Harpadol Hard Capsules

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

DEVILS CLAW SECONDARY ROOTS

Доступно од:

Laboratoires ARKOPHARMA

INN (Међународно име):

DEVILS CLAW SECONDARY ROOTS

Дозирање:

.

Фармацеутски облик:

Capsule, hard

Тип рецептора:

Product not subject to medical prescription

Статус ауторизације:

Not marketed

Датум одобрења:

2012-03-23

Информативни летак

1
PACKAGE LEAFLET_RV16
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
HARPADOL HARD CAPSULES
_Devil’s Claw Root 435 mg_
_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. _
-
_You must talk to a doctor if you feel worse or do not feel better
after 4 weeks._
_ _
WHAT IS IN THIS LEAFLET.
1.
What HARPADOL is and what it is used for.
2.
What you need to know before you take HARPADOL.
3.
How to take HARPADOL.
4.
Possible side effects.
5.
How to store HARPADOL.
6.
Contents of the pack and other information.
1.
WHAT HARPADOL IS AND WHAT IT IS USED FOR.
Harpadol contains the active substance Devil's claw root (
_Harpagophytum procumbens D.C. and / or _
_H. zeyheri L. Decne)._
Harpadol is a traditional herbal medicinal product for the relief of
minor joint pain in adults over 18
years of age, exclusively based on longstanding use.
You must talk to a doctor if you feel worse or do not feel better
after 4 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE HARPADOL.
DO NOT TAKE HARPADOL:

If you are allergic to Devil’s claw (also known as Harpagophytum) or
any of the
ingredients of this product.

If you are pregnant or breast-feeding.

If you are under 18 years.
WARNINGS AND PRECAUTIONS :
Talk to your doctor or pharmacist before taking Harpadol.
Talk to your doctor:

if you have other symptoms such as swelling, redness of a joint, or
fever in addition to
joint pain.

if new symptoms develop or if your symptoms worsen or last for more
than 4 weeks

if you have an ulcer (either a gastric and/or duodenal ulcer).
_ _

if you have heart disease.
CHILDREN AND ADOLESCEN

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Harpadol Hard Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 435 mg_ Harpagophytum procumbens D.C. and/or H.
zeyheri L. Decne (devil's claw root)._
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Hard capsule (capsule).
Translucent colourless capsules filled with brown/yellow powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product 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 Use
Adults and the elderly:
One capsule to be taken 3 times daily with a large glass of water.
Duration of use
For oral short-term use only
If the condition worsens, new symptoms develop or symptoms persist
during the use of Harpadol, or for more than four
weeks, a doctor should be consulted.
The safety of Harpadol in children and adolescents under 18 years of
age has not yet been established as no data are
available.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Pregnancy and breast-feeding.
The safety of Harpadol in children and adolescents under 18 years of
age has not yet been established as no data are
available.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Articular pain accompanied by swelling of joint, redness or fever
should be examined by a doctor.
As a general precaution, patients with gastric or duodenal ulcers
should not use Harpadol.
Some studies in animals have shown at high concentrations of Devil’s
claw, possible calcium antagonistic effects
similar to verapamil, caution should be taken when Devil’s claw is
administered to patients with cardiac disorders.
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