Hedelix

Package Leaflet: Information for the User

Hedelix, 50 mg, Effervescent Tablets

Hederae helicis folii extractum siccum

Read the Package Leaflet Carefully Before Taking the Medicinal Product

This medicinal product must be taken exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you have any further questions, ask your doctor or pharmacist.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your pharmacist.
• If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Package Leaflet

• 1. What is Hedelix and What is it Used For
• 2. Important Information Before Taking Hedelix
• 3. How to Take Hedelix
• 4. Possible Side Effects
• 5. How to Store Hedelix
• 6. Contents of the Package and Other Information

1. What is Hedelix and What is it Used For

Hedelix is a herbal medicinal product used as an expectorant in the treatment of cough with phlegm production.

2. Important Information Before Taking Hedelix

When Not to Take Hedelix

Hypersensitivity to the active substance, to plants of the Araliaceae family, menthol, or any of the other ingredients of this medicinal product (listed in section 6).

Warnings and Precautions

Before taking Hedelix, talk to your doctor or pharmacist. If you experience shortness of breath, fever, or purulent sputum, consult your doctor or pharmacist. Patients with gastric mucosa inflammation or stomach ulcers should exercise caution.

Children

Hedelix effervescent tablets are not intended for use in children under 6 years of age.

Hedelix and Other Medicinal Products

Tell your doctor or pharmacist about all medicinal products you are taking or have recently taken, and about any medicinal products you plan to take. There are no data on the interaction of Hedelix effervescent tablets with other medicinal products. No interaction studies have been performed.

Taking Hedelix with Food, Drink, and Alcohol

Take the medicinal product after a meal.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicinal product. The safety of Hedelix during pregnancy and breast-feeding has not been established. Due to the lack of sufficient data, the use of Hedelix is not recommended during pregnancy and breast-feeding. There are no data on fertility.

Driving and Using Machines

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

Hedelix Contains Sodium

This medicinal product contains 316 mg of sodium (the main component of common salt) per effervescent tablet, which is 15.8% of the maximum recommended daily intake of sodium for adults.

Hedelix Contains Macrogol Hydroxystearate

Macrogol hydroxystearate may cause stomach upset and diarrhea.

Hedelix Contains Glucose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to Take Hedelix

Take this medicinal product exactly as described in this package leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

Recommended Dose:

Unless otherwise directed by your doctor, the recommended dose is: Adolescents from 12 years of age, adults, and the elderly: Take 1 effervescent tablet (corresponding to 50 mg of dry extract of ivy leaves) twice daily (in the morning and in the evening). Children from 6 to 11 years of age: Take ½ effervescent tablet (corresponding to 25 mg of dry extract of ivy leaves) twice daily (in the morning and in the evening). This medicinal product is not intended for use in children under 6 years of age. Tube: Store the other half of the effervescent tablet in the tube until the next use (maximum 24 hours). Close the tube tightly after taking the tablet. Sachet: Store the other half of the effervescent tablet in the closed sachet until the next use (maximum 24 hours). Fold the open edge of the sachet twice to close it. The tablet can be divided into two equal doses. In patients with renal or hepatic impairment, due to the lack of sufficient data, no special dosage recommendations can be given. Method of administration: Oral use. Dissolve the tablet in half a glass of water and drink after a meal. Duration of use: If symptoms persist for more than one week, consult your doctor or pharmacist.

Overdose of Hedelix

Normally, no side effects are expected if one effervescent tablet more than recommended is taken. If significantly more tablets are taken, nausea, diarrhea, and restlessness may occur. One case of a 4-year-old child who developed aggression and diarrhea after accidentally ingesting an amount of ivy extract corresponding to 6 effervescent tablets has been reported. In such cases, consult your doctor.

Missed Dose of Hedelix

Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicinal product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicinal products, Hedelix can cause side effects, although not everybody gets them. The following list includes all known side effects, which have been reported in clinical trials and post-marketing experience with ivy leaf extract, including those occurring at higher doses and during long-term treatment.

Side Effects:

Gastrointestinal reactions (nausea, vomiting, diarrhea) have been reported. The frequency is not known. Allergic reactions (hives, skin rash, shortness of breath, anaphylactic reactions) have been reported. The frequency is not known. If you experience any side effects not listed in this package leaflet, please inform your doctor or pharmacist.

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, please inform your doctor or pharmacist. Side effects can be reported to the Department of Pharmacovigilance, 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to Store Hedelix

Keep this medicinal product out of the sight and reach of children. Do not use this medicinal product after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Storage Conditions:

No special storage conditions are required. Tube: Store in the original package in order to protect from moisture. After first opening, store below 25°C. Sachet: Store in the original package in order to protect from moisture.

Shelf-Life After First Opening of the Package:

3 years. Tube: Shelf-life after first opening: 6 months. Sachet: Shelf-life after first opening: 24 hours. Medicinal products should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicinal products no longer required. This will help protect the environment.

6. Contents of the Package and Other Information

What Hedelix Contains

The active substance is: Dry extract of ivy leaves (Hederae helicis folii extractum siccum). One effervescent tablet contains 50 mg of dry extract of ivy leaves (4-8:1); extraction solvent: ethanol 30% (m/m). The other ingredients are: Anhydrous citric acid, sodium hydrogen carbonate, sodium carbonate, mannitol, sodium saccharin, sodium citrate, simethicone, triglycerides of saturated fatty acids of medium chain length, macrogol hydroxystearate, enocianina (E 163) powder (composition: anthocyanin extract from grape skin (E 163), glucose syrup, beetroot red (E 162) powder (composition: beetroot juice concentrate (E 162), maltodextrin, citric acid), blackcurrant flavor 0002151 (composition: ethyl butyrate, raspberry ketone, linalool, hex-3-en-1-ol, L-menthol, maltodextrin, propylene glycol (E 1520), modified starch (E 1450)).

What Hedelix Looks Like and Contents of the Package

Hedelix effervescent tablets are round, flat, with purple spots and a dividing line on one side, 22 mm in diameter and 5.2 mm thick. Packaging: Tube with PP closure with a desiccant, in a cardboard box, with a package leaflet. Pack sizes: 10, 20, 50, 100 effervescent tablets. Sachet paper/Aluminum, in a cardboard box, with a package leaflet. Pack sizes: 12, 20, 24 effervescent tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Krewel Meuselbach GmbH, Krewelstr. 2, 53783 Eitorf, Germany. Telephone: +49 (0)2243/ 87-0, Fax: +49 (0)2243/ 87-175, email: [email protected]

This Medicinal Product is Authorized in the Member States of the European Economic Area 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

Date of Last Revision of the Package Leaflet: 01/2023