Spraymik 4% Cutaneous Spray
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
SPRAYMIK 4% cutaneous spray
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of SPRAYMIK 4% cutaneous spray contains 40 mg of diclofenac sodium. Each pump stroke delivers 8 mg of diclofenac sodium.
Excipients:
Propylene glycol 150 mg/g Soy bean lecithin 100 mg/g For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous spray, solution.
A golden-yellow, transparent solution (pH value: 6.5-7.6), which turns to a gel-like consistency after administration.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the local symptomatic relief of mild to moderate pain and inflammation following acute blunt trauma of small and medium-sized joints and periarticular structures.
4.2 Posology and method of administration
For cutaneous use only.
Adults and adolescents aged 14 years and over
Sufficient solution of SPRAYMIK 4% cutaneous spray should be sprayed onto the skin of the affected site. Depending on the size to be treated, 4-5 pump strokes (0.8-1.0 g of spray containing 32-40 mg of diclofenac sodium) should be applied 3 times a day at regular intervals. The maximum single dose of 1.0 g of the product should not be exceeded. The maximum daily dose is 15 pump strokes (3.0 g of spray containing 120 mg of diclofenac sodium).
SPRAYMIK 4% cutaneous spray should be massaged gently into the skin. After this the hands should be washed unless they are the site to be treated. After application some minutes for drying should be allowed before dressing or binding the treated area.
The treatment may be discontinued when the symptoms (pain and swelling) have subsided. Treatment should not be continued beyond 7 days without review. The patient is requested to consult the doctor if no improvement is seen after 3 days.
Children and adolescents
There are insufficient data on efficacy and safety available for children and adolescents below 14 years (see also contraindication section 4.3.
In adolescents aged 14 years and over, if this product is required for more than 7 days for pain relief or if the symptoms worsen the patient/parents of the adolescent is/are advised to consult a doctor.
Elderly
The posology is the same as for adults.
Patients with hepatic or renal insufficiency
For the use of SPRAYMIK 4% cutaneous spray in patients with hepatic or renal insufficiency see section 4.4.
4.3 Contraindications
• Hypersensitivity to diclofenac, peanut, soya or to any of the excipients. Hypersensitivity to acetylsalicylic acid or other non-steroidal antiinflammatory drugs (NSAIDs)
• Patients with or without asthma in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
• During the third trimester of pregnancy.
• Application to the breast area of breast-feeding mothers
• Use in children and adolescents less than 14 years is contraindicated.
4.4 Special warnings and precautions for use
The possibility of systemic adverse events from application of SPRAYMIK 4% cutaneous spray cannot be excluded if the preparation is used on large areas of skin and over a prolonged period (see the product information on systemic forms of diclofenac).
SPRAYMIK 4% cutaneous spray should be applied only to intact non-diseased skin, and not to skin wounds or open injuries. It should not be allowed to come into contact with the eyes or mucous membranes and should not be ingested.
SPRAYMIK 4% cutaneous spray can be used with non-occlusive bandages but should not be used with an airtight occlusive dressing.
Patients should be warned against excessive exposure to sunlight in order to reduce the incidence of photosensitivity.
Discontinue the treatment if a skin rash develops after applying the product.
The concomitant use of SPRAYMIK 4% cutaneous spray with oral NSAIDs should be cautioned as the incidence of systemic undesirable effects may increase (see section 4.5).
Where SPRAYMIK 4% cutaneous spray is applied to a relatively large area of skin (i.e. more than 600 square centimetres of the body surface) and over a prolonged period (i.e. more than 4 weeks), the possibility of systemic undesirable effects from application of SPRAYMIK 4% cutaneous spray cannot be excluded (for example, there is the potential for hypersensitivity, asthmatic and renal adverse reactions). Bronchospasm may be precipitated in patients suffering from or with previous history of bronchial asthma or allergenic disease.
SPRAYMIK 4% cutaneous spray should only be used with caution in patients with a history of peptic ulcer, hepatic or renal insufficiency, or bleeding diathesis, or inflammatory bowel disease, as isolated cases with topical diclofenac have been reported.
Information concerning excipients
SPRAYMIK 4% cutaneous spray contains:
propylene glycol which may cause skin irritation in some people.
peppermint oil which may cause allergic reactions.
4.5 Interaction with other medicinal products and other forms of interaction
Since systemic absorption of diclofenac from a topical application of SPRAYMIK 4% cutaneous spray is very low such interactions are very unlikely.
Concurrent acetylsalicylic acid or other NSAIDs may result in an increased incidence of adverse reactions (see section 4.4).
4.6 Fertility, pregnancy and lactation
Pregnancy
The systemic concentration of SPRAYMIK 4% cutaneous spray is lower after topical administration, compared to oral formulations. With reference to experience from treatment with NSAIDs with systemic uptake, the following is recommended:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1%, up to approximately 1.5%. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
During the first and second trimester of pregnancy, SPRAYMIK 4% cutaneous spray should not be given unless clearly necessary. If SPRAYMIK 4% cutaneous spray is used by a woman attempting to conceive, or during the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.
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.
Lactaction
Like other NSAIDs, diclofenac passes into breast milk in small amounts. However, at therapeutic doses of SPRAYMIK 4% cutaneous spray no effects on the suckling child are anticipated. Because of a lack of controlled studies in lactating women, the product should only be used during lactation under advice from a healthcare professional. Under this circumstance, SPRAYMIK 4% cutaneous spray should not be applied on the breasts of nursing mothers, nor to elsewhere on large areas of skin or for a prolonged period of time (see section 4.4).
4.7 Effects on ability to drive and use machines
Cutaneous application of SPRAYMIK 4% cutaneous spray has no influence on the ability to drive and use machines.
4.8 Undesirable effects
Skin disorders are commonly reported.
Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common (> 1/10); common (> 1/100 to < 1/10); uncommon (> 1/1,000 to < 1/100); rare (> 1/10,000 to < 1/1,000); very rare (< 1/10,000), or not known (can not to be estimated from available data). Within each
|
frequency grouping, adverse reactions are seriousness. |
presented in order of decreasing |
|
Table 1 | |
|
Immune system disorder | |
|
Very rare |
Hypersensitivity (including urticaria), angioneurotic oedema |
|
Infections and infestations | |
|
Very rare |
Rash pustular |
|
Respiratory, thoracic and mediastinal disorders | |
|
Very rare |
Asthma |
|
Skin and subcutaneous tissue disorders | |
|
Common |
Rash, eczema, erythema, dermatitis (including dermatitis contact), pruritus* |
|
Rare |
Dermatitis bullous |
|
Very rare |
Photosensitivity reaction |
|
Not known |
Application site reaction, dry skin, burning sensation |
* Pruritus has been reported at a frequency of 0.9% in a clinical trial, 236 patients with ankle distortions were treated with 4-5 pump strokes of SPRAYMIK4% cutaneous spray t.i.d. (120 patients) or placebo (116 patients) for 14 days.
Undesirable effects may be reduced by using the minimum effective dose for the shortest possible duration. The total single dose of product should not exceed 1.0 g (equivalent to 5 pump strokes) of spray.
Nevertheless during long term treatment (> three weeks) and/or when treating large areas (i.e. more than 600 square centimetres of the body surface) there is a possibility of systemic adverse reactions. Reactions like abdominal pain, dyspepsia, gastric and renal disorders may occur.
4.9 Overdose
The low systemic absorption of topical diclofenac renders overdose very unlikely.
However undesirable effects similar to those observed following an overdose of diclofenac tablets can be expected if SPRAYMIK 4% cutaneous spray is inadvertently ingested (i.e. a 15 ml spray bottle containing 500 mg of diclofenac sodium).
In the event of accidental ingestion resulting in significant systemic adverse effects, general therapeutic measures normally adopted to treat poisoning with non-steroidal anti-inflammatory medicines should be used. Gastric decontamination and the use of activated charcoal should be considered, especially within a short time of ingestion.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Antiinflammatory preparations, non-steroids for topical use.
ATC code: M02AA 15
Sodium diclofenac is a non-steroidal anti-inflammatory drug (NSAID) which has also analgesic properties. Diclofenac is a potent inhibitor of prostaglandin bio-synthesis and modulator of arachidonic acid release and uptake.
5.2 Pharmacokinetic properties
After cutaneous application of 1.5 g SPRAYMIK 4% cutaneous spray, a rapid onset of diclofenac absorption can be observed leading to measurable plasma levels of about 1 ng/ml as early as 30 minutes and to maximum levels of about 3 ng/ml at about 24 hours after application.
The achieved systemic concentrations of diclofenac are about 50 times lower than those achieved following oral administration of equivalent amounts of diclofenac. Systemic plasma levels are not supposed to contribute to the efficacy of SPRAYMIK 4% cutaneous spray.
Diclofenac is extensively bound to plasma proteins (about 99 %).
5.3 Preclinical safety data
In rabbit skin, SPRAYMIK 4% cutaneous spray is classified as non-irritant.
Non-clinical data based on conventional studies of safety pharmacology, genotoxicity and carcinogenic potential of diclofenac reveal no special hazard for humans beyond those already outlined in other sections of the SPC. 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 rats and rabbits oral doses of diclofenac were not teratogenic but caused embryotoxicity at maternally toxic doses.
Diclofenac did not affect fertility in rats but inhibited ovulation in rabbits and reduced implantation in rats.
In rats, diclofenac resulted in dose-dependent constriction of the fetal ductus arteriosus, dystocia and delayed parturition (see section 4.3). Doses below the materno-toxic threshold had no influence on the postnatal development of the progeny.
6.1 List of excipients
Isopropyl alcohol Soybean lecithin Ethanol
Disodium phosphate dodecahydrate Sodium dihydrogen phosphate dihydrate Disodium edetate Propylene glycol
Peppermint oil (contains menthol and cineole)
Ascorbyl palmitate
Hydrochloric acid 10% (w/w) for pH adjustment Sodium hydroxide 10% (w/w) for pH adjustment Purified water.
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
After first opening: 6 months
6.4 Special precautions for storage
Store in the original package.
6.5 Nature and contents of container
Glass bottle (Type III Ph.Eur.) with metering pump and protection cap.
Pack sizes of 12.5 g solution (15 ml bottle) and 25 g solution (30 ml bottle). Not all pack sizes may be marketed.
6.6 Special precautions for disposal
No special requirements.
7 MARKETING AUTHORISATION HOLDER
MIKA Pharma GmbH AuestraBe 39, 67346 Speyer,
Germany
8 MARKETING AUTHORISATION NUMBER(S)
PL 18017/0008
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
29/08/2008
10 DATE OF REVISION OF THE TEXT
23/10/2014