Sortis 80

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
SORTIS 80 (SORTIS 80 mg)
80 mg, film-coated tablets
Atorvastatinum
SORTIS 80 and SORTIS 80 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking the 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 them, even if their symptoms are the same.
• 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 80 is and what it is used for
2. Important information before taking SORTIS 80
3. How to take SORTIS 80
4. Possible side effects
5. How to store SORTIS 80
6. Contents of the pack and other information

1. What SORTIS 80 is and what it is used for

SORTIS 80 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
SORTIS 80 is used to reduce blood levels of lipids known as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone are not effective. SORTIS 80 may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. A standard low-cholesterol diet should be continued during treatment.

2. Important information before using SORTIS 80

When not to use SORTIS 80:

• 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 contraceptive methods,
• 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 80, 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 (a medicine used to treat bacterial infections) orally or by injection within the last 7 days. Concomitant use of fusidic acid with SORTIS 80 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 generalised 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). For patients with any of the above conditions, the doctor may order a blood test before starting treatment with SORTIS 80 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 80 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 blood sugar and fats, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

SORTIS 80 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 80 or the effect of these medicines may be altered by SORTIS 80. 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 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 80 include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat heartburn and stomach ulcers), phenazone (a painkiller), 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. The doctor will inform the patient when it is safe to restart treatment with SORTIS 80. Taking SORTIS 80 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 80 with food, drink, and alcohol
Information on the use of SORTIS 80 can be found in section 3.
However, please pay attention to the following information:
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 80.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further details on this topic are provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
The use of SORTIS 80 in women who are pregnant or planning to become pregnant is contraindicated.
The use of SORTIS 80 in women of childbearing age is contraindicated if they are not using effective contraceptive methods.
The use of SORTIS 80 during breastfeeding is contraindicated.
The safety of SORTIS 80 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
SORTIS 80 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 any tools or machines if taking this medicine affects your ability to operate them.

SORTIS 80 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 80 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

SORTIS 80 contains benzoic acid (E 210)
This medicine contains 0.00032 mg of benzoic acid per tablet.

3. How to use SORTIS 80

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 80.
Available on the market are: SORTIS 10 (10 mg), SORTIS 20 (20 mg), SORTIS 40 (40 mg), SORTIS 80 (80 mg).
The usual initial dose of SORTIS 80 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 80 is 80 mg once daily.
SORTIS 80 tablets should be swallowed whole with water; they may be taken at any time of day, with or without food. However, you should try 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 80 is determined by your doctor.
If you feel that the effect of SORTIS 80 is too strong or too weak, consult your doctor.
Taking more SORTIS 80 than prescribed
If you accidentally take too many SORTIS 80 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of SORTIS 80
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 SORTIS 80 treatment
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 without delay.

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 peeling and swelling of the skin, skin blisters, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly accompanied by blisters.
• Weakness, tenderness, muscle pain, or muscle rupture, or red-brown discoloration of urine. If these symptoms are accompanied by malaise or high fever, this may indicate breakdown of skeletal muscle (rhabdomyolysis). Rhabdomyolysis may not always resolve even after the patient stops taking atorvastatin, 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 abnormalities. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects of SORTIS 80:

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 closely monitored), increased blood creatine kinase levels
• Headache
• Nausea, constipation, bloating, indigestion, diarrhoea
• Joint pain, muscle pain, and 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 closely 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, burping, 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 not more than 1 in 1,000 people

• Visual disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture
• Skin rash or oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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, swelling of the eyelids, face, lips, mouth, tongue, or throat, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of breast glandular 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).

The patient should speak to their doctor if they experience weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or breathlessness.

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 levels of blood sugar and fats, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests in the patient.

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 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, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store SORTIS 80

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 specified month.
No special storage instructions apply.
Medicines should 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 packaging and other information

What SORTIS 80 contains

• The active substance is atorvastatin. Each coated tablet contains 80 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• The other components are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate. The coating of SORTIS 80 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (polysorbate 65, polyethylene glycol stearate 400, glycerol monostearate 40-50), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What SORTIS 80 looks like and contents of the packaging
White, round coated tablets with a diameter of 11.9 mm, embossed with "80" on one side and "ATV" on the other side.
Blister packs made of PA/Al/PVC//Al/vinyl foil in cardboard boxes.
SORTIS 80 is available in blister packs containing 30 coated tablets.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing Authorization Holder in the Czech Republic, the 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, 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, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorization Number in the Czech Republic, the country of export: 31/397/03-C
Parallel Import Authorization Number: 283/22