Medicated Pain Relief Plaster
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
MEDIPLASTER L (8x13 cm)
MEDICATED PAIN RELIEF PLASTER
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each plaster contains:
Methyl Salicylate 74.88 mg
Levomenthol 37.44 mg
Camphor 46.8 mg
3 PHARMACEUTICAL FORM
Medicated plaster and adhesive covering for dermal application.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
The temporary and short term relief of minor aches and pains of muscles and tendons associated with simple backache (lumbago), sprains and strains.
4.2. Posology and Method of Administration
MEDIPLASTER L(8x13cm) is a dermal application system which is affixed to the skin.
Two plasters per day (morning/evening) topically at the most painful sites. Reduction of dosage (1 plaster/day) is recommended in case of sufficient pain relief or symptoms.
MEDIPLASTER L should not be used in children under 14 years of age.
4.3. Contra-indications
Patients with hypersensivity to salicylate, menthol, camphor and peppermint oil are contraindicated.
The plaster is not to be used on top of wounds or inflammatory skin disease with secretion or on broken or damaged skin.
Patients with active peptic ulcer as well as patients with asthma or a history of asthma are contraindicated. Patients with severe hepatic and renal disease are also contraindicated.
4.4. Special Warnings and Precautions for Use
For external use only! Avoid contact with the eyes.
If symptoms persist or worsen, seek medical advise.
The plaster should be removed immediately if an intense burning or itching reaction occurs.
Do not exceed the stated dose. Not for long term use.
Concomitant therapy with NSAIDs and aspirin may potentiate the side effects of such concomitant drugs.
4.5. Interactions with other Medicaments and other forms of Interaction
The gastrointestinal tract side effects of aspirin and non-steroidal antiinflammatory drugs may be potentiated when used concomitantly with MEDIPLASTER e.g. dyspepsia, nausea and/or vomiting, abdominal pain etc.
4.6. Pregnancy and Lactation
The plaster should not be used during pregnancy and lactation because the active ingredients cross the placenta. Medical advice should be sought if this plaster is to be used because an assessment of the risk vs. benefit during pregnancy and lactation should be made by a medical practitioner.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8.
Undesirable Effects
Side effects are generally infrequent and are mild topical disorders at the application site:
itching, reddening, contact eczema, contact allergy, burning, adverse experience of local coolness. Nausea or gastrointestinal effects are possible.
4.9. Overdose
In case of adverse feelings like burning or coolness remove the MEDIPLASTER.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The active constituents have pharmacodynamic properties as follows:
Methyl Salicylate: local analgesic with antiinflammatory properties
Levomenthol: local analgesic and antipruritic Camphor: local analgesic and antipruritic
5.2. Pharmacokinetic Properties
Methyl salicylate as well as Camphor and Levomenthol are absorbed by the skin and may exert systemic actions.
Methyl salicylate is already hydrolized during absorption through the skin to salicylic acid. Salicylic acid is excreted as salicyluric acid, salicyl phenol glucuronide, salicyl ethyl glucuronide, salicylic acid or gentisinic acid.
Camphor is hydrolized in the liver and the hydroxylation product is excreted as glucuronide in the urine.
Menthol is excreted as glucuronide by the kidney and by the liver.
5.3. Preclinical Safety Data
Following the therapeutic dermal application MEDIPLASTER the resulting systemic concentration of each of the three active ingredients is far below its respective toxic level recorded in preclinical trials.
Toxic effects in humans, systemic or local, have not been observed in single or repeat application.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol
Carbomer (Carboxyvinyl-Polymer)
Starch Grafted Acrylate 300 (= Sanwet IM-3 00) Polyvinyl Alcohol, partially hydrolized Gelatin
Titanium Dioxide
Dried Aluminium Hydroxide
Heavy Kaolin
Methylcellulose
Malic Acid
Polysorbate 80
Self-emulsifying Glyceryl Monostearate Sodium Polyacrylate Purified Water
Unwoven Cloth
Polyethylene Film
6.2. Incompatibilities
Not known.
6.3. Shelf Life
If stored between 5 - 25°C and at a relative humidity of 40 - 70 % MEDIPLASTER L has a shelf life of 2 years.
6.4. Special Precautions for Storage
Keep this medicine below 25°C.
6.5. Nature and Contents of Container
Collapsible box: thin cardboard
1 sachet: polyethylen-laminated aluminium foil lined paper bag, heat-sealed, containing 1 medicated plaster. 1 plastic bag, containing 1 adhesive covering. or
1 sachet: polyethylen-laminated aluminium foil lined paper bag, heat-sealed, containing 5 medicated plasters. 5 plastic bags, each containing 1 adhesive covering.
6.6. Instruction for Use/Handling
Strip off the polyethylene film and cover the affected area with the plaster and hold it in place with the adhesive covering.
Keep out of reach of children.
Use all MEDIPLASTER pads within 10 days after the package is opened.
7 MARKETING AUTHORISATION HOLDER
Sato Pharmaceutical Co., Ltd.
Immermann StraBe 40 40210 Dusseldorf Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 12198/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15 April 1996
10 DATE OF REVISION OF THE TEXT
June 1998