HEDELIX

HEDELIX cough syrup

Important notes (mandatory information)

Hedelix Cough Syrup. Active ingredient: Ivy leaf extract. Areas of application: for colds of the respiratory tract, to alleviate symptoms of chronic inflammatory bronchial diseases.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Hedelix Cough Syrup 0.8 g/100 ml
Active ingredient: Ivy leaf extract
Herbal medicinal product

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, Hedelix Cough Syrup must be used as directed in order to be effective.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor.
• If any of the side effects listed here affect you severely or if you notice any side effects not listed in this package leaflet, please tell your doctor or pharmacist.

This package leaflet contains

1. WHAT IS HEDELIX COUGH SYRUP AND WHAT IS IT USED FOR?
2. WHAT YOU NEED TO KNOW BEFORE TAKING HEDELIX COUGH SYRUP?
3. HOW TO TAKE HEDELIX COUGH SYRUP?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE HEDELIX COUGH SYRUP?
6. FURTHER INFORMATION

1. WHAT IS HEDELIX COUGH SYRUP AND WHAT IS IT USED FOR?

Hedelix Cough Syrup is a herbal medicinal product for colds of the respiratory tract. Hedelix Cough Syrup is used for colds of the respiratory tract, to alleviate symptoms of chronic inflammatory bronchial diseases. If symptoms persist or if shortness of breath, fever, or purulent or bloody sputum occur, a doctor should be consulted immediately.

2. WHAT YOU NEED TO KNOW BEFORE TAKING HEDELIX COUGH SYRUP?

Hedelix Cough Syrup must not be taken:

• if you are allergic (hypersensitive) to ivy leaves or any of the other ingredients of Hedelix Cough Syrup.
• in case of argininosuccinate synthetase deficiency (metabolic disorder of the urea cycle).

Take special care with Hedelix Cough Syrup

No information available.

Taking Hedelix Cough Syrup with other medicines

No interactions are known. However, please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Taking Hedelix Cough Syrup with food and drink

No special precautions are necessary.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking/using any medicine. This medicine should not be used during pregnancy and breast-feeding, as there is insufficient research available.

Driving and using machines

No special precautions are necessary.

Important information about certain other ingredients of Hedelix Cough Syrup

This medicine contains sorbitol. Please only take Hedelix Cough Syrup after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 5 ml of liquid contain 1.75 g of sorbitol (equivalent to 0.44 g of fructose) corresponding to approx. 0.15 bread units (BUs). Sorbitol may have a mild laxative effect.

3. HOW TO TAKE HEDELIX COUGH SYRUP?

Always take Hedelix Cough Syrup exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the usual dose is:

• for adults and children over 10 years of age, 5 ml of cough syrup 3 times a day.
• for children aged 4 to 10 years, 2.5 ml of cough syrup 4 times a day.
• for children aged 1 to 4 years, 2.5 ml of cough syrup 3 times a day.
• for children aged 0 to 1 year, 2.5 ml of cough syrup once a day.

Method of administration

For oral use. Please take the cough syrup undiluted and drink plenty of fluids afterwards (preferably drinking water). A dosing syringe with a printed measuring scale is included in the pack for accurate dosing.

Instructions for using the dosing syringe

1. Insert the dosing syringe into the opened bottle and press it down until it is firmly seated. The syringe plunger should be inserted into the syringe up to the stop.
2. Carefully turn the bottle upside down and slowly draw the liquid into the dosing syringe by pulling the syringe plunger out to the desired mark.
3. Turn the bottle right side up again and carefully pull the syringe out of the neck of the bottle. Close the bottle again after removing it.
4. Administer the cough syrup either directly with the syringe by slowly emptying the syringe against the inside of the cheek or on a spoon.
5. After use, pull the plunger out of the syringe barrel, clean the parts with warm water and then dry the syringe.

Duration of use

Do not take Hedelix Cough Syrup for more than a few days without medical advice. See also section 1. "What is Hedelix Cough Syrup and what is it used for?". Please talk to your doctor or pharmacist if you have the impression that the effect of Hedelix Cough Syrup is too strong or too weak.

If you have taken more Hedelix Cough Syrup than you should

If you have accidentally taken one or two single doses (e.g. for adults 5 ml or 10 ml of cough syrup) more than intended, this will generally have no adverse effects. However, taking significantly more than this could cause nausea, vomiting and diarrhoea. In this case, you should contact a doctor.

If you forget to take Hedelix Cough Syrup

Do not take a double dose the next time, but continue taking it as prescribed by your doctor or as described in this package leaflet.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Hedelix Cough Syrup can have side effects, although not everybody gets them.

The following categories are used to classify the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Very rarely, allergic reactions (shortness of breath, swelling, skin redness, itching) may occur after taking ivy-containing medicines. In sensitive individuals, gastrointestinal complaints (nausea, vomiting, diarrhoea) may occasionally occur.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE HEDELIX COUGH SYRUP?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after "Use by:". The expiry date refers to the last day of the month. Storage conditions: No special storage conditions are required for this medicine. Note on shelf life after opening: Hedelix Cough Syrup can be stored for 6 months after opening.

6. FURTHER INFORMATION

What Hedelix Cough Syrup contains

The active ingredient is: Ivy leaf extract. 100 ml of syrup contain: 0.8 g of extract from ivy leaves in a ratio of drug to extract as (2.2 - 2.9 : 1). The extraction agent is ethanol 50% (V/V), propylene glycol (98 : 2). No ethanol is contained in the final product. The other ingredients are: Macrogol glycerol hydroxystearate, star anise oil Ph. Eur., hypromellose, sorbitol solution 70% (non-crystallising), propylene glycol, glycerol, purified water.

What Hedelix Cough Syrup looks like and contents of the pack

Hedelix Cough Syrup is a clear, yellow-brown liquid. Hedelix Cough Syrup is available in packs of 100 ml (N1) and 200 ml (N2) of cough syrup. Each pack contains a dosing syringe (marking of the medical device: CE 0120).

Further information

Hedelix Cough Syrup is sugar-free and therefore suitable for diabetics. 5 ml of cough syrup contain 1.75 g of sorbitol, corresponding to 0.15 BUs. Hedelix Cough Syrup is alcohol-free (ethanol) and therefore also suitable for patients who must avoid alcohol (ethanol). Due to the content of plant extractives, Hedelix Cough Syrup may occasionally show turbidity, sediment and/or slight taste deviations.

Pharmaceutical entrepreneur and manufacturer

Krewel Meuselbach GmbH
Krewelstr. 2
53783 Eitorf
Phone: 02243 / 87-0
Fax: 02243 / 87-175
E-mail: info@krewelmeuselbach.de

This package leaflet was last revised in July 2014.

Source: Information from the package leaflet
Status: 05/2018
Active ingredient: Ivy leaf extract. Areas of application: for colds of the respiratory tract, to alleviate symptoms of chronic inflammatory bronchial diseases.