Swiss Relief Dual Release

/ Mediline

The dose of diclofenac depends on the severity of the condition. The recommended dose range for adults lies between 50 and 150 mg diclofenac sodium per day.
Adults: single dose: 1 capsule (equivalent to 75 mg diclofenac sodium). Total daily dose: 2 capsules (equivalent to 150 mg diclofenac sodium).
Method and duration of administration: Swiss relief dual release is taken without chewing and with plenty of fluid.
Those with sensitive stomachs are recommended to take Swiss relief dual release during meals.
The patient’s doctor decides the length of administration.
For rheumatic diseases, it can be necessary to take Swiss relief dual release for a long time.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
Elderly patients: No specific dose adjustment is required. Because of the potential undesirable effect profile, elderly patients should be monitored with particular care.
Impaired renal function: Swiss relief dual release is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Swiss Relief Dual release to patients with mild to moderate renal impairment.
Hepatic impairment: Swiss relief dual release is contraindicated in patients with hepatic failure.
No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Swiss Relief Dual Release to patients with mild
to moderate hepatic impairment.
Established cardiovascular disease or significant cardiovascular risk factors
Swiss Relief Dual Release is contraindicated in patients with established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Patients with congestive heart failure (NYHA-1) and patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration- and only at doses ≤100 mg daily when treatment continues for more than 4 weeks.
Children and adolescents: Swiss relief dual release is not suitable for children and adolescents under 18 years because the content of active substance is too high.

As a non-steroidal anti-inflammatory analgesic in symptomatic management of rheumatoid arthritis, osteoarthritis and ankylosying spondylitis, acute musculo-skeletal disorders such as periarthritis, tendinitis, tensynovitis, bursitis, sprains, strains and dislocations, relief of pain in fractures, low back pain, acute gout, psoriatic arthropathy. In the management of pain and inflammation associated with orthopedic, dental and minor surgery.

– Hypersensitivity to the active substance diclofenac or to any of the excipients;
− Known past reactions of bronchospasm, asthma, rhinitis or urticaria after taking acetylsalicylic acid or other non-steroidal antirheumatic/anti-inflammatory agents (NSAIDs);
− Unexplained haematopoietic disorders;
− Existing or past history of repeated peptic ulceration or haemorrhage (at least 2 different episodes of proven ulceration or bleeding);
− History of gastrointestinal bleeding or perforation, associated with previous NSAIDs treatment;
− Cerebrovascular or other active bleeding;
− Severe hepatic dysfunction or renal impairment;
− Severe cardiac impairment;
− Established congestive heart failure (NYHA II-IV), ischemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
− Last trimester of pregnancy
– Children and adolescents under 18 years.

Gastrointestinal safety: 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. NSAIDs, may be associated with increased risk of gastrointestinal anastomotic leak. Close medical supervision and caution are recommended when using after gastrointestinal surgery.
Elderly: Increased frequency of adverse reactions to NSAIDs, especially gastrointestinal hemorrhage and perforation, which may be fatal.
Gastrointestinal hemorrhage, ulceration and perforation: 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, 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. 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.
Treatment 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
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.
Skin effects: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis and generalised bullous fixed drug eruption, have been reported very rarely in association with the use of diclofenac. 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. This medical product 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 this medical product, regular monitoring of hepatic function is indicated as a precautionary measure. If clinical signs consistent with liver disease develop, this medical product should be discontinued immediately.
Close monitoring:
* 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.
See prescribing information for full details.

Headache, dizziness or vertigo, Epigastric pain, nausea, vomiting, diarrhea, abdominal pain. Dyspepsia, flatulence, anorexia. Rash, Elevated transaminases (ASAT, ALAT).
See prescribing information for full details.

Dicumarol group and ticlopidine, heparin, pentoxifylline, zidovudine. Corticosteroids and alcohol, diuretics. Antihypertensive agents, other analgesics including cycle-oxygenase-2 selective inhibitors, mifepristone, quinolone antibiotics, anti-platelet agents and SSRIs.
See prescribing information for full details.

Pregnancy: Diclofenac should not be administered during the first and second trimesters of pregnancy unless absolutely necessary. If it used by a woman attempting to conceive or during the first and second trimesters of pregnancy, the dose should be kept as low as possible, and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors
may expose the foetus to:
* Cardiopulmonary toxicity (premature constriction/closure of the ductus arteriosus and pulmonary hypertension)
* Renal dysfunction
Consequently, it is contraindicated during the third trimester of pregnancy
Lactation: Diclofenac and its metabolites pass into breast milk in small amounts. Since there are to date no known adverse effects on infants, discontinuation of breastfeeding is usually not required with short-term use. Early ablactation, however, should be considered if prolonged use/increased doses are prescribed to treat inflammatory disorders.
See prescribing information for full details