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Cold and flu relief

image descriptionEchinaCold Echinacea Cold & Flu Relief Effervescent Tablets

Dried juice of Echinacea purpurea herb

20 effervescent tablets

Traditionally used for:

  • Colds
  • Flu
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A traditional herbal medicinal product used for the relief of symptoms of the common cold and influenza type infections, exclusively based upon long-standing use as a traditional remedy. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herbal Active
Echinacea (Echinacea purpurea ( L.) Moench)
Strength
176mg of dried pressed juice (equivalent to 3520-4928mg of Echinacea)
Dose
One to two effervescent tablets daily

One EchinaCold effervescent tablet contains 176 mg of dried pressed juice from fresh flowering Echinacea purpurea (L.) Moench herb (20-28:1). Over many years, Echinacea has grown in popularity in the fight against colds and flu-like infections.

A licensed herbal medicine means a safe, high quality product

EchinaCold Echinacea Cold & Flu Relief Effervescent Tablets have been registered under the Traditional Herbal Registration Scheme (THRS), a regulatory approval process for herbal treatments in the EU. Registration under this scheme primarily means that:

  • EchinaCold is a regulated herbal product and meets specific standards of safety and quality
  • EchinaCold is of pharmaceutical quality and has been manufactured to European Good Manufacturing Practice (GMP) Guidelines

The quality of many herbal products on the UK market at present is unknown and there are no independent quality and safety checks available to offer you reassurance about these products. EchinaCold’s registration under the THRS scheme provides you with the reassurance that it has been assessed by the MHRA and meets the required standard of safety and quality, as well as providing reliable patient information. The THR number on product packaging provides the proof of evidence that EchinaCold has met the MHRA’s agreed level of safety and quality, and that the on-pack consumer information has been approved by the MHRA.

The pharmaceutical grade EchinaCold effervescent tablets are packed in an air tight tube to retain their freshness and maintain potency.

Taking one or two effervescent tablets daily can help adults and children 12 years + to relieve symptoms of cold and flu type infections. For best results EchinaCold should be taken at the first sign of infection. EchinaCold should not be taken 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.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products. Please click Trust Schwabe for more information about our company.

Also available from…

Holland & Barrett, Ocado and other leading independent pharmacies and health food stores nationwide.

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About Echinacea Purpurea

Over many years, Echinacea has grown in popularity in the fight against colds and flu-like infections.

Visit Herbfacts.co.uk

About the common cold

The common cold is an infection that affects the upper respiratory tract – the nose, throat, sinuses, trachea, larynx and bronchial tubes. How can natural remedies help to relieve the common cold?

What this product is and what it is used for

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

EchinaCold Effervescent 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.

Before you take this product

DO NOT TAKE EchinaCold Effervescent 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 such as sarcoidosis
  • suffer from autoimmune diseases such as inflammation of the connective tissue (collagenoses) or multiple sclerosis
  • suffer from conditions which reduce your immunity to infection such as HIV
  • are on therapy which reduces your resistance to infection such as cancer
  • drug treatment or radiotherapy, history of organ or bone marrow transplant
  • suffer from blood disorders involving the white blood cells count due to bone marrow disorders (agranulocytosis) or leukaemia
  • are taking immunosuppressant medicines such as ciclosporin or methotrexate

TAKE SPECIAL CARE with this product

  • Do not exceed the stated dose
  • If you are prone to allergies, there is a risk of developing serious allergic reactions to Echinacea e.g. Anaphylactic reactions
  • Taking Echinacea containing products may trigger autoimmune diseases

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

How to take this product

Adults, elderly and children over 12

Take 1-2 effervescent tablets daily, dissolved in a glass of water (about 200ml).

The dissolved tablet should be drunk immediately. Start taking at the first sign of a cold or flu.

Do not take for longer than 10 days.

Do not give EchinaCold Effervescent to children under 12 years old.

If you take too much EchinaCold Effervescent (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take EchinaCold Effervescent

Do not take a double dose to make up for a forgotten dose. It doesn’t matter if you miss a dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

Possible Side-effects

Like all medicines, this product can have side-effects, although not everyone
gets them. Stop taking this product and check with your doctor, pharmacist
or qualified healthcare practitioner 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 (Sjögren 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.

After taking this product

You must see your doctor or a qualified healthcare practitioner if your symptomsworsen, if you experience a high fever or your symptoms persist after 10 days.

If any of these side-effects become troublesome, or if you notice side-effects not listed in this leaflet, please tell your doctor, pharmacist or qualified healthcare practitioner.

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).

How to store this product

Do not use your tablets after the expiry date. Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the tube and the outer carton.

You can use EchinaCold Effervescent tablets up to 7 months after first opening the packaging.

Store the tablets in a cool dry place.

Keep the tablets out of the reach and sight of children.

Keep your tablets in the tube until it is time to take them.

Product description

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

EchinaCold Effervescent also contains the following ingredients:

Herbal preparation: Maltodextrin, precipitated silicon dioxide, citric acid monohydrate.

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

Each original pack contains 20 effervescent tablets.

Registration holder and manufacturer for EchinaCold Effervescent:

Swiss Caps GmbH,
Grassingerstrasse 9, D-83043 Bad Aibling, Germany

Traditional herbal registration number: THR 18397/0004

If you would like further information about this product, please contact:

Schwabe Pharma (UK) Ltd
Alexander House, Mere Park,
Dedmere Road, Marlow, Bucks SL7 1PD
Telephone: 01628 401980 Email: info@schwabepharma.co.uk

This leaflet was revised 01/2013

1. Name of the medicinal product

  • ECHINAFLU Effervescent Tablets
  • ECHINACOLD Echinacea Cold & Flue Relief Effervescent Tablets
  • LLOYDSPHARMACY Echinacea Cold Relief Effervescent Tablets
  • BOOTS Cold & Flu Relief Effervescent Tablets
  • TESCO Echinacea Cold and Flu Relief Effervescent Tablets

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, Sjögren 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 pharmacist 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
Grassingerstraße 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

09/03/2013

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