RHUMALGAN SR

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

). Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties. Rhumalgan SR 75 mg Modified Release Capsules contain lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Rhumalgan SR 75 mg Modified Release Capsules also contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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 GI events.

They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn. 8 Undesirable effects). 3 Contraindications). 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. 2 Posology and method of administration). 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.

g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal products likely to increase gastrointestinal risk.

5 Interactions with other medicaments and other forms of interaction). Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding). 5 Interaction with other medicaments and other forms of interaction).

8 Undesirable effects).

Hepatic effects:

Close medical surveillance is required when prescribing Rhumalgan SR 75 to patients with impairment of 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. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Rhumalgan SR 75 should be discontinued.

Hepatitis may occur with diclofenac without prodromal symptoms. Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack. g. 3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases.

Discontinuation therapy is usually followed by recovery to the pre- treatment state. 8 Undesirable effects). Patients appear to be at the 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.

Rhumalgan SR 75 should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. 8 Undesirable effects).

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 […]

). For oral administration.

Adults:

One Rhumalgan SR 75 mg Capsule once or twice daily, swallowed whole, preferably with or after food. In milder cases, as well for long-term therapy, 75 mg daily is usually sufficient. The recommended maximum daily dosage is 150 mg. Where the symptoms are most pronounced during the night or in the morning Rhumalgan SR 75 capsules should preferably be taken in the evening.

Special populations Paediatrics Children:

Rhumalgan SR 75 are not suitable for children.

Elderly:

Although the pharmacokinetics of Rhumalgan SR 75 are not impaired to any clinically relevant extent in elderly patients, nonsteroidal anti- inflammatory drugs (NSAIDs) 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 for the shortest possible duration 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.

4 special warnings and precautions). 4 special warnings and precautions). 3 Contraindications • Hypersensitivity to the active substance or any of the excipients. • Active, gastric or intestinal ulcer, bleeding or perforation. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs or diclofenac therapy.

• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • Last trimester of pregnancy (See section

• Hypersensitivity to the active substance or any of the excipients. • Active, gastric or intestinal ulcer, bleeding or perforation. • History of gastrointestinal bleeding or perforation, related to previous NSAIDs or diclofenac therapy.

• Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). 6 Pregnancy and lactation). • Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.

• Severe hepatic, renal and cardiac failure (See section