Document: document 1 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5
• document 6
• document 7
• document 8

---

101697 EchinaCold

5: How to store this product

Do not use your capsules after the expiry date.

Return any out-of-date capsules to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Store the capsules in a cool dry place.

Do not store the capsules in a place where the temperature goes above 25^oC.

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

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

6: Further information

Each soft capsule 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.

This product also contains the following ingredients:

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

Soft capsule: Refined soya-bean oil, refined coconut oil, white beeswax, rice starch, fractionated palm kernel oil, phospholipids from soya-beans, succinylated gelatine, glycerol, non-crystallising sorbitol solution 70%, titanium dioxide E171, ferric (II, III) oxide E172, quinoline yellow E104, patent blue V E E131, purified water.

Each pack contains 30 soft capsules.

Registration holder and manufacturer for this product

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

Certification Mark. Traditional herbal registration number: THR 18397/0003

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

Goldshield Limited (Reg No: 3561477)

No.1 Croydon, 12-16 Addiscombe Road, Croydon CR0 0XT

Telephone: 080 8168 0712. Email: info@goldshield.co.uk

This leaflet was prepared in March 2011    101697

Patient Information Leaflet

Echinacea Cold Relief® soft capsules

Dried juice of Echinacea purpurea herb

1: What this product is and what it is used for..........................................page    1

2: Before you take this product................................................................page    2

3: How to take this product ......................................................................page    2

4: Possible side-effects............................................................................page    3

5: How to store this product......................................................................page    4

6: Further information ..............................................................................page    4

1: What this product is and what it is used for

This product is a traditional herbal medicinal product containing Echinacea purpurea herb. Each capsule of this product 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.

Goldshield Echinacea Cold Relief 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.

2: 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 allergic to peanut or soya

•    are fructose-intolerant (react badly to some sugars)

•    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 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

3: How to take this product

Adults, elderly and children over 12

Take 1-2 capsules daily. Swallow them whole with some water or other liquid.

Start taking at the first sign of a cold or flu. Do not take for longer than 10 days.

Do not give this product to children under 12 years old.

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.

4: 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 (Sjogren 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.

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. 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).