Diarelax Tablets
DiaRelax, coated tablets - THR 42340/0003
May 2013
Page 5/8
1.3 - Product Information
1.3.1 - Labelling
Module 1.3.1 Package Leaflet
Patient Information Leaflet
DiaRelax Tablets
Melissa leaf extract 112.5 mg, Valerian root extract 125 mg and Passion flower herb extract 80 mg
Please read this leaflet carefully before you start taking these tablets.
It contains some important information about DiaRelax.
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: Possible side-effects
5: How to store this product
6: Further information
1: What this product is and what it is used for
This product is a traditional herbal medicinal product containing extracts of:
• Melissa leaf
• Valerian root
• Passion flower herb For full details see section 6.
DiaRelax is a traditional herbal medicinal product used for:
• the temporary relief of symptoms of mild anxiety
• to aid sleep
• for mild digestive complaints, such as bloating and flatulence.
This usage is 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
• are allergic to any of the ingredients (see section 6)
• already taking a medicine for sleep or anxiety
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 be avoided.
1.3 - Product Information May 2013
1.3.1 - Labelling Page 6 / 8
DiaRelax, coated tablets - THR 42340/0003
3: How to take this product
Adults and the elderly
For the temporary relief of symptoms of mild anxiety take 2 tablets two or three times a day.
For the relief of symptoms of mild digestive complaints, such as bloating and flatulence, take 2 tablets two or three times a day.
To aid sleep take 1 to 2 tablets half an hour before bedtime.
The maximum recommended daily dose is 6 tablets.
Swallow the tablets whole with a little liquid. Do not chew the tablets.
As treatment effects may not be apparent immediately, DiaRelax should be taken for at least 2 weeks continuously.
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: Possible side-effects
Like all medicines, this product can have side-effects. These are listed below.
One case of hypersensitivity (vasculitis) and one case of increased heart beat (tachycardia) have been reported in patients using Passion flower herb.
Tell your doctor or pharmacist if any of the side effects become serious or if you experience any other side-effect not listed above.
This product may cause drowsiness. If you are affected do not drive or operate machines.
|
Side-effects | |
|
• stomach cramps • nausea or feeling sick |
If these persist for more than a few days, or become troublesome, stop taking this product. |
|
• mild allergic skin reactions itching and/or rash of the skin |
Stop taking this product immediately if you experience any allergic skin reactions. |
|
Other side-effects | |
After taking this product
You must speak to a doctor or healthcare practitioner if your symptoms worsen, if they do not improve after four weeks, or if side-effects not mentioned in this leaflet occur.
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.
Store the tablets in a cool dry place.
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: Further information
Each coated tablet of this product contains
• 112.5 mg of extract (as dry extract) from Melissa leaf (Melissa officinalis L.) (4-6:1) (equivalent to 450-675 mg of Melissa leaf). Extraction solvent: Methanol 30% v/v
• 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
• 80 mg of extract (as dry extract) from Passion flower herb (Passiflora incarnata L.) (5-7:1) (equivalent to 400-560 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, stearic acid, talc, liquid glucose.
Coating: Sucrose, talc, calcium carbonate (E170), acacia, tragacanth, titanium dioxide (E171), liquid glucose, quinoline yellow (E104), indigotin 85 (E132), white beeswax, carnauba wax, shellac This product contains glucose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product. Each tablet contains 187 mg of sucrose and 40 mg of glucose.
Each pack contains 30, 60, 90 or 100 coated tablets. Not all packs may be marketed.
Registration holder and manufacturer of this product
Diapharm GmbH & Co. KG Hafenweg 18-20 48155 Munster Germany
Traditional herbal registration number: THR 42340/0003
Certification Mark
If you would like further information about this product, please contact:
Diapharm GmbH & Co. KG
Wurzburger Str. 3
26121 Oldenburg
Germany
Telephone: +49 (0)441 - 98344-0 Email: info@diapharm.de
This leaflet was prepared in October 2009.
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 freephone 0808 100 3352 (available 10am-2pm Monday to Friday).