HEDELIX TROPFEN 50ML

ATC code: R05CA12 

Active substances: Hederae Helicis Folii Extractum Siccum

Vendor, principal: Krewell Meuselbach. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

HEDELIX S.A. 40MG/1ML 50ML

Package leaflet: Information for the user

HEDELIX s.a., oral drops, solution

Ivy (Hedera helix) leaf extract

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you.
-   Keep this leaflet. You may need to read it again.
-   Ask your pharmacist if you need more information or advice.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
-   You must talk to a doctor if you do not feel better or if you feel worse after a few days.

What is in this leaflet:

1.   What Hedelix s.a. is and what it is used for
2.   What you need to know before you use Hedelix s.a.
3.   How to take Hedelix s.a.
4.   Possible side effects
5.   How to store Hedelix s.a.
6.   Contents of the pack and other information

1.   What Hedelix s.a. is and what it is used for

Hedelix s.a. is an herbal preparation that is used to loosen sputum.
Consult a doctor immediately if the symptoms (shortness of breath, fever, purulent and bloody sputum) persist.
You must talk to a doctor if you do not feel better or if you feel worse after a few days.

2.   What you need to know before you use Hedelix s.a.

Do not take Hedelix s.a.:

-   if you are allergic to ivy leaves, the Araliaceae plant family, menthol or to any of the excipients of this medicine;
-   if you have argininosuccinate synthetase deficiency (metabolic urea cycle disorder);

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Hedelix s.a..

Children

Do not give Hedelix s.a. to children less than two years of age because it may increase the risk of exacerbation of general respiratory symptoms.

Other medicines and Hedelix s.a.

No known interactions.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Hedelix s.a. with food and drink

No special precautions are necessary.

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 for advice before taking this medicine.
This medicine should not be used without medical advice as there are insufficient data about the use in pregnant women.

Driving and using machines

No special precautions are necessary.

3. How to take Hedelix s.a.

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
-   adults and children over 10 years of age: 31 drops 3 times daily (equivalent to 300 mg of dried ivy leaves per every 24 hours);
-   children between 4 and 10 years of age: 21 drops 3 times daily (equivalent to 200 mg of dried ivy leaves per every 24 hours);
-   children between 2 and 4 years of age: 16 drops 3 times daily (equivalent to 150 mg of dried ivy leaves per every 24 hours).
Method of administration
For oral administration.
Take Hedelix s.a. undiluted, with a sufficient amount of water. It is recommended to give Hedelix s.a. to infants together with tea or juice.
You can take the medicine independent of meals.
Treatment duration
If you have the impression that the effect of the medicine is too strong or too weak, talk to your doctor.
You must talk to a doctor if the symptoms persist, or even worsen, after a few days.

If you take more Hedelix s.a. than you should

Exceeding one or two dose limits (30 to 60 drops for adults) does not usually cause overdose symptoms.
Administration of higher doses may cause nausea, vomiting, diarrhoea and restlessness. If you develop any symptoms that you associate with this medicine, inform your doctor.

If you forget to use Hedelix s.a.

Continue the treatment according to the dosage mentioned above or prescribed by your doctor.
Do not take a double dose to make up for a forgotten dose.

If you stop taking Hedelix s.a.

If you have any further questions on 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.
Medicines containing ivy leaves may cause allergic reactions (shortness of breath, redness, itching). Sensitive persons may sometimes develop gastrointestinal tract complaints (nausea, vomiting, diarrhoea).
If you develop any side effects that you associate with this medicine, inform your doctor.
If your symptoms persist or if you develop shortness of breath, fever, or purulent or bloody sputum, consult your doctor immediately.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Hedelix s.a.

Keep this medicine out of the sight and reach of children.
The expiry date is printed on the package.
Do not use Hedelix s.a. after the expiry date which is stated on the package. The expiry date refers to the last day of that month. This product does not require any specific storing conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information What Hedelix s.a. contains

-   The active substance is ivy (Hedera helix) leaf extract.
1 mL contains 40 mg of ivy leaf extract (2.2 to 2.9:1).
Extractive agents: ethanol 50 % v/v, propylene glycol (98:2)
-   The excipients are propylene glycol, glycerol and flavouring: anise oil, eucalyptus oil, menthol and peppermint oil.
-   Hedelix s.a. contains no alcohol.
Hedelix s.a. is sugar free and non-alcoholic. It can therefore also be used by diabetics and patients who must avoid alcohol consumption.

What Hedelix s.a. looks like and contents of the pack

Hedelix s.a. drops are a greenish-brown, viscous solution, with an aromatic odour.
Hedelix s.a. drops contain herbal extractive matter and may therefore turn cloudy over time, and the taste of the drops may also change.
Hedelix s.a. drops are available in bottles of 20 mL, 50 mL or 100 mL.

Marketing Authorisation Holder and Manufacturer

Krewel Meuselbach GmbH Krewelstraße 2 53783 Eitorf Germany
Tel: +49 (0) 2243 / 87-0
Fax: +49 (0) 2243 / 87-175 E-mail: [email protected]
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:
Representative of Marketing Authorisation Holder in the Baltic states:
Krewel Meuselbach Office Riga, Kleistu 24, LV-1067, Riga, Latvia

This leaflet was last revised in June 2016.