SOCOMOL Tablet Ref.[115638] Active ingredients: Diclofenac Paracetamol

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control the symptoms (see Section 4.2 and Gastrointestinal and cardiovascular risks, hereunder).

Cardiovascular and cerebrovascular effects:

• As fluid retention and oedema have been reported in association with non-steroidal antiinflammatory drugs (NSAIDs) therapy, caution is required in patients with history of high blood pressure and/or heart failure.
• Clinical studies and epidemiologic data suggest that diclofenac use, especially at high dose (150 mg daily) and prolonged use can be associated to a slight increase in arterial thrombotic events (such as cardiac infarction or stroke).
• Patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.
• As the cardiovascular risks of diclofenac 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 reevaluated periodically.

Gastrointestinal effects:

• Gastrointestinal (GI) bleeding, ulceration or perforation have been reported with all NSAIDs at any time during treatment, with or without warning symptoms or in patients without any history of GI events. In elderly patients these events are usually more severe.
• Should GI bleeding or ulceration occur in patients receiving diclofenac, treatment should be discontinued.
• As with others anti-inflammatory drugs, allergic reactions including anaphylactic reactions can occur, even without prior exposure to the drug.
• NSAIDs can mask the signs or symptoms of infection (due to antalgic and antipyretic effects) resulting in delayed diagnosis and treatment.
• Patients with GI disorders or with a history ulcer as well as patients with ulcerous colitis, Crohn’s disease, impaired hepatic function should be closely monitored.
• During diclofenac treatment, increase in several hepatic enzymes levels can occur.
• Hepatic function monitoring is recommended, as a preventive measure, during long term treatment. SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets treatment should be discontinued if hepatic function tests remain abnormal or worsen, if clinical symptoms of hepatic affections occur, or in case of other signs (such as eosinophilia, rash, …). Hepatitis can appear without prodromal symptoms. Risk of hepatic toxicity significantly increases in case of chronic alcoholism. Dosage reduction is required in alcoholic patients. Special care is recommended in case of observed hepatic failure. The same recommendation is applicable for patients treated by hepatic enzymes inductors (alcohol, barbiturates and anti-epileptics). In those cases, paracetamol toxic metabolites accumulation may lead to or worse hepatic lesions.
• In patient with hepatic porphyria, special care is recommended as diclofenac can induce an attack.
• Due to the role of prostaglandins in maintaining renal blood flow, particular monitoring is required when diclofenac is used in patients with impaired heart, hepatic or renal function, in elderly patients, in patients treated by diuretics and in patients who have lost large extracellular volumes (for example during the peri-operative or post-operative phase of major surgical procedures). The effect is reversible upon discontinuation of the treatment.
• In case of prolonged use, blood analysis, including haematocrit, transaminase levels, total proteins and serum albumin, should be performed regularly.
• As with others NSAIDs, SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets may temporarily inhibit platelets aggregation.
• Special care is required in patients with haemostasis disorders.
• Special attention should be paid in elderly patients, especially regarding gastro-intestinal and renal undesirable effects. It is recommended to administer the lowest effective dose, particularly in debilitated patients.
• Administration of SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets to patients with bronchial asthma should be carefully considered because of the risk of worsening symptoms.
• As with others NSAIDs, increase in uraemia and creatininaemia can occur.
• Prostaglandins synthesis inhibitors can modify the renal function especially if this function is already affected for example in case of sodium depletion, cardiac decompensation or severe liver affection.
• As with others prostaglandins synthesis inhibitors, the following renal abnormalities can occur: glomerulonephritis, interstitial nephritis, papillary necrosis, nephrotic syndrome, acute renal failure.

Paracetamol:

• A frequent or time extended use is unadvised. A time extended use, unless controlled by a medical professional, can harm the health.
• The maximal dose should not be exceeded. In order to prevent the risk of overdose, no othermedical product containing paracetamol should be taken simultaneously.
• Taking at once a dose corresponding to several times the daily dose can seriously damage the liver; there might not be any conscious loss. Despite, it is recommended to call a doctor in regard to the risk of irreversible liver damage.
• Caution should be given if the following risk factors, lowering the liver toxicity threshold, are present: liver failure (including Gilbert’s syndrome), acute hepatitis, kidney failure, chronic alcoholism and very meagre adults (<50 kg). In those cases, the posology should be adapted (see 4.2).
• A concomitant treatment with drugs influencing the liver function, dehydration, chronic malnutrition (low glutathione liver stock) are as well regarded as risk factors for the emergence of liver toxicity and that can lower the liver toxicity threshold. The maximal daily dose should certainly not be exceeded in these patients.
• Caution should be given in case of paracetamol administration to patients with glucose6-phosphate dehydrogenase deficiency and with haemolytic anaemia.
• In case of acute fever, signs of secondary infection or persistency of the complaints, the patients should be referred to the doctor.
• Paracetamol administration in patients with moderate to severe renal failure may lead to accumulation of conjugated derivatives.

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. As with other NSAIDs, caution should be exercised in patients receiving oral anticoagulants, heparin via parenteral route and ticlopidine, thiazide diuretics, moclobemide, lithium, sulphonamide hypoglycemiant, methotrexate, pentoxifylline, zidovudine and baclofen. Take into account interactions with antihypertensives (beta-blockers, conversion enzyme inhibitors, and diuretics), digoxin, and thrombrolytics.

Paracetamol crosses the placental barrier and is excreted in breast milk. Diclofenac appears in the breast milk in very low concentrations and is likely to affect the breast-fed infant adversely. Whilst, human and animal studies have not identified any risk to pregnancy or embryofoetal development, the use of SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets during pregnancy should, if possible, be avoided. Human studies have not identified any risk to lactation or the breast-fed offspring.

Vertigo or central nervous system effects can occur during treatment with SOCOMOL Paracetamol325 mg & Diclofenac Sodium 50 mg Tablets. If these effects appear while using SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets, driving a car and using machines are not recommended.

At recommended doses SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablet is generally well tolerated. At the start of treatment, however, patients may sometimes complain of epigastric pain, nausea, diarrhoea, dizziness or headache. These unwanted effects are normally of a mild nature. Peripheral oedema and skin reactions such as drug rash, urticaria, and eczema, have also been reported.

The following side-effects have seldom been reported with SOCOMOL Paracetamol 325 mg & Diclofenac Sodium 50 mg Tablets, although there are reported cases:

• CNS side-effects, such as tiredness, insomnia, and irritability.
• Gastrointestinal effects such as ulceration and haemorrhage, hypersensitivity reactions such as bronchospasm, elevated transaminase levels, hepatitis, renal failure and nephrotic syndrome; isolated cases of leucopenia, and thrombocytopenia have also been observed.

Not applicable.