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PARDELPRIN MR is a brand name for Indomethacin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Indometacin has non-steroidal analgesic and anti-inflammatory properties. It is indicated for the following conditions: • active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders and low back pain • periarticular disorders…
Verbatim from this product's MHRA label. Tap a section to expand.
Method of Administration For oral administration Pardelprin should always be given with food or milk to reduce the chance of gastro-intestinal disturbance. 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. 3).
• Blood and lymphatic disorders: blood dyscrasias (such as thrombocytopenia, neutropenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia), bone marrow depression, petechiae, ecchymoses, purpura, and disseminated intravascular coagulation may occur infrequently.
As some patients manifest anaemia secondary to obvious or occult gastro-intestinal bleeding, appropriate blood determinations are recommended. Epistaxis has been reported rarely. • Hypersensitivity: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, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
• Metabolic and nutrition disorders: Hyperglycaemia, glycosuria, hyperkalaemia has been reported rarely. • Nervous system disorders: Visual disturbances, optic neuritis, tinnitus, headache, dizziness and lightheadedness 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.
4), depression, vertigo, fatigue, malaise, dysarthria, syncope, coma, cerebral oedema, nervousness, confusion, anxiety and other psychiatric disturbances, depersonalisation, hallucinations, drowsiness, convulsions and aggravation of epilepsy and parkinsonism, peripheral neuropathy, paraesthesia, involuntary movements and insomnia.
These effects are often transient and abate or disappear on reduced or stopping treatment. However, the severity of these may, on occasion, require cessation of therapy. • Eye disorders: blurred vision, diplopia, optic neuritis and orbital and peri- orbital pain are seen infrequently.
2, and GI and cardiovascular risks below). 5) • 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. Patients should be warned that they may experience dizziness and, if they do, should not drive a car or undertake potentially dangerous activities needing alertness.
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, 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, liver dysfunction, cardiac impairment, those taking diuretics, the elderly, diabetes mellitus, extracellular volume depletion, congestive heart failure, sepsis or concomitant use of any nephrotoxic drug.
• Hypersensitivity to indometacin or to any of the excipients. • 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 NSAIDs therapy. 4). • Not to be used in patients with nasal polyps.
6). • Safety in children has not been established.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Corneal deposits and retinal or macular disturbances have been reported in some patients with rheumatoid arthritis on prolonged therapy with indometacin. Ophthalmic examinations are desirable in patients given prolonged treatment. • Ear and labyrinth disorders: tinnitus or hearing disturbances (rarely deafness) have been reported.
• Cardiac disorders: There have been reports of hypotension, tachycardia, chest pain, arrhythmia, palpitations. • Vascular disorders: flushing has been reported rarely. • Respiratory, thoracic and mediastinal disorders: pulmonary eosinophilia.
There may be bronchospasm in patients with a history of bronchial asthma or other allergic disease. • Gastrointestinal disorders: The most commonly-observed adverse events are gastrointestinal in nature. Anorexia, epigastric discomfort,ulceration at any point in the gastro-intestinal tract (even with resultant stenosis and bstruction), with suppositories, tenesmus and irritation of the rectal mucosa have occasionally been reported, bleeding (even without obvious ulceration or from a diverticulum) and perforation of preexisting sigmoid lesions (such as diverticulum or carcinoma), increased abdominal pain or exacerbation of the condition in patients with ulcerative colitis or Cohn’s disease (or the development of this condition), intestinal strictures and regional ileitis have been rarely reported.
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. 4) have been reported following administration.
Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely. • Hepato-biliary disorders: cholestasis, 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 manifestations such as rash or eosinophilia occur, indometacin should be stopped. Abnormal liver function, hepatitis and jaundice.
• Skin and subcutaneous tissue disorders: pruritus, urticaria, angioneurotic oedema, angiitis, erythema nodosum, rash, photosensitivity, exfoliative dermatitis, bullous reactions including Stevens Johnson syndrome and Toxic Epidermal Necrolysis (very rare).
Photosensitivity, erythema multiforme, hair loss, sweating and exacerbation of psoriasis. • Musculo-skeletal, connective tissue and bone disorders: muscle weakness and acceleration of cartilage degeneration. • Renal and urinary disorders: haematuria, nephrotoxicity in various forms, including interstitial nephritis, nephrotic syndrome and renal failure, renal insufficiency, proteinuria including renal failure (all rare), blood urea elevation, and haematuria (all infrequent)..
In patients with renal, cardiac or hepatic impairment, caution is required since the use of non-steroidal anti- inflammatory drugs may result in deterioration of renal function. The dose should be kept as low […]
3) Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state. 8). The dose should be kept as low as possible and renal function should be monitored. NSAIDs may also cause fluid retention which may further aggravate these conditions.
• As with other non-steroidal anti-inflammatory drugs, there have been reports of acute interstitial nephritis with haematuria, proteinuria, and occasionally nephrotic syndrome in patients receiving long-term administration of indometacin.
• 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 precipitate 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 previous history of serious GI events.
When GI bleeding or ulceration occurs in patients receiving indometacin, the treatment should be withdrawn. Rarely, intestinal ulceration has been associated with stenosis and obstruction. 3), and in the elderly. These patients should commence treatment on the lowest dose available.
g. 5). 8). 8). • Gastro-intestinal disorders which occur can be reduced by giving indometacin with food, milk or antacids. They usually disappear on reducing the dosage; if not, the risks of continuing therapy should be weighed against the possible benefits.
5). • Patients with a history of GI […]