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DIAPASSION TABLETS

Active substance(s): PASSION FLOWER DRY EXTRACT 5.7:1 50% ETHANOL / PASSION FLOWER DRY EXTRACT 5.7:1 50% ETHANOL / PASSION FLOWER DRY EXTRACT 5.7:1 50% ETHANOL

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
DiaPassion 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) (equivalent to 2125-2975 mg of Passion flower herb).
Extraction solvent: Ethanol 50% v/v
Excipients: each coated tablet contains 187 mg of sucrose and 5 mg of glucose.
For full list of excipients, see section 6.1

3

PHARMACEUTICAL FORM
Coated tablet.
Light-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 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. The patient should consult a healthcare practitioner if
symptoms worsen or do not improve after 4 weeks.

For adults and the elderly: take 1 tablet daily. Tablets should be swallowed whole
with a little liquid. The tablet should not be chewed.
This product is not indicated for use in patients less than 18 years old.

4.3

Contraindications
Hypersensitivity to Passion flower or any of the other ingredient in this product.
Pregnancy
Lactation
Patients under 18 years of age.

4.4

Special warnings and precautions for use
Do not exceed the stated dose.
If the condition worsens, or if symptoms persist for more than four weeks, or if
adverse effects not mentioned in the package leaflet occur, consult a healthcare
practitioner.
This product contains glucose.
1 coated tablet contains max. 5 mg glucose.
This product contains sucrose.
1 coated tablet contains max. 187 mg of sucrose or 0.29 carbohydrate units.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or
sucrase-isomaltase insufficiency 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.

4.6

Fertility, Pregnancy and lactation
The safety of the product during pregnancy and lactation has not been established.
Use during pregnancy or lactation is not recommended.

4.7

Effects on ability to drive and use machines
May cause drowsiness and impair the ability to drive and operate machines. If
affected, patients should not drive or operate 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 or 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
Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended, unless
necessary for the safe use of the product.
Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been
performed.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Extract excipients:
Maltodextrin
Silica, colloidal anhydrous
Tablet core
Silica, colloidal anhydrous
Cellulose, powdered
Croscarmellose sodium
Magnesium stearate
Stearic acid
Talc
Coating
Sucrose
Talc
Calcium carbonate E170
Acacia
Tragacanth
Titanium dioxide E 171
Liquid glucose, spray dried
Iron oxide hydrate E 172 (= 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 4 years

6.4

Special precautions for storage
Do not store above 30° C.

6.5

Nature and contents of container
Original packages contain 30, 60, 90 or 100 coated tablets
DiaPassion Tablets are packed in PVC/ PVDC- aluminium blisters and inserted into a
carton.

6.6

Special precautions for disposal
No special requirements

7

MARKETING AUTHORISATION HOLDER
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany

8

MARKETING AUTHORISATION NUMBER(S)
THR 42340/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
07/07/2009

10

DATE OF REVISION OF THE TEXT
06/08/2013

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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