HARPADOL

HarpadolHardCapsules

Each capsule contains 435 mg devil’s claw root (Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne).

For a full list of excipients, see section 6.1.

Hard capsule (capsule).

Translucent colourless capsules filled with brown/yellow powder.

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.

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.

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.

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.

If the symptoms worsen during the use of the medicinal product or if symptoms persist for more than 4 weeks, a qualified health care professional e.g. a doctor or pharmacist should be consulted.

Do not exceed the stated dose.

No noticeable interaction reported.

There are no or limited amount of data from the use of Devil’s claw in pregnant women (see section 5.3). Harpadol is not recommended during pregnancy and in women of childbearing potential not using contraception.

There is insufficient information on the excretion of Devil’s claw/metabolites in human milk. A risk to newborns/infants cannot be excluded. Harpadol should not be used during breast-feeding.

No studies on the effect on the ability to drive and use machines have been performed.

In rare cases, some patients have experienced dizziness and somnolence while taking Devil’s claw. If affected, patients should not drive or use machinery.

Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain.

Nervous system disorders: headache, dizziness.

Skin and subcutaneous tissue disorders: allergic skin reactions.

The frequency is not known.

If other adverse reactions not mentioned above occur, a qualified health care professional e.g. a doctor or pharmacist should be consulted.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

Preclinical data reveal no special hazard for humans based on conventional studies of single dose toxicity, repeated dose toxicity and genotoxicity.

Carcinogenicity studies and studies on reproduction have not been conducted, however as there is evidence of oxytocic effects of devil’s claw, its use in pregnancy is contra-indicated.

Magnesium stearate

Colloidal hydrated silica

Hypromellose (capsule shell)

Not applicable.

5years.

Do not store above 25°C.

Store in the original package to protect from light and moisture.

Brown polyvinyl chloride container of 45 or 150 capsules, with a security cap made of low-density polyethylene.

Not all pack sizes may be marketed.

Laboratoires ARKOPHARMA

LID de Carros Le Broc – 1^ère avenue, 2709 m

06510 Carros

France

No special requirements.

TR1450/1/1