Patient info Open main menu

DIASLEEP PLUS TABLETS - patient leaflet, side effects, dosage

Dostupné balení:

Patient leaflet - DIASLEEP PLUS 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 extracts of 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, 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)
  • already taking a medicine for anxiety or to help you sleep

Tell your doctor before taking this 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

DiaSleep Plus Tablets – THR 23056/0027

be avoided.

Driving and using machines

If you feel drowsy, do not drive or use machines

You must speak to a qualified healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if side-effects not mentioned in this leaflet occur.

3: how to take this product

For oral use only.

Adults and the elderly

Take 1 to 2 tablets 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 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.

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.

DiaSleep Plus Tablets – THR 23056/0027

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.

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 the tablets above 30oC. Store in the original container.

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.

6: contents of the pack and other information

Each coated tablet of this product contains 125 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L.) (3–6:1) (equivalent to 375–750 mg of Valerian root). Extraction solvent: Ethanol 70 % v/v and 250 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5–7:1) (equivalent to 1250–1750 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, 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

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road, Marlow SL7 1FX

Manufacturer of this product

Diapharm GmbH & Co. KG

or

Wiewelhove GmbH

Wurzburger Str. 3

Dornebrink 19

26121 Oldenburg

49479 Ibbenburen

Germany

Germany

DiaSleep Plus Tablets – THR 23056/0027

Traditional herbal registration number: THR 23056/0027

THR"

Certification Mark

If you would like further information about this product, please contact: Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road,

Marlow SL7 1FX

Telephone: +44 1628 401980

Email:

This leaflet was last revised in November 2019.

For a large print, Braille or audio version update of this leaflet, call [to be updated].