ECHINAFORCE COLD AND FLU Unknown Oral Drops Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB (1:12-13) EXTRACTION SOLVENT: ETHANOL 57.3%M/M, TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH ROOT (1:11-12). EXTRACTION SOLVENT: ETHANOL 57.3%M/M

Available from:

Bioforce (UK) Ltd

ATC code:

L03A

INN (International Name):

TINCTURE FROM FRESH ECHINACEA PURPUREA (L.) MOENCH HERB (1:12-13) EXTRACTION SOLVENT: ETHANOL 57.3%M/M, TINCTURE FROM FRESH ECHI

Dosage:

Unknown

Pharmaceutical form:

Oral Drops Solution

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Immunostimulating agents

Authorization status:

Authorised

Authorization date:

2013-07-19

Patient Information leaflet

Bioforce UK
Echinaforce drops
GB – Irvine, Ayrshire
CTD Module 1
April 2018
___________________________________________________________________________________
PACKAGE LEAFLET
Page 1 of 5
Echinaforce (4)
Art. no. 01311600
PACKAGE LEAFLET: INFORMATION FOR THE USER
ECHINAFORCE
Cold & Flu oral drops
Echinacea purpurea herb & root tinctures
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
PRODUCT BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this product exactly as described in this leaflet or as
your doctor, pharmacist or
nurse has told you.
•
Keep this leaflet. You may need to read it again.
•
Ask your pharmacist if you need more information or advice.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
•
You must talk to a doctor if you do not feel better or if you feel
worse after 10 days.
WHAT IS IN THIS LEAFLET:
1.
What Echinaforce is and what it is used for
2.
What you need to know before you take Echinaforce
3.
How to take Echinaforce
4.
Possible side effects
5.
How to store Echinaforce
6.
Contents of the pack and other information
1.
WHAT ECHINAFORCE IS AND WHAT IT IS USED FOR
Echinaforce is a traditional herbal medicinal product containing the
extracts of fresh
_Echinacea purpurea_
herb and root.
It is used to relieve:
•
Common cold symptoms
•
Flu-like symptoms
This is exclusively based on long-standing use.
Echinaforce is for use in adults and adolescents over 12 years of age.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ECHINAFORCE
DO NOT TAKE ECHINAFORCE
•
If you are under 12 years of age.
•
If you are
ALLERGIC
to
o
Echinacea or plants of the daisy (Asteraceae/Compositae) family.
Echinacea is
a member of the daisy family.
Bioforce UK
Echinaforce drops
GB – Irvine, Ayrshire
CTD Module 1
April 2018
___________________________________________________________________________________
PACKAGE LEAFLET
Page 2 of 5
Echinaforce (4)
Art. no. 01311600
o
Any of the ot

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Echinaforce Cold and Flu Oral Drops
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
20 drops (one dose) is equivalent to 0.714 ml.
0.714 ml [ approx. 0.646 g] of oral drops contains:
614 mg of tincture from fresh_ Echinacea purpurea_ (L.) Moench herb
(purple coneflower herb) (1:12-13) Extraction
solvent: Ethanol 65% v/v
and
32 mg of tincture from fresh_ Echinacea purpurea_ (L.) Moench root
(purple coneflower root) (1:11-12) Extraction
solvent: Ethanol 65% v/v
Excipients with known effect:
One dose (20 drops) contains approx 0.464 ml (366 mg) of ethanol
(alcohol).
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral drops
Clear, olive-green coloured liquid
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used to relieve common cold and
flu-like symptoms, exclusively based on long-
standing use.
This product is indicated for use in adults and adolescents over 12
years.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults, older people and adolescents over 12 years:
20 drops in a little water two to five times daily.
Start at first signs of common cold.
If symptoms persist, worsen or do not improve after 10 days use of
this product, a qualified healthcare professional e.g.
a doctor or pharmacist should be consulted.
The use in children below 12 years of age is not recommended (see 4.4
Special warnings and precautions for use).
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance,
to plants of the Asteraceae (Compositae) family
or to any of the excipients listed in section 6.1.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
__