Fortius 20 (Rosuvastatin 20mg) 10 Tablets/Pack

General information

What is Fortius 20 Tablets used for?

Fortius 20 tablets are used to lower high levels of cholesterol (hypercholesterolaemia) and other fats (triglycerides) in the blood to reduce health risks associated with coronary heart disease (CHD), including heart attack and angina that can be caused by high cholesterol.  There are usually no symptoms associated with high cholesterol, which may be due to lifestyle (high-fat diet and lack of exercise) or can be inherited (familial hypercholesterolaemia) and is not always lifestyle dependent.  Fortius 20 tablets are used in conjunction with a low-fat diet, when lifestyle changes (diet and exercise) are not sufficient to lower cholesterol in patients with primary hypercholesterolaemia, without clinical evidence of CHD, to reduce risk of CHD and reduce the need for surgery.  Fortius 20 tablets are used to prevent major cardiovascular events (heart attack) or cerebrovascular events (stroke) and to prevent the need for coronary artery revascularisation (bypass surgery), in those who are at risk of heart attack or stroke and to slow the progression of atherosclerosis (hardening of the arteries).  Hypercholesterolaemia may be due to secondary causes such poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism.  These should be identified and treated before therapy with Fortius 20 tablets is started.

How does Fortius 20 Tablets work?

Fortius 20 tablets contain rosuvastatin which belongs to a group of cholesterol-lowing medications called statins.  Cholesterol is needed by the body for many functions such as building cell membranes, producing certain hormones and transporting fat soluble vitamins around the body.  However, if there is more cholesterol than the body needs, it becomes deposited in the artery walls where it can build up, blocking the arteries and increasing risk of heart disease.  Rosuvastatin in Fortius 20 reduces the production of cholesterol in the liver, by inhibiting HMG-CoA reductase, an important enzyme involved in cholesterol synthesis.  Rosuvastatin in Fortius 20 tablets lowers levels of “bad” cholesterol (LDL) that can cause arteries to become hardened and blocked, and also increases levels of “good” cholesterol (HDL) that helps unblock hardened arteries.  Fortius 20 tablets only blocks cholesterol that is produced in the liver but has no effect on cholesterol that comes from fat in food, which is why a low-fat diet is important even when you are taking Fortius 20 tablets. 

What does Fortius 20 Tablets contain?

Fortius 20 tablets contain the active ingredient rosuvastatin, which is a cholesterol-lowing medication that belongs to a group of drugs called statins used to treat hypercholesterolaemia.

Treating high cholesterol (hypercholesterolaemia) with Fortius 20 Tablets

Fortius 20 tablets contain the cholesterol-lowing statin medication rosuvastatin, which is used to lower levels of cholesterol and other fats (triglycerides) in the blood to reduce health risks associated with coronary heart disease (CHD), including heart attack and angina that can be caused by high cholesterol.  There are usually no symptoms associated with high cholesterol, which may be due to lifestyle (high-fat diet and lack of exercise) or can be inherited (familial hypercholesterolaemia) and is not always lifestyle dependent.  Cholesterol is needed by the body for many functions such as building cell membranes, producing certain hormones and transporting fat soluble vitamins around the body, however, if there is more cholesterol than the body needs, it becomes deposited in the artery walls where it can build up, blocking the arteries and increasing risk of heart disease.  Rosuvastatin in Fortius 20 tablets reduces the production of cholesterol in the liver, by inhibiting HMG-CoA reductase, an important enzyme involved in cholesterol synthesis.  This action lowers levels of total cholesterol in the blood as well as reducing “bad” cholesterol (LDL) that can cause arteries to become hardened and blocked, and also increases levels of “good” cholesterol (HDL) that helps unblock hardened arteries.  Fortius 20 tablets only blocks cholesterol that is produced in the liver but has no effect on cholesterol that comes from fat in food, which is why a low-fat diet is important even when you are taking Fortius 20 tablets.

What are the side effects of Fortius 20 Tablets?

The most commonly reported side effects when taking Fortius 20 tablets include constipation, abdominal pain, nausea, headache and dizziness, unusual tiredness, skin rash, itching or hives.  More serious side effects are less common and may include: muscle ache, tenderness or weakness, not caused by exercise (myopathy), rhabdomyolysis (breakdown of skeletal muscle).

When should Fortius 20 Tablets not be used?

You should not use Fortius 20 tablets if you:

• are allergic to rosuvastatin or any ingredients in Fortius 20
• are pregnant or are breastfeeding
• have active liver disease or severe kidney disease
• have a personal or family history of hereditary muscular disorders
• have pre-disposing factors for myopathy/rhabdomyolysis, such as hypothyroidism, history of hereditary muscular disorders, alcohol abuse
• have a previous history of muscular problems from using other lipid-lowering agents
• are taking medicines that interact with Fortius 20, including: other lipid-lowering medications like gemfibrozil, the immunosuppressant cyclosporine, anticoagulants like warfarin, ritonavir and lopinavir for HIV, antacids for indigestion (within 2 hours)

What medications interact with Fortius 20 Tablets?

Medicines that interact with Fortius 20, include:

• other lipid-lowering medications like gemfibrozil
•  the immunosuppressant cyclosporine
•  anticoagulants like warfarin
•  ritonavir and lopinavir for HIV
•  antacids for indigestion (within 2 hours)

Effects of alcohol and grapefruit on Fortius 20 Tablets

If you drink large quantities of alcohol, you may increase the risk of liver problems when taking Fortius 20 Tablets.  Grapefruit juice in large quantities (more than one litre a day) can also increase risk of side effects as it increases the amount of Fortius 20 that gets into your blood.

How should Fortius 20 Tablets be taken?

You should take your Fortius 20 tablets swallowed whole with a glass of water once a day, preferably in the evening after your evening meal, although you can take Fortius 20  with or without food.  Fortius 20 tablets are most effective at night when your body is resting and your liver is producing the most cholesterol.  Your doctor may increase your dose, as required.  You should see your cholesterol levels fall to within normal limits within 4 weeks, but you should continue to take Fortius 20 tablets for as long as recommended by your doctor, which may be for the rest of your life as it helps keep your cholesterol levels from being too high and if you stop taking Fortius 20 tablets, your cholesterol levels may rise again.  

Missed dose of Fortius 20 Tablets

If you miss a dose of Fortius 20 tablets take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Fortius 20 Tablets be stored?

Store below 25°C and keep away from moisture and direct sunlight.