Package Insert: Information for the Patient

Tossevo6mg/ml EFG Syrup

Levodropropizina

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

Follow exactly the medication administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 4 days.

Thismedicationcontains levodropropizine and belongs to the group of medications called antitussives.

Levodropropizineis indicated for:

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

You should consult a doctor if it worsens or does not improve after 4 days.

Do not take Tossevo:

• Ifyou are allergic to levodropropizine 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).
• During pregnancy and lactation
• Children under 2 years old.

Warnings and precautions

Consult your doctor or pharmacist before starting to takeTossevo.

This medication should be evaluated for administration:

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

Children

Do not administer to children under 2 years old.

Taking Tossevo with other medications

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

No interactions or incompatibilities with other medications have been observed. However, caution is necessary in the case of concurrent administration of anxiolytic drugs (which reduce anxiety), such as benzodiazepines, particularly in sensitive patients, as it may cause an increase in sedative effect.

Use of Tossevo with food

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

Pregnancy, lactation, and fertility

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

This medication is not recommended during pregnancy, nor in women of childbearing age who are not using contraceptive methods.

Levodropropizine is excreted in breast milk, so it is not recommended to use during lactation.

Driving and operating machinery

Since this product may, although rarely, cause drowsiness, you should exercise caution when driving vehicles, operating hazardous machinery, and in general in activities where lack of concentration and dexterity may pose a risk.

Tossevo containssucrose,phthalylparahydroxybenzoateandphthalylparahydroxybenzoate

Thismedicationcontainssucrose.If your doctor has indicated that you have a certain sugar intolerance, 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 (to be measured with the graduated measuring cup provided in the package).

Itmayproducetooth decay.

Itmayproduce allergic reactions (possibly delayed) because it contains phthalylparahydroxybenzoate (E-218) and phthalylparahydroxybenzoate (E-216).

Follow exactly the medication administration instructions contained in this leaflet or those indicated by your doctororpharmacist. In case of doubt, ask yourdoctororpharmacist.

Measure the amount of medication to be administered using the dosing cup provided in the packaging.

Once used, wash the dosing cup with water.

Do not administer with food.

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

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

If the patient worsens or symptoms persist after 4 days of treatment, the treatment should be interrupted 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

-Childrenunder2years:Do not takethismedication.

-Children 2-6 years:Only under medical supervision.

-Adolescentsandchildren6yearsandolder:The dose is calculated based on 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 table below:

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

Patientsofadvancedage

Patients of advanced age do not require any adjustments or modifications to the dosing 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. Telephone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Tossevo

Do not take a double dose to compensate for the missed doses.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects detected include:

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

• Gastrointestinal disorders: nausea, heartburn, indigestion, 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: rarely, cases of cutaneous allergy have been observed.
• Respiratory, thoracic, and mediastinal disorders: dyspnea (difficulty breathing)

Unknown frequency (cannot be estimated from available data)

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

Reporting Adverse Effects

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

Keep this medication out of the 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 that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Tossevo

• The active ingredient is levodropropizina. Eachml ofsyrupcontains6 mg oflevodropropizina.
• The other components (excipients) are sucrose, parahydroxybenzoic acid methyl ester (E-218), parahydroxybenzoic acid propyl ester (E-216), citric acid, sodium hydroxide, cherry aroma, purified water.

Appearance of the product and contents of the packaging

Thismedicine is presented as an colorless to slightly yellow solution.

Levodropropizina is presented in a glass bottle with 200 ml of syrup, closed by a child-resistant cap and provided with a graduated measuring cup.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

STADA Laboratory, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible for manufacturing

Doppel Farmaceutici S.r.l

Via Martiri delle Foibe, 1

29016 Cortemaggiore (Piacenza)

Italy

Last review date of this leaflet:January 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/