Boots Sleepeaze Herbal

For excipients see 6.1.

Film coated tablet.

To soothe and so aid restful sleep.

Method of administration:

Oral.

Adults:

Two tablets to be taken approximately one hour before retiring.

This dose is also applicable to the elderly.

Children:

Not recommended.

Patients with depressive illnesses.

Causes drowsiness which may persist the next day. If affected, do not drive or operate machinery. Avoid alcoholic drink.

Possible additive effect with alcohol and other CNS depressants. May increase the risk of visual disturbances with Beta blockers.

There is no evidence of safety of the herbs in human pregnancy nor is there evidence from animal studies that they are free from hazard. However, they have been widely used for many years without apparent ill effects. Avoid in pregnancy if a better known and safer alternative is available, although safety in pregnancy is likely.

No information is available on excretion into breast milk.

As with all products possessing CNS depressant activity, Quiet Night/Peaceful Night/Sleep Aid tablets may impair judgement and increase reaction time, so affecting the patient's ability to drive or operate machinery.

The frequency of adverse reactions is exceptionally low. Those that have been reported are thought to relate to hypersensitivity to one or more of the herbal active ingredients. Symptoms have included stomach cramps, nausea, vomiting, gastro-enteritis, diarrhoea, fever, headache, palpitations and faintness.

Symptoms likely to be observed include vomiting, drowsiness and possibly ataxia, hypothermia and increased muscle relaxation. If necessary, the stomach should be emptied by aspiration and lavage and symptomatic treatment initiated.

The sedative action of valerian is believed to be mainly due to a number of epoxy-iridoid esters known as valepotriates, particularly valtrate, didrovaltrate and isovaltrate, but certain components of the volatile oil, especially valerenal, valerenic acid and valeranone, are also thought to contribute to the sedative effect. It has been suggested that the active sedative principles of hops are polyphenolic compounds, particularly humulone and lupulone, or another compound which has been isolated from hops, 2-methyl-3-buten-2-ol. The basis for the sedative activity of passion flower is less certain. A pyrone derivative known as maltol, which has been obtained from the alkaloidal fraction of the herb induces depression in mice and possesses other sedative properties.

Not known.

Not known.

EXTRACT EXCIPIENTS

Maltodextrin

Colloidal Anhydrous Silica

CORE EXCIPIENTS

Calcium Hydrogen Phosphate

Microcrystalline Cellulose

Stearic Acid

Magnesium Stearate

Film coating (after drying)

Film coating suspension consists of:

Polyethylene Glycol 400

Hypromellose 4500

Hydroxypropyl Methylcellulose

Iron Oxide – yellow (E172)

Iron Oxide – red (E172)

Iron Oxide – black (E172)

Titanium Dioxide (E171)

Industrial Methylated Spirits 74 OP

Purified Water

Potable Water

Not applicable.

3 years.

Do not store above 30°C.

Blister pack containing 6, 30, 60, 90 or 120 tablets.

High Density Polyethylene container with a polypropylene child resistant closure containing 60 tablets.

The tablets are easily removed from the blister pack.

BRUNEL HEALTHCARE MANUFACTURING LIMITED

WILLIAM NADIN WAY

SWADLINCOTE

DERBYSHIRE

DE11 0BB

UNITED KINGDOM

PL 20894/0028

9 January 1989 / 13 January 1999

10^th March 2011