SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE MEDICINAL PRODUCT

Echinaflu Effervescent Tablets

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2 QUALITATIVE AND QUANTITATIVE COMPOSITION

One 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).

This product contains 17.05 mmol (or 392 mg) sodium per tablet.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Effervescent tablet

Round, flat, ivory-coloured effervescent tablets

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2 Posology and method of administration

For oral administration

Adults, elderly and children over 12 years: the recommended dosage is 1 or 2 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.

Start at first signs of common cold. Do not use the product for more than 10 days.

If symptoms worsen during the use of the product or persist for more than 10 days, a physician or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family. Because of its immunostimulating activity, Echinacea must not be used in cases of progressive systemic disorders (tuberculosis, sarcoidosis), autoimmune diseases (e.g.: collagenoses, multiple sclerosis), immunodeficiencies (e.g.: HIV infection; AIDS), immunosuppression (e.g.: oncological cytostatic therapy; history of organ or bone marrow transplant), diseases of the white blood cell system (e.g.: agranulocytosis, leukemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).

Children under 12 years of age.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens or high fever occurs during the use of the product or if symptoms persist for more than 10 days, consult a doctor or qualified healthcare practitioner.

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

There is a possible risk of anaphylactic reactions in atopic patients. Atopic patients should consult their doctor before using Echinacea.

In patients for whom sodium intake is of medical concern (e.g. patients with congestive heart failure, renal failure, nephrotic syndrome), the sodium content of this product should be taken into account. Refer to Section 2, Qualitative and Quantitative Composition for sodium chloride content.

4.5 Interaction with other medicinal products and other forms of interaction

Not to be used concomitantly with immunosuppressant medications such as ciclosporin and methotrexate.

4.6 Fertility, pregnancy and lactation

In the absence of sufficient data the use in pregnancy and lactation is not recommended. Limited data (several hundreds of exposed pregnancies) indicate no adverse effects of Echinacea on pregnancy or on the health of the foetus/newborn child. Data concerning the immune system of the newborn child are not available. To date, no other relevant epidemiological data are available. The potential risk for humans is unknown.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Hypersensitivity reactions (rash, urticaria, Stevens-Johnson Syndrome, angioedema of the skin, Quincke edema, bronchospasm with obstruction, asthma and anaphylactic shock) may occur.

Echinacea can trigger allergic reactions in atopic patients.

Association with autoimmune diseases (encephalitis disseminata, erythema nodosum, immunothrombocytopenia, Evans Syndrome, Sjogren syndrome with renal tubular dysfunction) has been reported.

Leucopenia may occur in long-term use (more than 8 weeks).

The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Echinacea purpurea showed no toxicity in single-dose toxicity, repeated-dose toxicity and genotoxicity studies.

Tests on reproductive toxicity and on carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients of the herbal preparation: Maltodextrin

Precipitated silicon dioxide

Citric acid monohydrate Excipients of the tablet:

Ascorbic acid

Sodium hydrogen carbonate

Saccharin sodium

Sodium cyclamate

Citric acid anhydrous

Citric flavour Permaseal 84260-51.

6.2 Incompatibilities

None known.

6.3 Shelf life

Unopened 3 years.

After first opening the container 7 months.

6.4 Special precautions for storage

Store in the original packaging.

6.5 Nature and contents of container

Effervescent tablets are packed in polypropylene tubes with polyethylene closures filled with the drying agent silica gel.

One tube contains 20 effervescent tablets.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Swiss Caps GmbH GrassingerstraBe 9 D-83043 Bad Aibling Germany

8    MARKETING AUTHORISATION NUMBER(S)

THR 18397/0004

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

16/06/2008

10 DATE OF REVISION OF THE TEXT

16/08/2014