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LLOYDSPHARMACY ECHINACEA COLD RELIEF EFFERVESCENT TABLETS

Active substance(s): PRESSED JUICE OF PURPLE CONEFLOWER / PRESSED JUICE OF PURPLE CONEFLOWER / PRESSED JUICE OF PURPLE CONEFLOWER

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LP Echinacea Efferv PIL Nov 2010

3/11/10

13:18

Page 1

3rd November 2010

THR 18397/0004
Patient Information Leaflet

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Return any out-of-date tablets to your pharmacist who will dispose of them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

Echinacea Cold Relief



Effervescent tablets

Dried juice of Echinacea purpurea herb
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about Lloydspharmacy
Echinacea Cold Relief Effervescent.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or
qualified healthcare practitioner.

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.

This leaflet was prepared in November 2010
4

Lloyds Echinacea Cold Relief Effervescent Tablets Proposed PIL

Swiss Caps GmbH

1

LP Echinacea Efferv PIL Nov 2010

3/11/10

13:18

Page 2

3rd November 2010

2: Before you take this product
DO NOT TAKE this product if you:
G are allergic to any of the ingredients or to plants of the Asteraceae/
Compositae family such as daisies, marigolds or artichokes (see section 6)
G have a tendency to allergies such as hives, allergic eczema or asthma
G are pregnant or breast-feeding
G suffer from the infection tuberculosis
G suffer from connective tissue disease such as sarcoidosis
G suffer from autoimmune diseases such as inflammation of the
connective tissue (collagenoses) or multiple sclerosis
G suffer from conditions which reduce your immunity to infection such as HIV
G are on therapy which reduces your resistance to infection such as cancer
drug treatment or radiotherapy, history of organ or bone marrow transplant
G suffer from blood disorders involving the white blood cells count due
to bone marrow disorders (agranulocytosis) or leukaemia
G are taking immunosuppressant medicines such as ciclosporin or methotrexate
TAKE SPECIAL CARE with this product
G Do not exceed the stated dose
G If you are prone to allergies, there is a risk of developing serious allergic
reactions to Echinacea e.g. Anaphylactic reactions
G 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.
2

THR 18397/0004

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:
G rash
G hives
G inflammatory disorder of the skin (Stevens-Johnson Syndrome)
G

swelling of the skin due to fluid

G

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)

G
G

Echinacea can trigger allergic reactions in patients who have a tendency
to develop allergic conditions
Association with autoimmune diseases has been reported such as:
G inflammation of the brain and spinal cord (disseminated encephalitis)
G painful lumps on the shins (erythema nodosum)
G low blood platelet count (immunothrombocytopenia)
G destruction of blood cells by antibodies (Evans Syndrome)
G dryness in the mouth and eyes with renal tubular dysfunction
(Sj gren 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).

Lloyds Echinacea Cold Relief Effervescent Tablets Proposed PIL

Swiss Caps GmbH

3

LP Echinacea Efferv PIL Nov 2010(tracked)

3/11/10

13:18

Page 1

3rd November 2010

THR 18397/0004
Patient Information Leaflet

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.
Insert ........

(equivalent to 3520 4928 mg
of fresh flowering Echinacea
purpurea (L.)
Moench herb), ..............

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
Delete: April 2010
Insert: November 2010

If you would like further information about this product,
please contact:
Lloyds Pharmacy Limited, Coventry CV2 2TX

Echinacea Cold Relief



Effervescent tablets

Dried juice of Echinacea purpurea herb
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about Lloydspharmacy
Echinacea Cold Relief Effervescent.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or
qualified healthcare practitioner.

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. .

Insert ........

(equivalent to 3520 4928
mg of fresh flowering Echinacea purpurea (L.)
Moench herb), ..............

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.

This leaflet was prepared in November 2010

Lloyds Echinacea 4Cold Relief Effervescent Tablets Proposed PIL (tracked)

1

Swiss Caps GmbH

LP Echinacea Efferv PIL Nov 2010(tracked)

3/11/10

13:18

Page 2

3rd November 2010

2: Before you take this product

DO NOT TAKE this product if you:
G are allergic to any of the ingredients or to plants of the Asteraceae/
Compositae family such as daisies, marigolds or artichokes (see section 6)
G have a tendency to allergies such as hives, allergic eczema or asthma
G are pregnant or breast-feeding
G suffer from the infection tuberculosis
G suffer from connective tissue disease such as sarcoidosis
G suffer from autoimmune diseases such as inflammation of the
connective tissue (collagenoses) or multiple sclerosis
G suffer from conditions which reduce your immunity to infection such as HIV
G are on therapy which reduces your resistance to infection such as cancer
drug treatment or radiotherapy, history of organ or bone marrow transplant
G suffer from blood disorders involving the white blood cells count due
to bone marrow disorders (agranulocytosis) or leukaemia
G are taking immunosuppressant medicines such as ciclosporin or methotrexate
TAKE SPECIAL CARE with this product
G Do not exceed the stated dose
G If you are prone to allergies, there is a risk of developing serious allergic
reactions to Echinacea e.g. Anaphylactic reactions
G 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.

Lloyds Echinacea 2Cold Relief Effervescent Tablets Proposed PIL (tracked)

THR 18397/0004

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:
G rash
G hives
G inflammatory disorder of the skin (Stevens-Johnson Syndrome)
G

swelling of the skin due to fluid

G

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)

G
G

Echinacea can trigger allergic reactions in patients who have a tendency
to develop allergic conditions
Association with autoimmune diseases has been reported such as:
G inflammation of the brain and spinal cord (disseminated encephalitis)
G painful lumps on the shins (erythema nodosum)
G low blood platelet count (immunothrombocytopenia)
G destruction of blood cells by antibodies (Evans Syndrome)
G dryness in the mouth and eyes with renal tubular dysfunction
(Sj gren 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).
3

Swiss Caps GmbH

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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