GEMFIBROZIL

Posology Prior to initiating gemfibrozil, other medical problems such as hypothyroidism and diabetes mellitus must be controlled as best as possible and patients should be placed on a standard lipid-lowering diet, which should be continued during treatment.

Adults and elderly (over 65 years old):

The dose range is 900mg to 1200mg daily. The only dose with documented effect on morbidity is 1200mg daily. The 1200mg dose is taken as 600mg twice daily, half an hour before breakfast and half an hour before the evening meal. The 900mg dose is taken as a single dose half an hour before the evening meal.

Paediatric population:

Gemfibrozil therapy has not been investigated in children. Due to the lack of data, the use of gemfibrozil tablets in children is not recommended. 73 m2, respectively), start treatment at 900mg daily and assess renal function before increasing dose.

3). 3).

Method of administration:

For oral use only.

Most commonly reported adverse reactions are of gastrointestinal character and are seen in approximately 7% of the patients. These adverse reactions do not usually lead to discontinuation of the treatment. Adverse reactions are ranked according to frequency using the following convention: Very common (>1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), including isolated reports: System Organ Class Undesirable effect Blood and lymphatic system disorders Rare Bone marrow failure, severe anaemia, thrombocytopenia, leukopenia, eosinophilia Psychiatric disorders Rare Depression, decreased libido Nervous system disorders Common Vertigo, headache Rare Neuropathy peripheral, paraesthesia, dizziness, somnolence Eye disorders Rare Vision blurred Cardiac disorders Uncommon Atrial fibrillation Respiratory, thoracic and mediastinal disorders Rare Laryngeal oedema Gastrointestinal disorders Very common Dyspepsia Common Diarrhoea, vomiting, nausea, abdominal pain constipation, flatulence Rare Pancreatitis, appendicitis Hepatobiliary disorders Rare Jaundice cholestatic, hepatitis, cholelithiasis, cholecystitis, hepatic function abnormal Skin and subcutaneous tissue disorders Common Eczema, rash Rare Angioedema, dermatitis exfoliative, urticaria, dermatitis, alopecia, photosensitivity reaction, pruritus Musculoskeletal and connective tissue disorders Rare Rhabdomyolysis, myopathy, myositis, muscular weakness, synovitis, myalgia, arthralgia, pain in extremity Reproductive system and breast disorder Rare Erectile dysfunction General disorders and administration site conditions Common Fatigue Investigations Rare Haemoglobin decreased, haematocrit decreased, white blood cell count decreased, blood creatine phosphokinase increased Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App store.

Muscle disorders (myopathy/rhabdomyolysis) There have been reports of myositis, myopathy and markedly elevated creatine phosphokinase associated with gemfibrozil. Rhabdomyolysis has also been reported rarely. Muscle damage must be considered in any patient presenting with diffuse myalgia, muscle tenderness and/or marked increase in muscle CPK levels (>5x times the upper limit of normal); under these conditions treatment must be discontinued.

Concomitant HMG-CoA reductase inhibitors The concomitant administration of gemfibrozil with simvastatin, as well as with rosuvastatin at 40 mg is contraindicated. Concomitant therapy of gemfibrozil with lower doses of rosuvastatin should be used only when the benefit outweighs the risks.

5). 5) and dosage adjustments may be necessary. The benefit of further alterations in lipid levels by the combined use of gemfibrozil and HMG-CoA reductase inhibitors should be carefully weighed against the potential risks of such combinations and clinical monitoring is recommended.

A creatine phosphokinase (CPK) level should be measured before starting such a combination in patients with pre-disposing factors for rhabdomyolysis as follows: • renal impairment • hypothyroidism • alcohol abuse • age> 70 years • personal or family history of hereditary muscular disorders • previous history of muscular toxicity with another fibrate or HMG-CoA reductase inhibitor.

In most subjects who have had an unsatisfactory lipid response to either drug alone, the possible benefits of combined therapy with HMG-CoA reductase inhibitors and gemfibrozil does not outweigh the risks of severe myopathy, rhabdomyolysis and acute renal failure.

Use in patients with gallstone formation Gemfibrozil may increase cholesterol excretion into the bile, raising the potential for gallstone formation. Cases of cholelithiasis have been reported with gemfibrozil therapy. If cholelithiasis is suspected, gallbladder studies are indicated.

1 - Hepatic impairment. - Severe renal impairment. - History of/or pre-existing gall bladder or biliary tract disease including gallstones. - Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.

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