Sortis 20

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Sortis 20 (Sortis), 20 mg, film-coated tablets
Atorvastatin
Sortis 20 and Sortis are different brand names of the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Sortis 20 is and what it is 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 pack and other information

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

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

2. Important information before using Sortis 20

When not to use 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 currently has or has previously had liver disease,
• if the patient has unexplained abnormal liver function test results,
• in women of childbearing age who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in 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, discuss the following with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken oral or injectable fusidic acid (a medicine used to treat bacterial infections) within the last 7 days. Concomitant use of fusidic acid with Sortis 20 may lead to serious muscle problems (rhabdomyolysis),
• in case of haemorrhagic stroke, or if there is a small amount of fluid in the brain from a previous stroke,
• if the patient has kidney problems,
• if the patient has hypothyroidism,
• if the patient has a history of recurrent or unexplained muscle pain or muscle problems, or if such problems occurred in family members,
• if the patient previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient regularly consumes large amounts of alcohol,
• if the patient has a history of liver disease,
• in patients over 70 years of age.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Sortis 20 and, whenever possible, during treatment to monitor the risk of muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 "Sortis 20 and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and treatment with other medicines may be necessary to diagnose and manage this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk factors for diabetes. Patients with high levels of blood sugar and lipids, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Sortis 20 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Some medicines may alter the effect of Sortis 20 or their own effects may be altered by Sortis 20.
This type of interaction may reduce the effectiveness of one or both medicines. It may also increase the risk of serious adverse effects, including severe muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressive medicines, e.g. cyclosporine,
• certain antibiotics or antifungal medicines, e.g. erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-regulating medicines, e.g. gemfibrozil, other fibrates, cholestyramine,
• certain calcium channel blockers used for angina or hypertension, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used to treat HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, e.g. telaprevir, boceprevir, and fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Sortis 20 include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (an analgesic),

colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminium or magnesium),

• over-the-counter medicines: St John's wort (Hypericum perforatum),
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily discontinued. Your doctor will inform you when it is safe to resume treatment with Sortis 20. Taking Sortis 20 together with fusidic acid may 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 how to take Sortis 20 is provided in section 3. However, please pay attention to the following:

Grapefruit juice
Do not consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Sortis 20.

Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further information on this topic is provided in section 2 "Warnings and precautions".

Pregnancy and breastfeeding
Use of Sortis 20 in women who are pregnant or planning to become pregnant is contraindicated.
Use of Sortis 20 in women of childbearing age is contraindicated if they are not using effective methods of contraception.
Use of Sortis 20 during breastfeeding is contraindicated.
The safety of Sortis 20 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Generally, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.

Sortis 20 contains lactose monohydrate
Patients who have been advised by their doctor that they have an intolerance to certain sugars should consult their doctor before taking this medicine.

Sortis 20 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

Sortis 20 contains benzoic acid
This medicine contains 0.00008 mg of benzoic acid per tablet.

3. How to use Sortis 20

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 20.
The following products are available: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), Sortis 80 (80 mg).
The usual starting dose of Sortis for adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by the doctor as needed, up to the dose appropriate for the patient. The doctor adjusts the dose 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 may be taken at any time of day, with or without food. However, it is recommended to take the tablet at approximately the same time each day.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 20 is determined by the doctor.
If you feel that the effect of Sortis 20 is too strong or too weak, consult your doctor.
Taking more Sortis 20 than prescribed
If you accidentally take too many Sortis 20 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Sortis 20
If you forget to take a dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.
Stopping Sortis 20
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the serious adverse reactions or symptoms listed below, they should
stop taking the medicine immediately and contact a doctor or go to the emergency department of the
nearest hospital.

Rare: may occur in not more than 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• Severe illness characterized by skin peeling and swelling, skin blisters, and sores in the mouth, eyes, genitals, accompanied by fever. Skin rash with pink-red spots, especially on palms or soles, possibly with blisters.
• Muscle weakness, tenderness, muscle pain or muscle rupture, or red-brown discoloration of urine. If these symptoms occur together with malaise or high fever, this may indicate breakdown of striated muscles (rhabdomyolysis). Muscle breakdown may not always resolve even after the patient stops taking atorvastatin; it may be life-threatening and may lead to kidney problems.

Very rare: may occur in not more than 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, this may indicate liver problems. Medical advice should be sought immediately.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Sortis 20:

Common: may occur in not more than 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 carefully monitored), increased blood creatine kinase levels
• Headaches
• Nausea, constipation, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain, back pain
• Blood test results indicating abnormal liver function.

Uncommon: may occur in not more than 1 in 100 people

• Anorexia (loss of appetite), weight gain, decreased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the head
• Vomiting, belching, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin rash and itching, urticaria, hair loss
• Neck pain, muscle fatigue
• Fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated body temperature
• Presence of white blood cells in urine analysis.

Rare: may occur in not more than 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 not more than 1 in 10,000 people

• Allergic reactions – symptoms may include sudden shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in men)

Frequency not known: frequency cannot be estimated from available data

• Persistent muscle weakness.

Other possible adverse reactions reported during treatment with some statins (medicines of the same type):

• Sexual dysfunction
• Depression
• Breathing problems, including persistent cough and (or) shortness of breath or fever
• Diabetes; the likelihood of developing diabetes is higher in patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for Monitoring Adverse Reactions to Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sortis 20

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Sortis 20 contains

• The active substance is atorvastatin. Each film-coated tablet contains 20 mg of atorvastatin (as 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 stearates (polyethylene glycol sorbitan tristearate, polyethoxylated stearate, glyceryl esters), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 20 looks like and contents of the pack

White, round, film-coated tablets with a diameter of 7.1 mm, embossed with "20" on one side and "ATV" on the other side.

Sortis 20 is available in blisters made of PA/Al/PVC//Al/vinyl foil, packed in a cardboard box. The pack contains 30 film-coated tablets.

For further detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, the country of export:
Pfizer spol. s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, Germany

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Marketing authorisation number in the Czech Republic, the country of export: 31/234/99-C
Parallel import authorisation number: 118/22