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1. Pascoflair Tablets
2. Pascoflair Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

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 incamata L.) (5-7:1).

Extraction solvent: ethanol 50% v/v

Each coated tablet contains 5 mg glucose and 187 mg sucrose.

For excipients, see section 6.1.

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.

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

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 or a qualified healthcare practitioner should be consulted.

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

Titanium dioxide E171

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

5 years.

6.4    Special precautions for storage

Do not store above 30°C. Keep the blister in the outer carton.

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 100 coated tablets

Not all pack sizes may be marketed.