Omega Passiflora Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omega Passiflora Tablets
Natracalm
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 71.4 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (7:1) Extraction solvent: Ethanol 60 % v/v
Each film coated tablet also contains 192 mg of lactose.
For full list of excipients (see Section 6.1)
3 PHARMACEUTICAL FORM
Film coated tablet.
White, circular biconvex, film coated tablet with “N” logo on one side.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of symptoms associated with stress such as mild anxiety, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
Adults and elderly:
One tablet to be taken three times a day with meals. If required a further tablet may be taken at bedtime.
Not recommended for children or adolescents under 18 years (see Section 4.4. Special warnings and precautions for use).
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to the active ingredients or any of the excipients
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.
Not recommended for use in children or adolescents under 18 years because data are not sufficient and medical advice should be sought.
Each tablet contains 192 mg of lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.
The effects of this product may be increased with alcohol. Therefore execssive alcohol use should be avoided.
4.6 Fertility, pregnancy and lactation
Safety during human pregnancy and lactation has not been established.
In the absence of sufficient data the use in pregnancy and lactation is not recommended.
Studies on fertility have not been performed.
4.7 Effects on ability to drive and use machines
May impair the ability to drive and use machines. Patients who are affected should not drive or use machines.
4.8 Undesirable effects
One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. The frequency is not known
If other adverse reactions not mentioned above occur, a doctor, pharmacist or qualified healthcare practitioner should be consulted.
4.9 Overdose
Symptomatic and supportive measures as appropriate.
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
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipient
Maltodextrin
Tablet core
Lactose
Microcrystalline Cellulose Magnesium Stearate Stearic Acid Tablet coat Talc
Colour Dispersion (containing Lactose, Hypromellose, Titanium Dioxide, Polyethylene Glycol 4000)
6.2 Incompatibilities
None known.
6.3 Shelf life
3 years
6.4 Special precautions for storage
Do not store above 25 °C. Store in the original packaging.
6.5 Nature and contents of container
Blister pack containing 12 tablets.
Blister pack containing 48 tablets.
Polypropylene container and cap containing 96 tablets.
Blister pack containing 100 tablets
The tablets are packaged into PVC/PVDC laminate with aluminium foil and inserted into a carton.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Omega Pharma Ltd.
1st Floor
32 Vauxhall Bridge Road LONDON, SW1V 2SA United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
THR 02855/0036
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28/03/2013
10 DATE OF REVISION OF THE TEXT
28/03/2013