Sortis . 20 mg. 30 tablets

WHAT Sortis 20 mg AND WHAT IT IS USED

Sortis belongs to a group of medicines known as statins - drugs that regulate lipid (fat)

Sortis used to lower lipids known as cholesterol and triglycerides in the blood when a diet low in fat and changes in lifestyle have failed. If you have an increased risk of heart disease Sortis can also reduce this risk even if your cholesterol levels are normal. Standard cholesterol lowering diet should be continued during treatment.

Cholesterol is a naturally occurring substance in the body necessary for normal growth. However, if there is too much cholesterol in your blood, it can build up in the walls of blood vessels, which may eventually be blocked. This is one of the most common causes of heart disease. It is assumed that elevated cholesterol levels increase the risk of heart disease. Other factors that will increase the risk of heart disease include high blood pressure, diabetes, obesity, lack of exercise, smoking, or family history of heart disease.

 

 BEFORE YOU TAKE Sortis 20 mg

 

Sortis 20 mg should not be used:

 

if you are hypersensitive (allergic) to Sortis or some similar • medicines used to lower blood lipids or to any of the excipients of the drug - see. Section 5 for details;

 

if you have or have ever had a disease that affects the liver, if you have unexplained abnormal blood tests for liver function if you are a woman of childbearing age not using reliable contraception if you are pregnant, trying to become pregnant or breast-feeding;

  If you have a muscle injury, called myopathy (repeated or unexplained muscle pain).

 

Take special care with Sortis 20 mg

 

The following are reasons why Sortis may not be suitable for you: if you have kidney problems;

if you have reduced thyroid function (hypothyroidism), if you have repeated or unexplained muscle pain, personal or family history of muscle problems - "if you have had previous muscle problems during treatment with other lipid-lowering drugs (eg . other "statin" or "fibrate") if you regularly drink large amounts of alcohol and if you have a history of liver disease if you are older than 70 years;

if your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this product.

If any of these apply to you, your doctor will do blood tests before and possibly during your treatment with Sortis to predict your risk of muscle related side effects.

 

Taking other medicines

 

There are some medicines that may interact with Sortis:

 

Drugs used to alter the way your immune system works, for example. cyclosporine;

Certain antibiotics or antifungal medicines, eg. erythromycin, clarithromycin, ketoconazole, itraconazole, rifampicin;

 

Other drugs that control lipid levels, eg. gemfibrozil, other fibrates, nicotinic acid derivatives, colestipol;

 

Some calcium channel blockers used for angina or high blood pressure, for example. nifedipine, drugs that regulate your heart rate, eg. digoxin;

 

Some benzodiazepines used for anxiety and other conditions, eg. nefazodone;

 

Protease inhibitors used in the treatment of AIDS;

 

Other drugs known to interact with Sortis including warfarin (a blood clotting), oral contraceptives, phenytoin (anticonvulsant for epilepsy), and antacids (for indigestion products containing aluminum or magnesium).

You should always talk to your doctor if you are taking or have recently taken any other medicines, even those who are without prescription because they may interact.

 

Taking Sortis 20 mg with food and drink

 

Grapefruit Juice

 

Do not take more than one or two small glasses of grapefruit juice a day because large quantities of grapefruit juice can alter the effects of Sortis.

 

Alcohol

 

Avoid drinking too much alcohol while taking this medicine. See. section 2 'Take special care with Sortis 20 mg "for details.

 

Pregnancy

 

Sortis Do not take if you are pregnant or think you are pregnant or trying to get pregnant. Women of childbearing age should take appropriate measures. contraception.

Ask your doctor or pharmacist before taking any medicine.

 

Breastfeeding

 

Sortis Do not use if you are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

 

Driving and operating machinery

 

Do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

 

 HOW TO TAKE Sortis 20 mg

 

The usual starting dose is 10 mg Sortis once daily. It can be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adjust the dosage at intervals of 4 weeks or more. The maximum dose is 80 mg Sortis once daily.

Sortis tablets should be swallowed whole with a little water and can be taken at any time of day with or without food. However, try to take your tablets at the same time each day.

Always Sortis 20 mg exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Before starting treatment, your doctor will prescribe a diet low in cholesterol, which should be continued during treatment with 20 mg Sortis.

The duration of treatment with 20 mg Sortis determined by your doctor.

Please ask your doctor if you think that the effect of Sortis 20 mg is too strong or too weak.

If you take too much Sortis 20 mg than you should If you accidentally take too many tablets Sortis (more than your usual daily dose), contact your doctor or nearest hospital for advice.

 

If you forget to take 20 mg Sortis

 

If you forget to take a dose, just take your next scheduled dose at the right time. Do not take a double dose to make up for a missed dose.

 

If you stop taking 20 mg Sortis

 

If you have any questions about using this medicine, ask your doctor or pharmacist.

 

 POSSIBLE SIDE EFFECTS

 

Like all medicines, Sortis 20 mg can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The following side effects are important and require immediate attention if you get them.

Angioneurotic edema (swelling of the face, tongue and windpipe which can cause great difficulty in breathing). This is a very rare reaction, which can be serious, if it appears. You should immediately tell your doctor if this happens.

Sometimes patients develop muscle wasting or inflammation of the muscles and very rarely it can cause serious, potentially life-threatening condition (referred to as "rhabdomyolysis"). If you have muscle weakness, tenderness or pain, especially if at the same time feel unwell or have a fever, stop taking Sortis and tell your doctor.

Very rare condition affecting less than I in 10,000 patients taking Sortis (this means that for every 10,000 patients taking Sortis in 9.999 is not expected to have these side effects).

If you have any problems with unexpected or unusual bleeding or bruising that may suggest liver complaint. You should consult with your doctor as soon as possible.

 

Other possible side effects with Sortis:

 

Like all medicines, Sortis can sometimes cause side effects in some people. Common conditions affecting at least 100 out of 10,000 patients receiving Sortis (this means that every patient to 9.900 10.000 is not expected to have these side effects).

 

They include:

 

Nausea, abdominal pain, constipation, flatulence, indigestion, headache, muscle pain, weakness, diarrhea, insomnia, dizziness, chest pain, allergic reactions, numbness, joint pain and back pain, weakness, edema peripheral, pruritus.

Other less common side effects have been observed in some patients taking Sortis or other drugs of this type. Not all of these effects are not necessarily related to the use of these drugs; uncommon condition affecting less than 100 out of 10,000 patients receiving Sortis (this means that for every 10,000 patients taking Sortis at least 9.900 is not expected to have these side effects).

They include:

Anorexia (loss of appetite), numbness or tingling in the fingers and feet, vomiting, rash, muscle cramps, unexpected bleeding and bruising, ringing in the ears and / or head, weight gain, memory loss, urticaria, malaise, impotence hair loss, pakreatit (inflammation of the pancreas leading to abdominal pain).

Rare condition, affecting less than 10 per 10,000 patients receiving Sortis (this means that for every 10,000 patients taking Sortis, at least 9.990 is not expected to have these side effects).

 

They include:

 

Reduction of skin sensitivity to light touch or pain, muscle tenderness, blistering rash, peripheral edema (swelling of the ankles example), hepatitis (liver inflammation), jaundice (yellowing of the skin and whites of the eyes), rhabdomyolysis (severe pain and muscle weakness, often associated with fever).

Very rare condition, affecting less than 1 in 10,000 patients receiving Sortis (this means that for every 10,000 patients taking Sortis, at least at 9.999 is not expected to have these side effects).

 

 These include:

 

Angioneurotic edema (swelling of the face, tongue and windpipe, which could lead to great difficulty in breathing) syndrome, Stevens-Johnson (severe blistering condition of the skin, mouth, eyes and genitals), erythema multiforme (a red blotchy rash). There was also an increase or decrease in blood sugar levels. (If you are diabetic, you should continue to closely monitor the levels of your blood sugar.)

 

If you have any side effects, please inform your doctor. He / she will decide what further steps to take.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

 

 STORAGE OF Sortis 20 mg

 

Keep out of reach of children.

This medicinal product does not require any special storage conditions.

Do not use Sortis 20 mg after the expiry date stated on the packaging and outer box. The expiry date refers to the last day of that month.

Do not use Sortis 20 mg if you notice visible signs of deterioration of the product.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

 

 ADDITIONAL INFORMATION

 

What Sortis 20 mg

 

Active ingredient is 20 mg Sortis atorvastatm (atorvastatin). Each tablet contains 20 mg of atorvastatin as atorvastatin calcium trihydrate.

 

Sortis tablet contains ingredients: calcium carbonate, microcrystalline cellulose, lactose, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose, and magnesium stearate.

Sortis shell contains hypromellose, macrogol 8000, titanium dioxide (E171), talc, simethicone, macrogol stearate, sobritolova acid and Candelilla wax.