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BERLIND is a brand name for Indomethacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Non-steroidal analgesic and anti-inflammatory agent indicated for the following conditions: • Active rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders and low back pain • Periarticular disorders such as bursitis, tendinitis, synovitis,…
Verbatim from this product's MHRA label. Tap a section to expand.
4) Adults: One capsule once or twice daily, depending on patient needs and response.
Dysmenorrhoea:
One capsule a day, starting with onset of cramps or bleeding, and continuing for as long as symptoms usually last.
Elderly:
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for gastrointestinal bleeding during treatment with indometacin.
3). Method of administration For oral administration. Berlind MR Capsules should always be given with food or milk to reduce the chance of gastro-intestinal disturbance.
• Blood and lymphatic system disorders: Blood dyscrasias (such as thrombocytopenia, neutropenia, leukopenia, agranulocytosis, aplastic and haemolytic anaemia), bone marrow depression, petechiae, epistaxis, ecchymosis, purpura and disseminated intravascular coagulation may occur infrequently.
Some patients may develop anaemia secondary to obvious or occult gastro-intestinal bleeding. Appropriate blood determinations are recommended. • Immune and system disorders: Hypersensitivity reactions have been reported following treatment with NSAIDs.
These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, rhinitis or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema (swelling of the face, tongue, and inner larynx with constriction of the respiratory passages), and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
• Metabolism and nutrition disorders: Hyperglycaemia, hyperkalaemia and glycosuria have been reported rarely. • Nervous system disorders: Headache, dizziness, light-headedness, depression, vertigo and fatigue (including malaise and listlessness) are common side effects.
Starting therapy with a low dose and increasing gradually minimises the incidence of headache. These symptoms frequently disappear on continued therapy or reducing the dosage, but if headache persists despite dosage reduction, indometacin should be withdrawn.
Reactions reported less frequently include mental confusion, anxiety, syncope, drowsiness, convulsions, coma, peripheral neuropathy, muscle weakness, involuntary muscle movements, insomnia and psychiatric disturbances such as hallucinations and depersonalisation.
2, and GI and cardiovascular risks below). 5). 2). 2).
Cardiovascular and cerebrovascular effects:
Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for indometacin. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with indometacin after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus and smoking).
Cardiovascular, renal and hepatic impairment:
In patients with reduced renal blood flow where renal prostaglandins play a major role in maintaining renal perfusion, the administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.
Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly, diabetes mellitus, extracellular volume depletion, congestive heart failure, sepsis or concomitant use of any nephrotoxic drug, indometacin should be given with caution and renal function should be monitored in these patients.
3 Contraindications). Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state. 8). The dose should be kept as low as possible and renal function should be monitored. NSAIDs may also cause fluid retention which could further aggravate these conditions.
1). • NSAIDS are contraindicated in patients with angioneurotic oedema. g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, 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 NSAID therapy. 4). • Patients with nasal polyps. 6). • Safety in children has not been established. • Patients with coagulation defects.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Rarely, paraesthesia, dysarthria, aggravation of epilepsy and Parkinsonism. 4), depression, vertigo, dizziness, fatigue, dysarthria, syncope, coma, cerebral oedema, confusion, nervousness, anxiety and other psychiatric disturbances, depersonalisation, hallucinations, drowsiness, convulsions and aggravation of epilepsy, peripheral neuropathy, paraesthesia, involuntary movements, insomnia and Parkinsonism.
These effects are often transient and abate or disappear with continued treatment or with reduced dosage. However, occasionally, severe reactions require stopping therapy. • Eye disorders: Visual disturbances, blurred vision, diplopia, optic neuritis, and orbital and peri-orbital pain are seen infrequently.
Corneal deposits, retinal or macular disturbances have been reported in some patients with rheumatoid arthritis on prolonged therapy with indometacin, but similar changes may also be expected in patients with rheumatoid arthritis who have not received indomethacin.
Ophthalmic examinations are desirable in patients given prolonged treatment. • Ear and labyrinth disorders: Tinnitus or hearing disturbance/auditory defects (rarely deafness) have been reported. • Cardiac disorders: There have been reports of oedema, hypertension, hypotension, tachycardia, chest pain, arrhythmia, palpitations and cardiac failure, congestive heart failure.
4). • Vascular disorders: Flushing and sweating has been reported. • Respiratory, thoracic and mediastinal disorders: Pulmonary eosinophilia. There may be bronchospasm in patients with a previous history of bronchial asthma or other allergic reactions.
• Gastro-intestinal disorders: The most commonly-observed adverse events are gastrointestinal in nature. Nausea, anorexia, vomiting, epigastric discomfort or abdominal pain, dyspepsia, melaena, haematemesis, constipation and diarrhoea all have been reported.
With suppositories, tenesmus and irritation of the rectal mucosa have occasionally been reported. 4). Pancreatitis has been reported very rarely. 4). If gastro-intestinal bleeding does occur, treatment with indometacin should be discontinued.
Gastro-intestinal disorders which occur can be reduced by giving indometacin with food, milk or antacids. • Hepatobiliary disorders: Cholestasis, abnormal liver function. Rarely hepatitis and jaundice (associated with some fatalities).
Borderline elevations of one or more liver tests may occur, and significant elevations of ALT (SGPT) or AST (SGOT) have been seen in less than 1% of patients receiving therapy with NSAIDs in controlled clinical trials. If abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic […]
It is reported that a few patients receiving non-steroidal anti-inflammatory drugs manifest borderline elevations in liver function test results. If these persist or worsen, or symptoms of liver disease, a rash or eosinophilia develop, treatment with indometacin should be stopped.
Headaches:
Headache, sometimes accompanied by dizziness and light-headedness, may occur, usually early in treatment. Starting therapy with a low dosage and increasing it gradually will usually minimise the incidence of headache. These symptoms frequently disappear on continuing therapy or reducing the dosage, but if headache persists despite dosage reduction, indometacin should be withdrawn.
Respiratory disorders:
Caution is required if administered to patients suffering from or with a previous history of bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. When GI bleeding or ulceration occurs in patients receiving indometacin, the treatment should be withdrawn.
3), and in the elderly. These patients should commence treatment on the lowest dose available and, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. g. 5). 8). Gastro-intestinal disorders that occur can be reduced by taking indometacin with food or milk.
5). 8).
Impaired female fertility:
The use of indometacin may impair female fertility and is not recommended in women attempting to conceive. In women who have […]