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עמוד הבית / סוויס רליף דואל רליס / מידע מעלון לרופא

סוויס רליף דואל רליס SWISS RELIEF DUAL RELEASE (DICLOFENAC SODIUM)

תרופה במרשם תרופה בסל נרקוטיקה ציטוטוקסיקה

צורת מתן:

פומי : PER OS

צורת מינון:

קפסולות : CAPSULES

Adverse reactions : תופעות לוואי

4.8 Undesirable effects

Adverse reactions are ranked under the following categories:
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (frequency cannot be estimated from the available data).

It must be noted that the following undesirable effects are predominantly dependent on dose and vary by individual.

The most commonly reported adverse reactions affect the intestinal tract. Peptic ulceration, perforation or hemorrhage , sometimes fatal, can occur, particularly in elderly patients (see section 4.4). Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melena, hematemesis, ulcerative stomatitis, and exacerbation of ulcerative colitis and Crohn’s disease (see section 4.4) have been reported after use. Gastritis is less common.

Edema, hypertension and heart failure have been reported in association with NSAID treatment.

Clinical trials and epidemiological data consistently point toward an 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 (see sections 4.3 and 4.4 for contraindications as well as special warnings and precautions for use).

Cardiac disorders:
Very rare: palpitations, edema, cardiac failure, myocardial infarction 
Not known: Kounis syndrome

Blood and lymphatic system disorders:
Very rare: blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis), haemolytic anemia First indications may be: fever, sore throat, superficial oral lesions, flu-like symptoms, abnormal fatigue, epistaxis and ecchymosis.

Blood count should be regularly monitored during long-term treatment.

Nervous system disorders:
Common: CNS (central nervous system) disturbances such as headache, dizziness, drowsiness, agitation, irritability, fatigue
Very rare: paresthesia, taste disturbances, memory impairment, disorientation, convulsions, tremor 
Eye disorders:
Very rare: vision disturbances (blurred vision and diplopia)

Ear and labyrinth disorders:
Very rare: tinnitus, temporary hearing impairment
Gastrointestinal disorders:
Very common: gastrointestinal symptoms such as nausea, vomiting and diarrhea as well as minor gastrointestinal hemorrhage that may result in anemia in rare cases
Common: dyspepsia, flatulence, abdominal pain, anorexia, gastrointestinal ulceration (occasionally with hemorrhage and diarrhea)
Uncommon: hematemesis, melena or hemorrhagic diarrhea
Very rare: stomatitis, glossitis, oesophageal lesions, hypogastric symptoms (e.g., hemorrhagic colitis or exacerbation of ulcerative colitis/Crohn’s disease), constipation, pancreatitis, diaphragm-like intestinal strictures Not known: ischemic colitis

Patients should be advised to discontinue the medicinal product and seek immediate medical attention if they experience intense epigastric pain, melena or hematemesis.

Renal and urinary disorders:
Uncommon: edema, particularly in patients with arterial hypertension or renal failure Very rare: renal tissue damage (interstitial nephritis, papillary necrosis), accompanied by acute renal failure, proteinuria and/or hematuria. nephrotic syndrome
Therefore, renal function should be regularly monitored.

Skin and subcutaneous tissue disorders:
Uncommon: alopecia.
Very rare: exanthema, eczema, erythema, photosensitivity reaction, purpura (including allergic purpura) and bullous skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome) 
Infections and parasitic disorders:
Exacerbation of infection-induced inflammation (e.g., necrotizing fasciitis) in conjunction with systemic use of NSAIDs is very rare. This may be associated with NSAIDs’ mechanism of action .

Patients noticing signs of an infection or worsening uof an existing infection while using Swiss Relief Dual Release should seek immediate medical attention to determine whether antibiotic treatment is indicated.

Symptoms of aseptic meningitis with neck stiffness, headache, nausea, vomiting, fever or drowsiness are very rare when using diclofenac. Patients with autoimmune disorders (SLE, mixed connective tissue disease) may have an increased risk.

Vascular disorders:
Very rare: hypertension.

Immune system disorders:
Common: hypersensitivity reactions such as rash and pruritus
Uncommon: urticaria.
Patients should be advised to inform their physician immediately and discontinue Swiss Relief Dual Release if this occurs.

Very rare: severe allergic hypersensitivity reactions. These may manifest as face edema, glossitis, laryngeal edema with airway stenosis, dyspnea, tachycardia, hypotension or life-threating shock.

Patients should be advised to discontinue Swiss Relief Dual Release and seek immediate medical attention if any of these symptoms occurs (symptoms may occur during first use).

Very rare: hypersensitivity vasculitis and pneumonitis

Hepatobiliary disorders:
Common: increased transaminases
Uncommon: liver damage, particularly with long-term treatment, acute hepatitis, possibly with icterus (very rarely fulminant, even without prodromal symptoms)
Therefore, Hepatic levels should be regularly monitored during long-term treatment.

Psychiatric disorders:
Very rare: psychotic reactions, depression, anxiety, nightmare

Swiss Relief Dual Release may cause an allergic reaction in very rare cases.
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il
In addition, you can report to Padagis.co.il

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