Bula do remedy Crestor

the package insert of the medicine is Crestor. Therapeutic class of Statins. The Active principles of Rosuvastatin cálcica..

what For?

Should be used as an adjunct to diet when the response to diet and exercise is inadequate.

In adult patients with hypercholesterolaemia (high cholesterol level in the blood) Crestor is indicated for:

    the

  • Reduction of LDL-cholesterol, total cholesterol and high triglycerides; increase HDL-cholesterol in patients with hypercholesterolemia primary (familial heterozygous and non-familial) and hyperlipidemia combined (mixed) (Fredrickson types IIa and IIb).
  • the

  • Crestor also lowers ApoB, non-HDL-C, VLDL-C, VLDL-TG, and the reasons for LDL-C/HDL-C, total/HDL-C, non-HDLC/HDL-C, ApoB/ApoA-I and increases ApoA-I in these populations.
  • the

  • Treatment of hypertriglyceridemia isolated (high level of triglycerides) (hyperlipidaemia of Fredrickson type IV).
  • the

  • Reduction of total cholesterol and LDL-C in patients with familial hypercholesterolaemia homozygous, both alone and as an adjuvant to diet and the other treatments of the reduction of lipids (by ex.: apheresis LDL), if such treatments are not sufficient.
  • the

  • Slow or reduce the progression of atherosclerosis (accumulation of fat in the walls of the blood vessels).

Children and adolescents 10 to 17 years of age

    the

  • Crestor is indicated for reduction of elevated total cholesterol, LDL-C and ApoB in patients with familial hypercholesterolaemia heterozygous (HeFH).

Use adult and children above 10 years – oral Use

Pharmacokinetics

How it works?

The rosuvastatin, the active ingredient of Crestor inhibits an important enzyme for the manufacture of cholesterol by the body called HMG-CoA reductase inhibitors, therefore, the continued use of Crestor reduces the level of lipids (fatty substances) in the blood, mainly cholesterol and triglycerides.

This reduction is usually obtained within up to 4 weeks and with the continuity of treatment is maintained after this period.

Dosage

How to use?

Your doctor will evaluate the appropriate criteria for indication and dosage of treatment with Crestor.

The range usual dose is 10 mg to 40 mg orally once a day.

The maximal daily dose is 40 mg.

The dose of Crestor should be individualized according to goal of therapy and patient response.

The majority of patients are controlled on the initial dose.

However, if required, the dose adjustment can be made at intervals of 2 to 4 weeks.

Crestor can be administered at any time of day, with or without food.

    the

  • Hypercholesterolemia primary (including familial hypercholesterolaemia heterozygous), dyslipidemia, mixed hypertriglyceridemia, isolated, and treatment of atherosclerosis: the usual starting dose is 10 mg once a day. A starting dose of 5 mg is available for special populations of patients when necessary. For patients with hypercholesterolemia severe (including familial hypercholesterolaemia heterozygous), one can consider a starting dose of 20 mg.
  • the

  • familial Hypercholesterolaemia homozygous: it is Recommended an initial dose of 20 mg once a day.

Children and adolescents 10 to 17 years of age:

    the

  • In children and adolescents with hypercholesterolemia heterozygous familial the usual dose is 5 – 20 mg once a day orally. The dose should be properly titrated to achieve the purpose of treatment. The safety and efficacy of doses greater than 20 mg have not been studied in this population.

This medicine should not be broken or chewed.

Crestor must be used continuously, until the doctor set when it should be discontinued the use of this medicine.

Side Effects

What are the evils that can cause me?

    the

  • common side Effects:

headache, myalgia (muscle pain), asthenia (general feeling of weakness), constipation, dizziness, nausea (motion sickness), and abdominal pain.

    the

  • unusual side Effects:

Pruritus (itching), exanthema (rash), and urticaria (allergic skin reactions).

    the

  • side Effects rare:

Myopathy (disease of the muscular system, including myositis – inflammation of a muscle), allergic reactions (including angioedema – swelling), rhabdomyolysis (a syndrome caused by damage to the skeletal muscle), pancreatitis (inflammation of the pancreas) and increase of liver enzymes in the blood.

    the

  • side Effects very rare :

Arthralgia (joint pain), jaundice (presence of yellow tinge on skin and eyes), hepatitis (liver inflammation) and memory loss.

    the

  • Frequency was:

Depression and sleep disturbances (including insomnia and nightmares).

Proteinuria (loss of protein through the urine) was observed in a small number of patients. Adverse events pharyngitis (inflammation of pharynx), and other respiratory events such as infections of the upper airways, rhinitis (inflammation of nasal mucosa accompanied by phlegm) and sinusitis (inflammation of the sinuses), have also been reported.

Contraindications

When should I not use?

You should not use Crestor if you are allergic to rosuvastatin, other medicines of the same class or any of the components of the medicine, if you are with liver disease, and if you have severe (bad functioning severe) in the liver or kidneys.

Crestor also should not be used in patients who are pregnant, trying to become pregnant and who are not using contraceptive methods appropriate, and during breast-feeding.

Crestor pregnancy: this medication should not be used by women who are pregnant or who may become pregnant during treatment.

it is Not indicated the use of Crestor in children, since it has not been established safety and effectiveness.

Warnings and Precautions

what should I know before using?

Patients who are taking ciclosporin (used after organ transplantation) should avoid the use of Crestor.

Crestor should be used with caution in patients who have a history of liver disease, regularly drink large amounts of alcohol.

it is Not expected that Crestor affect the ability to drive vehicles and operate machinery.

Tell your doctor if during treatment with Crestor, you will feel muscle aches and pains, unexplained or if you have a history of muscle pain.

as Well as other drugs of the class (statins), the use of rosuvastatin could lead to increased levels of glucose in the blood.

In the treatment of patients with risk factors for diabetes was observed an increased frequency of diabetes.

changes May occur in the results of laboratory tests relating to the functioning of the liver and muscle, and changes in the levels of glucose and hemoglobin glicada (examination for evaluation and diagnosis of diabetes).

If you become seriously ill or be hospitalized in the hospital, notify the medical staff that you are taking Crestor, it may be necessary to stop treatment for a short period of time.

This medicine contains lactose (94,88 mg/pill Crestor 5 mg; 91,30 mg/pill Crestor 10 mg; 182,60 mg/pill for Crestor 20 mg; 168,32 mg/pill for Crestor 40 mg).

Inform your doctor in case you have issues with lactose intolerance.

Crestor should be used with caution in patients who are taking the following medications:

Warfarin, cyclosporine, genfibrozila, protease inhibitors, and antacids.

The use of genfibrozila, in general, should be avoided for patients who are taking Crestor.

Overdose

what to do if someone use a larger amount than is recommended?

there is No specific treatment for the case of an overdose with Crestor.

In the case of use of large amount of this medicine, look for fast medical help and take the packaging or package insert for the drug, if possible.

please Call 0800 722 6001 if you need more guidance.

what should I do when I forget to use this medicine?

If you forget to take a day the pill Crestor, there is no need to take the missed dose, you should just take the next dose at the usual time. Never take a dose that is folded to make up for a missed dose.