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Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution – patient leaflet, side effects, dosage

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Patient leaflet - Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution

1. What Echinaforce Hot Drink Concentrate is and what it is used for

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TEXT 8.5 pt

Please turn over... Do's and Don'ts

Using

2. What you need to know before you take Echinaforce Hot Drink Concentrate

If you have had an organ or bone marrow transplant.

3. How to take Echinaforce Hot Drink Concentrate

If you take more Echinaforce Hot Drink Concentrate than you should

If you suffer from

TB (the infection tuberculosis) Sarcoidosis (a connective tissue disease disorder which causes the formation of clumps of cells mainly in the lymph nodes, lungs and liver) An autoimmune disease such as collagenoses

If you take too much and feel ill, talk to your doctor. Taking too much is unlikely to be harmful.

To be made into a hot drink by diluting in hot water before use.

Do not take Echinaforce Hot Drink Concentrate

If you forget to take

Echinaforce Hot Drink Concentrate

If you are under 12 years of age.

  1. 1. 2. 3.

If you are allergic to

Do not worry about a missed dose. Take the next dose as usual.

  1. 1. Fill the 5 ml measuring spoon

Echinacea or plants of the daisy (Asteraceae/ Compositae) family. Echinacea is a member of the daisy family.

(inflammation of the

provided with the product. 2. Pour the contents of the spoon

connective tissue) or multiple sclerosis

If you feel Echinaforce Hot Drink Concentrate is not working

into a cup.

HIV, AIDS or any other condition which decreases your resistance to infection A disorder which affects your white blood cells such as agranulocytosis (low white blood cell count due to bone marrow disorders) or

  1. 3. Add hot water and stir.

Any of the other ingredients of this product (listed in section 6).

Stop taking this product and see your doctor:

Adults and children over 12 years: Days 1 to 3: Take 5 ml diluted in hot water five times daily. Days 4 to 10: Take 5 ml diluted in hot water three times daily.

If you have a tendency to allergies such as hives, allergic eczema or asthma see your doctor before taking this product. It may not be suitable for you.

If you have a high temperature (fever).

If your symptoms worsen or if you do not feel an improvement within 10 days.

leukemia (blood cell cancer)

Start taking this product at the first signs of a cold.

Echinaforce Hot Drink

Concentrate contains sucrose and ethanol

If you are pregnant or breast-feeding.

Side effects not mentioned in this leaflet occur.

For oral use only. Do not take more than the recommended dose.

If you have been told by

If you are having treatment to reduce the response of your immune system (immunosuppression) e.g. chemotherapy, radiotherapy.

If you have any further questions on the use of this product ask your doctor or pharmacist.

Do not take this product for a cold or flu for more than 10 days.

your doctor that you have an intolerance to some sugars, talk to your doctor before taking this product.

This product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

If you are taking ciclosporin or methotrexate, or any other immunosuppressant medicine.

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Side effects

4. Possible side effects

Like all medicines, this product can cause side effects, although not everybody gets them.

Side effects

Allergic reactions

If you already suffer from allergies you may be more likely to get them. Allergic reactions which may occur are:

Skin rash

Red, itchy spots (hives)

These are often short-lived and should go away by themselves. However if they are troubling you, talk to your doctor or

pharmacist.

Swelling of the skin due to fluid (angioedema) or swelling of the face (Quincke's oedema)

Blistering of the skin and mucous membranes (Stevens-Johnson syndrome)

Difficulty in breathing

(bronchospasm with obstruction) Asthma or anaphylactic shock (a life-threatening allergic reaction) Stop taking this product

immediately if any of these occur. Seek medical advice and take this leaflet with you.

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There have been isolated reports suggesting an association

between Echinacea products and autoimmune diseases 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 of the above side effects is not known. This means it is not known how often these reactions occur as there have not been enough reports to allow this information to be calculated.

If you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed 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.

Information

5. How to store Echinaforce Hot Drink Concentrate

Keep this product out of the sight and reach of children.

Do not use this product after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.

Store below 25˚C.

Use within 1 month of opening.

After opening, store in the refrigerator (below 8˚C).

Do not use this product if you notice a change in appearance. The oral solution should be dark red to dark violet in colour.

6. Contents of the pack and other information

What Echinaforce Hot Drink Concentrate contains

5 ml of concentrate contains 1,140 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench herb (1:12-13) and 60 mg of extract (as tincture) of fresh Echinacea purpurea (L.) Moench root (1:11-12). Extraction solvent: Ethanol 65% V/V.

TEXT 8.5 pt

The other ingredients used are sucrose, purified water, concentrated elderberry juice, citric acid monohydrate, modified starch, medium-chain triglycerides, potassium sorbate and ethanol.

What Echinaforce Hot Drink Concentrate looks like and contents of the pack

Echinaforce Hot Drink Concentrate is a dark red to dark violet viscous liquid. It is available in 100 ml bottles.

Traditional Herbal

Registration Holder and Manufacturer

Traditional Registration Holder and Batch Release:

A.Vogel Ltd,

2 Brewster Place,

Irvine, Ayrshire, KA11 5DD - UK Tel: 01294 277344

enquiries@avogel.co.uk

Manufacturer:

A.Vogel AG, CH-9325, Roggwil Switzerland

THR 13668/0031

Certification Mark

This leaflet was revised on 01/2020.

What is Echinacea?

Echinacea is a plant which is native to America. The herb and root extracts of the Echinacea species, Echinacea purpurea, are combined to make Echinaforce Hot Drink Concentrate.

You should also know

A.Vogel runs a helpline by phone and email which can provide you with further information.

E-mail: enquiries@avogel.co.uk Phone: 0845 608 5858

You can get a larger print or audio version of this leaflet.

Call this number: 0845 608 5858.

About this document

Source: MHRA - Medicines and Healthcare products Regulatory Agency (products.mhra.gov.uk)

Last revision stated in the text: January 2020

What the sections and the side effect frequencies mean: How to read a patient leaflet

Found a mistake? Tell us on the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Facts about Echinaforce Hot Drink Cold & Flu Echinacea concentrate for oral solution

What these facts mean

Pharmaceutical form? Dark red to dark violet viscous liquid with an aromatic, fruity, elderberry-like odour and an aromatic, fruity, sweet, slightly sour taste.
Excipients? Sucrose, Purified water, Concentrated elderberry juice, Citric acid monohydrate, Modified starch, Medium-chain triglycerides, Potassium sorbate, Ethanol
Shelf life? 30 months unopened.
After opening:
Use within 1 month of opening.
Storage Store below 25°C. After opening, store in the refrigerator (below 8°C).
Marketing authorisation? THR 13668/0031 (first authorised 1 October 2014)
Marketing authorisation holder? A.Vogel Ltd

Sources: the MHRA product information (products.mhra.gov.uk). Contains public sector information licensed under the Open Government Licence v3.0.