Lamberts Devils Claw Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Preparatomtale Preparatomtale (SPC)
05-04-2018

Aktiv ingrediens:

Devil's claw extract (as dry root)

Tilgjengelig fra:

Lamberts Healthcare 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:

Not marketed

Autorisasjon dato:

2018-03-16

Informasjon til brukeren

                                PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMBERTS
®
DEVILS CLAW TABLETS
Devils Claw Root Extract
8003 EI
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,
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 this traditional herbal medicine is and what it is used for
2. What you need to know before you take this traditional herbal
medicine
3. How to take this traditional herbal medicine
4. Possible side effects
5. How to store this traditional herbal medicine
6. Contents of the pack and other information
1. WHAT THIS TRADITIONAL HERBAL MEDICINE IS AND WHAT IT IS USED FOR
This is a traditional herbal medicine containing Devils Claw root
extract.
Lamberts® Devils Claw Tablets is a traditional herbal medicinal
product for the relief
of minor joint pain in adults over 18 years of age, exclusively based
upon long-
standing use.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS TRADITIONAL HERBAL
MEDICINE
DO NOT TAKE THIS TRADITIONAL HERBAL MEDICINE IF YOU:
• have ever had or have a stomach ulcer or duodenal ulcer
• are pregnant or breastfeeding.
• are under 18 years of age.
• are allergic to Devil’s Claw or any of the other ingredients
(see section 6)
WARNINGS AND PRECAUTIONS
Talk to a qualified healthcare professional, e.g. your doctor or
pharmacist, before
taking this traditional herbal medicine:

If your symptoms worsen or do not improve after 4 weeks

If your joint pain is accompanied by swelling of the joint, redness or
fever

If you have heart problems and want to take this t
                                
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                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lamberts Devils Claw Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each fim-coated tablet contains 450 mg of dry extract from_
Harpagophytum procumbens_ D.C. and/or
_H. zeyheri_ L. Decne radix (devil’s claw root).
(Equivalent to 1575 – 2250 mg of Devil’s claw root)
Extraction solvent: ethanol 60 % v/v
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Small, green oval film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the relief of minor
joint pain in adults over 18 years of age, exclusively
based on long-standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral short-term use only.
For adults and the elderly,
take one tablet
twice a day (in the morning and in the evening).
The safety of Lamberts
Devils Claw Tablets in children and adolescents under the age of 18
years has not
been established as no data are
available.
Do not exceed the stated dose.
Tablets should be swallowed whole with some water or other liquid
If symptoms worsen or do not
improve after 4 weeks a doctor or qualified healthcare professional
e.g.
a doctor or
pharmacist should be consulted.
4.3 CONTRAINDICATIONS
Patients with active gastric or duodenal ulcer.
The safety of Lamberts Devils Claw Tablets in children and adolescents
under 18 years of age has not been established
as no data are available.
Do not use in case of known hypersensitivity to the active substance
or any of the excipients listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If the symptoms worsen during the use of the medicinal
product
or if symptoms persist
for more than 4 weeks,
a
qualified healthcare professional e.g. a doctor or a pharmacist should
be consulted.
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