WINTOGENO CREAM
Active substance(s): MENTHOL / METHYL SALICYLATE
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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
WINTOGENO CREAM
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 12.20% w/w Methyl Salicylate PhEur and 2.60% w/w Menthol
PhEur
3
PHARMACEUTICAL FORM
A white to off-white cream.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
1) As a topical application for the symptomatic relief of muscular pains and
stiffness, including backache, fibrositis, lumbago, muscular aches, neuralgia,
painful bruises, sciatica, sprains and strains.
4.2.
Posology and Method of Administration
Adults (including elderly): The affected area should be bathed in hot water
prior to the application of Wintogeno. A small amount of the cream should be
massaged into the skin with the palm of the hand until the area is almost dry,
using further amounts as necessary. The area should then preferably be
covered with a piece of warm dry flannel.
Wintogeno may be applied 2-3 times daily.
Children under 12 years: Not to be used for children under 12 years of age.
For topical application.
4.3.
Contra-indications
Known hypersensitivity to salicylates or menthol; broken or inflamed skin; use
under occlusive dressings or heating pads. Do not use for children under 12
years of age.
4.4
Special warnings and precautions for use
Use sparingly if aspirin or other salicylates are used concurrently.
The following warnings are also included on the product labelling:
For external use on unbroken skin only.
Do not use under occlusive dressings or heating pads.
Do not use during pregnancy or when breast feeding.
Do not use on the face.
Do not use if seal is broken.
Keep out of the reach of children.
4.5
Interaction with other medicinal products and other forms of interaction
None known.
4.6.
Pregnancy and Lactation
Do not use during pregnancy or when breast feeding.
4.7.
Effects on Ability to Drive and Use Machines
None known.
4.8.
Undesirable Effects
Skin sensitivity reactions have rarely been reported.
4.9
Overdose
No special requirements are anticipated.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Menthol is an essential oil which, when applied to the skin, dilates the blood
vessels, causing a sensation of coldness followed by an analgesic effect.
Methyl salicylate is a topical salicylate used for the relief of pain in rheumatic
conditions.
5.2.
Pharmacokinetic Properties
After absorption, menthol is excreted in the urine and bile as a glucuronide.
Methyl salicylate is absorbed through the skin.
5.3.
Preclinical Safety Data
Not applicable.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
6.2.
Also contains cetomacrogol, cetostearyl alcohol, isopropyl myristate, paraffin,
E216, E218
Incompatibilities
None known.
6.3.
Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4.
Special Precautions for Storage
Store below 25ºC.
6.5.
Nature and Contents of Container
The product container is a carton containing an aluminium tube with screw
cap.
Carton: White backed folding box board printed on white.
Tube: Manufactured from 99.5% pure aluminium; lacquered internally,
printed externally on white.
Pack sizes: 45g
6.6
Special precautions for disposal
Not applicable.
7
MARKETING AUTHORISATION HOLDER
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
8
MARKETING AUTHORISATION NUMBER(S)
PL 0142/0324
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24.9.91
10
DATE OF REVISION OF THE TEXT
30/08/2007
1
NAME OF THE MEDICINAL PRODUCT
WINTOGENO CREAM
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains 12.20% w/w Methyl Salicylate PhEur and 2.60% w/w Menthol
PhEur
3
PHARMACEUTICAL FORM
A white to off-white cream.
4
CLINICAL PARTICULARS
4.1
Therapeutic indications
1) As a topical application for the symptomatic relief of muscular pains and
stiffness, including backache, fibrositis, lumbago, muscular aches, neuralgia,
painful bruises, sciatica, sprains and strains.
4.2.
Posology and Method of Administration
Adults (including elderly): The affected area should be bathed in hot water
prior to the application of Wintogeno. A small amount of the cream should be
massaged into the skin with the palm of the hand until the area is almost dry,
using further amounts as necessary. The area should then preferably be
covered with a piece of warm dry flannel.
Wintogeno may be applied 2-3 times daily.
Children under 12 years: Not to be used for children under 12 years of age.
For topical application.
4.3.
Contra-indications
Known hypersensitivity to salicylates or menthol; broken or inflamed skin; use
under occlusive dressings or heating pads. Do not use for children under 12
years of age.
4.4
Special warnings and precautions for use
Use sparingly if aspirin or other salicylates are used concurrently.
The following warnings are also included on the product labelling:
For external use on unbroken skin only.
Do not use under occlusive dressings or heating pads.
Do not use during pregnancy or when breast feeding.
Do not use on the face.
Do not use if seal is broken.
Keep out of the reach of children.
4.5
Interaction with other medicinal products and other forms of interaction
None known.
4.6.
Pregnancy and Lactation
Do not use during pregnancy or when breast feeding.
4.7.
Effects on Ability to Drive and Use Machines
None known.
4.8.
Undesirable Effects
Skin sensitivity reactions have rarely been reported.
4.9
Overdose
No special requirements are anticipated.
5
PHARMACOLOGICAL PROPERTIES
5.1
Pharmacodynamic properties
Menthol is an essential oil which, when applied to the skin, dilates the blood
vessels, causing a sensation of coldness followed by an analgesic effect.
Methyl salicylate is a topical salicylate used for the relief of pain in rheumatic
conditions.
5.2.
Pharmacokinetic Properties
After absorption, menthol is excreted in the urine and bile as a glucuronide.
Methyl salicylate is absorbed through the skin.
5.3.
Preclinical Safety Data
Not applicable.
6
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
6.2.
Also contains cetomacrogol, cetostearyl alcohol, isopropyl myristate, paraffin,
E216, E218
Incompatibilities
None known.
6.3.
Shelf Life
Shelf-life
Three years from the date of manufacture.
Shelf-life after dilution/reconstitution
Not applicable.
Shelf-life after first opening
Not applicable.
6.4.
Special Precautions for Storage
Store below 25ºC.
6.5.
Nature and Contents of Container
The product container is a carton containing an aluminium tube with screw
cap.
Carton: White backed folding box board printed on white.
Tube: Manufactured from 99.5% pure aluminium; lacquered internally,
printed externally on white.
Pack sizes: 45g
6.6
Special precautions for disposal
Not applicable.
7
MARKETING AUTHORISATION HOLDER
Actavis UK Limited
(Trading style: Actavis)
Whiddon Valley
BARNSTAPLE
N Devon EX32 8NS
8
MARKETING AUTHORISATION NUMBER(S)
PL 0142/0324
9
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
24.9.91
10
DATE OF REVISION OF THE TEXT
30/08/2007
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
