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Cold & Flu relief

image descriptionEchinaCold Echinacea Cold & Flu Relief Tablets

Echinacea purpurea root extract

30 tablets

Traditionally used for:

  • Flu
  • Colds
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A traditional herbal medicinal product used for the relief of symptoms of the common cold and influenza type infections based on traditional use only. Always read the label.

  • Vegetarian
  • Vegan
  • Lactose free
  • Gluten free
  • Wheat free
  • Soya free
  • Corn free
  • Sugar free
  • GM free
Herble active
Echinacea purpurea root (Echinacea purpurea ( L.) Moench)
Strength
70 mg of dried root extract (equivalent to 420-560 mg of Echinacea)
Dose
One tablet three times a day

One tablet of EchinaCold contains 70 mg of extract (as dry extract) equivalent to 420-560 mg of Echinacea purpurea root (Echinacea purpurea (L.) Moench root). Over many years, Echinacea has grown in popularity in the fight against cold and flu-like infections.

EchinaCold is one of the few flu remedies on the market that contains Echinacea.

Taking one tablet three times 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.

A licensed herbal medicine means a safe, high quality product

EchinaCold Echinacea Cold & Flu Relief 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.

We are committed to improving people’s health and wellbeing and do so using only the finest plant based, natural healthcare products.

Also available from…

Boots, 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

Vists 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

Each film-coated tablet contains 70 mg of extract (as dry extract) from Echinacea purpurea root, (equivalent to 420 – 560 mg of Echinacea purpurea (L.) Moench root, which is the active ingredient.

Extraction solvent: Ethanol 75% v/v.

EchinaCold Echinacea Cold & Flu Relief Tablets is a traditional herbal medicinal product used to relieve the symptoms of the common cold and influenza type infections, based on traditional use only.

Before you take this product

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 lactose intolerant (react badly to lactose or milk)
  • Are intolerant to some sugars – this product contains lactose monohydrate, glucose and sorbitol
  • Are pregnant or breastfeeding
  • 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 in conditions such as cancer 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 methotrexa

TAKE SPECIAL CARE with this product and consult your doctor before taking:

  • 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

How to take this product

Adults, elderly and children over 12:

Take one tablet three times a day.

Start taking at the first sign of a cold or flu. Do not take for longer than 10 days. This product is not suitable for children under the age of 12 years.

Do not take more than the label/leaflet tells you to take.

If you take too much of this product (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 this product

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.

After taking this product

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

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.

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.

Reporting of side-effects

If you get any side-effects, talk to your doctor, pharmacist or nurse. This includes any possible side-effects not mentioned in this leaflet. You can also report side-effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side-effects you can help provide more information on the safety of this medicine.

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 label and the outer carton.

Store in the original packaging.

Do not store the tablets in a place where the temperature goes above 25°C.

Do not use this product if you notice a change in appearance in the tablets as this may mean that they have deteriorated.

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

Further information

Each film-coated tablet contains 70 mg of extract (as dry extract) from Echinacea purpurea root, (equivalent to 420 – 560 mg of Echinacea purpurea (L.) Moench root. Extraction solvent: Ethanol 75% v/v.

This product also contains the following ingredients:

Extract: Maltodextrin, colloidal anhydrous silica.

Tablet: Calcium hydrogen phosphate, cellulose microcrystalline , magnesium stearate, colloidal anhydrous silica.

Tablet Coating: Hypromellose, titanium dioxide E171, glycerol, talc.

Each pack contains 30 or 60 tablets. Not all pack sizes may be marketed.

Registration holder and manufacturer for this product:

Nutrition Group
Olympic Way, Blackpool,
Lancashire FY4 4QE, UK.

Traditional herbal registration number: THR 42574/0001

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

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

Leaflet prepared 11/2016.

1 NAME OF THE MEDICINAL PRODUCT

Healthsense EchinaSHIELD Cold and Flu Tablets

Zipvit Echinacea Cold and Flu Tablets

Schwabe EchinaCold Echinacea Cold and Flu Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film coated tablet contains 70mg of extract (as dry extract) from Ec(equivalent to 420 to 560mg of Echinacea purpurea (L.) Moench root.) Extraction Solvent: Ethanol 75% v/v.

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablet. White, round, biconvex tablet.

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: take one tablet three times a day. The use in children or adolescents under 18 years of age in not recommended (see section 4.4 special warnings and precautions for use)

Swallow tablets whole with water

Start at first signs of common cold.

Duration of Use

Do not use the medicinal product for more than 10 days. If symptoms worsen during the use of the product or persist for more than 10 days, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or to plants of the Asteraceae (Compositae) family or to any other excipients. 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, leukaemias) and allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If symptoms worsen 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.

The use of this product in children or adolescents under 12 years of age is not recommended because data are not sufficient and medical advice should be sought.

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

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 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 disseminate, 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

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Herbal Extract

Maltodextrin

Colloidal Anhydrous Silica

Tablet Core

Calcium hydrogen phosphate

Cellulose Microcrystalline

Magnesium Stearate

Colloidal Anhydrous Silica

Tablet Coating

Hypromellose

Titanium Dioxide (E171)

Glycerol

Talc

6.2 Incompatibilities

None known.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C

Store in the original packaging

6.5 Nature and contents of container

White PET Pot with heat-seal and a white tamper evident LDPE closure in a printed cardboard outer carton containing patient information leaflet.

Pack sizes of 30, 60, 90, and 120.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

Nutrition Group Plc

Olympic Way

Blackpool

FY4 4QE

UK

8 MARKETING AUTHORISATION NUMBER(S)

THR 42574/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

01/11/2011

10 DATE OF REVISION OF THE TEXT

06/03/2017

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