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Pascoflair Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

PASCOFLAIR®

tablets

Passion Flower herb extract 425 mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. However, you still need to take PASCOFLAIR® carefully to get the best results from it.

•    Keep this leaflet. You may need to read it again.

•    Ask your pharmacist if you need more information or advice.

•    If any of the side effects gets serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.


In this leaflet:

1.    What PASCOFLAIR® is and what it is used for    4. Possible side effects

2.    Before you take PASCOFLAIR®    5. How to store PASCOFLAIR®

3. How to take PASCOFLAIR®    6. Further information

1.    WHAT PASCOFLAIR® IS AND WHAT IT IS USED FOR

PASCOFLAIR® is a traditional herbal medicinal product used for the temporary relief of mild anxiety and to aid sleep. This usage is based on traditional use only

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

2.    BEFORE YOU TAKE PASCOFLAIR®

Do not use PASCOFLAIR® if you are:

•    under 18 years of age

•    pregnant or breastfeeding

•    allergic (hypersensitive) to Passion flower or any of the other ingredients (see section 6)

Take special care with PASCOFLAIR®

You must contact a doctor or healthcare practitioner if your symptoms worsen or do not improve after 4 weeks. PASCOFLAIR® is not recommended for use in children and adolescents under 18 years of age.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

This product should not be taken with synthetic sedatives (sleeping pills or tranquillisers) such as benzodiazepines unless your doctor has told you to.

Driving and using machines

This product may cause drowsiness. If you are affected do not drive or operate machines.

Important information about some of the ingredients of PASCOFLAIR®

This product contains sucrose and glucose. See section 6 for further information.

If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

3.    HOW TO TAKE PASCOFLAIR®

Dosage and administration; duration of treatment

Unless prescribed otherwise,

for the temporary relief of mild anxiety:

the usual dose for adults and the elderly is one tablet 2-3 times daily, spread evenly over the day. to aid sleep:

adults and the elderly should take 1-2 tablets half an hour before retiring.

The tablets should be swallowed whole with sufficient liquid (preferably a glass of drinking water).

The maximum daily dose is 3 tablets.

PASCOE

If symptoms worsen or persist for 4 weeks, consult a doctor or health care practitioner.

If you take more PASCOFLAIR® than you should

If you accidentally take two or three times the normal dose, this will not usually have any adverse effects. If this happens, keep taking this medicine as described in the dosing instructions or prescribed by your doctor. If you feel unwell, consult your doctor. If you accidentally take more than this, consult your doctor and take this leaflet with you.

If you forget to take PASCOFLAIR®

Do not take a double dose to make up for a forgotten dose.

Continue to take the next dose at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4.    POSSIBLE SIDE EFFECTS

Like all medicines, PASCOFLAIR® can cause side effects, although not everybody gets them.

One case of hypersensitivity (vasculitis or inflammation of the vessels) and one case of nausea (feeling sick) and tachycardia (increased heart beat) have been reported.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5.    HOW TO STORE PASCOFLAIR®

Keep out of the reach and sight of children. Do not use after the expiry date stated on the blister pack and carton.

Do not store above 30°C.

Keep the blisters in the outer carton in order to protect from light.

6.    FURTHER INFORMATION

What each PASCOFLAIR® tablet contains:

•    Each tablet contains: 425 mg of extract (as dry extract) of Passion flower herb (Passiflora incarnata L.) (5-7:1), extraction solvent: ethanol 50% v/v.

•    The other ingredients are: maltodextrin, colloidal anhydrous silica, cellulose powdered, croscar-mellose sodium, magnesium stearate, stearic acid, talc, sucrose, calcium carbonate (E170), gum acacia, tragacanth, liquid glucose spray dried, hypromellose, white bees wax, carnauba wax, shellac, colorants: titanium dioxide (E171), yellow iron oxide (E172)

Each PASCOFLAIR® tablet contains 5.1 mg glucose and 187 mg sucrose.

What PASCOFLAIR® looks like and contents of the pack

Pale yellow, round, coated tablets in blister pack containing 10 coated tablets per blister. Original packs of 30, 60 or 100 coated tablets. Not all pack sizes may be marketed.

Registration Holder and Manufacturer

PASCOE pharmazeutische Praparate GmbH

Schiffenberger Weg 55 ■ D-35394 Giessen ■ Germany ■ e-mail: info@pascoe.de

This leaflet was approved in 08/2011

You can help to make medicines safer by reporting any side-effects to the Yellow Card Scheme at www.yellowcard.gov.uk. Alternatively you can get a paper Yellow Card form from your GP's surgery or pharmacy, or call free phone 0808 100 3352 (available 10am-2pm Monday - Friday


Certification Mark

XXXXX-GB-001


PASCOE

pharmazeutische Praparate GmbH ■ 35394 Giessen