Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Gastrointestinal safety:
Swiss Relief Dual Release should not be combined with NSAIDs, including selective cyclo-oxygenase (COX) 2 inhibitors.

Adverse reactions may be minimized by administering the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 as well as gastrointestinal and cardiovascular risks below).

NSAIDs, including diclofenac, may be associated with increased risk of gastrointestinal anastomotic leak. Close medical supervision and caution are recommended when using diclofenac after gastrointestinal surgery.

Elderly:

The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which may be fatal (see section 4.2).

Gastrointestinal hemorrhage, ulceration and perforation:

Gastrointestinal hemorrhage, ulceration and perforation, which can be fatal, have been reported with all NSAIDs and may occur at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.

The risk of gastrointestinal hemorrhage, ulceration or perforation is higher with increasing NSAID doses in patients with a history of ulcer, particularly if complicated with hemorrhage or perforation (see section 4.3), and in elderly patients.
Treatment in these patients should be initiated at the lowest available dose.
Combination therapy with protective agents (e.g., misoprostol or proton pump inhibitors) should be considered for these patients as well as for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid (aspirin) or other medicinal products that may increase gastrointestinal risk (see below and section 4.5).

Patients with a history of gastrointestinal toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially gastrointestinal hemorrhage), particularly at the start of treatment.
Caution is recommended if patients receiving concomitant medicinal products that could increase the risk of ulceration or hemorrhage, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (SSRIs) or antiplatelet agents such as aspirin (see section 4.5).

Treatment with Swiss Relief Dual Release should be discontinued in patients experiencing gastrointestinal hemorrhage or ulceration.

NSAIDs should only be used with caution in patients with a history of gastrointestinal disorders (ulcerative colitis, Crohn’s 
disease), as their condition may be exacerbated (see section 4.8).

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 edema have been reported in association with NSAID therapy.

Clinical trials and epidemiological data suggest a potentially slightly increased risk of arterial thrombotic events (e.g., myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150 mg daily) and in long term treatment.

Patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration. As the cardiovascular risks of diclofenac may increase with the 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.

Skin effects:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), have been reported very rarely under NSAID therapy (see section 4.8).
The highest risk for these reactions appears to be early in the course of therapy, with the reaction occurring within the first month of treatment in the majority of cases. Swiss Relief Dual Release should be discontinued at the first sign of skin rash, mucosal lesions or any other signs of hypersensitivity.

Hepatic effects:

Caution is indicated when starting diclofenac treatment in patients with hepatic impairment, as their condition may be exacerbated. During prolonged treatment with Swiss Relief Dual Release, regular monitoring of hepatic function is indicated as a precautionary measure. If clinical signs consistent with liver disease develop, Swiss Relief Dual Release should be discontinued immediately.

Other information:

Swiss Relief Dual Release should only be used after careful consideration of risk to benefit: 
−    In patients with congenital porphyrin metabolic disorders (e.g., acute intermittent porphyria).
−    In patients with systemic lupus erythematosus (SLE) or mixed connective tissue disease (see section 4.8).

Close monitoring by a physician is required:
−    In patients with renal impairment.
−    In patients with hepatic impairment.
−    Immediately after major surgery.
−    In patients with seasonal allergic rhinitis, nasal polyps or chronic obstructive pulmonary diseases, as they are at an increased risk of allergic reaction, such as asthma exacerbations (referred to as analgesic-induced asthma), Quincke's edema or urticaria.
−    In patients who are allergic to other substances, as they are also at an increased risk of hypersensitivity reaction when using Swiss Relief Dual release.

Severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been reported very rarely. Therapy with Swiss Relief Dual Release should be discontinued at the first sign of a hypersensitivity reaction and the necessary steps taken by competent individual to alleviate symptoms.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can occur in rare cases also when using diclofenac even without earlier exposure to the drug. 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.

Diclofenac can temporarily inhibit platelet aggregation, so patients with coagulation disorders should be closely monitored.

As with other NSAIDs, diclofenac may mask the signs and symptoms of infection due to its pharmacodynamic properties.
Patients noticing signs of an infection or worsening of an existing infection while using Swiss Relief Dual Release should seek immediate medical attention to determine whether antibiotic treatment is indicated.

During prolonged treatment with Swiss Relief Dual Release, monitoring of renal function and blood counts is required.

Prolonged use of analgesics can result in headaches that should not be treated with an increased dose of the same medicinal product.

Habitual use of analgesics in general, especially the concomitant use of multiple analgesics, can result in permanent kidney damage and even renal failure (analgesic nephropathy).


Concomitant use of NSAIDs and alcohol can potentiate adverse reactions, particularly those affecting the gastrointestinal tract or central nervous system.

For female fertility, see section 4.6.

Effects on Driving

4.7 Effects on ability to drive and use machines

As the use of Swiss Relief Dual Release, particularly at higher doses, can result in adverse reactions of the central nervous system, such as fatigue and dizziness, reaction time may be affected in isolated cases and the ability to drive and operate machinery impaired, especially when combined with alcohol.