Hedetus 5,4 mg/ml jarabe
Como usar Hedetus 5,4 mg/ml jarabe
Introduction
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
1. What is Hedetus and how is it used
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.
2. What you need to know before starting to take Hedetus
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.
3. How to Take Hedetus
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:
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 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.
4. Possible Adverse Effects
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.
5. Hedetus Storage
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.
6. Contents of the packaging and additional information
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/
- País de registo
- Substância ativa
- Requer receita médicaNão
- Fabricante
- ComposiçãoAcido benzoico (e210) (1,11 mg mg), Sorbitol (418 mg mg)
- Esta informação é apenas para referência e não constitui aconselhamento médico. Consulte sempre um médico antes de tomar qualquer medicamento. A Oladoctor não se responsabiliza por decisões médicas baseadas neste conteúdo.
Consulte um médico online sobre o Hedetus 5,4 mg/ml jarabe
Consulte um médico online
Tem perguntas sobre este medicamento ou sintomas? Obtenha orientação de um médico qualificado, de forma prática e segura.
Receba novidades da plataforma e promoções exclusivas
Fique a par das atualizações da Oladoctor e receba promoções exclusivas para subscritores.
