Patient Information Leaflet

Hedetus, 5.4 mg/ml, syrup

Dry extract of ivy leaf

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

Follow exactly the administration instructions contained in this leaflet or those given 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 5 days.

1. What is Hedetus and what it is used for

2. What you need to know before starting to take Hedetus

3. How to take Hedetus

4. Possible side effects

5. Storage of Hedetus

6. Contents of the pack and additional information

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

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

Consult a doctor if symptoms worsen or do not improve after 5 days.

Do not take this medication:

• if you are allergic to ivy, other members of the Araliaceae family, or any of the other ingredients in this medication (listed in section 6.1).Araliaceae
• in children under 2 years of age, as symptoms may generally worsen in this age group.

Warnings and precautions

Consult your doctor before starting this medication:

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

Children

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

Taking Hedetus with other medications

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

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 medication.

Pregnancy

It is recommended not to take Hedetus during pregnancy.

Breastfeeding

Hedetus should not be used during the breastfeeding period.

Fertility

No data are available on fertility.

Driving and operating machinery

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

Hedetus contains:

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

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

The recommended dose is:

Hedetus should be taken orally. The container contains a dosing cup to measure the correct dose.

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

If symptoms persist for more than 5 days of medication use, you should consult your doctor.

If you take more Hedetus than you should

If you have taken more medication than you should, consult your doctor or pharmacist immediately. Excessive hawthorn extract can cause nausea, vomiting, diarrhea, and nervousness. In case of poisoning or overdose symptoms, symptomatic treatment will be applied.

If you forgot to take Hedetus

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

If you interrupt treatment with Hedetus

This does not apply

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

Like all medications, this medication may produce adverse effects, although not all people may experience them. The following adverse effects have been reported (unknown frequency):

• Gastrointestinal disturbances such as nausea, vomiting, or diarrhea.
• Hypersensitivity reactions, such as urticaria, skin rashes, difficulty breathing

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

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

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

Store below 25°C.

Once opened, the syrup expires after 28 days.

Do not use this medication after the expiration date that appears on the box and bottle after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Hedetus:

The active principle is:

Dried 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 dried extract) ofHedera helixL.,folium(ivy leaf) (5-7.5:1). Solvent: Ethanol 30% (m/m).

The other components are:

Lactose monohydrate, sorbitol (E420), benzoic acid (E210), xanthan gum, glycyrrhizic acid, eucalyptus oil (Eucalyptusradiata (Sieber ex DC)) and purified water.

Appearance of the product and contents of the packaging

Green, translucent liquid with a characteristic odor in an amber glass bottle of 200 ml with a child-resistant plastic closure and a dosing cup.

Holder of the marketing authorization and responsible for manufacturing

Conforma NV

Zenderstraat 10

9070 Destelbergen

Belgium

This medicinal product is authorized in the member states of the European Economic Area with the following names:

BE:Pulmocap Hedera, syrup

NL:Pulmocap Hedera, stroop

LU:Pulmocap Hedera, syrup

FR:Hedetus, syrup

DE:Pulmocap Hedera, Sirup

PL:Mituret

IT:Edera Conforma

ES:Hedetus, syrup

PTPulmocap Hedera, syrup

AT:Pulmocap Hedera, Sirup

Date of the last review of this leaflet: 12/2017

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