Harpagocaps Soft Capsules
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
HarpagoCaps, soft capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One soft capsule contains 225 mg of extract (as dry extract) from Harpagophytum procumbens D.C. and/or H. zeyheri L. Decne, radix (Devil's claw root) (3-5:1).
Extraction solvent: Ethanol 60% V/V Excipients:
Each capsule contains 210 mg soya oil and 10 mg soya phospholipids.
Each capsule contains 20 mg lactose monohydrate and 27 mg sorbitol (E420).
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, soft
It is an oval-shaped, tawny coloured soft capsule.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for:
(a) the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints
(b) digestive disorders such as bloating and flatulence and where there is loss of appetite
This is based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults
Indication (a)
1 soft capsule 2-3 times daily, half an hour before meals.
Indication (b)
1 soft capsule twice daily, half an hour before meals.
Not recommended for use in children and adolescents under 18 years (see section 4.4 ‘Special warnings and precautions for use’).
Duration of use
Indication (a)
Not to be taken for more than 4 weeks.
Indication (b)
Not to be taken for more than 2 weeks.
4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substance or one of the excipients.
This product contains soya oil and soya phospholipids and should not be used by patients who are allergic to peanut or soya. Refer to Section 2 for content. This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Refer to Section 2 for content. This product contains sorbitol (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine. Refer to Section 2 for content.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
The use in children and adolescents under 18 years of age is not recommended because of the lack of available experience.
If articular pain accompanied by swelling of joint, redness or fever are present a doctor should be consulted.
Caution should be taken when Devil’s claw is administered to patient with cardiac disorders.
As a general precaution, patients with gastric or duodenal ulcer should not use Devil’s claw preparations.
If the symptoms worsen during the use of the medicinal product, a doctor or a qualified health care practitioner should be consulted.
4.5 Interaction with other medicinal products and other forms of interaction
There is no evidence, from limited interaction studies, that Devil’s claw root extracts will interact with other medicinal products.
4.6 Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data the use during pregnancy or lactation is not recommended.
4.7 Effects on ability to drive and use machines
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.
4.8 Undesirable effects
Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain.
Central Nervous System disorders: headache, dizziness.
Skin disorders: allergic skin reactions (rash and itching).
The frequency is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.
4.9
Overdose
There are no data on human overdose with Devil’s claw. Symptomatic and supportive measures should be taken as appropriate.
5 PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: MUSCULO-SKELETAL SYSTEM ATC code: M01AX: Other anti-inflammatory / antirheumatic agents, nonsteroids
5.1 Pharmacodynamic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.2 Pharmacokinetic properties
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.
5.3 Preclinical safety data
The pre-clinical toxicology data available are limited.
Tests on reproductive toxicity and carcinogenicity have not been performed.
An in vitro microbial mutagenis (Ames) test conducted with the Devil’s claw extract to investigate genotoxic or mutagenic potential was negative.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Capsule filling Lactose monohydrate,
Silicon dioxide, precipitated Soya-bean oil, refined Coconut oil, refined Palm kernel oil, fractionated Beeswax, yellow
Phospholipids from soya-beans (Lecithin)
Butter fat Capsule shell Gelatin Glycerol
Sorbitol, liquid, partially dehydrated
Ferric (III)-hydroxide-oxide (E 172) (Ferric oxide yellow)
Water, purified
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This product does not require any special storage conditions.
6.5 Nature and contents of container
The soft capsules are packed in PVC/PVdC-aluminium blisters.
One package contains 30, 50, 60, 90 and 100 soft capsules. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Swiss Caps GmbH
GrassingerstraBe 9 D-83043 Bad Aibling Germany
tel: +49 (0) 80 61 / 9 31 01 fax: +49 (0) 80 61 / 9 31 200
8 MARKETING AUTHORISATION NUMBER(S)
THR 18397/0005
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
09/06/2010