LOPID

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.

Lopid should be taken orally. Posology Adult The dose range is 900 mg to 1200 mg daily. The only dose with documented effect on morbidity is 1200 mg daily. See Method of administration. Elderly (over 65 years old) As for adults Children and adolescents Gemfibrozil therapy has not been investigated in children.

Due to the lack of data the use of Lopid in children is not recommended. 73 m2, respectively), start treatment at 900 mg daily and assess renal function before increasing dose. 3). 3). Method of administration The 1200 mg dose is taken as 600 mg twice daily, half an hour before breakfast and half an hour before the evening meal.

The 900 mg dose is taken as a single dose half an hour before the evening meal.

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 to <1/10), Uncommon (>1/1,000 to <1/100), Rare (>1/10,000 to <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.

4. Special warnings and special precautions for use 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 ULN); 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. 5) • Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates