Helaflex
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Helaflex film-coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 film-coated tablet contains 480 mg extract (as dry extract) of Harpagophytum procumbens D.C., radix (Devil´s claw), equivalent to 2.1 – 2.4 g root of Devil´s claw.
Extraction solvent: ethanol 60% (V/V)
Excipient(s)with known effect: Lactose monohydrate 226 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL form
Film-coated tablet.
Beige to light-brown oblong tablet
Dimensions:
Length: 19.1 - 19.3 mm
Width: 8.1 - 8.3 mm
Height: 6.0 - 6.2 mm
4. Clinical particulars
4.1 Therapeutic indications
Traditional herbal medicinal product used for relief of pain in mild osteoarthritis (OA).
The product is a traditional herbal medicinal product for use in the specified indication exclusively based on long-standing use.
4.2 Posology and method of administration
Posology
Adults: 1 tablet morning and evening.
Paediatric population
Helaflex is not recommended for children and adolescents under 18 years (see section 4.4. Special warnings and precautions for use).
Method of administration
The tablets should be taken with food and preferably with ½ glass of water. The tablets should be swallowed whole.
Duration of use
If the symptoms worsen or persist after 4 weeks of Helaflex treatment a doctor or other health care professional should be consulted.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Gastric ulcer and duodenal ulcer.
4.4 Special warnings and precautions for use
The use in children and adolescents under 18 years of age is not recommended because of the lack of available experience.
Articular pain accompanied by swelling of joints, severe motion pain, redness or fever should be examined by a doctor.
Cautionshould be taken when administrated to patients with gallstone problems.
Caution should be taken when Helaflex is administrated to patients affected by cardiovascular disorders (see section 5.3 Preclinical safety data).
Helaflex contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
4.6 Fertility, pregnancy and lactation
Studies on possible effects on fertility are not available.
In the absence of sufficient data, the use during pregnancy and 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.
Undesirable effects
Diarrhoea, nausea, vomiting and abdominal pain have been reported, as well as dizziness, headache and allergic skin reactions.
The frequency is not known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the traditional herbal medicinal product is important. It allows continued monitoring of the safety of the traditional herbal medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
4.9 Overdose
No case of overdose has been reported.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
-
5.2 Pharmacokinetic properties
-
5.3 Preclinical safety data
No mutagenic effect of Helaflex has been observed in Ames' test (with and without metabolic activation).
Other tests on genotoxicity and carcinogenicity or tests on reproductive toxicity have not been performed.
In some animal studies at high concentrations of a methanolic extract from Devil's claw, a calcium antagonistic effect, similar to that of verapamil, has been shown.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Lactose monohydrate
Maize starch
Cellulose, microcrystalline
Silica, colloidal anhydrous
Magnesium stearate
Film coat:
Hypromellose
Talc
Titanium dioxide (E171)
Macrogol (6000)
Iron oxide, yellow (E172)
Iron oxide, brown (E172)
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25ºC.
Nature and contents of container
Blister (Al/PVC/PVDC): 50, 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements
7. REGISTRATION HOLDER
Dr. Loges + Co. GmbH
D-21423 Winsen
Germany
8. REGISTRATION NUMBER(S)
26897
9. DATE OF FIRST REGISTRATION/RENEWAL OF THE REGISTRATION
To be completed nationally.
10. DATE OF REVISION OF THE TEXT
04 May 2016
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