HEDELIX (EFEJAS EKSTRAKTS) SYRUP 100ML

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 8MG/1ML 100ML

Package leaflet: Information for the user Hedelix, 8 mg/mL syrup

Thick 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 take this medicine exactly as described in this leaflet or as your doctor or pharmacist 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 or pharmacist. 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 7 days.

What is in this leaflet:

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

1.   What Hedelix syrup is and what it is used for

Hedelix is an herbal preparation used as an expectorant.
Hedelix syrup is used to loosen sputum in the case of respiratory inflammation and for relief of chronic bronchitis symptoms.
If your symptoms persist or if you develop shortness of breath, fever, or purulent or bloody sputum, talk to your doctor immediately.

2.   What you need to know before you use Hedelix syrup Do not take Hedelix syrup:

-   if you are allergic to ivy (Hedera helix) or any of the other ingredients of Hedelix syrup (listed in section 6),
-   if you have argininosuccinate synthetase deficiency (metabolic urea cycle disorder).

Warnings and precautions

Talk to your doctor or pharmacist before taking Hedelix syrup.
Concurrent use with other antitussive medications such as codeine and dextromethorphan is not recommended, unless medically advised.

Other medicines and Hedelix syrup

No known interactions.
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Hedelix syrup with food and drink

No special precautions are necessary.

Pregnancy and breast-feeding

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.

Hedelix syrup contains sorbitol

If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product.
1 measuring spoonful (5mL) contains 1.75 g of sorbitol (equivalent to 0.44 g of fructose), corresponding to 0.15 bread units (BU).

3. How to take Hedelix syrup

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.
Recommended dose, unless the doctor has prescribed otherwise:
adults and children over 10 years of age take one measuring cup (5 mL) of syrup 3 times daily; children between 4 and 10 years of age take a 54 measuring cup (2.5 mL) of syrup 4 times daily; children between 1 and 4 years of age take a 54 measuring cup (2.5 mL) of syrup 3 times daily;
Children under 1 year of age take a 54 measuring cup (2.5 mL) of syrup once daily.
Method of administration
For oral administration.
Take Hedelix syrup undiluted, with a sufficient amount of water.
Duration of treatment
Duration of treatment depends on the severity of the condition. It is recommended to use the medication for at least one week. You must contact your doctor if the symptoms worsen or do not improve after 7 days.
If you feel that the effect of the medicine is too strong or too weak, talk to your doctor.

If you take more Hedelix syrup than you should

Exceeding one or two dose limits (1 to 2 measuring spoonfuls for adults) does not usually cause overdose symptoms. Administration of higher doses may cause nausea, vomiting, and diarrhoea. In such cases contact your doctor.

If you forget to use Hedelix syrup

Do not take a double dose to make up for a forgotten dose. Continue taking the recommended dosages of the medicine.

If you stop taking Hedelix syrup

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.
The assessment of side effects is based on the following frequency data:
Occur in more than one user in 10.
Uncommon: (affects less than one user in 100)
Rare: (affects less than one user in 1,000)
Rare: (affects less than one user in 10,000)
Very rare: (affects less than one user in 10,000)
Not known (cannot be estimated from the available data)
Immune system disorders
Very rare: allergic reactions such as shortness of breath, Quincke’s oedema (angiooedema), erythema and itching. Gastro-intestinal disorders:
Uncommon: sensitive persons may develop gastrointestinal disorders such as nausea, vomiting and diarrhoea. Very rare: allergic reactions (shortness of breath, swelling, erythema and itching)
Uncommon: sensitive persons may develop gastrointestinal disorders such as nausea, vomiting and diarrhoea.
If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 syrup

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after {date DD.MM.YYYY}. The expiry date refers to the last day of that month.
Storage conditions
This medicinal product does not require any special storage conditions.
Shelf-life after first opening of package: You can use Hedelix syrup within 6 months after first opening of package.
Do not use this medicine if you notice apparent signs of deterioration.
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 protect the environment.

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

-   The active substance is ivy (Hedera helix) leaf extract.
1 mL of the syrup contains 8 mg of thick ivy (Hedera helix) leaf extract (2.2 to 2.9:1).
Extractive agents: ethanol 50 % v/v, propylene glycol (98:2).
Medical preparation contains no alcohol (ethanol).
-   The other ingredients are macrogolglycerol hydroxystearate, star anise oil, hydroxyethyl cellulose, sorbitol solution (non-crystallising), propylene glycol, glycerol, distilled water.
Hedelix syrup is sugar free and non-alcoholic. It can therefore be used by diabetics and patients who have to avoid alcohol consumption. 5mL contains 1.75 g of sorbitol, corresponding to 0.15 bread units (BU). 1 bread unit corresponds to a quantity of food that contains 12 grams of carbohydrates.

What Hedelix syrup looks like and contents of the pack

Hedelix syrup is a clear, yellowish-brown solution.
Hedelix syrup contains herbal extractive matter and may therefore turn cloudy over time. The taste of the syrup may also change. These changes do not influence the therapeutic effect of the syrup.
The package includes 100 mL of syrup and a 5 mL measuring spoon.

Marketing Authorisation Holder and Manufacturer

Krewel Meuselbach GmbH
53783 Eitorf
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Representative of marketing authorisation holder in Baltics

Krewel Meuselbach office Riga Kleistu 24 1067 Riga Latvia
Tel: +371 7067912 Fax: +371 7067914 E-mail: [email protected]

This leaflet was last revised in August 2015.