication.
• Children from 2-6 years old: Only under medical supervision.
• Adolescents and children from 6 years old: The dose is calculated according to the patient's weight, administering 1 mg per kg per dose, every 6-8 hours. No more than 3 doses in 24 hours. The amount of medication to be administered is indicated in the following table:

unless the doctor establishes a different regimen, but in no case should more than 10 ml be administered 3 times a day.

Elderly patients

Elderly patients do not require adjustments or modifications to the dosage regimen; however, special attention should be paid when administering this medication and evaluating their clinical situation.

If you take more Tossevo than you should

You may experience mild and transient tachycardia (increased heart rate). Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

If you forget to take Tossevo

Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

The detected side effects include:

Frequent (affecting less than 1 in 10 patients but more than 1 in 100)

• Gastrointestinal disorders: nausea, pyrosis, dyspepsia, diarrhea, vomiting, and abdominal pain.
• Nervous system disorders: fatigue and/or asthenia, clumsiness, drowsiness, headache, and vertigo.
• Cardiac disorders: palpitations

Rare (affecting less than 1 in 1,000 patients but more than 1 in 10,000)

• Skin and subcutaneous tissue disorders: rare cases of skin allergy have been observed.
• Respiratory, thoracic, and mediastinal disorders: dyspnea (difficulty breathing)

Frequency not known (cannot be estimated from available data)

• Eye disorders: visual disturbances
• Cardiac disorders: precordial pain (chest pain).

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them through the Spanish Medication Surveillance System for Human Use https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Tossevo

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Discard 6 weeks after opening.

Do not use this medication after the expiration date shown on the package, after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Tossevo

• The active ingredient is levodropropizina. Each ml of syrup contains 6 mg of levodropropizina.
• The other components (excipients) are sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), citric acid, sodium hydroxide, cherry flavor, and purified water.

Appearance of the product and package contents

This medication is presented as a colorless to slightly yellowish solution.

Levodropropizina is presented in a 200 ml glass bottle with a child-resistant cap and a graduated measuring cup.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Manufacturer

Doppel Farmaceutici S.r.l

Via Martiri delle Foibe, 1

29016 Cortemaggiore (Piacenza)

Italy

Date of the last revision of this leaflet:January 2015

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/