Tossevo 6 mg/ml syrup EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Tossevo 6 mg/ml syrup EFG
Levodropropizine
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist.
- Keep this leaflet, as you may need to read it again.
- If you need advice or further information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 4 days.
Leaflet contents:
- What Tossevo is and what it is used for
- What you need to know before taking Tossevo
- How to take Tossevo
- Possible adverse effects
- Storage of Tossevo
- Contents of the pack and other information
1. What Tossevo is and what it is used for
This medicine contains levodropropizine and belongs to a group of medicines called antitussives.
Levodropropizine is indicated for:
The treatment of non-productive forms of cough, such as irritative cough or nervous cough in adults, adolescents, and children over 2 years of age.
You should consult a doctor if symptoms worsen or do not improve after 4 days.
2. What you need to know before starting to take Tossevo
Do not take Tossevo:
- If you are allergic to levodropropizine or to any of the other ingredients of this medicine (listed in section 6).
- If you have excessive mucus secretion in the bronchi or impaired mucus clearance (Kartagener syndrome, bronchial ciliary dyskinesia).
- During pregnancy and breastfeeding.
- Children under 2 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Tossevo.
Administration of this medicine should be evaluated:
- If you have hepatic or renal impairment.
- If you are diabetic.
Children
Do not administer to children under 2 years of age.
Taking Tossevo with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
No interactions or incompatibilities with other medicines have been observed. Caution is necessary when administering this medicine concomitantly with anxiolytic drugs (which reduce anxiety), such as benzodiazepines, particularly in sensitive patients, as an increased sedative effect may occur.
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, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
This medicine is not recommended during pregnancy, or in women of childbearing age who are not using contraceptive methods.
Levodropropizine is excreted in breast milk; therefore, its use is not recommended during breastfeeding.
Driving and using machines
Since this product may, although rarely, cause drowsiness, caution should be exercised when driving, operating dangerous machinery, and in general, in any activity where lack of concentration or alertness could pose a risk.
Tossevo contains sucrose, methyl parahydroxybenzoate and propyl parahydroxybenzoate
This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
Patients with diabetes mellitus should be aware that this medicine contains 1.84 g of glucose per 10 ml of syrup (measured with the graduated dosing cup provided in the package).
It may cause tooth decay.
It may cause allergic reactions (possibly delayed), as it contains methyl parahydroxybenzoate (E-218) and propyl parahydroxybenzoate (E-216).
3. How to take Tossevo
Follow exactly the instructions for use provided in this leaflet or those indicated by your doctor or pharmacist. If in doubt, ask your doctor or pharmacist.
Measure the amount of medication to be administered using the dosing cup provided in the package.
After use, wash the dosing cup with water.
Do not administer with food.
Antitussives are symptomatic medicines and should only be used while symptoms persist.
It is not advisable to use the medicine for more than 7 days.
If the patient worsens or symptoms persist after 4 days of treatment, treatment should be discontinued and the patient's clinical condition reassessed.
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: This medicine must not be given.
- Children 2–6 years: Only under medical supervision.
- Adolescents and children from 6 years onwards: 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:
kg | mL 3 times a day | |
Children | ||
10-15 | 2.5 | |
16-20 | 3 | |
21-30 | 5 | |
Adolescents | ||
31-45 | 7.5 | |
Over 45 | 10 |
unless otherwise directed by the physician; however, under no circumstances should more than 10 ml be administered three times a day.
Elderly patients
Elderly patients do not require dose adjustments or modifications in the dosing schedule; however, special caution should be exercised when administering this medicine, and the patient's clinical condition should be carefully evaluated.
If you take more Tossevo than you should
You may experience mild and transient tachycardia (increased heart rate). Contact your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, contact the Toxicology Information Service at telephone number 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 missed doses.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
The adverse effects observed include:
Common (affecting less than 1 in 10 people but more than 1 in 100)
- Gastrointestinal disorders: nausea, pyrosis, dyspepsia, diarrhoea, vomiting, and abdominal pain.
- Nervous system disorders: fatigue and/or asthenia, clumsiness, somnolence, headache, and dizziness.
- Cardiac disorders: palpitations
Rare (affecting less than 1 in 1,000 people but more than 1 in 10,000)
- Skin and subcutaneous tissue disorders: skin allergy cases have rarely been observed.
- Respiratory, thoracic and mediastinal disorders: dyspnoea (difficulty breathing)
Frequency not known (cannot be estimated from available data)
- Eye disorders: visual disturbances
- Cardiac disorders: precordial pain (chest pain)
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Tossevo
Keep this medicine out of sight and reach of children.
Do not store above 25°C.
Discard 6 weeks after opening.
Do not use this medicine after the expiry date stated on the packaging, after EXP. The expiry date refers to the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tossevo
- The active substance is levodropropizine. Each ml of syrup contains 6 mg of levodropropizine.
- The other components (excipients) are sucrose, methyl parahydroxybenzoate (E-218), propyl parahydroxybenzoate (E-216), citric acid, sodium hydroxide, cherry flavor, purified water.
Appearance of the product and contents of the container
This medicine is presented as a solution ranging from colorless to slightly yellow.
Levodropropizine is supplied in a glass bottle containing 200 ml of syrup, sealed with a child-resistant cap and provided with a graduated measuring cup.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Laboratorio STADA, S.L.
Frederic Mompou, 5
08960 Sant Just Desvern
(Barcelona)
Manufacturer
Doppel Farmaceutici S.r.l
Via Martiri delle Foibe, 1
29016 Cortemaggiore (Piacenza)
Italy
Date of the most recent revision of this leaflet: January 2015
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/