Passipas
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Passipas, coated tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
425 mg of dry extract from Passiflora incarnata L., (passion flower) herba, (DER 5-7:1) corresponding to approximately 2-3 g dried herb of passion flower.
Extraction solvent: ethanol 50% (V/V).
Excipients with known effect:
5.1 mg glucose, 187 mg sucrose
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Coated tablet
Pale yellow, round (13.0-13.7 mm in diameter and 7.3-8.1 mm in height)
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Traditional herbal medicinal product for relief of mild symptoms of mental stress and to aid sleep.
The product is a traditional herbal medicinal product for use in the specified indication exclusively based upon long-standing use.
4.2 Posology and method of administration
Posology
Adults, elderly and adolescents from 12 years of age:
For the relief of mild symptoms of mental stress:
2–3 tablets daily, spread evenly over the day.
To aid sleep: 1-2 tablets half an hour before bedtime.
Maximum daily dose: 3 tablets.
If symptoms get worse or do not get better within 14 days, a doctor should be consulted.
Children:
Passipas is not recommended for use in children under 12 years of age (see section 4.4).
Method of administration
Passipas should be swallowed whole with sufficient liquid (preferably a glass of drinking water).
4.3 Contraindications
Hypersensitivity to passion flower herb or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Passipas contains glucose and sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency should not take this medicinal product.
Children: Passipas is not recommended for use in children under 12 years of age due to lack of adequate data.
4.5 Interaction with other medicinal products and other forms of interaction
None reported.
4.6 Fertility, pregnancy and lactation
In the absence of sufficient data, the use during pregnancy and lactation is not recommended.
No studies of effects on fertility are available.
4.7 Effects on ability to drive and use machines
Passipas may impair ability to drive and use machines.
Affected patients should not drive or operate machinery.
4.8 Undesirable effects
None known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the safety of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system:
[Contact details for national reporting system acc. to appendix 5 to QRD template]
4.9 Overdose
There have been no reports of overdose.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other hypnotics and sedatives
ATC code: N05CM
5.2 Pharmacokinetic properties
-
5.3 Preclinical safety data
No mutagenic effects of the extract in Passipas have been observed in the Ames test (with and without metabolic activation).
Tests on reproductive toxicity and carcinogenicity have not been performed.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Tablet core:
Maltodextrin
Silica, colloidal anhydrous
Cellulose, powdered
Croscarmellose sodium
Magnesium stearate
Stearic acid
Talc
Tablet coating:
Sucrose
Talc
Calcium carbonate
Acacia
Tragacanth
Liquid glucose, spray dried
Hypromellose
Beeswax, white
Carnauba wax
Shellac
Titanium dioxide E171
Yellow iron oxide E172.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
5 years
6.4 Special precautions for storage
Do not store above 30°C.
6.5 Nature and contents of container
PVC/PVDC-aluminium blister.
Packs of 10, 30, 60, 90 or 100 tablets.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7. REGISTRATION HOLDER
<To be completed nationally>
8. REGISTRATION NUMBER
To be completed nationally.
9. DATE OF REGISTRATION / RENEWAL OF THE REGISTRATION
Date of registration: 29 September 2015
Date of latest renewal of registration: -
10. DATE OF REVISION OF THE TEXT
2016-04-14
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