Summary of Product Characteristics (SmPC) - Pascoflair tablets
1 NAME OF THE MEDICINAL PRODUCT
Pascoflair tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
425 mg of extract (as dry extract) from Passion Flower Herb (Passiflora incarnata L.) (5-7:1).
Extraction solvent: ethanol 50% v/v
Each coated tablet contains 5 mg glucose and 187 mg sucrose. See section 4.4. Special warnings and precautions for use.
3 PHARMACEUTICAL FORM
Coated tablets.
Pale yellow, round, biconvex, smooth glossy surface without ruptures.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
A traditional herbal medicinal product used for the temporary relief of mild anxiety and to aid sleep, based on traditional use only.
4.2 Posology and method of administration
For oral short term use only.
For adults and the elderly:
For the temporary relief of symptoms of mild anxiety take 1 tablet 2 to 3 times a day
To aid sleep take 1 to 2 tablets 30 minutes before bedtime.
The maximum daily dose is 3 tablets.
Tablets should be swallowed whole with a little liquid. The tablets should not be chewed.
If symptoms persist or worsen after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
The use of this product in children and adolescents under 18 years of age is not recommended. (See Section 4.4. Special warnings and precautions for use).
4.3 Contraindications
Hypersensitivity to Passion flower or any of the excipients.
4.4 Special warnings and precautions for use
Do not exceed the stated dose.
If symptoms persist or worsen after 4 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted.
This product contains glucose.
Each coated tablet contains maximum 5mg of glucose.
This product contains sucrose.
Each coated tablet contains maximum 187mg sucrose.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.
The use of this product in children and adolescents under 18 years of age is not recommended because data are not sufficient and medical advice should be sought.
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.
4.6 Fertility, 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 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
May impair the ability to drive and use machines. Affected patients should not drive or operate machinery.
4.8 Undesirable effects
The following side effects have been reported:
allergic skin reactions (e.g. allergic dermatitis, erythema, exanthema, urticaria, pruritus), tachycardia and gastrointestinal disorders (e.g. dyspepsia, flatulence, vomiting, nausea, abdominal pain and discomfort, diarrhoea). The frequency with which these side effects occur is not known.
If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare 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 and patients are asked to report any suspected adverse reactions via the Yellow Card Reporting Scheme;
www.yellowcard.mhra.gov.uk
4.9 Overdose
No case of overdose has been reported. Symptomatic and supportive measures should be taken 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 and carcinogenicity have been performed.
The herbal extract was negative in a test (Ames test) for mutagenicity.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Extract excipients:
Maltodextrin
Silica, colloidal anhydrous
Tablet core:
Maltodextrin
Silica, colloidal anhydrous Cellulose, powdered Croscarmellose sodium Magnesium stearate
Stearic acid
Talc
Coating:
Sucrose
Talc
Calcium carbonate E170 Acacia
Tragacanth
Liquid glucose, spray dried Iron oxide hydrate E172 (= yellow iron oxide) Hypromellose
Capol 600 T.S. containing: Beeswax, white
Carnauba wax
Shellac
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
The shelf life is 5 years.
6.4 Special precautions for storage
Do not store above 30°C. Keep the Blister in the outer carton in order to protect from light
6.5 Nature and contents of container
The tablets are packed in PVC/PVDC-aluminium blister(s) and inserted into a carton. Original packs of
30 coated tablets
60 coated tablets
90 coated tablets
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
Pascoe pharmazeutische Präparate GmbH
Schiffenberger Weg 55
D-35394 Giessen, Germany
Phone +49 (0) 641-7960-0
Fax +49 (0) 641-7960-109
e-mail: info@pascoe.de
8 MARKETING AUTHORISATION NUMBER(S)
THR 14369/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
06/02/2020
10 DATE OF REVISION OF THE TEXT
21/09/2023