Sortis 20

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

SORTIS 20 (SORTIS 20 mg)

20 mg, coated tablets

Atorvastatin
SORTIS 20 and SORTIS 20 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is SORTIS 20 and what is it used for
• 2. Important information before taking SORTIS 20
• 3. How to take SORTIS 20
• 4. Possible side effects
• 5. How to store SORTIS 20
• 6. Contents of the packaging and other information

1. What is SORTIS 20 and what is it used for

SORTIS 20 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
SORTIS 20 is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and changes in lifestyle are not effective. SORTIS 20 may also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking SORTIS 20

When not to take SORTIS 20:

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

Warnings and precautions

Before starting treatment with SORTIS 20, the patient should discuss it with their doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with SORTIS 20 can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding in the brain, or if there is a small amount of fluid in the brain from a previous stroke,
• in case of kidney problems,
• in case of hypothyroidism,
• in case of recurring or unexplained muscle pain, or muscle problems in the past, or similar problems in relatives,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g., other statins or fibrates),
• in case of regular consumption of large amounts of alcohol,
• in case of a history of liver disease,
• in patients over 70 years of age,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia gravis (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

In patients who are affected by any of the above situations, the doctor will order a blood test before starting treatment with SORTIS 20 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 20 and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
During treatment with SORTIS 20, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

SORTIS 20 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of SORTIS 20 or the effect of these medicines on the body may be changed by SORTIS 20.

• This type of interaction can lead to reduced efficacy 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, cholestyramine,
• 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 that are known to interact with SORTIS 20, 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 (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium),
• over-the-counter medicines: St. John's Wort,
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking SORTIS 20. The doctor will inform the patient when it is safe to restart treatment with SORTIS 20. Taking SORTIS 20 with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

SORTIS 20 with food, drink, and alcohol

Information on the use of SORTIS 20 can be found in section 3.
However, the following information should be noted:
Grapefruit juice
Patients should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of SORTIS 20.
Alcohol
During treatment with SORTIS 20, patients should avoid consuming excessive amounts of alcohol.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of SORTIS 20 in pregnant or breastfeeding women is contraindicated.
The use of SORTIS 20 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of SORTIS 20 during breastfeeding is contraindicated.
The safety of using SORTIS 20 during pregnancy and breastfeeding has not been established.
Before taking any medicine, patients should consult their doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, patients should not drive or use machines if the medicine affects their ability to do so.

SORTIS 20 contains lactose monohydrate

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

SORTIS 20 contains sodium

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

SORTIS 20 contains benzoic acid (E 210)

This medicine contains 0.00008 mg of benzoic acid per tablet.

3. How to take SORTIS 20

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 20.
SORTIS 10 (10 mg), SORTIS 20 (20 mg), SORTIS 40 (40 mg), and SORTIS 80 (80 mg) are available.
The usual starting dose of SORTIS for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of SORTIS at intervals of at least 4 weeks. The maximum dose of SORTIS is 80 mg once daily.
SORTIS 20 tablets should be swallowed whole, with water; they can be taken at any time of day, with or without food. However, patients should try to take the tablet at the same time every day.
This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, patients should consult their doctor or pharmacist.

The duration of treatment with SORTIS 20 is determined by the doctor.

If the patient feels that the effect of SORTIS 20 is too strong or too weak, they should consult their doctor.

Taking a higher dose of SORTIS 20 than recommended

In case of accidental ingestion of more tablets of SORTIS 20 than the usual daily dose, patients should contact their doctor or the nearest hospital for advice.

Missing a dose of SORTIS 20

If a dose is missed, patients should simply take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.

Stopping treatment with SORTIS 20

In case of further doubts about the use of this medicine, patients should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SORTIS 20 can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

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

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

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

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. They should consult their doctor as soon as possible.
• Systemic lupus erythematosus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of SORTIS 20:

Common: may occur in up to 1 in 10 people

• nasal congestion, 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 occur in 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 in the fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin rash and itching, hives, hair loss
• 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 occur in up to 1 in 1,000 people

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture

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

• allergic reactions - 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 (excessive breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing). Myasthenia gravis (a disease that causes muscle weakness in the eyes). Patients should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of SORTIS 20 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 risk of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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 can help gather more information on the safety of the medicine.

5. How to store SORTIS 20

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What SORTIS 20 contains

• The active substance of SORTIS 20 is atorvastatin. Each coated tablet contains 20 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• The other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate. The coating of SORTIS 20 contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (polysorbate 65, macrogol 400 stearate, glycerol monostearate 40-50), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What SORTIS 20 looks like and what the packaging contains

White, round, coated tablets with a diameter of 7.1 mm, with the inscription "20" on one side and "ATV" on the other side.
Blisters with PA/Al/PVC//Al/vinyl foil in a cardboard box.
SORTIS 20 is available in blisters containing 30 coated tablets.
For more detailed information, patients should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1,
79009 Freiburg, Germany
Mylan Hungary Kft., Mulan utca 1, Komárom 2900, Hungary

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
Marketing authorization number in the Czech Republic, the country of export: 31/234/99-C

Parallel import authorization number: 397/22

Date of leaflet approval: 20.11.2023

[Information about the trademark]