Sortis 10

LEAFLET INCLUDED IN THE PACKAGING: INFORMATION FOR THE USER

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

SORTIS 10

10 mg, coated tablets

Atorvastatin

You should carefully read the contents of this 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 you need to.
• If you have 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is SORTIS 10 and what is it used for
• 2. Important information before taking SORTIS 10
• 3. How to take SORTIS 10
• 4. Possible side effects
• 5. How to store SORTIS 10
• 6. Contents of the packaging and other information

1. What is SORTIS 10 and what is it used for

SORTIS 10 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
SORTIS 10 is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes are not effective on their own. SORTIS 10 can also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking SORTIS 10

When not to take SORTIS 10:

• 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 10, the patient should discuss the following 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 10 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 ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients who are affected by any of the above situations, the doctor will prescribe a blood test before starting treatment with SORTIS 10 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 10 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 10, 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 10 and other medicines

The patient should inform 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 can change the effect of SORTIS 10 or the effect of these medicines on the body can be changed by SORTIS 10.

• 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 10, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), fenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat 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 10. The doctor will inform the patient when it is safe to restart treatment with SORTIS 10. Taking SORTIS 10 with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

SORTIS 10 with food, drink, and alcohol

Information on the use of SORTIS 10 can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do 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 10.
Alcohol
Avoid drinking excessive amounts of alcohol while taking SORTIS 10.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of SORTIS 10 in pregnant or breastfeeding women is contraindicated.
The use of SORTIS 10 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of SORTIS 10 during breastfeeding is contraindicated.
The safety of using SORTIS 10 during pregnancy and breastfeeding has not been established.
Before taking any medicine, 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 or use machines if the medicine affects their ability to do so.

SORTIS 10 contains lactose

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

SORTIS 10 contains sodium

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

SORTIS 10 contains benzonic acid

This medicine contains 0.00004 mg of benzonic acid per tablet.

3. How to take SORTIS 10

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 10.
Usually, the initial dose of SORTIS 10 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 a dose suitable for the patient. The doctor will adjust the dose of SORTIS 10 at intervals of at least 4 weeks. The maximum dose of SORTIS 10 is 80 mg once a day.
The tablets of SORTIS 10 should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, the patient 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. If there are any doubts, the patient should consult their doctor or pharmacist.

The duration of treatment with SORTIS 10 is determined by the doctor.

If the patient feels that the effect of SORTIS 10 is too strong or too weak, they should consult their doctor.

Taking a higher dose of SORTIS 10 than recommended

In case of accidental ingestion of too many tablets of SORTIS 10 (more than the usual daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of SORTIS 10

If the patient forgets to take a dose, they should 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 10

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SORTIS 10 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 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. If this is accompanied by a feeling of being unwell or a high fever, it may be caused by the breakdown of striated muscle (rhabdomyolysis). The breakdown of striated muscle

may not always resolve, even if the patient stops taking atorvastatin, and may 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, this may indicate liver problems. The patient 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 10:

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 the urine

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

• vision disturbances
• 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). Ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should discuss with their doctor if they experience muscle weakness in the 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 10 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 those not listed in this leaflet, they should inform their 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
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store SORTIS 10

The medicine should be stored 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.
There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. The patient 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 10 contains

• The active substance of SORTIS 10 is atorvastatin. Each coated tablet contains 10 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 10 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), preservatives (benzoic acid (E 210), sorbic acid), and sulfuric acid.

The SORTIS 10 coating also contains the colorant titanium dioxide (E 171).

What SORTIS 10 looks like and what the packaging contains

White, round, coated tablets with a diameter of 5.6 mm, with the inscription "10" on one side and "ATV" on the other side.
Blister packs of PA/Al/PVC//Al/vinyl in a cardboard box.
SORTIS 10 is available in blister packs containing 30 coated tablets.
For more detailed information, please 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
79090 Freiburg
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

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Synoptis Industrial Sp. z o.o.
ul. Szosa Bydgoska 58
87-100 Toruń
CANPOLAND SPÓŁKA AKCYJNA
ul. Beskidzka 190
91-610 Łódź
Marketing authorization number in the Czech Republic, the country of export: 31/233/99-C
Parallel import authorization number: 230/21

Date of approval of the leaflet: 10.12.2024

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