Lloydspharmacy Valerian Sleep Well tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Valerian root extract; Lupulus; Melissa extract

Available from:

Lloyds Pharmacy Ltd

ATC code:

n/a

INN (International Name):

Valerian root extract; Lupulus; Melissa extract

Dosage:

100mg ; 45mg ; 25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Never Valid To Prescribe As A VMP

Product summary:

BNF: 09120000

Patient Information leaflet

SLEEP WELL
®
TABLETS
Valerian root extract 150mg
1
Patient Information Leaflet
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THESE
TABLETS.
It contains some important information about Lloydspharmacy Sleep
Well.
KEEP THIS LEAFLET WITH THE TABLETS.
You may want to read it again or show it to your doctor, pharmacist or
qualified healthcare practitioner.
WHAT IS IN THIS LEAFLET
1: WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR
1: WHAT THIS PRODUCT IS AND WHAT IT IS USED FOR
........................................
PAGE 1
2: BEFORE YOU TAKE THIS PRODUCT
................................................................
PAGE 2
3: HOW TO TAKE THIS PRODUCT
......................................................................
PAGE 2
4: POSSIBLE
SIDE-EFFECTS..............................................................................
PAGE 3
5: HOW TO STORE THIS PRODUCT
......................................................................
PAGE 3
6: FURTHER INFORMATION
................................................................................
PAGE 4
This product is a traditional herbal medicinal product containing
Valerian root.
Each coated tablet of this product contains 150mg of extract (as dry
extract) from
Valerian root (_Valeriana officinalis _L.) (equivalent to 450-900mg of
Valerian root).
Extraction solvent: ethanol 70%v|v.
LLOYDSPHARMACY SLEEP WELL 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.
Each coated tablet of this product contains 150mg of extract (as dry
extract) from
Valerian root (_Valeriana officinalis _L.) (equivalent to 450-900mg of
Valerian root).
Extraction solvent: ethanol 70%v|v.
THIS PRODUCT ALSO CONTAINS THE FOLLOWING INGREDIENTS:
Liquid glucose, silica colloidal anhydrous, cellulose powdered,
croscarmellose
sodium, stearic acid, talc, sucrose, calcium carbonate (E170), acacia,
tragacanth,
white beeswax, carnauba wax, shellac.
IF YOU HAVE BEEN TOLD BY YOUR DOCTOR THAT Y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Niteherb Valerian Tablets
Boots Sleep Well Valerian Tablets
Lloydspharmacy Sleep Well Tablets
Higher Nature Valerian Sleep Aid Tablets
Simply Supplements Valerian Sleep Aid Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains:
150 mg of extract (as dry extract) from Valerian root (_Valeriana
officinalis _L.) (equivalent to
450-900 mg of Valerian root).
Extraction solvent Ethanol 70% v/v
Also contains 35 mg of glucose and 136 mg of sucrose. (See Section 4.4
Special warnings
and precautions for use.’)
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Coated tablet.
White, glossy, round, biconvex.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for the temporary relief
of sleep disturbances due
to symptoms of mild anxiety based on traditional use only.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral short term use only.
For 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. The tablets
should not be chewed.
As treatment effects may not be apparent immediately, the tablets
should be taken for 2-4
weeks continuously.
If symptoms worsen or do not improve after 4 weeks a doctor or
qualified healthcare
practitioner should be consulted.
The use in children or adolescents under 18 years of age is not
recommended (see Section 4.4
‘Special warnings and precautions for use.’)
4.3
CONTRAINDICATIONS
Hypersensitivity to the active ingredient or any of the excipients
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose
This product contains glucose.
1 coated tablet contains max. 35mg of glucose.
This product contains sucrose.
1 coated tablet contains max. 136mg of sucrose or 0,21 carbohydrate
units.
Patients with rare hereditary problems of galactose intolerance, the
Lapp lactase
deficiency or glucose-galactose malabsorption should not take this
medicine