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)
20 mg, film-coated tablets
Atorvastatinum
SORTIS 20 and SORTIS 20 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm others, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, please 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 reduce 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 within the normal range. 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 results of liver function tests,
• 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 concurrently 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 failure,
• if the patient is taking or has taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). 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,
• in case of kidney problems,
• in case of hypothyroidism (underactive thyroid),
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• 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 previous liver disease,
• in patients aged over 70 years,
• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with SORTIS 20 and, where 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 with other medicines”).
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary for diagnosis and treatment of this condition.
During treatment, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, overweight patients, and those with high blood pressure may be more susceptible to the risk of developing diabetes.

SORTIS 20 with 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 the effect of those medicines 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, colestipol,
• certain calcium channel blockers used for angina or high blood pressure, e.g. amlodipine, diltiazem; and medicines regulating heart rhythm, e.g. digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus infection,
• medicines used in the treatment of HIV infection, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used in the treatment of hepatitis C virus infection, e.g. telaprevir, boceprevir, and combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with SORTIS 20 include ezetimibe (which lowers cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic used in epilepsy treatment), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), colchicine (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 for the treatment of a bacterial infection, treatment with SORTIS 20 should be temporarily discontinued. Your doctor will inform you when it is safe to restart treatment with SORTIS 20. Taking SORTIS 20 together with fusidic acid may, in rare cases, lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

SORTIS 20, food, drink and alcohol
Information on the use of SORTIS 20 can be found 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 amounts may alter the effect of SORTIS 20.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further information on this is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
The use of SORTIS 20 in women who are pregnant or planning to become pregnant is contraindicated.
The use of SORTIS 20 in women of childbearing age is contraindicated if they are not using effective methods of contraception.
The 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
SORTIS 20 usually does not affect the ability to drive or operate machinery. However, patients should not drive if the medicine affects their ability to do so. Do not use tools or machines if taking this medicine affects your ability to operate them safely.

SORTIS 20 contains lactose monohydrate
Patients who have been informed 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 the medicine is considered "sodium-free".

SORTIS 20 contains benzoic acid (E 210)
This medicine contains 0.00008 mg of benzoic acid in each 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 are available on the market: 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. If necessary, your doctor may increase this dose up to the dose appropriate for the patient. Your doctor will adjust 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 advisable to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with SORTIS 20 is determined by your doctor.
If you feel that the effect of SORTIS 20 is too strong or too weak, consult your doctor.
Taking more than the recommended dose of SORTIS 20
If you accidentally take too many SORTIS 20 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of SORTIS 20
If you forget to take your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.
Stopping treatment with SORTIS 20
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

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

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may cause 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, particularly on the palms or soles, possibly with blisters.
• Weakness, tenderness, muscle pain or muscle rupture, or red-brown discoloration of urine. If accompanied by malaise or high fever, this may indicate breakdown of skeletal muscle (rhabdomyolysis). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, may be life-threatening and may lead to kidney problems.

Very rare: may occur in up to 1 in 10,000 people

• Unexpected or unusual bleeding or bruising, which may indicate liver problems. Medical advice should be sought immediately.
• Drug-induced lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse effects of SORTIS 20:
Common: may occur in up to 1 in 10 people

• Inflammation of the nasal passages, 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, bloating, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in up to 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, regurgitation, pain in the upper and lower abdomen, pancreatitis (causing abdominal pain)
• Hepatitis
• Rash, skin eruptions 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 up to 1 in 1,000 people

• Vision disorders
• 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 shortness of breath and chest pain or tightness, eyelid, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive development of breast glandular tissue in males)

Frequency not known: cannot be estimated from available data

• Persistent muscle weakness
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease causing weakness of eye muscles). Talk to your doctor if you experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Other possible adverse effects 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. Your doctor will perform appropriate tests while you are taking this medicine.

Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 adverse effects 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 packaging. The expiry date refers to the last day of the stated month.
No special storage conditions required.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What SORTIS 20 contains

• The active substance is atorvastatin. Each 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 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone and stearic acid emulsifiers (polysorbate 65, polyglycolized stearate 400, glycerol monostearate 40-50), 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 coated tablets with a diameter of 7.1 mm, embossed with "20" on one side and "ATV" on the other side.
Blister packs made of PA/Al/PVC//Al/vinyl foil in cardboard boxes.
SORTIS 20 is available in blister packs containing 30 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in the Czech Republic, country of export:
Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, the Netherlands
Manufacturer:
Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1,
79009 Freiburg, Germany
Mylan Hungary Kft., Mulan utca 1, Komárom 2900, Hungary
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 31/234/99-C
Parallel Import Licence Number: 397/22