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Flu and cold relief

image descriptionEchinaBoost Echinacea Cold & Flu Relief Tablets

Echinacea purpurea root extract

40 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
30 mg of dried root extract (equivalent to 243-279 mg of Echinacea)
Dose
Two to three tablets three times a day

One tablet of EchinaBoost contains 30 mg of extract (as dry extract) equivalent to 243-279 mg Echninacea purpurea root (Echinacea purpurea (L.) Moench). Over many years, Echinacea has grown in popularity in the fight against cold and flu-like infections.

EchinaBoost is one of the few flu remedies on the market that contains Echinacea; each pharmaceutical grade tablet is foiled blister packed to retain its freshness and maintain its potency.

Taking two to three tablets three times daily can help adults and children 12 years + to relieve symptoms of cold and flu type infections. For best results EchinaBoost should be taken at the first sign of infection. EchinaBoost 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

EchinaBoost 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:

  • EchinaBoost is a regulated herbal product and meets specific standards of safety and quality
  • EchinaBoost 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. EchinaBoost’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 EchinaBoost 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. Please click Trust Schwabe for more information about our company.

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

This product is a traditional herbal medicinal product containing an extract of Echinacea purpurea root. Each film-coated tablet contains 30 mg of extract (as dry extract) equivalent to 243-279 mg Echinacea purpurea root (Echinacea purpurea L. Moench). Extraction solvent: Ethanol 45% V/V. EchinaBoost tablets 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 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

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

How to take this product

Adults, elderly and children over 12

Take 2 – 3 tablets 3 times daily. Chew the tablet or swallow it whole with water. Start taking at the first sign of cold or flu. Do not take for longer than 10 days. This product is not suitable for children under the age of 12 years.

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. Because of the sugar content taking too much of this product may cause diarrhoea.

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.

Possible side-effects

Like all medicines, EchinaBoost tablets can have side-effects, although not everyone gets them. Stop taking EchinaBoost 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 symptoms worsen, 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.

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 box and the blister pack.

Store the tablets in a cool dry place. Do not store the tablets in a place where the temperature goes above 25 C.

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

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

Further information

Each film-coated tablet contains 30 mg of extract (as dry extract) equivalent to 243-279 mg Echinacea purpurea root (Echinacea purpurea L. Moench). Extraction solvent: Ethanol 45% V/V.

This product also contains the following ingredients:

Extract excipients: lactose monohydrate, cellulose, colloidal anhydrous silica.
Tablet core: isomalt, liquorice dry extract, talc, glucose (in liquorice dry extract), microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, levomenthol, eucalyptus oil, anise oil, fennel oil, clove oil.
Tablet coating: hypromellose, macrogol.

Each pack contains 40 film-coated tablets.

Registration holder for this product

Pharbio Medical International AB, Box 715, SE 194 27 Upplands, Väsby, Sweden

Manufacturer for this product

Cederroth International Production Paramedical A/S, Vassingerødvej 3-7, DK-3540 Lynge, Denmark.

Distributed in the UK by:

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

Traditional herbal registration number: THR 15525/0009

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 401 980
Email:info@schwabepharma.co.uk

This leaflet was revised 02/2015

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Echinaboost film-coated tablets
Herbal Classics Echinacea Cold Relief film-coated tablets
EchinaCold Echinacea Cold & Flu Relief tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet contains:
30 mg of extract (as dry extract) equivalent to 243-279 of Echinacea purpurea root
(Echinacea purpurea L. Moench).
Extraction solvent: Ethanol 45% V/V.

Excipient(s): One tablet contains lactose monohydrate 7 mg, glucose 16-19 mg and isomalt
371.5 mg

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Film-coated tablets

Round, biconvex, beige to brown tablets.
4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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

4.2 Posology and method of administration

For oral short term use only.

The tablets can be chewed or swallowed whole.

Adults, elderly and children over 12 years:

2 to 3 tablets 3 times a day.

Maximum: 9 tablets per day.

Paediatric population

This tablet formulation is not recommended for children below 12 years.

Start at first signs of common cold.
Echinaboost should not be used 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 other plants of the Asteraceae
(Compositae) family or to any of the 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, leukemias) and
allergic diathesis (e.g.: urticaria, atopic dermatitis, asthma).

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

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

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

Since the tablet contains lactose monohydrate, glucose and isomalt (see section 6.1)
patients with rare hereditary problems of galactose intolerance, fructose intolerance,
the Lapp lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase
insufficiency should not take this medicine.

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 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.

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 oedema, bronchospasm with obstruction, asthma and anaphylactic
shock) may occur (see section 4.4). 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.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

No case of overdose has been reported. However, due to the isomalt content,
overdoses may result in diarrhoea.

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 with Echinacea purpurea root extracts.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Extract excipients.
Lactose monohydrate
Cellulose
Colloidal anhydrous silica

Tablet core
Isomalt
Liquorice Dry Extract
Talc
Glucose (in Liquorice Dry Extract)
Microcrystalline cellulose
Magnesium Stearate
Colloidal anhydrous silica
Levomenthol
Eucalyptus Oil
Anise Oil
Fennel Oil
Clove Oil

Tablet coating.
Hypromellose
Macrogol

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25°C

6.5 Nature and contents of container

Each cardboard carton of 40 tablets consists of 2 x 20 foil strip blister packs
Each cardboard carton of 60 tablets consists of 3 x 20 foil strip blister packs
Each cardboard carton of 80 tablets consists of 4 x 20 foil strip blister packs

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements

7 MARKETING AUTHORISATION HOLDER

PHARBIO MEDICAL INTERNATIONAL AB
BOX 715
SE-194 27 UPPLANDS VÄSBY
SWEDEN

8 MARKETING AUTHORISATION NUMBER(S)

THR 15525/0009

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

19/11/2010

10 DATE OF REVISION OF THE TEXT

25/03/2015

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