Sortis 10

Patient Information Leaflet

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Sortis 10 (Sortis), 10 mg, film-coated tablets
Atorvastatin
Sortis 10 and Sortis are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet for possible future reference.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine 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.

Table of Contents

1. What Sortis 10 is and what it is used for
2. What you need to know 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. During treatment, you should continue to follow a standard diet low in cholesterol.

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 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 10, discuss the following with your doctor, pharmacist or
nurse:

• if the patient has severe respiratory insufficiency,
• 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 10 may lead to serious muscle problems (rhabdomyolysis),
• in case of stroke with cerebral haemorrhage, 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 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).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Sortis 10 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 10 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, the doctor will closely monitor the patient for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, patients with overweight and high blood pressure may be susceptible to the risk of developing diabetes.

Sortis 10 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans 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 in 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 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 fixed-dose combinations 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 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, during treatment of a bacterial infection, the patient needs to take fusidic acid orally to treat the 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 10. Taking Sortis 10 together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Sortis 10 with food, drink and alcohol
Information on the use of Sortis 10 can be found in section 3. However, please pay attention to the following:
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
Avoid excessive alcohol consumption while taking this medicine.
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 do not use 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 a doctor or pharmacist.

Driving and using machines
This medicine usually 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 10 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 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.
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. This dose may be increased by the doctor as needed, up to the dose appropriate for the patient. The doctor adjusts the dose at intervals of at least 4 weeks. The maximum dose of Sortis 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 recommended to take the tablet at the same time each day.
This medicine should always be used as directed by the doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 10 is determined by the doctor.
If you feel that the effect of Sortis 10 is too strong or too weak, you should 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 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 a missed dose.
Stopping Sortis 10
If you have any further questions about using 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 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 characterized by peeling and swelling of the skin, 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 accompanied by malaise or high fever, this may be due to breakdown of skeletal muscle (rhabdomyolysis). Rhabdomyolysis may not resolve even after discontinuation of atorvastatin, may be life-threatening and may cause kidney problems.

Very rare: may occur in no 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 immediately.
• Lupus-like syndrome (including rash, joint disorders and effects on blood cells).

Other possible adverse reactions of Sortis 10:
Common: may occur in no 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 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 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 monitored carefully)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers, hands or feet, 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 no more than 1 in 1,000 people

• Vision disturbances
• Unexpected bleeding or bruising (bruises)
• Cholestasis (yellowing of the skin and whites of the eyes)
• Tendon rupture

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 cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in males)

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). Consult 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 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 levels of blood sugar and fat, overweight patients, and those with high blood pressure. During treatment with this medicine, your doctor will perform appropriate tests. Reporting of adverse reactions If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions can 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 reactions helps to provide more information on the safety of the medicine.

5. How to store the medicine Sortis 10

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 stated 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. This will help protect the environment.

6. Contents of the pack and other information

What Sortis 10 contains

• The active substance is atorvastatin. Each film-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 contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, stearic 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 10 looks like and contents of the pack
White, round film-coated tablets with a diameter of 5.6 mm, embossed with "10" on one side and "ATV" on the other side.
Sortis 10 is available in blisters made of PA/Al/PVC//Al/vinyl foil in a cardboard box.
The pack contains 30 film-coated tablets.
For further information, please contact the responsible party or the parallel importer.

Responsible party 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, 79090 Freiburg, Germany
Mylan Hungary Kft.
Mylan utca 1, Komárom 2900, Hungary

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland

Authorisation number in the Czech Republic, country of export: 31/233/99-C
Authorisation number for parallel import: 282/21