Leaflet: information for the user

Tusclin syrup

Extract ofHedera helix L.

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

Follow exactly the administration instructions for the medicine contained 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 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 you get worse or do not improve after 7 days.

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

Tusclin syrup is indicated for adults, adolescents, and children over 2 years old.

You should consult a doctor if it worsens or does not improve after 7 days.

Do not take Tusclin syrup

If you are allergic to the active ingredient, ivy (Hedera helix L.), or to any component of the araliaceae family or to any of the other components of this medication (listed in section 6).

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

Warnings and precautionsConsult 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 to take Tusclin syrup. Concurrent 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 between 2 and 4 years of age with persistent or recurrent cough, a medical diagnosis is required before starting treatment.

Do not administer the medication to children under 2 years of age due to the risk of worsening respiratory symptoms.

Use in patients with reduced renal and/or hepatic function

If you have renal insufficiency or hepatic insufficiency, consult your doctor or pharmacist before taking Tusclin syrup. There are no data for dose recommendations in these patients.

Other medications and Tusclin syrup

Taking Tusclin syrup with other medications.

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

Pregnancy and breastfeeding

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

No adequate and well-controlled studies have been conducted in pregnant women or breastfeeding women, so administration is not recommended.

Driving and operating machinery

No studies have been conducted on the ability to drive and operate machinery.

Tusclin syrup contains sorbitol (E-420).

This medication contains 498 mg in each 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 disease in which the patient cannot break down fructose, consult your doctor (or your child) before taking this medication.

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

The recommended dose is:

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

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

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

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

If you estimate that the medication's action 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, you should use the dosing cup included, which is graduated in 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 have accidentally taken more than the recommended dose, nausea, diarrhea, vomiting, or restlessness (feeling more excited) may appear.

In case of overdose or accidental ingestion, consult your pharmacist or doctor immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the product and the amount ingested.

If you forgot to take Tusclin syrup

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

If you forget a dose, take the medication as soon as possible and continue treatment as recommended. However, if the next dose is near, it is better not to take the missed dose and wait for the next one.

If you interrupt treatment with Tusclin syrup

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.

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

Infrequent (may affect between 1 and 10 of every 1000 patients): allergic reactions such as urticaria, skin eruptions, and difficulty breathing (dyspnea) have been reported. If you experience these symptoms, stop taking the medication and consult your doctor or pharmacist.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conditions for conservation.

Keep this medication out of the sight and reach of children.

Once the container is opened, discard the medication if it has been 3 months since the opening date. Mark the opening date in the white box on the medication container for this purpose.

Do not use Tusclin syrup after the expiration date that appears on the container, after the abbreviation “CAD”. The expiration date is the last day of the month indicated.

Medications should not be thrown down the drains or in the trash. Deposit the containers and medications you do not need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you do not need. In this way, you will help protect the environment.

Composition of Tusclin syrup

• The active principle is the dry extract of the 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 essence, and purified water.

Appearance of the product and contents of the packaging

Tusclin syrup is presented in amber-colored type III glass bottles of 100 ml and 200 ml with a child-resistant plastic cap. A graduated dosing cup of 2 ml to 15 ml, including measurements of 2.5 ml and 5 ml, is included.

Not all packaging sizes may be marketed.

Holder of the marketing authorization

LABORATORIOS ERN, S.A.

Perú, 228

08020 Barcelona, - Spain

Responsible for manufacturing

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona. Spain

Last review date of this leaflet: July 2017

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