Sortis 80

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sortis 80 (SORTIS), 80 mg, film-coated tablets
Atorvastatinum
Sortis 80 and SORTIS are different trade names for the same medicinal product.
Please read this leaflet carefully before taking 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 doubts, 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 other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Sortis 80 is and what it is used for
2. What you need to know 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 lower 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 the medicine 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 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 80, discuss this with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken orally or by injection fusidic acid (a medicine used to treat bacterial infections) 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,
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• if the patient has experienced muscle problems during previous treatment 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,
• if the patient currently has or has 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 will order blood tests before starting treatment with Sortis 80 and, as appropriate, 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 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 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 their effect on the body may be altered by Sortis 80.
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, colestyramine,
• 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 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 products 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 in epilepsy treatment), cimetidine (used in the treatment of heartburn and stomach ulcers), phenazone (a pain-relieving medicine), colchicine (a medicine used in the treatment of gout), and antacids (medicines used for indigestion containing aluminium or magnesium),
• over-the-counter medicines: St. John's wort,
• 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 is provided in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Sortis 80 with food, drink and alcohol
Information on the use of Sortis 80 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 80.

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 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 methods of contraception.
The use of Sortis 80 during breastfeeding is contraindicated.
The safety of using Sortis 80 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Usually, 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 machinery if taking this medicine affects your ability to operate them.

Sortis 80 contains lactose monohydrate
Patients who have been informed by their doctor about 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
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.
Sortis is available in doses of 10 mg, 20 mg, 40 mg, and 80 mg.
The usual starting 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, it is recommended to take the tablet at approximately the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If you are unsure, 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 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
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 no more 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 characterised by skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and 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 this occurs together with feeling unwell or high fever, it may be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after the patient stops taking atorvastatin; it may be life-threatening and may cause kidney problems.

Very rare: may occur in no more than 1 in 10,000 people

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

Other possible adverse effects of Sortis 80:

Common: may occur in no more than 1 in 10 people

• Nasopharyngitis, 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 and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in no 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, taste disturbances, memory loss
• Blurred vision
• Ringing in the ears and/or head
• Vomiting, regurgitation, 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 in the ankles, elevated temperature
• Presence of white blood cells in urine analysis

Rare: may occur in no 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
• Rash, which may appear on the skin, or oral ulcers (lichenoid drug reaction)
• Linear skin lesions (symptoms of vasculitis)

Very rare: may occur in no 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, 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 generalised muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease causing weakness of eye muscles). You should speak to your doctor if the patient experiences weakness in arms or legs that worsens after periods of 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 this condition is higher in patients with high levels of blood sugar and fats, 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, tell your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring of 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 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 blister and carton after "EXP".
The expiry date refers to the last day of the stated month.
No special storage conditions are required.
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 package 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 ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate.

The coating of Sortis 80 contains: Opadry YS-1-7040 white film-coating: hypromellose,
polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone,
stearic acid emulsifiers (polysorbate 65, polyethylene glycol 400 stearate, glycerol monostearate 40-55),
thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and
sulfuric acid.

What Sortis 80 looks like and contents of the pack
White, round coated tablets with a diameter of 11.9 mm, embossed with "80" on one side and "ATV"
on the other side.
Sortis 80 is available in blisters made of PA/Al/PVC//Al/vinyl, packed in a cardboard box.
The pack contains 30 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or the 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
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
Poland

Repackaged by:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 31/397/03-C
Parallel Import Licence Number: 53/25