TUSCLIN SYRUP

Introduction

Package Leaflet: Information for the User

Tusclin Syrup

Extract of Hedera helix L.

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

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist.

• Keep this package 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 side effects not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 7 days.

Contents of the Package Leaflet

1. What Tusclin Syrup is and what it is used for
2. What you need to know before taking Tusclin Syrup
3. How to take Tusclin Syrup
4. Possible side effects
5. Storage of Tusclin Syrup
6. Package Contents and Additional Information

1. What Tusclin Syrup is and what it is used for

It is a plant-based medicine used as an expectorant in cases of productive cough.

Tusclin Syrup is indicated for adults, adolescents, and children over 2 years of age.

You should consult a doctor if your 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 ingredient, ivy (Hedera helix L.), to any component of the araliaceae family, or to any of the other components of this medicine (listed in section 6).

Do not administer the medicine to children under 2 years of age, as there is a risk of worsening respiratory symptoms.

Warnings and PrecautionsConsult your doctor or pharmacist before taking Tusclin Syrup.

Consult your doctor or pharmacist if you experience difficulty breathing, fever, or purulent secretions.

If you are taking other cough suppressants such as codeine or dextromethorphan, you should consult your doctor or pharmacist before taking Tusclin Syrup. Concurrent use with other cough suppressants is not recommended.

If you have gastritis or gastric ulcer, consult your doctor before taking Tusclin Syrup.

Children

In children between 2 and 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

The medicine should not be administered to children under 2 years of age due to the risk of worsening respiratory symptoms.

Use in Patients with Renal and/or Hepatic Impairment

If you have renal or hepatic insufficiency, consult your doctor or pharmacist before taking Tusclin Syrup. There are no data to recommend a dose in 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 may need to take any other medicine.

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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, so its administration is not recommended.

Driving and Using Machines

No studies have been conducted on the ability to drive and use machines.

Tusclin Syrup contains Sorbitol (E-420)

This medicine contains 498 mg per ml. Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult your doctor before taking this medicine.

3. How to Take Tusclin Syrup

Follow the administration instructions for the medicine contained in this package leaflet or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

The recommended dose is:

Adults and adolescents over 12 years: 5 ml of syrup, 2 or 3 times a day (equivalent to 70-105 mg daily of dry extract of ivy leaves).

Children between 6 and 12 years: 2.5 ml of syrup, 2 to 4 times a day or 5 ml of syrup 2 times a day (equivalent to 35-70 mg daily of extract).

Children between 2 and 5 years: 2.5 ml of syrup, 2 times a day (equivalent to 35 mg daily of extract).

In children between 2 and 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Children under 2 years: Tusclin Syrup should not be administered to children under 2 years of age due to the risk of worsening respiratory symptoms.

If you think the effect of the medicine is too strong or too weak, tell your doctor or pharmacist.

Tusclin Syrup is taken orally. Shake the bottle well before use. To ensure you always take the recommended dose, you should use the measuring cup included, which is graduated in 2.5 ml, 5 ml, and 10 ml.

You should consult a doctor or pharmacist if your symptoms worsen or persist after 7 days of treatment.

If you take more Tusclin Syrup than you should

If you have accidentally taken more than the recommended dose, you may experience nausea, diarrhea, vomiting, or restlessness (feeling more excited).

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicology Information Service, phone 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.

In case of forgetting a dose, take the medicine as soon as possible, continuing the treatment as recommended. However, if the next dose is near, it is better not to take the forgotten dose and wait for the next one.

If you stop taking Tusclin Syrup

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Frequent (may affect 1 to 10 in every 100 patients): gastrointestinal system reactions such as nausea, vomiting, or diarrhea have been reported.

Uncommon (may affect 1 to 10 in every 1000 patients): allergic reactions such as hives, 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 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 package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing 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.

Once the package is opened, discard the medicine if 3 months have passed since the opening date. Mark the opening date on the white box of the medicine package provided for this purpose.

Do not use Tusclin Syrup after the expiration date shown on the package, after the abbreviation "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Tusclin Syrup

• The active ingredient is the dry extract of ivy leaf; 1 ml of syrup contains 7 mg of dry extract of ivy leaf (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.

Appearance of the Product and Package Contents

Tusclin Syrup is presented in 100 ml and 200 ml amber glass bottles with a child-resistant plastic cap. A graduated measuring cup of 2 ml to 15 ml, including 2.5 ml and 5 ml measures, is included.

Not all package 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 Barberá del Vallés, Barcelona, Spain

Date of the Last Revision of this Package Leaflet: July 2017

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