Tusclin syrup
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Tusclin syrup
Extract of Hedera helix L.
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 more information, consult your pharmacist.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
- You should consult a doctor if you worsen or do not improve after 7 days.
Contents of the leaflet
- What Tusclin syrup is and what it is used for
- What you need to know before taking Tusclin syrup
- How to use Tusclin syrup
- Possible adverse effects
- How to store Tusclin syrup
- Contents of the pack and other information
1. What Tusclin syrup is and what it is used for
It is a herbal medicine used as an expectorant in productive cough.
Tusclin syrup is indicated for adults, adolescents, and children over 2 years of age.
You should consult a doctor if symptoms worsen or do not improve after 7 days.
2. What you need to know before taking Tusclin syrup
Do not take Tusclin syrup
If you are allergic to the active substance, ivy (Hedera helix L.), to any component of the Araliaceae family, or to any of the other ingredients of this medicine (listed in section 6).
Do not administer this medicine to children under 2 years of age, as there is a risk that respiratory symptoms may worsen.
Warnings and precautions
Consult your doctor or pharmacist before starting to take Tusclin syrup.
Consult your doctor or pharmacist if you experience difficulty breathing, fever, or purulent secretions.
If you are taking other antitussives such as codeine or dextromethorphan, you must consult your doctor or pharmacist before starting Tusclin syrup. Simultaneous use with other antitussives is not recommended.
If you have gastritis or gastric ulcer, consult your doctor before starting to take Tusclin syrup.
Children
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Do not administer this medicine to children under 2 years of age due to the risk of worsening respiratory symptoms.
Use in patients with impaired renal and/or hepatic function
If you have renal or hepatic insufficiency, consult your doctor or pharmacist before taking Tusclin syrup. There are no data available to recommend a dosage for these patients.
Other medicines and Tusclin syrup
Taking Tusclin syrup with other medicines.
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Pregnancy and breastfeeding
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.
There are no adequate and well-controlled studies in pregnant or breastfeeding women; therefore, administration is not recommended.
Driving and use of machines
No studies have been conducted on the ability to drive or use machinery.
Tusclin syrup contains sorbitol (E-420).
This medicine contains 498 mg per ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which the patient cannot break down fructose, consult your doctor (or your child's doctor) before taking this medicine.
3. How to take Tusclin Syrup
Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The recommended dose is:
Adults and adolescents over 12 years of age: 5 ml of syrup, 2 or 3 times daily (equivalent to 70 – 105 mg daily of dry ivy leaf extract).
Children between 6 and 12 years of age: 2.5 ml of syrup, 2 to 4 times daily, or 5 ml of syrup twice daily (equivalent to 35 – 70 mg daily of extract).
Children between 2 and 5 years of age: 2.5 ml of syrup, twice daily (equivalent to 35 mg daily of extract).
In children aged 2 to 4 years with persistent or recurrent cough, a medical diagnosis is required before starting treatment.
Children under 2 years of age: Tusclin syrup must not be administered to children under 2 years of age due to the risk of worsening respiratory symptoms.
If you feel the effect of the medicine is too strong or too weak, inform your doctor or pharmacist.
Tusclin syrup is taken orally. Shake the bottle well before use. To ensure you always take the recommended dose, use the dosing cup provided, which is graduated at 2.5 ml, 5 ml, and 10 ml.
Consult a doctor or pharmacist if symptoms worsen or persist after 7 days of treatment.
If you take more Tusclin syrup than you should
If you accidentally take more than the recommended dose, symptoms such as nausea, diarrhea, vomiting, or restlessness (feeling more excited) may occur.
In case of overdose or accidental ingestion, contact your pharmacist or doctor immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the product and the amount ingested.
If you forget to take Tusclin syrup
Do not take a double dose to make up for forgotten doses.
If you miss a dose, take the medicine as soon as possible and continue treatment as recommended. However, if it is almost time for the next dose, it is better not to take the missed dose and wait for the next scheduled dose.
If you stop taking Tusclin syrup
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 will experience them.
Frequent (may affect between 1 and 10 out of 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.
Uncommon (may affect between 1 and 10 out of 1,000 patients): allergic reactions such as urticaria, skin rashes, and difficulty breathing (dyspnea) have been reported. If you experience these symptoms, stop taking the medicine and consult your doctor or pharmacist.
Reporting of adverse reactions
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 directly 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 Tusclin syrup
No special storage conditions are required.
Keep this medicine out of the sight and reach of children.
After opening the container, discard the medicine if 3 months have passed since the date of opening. Mark the date of opening in the white box on the medicine container provided for this purpose.
Do not use Tusclin syrup after the expiry date stated on the container, following the abbreviation “CAD”. 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 unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.
6. Contents of the pack and other information
Composition of Tusclin syrup
- The active substance is dry extract of ivy leaves; 1 ml of syrup contains 7 mg of dry extract of ivy leaves (Hedera helix L.), (4-8:1). Extraction solvent: ethanol 30% (m/m).
- The other components are: potassium sorbate, anhydrous citric acid, xanthan gum, non-crystallizable liquid sorbitol (E-420), cherry flavor, and purified water.
Nature of the product and pack contents
Tusclin syrup is supplied in 100 ml and 200 ml amber-colored type III glass bottles with child-resistant plastic caps. A graduated dosing cup is included, ranging from 2 ml to 15 ml, with markings at 2.5 ml and 5 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
LABORATORIOS ERN, S.A.
Perú, 228
08020 Barcelona, Spain
Manufacturer
LABORATORIOS ERN, S.A.
Gorgs Lladó, 188
08210 Barberà del Vallès, Barcelona, Spain
Date of the most recent revision of this leaflet: July 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/