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BELLADONNA PLASTER

Active substance(s): ATROPINE / BELLADONNA ALKALOIDS / ATROPINE / BELLADONNA ALKALOIDS / ATROPINE / BELLADONNA ALKALOIDS

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
BELLADONNA PLASTER

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Belladonna Alkaloids (as Hyoscamine)

0.25% w/w

For the full list of excipients, see section 6.1

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

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
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

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
women.
Systemic absorption of active from the topical patch is not measurable.

4.7

Effects on ability to drive and use machines
Not relevant.

4.8

Undesirable effects
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.

4.9

Overdose

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

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
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.

5.2

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 25ºC. Store in original package.
Keep away from sources of direct heat and sunlight.

6.5

Nature and contents of container
Each plaster is packed in a polypropylene/metallised polypropylene laminate bag.
Pack sizes:
2 individually wrapped plasters of 9.5 x 12.5 cm in an outer carton
1 wrapped plaster of 28 x 17.5 cm

6.6

Special precautions for disposal
No special requirements for disposal.

7.

MARKETING AUTHORISATION HOLDER
Cuxson Gerrard & Co. Ltd
125 Broadwell Road
Oldbury
West Midlands.
B69 4BF

8.

MARKETING AUTHORISATION NUMBER
PL 00089/50013R.

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24/02/2011

10

DATE OF REVISION OF THE TEXT
15/11/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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