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DIASLEEP PLUS TABLETS

Active substance(s): PASSION FLOWER EXTRACT / VALERIAN ROOT DRY EXTRACT

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MODULE 1

Administrative Information and
Prescribing Information

November 24th 2008

Module 1.3.1 Package Leaflet
Patient Information Leaflet
DiaSleep Plus tablets
Valerian root extract 125mg and Passion Flower herb extract 250mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about DiaSleep Plus.
Keep this leaflet with the tablets.
You may want to read it again or show it to your doctor, pharmacist or healthcare
practitioner.

What is in this leaflet
1: What this product is and what it is used for
2: Before you take this product
3: How to take this product
4: Side-effects
5: After taking this product
6: Product description

1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing Valerian root and Passion flower
herb. Each coated tablet of this product contains 125mg of extract (as dry extract) from Valerian root
(Valeriana officinalis L.) (3-6:1) (equivalent to 375-750mg of Valerian root). Extraction solvent:
Ethanol 70 % v/v and 250mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata
L.) (5-7:1) (equivalent to 1250-1750mg of Passion Flower Herb). Extraction solvent: Ethanol 50 %
v/v.
DiaSleep Plus is a traditional herbal medicinal product used for the temporary relief of sleep
disturbances due to symptoms of mild anxiety. This usage is based on evidence of 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
• are allergic to any of the ingredients (see section 6)
• already taking a medicine which makes you drowsy
Tell your doctor before taking his product if you have an intolerance to some sugars (see section 6).
The effects of this product may be increased by alcohol. Excessive use of alcohol should therefore
be avoided.
Passiflora-Valerian coated tablets

Module 1.3.1
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MODULE 1

Administrative Information and
Prescribing Information

November 24th 2008

3: How to take this product
Adults and the elderly
Take 1 to 2 tablet half an hour before bedtime. If necessary an additional tablet can be taken earlier in
the evening. Swallow the tablets whole with some water or other liquid. Do not chew the tablets.
As the effects of this product may not occur immediately, the tablets should be taken continuously for
2-4 weeks.
Do not exceed the stated dose.
If you take too much of this product (overdose)
If you take more than the recommended dose, speak to a doctor, pharmacist or 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.
If you have any questions, or are unsure about anything, please ask your doctor, pharmacist or
healthcare practitioner.

4: Side-effects
Like all medicines, this product can have side-effects. These are listed below.
Side-effects
• abdominal pain
• nausea or feeling sick

If these persist for more than a few days, or
become troublesome, stop taking this product.

Other side-effects
There has been one report of 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.
This product may cause drowsiness. If you are affected do not drive or operate
machines.

5: After taking this product
You must speak to a healthcare practitioner if your symptoms worsen, if they do not improve or after
four weeks, or if side-effects not mentioned in this leaflet occur.
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.
Store the tablets in a cool dry place.
Do not store the tablets in a place where the temperature goes above 30oC.
Keep the tablets out of the reach and sight of children.
Keep your tablets in the blister pack until it is time to take them.
Passiflora-Valerian coated tablets

Module 1.3.1
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MODULE 1

Administrative Information and
Prescribing Information

November 24th 2008

6: Product description
Each coated tablet of this product contains 125mg of extract (as dry extract) from Valerian root
(Valeriana officinalis L.) (3-6:1) (equivalent to 375-750mg of Valerian root). Extraction solvent:
Ethanol 70 % v/v and 250mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata
L.) (5-7:1) (equivalent to 1250-1750mg 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, liquid glucose.
Coating: Sucrose, talc, calcium carbonate (E170), acacia, tragacanth, titanium dioxide (E171), liquid
glucose, iron oxide hydrate (E172), hypromellose, white beeswax, carnauba wax, shellac
Each pack contains 30, 60, 90 or 100 coated tablets.
Registration holder and manufacturer of this product
Diapharm GmbH & Co. KG
Hafenweg 18-20
48155 Münster
Germany
Manufacturer of bulk
Wiewelhove GmbH
Dörnebrink 19
49479 Ibbenbüren
Germany
Traditional herbal registration number: THR 42340/0004
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG
Würzburger Str. 3
26121 Oldenburg
Germany
Telephone: +49 (0)441 - 98344-0
Email: info@diapharm.de
This leaflet was prepared in October 2008.

Passiflora-Valerian coated tablets

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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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