Summary of medicine characteristics - PHYTOFLEX, HARPADOL
1 NAME OF THE MEDICINAL PRODUCT
HARPADOL
PHYTOFLEX
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Capsule, hard
4.1 Therapeutic indications
A traditional herbal medicinal product used for the relief of backache, rheumatic or muscular pain, and general aches and pains in the muscles and joints, based on traditional use only.
4.2 Posology and method of administration
For oral use only.
Adults and the elderly:
1 capsule morning, noon and evening during meals with a large glass of water.
The patient should consult a doctor if symptoms worsen, or do not improve after 4 weeks.
The use in children or adolescents under 18 years of age is not recommended (see section 4.4 special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients.
Patients with active gastric or duodenal ulcer
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than 4weeks, a doctor or qualified health care practitioner should be consulted.
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 patients affected by cardiovascular disorders.
The use of this product in children or adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
Patients with gallstones should consult a doctor prior to using Devil’s Claw.
4.5 Interaction with other medicinal products and other forms of interaction
None reported
4.6 Fertility, pregnancy and lactation
Safety during pregnancy and lactation has not been established.
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
Studies on the effects on fertility have not been performed.
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. Some patients have experienced dizziness while taking Devil’s claw.
4.8 Undesirable effects
Gastrointestinal disorders: diarrhoea, nausea, vomiting, abdominal pain.
Central Nervous system disorders: headaches, dizziness.
Hypersensitivity reactions: rash, hives facial oedema have been reported The frequency is not known.
If other adverse effects not mentioned above occur, a doctor or qualified health care practitioner should be consulted.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
4.9 OverdoseNo case of overdose has been reported.
5 PHARMACOLOGICAL PROPERTIES
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
5.3 Preclinical safety dataA reverse mutation assay on bacteria indicated that Harpagophytum powder contained in HARPADOL was not found to be mutagenic in Salmonella typhimurium (strains TA 1535, TA 1537, TA98, TA 100) and Escherichia coli (strain WP2 pKM101/uvrA-) mutation assays with or without metabolic activation.
Tests on reproductive toxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Magnesium stearate
Silica colloidal hydrated
Hypromellose (capsule shell)
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Store below 25°C
Store in the original package
6.5 Nature and contents of container
6.5 Nature and contents of containerBrown polyvinyl chloride bottle of 45 or 150 capsules, with a security cap made of low-density polyethylene.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal No special requirements.