HEDETUS 5.4 mg/ml SYRUP
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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
- What is Hedetus and what is it used for
- What you need to know before taking Hedetus
- How to take Hedetus
- Possible side effects
- Storage of Hedetus
- 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
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:
Age | Dose |
Adults, adolescents, and elderly | 5 ml, 2 to 3 times a day |
Children between 6 and 12 years of age | 5 ml, 2 times a day |
Children between 2 and 5 years of age | 2.5 ml, 2 times a day |
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/
- Country of registration
- Active substance
- Prescription requiredNo
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to HEDETUS 5.4 mg/ml SYRUPDosage form: ORAL SOLUTION/SUSPENSION, 7 mg/mlActive substance: Hederae helicis foliumManufacturer: Engelhard Arzneimittel Gmbh & Co. KgPrescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 35 mgActive substance: Hederae helicis foliumManufacturer: Adventia Pharma S.L.Prescription not requiredDosage form: ORAL SOLUTION/SUSPENSION, 7 mg/mlActive substance: Hederae helicis foliumManufacturer: Adventia Pharma S.L.Prescription not required
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