ATROSAN DEVIL'S CLAW Film Coated Tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

DEVIL'S CLAW EXTRACT (AS DRY ROOT)

Available from:

Bioforce (UK) Ltd

INN (International Name):

DEVIL'S CLAW EXTRACT (AS DRY ROOT)

Dosage:

480 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

2011-12-09

Patient Information leaflet

Bioforce UK
Atrosan film-coated tablets
GB – Irvine, Ayrshire
CTD Module 1
July 2017
___________________________________________________________________________________
PACKAGE LEAFLET
Harpagophytum-Filmtabletten
Page 1 of 5
Art. No. 01322600
PACKAGE LEAFLET: INFORMATION FOR THE USER
ATROSAN
Devil’s Claw
film-coated tablets
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 4
weeks.
WHAT IS IN THIS LEAFLET:
1.
What Atrosan is and what it is used for
2.
What you need to know before you take Atrosan
3.
How to take Atrosan
4.
Possible side effects
5.
How to store Atrosan
6.
Contents of the pack and other information
1.
WHAT ATROSAN IS AND WHAT IT IS USED FOR
Atrosan is a traditional herbal medicinal product containing the
extract of Devil’s
Claw root.
It is used to relieve:
•
Minor joint pain
This is exclusively based on long-standing use.
Atrosan is for use in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATROSAN
DO NOT TAKE ATROSAN
•
If you are allergic to:
o
Devil’s Claw (also known as Harpagophytum). This product contains
Devil’s Claw root.
o
Any of the other ingredients of this product (listed in section 6).
•
If you have an ulcer (either a gastric and/or duodenal ulcer).
Bioforce UK
Atrosan film-coated tablets
GB – Irvine, Ayrshire
CTD Module 1
July 2017
___________________________________________________________________________________
PACKAGE LEAFLET
Harpagophytum-Filmtabletten
Page 2 of 5
Art. No. 01322600
•
If you are under 18 years of age.
•
If

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Atrosan Devil's Claw film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 480 mg of extract (as dry extract)
from
_Harpagophytum procumbens_ D.C. and/or H. zeyheri L. Decne, radix
(Devil’s claw root).
(1.5 – 3.0:1).
Extraction solvent: Ethanol 60% v/v.
Excipients with known effect:
Each tablet contains 226.08 mg lactose monohydrate.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet (tablet)
It is an oval-shaped, white coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product for the relief of minor
articular pain, exclusively based on long-standing use.
This product is indicated for use in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and older people: One tablet twice daily immediately after
food.
The dose can be increased to two tablets twice daily if relief is not
obtained after 3 to 5 days.
This product is not indicated in patients less than 18 years old.
If the condition worsens, new symptoms develop or symptoms persist
during the use of Atrosan or for more than four
weeks, a doctor should be consulted.
METHOD OF ADMINISTRATION
For oral short-term use only.
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to the active substance
or one of the excipients listed in section 6.1.
Patients under 18 years of age.
Pregnancy and lactation.
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