Sortis 20

Leaflet accompanying the packaging: information for the user

SORTIS 10, 10 mg, film-coated tablets

SORTIS 20, 20 mg, film-coated tablets

SORTIS 40, 40 mg, film-coated tablets

SORTIS 80, 80 mg, film-coated tablets

Atorvastatin

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

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a 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.
• 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 and what is it used for
• 2. Important information before taking SORTIS
• 3. How to take SORTIS
• 4. Possible side effects
• 5. How to store SORTIS
• 6. Contents of the packaging and other information

1. What is SORTIS and what is it used for

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

2. Important information before taking SORTIS

When not to take SORTIS:

• 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, or women planning to become pregnant,
• in breastfeeding women, if the patient is also taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting to take SORTIS, you should discuss this with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection in the last 7 days. Taking fusidic acid with SORTIS can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding into 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 myasthenic syndrome (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 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 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, 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 and other medicines

You should 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 can change the effect of SORTIS or the effect of these medicines on the body may be changed by SORTIS.
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 heart rhythm regulators, 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, 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. The doctor will inform the patient when it is safe to restart treatment with SORTIS. Taking SORTIS with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

SORTIS with food, drink, and alcohol

Information on taking SORTIS can be found in section 3. However, please note the following:

Grapefruit juice
You 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.
Alcohol
You should avoid drinking excessive amounts of alcohol while taking this medicine.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

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

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. You should not use any tools or machines if taking the medicine affects your ability to use them.

SORTIS contains lactose

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

SORTIS contains sodium

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

SORTIS contains benzene acid

10 mg, film-coated tablet
This medicine contains 0.00004 mg of benzene acid per tablet.
20 mg, film-coated tablet
This medicine contains 0.00008 mg of benzene acid per tablet.
40 mg, film-coated tablet
This medicine contains 0.00016 mg of benzene acid per tablet.
80 mg, film-coated tablet
This medicine contains 0.00032 mg of benzene acid per tablet.

3. How to take SORTIS

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS.
Usually, the initial dose of SORTIS for adults and children over 10 years of age is 10 mg per day. This dose may be increased by the doctor if necessary, up to the 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 a day.

SORTIS tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.
This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a doctor or pharmacist.

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

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

Taking a higher dose of SORTIS than recommended

In case of accidental ingestion of too many SORTIS tablets (more than the usual daily dose), you should contact a doctor or the nearest hospital for advice.

Missing a dose of SORTIS

In case of forgetting to take the medicine, you should simply take the next dose at the scheduled time. You should not take a double dose to make up for the missed dose.

Stopping treatment with SORTIS

In case of any further doubts about taking this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the patient experiences any of the 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 less than 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 peeling and swelling of the skin, blisters on the skin, mouth, eyes, genitals, and 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 color. If this is accompanied by a feeling of illness or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown does 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 less than 1 in 10,000 people
• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The patient should consult a doctor as soon as possible.
• Systemic lupus erythematosus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of SORTIS:

Common: may occur in less than 1 in 10 people

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

Uncommon: may occur in less than 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 of the hands and feet, 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)
• hepatitis
• 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 the urine

Rare: may occur in less than 1 in 1,000 people

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the eyes)
• tendon rupture
• skin rash that may occur on the skin or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (symptoms of vasculitis)

Very rare: may occur in less than 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 growth of breast tissue 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). Myasthenic syndrome (a disease that causes muscle weakness in the eyes). You should talk to your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

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 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 you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 Side effects can also be reported to the marketing authorization holder or its representative.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store SORTIS

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the blister and carton after "EXP".
The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 contains

• The active substance of the medicine is atorvastatin. SORTIS 10: Each film-coated tablet contains 10 mg of atorvastatin (in the form of a trihydrate calcium salt). SORTIS 20: Each film-coated tablet contains 20 mg of atorvastatin (in the form of a trihydrate calcium salt). SORTIS 40: Each film-coated tablet contains 40 mg of atorvastatin (in the form of a trihydrate calcium salt). SORTIS 80: Each film-coated tablet contains 80 mg of atorvastatin (in the form of a trihydrate calcium salt).
• Other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropyl cellulose, and magnesium stearate.

The coating of SORTIS 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), benzene acid (E 210), sorbic acid, and sulfuric acid.

What SORTIS looks like and what the pack contains

SORTIS 10: White, round film-coated tablets with a diameter of 5.6 mm, with the inscription "10" on one side and "ATV" on the other side.
SORTIS 20: White, round film-coated tablets with a diameter of 7.1 mm, with the inscription "20" on one side and "ATV" on the other side.
SORTIS 40: White, round film-coated tablets with a diameter of 9.5 mm, with the inscription "40" on one side and "ATV" on the other side.
SORTIS 80: White, round film-coated tablets with a diameter of 11.9 mm, with the inscription "80" on one side and "ATV" on the other side.
The blisters consist of a shaping film made of polyamide/aluminum/polyvinyl chloride and a rear leaf made of a heat-sealable layer of aluminum foil/vinyl.
The bottle is made of HDPE, contains a desiccant, and is equipped with a "press-and-turn" child-resistant closure.
SORTIS is available in blisters containing 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 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 authorization holder

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

Manufacturer

Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
MEDIS INTERNATIONAL a.s., výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice
Czech Republic
To obtain more detailed information, you should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

tel. 22 546 64 00
Date of last revision of the leaflet:01/2025