Product Summary

1.    NAME OF THE MEDICINAL PRODUCT

BELLADONNA PLASTER

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Belladonna Alkaloids (as Hyoscamine)    0.25% w/w

3.    PHARMACEUTICAL FORM

Medicated adhesive plaster, containing Belladonna Alkaloids in the adhesive mass.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

For the relief of aches and pains, such as - muscular tension and strain, stiff neck and aching shoulders, sciatica, lumbago, rheumatism, backache.

4.2    Posology and method of administration

One plaster to be applied over the affected area as required. Plaster to be removed after 2 - 3 days. Apply another plaster if required.

Children: - Not recommended for use by children under 10 years of age.

4.3    Contraindications

Do not use if you suffer from Glaucoma. Do not use on the face. Do not use if you are allergic to adhesive plasters. Do not use if you are using a medication that contains antihistamines.

4.4    Special warnings and special precautions for use

Occasionally local irritation may occur while using this product.

If the skin beneath the plaster begins to hurt, remove the plaster immediately and wash with soap and water.

If symptoms persist consult your doctor.

Keep out of the reach of children.

Report any unwanted effects to your doctor or pharmacist.

Do not use if you have inflamed or broken skin.

Do not use if you have applied any other medication to the skin.

4.5    Interactions with other medicinal products and other forms of interaction

The plaster should not be applied over other medication which has been applied to the skin as there is the potential for occlusion which may affect the action of the other medication.

Atropine is an antimuscarinic and may be absorbed. It has the potential for interacting with other drugs having similar affect such as antihistamines.

4.6    Pregnancy and lactation

Not recommended for use by pregnant women, nursing mothers. Systemic dosing, (oral, SC et) of Atropine is contra-indicated in pregnant and lactating women. Systemic absorption of active from the topical patch is not measurable.

4.7    Effects on ability to drive and use machines

Not applicable

4.8    Undesirable effects

May cause local irritation

4.9    Overdose

Over - dosage from adhesive plaster is rare. If over - dosage does occur it should be treated as for Atropine poisoning.

5.    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Atropine is an antimuscarinic alkaloid with both peripheral and central actions. When applied topically the Atropine is transported to the affected area where it desensitises the nerve endings associated with the pain response.

Pharmacokinetic properties

There is minimal systemic absorption of Atropine from a dermal patch.

Atropine is rapidly cleared from the blood and is excreted in the urine as Hepatic Metabolites and unchanged drug.

The mean half life of an IV injection is 4 hours.

5.3    Preclinical safety data

None

6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

A pressure sensitive adhesive base containing - Lanolin BP, Natural Rubber, Partly Hydrogenated Wood Resins, Corn Starch, Kaolin,

2,5 di-tert-amylhydroquinone.

6.2    Incompatibilities

Not known

6.3    Shelf life

36 months

6.4    Special precautions for storage

Do not store above 25°C. Store in original package.

Keep away from sources of direct heat and sunlight.

6.5    Nature and contents of container

1 plaster in a polyproplene/metallised polypropylene laminate bag.

6.6    Instructions for use/handling

No special instructions apply.