HEDETUS 5.4 mg/ml SYRUP

Introduction

Package Leaflet: Information for the Patient

Hedetus, 5.4 mg/ml, Syrup

Dry Extract of Ivy Leaf

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

Follow exactly the administration instructions of 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 not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 5 days.

Contents of the Package Leaflet

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

1. What is Hedetus and what is it used for

Hedetus is a herbal medicine used as an expectorant in cases of productive cough. It contains the dry extract of ivy leaf (Hedera helixL., folium).

Hedetus is indicated in adults, adolescents, and children over 2 years of age.

You should consult a doctor if your symptoms worsen or do not improve after 5 days.

2. What you need to know before taking Hedetus

Do not take this medicine:

• if you are allergic to ivy, other members of the Araliaceaefamily, or to any of the other components of this medicine (listed in section 6.1).
• in children under 2 years of age, as respiratory symptoms can generally worsen in this patient group.

Warnings and Precautions

Consult your doctor before taking this medicine:

• if you have difficulty breathing, fever, or purulent sputum
• if symptoms persist for more than 5 days, or if you are using opioid antitussives, such as codeine or dextromethorphan
• if you have gastritis or gastric ulcer

Children

• Do not use in children under 2 years of age. See the section "Do not take this medicine"
• If children between 2 and 4 years of age have persistent or recurrent cough, a medical diagnosis will be required before starting treatment.

Taking Hedetus with Other Medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Hedetus with Food, Drinks, and Alcohol

No interactions with food, drinks, or alcohol are known.

Pregnancy, Breastfeeding, and Fertility

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.

Pregnancy

Hedetus should not be taken during pregnancy.

Breastfeeding

Hedetus should not be used during breastfeeding.

Fertility

No data on fertility are available.

Driving and Using Machines

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

Hedetus Contains:

• 292.6 mg/ml sorbitol(E420). Sorbitol may have a mild laxative effect. Energy value 2.6 kcal/g sorbitol. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.
• 2.3 mg/ml . If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to Take Hedetus

Follow exactly the administration instructions of 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:

Hedetus should be taken orally. The package contains a measuring cup to measure the correct dose.

There are not enough data to make specific dosage recommendations in case of renal/hepatic insufficiency.

If symptoms persist for more than 5 days of using the medicine, you should consult a doctor.

If You Take More Hedetus Than You Should

If you have taken more medicine than you should, consult your doctor or pharmacist immediately. Overdose of ivy leaf extract may cause nausea, vomiting, diarrhea, and nervousness. In case of symptoms of poisoning or overdose, symptomatic treatment will be applied.

If You Forget to Take Hedetus

Do not take a double dose to make up for forgotten doses.

If You Stop Taking Hedetus

Not applicable

If you have any other questions 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. The following side effects have been reported (frequency unknown):

• Gastrointestinal disorders such as nausea, vomiting, or diarrhea.
• Hypersensitivity reactions, such as hives, skin rash, difficulty breathing

If you notice symptoms of hypersensitivity, stop taking Hedetus and consult your doctor.

Reporting Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Hedetus

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

Store below 25°C.

Once opened, the syrup expires after 28 days.

Do not use this medicine after the expiration date stated on the carton and bottle after "EXP". The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Hedetus:

The active substance is:

Dry extract of ivy leaf (Hedera helixL., folium). 1 ml of syrup (equivalent to 1.1 g) contains 5.4 mg of extract (in the form of dry extract) of Hedera helixL., folium(ivy leaf) (5-7.5:1). Extraction solvent: Ethanol 30% (m/m).

The other components are:

Lactose monohydrate, sorbitol (E420), benzoic acid (E210), xanthan gum, ammonium glycyrrhizate, essential oil of Eucalyptusradiata (Sieber ex DC), and purified water.

Appearance and Package Contents

Green, translucent liquid with a characteristic odor in a 200 ml amber glass bottle with a child-resistant plastic cap and measuring cup.

Marketing Authorization Holder and Manufacturer

Conforma NV

Zenderstraat 10

9070 Destelbergen

Belgium

This medicine is authorized in the Member States of the European Economic Area under the following names:

BE: Pulmocap Hedera, siroop

NL: Pulmocap Hedera, stroop

LU: Pulmocap Hedera, sirop

FR: Hedetus, sirop

DE: Pulmocap Hedera, Sirup

PL: Mituret

IT: Edera Conforma

ES: Hedetus, jarabe

PT: Pulmocap Hedera, xarope

AT: Pulmocap Hedera, Sirup

Date of Last Revision of this Package Leaflet: 12/2017

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/