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Echinacin Juice Madaus

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Echinacin® Juice Madaus

ADAUS


PACKAGE LEAFLET: INFORMATION FOR THE USER

ECHINACIN JUICE MADAUS

Dried pressed juice from Echinacea purpurea fresh herb.

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take Echinacin Juice MADAUS carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Ask your pharmacist or qualified healthcare practitioner if you need more information or advice. You must contact a doctor if your symptoms worsen or do not improve after ten days.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What this product is and what it is used for

2.    Before you take Echinacin Juice MADAUS

3.    How to take Echinacin    Juice    MADAUS

4.    Possible side effects

5.    How to store Echinacin Juice MADAUS

6.    Further information

1.    WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR

Echinacin Juice MADAUS is a traditional herbal medicinal product used to relieve the symptoms of:

•    Colds

•    Flu.

This is based on traditional use only.

2.    BEFORE YOU TAKE ECHINACIN JUICE MADAUS

Do not take Echinacin Juice MADAUS

•    if you are allergic (hypersensitive) to the active ingredient or to plants of the daisy (Asteraceae/Compositae) family or any of the other ingredients of Echinacin Juice MADAUS (Please see section 6, Further information)

•    if you have a tendency to allergies such as hives, allergic eczema or asthma

•    if you suffer from the infection tuberculosis

•    if you suffer from connective tissue disease with formation of clumps of cells (sarcoidosis), mainly occuring in the lymph nodes, lung and liver

•    if you suffer from autoimmune diseases such as inflammation of the connective tissue (collagenoses) or multiple sclerosis

•    if you suffer from conditions which decrease your resistance to infections (e.g. HIV infections or AIDS) or are on therapy to reduce your natural response to infection (immunosuppression) e.g. chemo therapy for cancer, radiotherapy.

•    if you have had an organ or bone marrow transplant

•    if you suffer from blood disorders involving the white blood cell system such as low white blood cell count due to bone marrow disorders (agranulocytosis) or blood cell cancer (leukemia).

Do not give Echinacin Juice MADAUS to children below 12 years of age.

Take special care with Echinacin Juice MADAUS

- if the symptoms worsen or high fever occurs while using this product or if symptoms do not improve after 10 days, consult your doctor or pharmacist as soon as possible.

There is a possible risk of anaphylactic reactions in people who are prone to allergies. If you have suffered from hypersensitivity reactions in the past, consult your doctor before using Echinacin Juice MADAUS.

Taking other medicines

Please tell your qualified healthcare practitioner or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Do not take Echinacin Juice MADAUS with:

• medicines that suppress your immune system (such as ciclosporin and methotrexate).

Pregnancy and breast-feeding

Do not take this medicine if pregnant or breastfeeding.

Driving and using machines

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

3. HOW TO TAKE ECHINACIN JUICE MADAUS

For oral use only.

Always take Echinacin Juice MADAUS as your qualified healthcare practitioner or pharmacist has told you. You should check with your qualified healthcare practitioner or pharmacist if you are not sure.

The usual dose is:

Adults, the elderly and children over 12 years:

one 5 ml teaspoonful to be taken 3 times a day with sufficient liquid.

Start taking it at the first signs of a common cold. Echinacin Juice MADAUS should not be used for longer than 10 days.

Do not exceed the recommended dose.

If you take more Echinacin Juice MADAUS than you should

If you take too much of this medicine and feel unwell, consult your doctor as soon as possible.

If you forget to take Echinacin Juice MADAUS

If you have missed a dose, do not take a double dose to make up for a missed dose but continue taking the medicine as instructed by your qualified healthcare practitioner or pharmacist or as described in this leaflet.

Echinacin® Juice Madaus

ADAUS


If you have any further questions on the use of this product, ask your pharmacist or qualified healthcare practitioner.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, Echinacin Juice MADAUS can cause side effects, although not everybody gets them.

Stop taking Echinacin Juice MADAUS and consult your doctor at once if one of the following side effects occur:

•    allergic reactions such as itching (hives), rash

•    difficulty in breathing (bronchospasm with obstruction)

•    asthma or anaphylactic shock (a life-threatening allergic reaction)

•    blistering of the skin and mucous membranes (Stevens-Johnson Syndrome)

•    swelling of the skin due to fluid (angioedema) or swelling of the facial area (Quincke's oedema).

Echinacea can trigger allergic reactions in people who are prone to allergies.

Other side effects

There have been isolated reports suggesting an association between Echinacea products and autoimmune diseases which can cause:

•    inflammation of the brain and spinal cord (disseminated encephalitis)

•    reddish, painful, tender lumps on the skin usually below the knees (erythema nodosum)

•    low platelet count (immunothrombocytopenia)

•    destruction of blood cells by antibodies (Evans Syndrome)

•    dryness in the mouth and eyes with renal tubular dysfunction (Sjogren Syndrome).

A low white blood cell count (leucopenia) may occur in long-term use (more than 8 weeks). This may mean you are more likely to have infections.

The frequency of these side effects is not known.

If any of the side effects gets serious, or if symptoms persist for more than 10 days, or if you notice any side effects not listed in this leaflet, consult your doctor or pharmacist.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy, or call freephone 0808 100 3352 (available 10am-2pm Monday - Friday).

5.    HOW TO STORE ECHINACIN JUICE MADAUS

Keep out of the sight and reach of children.

Do not store above 25 °C. Keep in the original container.

This product should be discarded 6 months after first opening.

Do not use Echinacin Juice MADAUS after the expiry date which is stated on the label and on the carton after “EXP”. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines which are no longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Echinacin Juice MADAUS contains

Each 5 ml of oral solution contains 0.117 g of dried pressed juice from Echinacea purpurea fresh herb [31.5 - 53.6 : 1] equivalent to 3.7 - 6.3 g Echinacea purpurea (L.) Moench.

The other ingredients are:

Potassium sorbate, Citric acid, Xanthan gum,

Xylitol, Orange flavour, Water.

What Echinacin Juice MADAUS looks like and contents of the pack

Viscous brownish solution in amber glass bottles of 100 ml.

On standing, clouding or settling of the contents may occur. This will not affect the product.

Traditional Herbal Registration holder and Manufacturer

MADAUS GmbH 51101 Cologne, Germany Telephone: 0221/8998-0 Fax: 0221/8998-711

e-mail: info@rottapharm-madaus.de

Distributed by

HFA Healthcare Ltd.

30 Blossomfield Road Solihull, West Midlands,B91 1 NF

This leaflet was last revised in November 2013.

For a copy of this leaflet in Braille, large print or audio, please call HFA Healthcare Ltd medical information on

+44(0) 844 335 8270