Lasonil (also available GSL as Bruiseze).

100g of ointment contains Heparinoid 'Bayer' 5000 HDB-U (Heparinoid Bayer Units). This is equivalent to 0.8% w/w.

Ointment.

The relief of traumatic conditions: e.g. bruises, sprains and soft tissue injuries.

Adults and Elderly:

The ointment should be applied thickly and gently massaged into the affected area two or three times daily.

Children:

No clinical studies have been performed in children up to the age of 12 years. However, there is documented use of this product in children and the safety profile is similar to that reported in adults.

For GSL use:

Not recommended in children under 6 years of age. Medical advice should be sought if no improvement is seen within 5 days of treatment.

The ointment is contraindicated for use in:

Patients with known hypersensitivity to any of the ingredients.

Patients taking oral anticoagulants (see Section 4.5 Interactions).

Senile purpura.

Lasonil should be applied to unbroken skin only. It should not be applied to open or infected wounds or ulcers, mucous membranes and large areas of skin.

A physician should be consulted if the patient:

Experiences spontaneous bruising.

Is unable to weight-bear as a result of the injury.

Has extensive bruising of the lower limbs.

Suffers recurrent bruising or bruising in response to minor trauma.

First aid measures such as rest, ice, compression and elevation should be implemented before the ointment is applied.

Concurrent use of this product with systemically administered anticoagulants may lead to further prolongation of prothrombin time.

There is no evidence to suggest that Lasonil should not be used during pregnancy and lactation. However, it should be used with caution during the first trimester.

None.

Very rarely (<1/10,000) erythema and hypersensitivity reactions occur which subside when treatment with the ointment is stopped.

In the unlikely event of Lasonil being taken orally, treat symptomatically.

Heparinoid has been shown to prolong blood-clotting time locally and has anti-inflammatory, thrombolytic and anti-exudatory activity.

Heparinoids have a half-life of 2-6 hours after intravenous administration. There is no definitive evidence to date that heparins or heparinoids are absorbed after oral administration.

The transdermal absorption under intact anatomical conditions is between 1% and 2%. The transdermal absorption of high-dose heparinoids has been demonstrated by detecting their anticoagulant activities in both intact and surface-modified skin preparations (skin without epidermis) from various animals and man. Topical effects are assessed by measuring the influence of the substances on oedemas and haematomas.

The recalcification time and the thrombin time in blood were significantly prolonged after topical application of a heparinoid ointment to human subjects. The anticoagulant effect was seen about 2 hours after application of the ointment. It reached a peak after 5 hours and remained detectable for 8 hours.

The absorption rate of radio-labelled heparinoid in guinea-pigs following depilation of the skin was over 33% after 10 hours.

There are no pre-clinical data of relevance to the prescriber which are additional to the information included in other sections of the SPC.

Lasonil contains the following excipients:

White petroleum jelly DAB

Wool Alcohols Ph.Eur

None known.

36 months.

Do not store above 30^oC.

Aluminium tube with an inner protective layer and cardboard outer carton. Sizes available are 20g (GSL) and 40g (P).

Not applicable.

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire RG14 1JA

Trading as Bayer plc, Consumer Care Division

PL 0010/0241

Date of first authorisation: 4 October 1999.

August 2001