SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Nupercainal ointment.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Cinchocaine Hydrochloride 1.1 % w/w.

3 PHARMACEUTICAL FORM

Ointment.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Anaesthetic Analgesic for symptomatic relief of various conditions e.g. pain of the skin and mucocutaneous junctions. Relief of pain caused by haemorrhoids. Anal and nipple fissures

4.2 Posology and method of administration

Adults - apply to the affected area not more than three times daily.

Ointment is inserted into the rectum three times daily ( via an applicator) and / or externally in the anal region.

No special recommendations for children and the elderly.

4.3 Contraindications

Do not use in exudative dermatoses.

Or known hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

If symptoms persist consult your doctor.

Keep all medicines out of the reach of children.

For external use only.

Excessive use of local anaesthetic ointments can lead to absorption through the rectal mucosa and should be avoided, especially in infants and children. It has also been recommended that these products only be used for short periods (no longer that a few days) in order to prevent sensitisation of the anal skin.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Fertility, Pregnancy and lactation

There is no evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence. No foetal toxicity or fertility studies have been carried out in animals.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

May cause sensitivity reactions.

4.9 Overdose

Symptoms of overdose include convulsions, with neurological, cardiovascular and respiratory disturbances, and coma. There is no specific antidote.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Cinchocaine hydrochloride is a local anaesthetic of the amide type which is suitable for surface anaesthesia.

5.2 Pharmacokinetic properties

Cinchocaine hydrochloride is rapidly absorbed into the circulation following topical application to the mucosa membrane, and is metabolised in the liver. No further information is available.

5.3 Preclinical safety data

None

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Purified water, anhydrous Lanolin, white soft paraffin, liquid paraffin, palmarosa oil terpeneless, neroli oil 8324.

6.2 Incompatibilities

None.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Protect from heat. Store below 30°C.

6.5 Nature and contents of container

30g aluminium tubes with a screw cap in a cardboard carton together with a pile pipe.

6.6 Special precautions for disposal

None

7 MARKETING AUTHORISATION HOLDER

Boston Healthcare Limited Unit 6, Navigation Court Calder Park Wakefield

West Yorkshire WF2 7BJ United Kingdom

8    MARKETING AUTHORISATION NUMBER(S)

PL 39974/0016

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

20^th January 2005

10 DATE OF REVISION OF THE TEXT

04/02/2012