DIAPASSION TABLETS - patient leaflet, side effects, dosage

Patient leaflet - DIAPASSION TABLETS

1: What this product is and what it is used for

2: Before you take this product

3: How to take this product

4: Possible side effects

5: How to store this product

6: Contents of the pack and other information

1: what this product is and what it is used for

This product is a traditional herbal medicinal product containing Passion flower herb extract. Each coated tablet of this product 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.

DiaPassion Tablets is a traditional herbal medicinal product used for the temporary relief of symptoms associated with stress, such as mild anxiety, based on traditional use only.

2: Before you take this product

DO NOT TAKE this product if you are:

under 18 years of age
pregnant or breastfeeding
allergic to any of the ingredients (see section 6)
are taking any other medicines for anxiety or to help you sleep

3: how to take this product

For oral use only.

Adults and the elderly

Take 1 tablet daily. Swallow the tablet whole with a little liquid. Do not chew the tablet.

Do not take more than the leaflet tells you to.

If you take too much of this product (overdose)

If you take more than the recommended dose, speak to a doctor, pharmacist or qualified healthcare practitioner and take this leaflet with you.

If you forget to take this product

Continue to take your usual dose at the usual time; it does not matter if you have missed a dose. Do not take a double dose to make up for the missed dose.

If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or qualified healthcare practitioner.

4: possible side effects

Like all medicines, this product can have side-effects. These are listed below.

There has been one report of nausea and tachycardia (increased heart beat) and one report of hypersensitivity (vasculitis) in patients using Passion flower herb. Tell your doctor or pharmacist if you notice any other side-effect not mentioned in this leaflet.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or qualified healthcare practitioner This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

Passiflora 425 mg coated tablets – THR 23056/0023

5: how to store this product

Do not use your tablets after the expiry date.

Return any out-of-date tablets to your pharmacist who will dispose of them for you. The expiry date is printed on the box and the blister pack.

Do not store above 30° C. Store in the original packaging.

Keep the tablets out of the sight and reach of children.

Keep your tablets in the blister pack until it is time to take them.

6: contents of the pack and other information

Each coated tablet of this product 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.

This product also contains the following ingredients:

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: white beeswax, carnauba wax, shellac.

If you have been told by your doctor that you have an intolerance to some sugar, contact your doctor before taking this product.

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

Each pack contains 30, 60, 90 or 100 coated tablets.

Registration holder

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road,

Marlow SL7 1FX

Passiflora 425 mg coated tablets – THR 23056/0023

Manufacturer of this product

Diapharm GmbH & Co. KG or

Wiewelhove GmbH

Dornebrink 19 49479 Ibbenburen

Germany

Wurzburger Str. 3

26121 Oldenburg