Summary of medicine characteristics - NUROFEN LONG LASTING PAIN RELIEF 300 MG PROLONGED-RELEASE CAPSULES, NUROFEN BACK PAIN 300 MG SUSTAINED RELEASE CAPSULES
1 NAME OF THE MEDICINAL PRODUCT
Nurofen Back Pain 300mg Sustained Release Capsules
Nurofen Long Lasting Pain Relief 300mg Prolonged Release Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 300 mg/capsule
Excipient(s) with known effect:
Sucrose: 34.5 mg/capsule
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged-release capsules, hard
Size 0, hard gelatin capsules with transparent, colourless caps and transparent colourless bodies, imprinted axially in red ink with „N 300“, containing spherical white granules.
4 CLINICAL PARTICULARS
4 CLINICAL PARTICULARS4.1 Therapeutic indications
For the effective relief of backache, rheumatic pain and muscular pains.
4.2 Posology and method of administration
During short-term use, if symptoms persist or worsen the patient should be advised to consult a doctor.
The lowest effective dose should be used for the shortest duration necessary to relieve symptoms (see section 4.4).
If in children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen a doctor should be consulted.
If in adults the product is required for more than 10 days, or if the symptoms worsen, the patient should consult a doctor.
For oral administration.
Adults: One or two capsules taken twice daily.
The capsules should be taken together with water and swallowed whole. Do not chew or suck the capsules.
Do not take more than 4 capsules in 24 hours.
There should be at least 8 hours between doses.
4.3 Contraindications
Patients with a known hypersensitivity to ibuprofen or any other constituent of the medicinal product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angiodema, or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding.
History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy.
Patients with severe hepatic failure, severe renal failure or severe heart failure (NYHA Class IV). (See section 4.4)During the last trimester of pregnancy as there is a risk of premature closure of the fetal ductus arteriosus with possible persistent pulmonary hypertension. The onset of labour may be delayed and the duration increased with an increased bleeding tendency in both mother and child (see Section 4.6).
Severe heart failure.
4.4 Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).
The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.
Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
The use of Nurofen long lasting pain relief 300mg sustained release capsules with concomitant NSAIDs, including cyclo-oxygenase-2 selective inhibitors should be avoided (see section 4.5)
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8)
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)
There is a risk of renal impairment in dehydrated children and adolescents
Hepatic dysfunction (see sections 4.3 and 4.8)
Caution (discussion with doctor or pharmacist) is required prior to starting treatment in patients with a history of hypertension and/or heart failure as fluid retention, hypertension and oedema have been reported in association with
NSAID therapy
Clinical studies suggest that use of ibuprofen, particularly at high dose (2400mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. <1200mg/day) is associated with an increased risk of arterial thrombotic events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III), established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration and high doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking), particularly if high doses of ibuprofen (2400 mg/day) are required.
There is some evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin synthesis may cause impairment of female fertility by an effect on ovulation. This is reversible on withdrawal of treatment.
NSAIDS should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease) as these conditions may be exacerbated (see section 4.8).
The elderly are at increased risk of the consequence of adverse reactions.
The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), and in the elderly. These patients should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as corticosteroids, or anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or anti-platelet agents such as aspirin (see Section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the treatment should be withdrawn.
Severe skin reactions
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Acute generalised exanthematous pustulosis (AGEP) has been reported in relation to ibuprofen-containing products. Nurofen long lasting pain relief 300mg sustained release capsules should be discontinued at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other signs of hypersensitivity.
Masking of symptoms of underlying infections
This medicinal product can mask symptoms of infection, which may lead to delayed initiation of appropriate treatment and thereby worsening the outcome of the infection. This has been observed in bacterial community acquired pneumonia and bacterial complications to varicella. When this medicine is administered for pain or fever in relation to infection, monitoring of infection is advised. In non-hospital settings, the patient should consult a doctor if symptoms persist or worsen.
Excipients
Sucrose – Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
The leaflet will include:
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
o have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
o are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers
o are taking other NSAID pain killers, or aspirin with a daily dose above 75mg o or the patient is under 12 years of age.
Speak to your doctor or pharmacist before use if you
o Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems or are dehydrated
o Are a smoker
o Are pregnant
If symptoms persist or worsen, or if new symptoms occur, consult your doctor or pharmacist.
4.5 Interaction with other medicinal products and other forms of interaction
Aspirin (Acetylsalicylic acid): concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects, unless low-dose aspirin (not above 75mg daily) has been advised by a doctor as this may increase the risk of adverse reactions (see Section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are dosed concomitantly. Although there are uncertainties regarding extrapolation of these data to the clinical situation the possibility that regular, long-term use of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1).
Other NSAIDS including cyclooxygenase-2 selective inhibitors: Avoid concomitant use of two or more NSAIDS as this may increase the risk of adverse effects (see section 4.4)
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. In some patients with compromised renal function (e.g. dehydrated patients or elderly patients with compromised renal function) the coadministration of an ACE inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase may result in further deterioration of renal function, including possible acute renal failure, which is usually reversible. These interactions should be considered in patients taking a coxib concomitantly with ACE inhibitors or angiotensin II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see section 4.4)
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4)
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduced GFR and increased plasma glycoside levels.
Lithium. There is evidence for potential increases in plasma levels of lithium.
Methotrexate: There is evidence for the potential increase in plasma levels of methotrexate.
Ciclosporin: Increased risk of nephrotoxicity
Mifepristone: NSAIDs should not be used for 8–12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.
Quinolone antibiotics: Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.
4.6 Fertility, pregnancy and lactation
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 embryfoetal 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, Nurofen should not be given unless clearly necessary. If Nurofen 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 oligohydroamniosis;
the mother and the neonate, at the end of the 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, Nurofen is contraindicated during the third trimester of pregnancy.
In limited studies, ibuprofen appears in the breast milk in very low concentration and is unlikely to affect the breast-fed infant adversely.
See section 4.4 regarding female fertility.
4.7 Effects on ability to drive and use machines
5 PHARMACOLOGICAL PROPERTIES
6.1 List of excipients
Sucrose and maize starch microgranules, polymers of methacrylic acid esters, povidone, polymers of acrylic and methacrylic acid esters, talc, colloidal silica.
Capsule Shells:
Gelatine, iron oxide ink (E172)
6.2 Incompatibilities
None
6.3
Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25°C
6.5 Nature and contents of container
Blister packs composed of aluminium and opaque or clear PVC
Boxes of 12, 24, 28, 30, 36, 56 and 60 capsules
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ
8 MARKETING AUTHORISATION NUMBER(S)
PL 00063/0378
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
17/09/1997