EZETIMIBE/ATORVASTATIN

Posology The dose range of Ezetimibe/Atorvastatin Tablets is 10/10 mg/day through 10/80 mg/day. The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe/Atorvastatin Tablets.

Ezetimibe/Atorvastatin Tablets is not suitable for initial therapy. Treatment initiation or dose adjustment if necessary should only be done with the mono-components and after setting the appropriate doses the switch to the fixed dose combination of the appropriate strength is possible.

Co-administration with other medicines Dosing of Ezetimibe/Atorvastatin Tablets should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant. 5). 4. 5). 2). 2). 3). 2). 2). No data are available. Method of administration Ezetimibe/Atorvastatin Tablets is for oral administration.

Ezetimibe/Atorvastatin Tablets can be administered as a single dose at any time of the day, with or without food.

Tabulated list of adverse reactions Adverse reactions observed in clinical studies of Ezetimibe/Atorvastatin Tablets (or co-administration of ezetimibe and atorvastatin equivalent to Ezetimibe/Atorvastatin Tablets) or ezetimibe or atorvastatin or reported from post-marketing use with Ezetimibe/Atorvastatin Tablets or ezetimibe or atorvastatin are listed in Table below.

These reactions are presented by system organ class and by frequency. Frequencies are defined as: very common (≥1/10); common ≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000); and not known (cannot be estimated from the available data).

6% for patients treated with Ezetimibe/Atorvastatin Tablets. These elevations were generally asymptomatic, not associated with cholestasis, and returned to baseline spontaneously or after discontinuation of therapy. 6 mmol/L, BMI>30 kg/ m2, raised triglycerides, history of hypertension) 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. Healthcare professionals are asked to report any suspected adverse […]

Myopathy/Rhabdomyolysis In post-marketing experience with ezetimibe, cases of myopathy and rhabdomyolysis have been reported. Most patients who developed rhabdomyolysis were taking a statin concomitantly with ezetimibe. However, rhabdomyolysis has been reported very rarely with ezetimibe monotherapy and very rarely with the addition of ezetimibe to other agents known to be associated with increased risk of rhabdomyolysis.

Ezetimibe/Atorvastatin Tablets contains atorvastatin. Atorvastatin, like other HMG- CoA reductase inhibitors, may in rare occasions affect the skeletal muscle and cause myalgia, myositis, and myopathy that may progress to rhabdomyolysis, a potentially life-threatening condition characterised by markedly elevated creatine phosphokinase (CPK) levels (> 10 times ULN), myoglobinaemia and myoglobinuria, which may lead to renal failure.

8). Ezetimibe/Atorvastatin Tablets should be discontinued in case of aggravation of symptoms. Recurrences when the same or a different statin was (re-) administered have been reported. Before the treatment Ezetimibe/Atorvastatin Tablets should be prescribed with caution in patients with pre- disposing factors for rhabdomyolysis.

2). In such situations, the risk of treatment should be considered in relation to possible benefit, and clinical monitoring is recommended. If CPK levels are significantly elevated (> 5 times ULN) at baseline, treatment should not be started.

Creatine phosphokinase measurement Creatine phosphokinase (CPK) should not be measured following strenuous exercise or in the presence of any plausible alternative cause of CPK increase as this makes value interpretation difficult.

If CPK levels are significantly elevated at baseline (> 5 times ULN), levels should be remeasured within 5 to 7 days later to confirm the results. Whilst on treatment ● Patients must be asked to promptly report muscle pain, cramps, or weakness especially if accompanied by malaise or fever or if muscle signs and symptoms persist after discontinuing Ezetimibe/Atorvastatin Tablets.

1. 6). Ezetimibe/Atorvastatin Tablets is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases exceeding 3 times the upper limit of normal (ULN). Ezetimibe/Atorvastatin Tablets is contraindicated in patients treated with the hepatitis C antivirals glecaprevir/pibrentasvir.