Sortis 10

PACKAGE LEAFLET: INFORMATION FOR THE USER

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language!
SORTIS 10
10 mg, film-coated tablets
Atorvastatin
Please read the entire leaflet carefully before using 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 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 someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What SORTIS 10 is and what it is 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 pack and other information

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

SORTIS 10 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
SORTIS 10 is used to lower blood levels of lipids known as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone are not effective. SORTIS 10 may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. A standard low-cholesterol diet should be maintained during treatment.

2. Important information before using the medicine SORTIS 10

When not to use 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 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 concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with SORTIS 10, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken fusidic acid (a medicine used to treat bacterial infections) orally or by injection within the last 7 days. Concomitant use of fusidic acid with SORTIS 10 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 over 70 years of age,
• if the patient currently has or has previously had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients affected by any of the above conditions, the doctor may order a blood test before starting treatment with SORTIS 10 and, as far as 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 greater when certain medicines are used concomitantly (see section 2 “SORTIS 10 and other medicines”).
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat 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 sugar and fats in the blood, patients who are overweight, and those with high blood pressure may be more susceptible to the risk of developing diabetes.

SORTIS 10 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 10 or their effect on the body may be altered by SORTIS 10.
This type of interaction may result in reduced 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 disease,
• 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 combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with SORTIS 10 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 (a pain-relieving medicine), 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 restart treatment with SORTIS 10. Taking SORTIS 10 together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information about 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 10 with food, drink and alcohol
Information about the use of SORTIS 10 can be found in section 3. However, please pay attention to the following information:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of SORTIS 10.
Alcohol
While taking this medicine, avoid consuming excessive amounts of alcohol.
Further information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
The use of SORTIS 10 in women who are pregnant or planning to become pregnant is contraindicated.
The use of SORTIS 10 in women of childbearing age is contraindicated if they are not using 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 your doctor or pharmacist.

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

SORTIS 10 contains lactose
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 10 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

SORTIS 10 contains benzoic acid
This medicine contains 0.00004 mg of benzoic acid per tablet.

3. How to use SORTIS 10

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 10.
The usual starting dose of SORTIS 10 in 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 individual patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of SORTIS 10 is 80 mg once daily.
SORTIS 10 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 directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with SORTIS 10 is determined by your doctor.
If you feel that the effect of SORTIS 10 is too strong or too weak, consult your doctor.
Taking more SORTIS 10 than prescribed
If you accidentally take too many SORTIS 10 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of SORTIS 10
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 the missed dose.
Stopping SORTIS 10
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 will experience them.
If the patient experiences any of the serious adverse reactions 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 less than 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, especially 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 be due to rhabdomyolysis (breakdown of striated muscles). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, may be life-threatening and may lead to kidney problems.

Very rare: may occur in less than 1 in 10,000 people

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

Other possible adverse reactions of SORTIS 10:
Common: may occur in less 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 monitored carefully), 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 less 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 monitored carefully)
• 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 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 temperature
• Presence of white blood cells in urine analysis

Rare: may occur in less than 1 in 1,000 people

• Vision disorders
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Rash which may appear on the skin or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

Very rare: may occur in less 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: 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). If the patient experiences weakness in hands or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, they should speak to their doctor.

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. The doctor will perform appropriate tests during treatment with this medicine.

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 also be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 to gather more information on the safety of the medicine.

5. How to store SORTIS 10

Keep this medicine 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 stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What SORTIS 10 contains

• The active substance is atorvastatin. Each coated tablet contains 10 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 10 tablets contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, stearic acid emulsifiers (polysorbate 65, stearic acid macrogol 400, glyceryl monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What SORTIS 10 looks like and contents of the pack
White, round coated tablets with a diameter of 5.6 mm, embossed with "10" on one side and "ATV" on the other side.
Blister packs made of PA/Al/PVC//Al/vinyl foil in cardboard boxes.
SORTIS 10 is available in blister packs containing 30 coated tablets.
For more detailed information, please contact the marketing authorization holder or parallel importer.
Marketing authorization 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
Mooswaldallee 1
79108 Freiburg Im Breisgau
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 in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warszawa
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warszawa
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, country of export: 31/233/99-C
Parallel import authorization number: 230/21