Summary of medicine characteristics - DIOMED SUNBURN LOTION
1 NAME OF THE MEDICINAL PRODUCT
1 NAME OF THE MEDICINAL PRODUCTDiomed Sunburn Lotion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 10 mg/ml
Isopropyl myristate 100 mg/ml
For excipients see 6.1
3. PHARMACEUTICAL FORM
Cutaneous emulsion
White aqueous lotion
4. CLINICAL PARTICULARS
4.1. Therapeutic indications
For the relief of pain associated with mild to moderate sunburn.
4.2. Posology and method of administration
For adults, the elderly and children over the age of 12 years:
Commencing as soon as possible after the first sign of any sunburn, apply the lotion to the affected area(s) and massage gently into the skin. Repeat as required, if necessary up to 8 times daily, but leaving at least 2 hours between applications. Treatment should be continued for two to three days, by which time the symptoms should have subsided. Wash hands after use, unless treating them. In cases where children are to be treated, the lotion should always be applied by an adult.
The lotion spreads easily, and a small amount goes a long way. Individual doses should not exceed 15 ml, and the maximum dose should not exceed 120 ml. As a guide, the cap holds approximately 12 ml.
Diomed Sunburn Lotion is not recommended for children under the age of 12 years.
4.3. Contraindications
Not to be used if allergic to any of the ingredients, or in cases of hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis or urticaria.
Not to be used on areas of skin which are cut or grazed, or in cases of any unrelated skin condition where the skin is broken.
4.4. Special warning and precaution for use
Diomed Sunburn Lotion is not a sunscreen or sunblock, and must not be used for this purpose. Care should be taken to prevent further exposure to the sun's harmful rays until the signs and symptoms of the sunburn have completely resolved. Patients should be advised to stay in the shade and keep the affected area(s) completely covered up. This is especially important when the effect of the sun is most intense (between 11 am and 3 pm).
The pain and redness of sunburn have a delayed onset and are likely to worsen after being first noticed. Patients should be reminded that this may happen even after taking corrective measures, such as keeping out of the sun and treating the sunburn, because the signs and symptoms take several hours (up to a day) to develop fully. Cases of severe or extensive sunburn (involving more than 10% of a child's body surface area, or more than 20% of an adult's body surface area) and cases involving obviously blistered skin, may require more comprehensive medical intervention, and such patients should therefore be encouraged to seek medical advice.
Excessive exposure to sunlight in a hot and/or humid environment can also cause heat stroke. If the patient develops a high temperature, is confused or weak, or has convulsions, they should consult a doctor immediately.
Keep away from the eyes and mouth.
Although systemic absorption of topically applied ibuprofen is less than for oral dosage forms, patients with asthma, an active peptic ulcer or a history of kidney problems, should seek medical advice before using the lotion.
Patients should be encouraged to seek medical advice if symptoms persist. Keep out of the reach and sight of children.
For external use only.
4.5 Interaction with other medicinal products and other forms of interaction
Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.
The formulation is designed to resist being washed off whilst swimming or bathing.
4.6. Pregnancy and lactation
Not to be used during pregnancy or lactation. Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased.
Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast-fed infants adversely.
4.7. Effects on ability to drive and use machines
None known.
4.8. Undesirable effects
The initial application of Diomed Sunburn Lotion or other liquid preparations to sunburned skin may occasionally be associated with a temporary sensation of tingling or stinging, but this should subside after a few minutes.
Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:-
Hypersensitivity: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a ) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or © assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Renal: renal impairment can occur in patients with a history of kidney problems.
Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.
Peeling and tanning of the skin are normal reactions to sunburn, and may occur 4 – 7 days after being burnt.
4.9. Overdose
Overdose with a topical presentation of ibuprofen is extremely unlikely.
Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension.
Correction of severe electrolyte abnormalities should be considered.
5. PHARMACOLOGICAL PROPERTIES
5.1. Pharmacodynamic properties
ATC Code: D11AX – Other Dermatological Preparations
Diomed Sunburn Lotion is for topical application. Ibuprofen is a phenylpropionic acid derivative which exerts its anti-inflammatory and analgesic effects directly in tender skin at the site of application, mainly by inhibiting prostaglandin biosynthesis. Diomed Sunburn Lotion also contains isopropyl myristate which is an emollient.
5.2. Pharmacokinetic properties
There do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion of ibuprofen.
There is evidence that percutaneous absorption of topically applied drug substances is not influenced by non-severe sunburn. Accordingly, and bearing in mind the low absolute doses of ibuprofen involved, pharmacokinetic studies on the percutaneous absorption of ibuprofen from Diomed Sunburn Lotion have not been performed.
5.3. Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6.
PHARMACEUTICAL PARTICULARS
6.1. List of excipients
Coconut Oil Carbomers Sorbitan Laurate
2-Diethylaminoethanol
Phenoxyethanol Purified Water
6.2. Incompatibilities
None known.
6.3. Shelf life
36 months.
Diomed Sunburn Lotion is for single patient use. It should be discarded following a single course of treatment or after one week.
6.4. Special precautions for storage
Do not store above 25°C
6.5. Nature and contents of container
HDPE BOTTLES fitted with a single-holed LDPE dispensing plug and spigotted polypropylene SCREW CAP, containing 100 ml or 200 ml.
6.6. Instructions for use and handling
No special instructions.
7. MARKETING AUTHORISATION HOLDER
Diomed Developments Limited
T/A Dermal Laboratories Tatmore Place, Gosmore Hitchin, Herts SG4 7QR, United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 00173/0197
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION8th October 2004