Sortis 40

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 40 (Lipitor), 40 mg, film-coated tablets

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

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor, pharmacist, or nurse should be consulted.
• 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 inform their 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 using Sortis 40
• 3. How to use Sortis 40
• 4. Possible side effects
• 5. How to store Sortis 40
• 6. Contents of the packaging 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 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 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 using Sortis 40

When not to use Sortis 40:

• if the patient is allergic to atorvastatin or any other ingredient 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 40, the doctor, pharmacist, or nurse should be consulted:

• 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. Concurrent use of fusidic acid with Sortis 40 may 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 old,
• 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 may 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 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 used concurrently (see section 2 "Sortis 40 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 40, the doctor will closely monitor the patient for the development of diabetes or the risk of diabetes. Patients with high blood sugar and lipid levels, patients with overweight and high blood pressure may be at risk of developing diabetes.

Sortis 40 and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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.
This type of interaction may lead to reduced efficacy of one or both medicines. At the same time, it may 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 that are 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 (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, the use of this medicine should be temporarily discontinued. The doctor will inform the patient when it is safe to restart treatment with Sortis 40. Taking Sortis 40 with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bloodstream infections caused by bacteria).

Sortis 40 with food, drink, and alcohol

Information on the use of Sortis 40 can be found in section 3. However, attention should be paid to the following information:
Grapefruit juice
More than one or two small glasses of grapefruit juice should not be consumed per day, as larger amounts of grapefruit juice may change the effect of Sortis 40.
Alcohol
Excessive alcohol consumption should be avoided while taking this medicine.
Detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of Sortis 40 in pregnant or breastfeeding women is contraindicated.
The use of Sortis 40 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of Sortis 40 during breastfeeding is contraindicated.
The safety of using Sortis 40 during pregnancy and breastfeeding has not been established.
Before using any medicine, the doctor or pharmacist should be consulted.

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. No tools or machines should be used if the use of the medicine affects the ability to use them.

Sortis 40 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 40 contains sodium

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

Sortis 40 contains benzoic acid (E 210)

This medicine contains 0.00016 mg of benzoic acid (E 210) per tablet.

3. How to use Sortis 40

Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg) are available.
Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 40.
Typically, 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 the doctor if necessary, up to a dose suitable for the patient. The 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 a day.
Sortis 40 tablets should be swallowed whole, with water; they can be taken at any time of day, with or without food. However, it is recommended to take the tablet at the same time every day.
This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.

The duration of treatment with Sortis 40 is determined by the doctor.

If the patient feels that the effect of Sortis 40 is too strong or too weak, they should consult their doctor.

Using a higher dose of Sortis 40 than recommended

In case of accidental ingestion of more than the recommended dose of Sortis 40 (more than the usual daily dose), the doctor or the nearest hospital should be contacted for advice.

Missing a dose of Sortis 40

In case of forgetting to take the medicine, the patient should simply take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.

Stopping treatment with Sortis 40

In case of any further doubts about using this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

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

If the patient experiences any of the serious side effects or symptoms, they should stop using 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 skin disease characterized by peeling and swelling of the skin, blisters, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. 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 up to 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. The doctor should be consulted as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Sortis 40:

Common: may occur in up to 1 in 10 people

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in patients with diabetes, 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 patients with diabetes, 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, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• 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 the urine test

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

• vision disturbances
• unexpected bleeding or bruising (bruises)
• jaundice (yellowing of the skin and eyes)
• tendon rupture
• skin rash, which may occur on the skin, or ulcers in the mouth (lichenoid drug reaction)
• purple skin changes (symptoms of vasculitis)

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 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). Ocular myasthenia (a disease that causes muscle weakness in the eyes).

The doctor should be consulted if the patient experiences 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 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 with overweight and high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests on the patient.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor, pharmacist, or nurse should be informed. 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 the medicine.

5. How to store Sortis 40

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. The pharmacist should be asked 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 40 contains

• The active substance of Sortis 40 is atorvastatin. Each film-coated tablet contains 40 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 40 contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (polysorbate 65, macrogol 400 stearate, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 40 looks like and what the packaging contains

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.
Blister packs of polyamide/Al/PVC coated with an aluminum/vinyl layer in a cardboard box.
Sortis 40 is available in blister packs containing 28 film-coated tablets.
For more detailed information, the marketing authorization holder or parallel importer should be contacted.

Marketing authorization holder in Ireland, 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:

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
Ireland export license number: PA 23055/017/003

Parallel import license number: 190/20

Translation of certain entries on the blister pack:

MON

• Monday TUE
• Tuesday WED
• Wednesday THUR - Thursday FRI
• Friday SAT
• Saturday SUN
• Sunday

Date of leaflet approval: 01.07.2025

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