Sortis 40

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging in a foreign language.
Sortis 40 (Sortis), 40 mg, film-coated tablets
Atorvastatin
Sortis 40 and Sortis are different brand names of the same medicine.
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 questions, ask 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of the leaflet

1. What Sortis 40 is and what it is used for
2. Important information before taking Sortis 40
3. How to take Sortis 40
4. Possible side effects
5. How to store Sortis 40
6. Contents of the pack and other information

1. What Sortis 40 is and what it is used for

Sortis 40 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism
in the body.
Sortis 40 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 40 may also be used to reduce the risk of heart disease, even when
cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. Important information before using Sortis 40

When not to use Sortis 40:

• 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 potential 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 40, discuss this 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 40 may lead to serious muscle problems (rhabdomyolysis),
• in case of hemorrhagic 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,
• 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 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), as statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients who fall under any of the above conditions, the doctor will order a blood test before starting treatment with Sortis 40 and, as appropriate, during treatment to monitor the risk of muscle-related adverse reactions. It is known that the risk of muscle-related adverse reactions, such as rhabdomyolysis, is higher when certain medicines are used concomitantly (see section 2 “Sortis 40 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.
While taking this medicine, 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 at risk of developing diabetes.

Sortis 40 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Some medicines may alter the effect of Sortis 40 or the effect of these medicines may be altered by Sortis 40.
This type of interaction may result in reduced effectiveness of one or both medicines. It may also increase the risk of serious adverse reactions, 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 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 fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Sortis 40 include ezetimibe (which reduces cholesterol levels), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used to treat epilepsy), cimetidine (used to treat indigestion 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,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily suspended. Your doctor will inform you when it is safe to restart treatment with Sortis 40. Taking Sortis 40 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 tissue infections and bloodstream infections caused by bacteria).

Sortis 40 with food, drink, and alcohol
Information on the use of Sortis 40 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 of grapefruit juice may alter the effect of Sortis 40.
Alcohol
While taking this medicine, avoid excessive alcohol consumption.
More detailed information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
The use of Sortis 40 in women who are pregnant or planning to become pregnant is contraindicated.
The use of Sortis 40 in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
The use of Sortis 40 during breastfeeding is contraindicated.
The safety of Sortis 40 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, the patient 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 40 contains lactose monohydrate
Patients who have been informed by their doctor of an intolerance to certain sugars should consult their doctor before taking this medicine.

Sortis 40 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Sortis 40 contains benzoic acid
This medicine contains 0.00016 mg of benzoic acid per tablet.

3. How to use Sortis 40

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 40.
Available on the market are: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg).
The usual initial 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 gradually until the appropriate dose for the patient is reached. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Sortis is 80 mg once daily.
Sortis 40 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 approximately the same time each day.
This medicine should always be used according to the instructions given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 40 is determined by the doctor.
If you feel that the effect of Sortis 40 is too strong or too weak, consult your doctor.
Taking more Sortis 40 than prescribed
If you accidentally take too many Sortis 40 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of Sortis 40
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 40
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 gets 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 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.
• Serious illness characterized by peeling and swelling of the skin, skin blisters, and sores in the mouth, eyes, and genital area, 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 these symptoms occur together with malaise or high fever, this may indicate breakdown of skeletal muscle (rhabdomyolysis). Breakdown of skeletal muscle does not always resolve even after the patient stops taking atorvastatin; it may also be life-threatening and 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 40:
Common: may occur in not more than 1 in 10 people

• Nasal inflammation, 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, 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 in the ankles, elevated temperature
• Presence of white blood cells in urine analysis.

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

• Vision disorders
• Unexpected bleeding or bruising
• 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 glandular breast tissue in men)

Frequency not known: frequency 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 the eye muscles).

Talk to your doctor if the patient experiences weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
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 this condition 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 on the patient.

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 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 reactions helps provide more information on the safety of this medicine.

5. How to store Sortis 40

Keep the 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 conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Sortis 40 contains

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

What Sortis 40 looks like and contents of the pack

White, round film-coated tablets with a diameter of 9.5 mm, embossed with "40" on one side and "ATV" on the other side.

Sortis 40 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:
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:
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: 31/235/99-C
Parallel Import Authorisation Number: 146/22