Harpatinum soft capsules

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

HARPAGOPHYTUM, DEVIL, S CLAW

Tilgjengelig fra:

Florealis ehf. Síðumúla 25, 108 Reykjavík, Iceland

ATC-kode:

M01AX

INN (International Name):

HARPAGOPHYTUM (DEVIL'S CLAW) 225 mg

Legemiddelform:

SOFT CAPSULE

Sammensetning:

HARPAGOPHYTUM (DEVIL'S CLAW) 225 mg

Resept typen:

OTC

Terapeutisk område:

ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2017-07-12

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
HARPATINUM SOFT CAPSULES
Devil’s claw root dry extract
TRADITIONAL HERBAL MEDICINAL PRODUCT
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist 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 or pharmacist. 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 2 weeks of treatment
(mild digestive disorders) or 4 weeks of treatment (minor joint pain).
See section 3.
WHAT IS IN THIS LEAFLET
1.
What Harpatinum is and what it is used for
2.
What you need to know before you take Harpatinum
3.
How to take Harpatinum
4.
Possible side effects
5.
How to store Harpatinum
6.
Contents of the pack and other information
1.
WHAT HARPATINUM IS AND WHAT IT IS USED FOR
Harpatinum is a traditional herbal medicinal product used in adults
for the relief of:
-
Minor joint pain
-
Mild digestive disorders (such as bloating, flatulence, and temporary
loss of appetite).
The product is a traditional herbal medicinal product for use in the
specified indications exclusively
based upon long-standing use.
Harpatinum contains dry extract from devil’s claw root.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARPATINUM
DO NOT TAKE THIS MEDICINE:
-
If you are allergic to devil’s claw root (also known as
_Harpagophytum_
), peanut, soya or any of
the other ingredients of this medicine (listed in section 6).
-
If you suffer from ulcers in your stomach or intestines.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Harpatinum, if you have:
-
joint pain accompanied by swelling of joints, redness or fever;
-
gallstone problems.
If the symptoms worsen during the use of this medicinal product, y

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Harpatinum soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
225 mg of extract (as dry extract) from
_Harpagophytum procumbens _
DC. and/or
_Harpagophytum zeyheri _
Decne. (devil’s claw), radix (equivalent to 990-1125 mg of devil’s
claw root). Extraction solvent: ethanol 60% (V/V).
Excipients with known effect
Lactose monohydrate, 20 mg per capsule, corresponding to 19 mg lactose
anhydrous. Soya-
bean oil, refined and lecithin (phospholipids from soya beans), 210 mg
and 10 mg per
capsule, respectively.
Sorbitol, approximately 27 mg per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Capsule, soft.
Oval (15x10 mm), light brown, soft capsules. The capsule contents are
dark brown.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Harpatinum is a traditional herbal medicinal product indicated:
-
For the relief of minor articular pain.
-
For the relief of mild digestive disorders such as bloating and
flatulence and where
there is temporary loss of appetite.
It is a traditional herbal medicinal product for use in the specified
indications exclusively
based upon long-standing use.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults: Two capsules twice daily.
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Maximum daily dose: four capsules.
_Duration of use _
If the symptoms persist longer than 4 weeks while using Harpatinum for
the relief of minor
joint pain or 2 weeks for the relief of mild digestive disorders, a
doctor or a qualified health
care practitioner should be consulted.
_ _
_Paediatric population _
_ _
The safety and efficacy of devil’s claw root in children and
adolescents under 18 years of age
has not been established (see section 4.4 ‘Special warnings and
precautions for use’).
_ _
Method of administration
Oral.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Active gastric or duodenal ulcer.
Harpatinum contains refi