Atrosan Devil's Claw film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Devil's claw extract (as dry root)

Tilgjengelig fra:

A.Vogel Ireland Limited

INN (International Name):

Devil's claw extract (as dry root)

Dosering :

.

Legemiddelform:

Film-coated tablet

Resept typen:

Product not subject to medical prescription

Autorisasjon status:

Marketed

Autorisasjon dato:

2011-12-09

Informasjon til brukeren

A.Vogel Ireland
Atrosan film-coated tablets
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2585.e04
Page 1 of 6
Harpagophytum-Filmtabletten
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:
A.Vogel Ireland
Atrosan film-coated tablets
IE - Dublin
CTD Module 1
July 2022
___________________________________________________________________________________
PACKAGE LEAFLET
PIL2585.e04
Page 2 of 6
Harpagophytum-Filmtabletten
Art. No. 01322600
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).
•
If you are under 18 years of age.

Preparatomtale

Health Products Regulatory Authority
14 December 2022
CRN00D8KL
Page 1 of 4
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.
Patients with active gastric or duodenal ulcer.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Health Products Regulatory Authority
14 December 2022
CRN00D8KL
Page 2 of 4
Do not exceed the stated dose.
If the symptoms worsen during the use of the medicinal product, a
qualified health care professional e.g. a doctor or
pharmacist should be consulted.
If articular pain accompanied by swelling of joint, redness or fever
are present a doctor should be consulted.
The dosing and s