Document: document 2 change

• document 0
• document 1
• document 2
• document 3
• document 4
• document 5

---

LP Echinacea Efferv PIL Nov 2010    3/11/10    13:18 Page

3rd November 2010

5: 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Return any out-of-date tablets to your pharmacist who will dispose of them for you.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 these 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.

6: Further information

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.

This product 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 this product:

Swiss Caps GmbH,

Grassingerstrasse 9, D-83043 Bad Aibling, Germany Traditional herbal registration number: THR 18397/0004 UK distributor:

Schwabe Pharma (UK) Ltd, Marlow, Bucks SL7 1PD Packed for Lloyds Pharmacy Limited, Coventry CV2 2TX If you would like further information about this product, please contact:

Lloyds Pharmacy Limited, Coventry CV2 2TX This leaflet was prepared in November 2010

THR 18397/0004

Patient Information Leaflet

Echinacea Cold Relief

Dried juice of Echinacea purpurea herb

What is in this leaflet

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 3

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..

Lloydspharmacy Echinacea Cold Relief 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.

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 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.

3: How to take this product

Adults, elderly and children over 12

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

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.

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 abo^THn^Rhmg³p⁹ease⁰°<⁴your 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).

Lloydspharmacy

Patient Information Leaflet

Echinacea Cold Relief'

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 3

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..

Lloydspharmacy Echinacea Cold Relief 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.

OSwiss Caps GmbH

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/ Composltae 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 clclosporln 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.

3: How to take this product

Adults, elderly and children over 12

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

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.

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).

© Swiss Caps GmbH