Sortis 40

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

SORTIS 40 (Lipitor), 40 mg, Film-Coated Tablets

Atorvastatin
SORTIS 40 and Lipitor are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is SORTIS 40 and what is it used for
• 2. Important information before taking SORTIS 40
• 3. How to take SORTIS 40
• 4. Possible side effects
• 5. How to store SORTIS 40
• 6. Contents of the pack and other information

1. What is SORTIS 40 and what is it used for

SORTIS 40 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
SORTIS 40 is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. SORTIS 40 may also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. Important information before taking SORTIS 40

When not to take SORTIS 40:

• if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6),
• if you have or have had liver disease,
• if you have unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective contraception,
• in pregnant or breastfeeding women,
• if you are taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with SORTIS 40, discuss with your doctor, pharmacist, or nurse:

• if you have severe respiratory failure,
• if you are taking or have taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with SORTIS 40 can lead to serious muscle problems (rhabdomyolysis),
• if you have had a stroke with bleeding in the brain or if there is a small amount of fluid in the brain from a previous stroke,
• if you have kidney problems,
• if you have hypothyroidism,
• if you have recurring or unexplained muscle pain or muscle problems in the past, or similar problems in relatives,
• if you have had muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• if you regularly consume large amounts of alcohol,
• if you have had liver disease in the past,
• if you are over 70 years old.

Your doctor will order a blood test before starting treatment with SORTIS 40 and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "SORTIS 40 and other medicines").
Your doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medicines may be necessary to diagnose and treat this condition.
During treatment with SORTIS 40, your doctor will closely monitor you for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

SORTIS 40 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Some medicines may change the effect of SORTIS 40 or the effect of these medicines on the body may be changed by SORTIS 40.

• 40. This type of interaction can reduce the effectiveness of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:
• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with SORTIS 40, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (used to treat gout), and antacids (used to treat heartburn, containing aluminum or magnesium),

over-the-counter medicines: St. John's Wort,

• if you need to take fusidic acid orally to treat a bacterial infection, you should temporarily stop taking SORTIS 40. Your doctor will tell you when you can safely restart treatment with SORTIS 40. Taking SORTIS 40 with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

SORTIS 40 with food, drink, and alcohol

Information on taking SORTIS 40 can be found in section 3. However, pay attention to the following:

Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may change the effect of SORTIS 40.
Alcohol
Avoid excessive alcohol consumption while taking SORTIS 40.
More information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking SORTIS 40 during pregnancy or if you are planning to become pregnant is contraindicated.
Taking SORTIS 40 in women of childbearing age is contraindicated if they do not use effective contraception.
Taking SORTIS 40 during breastfeeding is contraindicated.
The safety of taking SORTIS 40 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

Usually, the medicine does not affect the ability to drive or use machines. However, do not drive or use machines if the medicine affects your ability to do so.

SORTIS 40 contains lactose monohydrate

Patients who have been informed by their doctor about intolerance to some sugars should contact their doctor before taking this medicine.

SORTIS 40 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

SORTIS 40 contains benzoes acid

This medicine contains 0.00016 mg of benzoes acid per tablet.

3. How to take SORTIS 40

SORTIS 10 (10 mg), SORTIS 20 (20 mg), SORTIS 40 (40 mg), and SORTIS 80 (80 mg) are available.
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 40.
Usually, the initial dose of SORTIS 40 in adults and children over 10 years old is 10 mg per day. This dose may be increased by your doctor if necessary, up to a dose suitable for you. Your doctor will adjust the dose of SORTIS 40 at intervals of at least 4 weeks. The maximum dose of SORTIS 40 is 80 mg once daily.
Take the tablets with water, and they can be taken at any time of day, with or without food. However, try to take the tablet at the same time every day.
Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.

The duration of treatment with SORTIS 40 is determined by your doctor.

If you feel that the effect of SORTIS 40 is too strong or too weak, consult your doctor.

Taking more than the recommended dose of SORTIS 40

If you accidentally take more tablets than the usual daily dose, contact your doctor or the nearest hospital for advice.

Missing a dose of SORTIS 40

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

Stopping treatment with SORTIS 40

If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SORTIS 40 can cause side effects, although not everybody gets them.

If you experience any serious side effects or symptoms, stop taking the medicine and contact your doctor or go to the emergency department of your nearest hospital immediately.

Rare: may affect up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters, and fever. Skin rash with reddish-purple spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or brownish discoloration of the urine. If you also feel unwell or have a high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does not always resolve, even if you stop taking atorvastatin, and it can be life-threatening and cause kidney problems.

Very rare: may affect up to 1 in 10,000 people

• If you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. Consult your doctor as soon as possible.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of SORTIS 40:

Common: may affect up to 1 in 10 people

• nasal inflammation, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon: may affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling of fingers and toes, reduced sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin itching, and hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in urine tests

Rare: may affect up to 1 in 1,000 people

• vision disturbances
• unexpected bleeding or bruising (bruises)
• jaundice (yellowing of the skin and eyes)
• tendon rupture

Very rare: may affect up to 1 in 10,000 people

• allergic reactions - symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness

Other possible side effects reported during treatment with some statins (medicines of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the likelihood of developing this disease is higher in patients with high blood sugar and fat levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, your doctor will perform the necessary tests.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store SORTIS 40

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
No special storage precautions are required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SORTIS 40 contains

• The active substance is atorvastatin. Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
• The other ingredients are calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hypromellose, and magnesium stearate. The coating of SORTIS 40 contains hypromellose, macrogol 8000, titanium dioxide (E 171), talc, and simethicone emulsion containing simethicone, emulsifying stearyl alcohol, (sorbitan trioleate, polyoxyethylated stearyl alcohol, glycerides), thickening agents (methylcellulose, xanthan gum), benzoes acid, sorbic acid, and sulfuric acid.

What SORTIS 40 looks like and contents of the pack

White, round, film-coated tablets, 9.5 mm in diameter, with "40" engraved on one side and "ATV" on the other.
Polyamide/Al/PVC blisters in a cardboard box.
SORTIS 40 is available in blisters containing 28 film-coated tablets.
For more detailed information, contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the UK, country of export:

Upjohn UK Limited
Ramsgate Road, Sandwich
Kent, CT13 9NJ
United Kingdom

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
UK license number: PL 50622/0041

Parallel import license number: 70/17 Date of leaflet approval: 02.03.2022

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