Algopain-Eze 140 Mg Medicated Plaster
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ALGOPAIN-Eze 140 mg medicated plaster
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each medicated plaster contains 140 mg diclofenac sodium.
Excipients: 2.8 mg butylhydroxytoluene (E321) and 1.4 g propylene glycol (E1520). For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM Medicated plaster
10 x 14 cm plaster with a white to light brown paste spread as a uniform layer onto unwoven support and with a detachable protective film.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For short-term treatment.
Local symptomatic treatment of pain in acute strains, sprains or bruises of the extremities following blunt trauma, e.g. sport injuries.
4.2 Posology and method of administration
Dosage
In adults and adolescents aged 16 years and over, one medicated plaster should be attached to the painful area twice daily, in the morning and the evening. The maximum total daily dose is 2 medicated plasters, even if there is more than one injured area to be treated. Only one painful area should be treated at once.
Method of administration For cutaneous use.
The medicated plaster should not be divided.
If necessary, the medicated plaster can be held in place using an elastic net bandage.
Duration of use
ALGOPAIN-Eze 140 mg medicated plaster should be used for as short a period as possible. The duration of use should not exceed 7 days. The therapeutic benefit of longer administration has not been established.
Elderly _patiens and_patients with renal or hepatic impairments There are no special dosage recommendations (see section 4.4).
Children and adolescents
There are insufficient data on efficacy and safety for children and adolescents below 16 years of age (see section 4.3)
4.3 Contraindications
ALGOPAIN-Eze 140 mg medicated plaster must not be used under the following circumstances:
- hypersensitivity to the active substance or any of the excipients of the medicinal product (e.g. propylene glycol, butylhydroxytoluene)
- hypersensitivity to any other analgetic and antirheumatic medicinal product (non-steroidal anti-inflammatory drugs [NSAIDs], including acetylsaliylic acid)
- patients who have previously had an attack of asthma, urticaria or acute rhinitis due to acetylsalicylic acid or any other NSAID
- active peptic ulcer
- on open injuries, burns, skin infections or eczema
- during the last trimester of pregnancy
- the use in children and adolescents aged less than 16 years is contraindicated
4.4 Special warnings and precautions for use
If symptoms persist for longer than 3 days or worsen, a physician should be consulted.
The medicated plaster should not come into contact with or be applied to the eyes or the mucous membranes.
Undesirable effects can be reduced by using the lowest effective dose for the shortest possible time.
Bronchospasm can occur in patients who suffer or have previously suffered from bronchial asthma or allergies.
The treatment should immediately discontinued if a skin rash develops after applying the medicated plaster.
Patients should be warned against exposure of the treated area to direct and solarium sunlight after removal of the medicated plaster for about one day in order to reduce the risk of photosensitivity.
Although the systemic effects may be minimal, the medicated plaster should be used with caution in patients with impaired renal, cardiac or hepatic function, or a history of
peptic ulcer, intestinal inflammation or haemorrhagic diathesis. Non-steroidal antiinflammatory drugs should be used with caution in elderly patients, as they are more likely to experience undesirable effects.
ALGOPAIN-Eze 140 mg medicated plaster contains propylene glycol and butylhydroxytoluene. Propylene glycol may cause skin irritation. Butylhydroxytoluene may cause local skin reactions (e.g. contact dermatitis), or irritation of the eyes and mucous membranes.
Do not administer concurrently, by either the topical or the systemic route, any medicinal product containing diclofenac or other NSAIDs.
4.5 Interaction with other medicinal products and other forms of interaction
If the medicated plaster is used correctly, the rate of systemic transfer is low, so that the interactions reported in association with oral diclofenac are unlikely to occur.
4.6 Pregnancy and lactation
Pregnancy
There are insufficient clinical data available regarding cutaneous use of diclofenac during pregnancy. Animal studies have shown reproductive toxicity following systemic application (see section 5.3).
As the effect of prostaglandin biosynthesis inhibition on pregnancy has not been established, ALGOPAIN-Eze 140 mg medicated plaster should only be used during the first and second trimester of pregnancy after careful balancing the benefit to risk ratio. The maximum daily dose is two medicated plasters (see section 4.2).
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to:
- cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension);
- renal dysfunction, which may progress to renal failure with oligo-hydroamniosis; the mother and the neonate, at the end of pregnancy, to:
- possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
- inhibition of uterine contractions resulting in delayed or prolonged labour. Consequently, diclofenac is contraindicated during the third trimester of pregnancy.
Lactation
Minimal quantities of diclofenac and its metabolites are excreted into the breast milk.
As no adverse effects are known for the infant, there is no need in general to interrupt breast-feeding during short-term use. However, ALGOPAIN-Eze 140 mg 140 mg medicated plaster should not be directly applied onto the breast area.
4.7 Effects on ability to drive and use machines
ALGOPAIN-Eze 140 mg medicated plaster has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
The following frequency conventions are used in the rating of undesirable effects:
Very common (>1/10)
Common (>1/100 to < 1/10)
Uncommon (>1/1000 to < 1/100)
Rare (>1/10,000 to < 1/1000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)
Skin and subcutaneous tissue disorders Common:
Local skin reactions, such as skin redness, a burning sensation, pruritus, erythema, skin rash, sometimes with pustules or wheals.
Uncommon:
Hypersensitivity reactions or local allergic reactions (contact dermatitis).
Frequency not known:
In patients using topical NSAIDs, isolated cases of generalised skin rash, hypersensitivity reactions, such as angioedema, anaphylactic-type reactions, and photosensitisation have been reported.
Systemic absorption of topically applied diclofenac is very low compared with plasma levels of the active substance following oral intake of diclofenac. The probability of systemic undesirable effects (such as gastrointestinal or renal disturbances, bronchospasm) is thus very low following topical application compared with the frequency of undesirable effects associated with oral intake of diclofenac. If diclofenac is used on a large area of skin and for a prolonged period, however, systemic undesirable effects may occur.
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
No cases of overdose have been reported.
If serious systemic undesirable effects occur following incorrect use or inadvertent overdose (e.g. in children), the precautionary measures appropriate for intoxication with non-steroidal anti-inflammatory drugs should be taken.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use ATC code: M02AA15
Diclofenac is a non-steroidal anti-inflammatory/analgesic substance which, in the standard animal models of inflammation, has been shown effectively to inhibit prostaglandin synthesis. In humans, diclofenac reduces pain, swelling, and fever due to inflammation. In addition, diclofenac reversibly inhibits ADP-induced and collagen-induced platelet aggregation.
5.2 Pharmacokinetic properties
Diclofenac is absorbed slowly and incompletely from cutaneous formulations. The plasma concentrations of diclofenac at steady state are characterised by continuous absorption of diclofenac from the plaster, irrespective of whether the plaster is applied in the morning or the evening. Following cutaneous administration, diclofenac may possibly be absorbed in a dermal depot, from where it is released slowly into the central compartment.
The observed therapeutic efficacy is mainly explained by therapeutically relevant tissue concentrations of the active substance beneath the site of application. The penetration to the site of action may vary depending on the extent and type of disorder and the sites of administration and action.
Mean plateau concentrations are approximately 3 ng/ml. Plasma protein binding of diclofenac is high at 99%. Metabolism and elimination are comparable following cutaneous and oral administration. Following rapid hepatic metabolism (hydroxylation and binding to glucuronic acid), /3 of the active substance are eliminated renally and /3 is eliminated via the biliary route.
5.3 Preclinical safety data
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential reveal no special hazards for humans beyond those already outlined in other sections of the Summary of Product Characteristics. In animal studies, chronic toxicity of diclofenac following systemic administration mainly took the form of gastrointestinal lesions and ulcers. In a 2-year toxicity study, rats treated with diclofenac showed a dose-dependent increase in thrombotic occlusion of the cardiac vessels.
In experimental animal studies on reproductive toxicity, systemically applied diclofenac caused an inhibition of ovulation in rabbits as well as impairment of implantation and early embryonic development in rats. Gestation period and parturition time were prolonged by diclofenac. The embryotoxic potential of diclofenac was studied in three animal species (rat, mouse, rabbit). Foetal demise and growth retardation occurred at maternotoxic dose levels. Based on the available data, diclofenac is classified as nonteratogenic. Doses below the materno-toxic threshold had no influence on the postnatal development of the progeny.
Conventional studies on local tolerability have not indicated any particular risk in humans.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
glycerol
propylene glycol (E1520)
diisopropyl adipate
sorbitol, liquid (crystallising) (E420)
carmellose sodium
polyacrylic acid sodium salt
basic butylated methacrylate copolymer
disodium edetate
sodium sulphite, anhydrous (E221)
butylhydroxytoluene (E321)
aluminium-potassium-bis(sulphate)
silica, colloidal anhydrous
light kaolin (natural)
macrogol lauryl ether (9 EO units)
levomenthol
tartaric acid
purified water
unwoven polyester support
polypropylene protective film
6.2 Incompatibilities
Not applicable
6.3 Shelf life
30 months
Shelf life after first opening of a bag: 4 months
6.4 Special precautions for storage
Do not store above 25 °C.
Store in the original package in order to protect from desiccation and light. Keep the bag tightly closed in order to protect from desiccation.
6.5 Nature and contents of container
Sealed, re-sealable bags made of paper/polyethylene/aluminium/ethylene and methacrylic acid copolymer with 2 or 5 medicated plasters.
Each pack contains 2, 5, 10 or 14 medicated plasters.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Used plasters should be folded in half, with the adhesive side inwards
7 MARKETING AUTHORISATION HOLDER
Ratiopharm GmbH Graf-Arco-Str.3 D-89079 Ulm Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 15773/0711
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
24/11/2010
10 DATE OF REVISION OF THE TEXT
29/04/2015
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