Sortis 20

Leaflet attached to the packaging: information for the user

SORTIS 10, 10 mg, chewable tablets

SORTIS 20, 20 mg, chewable tablets

Atorvastatin

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. 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 are not effective. SORTIS 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

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,
• if the patient is taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

Before starting treatment with SORTIS, 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 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 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 may 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 prescribe 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 diabetes. Patients with high sugar and fat levels in the blood, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

SORTIS and other medicines

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

• medicines that modify the immune system, 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 include 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 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 skin structure infections and bloodstream infections caused by bacteria).

SORTIS with food, drink, and alcohol

Information on the use of SORTIS 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 may change the effect of SORTIS.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of SORTIS in pregnant or breastfeeding women is contraindicated.
The use of SORTIS in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of SORTIS during breastfeeding is contraindicated.
The safety of SORTIS 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 if the medicine affects their ability to do so. Do not use any tools or machines if the medicine affects the ability to use them.

SORTIS contains aspartame

10 mg, chewable tablet
This medicine contains 1.25 mg of aspartame per chewable tablet.
20 mg, chewable tablet
This medicine contains 2.5 mg of aspartame per chewable tablet.
Aspartame is a source of phenylalanine. Phenylalanine may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired elimination.

SORTIS contains sodium

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

3. How to take SORTIS

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS.
The usual starting dose of SORTIS in adults and children over 10 years of age is 10 mg once a 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 at intervals of at least 4 weeks. The maximum dose of SORTIS is 80 mg once a day.
SORTIS tablets can be chewed or 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 as directed by the doctor or pharmacist. In case of doubts, consult a doctor or pharmacist.

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

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

Taking a higher dose of SORTIS than recommended

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

Missing a dose of SORTIS

If a dose is missed, the patient 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

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

4. Possible side effects

Like all medicines, SORTIS 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 SORTIS and contact a 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 color. If accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown 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, it may indicate liver problems. The patient should consult a doctor as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of SORTIS:

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, taste changes, 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 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
• skin rash that may occur on the skin or mouth ulcers (lichenoid drug reaction)
• purple skin changes (signs 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 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). Myasthenic syndrome (a disease that causes muscle weakness in the eyes). The patient should talk to 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 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 sugar and fat levels in the blood, 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 this leaflet, they should tell their 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
Side effects can also be reported to the marketing authorization holder or its representative.
Reporting side effects will help to gather 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 use this medicine after the expiry date stated on the blister pack 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. 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 contains

• The active substance of SORTIS is atorvastatin.

SORTIS 10: Each chewable tablet contains 10 mg of atorvastatin (in the form of a trihydrate calcium salt)
SORTIS 20: Each chewable tablet contains 20 mg of atorvastatin (in the form of a trihydrate calcium salt)

• The other ingredients are: calcium carbonate, microcrystalline cellulose, sodium croscarmellose, polysorbate 80, hydroxypropyl cellulose, maize starch, mannitol, aspartame (E 951), sucralose, grape flavor (maltodextrin, grape juice concentrate, gum arabic, pineapple juice concentrate, citric acid, natural flavor), and magnesium stearate.

What SORTIS looks like and what the pack contains

SORTIS 10, 10 mg, chewable tablets: White or almost white, round chewable tablets with pink to purple spots, with the number "10" embossed on one side and "LCT" on the other.
SORTIS 20, 20 mg, chewable tablets: White or almost white, round chewable tablets with pink to purple spots, with the number "20" embossed on one side and "LCT" on the other.
This medicine is available in blisters containing 30 chewable tablets.

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
To obtain more detailed information, please 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