Active substance(s): ATROPINE / BELLADONNA ALKALOIDS
NAME OF THE MEDICINAL PRODUCT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Belladonna Alkaloids (as Hyoscamine)
For the full list of excipients, see section 6.1
Medicated adhesive plaster, containing Belladonna Alkaloids in the adhesive
For the relief of aches and pains, such as - muscular tension and strain, stiff
neck and aching shoulders, sciatica, lumbago, rheumatism, backache.
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.
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.
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.
Interaction 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
Atropine is an antimuscarinic and may be absorbed. It has the potential for
interacting with other drugs having similar affect such as antihistamines.
Fertility, pregnancy and lactation
The plaster is not recommended for use during pregnancy or breast-feeding.
Systemic dosing, (oral, SC et) of Atropine is contra-indicated in pregnant and lactating
Systemic absorption of active from the topical patch is not measurable.
Effects on ability to drive and use machines
May cause local irritation (Very rare, <1/10,000).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
Over–dosage from adhesive plaster is rare. If over-dosage does occur it should be
treated as per Atropine poisoning.
Pharmacotherapeutic group: Belladonna alkaloids, tertiary amines ATC Code: A03BA
Atropine is an antimuscarinic alkaloid with both peripheral and central actions.
When applied topically Atropine is transported to the affected area where it
desensitises the nerve endings associated with the pain response.
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.
Preclinical safety data
List of excipients
A pressure sensitive adhesive base containing - Lanolin BP, Natural
Rubber, Partly Hydrogenated Wood Resins, Corn Starch, Kaolin,
Special precautions for storage
Do not store above 25ºC. Store in original package.
Keep away from sources of direct heat and sunlight.
Nature and contents of container
Each plaster is packed in a polypropylene/metallised polypropylene laminate bag.
2 individually wrapped plasters of 9.5 x 12.5 cm in an outer carton
1 wrapped plaster of 28 x 17.5 cm
Special precautions for disposal
No special requirements for disposal.
MARKETING AUTHORISATION HOLDER
Cuxson Gerrard & Co. Ltd
125 Broadwell Road
MARKETING AUTHORISATION NUMBER
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
DATE OF REVISION OF THE TEXT