Panamor 50 Mg Dispersible Tablets

PANAMOR 50 mg DISPERSIBLE TABLET is indicated as short-term treatment in the following acute condition:

• Emergency treatment of acute gout attacks, subject to a maximum daily dose of 150 mg for a maximum treatment period of 3 days (see section 4.2).

Posology

Adults

As a general recommendation, the dose should be individually adjusted. Use the lowest effective dose for the shortest possible duration of treatment. Dissolve one tablet in water three times a day for acute gout attacks. The recommended initial daily dose is 100 mg to 150 mg. In milder cases 50 mg to 100 mg daily is usually sufficient. The total daily dosage should generally be divided into 2 to 3 separate doses. The maximum daily dose is 150 mg for a maximum treatment period of 3 days (3 tablets of PANAMOR 50 mg DISPERSIBLE TABLET in divided doses).

Adolescents

For adolescents aged 14 years or over, a daily dose of 50 mg to 100 mg is usually sufficient. The total daily dose should generally be divided in 2 to 3 doses. The maximum daily dose of 150 mg should not be exceeded.

Paediatric population

PANAMOR 50 mg DISPERSIBLE TABLET should not be used in children and adolescents under 14 years of age.

Method of administration

For oral administration. PANAMOR 50 mg DISPERSIBLE TABLET should preferably be taken on an empty stomach. PANAMOR 50 mg DISPERSIBLE TABLET should be dropped into a glass of water and the liquid stirred to aid dispersion before swallowing. Since a proportion of the active medicine may remain in the glass after swallowing, it is advisable to rinse the glass with a small amount of water and to swallow again. The tablets must not be divided or chewed.

PANAMOR 50 mg DISPERSIBLE TABLET is contraindicated in:

• Patients with hypersensitivity to diclofenac or to any of the excipients in PANAMOR 50 mg DISPERSIBLE TABLET (see section 6.1).
• Hypersensitivity to other NSAIDs including aspirin.
• Gastric or intestinal ulcer, bleeding or perforation.
• Active or history of recurrent ulcer/haemorrhage/perforations.
• A history of gastrointestinal bleeding, ulceration or perforation (PUBs) related to previous NSAIDs including PANAMOR 50 mg DISPERSIBLE TABLET.
• Heart failure, established ischaemic heart disease and/or cerebrovascular disease (stroke) and peripheral arterial disease.
• Hepatic or renal failure (see section 4.4).
• Asthmatic patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other medicines with prostaglandin-synthetase inhibiting activity.
• Pregnancy and lactation. Pregnant women from around 20 weeks of gestation or later in pregnancy (see section 4.4 and 4.6).
• Porphyria.

Close medical surveillance and strict accuracy of diagnosis are imperative in patients with:

• Symptoms indicative of gastrointestinal disease
• Ulcerative colitis
• Crohnu2019s disease
• A case history suggestive of gastrointestinal disease
• Impaired hepatic function
• Pre-existing dyshaemopoiesis of disorders of blood coagulation.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2).

NSAIDs including cyclooxygenase-2 selective inhibitors

The concomitant use of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see section 4.5).

Elderly

Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight (see section 4.2). The elderly have an increased frequency of adverse reactions to NSAIDs including diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal.

Anaphylactic/anaphylactoid reactions

Allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, (see section 4.8). 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.

Methotrexate

Concomitant use of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and methotrexate could result in serious interactions (see section 4.5).

Infections

Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may mask signs and symptoms of infection due to its pharmacodynamic properties.

Cardiovascular and cerebrovascular effects

Caution, appropriate monitoring and advice is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, therapy. In view of the diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.

Caution is required in patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) and should only be treated with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, after careful consideration. As the cardiovascular risks of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.

Clinical trial and epidemiological data consistently point towards increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, particularly at high dose (150 mg daily) and in long term treatment. Patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a medical practitioner immediately in case of such an event.

Hepatic impairment

Close medical surveillance is required when prescribing diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, to patients with impairment of hepatic function, as their condition may be exacerbated. As with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, values of one or more liver enzymes may increase. During prolonged treatment with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, regular monitoring of hepatic function is indicated as a precautionary measure. If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop, or if other manifestations occur (such as eosinophilia, rash), PANAMOR 50 mg DISPERSIBLE TABLET should be discontinued. Hepatitis may occur with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, without prodromal symptoms.

Renal impairment

As fluid retention and oedema have been reported in association with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicines that can significantly impact renal function, and in those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3). Monitoring of renal function is recommended as a precautionary measure when using diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

During prolonged treatment with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, monitoring of blood counts is recommended. Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may reversibly inhibit platelet aggregation (see section 4.5). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

Gastrointestinal effects

Gastrointestinal bleeding (haematemesis, melaena), ulceration or perforation, which can be fatal has been reported with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal (GI) events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, the medicine should be withdrawn.

Close medical surveillance is imperative and particular caution should be exercised when prescribing diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, in patients with symptoms indicative of gastrointestinal disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation (see section 4.8). The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, in patients with a history of ulcers, particularly if complicated with haemorrhage or perforation, and the elderly. 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 maintained at the lowest effective dose. Combination therapy with protective medicines (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicines containing low dose acetylsalicylic acid (ASA/aspirin), or other medicines likely to increase gastrointestinal risk (see section 4.5). Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medicines which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet medicines such as acetylsalicylic acid (see section 4.5). Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohnu2019s disease, hiatus hernia, gastro-oesophageal reflux disease, angiodysplasia) as the condition may be exacerbated (see section 4.8). Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET may be associated with increased risk of gastrointestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, after gastrointestinal surgery.

Skin effects

Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (TEN) Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis (TEN) have been reported. Patients appear to be at highest risk of 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. Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.

Drug reaction with eosinophilia and systemic symptoms

Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in patients taking NSAIDs such as diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, haematological abnormalities, myocarditis, or myositis. Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, discontinue diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and evaluate the patient immediately.

SLE and mixed connective tissue disease

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8).

Pre-existing asthma

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions to diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, such as asthma exacerbations (so-called intolerance to analgesics / analgesics-asthma), Quincke's oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other medicines, e.g. with skin reactions, pruritus or urticaria. Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.

Methotrexate

Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, can inhibit the tubular renal clearance of methotrexate hereby increasing methotrexate levels. Caution is recommended when diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, is administered less than 24 hours before or after treatment with methotrexate, since concurrent administration of methotrexate with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may result in increased methotrexate toxicity (see section 4.4). Cases of serious toxicity have been reported when methotrexate and NSAIDs including diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, are given within 24 hours of each other. This interaction is mediated through accumulation of methotrexate resulting from impairment of renal excretion in the presence of the NSAID.

Lithium or digoxin

Raised plasma concentrations of lithium or digoxin may occur if taken together with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET. Monitoring of the serum lithium or digoxin level is recommended.

Diuretics and antihypertensive medicines

Concomitant use of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, with diuretics or antihypertensive medicines (e.g. beta-blockers, angiotensin converting enzyme (ACE) inhibitors) may cause a decrease in their antihypertensive effect via inhibition of vasodilatory prostaglandin synthesis. Therefore, the combination should be administered with caution and patients, especially the elderly, should have their blood pressure periodically monitored. Patients should be adequately hydrated, and consideration should be given to monitoring of renal function after initiation of concomitant therapy and periodically thereafter, particularly for diuretics and ACE inhibitors due to the increased risk of nephrotoxicity.

Medicines known to cause hyperkalaemia

Concomitant treatment with potassium-sparing diuretics, ciclosporin, tacrolimus or trimethoprim may be associated with increased serum potassium levels, which should therefore be monitored frequently (see section 4.4).

Glucocorticoids and corticosteroids

Increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs).

Other NSAIDs including cyclo-oxygenase-2 selective inhibitors

Gastrointestinal adverse effects may be exacerbated by the concomitant administration of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and other systemic NSAIDs. Concurrent treatment with two or more NSAIDs may increase the risk of adverse effects. Avoid concomitant use of two or more NSAIDs (see section 4.4).

Antidiabetic medicines

Studies have shown that diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, can be given together with oral antidiabetic medicines without influencing their clinical effect. However, there have been reports of both hypoglycaemic and hyperglycaemic effects necessitating changes in the dosage of the antidiabetic medicine during treatment with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET. For this reason, monitoring of the blood glucose level is recommended as a precautionary measure during concomitant therapy.

Anticoagulants and anti-platelet medicines

Caution is recommended since concomitant administration could increase the risk of bleeding (see section 4.4). There is an increased risk of haemorrhage if diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, is used concurrently with any anticoagulants, such as warfarin. Therefore, to be certain that no change in anticoagulant dosage is required, careful monitoring of such patients is necessary. Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, in high dose can reversibly inhibit platelet aggregation.

Selective serotonin reuptake inhibitors (SSRIs)

Increased risk of gastrointestinal bleeding.

Ciclosporin

Nephrotoxicity of ciclosporin may be increased by the effects of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, on renal prostaglandins. Therefore, it should be given at doses lower than those that would be used in patients not receiving ciclosporin.

Tacrolimus

Possible increased risk of nephrotoxicity when diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, is given with tacrolimus. This might be mediated through renal anti prostaglandin effects of both diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and calcineurin inhibitor.

Quinolone antibiotics

There have been reports of convulsions which may have been due to concomitant use of quinolone antibiotics and NSAIDs, such as diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET. This may occur in patients with or without a previous history of epilepsy or convulsions. Therefore, caution should be exercised when considering the use of a quinolone in patients who are already receiving an NSAID.

Acetylsalicylic acid/aspirin

The bioavailability of both diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, and acetylsalicylic acid may be reduced if used concurrently.

Phenytoin

When using phenytoin concomitantly with diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, monitoring of phenytoin plasma concentrations is recommended due to an expected increase in exposure to phenytoin.

Colestipol and cholestyramine

These medicines can induce a delay or decrease in absorption of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET. Therefore, it is recommended to administer diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, at least one hour before or 4 to 6 hours after administration of colestipol/ cholestyramine.

Cardiac glycosides

Concomitant use of cardiac glycosides and diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, in patients may exacerbate cardiac failure, reduce GFR and increase plasma glycoside levels.

Mifepristone

Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, should not be used for 8 to 12 days after mifepristone administration as diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, can reduce the effect of mifepristone.

Potent CYP2C9 inhibitors

Caution is recommended when co-prescribing diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, with potent CYP2C9 inhibitors (such as sulfinpyrazone and voriconazole), which could result in a significant increase in peak plasma concentration and exposure to diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, due to inhibition of diclofenac metabolism.

The use of PANAMOR 50 mg DISPERSIBLE TABLET is contraindicated in pregnancy and lactation (see section 4.3).

Pregnancy

First trimester

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the embryo/foetal development. Data from epidemiological studies raise concern about an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation was increased from less than 1 %, up to approximately 1,5 %.

The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality.

From the 20th week of pregnancy onward, diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, use may cause oligohydramnios resulting from foetal renal dysfunction. This may occur shortly after treatment initiation and is usually reversible upon discontinuation. In addition, there have been reports of ductus arteriosus constriction following treatment in the second trimester, most of which resolved after treatment cessation. Antenatal monitoring for oligohydramnios and ductus arteriosus constriction should be considered after exposure to diclofenac for several days from gestational week 20 onward. Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, should be discontinued if oligohydramnios or ductus arteriosus constriction are found.

Third trimester

During the third trimester of pregnancy, prostaglandin synthesis inhibitors, such as diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may expose the foetus to:

• cardiopulmonary toxicity (with premature closure of the ductus arteriosus in utero and persistent pulmonary hypertension in the newborn);
• renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

At the end of pregnancy, the mother and the neonate may be exposed to:

• possible prolongation of bleeding time, an anti-aggregating effect which may occur even at very low doses;
• inhibition of uterine contractions resulting in delayed or prolonged labour (see section 4.4).

It is recommended that diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, is avoided in pregnant women at 20 weeks or later in pregnancy (see section 4.3 and 4.4).

Breastfeeding

Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, passes into the breastmilk in small amounts. Therefore, diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, should not be administered during breastfeeding in order to avoid undesirable effects in the infant (see section 4.3).

Fertility

The use of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, should be considered (see section 4.6).

Diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, has a minor influence on the ability to drive or use machines. Since adverse reactions such as dizziness or visual disturbances have been reported in patients receiving diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, patients should not drive, use machinery or perform any tasks that require concentration, until they are certain that diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, does not adversely affect their ability to do so (see section 4.8).

a) Summary of the safety profile

The most commonly observed adverse events are gastrointestinal in nature.

b) Tabulated summary of adverse reactions

System organ class Frequency Adverse reactions

Blood and lymphatic system disorders Less frequent Leucopenia, thrombocytopenia, aplastic anaemia, haemolytic anaemia, agranulocytosis.

Immune system disorders Less frequent Hypersensitivity reactions (such as bronchospasm, anaphylactoid and anaphylactic systemic reactions including hypotension and shock), angioneurotic oedema (including face oedema).

Psychiatric disorders Less frequent Disorientation, depression, insomnia, nightmares, irritability, psychotic reactions.

Nervous system disorders Frequent Headache, dizziness, nervousness. Less frequent Tiredness, disturbances of sensation (including paraesthesia), memory disturbance, convulsions, anxiety, tremor, aseptic meningitis, somnolence, cerebrovascular accident, alteration in taste, confusion, hallucinations, malaise.

Eye disorders Less frequent Disturbances of vision (diplopia, blurred vision). Frequency unknown Optic neuritis.

Ear and labyrinth disorders Frequent Vertigo. Less frequent Impaired hearing, tinnitus.

Cardiac disorders Less frequent Palpitations, chest pain, congestive heart failure, cardiac failure, myocardial infarction. Frequency unknown Kounis syndrome.

Vascular disorders Less frequent Hypertension, hypotension, vasculitis.

Respiratory, thoracic and medias disorders Less frequent Asthma (including dyspnoea), pneumonitis.

Gastrointestinal disorders Frequent Peptic ulcers, perforation or gastrointestinal bleeding, sometimes fatal, constipation, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohnu2019s disease, gastritis, epigastric pain, nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence, eructation, anorexia, local irritation. Less frequent Gastrointestinal bleeding, bloody diarrhoea, peptic ulcer with or without bleeding or perforation, lower gut disorders such as non-specific haemorrhagic colitis, glossitis, aphthous stomatitis, oesophageal lesions, diaphragm-like intestinal strictures, pancreatitis, diarrhoea haemorrhagic. Frequency unknown Ischaemic colitis.

Hepato-biliary disorders Frequent Elevated transaminase levels (ALT, AST). Less frequent Hepatitis with or without jaundice, fulminant hepatitis, liver disorder, hepatic necrosis, hepatic failure.

Skin and subcutaneous tissue disorders Frequent Rash and skin reactions. Less frequent Urticaria, bullous eruptions, eczema, erythema, erythema multiforme, Stevens-Johnson Syndrome, toxic epidermal necrolysis (TEN) (Lyellu2019s syndrome acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reaction, purpura, including allergic purpura, pruritus. Frequency unknown Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) (see section 4.4).

Renal and urinary disorders Less frequent Acute renal failure, urinary abnormalities such as haematuria, proteinuria, interstitial nephritis, nephritic syndrome, papillary necrosis.

Reproductive system and breast disorders Less frequent Impotence.

General disorders and administration site conditions Less frequent Oedema.

Symptoms

There is no typical clinical picture resulting from diclofenac, as in PANAMOR 50 mg DISPERSIBLE TABLET, overdosage. Overdosage can cause symptoms such as headache, nausea, vomiting, epigastric pain, gastrointestinal haemorrhage, diarrhoea, dizziness, disorientation, excitation, coma, drowsiness, tinnitus, fainting or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible (see section 4.4 and 4.8).

Treatment

Treatment is symptomatic and supportive, especially for hypotension, renal failure, convulsions, gastro-intestinal irritation and respiratory depression. Specific therapies such as forced diuresis, dialysis or haemoperfusion are of little value in eliminating PANAMOR 50 mg DISPERSIBLE TABLET because of its high protein binding and extensive metabolism.