Hedelix
Poland
Table of Contents
Patient Information Leaflet: Information for the User
Hedelix, 50 mg, effervescent tablets
Hederae helicis folii extractum siccum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.
This medicine should always be taken exactly as described in this patient leaflet or as directed by your
doctor or pharmacist.
- Keep this leaflet so that you can read it again if necessary.
- If you have any questions, please consult your pharmacist.
- If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
- If there is no improvement after 7 days, or if your condition worsens, you should contact your doctor.
Table of contents
- What Hedelix is and what it is used for
- What you need to know before taking Hedelix
- How to take Hedelix
- Possible side effects
- How to store Hedelix
- Contents of the pack and other information
1. What Hedelix is and what it is used for
Hedelix is a herbal medicinal product used as an expectorant in productive cough associated with mucus.
2. Important information before taking Hedelix medicine
When not to take Hedelix
Hypersensitivity to the active substance, to plants of the Araliaceae family (Araliaceae), menthol, or
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before using Hedelix medicine, talk to your doctor or pharmacist.
If shortness of breath (difficulty breathing), fever, or purulent (pus-containing) sputum occurs, consult your doctor or pharmacist.
Caution is advised in patients with gastric mucosal inflammation or gastric ulcer.
Children
Hedelix effervescent tablets are not intended for use in children under 6 years of age.
Hedelix medicine with other medicines
Inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
There is no data available on interactions between Hedelix effervescent tablets and other medicines. Interactions have not been studied.
Use of Hedelix medicine with food, drink, and alcohol
This medicine should be taken after food.
Pregnancy, breastfeeding, and fertility
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, you should consult your doctor or pharmacist before using this medicine.
The safety of use during pregnancy and breastfeeding has not been established. Due to insufficient data, the use of this medicine is not recommended during pregnancy and breastfeeding.
There is no data available regarding fertility.
Driving and operating machinery
No studies have been conducted on the influence of this medicine on the ability to drive or operate machinery.
Hedelix medicine contains sodium.
This medicine contains 316 mg of sodium (main component of table salt) per effervescent tablet. This corresponds to 15.8% of the maximum recommended daily dietary sodium intake for adults.
Hedelix medicine contains macrogolglycerol hydroxystearate.
Macrogolglycerol hydroxystearate may cause stomach irritation and diarrhoea.
Hedelix medicine contains glucose.
If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking this medicine.
3. How to take Hedelix
This medicine should always be taken exactly as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
If your doctor has not advised otherwise, the recommended dose is:
Adolescents aged 12 years and above, adults and elderly patients
Take 1 effervescent tablet (equivalent to 50 mg of dry ivy leaf extract) twice daily (morning and evening).
Children aged 6–11 years
Take ½ effervescent tablet (equivalent to 25 mg of dry ivy leaf extract) twice daily (morning and evening).
This medicine is not intended for use in children under 6 years of age.
Tube:
Store the remaining half of the effervescent tablet in the tube until next use (for a maximum of 24 hours).
Close the tube tightly after taking the tablet.
Pouch:
Store the remaining half of the effervescent tablet in the sealed pouch until next use (for a maximum of 24 hours).
Seal the open edge of the pouch by folding it over twice.
The tablet may be divided into two equal doses.
In patients with renal and/or hepatic impairment, due to insufficient data, specific dosage recommendations cannot be provided.
Method of administration
For oral use.
Dissolve the tablet in half a glass of water and take after meals.
Duration of treatment
If symptoms persist for more than one week during treatment with this medicine, consult your doctor or pharmacist.
Taking more Hedelix than recommended
Usually, no adverse effects are expected if one extra effervescent tablet has been taken.
However, if significantly more tablets have been taken, nausea, diarrhoea, and agitation may occur.
One case has been reported in a 4-year-old child who developed aggression and diarrhoea after accidental ingestion of ivy extract equivalent to 6 effervescent tablets.
In such cases, medical advice should be sought immediately.
If you forget to take Hedelix
Do not take a double dose to make up for a missed dose.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.
4. Possible adverse reactions
Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
The list below includes all known adverse reactions reported during the use of ivy leaf extract, including those occurring after administration of higher doses and during long-term treatment.
Possible adverse reactions:
Gastrointestinal reactions (nausea, vomiting, diarrhoea) have been reported. Frequency is unknown.
Allergic reactions (urticaria, skin rash, dyspnoea, anaphylactic reactions) have been reported. Frequency is unknown.
If any other adverse reactions occur which are not listed above, consult your doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to:
Department of Monitoring of Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions may also be reported to the Marketing Authorisation Holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.
5. How to store Hedelix medicine
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after "EXP":
The expiry date refers to the last day of the stated month.
Storage conditions:
No special temperature requirements for storage of the medicinal product.
Tube: store in a tightly closed container to protect from moisture. After first opening, store below 25°C.
Sachet: store in the original packaging to protect from moisture.
Information on shelf life after first opening of the container:
3 years
Tube: shelf life after first opening: 6 months
Sachet: shelf life after first opening: 24 hours
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.
6. Package contents and other information
What Hedelix effervescent tablets contain
Active substance: dried ivy leaf extract (Hederae helicis folii extractum siccum).
One effervescent tablet contains 50 mg of dried extract from Hedera helix L., folium (common ivy leaf) (4–8:1); extraction solvent: ethanol 30% (m/m).
Other ingredients:
Anhydrous citric acid, sodium hydrogen carbonate, anhydrous sodium carbonate, mannitol, sodium saccharin, sodium cyclamate, trisodium citrate, simethicone, medium-chain saturated triglycerides, macrogol glyceryl hydroxystearate, anthocyanin (E 163) powder (composition: anthocyanin extract from grape skins (E 163), glucose syrup), beetroot red (E 162) powder (composition: beetroot juice concentrate (E 162), maltodextrin, citric acid), blackcurrant flavour 0002151 (composition: ethyl butyrate, raspberry ketone, linalool, (Z)-3-hexenyl acetate, L-menthol, maltodextrin, propylene glycol (E 1520), modified starch (E 1450)).
What Hedelix effervescent tablets look like and contents of the pack
Hedelix effervescent tablets are round, flat, with purple speckles and a break line on one side, 22 mm in diameter and 5.2 mm thick.
Packaging:
PP tube with a PP closure containing a desiccant, in a cardboard box, with an enclosed leaflet.
Pack sizes: 10, 20, 50, 100 effervescent tablets.
Aluminum foil blister pack in a cardboard box, with an enclosed leaflet.
Pack sizes: 12, 20, 24 effervescent tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Dr. Theiss Naturwaren GmbH
Michelinstrasse 10
66424 Homburg
Germany
Manufacturer
Krewel Meuselbach GmbH
Krewelstrasse 2
53783 Eitorf
Germany
This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Hedelix Brausetabletten
Czech Republic: Hedelix
Estonia: Hedelix
Germany: Hedelix Brausetabletten
Hungary: Hedelix pezsgőtabletta
Latvia: Hedelix putojošās tabletes
Poland: Hedelix
Romania: Hedelix 50 mg comprimate efervescente