ECONAC

4). Posology Adults One 100mg suppository may be given as a once daily treatment usually at night. Where necessary therapy may be combined with tablets up to a total maximum dose of 150 mg diclofenac per day. Special population Elderly patients Although the pharmacokinetics of Diclofenac Sodium are not impaired to any clinically relevant extent in elderly patients, non-steroidal anti-inflammatory drugs should be used with particular caution in such patients who, generally, are more prone to adverse reactions.

In particular, it is recommended that the lowest effective dosage be used in frail, elderly patients or those with a low body weight (see also Precautions) and the patient should be monitored for GI bleeding during NSAID therapy. 3).

No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. 4). 3). No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made.

4).

Paediatric population Children (aged 1 - 12 years):

Diclofenac Sodium 100 mg suppositories are not suitable for children.

Method of administration:

Not to be taken by mouth, as per rectal administration only. The suppositories should be inserted well into the rectum. It is recommended to insert the suppositories after passing stools.

Adverse reactions (Table 1) are ranked under heading of frequency, the most frequent first, using the following convention: very common: (>1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); Not known: cannot be estimated from the available data.

The following undesirable effects include those reported with either short-term or long-term use. System organ class Frequency Adverse reactions Blood and lymphatic system disorders Very rare Thrombocytopenia, leukopenia, anaemia (including haemolytic and aplastic anaemia), Agranulocytosis.

Immune system disorders Rare Very rare Anaphylactic, anaphylactoid reactions (including hypotension and shock) and hypersensitivity. Angioneurotic oedema (including face oedema). Psychiatric disorders Very rare Disorientation, depression, insomnia, nightmare, irritability, psychotic disorder.

Nervous system disorders Common Rare Very rare Not known Headache, dizziness. Somnolence, tiredness cerebrovascular accident, aseptic meningitis, convulsion, memory impairment, anxiety, tremor, paraesthesia, taste disturbances. Hallucination, confusion, disturbances of sensation Eye disorders Very rare Not known Visual disturbance, vision blurred, diplopia.

Optic Neuritis Ear and labyrinth disorders Common Very rare Vertigo. Tinnitus, hearing impaired. Very rare cardiac failure, myocardial infarction. chest pain Palpitations Cardiac disorders Not known Kounis syndrome Vascular disorders Very rare Hypertension, vasculitis, hypotension Respiratory, thoracic and mediastinal disorders Rare Very rare Asthma (including dyspnoea).

Pneumonitis. Gastrointestinal disorders Common Rare Very rare Not known Nausea, vomiting, diarrhoea, dyspepsia, abdominal pain, flatulence, anorexia. Gastrointestinal ulcer with or without bleeding or perforation (sometimes fatal particularly in the elderly), gastrointestinal haemorrhage, haematemesis, diarrhoea haemorrhagic, melaena, gastritis, Colitis (including haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), constipation, Stomatitis (including ulcerative stomatitis), glossitis, oesophageal disorder, diaphragm-like intestinal strictures, pancreatitis.

Ischaemic colitis Hepatobiliary disorders Common Rare Very rare Transaminases increased. Hepatitis, jaundice, liver disorder. Hepatic failure, Fulminant hepatitis, hepatic necrosis. Skin and subcutaneous tissue disorders Common Rare Very rare Not known Rash.

Urticaria. Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), Generalised Bullous fixed drug eruptions, eczema, erythema, erythema multiforme, dermatitis exfoliative, loss of hair, photosensitivity reaction, purpura, allergic purpura, pruritus.

Fixed drug eruption Renal and urinary disorders Very rare Acute renal failure, haematuria, proteinuria, nephrotic syndrome, interstitial nephritis, renal papillary necrosis. Reproductive system and breast disorders Very rare Impotence.

4 for Contraindications and Special warnings and special precautions for use). Reporting of suspected adverse reactions If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

2 and GI and cardiovascular risks below). 5). Caution is indicated in the elderly on basic medical grounds. 2). 8). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction.

Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac. Like other NSAIDs, Diclofenac Sodium 100 mg suppositories may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Gastrointestinal effects:

Gastrointestinal bleeding, haematemesis, melaena, ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events.

They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving Diclofenac Sodium 100 mg suppositories, the medicinal product should be withdrawn. 8). The risk of GI bleeding, is higher with increasing NSAID doses, and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.

2). To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly, the treatment should be initiated and maintain at the lowest effective dose. g.

5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). 5). 8). NSAIDs, including diclofenac, may be associated with increased risk of gastro- intestinal anastomotic leak.

Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery.

Hepatic effects:

Close medical surveillance is required when prescribing Diclofenac to patients with impaired hepatic function, as their condition may be exacerbated. As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase.

During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure. g. eosinophilia, rash), Diclofenac should be discontinued. Hepatitis may occur with use of diclofenac without prodromal symptoms.

Caution is called for when using Diclofenac in patients with hepatic porphyria, since it may trigger an attack. g. 3). Monitoring of renal function is recommended as a precautionary measure when using Diclofenac in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, those being treated with diuretics or recovering from major surgery. Effects on renal function are usually reversible on withdrawal of Diclofenac Sodium 100 mg suppositories.

8). Patients appear to be at the highest risk of […]

1. • Active, gastric or intestinal ulcers, bleeding or perforation • History of gastrointestinal bleeding or perforation, relating to previous NSAID therapy. • Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding).

6). 4). • Like other non-steroidal anti-inflammatory drugs (NSAIDs), diclofenac is also contraindicated in patients in whom attacks of asthma, angioedema, urticaria or acute rhinitis are precipitated by ibuprofen, acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.

• Proctitis • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.