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Echinacea Effervescent Tablets    Module 1 - Administrative Information

And Prescribing Information

Package Leaflet: Information for the User

ECHINAFLU effervescent tablets

The active substance is dried juice of Echinacea purpurea herb 176mg.

In this leaflet:

1.    What Echinaflu is and what it is used for

2.    Before you take Echinaflu

3.    How to take Echinaflu

4.    Possible side effects

5.    How to store Echinaflu

6.    Further information

1. WHAT ECHINAFLU IS AND WHAT IT IS USED FOR

This product is a traditional herbal medicinal product containing Echinaceapurpura herb. Each effervescent tablet of this product contains 176 mg of dried pressed juice from fresh flowering Echinacea purpurea (L.) Moench herb (20-28:1) (equivalent to 3520 mg - 4928 mg of fresh flowering Echinacea purpurea (L.) Moench herb).

This product is a traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections. This usage is based on traditional use only.

2. BEFORE YOU TAKE ECHINAFLU

Do not take this product if you

■    are allergic to any of the ingredients or to plants of the Asteraceae (Compositae) family such as daisies, marigolds or artichokes (see section 6)

■    have a tendency to allergies such as hives, allergic eczema or asthma

■    are pregnant or breast-feeding

■    suffer from the infection tuberculosis

■    suffer from connective tissue disease with formation of clumps of cells (sarcoidosis), mainly occurring in the lymph nodes, lungs and liver

■    suffer from autoimmune diseases such as inflammation

of the connective tissue (collagenoses) or multiple sclerosis

■    suffer from conditions which decrease your resistance to infection (e.g. HIV infection or AIDS) or

■    are on therapy to reduce your natural response to infection (immunosuppression e.g. chemotherapy or radiotherapy for cancer; history of organ or bone marrow transplant)

■    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 (leukemias)

■    are under 12 years of age

Take special care with Echinaflu

Do not exceed the stated dose.

You must contact a doctor or qualified healthcare practitioner if

■    you have a high fever or your condition worsens

■    symptoms persist for more than 10 days

■    adverse effects not mentioned in the package leaflet occur

If you are prone to allergies there is a risk of developing serious allergic reactions to Echinacea (eg. anaphylactic reactions).

Patients should be aware that the intake of products containing Echinacea species may trigger autoimmune diseases.

This product contains 17.05 mmol (or 392 mg) sodium per tablet. This is to be taken into consideration by patients on a controlled sodium diet.

This formulation is not suitable for children under 12 years of age.

Taking other medicines

Echinaflu must not be used together with immunosuppressant medications such as ciclosporin and methotrexate.

Always remember to tell your doctor about any medicines you are taking including those obtained without a prescription.

Pregnancy and breast-feeding

The safety of this product has not been sufficiently established in pregnant and breast-feeding women. Do not take this product if you are pregnant or breast-feeding.

Driving and using machines

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

3. HOW TO TAKE ECHINAFLU

You should speak to your doctor, pharmacist or healthcare practitioner if you are not sure if this product is suitable for you.

Adults, elderly, children over 12 years

Take one or two effervescent tablets daily, dissolved in a glass of water (about 200 ml). The dissolved tablets should be drunk immediately.

The effervescent tablet formulation is not intended for children below 12 years.

Echinacea Effervescent Tablets    Module 1 - Administrative Information    Page 2

And Prescribing Information

Start taking at the first signs of common cold. Do not take Echinaflu for more than 10 days.

If your symptoms worsen during the use of Echinaflu or persist for more than 10 days, you should speak to your doctor or a qualified healthcare practitioner.

If you take more Echinaflu than you should

The complaints described in section 4 (Possible side effects) may increasingly occur. In this case speak to your doctor or qualified healthcare practitioner and take this leaflet with you.

If you forgot to take Echinaflu

Continue to take your usual dose at the usual time. Do not take a double dose to make up for forgotten individual doses.

4. POSSIBLE SIDE EFFECTS

Echinaflu can cause side effects, although not everybody gets them. Stop taking Echinaflu and check with your doctor, pharmacist or qualified healthcare practitioner immediately if any of the following side effects occur:

Allergic (hypersensitive) reactions such as:

■    rash

■    hives

■    inflammatory disorder of the skin (Stevens-Johnson-Syndrome)

■    swelling of the skin due to fluid

■    swelling of the facial area (Quincke's oedema)

■    shrinking of the airways in the lungs with obstruction (bronchospasm)

■    asthma and life-threatening allergic reactions (anaphylactic shock).

Echinacea can trigger allergic reactions in patients who have a tendency to develop allergic conditions.

Association with autoimmune diseases has been reported such as

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

■    painful lumps on the shins (erythema nodosum)

■    low blood platelet count (immunothrombocytopenia)

■    destruction of blood cells by antibodies (Evans Syndrome)

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

A decrease in the number of white blood cells (Leucopenia) may occur in long-term use (more than 8 weeks). The frequency is not known.

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

5. HOW TO STORE ECHINAFLU

Keep out of the reach and sight of children.

Do not use Echinaflu after the expiry date which is stated on the bottom of the tube. The expiry date refers to the last day of that month.

You can use Echinaflu 7 months after first opening the packaging.

Store in the original packaging.

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

6. FURTHER INFORMATION

What Echinaflu contains

Each effervescent tablet contains 176 mg of dried pressed juice from fresh flowering Echinacea purpurea (L.) Moench herb (20-28:1) (equivalent to 3520 mg - 4928 mg of fresh flowering Echinacea purpurea (L.) Moench herb).

Echinaflu also contains the following ingredients

Herbal preparation:

Maltodextrin, precipitated silicon dioxide and citric acid monohydrate

Tablet:

Citric acid anhydrous, sodium hydrogen carbonate, maltodextrin, saccharin sodium, sodium cyclamate, ascorbic acid and citric flavour Permaseal 84260-51

What Echinaflu looks like and contents of the pack

The effervescent tablet is round, flat, ivory-coloured.

One original pack contains 20 effervescent tablets.

Traditional Herbal Registration Holder and Manufacturer

Swiss Caps GmbH GrassingerstraBe 9 D-83043 Bad Aibling Germany

For any information about this medicinal product, please contact the local representative of the Traditional Herbal Registration Holder:

Swiss Caps UK Ltd.

Suite 1 Old Coach House Robin Hoods Well Skelbrooke

Doncaster DN6 8LS - UK Tel.: 44 (0) 1302 33 82 20 Fax: 44 (0) 1302 33 82 21

This leaflet was last approved in November 2010

1.3.2 Mock-up PIL Version 0007 04 January 2011