You can overdose on cough syrup

HEDELIX CUFF JUICE

Patient information for HEDELIX COUGH JUICE

1. What is HEDELIX CUFF JUICE and what is it used for?

1.1 What are the properties of the medicinal product?

HEDELIX COUGH JUICE contains the active ingredient ivy leaves, a drug from the group of so-called herbal medicines for colds of the respiratory tract.

An expectorant effect is said to come about through stimuli on the mucous membranes of the stomach. The mucous glands in the bronchial mucosa are stimulated.

Ivy leaves are usually used in the form of ivy leaf extract.

HEDELIX COUGH JUICE is only available in pharmacies and without a prescription.

1.2 Effective strength and dosage form of HEDELIX CUFF JUICE

Syrup containing 0.8 g extract from ivy leaves in 100 ml (2.2 to 2.9: 1).

Extraction agent: ethanol 50% (V / V), propylene glycol (98: 2). There is no ethanol in the end product.

Your doctor or your pharmacist will advise you whether this strength and dosage form are suitable for your treatment.

1.3 HEDELIX CUFF JUICE is used

- for colds of the respiratory tract,

- to improve the symptoms of chronic inflammatory bronchial diseases.

2. What you need to know before you take HEDELIX COUGH JUICE?

2.1 HEDELIX CUFF JUICE must not be taken

- if you are hypersensitive (allergic) to ivy leaves or any of the other ingredients.

- with arginine succinate synthetase deficiency (metabolic disease of the urea cycle).

2.2 Special care is required when taking HEDELIX COUGH JUICE

If symptoms persist or if you experience shortness of breath, fever or purulent or bloody sputum, a doctor should be consulted immediately.

Note on other ingredients: 5 ml of liquid contain 1.75 g sorbitol (corresponds to 0.44 g fructose) corresponding to approx. 0.15 bread units (BU). Sorbitol can have a mild laxative effect. Patients with the rare hereditary problems of fructose intolerance should not take HEDELIX COUGH JUICE.

2.2.a) Children

Ask your pediatrician for advice before using any medicine.

2.2.b) Elderly patients

There are no special precautions.

2.2.c) Pregnancy

This medicine should not be used during pregnancy as insufficient studies are available.

2.2.d) Breastfeeding

This medicine should not be used during breastfeeding as insufficient studies are available.

2.2.e) Ability to drive and use machines

There are no special precautions required.

2.3 Which interactions with other medicinal products have to be considered?

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

Interactions with other drugs have not been investigated. So far, no interactions have become known.

2.4 What should be thought of when taking HEDELIX COUGH JUICE together with food, beverages and tobacco?

There are no special features to consider.

3. How to take HEDELIX CUFF JUICE?

Always take HEDELIX CUFF JUICE exactly as your doctor has told you. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

To take.

Shake the bottle before each use!

Do not take HEDELIX CUFF JUICE for more than a few days without medical advice.

Please talk to your doctor or pharmacist if you have the impression that the effect is too strong or too weak.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

A dosing syringe with a printed measuring scale is included in the package for precise dosing.

3.2.a) Adults and children over 10 years

5 ml cough syrup 3 times a day (equivalent to 300 mg drug per day).

3.2.b) Children from 4 to 10 years

2.5 ml cough syrup 4 times a day (equivalent to 200 mg drug per day).

3.2.c) Children from 1 to 4 years

2.5 ml cough syrup 3 times a day (equivalent to 150 mg drug per day).

3.2.d) Children from 0 to 1 year

2.5 ml cough syrup once a day (equivalent to 50 mg drug per day).

3.3 If you have taken more HEDELIX CUFF REFRIGERANT than you should

If you take more of this medicine than you should, please notify your doctor. This can decide on any necessary measures. The side effects listed below may be more pronounced.

3.4 If you forget to take HEDELIX CUFF JUICE

Next time do not take a double amount, but continue with the intake as prescribed by your doctor or as described in section 3.2.

3.5 Effects of stopping treatment with HEDELIX COUGH JUICE

If you want to stop the treatment, please discuss this with your doctor or pharmacist beforehand.

4. What are the possible side effects?

Like all medicines, HEDELIX CUFF PULSET can cause side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100 but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

The list includes all known side effects under treatment with ivy leaves, including those under higher doses or long-term therapy.

4.1.a) Very rare

Allergic reactions (shortness of breath, swelling, reddening of the skin, itching) may occur after taking ivy-containing drugs.

4.1.b) Occasionally

In sensitive people, gastrointestinal complaints (nausea, vomiting, diarrhea) can occur.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. 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 JUICE

Store HEDELIX COUGH JUICE at normal room temperature and keep the medicine in the original packaging away from light and moisture.

Medicines should generally be kept out of the reach of children. Shelf life after opening: 6 months

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; September 2015 (2)