Diclofenac 100 Stada Retard

Diclofenac sodium.

1 modified release tablet contains: Diclofenac sodium 100 mg.
Excipients/Inactive Ingredients: Sucrose, Cetyl alcohol, colloidal anhydrous silica, magnesium stearate, povidone, hydroxypropyl methyl cellulose, polyethylene glycol 6000, polysorbate 80, talc, Titanium dioxide E171, and Ferric oxide red E172.

Pharmacology: Diclofenac is a non-steroidal anti-inflammatory drug (NSAID) advocated for use in painful and inflammatory rheumatic and certain non-rheumatic conditions. It is available in a number of administration forms which can be given orally, rectally or intramuscularly.
Conveniently, dosage adjustments are not required in the elderly or in those patients with renal or hepatic impairment. The drug has a relatively short elimination half-life, which limits the potential for drug accumulation.

Painful conditions in inflammatory and degenerative rheumatic diseases, such as chronic rheumatoid arthritis, ankylosing spondylitis, arthroses, spondylarthroses and spondylarthritis; spondylogenic pain syndrome; extra-articular rheumatism; acute gout; renal and biliary colic. Non-rheumatic painful inflammations and swellings, post-traumatic, post-operative, following dental surgery and as an adjuvant in gynecology.

The dosage should be individually adjusted to the clinical picture.
To minimize the potential risk for an adverse cardiovascular event, Diclofenac should be used at the lowest effective dose for shortest possible time.
Adults: 1 Diclofenac 100 Stada Retard modified release tablet once daily.
Diclofenac, particular at higher doses (150 mg per day), is associated with an increased risk of serious cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events which can be fatal) that is comparable to COX-2 inhibitors. Evidence suggests that the risk may increase with the dose and duration of use.
Diclofenac 100 Stada Retard tablets should not be administered to children.
Lower-dosage diclofenac preparations are available for the treatment of children aged 6 and above.

Possible symptoms of overdose are dysfunctions of the CNS (giddiness, headache, hyperventilation, disorientation, in children also myoclonic spasms), the gastrointestinal tract (nausea, vomiting, abdominal pain, bleeding) as well as hepatic and renal dysfunctions.

Diclofenac is contraindicated in: (i) in patients with severe heart failure and (ii) for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy; active, or history of recurrent peptic ulcer / hemorrhage.
Ventricular and duodenal ulcers. Hypersensitivity to components of the preparation. Patients in whom an asthma attack, urticaria or acute rhinitis has occurred following acetylsalicylic acid (aspirin) or other drugs with an inhibitory effect on prostaglandin synthesis. Porphyria, haemorrhagic diathesis, haematopoietic disorders.

A careful medical examination is necessary for patients with gastrointestinal complaints, with a history of gastrointestinal ulcers, ulcerative colitis, Crohn's syndrome, and patients with a severely restricted hepatic function.
In elderly patients, gastrointestinal bleeding or ulcerations / perforations generally have serious consequences. They may occur at any time during therapy without warning signs and without any indications in the case history.
In rare cases where a peptic ulcer or bleeding in the alimentary tract occurs in connection with the medication, administration must be discontinued.
Due to the important function of prostaglandins in maintaining renal circulation, particular caution is necessary for patients with a restricted cardiac or renal function, elderly patients, patients taking diuretics and patients with fluid deficits in the extra-cellular space, irrespective of cause, e.g. during the peri- or post-operative phase of major surgery. If diclofenac is used in such cases, monitoring of the renal function is recommended as a precautionary measure.
After therapy has been discontinued, the status before therapy is normally restored. Caution is urged in patients of very advanced age for reasons of fundamental medical principles. In particular, it is recommended that with frail elderly patients or those with a low body weight, the lowest effective dose be used. As with other non-steroidal antiphlogistics, diclofenac too may result in the increase of one or more liver enzymes. Monitoring of the hepatic function is recommended as a precautionary measure if diclofenac is used over a long period.
Diclofenac should be discontinued if a hepatic dysfunction persists or worsens, and in the event that other clinical signs and symptoms indicating the disease of the liver or other manifestations occur (e.g. eosinophilia, skin rash, etc.). Hepatitis may occur without premonitory symptoms. In patients with hepatic porphyria, diclofenac should be used with caution, as the medicine may trigger off an attack.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diurectics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pre-treatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of Diclofenac in patients with advanced renal disease. Therefore, treatment with Diclofenac is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
As with other non-steroidal antiphlogistics, blood counts are recommended if diclofenac is used over long periods. As with other non-steroidal antiphlogistics, allergic reactions, including anaphylactic or pseudoanaphylactic reactions, may occur even if the drug is used for the first time.
Caution is advised for patients suffering from asthma, hay fever and chronic respiratory tract diseases, as well as severe hypertension.
In rare cases, Diclofenac has been associated with serious liver injury.
Treatment with Diclofenac is not recommended in patients with pre-existing cardiovascular disease or cerebrovascular disease, or presenting risk factors for cardiovascular disease. For these patients, treatment option other than NSAIDs, particularly COX-2 inhibitors and diclofenac, should be considered first.

During pregnancy, administration is indicated for urgent reasons only, and then only in the lowest necessary dose. Diclofenac may not be used in the last three months of pregnancy (possibility of inhibition of uterine contractions and premature closing of Botallo's arterial duct).
The active component passes into the breast milk in such low quantities that the treatment of nursing mothers, if absolutely necessary, can be tolerated. There is no experience of the affects on the infant.

Gastrointestinal tract: Epigastralgia, heartburn, other gastrointestinal disorders, such as appetite loss, nausea, vomiting, diarrhea, slight gastrointestinal bleeding.
Rarely: gastrointestinal bleeding (also concealed), haematemesis, melaena, peptic ulcers with or without bleeding or perforation, sanguinodiarrhoea.
In isolated instances: symptoms in the lower abdominal region (e.g. unspecific bleeding colitis and worsening of ulcerative colitis or Crohn's syndrome), pancreatitis, aphthous stomatitis, glossitis, lesions of the oeosophagus, constipation.
Central nervous system: Headache, giddiness, tiredness, drowsiness.
Rarely: agitation, somnolence, restlessness.
In isolated instances: impairment of vision (e.g. blurred vision, double vision), disorientation, impaired hearing (e.g. tinnitus), insomnia, irritability, spasms, parasthesia, impaired memory, depression, anxiety feelings, nightmares, tremors, psychotic reactions, impaired sensation of taste.
Skin: Exanthem, rash.
Rarely: urticaria, pruritus.
In isolated instances: reversible alopecia, bulbous eruptions, eczema, erythema exudativum multiforme, Stevens-Johnson syndrome, Lyell's syndrome, photosensitisation, erythrodermia, purpura including allergic purpura.
Kidneys: Rarely: Renal insufficiency, acute renal failure, haematuria.
In isolated instances: interstitial nephritis, nephrotic syndrome, papillary necrosis.
Liver: Rarely: hepatic dysfunctions of various degrees of severity, transitory transaminase increase, hepatitis (including urticaria), fulminating in some cases.
Blood: In isolated instances: thrombocytopenia, purpura, leucopenia, agranulocytosis, haemolytic or aplastic anemia, panmyelopathy.
Other organ systems: Rarely: sodium and water retention, peripheral oedema, hypertension, palpitations, chest pains, hypersensitivity reactions (anaphylactic or pseudo-anaphylactic systemic reactions including hypertension up to shock bronchospasm).

The simultaneous administration of diclofenac with other pharmaceutical products may result in the increase or reduction of their effect: Increase: The plasma level of lithium and digoxin.
The risk of gastrointestinal bleeding with simultaneous therapy with glucocorticoids, the side-effects of other non-steroidal anti-rheumatic agents.
The affect of potassium-saving diuretics (control potassium level).
The effect of platelet aggregation inhibition drugs.
Reduction in the effect of: Furosemide and other "loop diuretics".
Antihypertensive agents.
The simultaneous administration of acetylsalicylic acid (aspirin) reduces the serum concentration of diclofenac and vice-versa.
The administration of non-steroidal antiphlogistics less than 24 hours before or after therapy with methotrexate should be avoided, as otherwise the blood level of methotrexate may rise, with a consequent increase in the toxicity of this substance. The effect of non-steroidal antiphlogistics on the prostaglandins of the kidney may increase the nephrotoxicity of cyclosporin.
Clinical studies show evidence that diclofenac does not impair the effect of either oral antidiabetics or anticoagulants. Despite this, it is recommended as a precautionary measure that in the case of the simultaneous administration of diclofenac and anticoagulants, the achievement of the desired anticoagulant effect be monitored by laboratory tests.

Store below 25°C. Keep dry.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

M01AB05 - diclofenac ; Belongs to the class of acetic acid derivatives and related substances of non-steroidal antiinflammatory and antirheumatic products.

P₁S₁S₃

Retard tab 100 mg x 100's.