SORTIS FILMTBL 40MG N30

ATC code: C10AA05 

Active substances: Atorvastatinum

Vendor, principal: Pfizer European Service Center. 
SORTIS FILMTBL 40MG N30 is compensated medicine in Latvia. 

 Prescription drug (℞) 

SORTIS 40MG N30

Package leaflet: Information for the user

Sortis, 10 mg film-coated tablets Sortis, 20 mg film-coated tablets Sortis, 40 mg film-coated tablets Sortis 80 mg, 80 mg film-coated tablets
Atorvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor, pharmacist or nurse.
-   This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
-   If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Sortis is and what it is used for
2.   What you need to know before you take Sortis
3.   How to take Sortis
4.   Possible side effects
5.   How to store Sortis
6.   Contents of the pack and other information

1. What Sortis is and what it is used for

Sortis belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.
Sortis is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Sortis can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2. What you need to know before you take Sortis

Do not take Sortis:

-   if you are allergic to atorvastatin 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 had any unexplained abnormal blood tests for liver    function
-   if you are a woman able to have children and not using    reliable    contraception
-   if you are pregnant or trying to become pregnant
-   if you are breast-feeding
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Sortis:
-   if you have severe respiratory failure
-   if you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Sortis can lead to serious muscle problems (rhabdomyolysis)
-   if you have had a previous stroke with bleeding into the brain, or have small pockets of fluid in the brain from previous strokes
-   if you have kidney problems
-   if you have an under-active thyroid gland (hypothyroidism)
-   if you have had repeated or unexplained muscle aches    or pains, a personal history or family
history of muscle problems
-   if you have had previous muscular problems during treatment with other lipid-lowering medicines (e.g. other ‘-statin’ or ‘-fibrate’ medicines)
-   if you regularly drink a large amount of alcohol
-   if you have a history of liver disease
-   if you are older than 70 years
If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Sortis treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g. rhabdomyolysis is known to increase when certain medicines are taken at the same time (see section 2 “Other medicines and Sortis”).
Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, 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 any other medicines. There are some medicines that may change the effect of Sortis or their effect may be changed by Sortis. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in section 4:
-   Medicines used to alter the way your immune system works, e.g. ciclosporin
-   Certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampin, fusidic acid
-   Other medicines to regulate lipid levels, e.g. gemfibrozil, other fibrates, colestipol
-   Some calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem,; medicines to regulate your heart rhythm e.g. digoxin, verapamil, amiodarone
-   Medicines used in the treatment of HIV e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir etc.
-   Some medicines used in the treatment of hepatitis C e.g. telaprevir
-   Other medicines known to interact with Sortis include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anti-convulsant for epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a painkiller), colchicine (used to treat gout), antacids (indigestion products containing aluminium or magnesium) and boceprevir (used to treat liver disease such as hepatitis C)
-   Medicines obtained without a prescription: St John’s Wort
-   If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Sortis. Taking Sortis with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Sortis with food and drink

See section 3 for instructions on how to take Sortis. Please note the following:
Grapefruit juice
Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Sortis.
Alcohol
Avoid drinking too much alcohol while taking this medicine. See section 2 “Warnings and precautions” for details.

Pregnancy and breast-feeding

Do not take Sortis if you are pregnant, or if you are trying to become pregnant. Do not take Sortis if you are able to become pregnant unless you use reliable contraceptive measures.
Do not take Sortis if you are breast-feeding.
The safety of Sortis during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, 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.

Sortis contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Sortis

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Sortis.
The usual starting dose of Sortis is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Sortis is 80 mg once a day.
Sortis tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The duration of treatment with Sortis is 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 Sortis than you should

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

If you forget to take Sortis

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

If you stop taking Sortis

If you have any further questions on the use of this medicine or wish to stop your 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 you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Rare: may affect up to 1 in 1,000 people
- Serious allergic reaction which causes swelling of the face, tongue and throat that can cause
great difficulty in breathing.
-   Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.
-   Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown (rhabdomyolysis). The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it can be life-threatening and lead to kidney problems.
Very rare: may affect up to 1 in 10,000 people
-   If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Sortis

Common: may affect up to 1 in 10 people
•   inflammation of the nasal passages, pain in the throat, nose bleed
•   allergic reactions
•   increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
•   headache
•   nausea, constipation, wind, indigestion, diarrhoea
•   joint pain, muscle pain and back pain
•   blood test results that show your liver function can become abnormal Uncommon: may affect up to 1 in 100 people
•   anorexia (loss of appetite), weight gain, decreases in blood sugar levels (if you have diabetes you should continue careful monitoring of your blood sugar levels)
•   having nightmares, insomnia
•   dizziness, numbness or tingling in the fingers and toes, reductions of sensation to pain or touch, change in sense of taste, loss of memory
•   blurred vision
•   ringing in the ears and/or head
•   vomiting, belching, abdominal pain upper and lower, pancreatitis (inflammation of the pancreas leading to stomach pain)
•   hepatitis (liver inflammation)
•   rash, skin rash and itching, hives, hair loss
•   neck pain, muscle fatigue
•   fatigue, feeling unwell, weakness, chest pain, swelling especially in the ankles (oedema), raised temperature
•   urine tests that are positive for white blood cells Rare: may affect up to 1 in 1,000 people
•   visual disturbance
•   unexpected bleeding or bruising
•   cholestasis (yellowing of the skin and whites of the eyes)
•   tendon injury
Very rare: may affect up to 1 in 10,000 people
•   an allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue or throat, difficulty breathing, collapse
•   hearing loss
•   gynecomastia (breast enlargement in men).
Not known: frequency cannot be estimated from the available data: Muscle weakness that is constant. Possible side effects reported with some statins (medicines of the same type):
•   Sexual difficulties
Depression
•   Breathing problems including persistent cough and/or shortness of breath or fever
•   Diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee .By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sortis

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container and outer packaging after {EXP}. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Sortis contains

-   The active substance is atorvastatin.
Each film-coated   tablet    contains    10    mg    atorvastatin    (as atorvastatin    calcium trihydrate).
Each film-coated   tablet    contains    20    mg    atorvastatin    (as atorvastatin    calcium trihydrate).
Each film-coated   tablet    contains    40    mg    atorvastatin    (as atorvastatin    calcium trihydrate).
Each film-coated   tablet    contains    80    mg    atorvastatin (as atorvastatin calcium trihydrate).
-   The other ingredients are:
calcium carbonate, microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, polysorbate 80, hydroxypropyl cellulose and magnesium stearate.
The coating of Sortis contains hypromellose, macrogol 8000, titanium dioxide (E171), talc, simethicone emulsion containing simethicone, stearate emulsifiers (polyethylene glycol sorbitan tristearate, polyethoxylate stearate, glycerides), thickeners (methylcellulose, xantham gum), benzoic acid, sorbic acid and sulfuric acid.

What Sortis looks like and contents of the pack

Sortis 10 mg film-coated tablets are white 5.6 mm in diameter with a round shape. They are marked with 10 on one side and “ATV” on the other side.
Sortis 20 mg film-coated tablets are white 7.1 mm in diameter with a round shape. They are marked with 20 on one side and “ATV” on the other side.
Sortis 40 mg film-coated tablets are white 9.5 mm in diameter with a round shape. They are marked with 40 on one side and “ATV” on the other side.
Sortis 80 mg film-coated tablets are white 11.9 mm in diameter with a round shape. They are marked with 80 on one side and “ATV” on the other side.
The blisters consist of a forming film made of polyamide/aluminium foil/polyvinyl chloride and a backing made of aluminium foil/vinyl heat-seal coating.
The bottle is made of HDPE, containing desiccant, with squeeze-and-turn child-resistant closure. Sortis are 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 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Pfizer Europe MA EEIG Ramsgate Road, Sandwich Kent CT13 9NJ United Kingdom
Manufacturer
Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee 1 79090 Freiburg Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Pfizer Luxembourg SARL Estonian branch Söpruse pst 157 13417 Tallinn Phone: +372 666 7500

This leaflet was last revised in May 2017.