BOOTS SLEEPEAZE HERBAL

Active substance: VALERIAN EXTRACT 4:1

View full screen / Print PDF » Download PDF ⇩

Transcript
P13114

Sleep Aid Tablet
Extracts of Hop Strobile, Valerian, Passion Flower

Patient Information Leaflet
Read all of this leaflet carefully before
you take this product because it contains
important information you need to know.
This product is available without prescription;
however, you still need to use this product
carefully to get the best results from it.
Keep this leaflet as you may need to read it
again. Ask your doctor, pharmacist or qualified
healthcare practitioner if you need more
information or advice.
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 medicine contains extracts of:
hop strobile
valerian root
passion flower herb
A traditional herbal medicinal product used
for the temporary relief of sleep
disturbances based on traditional use only.

2. Before you take this product
Do not take this product if you are:
allergic to any of the ingredients
(see section 6)
under 18 years of age
already taking a medicine for sleep
or anxiety

Pregnancy and breast feeding
Do not take this product if you are pregnant
or breast feeding, because there is no
evidence that it is safe to do so.
The effects of this product may be increased
by alcohol. Excessive use of alcohol should
therefore be avoided.
Driving and using machinery.
These tablets might cause drowsiness
which can persist into the following day.
If affected do not drive or operate machinery.
Each tablet contains glucose. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.

3. How to take this product
For oral use. Swallow the tablet whole with
water. Do not chew.
Adults and the elderly:
2 tablets, 1 hour before you go to bed.
Not recommended for use in children or
adolescents under 18 years old.
As the effects of this product may not occur
immediately, it should be taken continuously
for 2 - 4 weeks. If symptoms worsen or persist
after 4 weeks consult your doctor, pharmacist
or qualified healthcare practitioner.
Do not exceed the stated dose.
What to do if too many tablets are taken
If you take too many tablets by mistake,
contact your doctor or pharmacist straight
away and take this leaflet with you.
What to do if you miss a dose:
If you miss a dose just take the next dose
when it is due. Do not take a double dose to
make up for the missed dose.

4. Possible side effects

6. Further Information

Like all medicines, this product can
cause side effects, although not
everybody gets them.

Each film coated tablet contains the active
ingredients:
34 mg of extract (as dry extract) from
Hop strobile (Humulus lupulus L.) (4-6:1)
Extraction solvent: Ethanol 70% (v/v)
30.8 mg of extract (as dry extract) from
Valerian root (Valeriana officinalis L.) (4:1)
Extraction solvent: Ethanol 60% (v/v)
15.2 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:
Extract excipients: Maltodextrin, colloidal
anhydrous silica, liquid glucose.
Core excipients: Calcium hydrogen phosphate,
microcrystalline cellulose, stearic acid,
magnesium stearate.
Film-coating: Polyethylene glycol 400,
hypromellose 4500, hydroxypropylmethyl
cellulose, iron oxides (E172), titanium
dioxide (E171).
This product is available in pack sizes of
6, 30, 50, 60, 90 and 120 tablets. Not all
pack sizes are marketed.

The frequency of the side effects is not
known. The following side effects have
been reported:
Gastrointestinal symptoms such as
nausea (feeling sick) and stomach
cramps have been reported with
Valerian root preparations
Other side effects:
One case of hypersensitivity (vasculitis)
and one case of increased heartbeat
(tachycardia) have been reported in
patients using Passion Flower herb.
If you are concerned about any side
effect, if a side effect becomes serious
or if you notice a side effect not listed
in this leaflet, please tell your doctor
or qualified healthcare practitioner.
You can help to make medicines safer
by reporting any side-effects to the
Yellow Card Scheme at
www.mhra.gov.uk/yellowcard
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 - Friday)

5. How to store this product
Keep out of the reach and sight of
children.
Do not use these tablets after the
expiry date printed on the pack.
Do not store above 25°C.
Store in the original package.

This product is a tan brown, circular biconvex,
film coated tablet.
Is this leaflet hard to see or read? Contact us on:
Telephone: +44 (0)1283 228300
Email: info@bruhealth.co.uk
THR Holder & Manufacturer is:
Brunel Healthcare Manufacturing Ltd.,
William Nadin Way, Swadlincote, Derbyshire,
DE11 0BB, U.K.
Text revised: March 2013
THR: 20894/0073
Certification Mark

Expand view ⇕

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.

Hide
(web2)