SORTIS. 10 mg. 30 tablets

What SORTIS and what it is used
SORTIS belongs to a group of medicines known as statins - drugs that regulate lipids (fats ) .
SORTIS is used for the reduction of lipids known as cholesterol and triglycerides in the blood, where only a diet low in fat and changes in lifestyle are insufficient. If you are at increased risk of heart disease SORTIS can also reduce this risk even if your cholesterol levels are normal. A standard cholesterol lowering diet should be continued during the treatment .

2 . What you should know before taking SORTIS
Do not take SORTIS :
if you are hypersensitive (allergic) to SORTIS or similar to some drugs used to lower blood lipids or any of the other ingredients of this medicine (listed in section 6) if you have or have ever had a disease which 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 or trying to get pregnant ;
if you are breastfeeding .
Warnings and Precautions
Talk to your doctor, pharmacist or nurse before taking SORTIS .
Listed here are the reasons why SORTIS may not be suitable for you:
if you had a previous stroke ( stroke) with bleeding in the brain or have small collections of fluid in the brain as a result of previous stroke;
if you have kidney problems ;
if you have an under-active thyroid ( hypothyroidism ) ;
If you have repeated or unexplained muscle pain, personal or family history of muscle problems ;
if you have had previous problems with muscles during treatment with other lipid-lowering drugs (eg statins or fibrates other ) ;
If you regularly drink large amounts of alcohol;
if you have a history of liver disease ;
if you are older than 70 years.
Ask your doctor, pharmacist or nurse before taking SORTIS :
if you have severe respiratory failure.
If any of these conditions apply to you , your doctor will do blood tests before and possibly during treatment with SORTIS to predict the risk of muscle related side effects . It is known that the risk of muscle related side effects , e. rhabdomyolysis is increased when certain drugs are co-administered (see section 2, " Other medicines and SORTIS " ) .
If you have diabetes or are at risk of developing diabetes , your doctor will closely monitor your condition while you are taking this medicine. You're probably at risk of developing diabetes if you have high levels of sugar and fat in the blood, if you are overweight and have high blood pressure.

Other medicines and SORTIS
Tell your doctor or pharmacist if you are taking , have recently taken or might take other medicines. There are some medicines that can change the effect of SORTIS or their effect can be modified by SORTIS . This kind of interaction could reduce the effectiveness of one or both drugs. Conversely, it could increase the risk or severity of side effects , including severe muscle wasting condition known as rhabdomyolysis and described in Section 4:
Drugs used to alter the way your immune system works , eg . cyclosporin;
Certain antibiotics or antifungal drug , e. erythromycin , clarithromycin , telithromycin, ketoconazole , itraconazole, voriconazole , fluconazole , posaconazole, rifampin, fusidic acid ;
Other drugs that control lipid levels , eg . gemfibrozil, other fibrates , colestipol ;
Certain calcium channel blockers , used for angina , or hypertension, for example . amlodipine , diltiazem , medications to regulate your heartbeat such as digoxin , verapamil , amiodarone ;
Drugs used to treat HIV such . ritonavir , lopinavir , atazanavir , indinavir, darunavir combination tipranavir / ritonavir and others. ;
Certain drugs used to treat hepatitis C , for example . telaprevir ;
Other drugs known to interact with SORTIS including ezetimibe ( cholesterol lowering ), warfarin ( which reduces bleeding ) oral contraceptives , stiripentol ( anti- product ) , cimetidine (used for ulcers and heartburn ) , phenazone ( anodyne product), colchicine (used for the treatment of gout ), and antacids ( indigestion products containing aluminum or magnesium) ;
Medicines obtained without a prescription : St. John's Wort .
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

SORTIS with food and drink
Cf. Section 3 for instructions on how to accept SORTIS . Please note the following:

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. Cf. Section 2 " Warnings and Precautions " section for more information.

Pregnancy and lactation
SORTIS not take if you are pregnant or trying to get pregnant .
Do not take SORTIS if you could become pregnant , unless you take certain contraceptive measures.
SORTIS not take if you are breastfeeding .
SORTIS safety during pregnancy and lactation has not been established.
Ask your doctor or pharmacist before taking any medicine.

Driving and using machines
In general, this drug did not affect the ability to drive and use machines. However, do not drive , if it affects your ability to drive . Do not use any tools or machines if your ability to use them is affected by this medicine.

Important information about some of the ingredients of SORTIS
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine .

3 . How to take SORTIS
Before starting treatment , your doctor will prescribe you a diet low in cholesterol, which should be continued during treatment with SORTIS .
The usual starting dose of SORTIS is 10 mg once daily in adults and children 10 and older. It can be increased if necessary by your doctor , until the amount you need. Your doctor will adjust the dose at intervals of 4 weeks or more. The maximum dose of SORTIS is 80 mg once daily for adults and 20 mg once daily for children.
SORTIS tablets should be swallowed whole with a little water and can be taken at any time of the day with or without food. However, try to take your tablets at the same time each day.
Always take this medicine exactly as your told your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.

The duration of treatment with SORTIS determined by your doctor.
Please ask your doctor if you think that the effect of SORTIS is too strong or too weak .

If you take more dose SORTIS
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 SORTIS
If you miss 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 SORTIS
If you have any further questions on the use of this product or want to stop treatment , ask your doctor or pharmacist.

4 . Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them .
If any of the following serious side effects, stop taking the tablets and tell your doctor immediately or go to the nearest hospital or emergency room .
Rare: may affect up to 1 in 1000 people :
Serious allergic reactions that cause swelling of the face , tongue and throat , causing great difficulty in breathing ;
Serious illness with severe peeling and swelling of the skin with blisters on the skin, mouth , eyes, genitals , and fever. Skin rash as a pink - red spots , usually on the palms of the hands and feet, with possible blistering ;
Muscular weakness , tenderness or pain , especially if at the same time feel sick or have a high temperature, it may be caused by increased degradation of the muscle , which in turn is lethal and leads to problems with their kidneys.
Very rare: may affect up to 1 in 10 000 people :
If you have problems with unexpected or unusual bleeding or bruising, it may suggest liver complaint. You should consult with your doctor as soon as possible .
Other possible side effects with SORTIS :
Common side effects (may affect up to 1 in 10 people ) include:
inflammation of the pharynx , sore throat , nose bleeds ;
allergic reactions;
elevated levels of blood glucose (if you have diabetes, keep checking your levels of blood sugar) , increased levels of creatine kinase in the blood ;
headache ;
nausea, constipation, flatulence , indigestion , diarrhea ;
joint pain , muscle pain and back pain ;
abnormal blood tests for liver function.
Uncommon side effects (may affect up to 1 in 100 people ) include:
anorexia (loss of appetite) , weight gain , low blood sugar levels (if you have diabetes, continue to monitor the levels of your blood sugar) ;
nightmares, insomnia ;
dizziness, numbness and tingling in fingers and toes, reduced sensitivity to pain and touch, taste changes , loss of memory ;
blurred vision ;
ringing in the ears and / or head ;
vomiting , belching , pain in the upper and lower abdomen , pancreatitis ( inflammation of the pancreas , causing abdominal pain ) ;
hepatitis ( liver inflammation ) ;
rash , skin rash and pruritus, urticaria , alopecia ;
neck pain, muscle weakness ;
fatigue , malaise , weakness, chest pain, swelling, particularly of the ankles (edema ), fever ;
white blood cells in urine tests.
Rare side effects (may affect up to 1 in 1000 people ) include:
visual disturbances ;
unexpected bleeding or bruising ;
cholestasis (yellowing of the skin or eyes ) ;
tendon injury .
Very rare side effects (may affect up to 1 in 10 000 people ) include:
allergic reaction - symptoms may include sudden shortness of breath and chest pain or tightness , swelling of eyelids, face , lips, mouth, tongue and throat , difficulty breathing , fainting ;
hearing loss ;
gynecomastia ( breast enlargement in men and women ) .
Possible adverse events reported with some statins (drugs of the same type ):
sexual offenses;
depression ;
breathing problems including persistent cough and / or shortness of breath, and fever ;
diabetes . This is more likely if you have high levels of sugar or lipids in the blood, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Adverse event reporting
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all listed in this leaflet . You can also report side effects directly through the national system of communication. As reported side effects , you can do your bit to get more information on the safety of this medicine.

5 . How to store SORTIS
Keep out of reach of children.
This medicinal product does not require any special storage conditions .
Do not use this medicine after the expiry date stated on the label and carton after " EXP" . The expiry date refers to the last day of that month.
Do not dispose of medications in wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.

6 . Package Contents and more information
What does SORTIS
The active substance is atorvastatin . Each tablet contains the 10 mg, 20 mg, 40 mg or 80 mg of atorvastatin ( such as atorvastatin calcium trihydrate) .
Other ingredients are: calcium carbonate , microcrystalline cellulose , lactose monohydrate, croscarmellose sodium , polysorbate 80 , hyprolose and magnesium stearate.
SORTIS shell contains hypromellose , macrogol 8000 , titanium dioxide (E 171 ) , talc , simethicone , stearate emulsifiers and sorbic acid .

SORTIS looks like and contents of pack
SORTIS film-coated tablets are white and round . They are marked by " 10" , "20" , "40" or "80 " on one side and "ATV" on the other.
The blisters consist of a formula film from polyamide / aluminum foil / PVC and heat seal coated aluminum foil / vinyl .
The bottle consists of HDPE, containing desiccant , with a child -resistant closure.
SORTIS is available in blister packs containing 4, 7, 10, 14, 20, 28 , 30, 50 , 56, 84, 90 , 98 and 100 film-coated tablets , hospital packs containing 50, 84 , 100, 200 (10 x 20 ) or 500 film-coated tablets and bottles containing 90 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
PFIZER