1. Name Of The Medicinal Product
Nurofen Back Pain 300mg Sustained Release Capsules
2. Qualitative And Quantitative Composition
Ibuprofen 300 mg/capsule.
3. Pharmaceutical Form
Sustained-release capsules.
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
4.1 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.
Adults, the elderly and children over 12 years:
The minimum effective dose should be used for the shortest time necessary to relieve symptoms. If the product is required for more than 10 days, or if the symptoms worsen the patient should consult a doctor.
For oral administration.
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 anti-inflammatory 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. See also 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 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.
Respiratory:
Bronchospasm may be precipitated in patients suffering from, or with a history of, bronchial asthma or allergic disease.
Other NSAIDs:
The use of Nurofen Back Pain SR Capsules with concomitant NSAIDs, including cyclo-oxygenase-2 selective inhibitors should be avoided (see section 4.5)”
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease – increased risk of aseptic meningitis (see section 4.8)
Renal:
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8)
Hepatic:
Hepatic dysfunction (see sections 4.3 and 4.8)
Cardiovascular and cerebrovascular effects:
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 trial and epidemiological data suggest that use of ibuprofen, particularly at high doses (2400mg daily) and in long-term treatment 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.
Impaired female fertility:
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.
Gastrointestinal:
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.
Dermatological:
Seriouos skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very 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. Nurofen back Pain SR Capsules should be discontinued at the first appearance of skin rash, mucosal lesions, or any other signs of hypersensitivity.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:
• have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• are allergic to ibuprofen, to any of the ingredients, or to aspirin or other painkillers
• are taking other NSAID pain killers, or aspirin with a daily dose above 75mg
• or the patient is under 12 years of age.
Speak to your doctor or pharmacist before use if you
• Have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke, heart, liver, kidney or bowel problems,
• Are a smoker
• 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
Ibuprofen (like other NSAIDs) should be avoided in combination with:
• Aspirin 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 inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusions can be made for regular ibuprofen use, and 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)
Ibuprofen should be used in caution in combination with:
• Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
• Antihypertensives and diuretics: since NSAIDs may diminish the effects of these drugs. 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 gastric 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 Pregnancy And Lactation
Whilst no teratogenic effects have been demonstrated in animal experiments, the use of Nurofen Back Pain SR Capsules should, if possible, be avoided during the first 6 months of pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of premature closure of the foetal 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 4.3)
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
No Data Held
4.8 Undesirable Effects
Hypersensitivity reactions have been reported and these may consist of
a. non-specific allergic reactions and anaphylaxis
b. respiratory tract reactivity e.g. asthma, aggravated asthma, bronchospasm, dyspnoea
c. various skin reactions e.g. pruritus, urticaria, angioedema and more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erthema multiforme)
The list of the following adverse effects relates to those experienced with ibuprofen at OTC doses, for short-term use. In the treatment of chronic conditions, under long-term treatment, additional adverse effects may occur.
Hypersensitivity Reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: Severe hypersensitivity reactions. Symptoms could be: facial, tongue and larynx swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis, angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal Disorders:
The most commonly-oberved adverse events are gastrointestinal in nature.
Uncommon: Abdominal pain, dyspepsia and nausea.
Rare: Diarrhoea, flatulence, constipation and vomiting
Very rare: Peptic ulcer, perforation or gastrointestinal hemorrhage, melaena, haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis, gastritis.
Exacerbation of ulcerative colitis and Chrohn's disease (See section 4.4)
Nervous System:
Uncommon: Headache
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use, associated with increased serum urea and odema.
Hepatic:
Very rare: Liver disorders, especially in long-term treatment.
Haematological
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia, pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and bruising.
Dermatological:
Uncommon: Various skin rashes
Very rare: Severe forms of skin reactions such as bullous reactions, including Stevens-Johnson Syndrome, erythema multoforme and toxic epidermal necrolysis can occur.
Immune System:
In patients with existing auto-immune disorders (such as systemic lupus erythematosus, mixed connective tissue disease) during treatment with ibuprofen, single cases of symptoms of aseptic meningitis, such as stiff neck, headache, nausea, vomiting, fever or disorientation have been observed.
Cardiovascular and Cerebrovascular:
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly at high doses 2400mg daily) and in long-term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke), (see section 4.4).
4.9 Overdose
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the dose response effect is less clear cut. This product, sustained release capsules, has a half life of approximately 8 hours.
Symptoms – Most patients who have ingested clinically important amounts of NSAIDs will develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea. Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious poisoning, toxicity is seen in the central nervous system, manifesting as drowsiness, occasionally excitation and disorientation or coma. Occasionally patients develop convulsions. In serious poisoning metabolic acidosis may occur and the prothrombin time/ INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma is possible in asthmatics.
Management –
Management should be symptomatic and supportive and include the maintenance of a clear airway and monitoring of cardiac and vital signs until stable. Consider oral administration of activated charcoal if the patient presents within 1 hour of ingestion of a potentially toxic amount. If frequent or prolonged, convulsions should be treated with intravenous diazepam or lorazepam. Give bronchodilators for asthma.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by inhibition of prostaglandin synthesis. In humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet aggregation.
Experimental data suggests that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 h before or within 30 min after immediate release dosing (81 mg), a decreased effect of acetylsalicylic acid on the formation of thromboxane of platelet aggregation occurred. However, the limitations of these data and the uncertainties regarding extrapolation of ex vivo data to the clinical situation imply that no firm conclusion can be made for regular ibuprofen use, and no clinically relevant effect is considered to be likely for occasional ibuprofen use.
The analgesic effects of a 2 capsule-dose (600mg) of sustained release ibuprofen last for up to 12 hours
5.2 Pharmacokinetic Properties
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively bound to plasma proteins.
Peak serum concentration occurs approximately 1-2 hours after administration.
Ibuprofen is metabolised in the liver to two major metabolites with primary excretion via the kidneys, either as such or as major conjugates, together with a negligible amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.
Elimination half-life is approximately 2 hours.
T½ with this formulation is prolonged from 2 to 8 hours.
No significant differences in pharmacokinetic profile are observed in the elderly.
5.3 Preclinical Safety Data
No relevant information, additional to that contained elsewhere in the SPC.
6. Pharmaceutical Particulars
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
None.
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 And Other Handling
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 Authorisation
17th September 1997
10. Date Of Revision Of The Text
21/06/2011
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