Sortis 10

Package leaflet: Information for the user

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

• Keep this leaflet so that you can read it again if necessary.
• 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet 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 normal. During treatment, you should continue to follow a standard low-cholesterol diet.

2. Important information before using 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 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 10, discuss this with your doctor, pharmacist, or nurse:

• if the patient suffers from severe respiratory insufficiency,
• 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 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 a history of 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), as statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with Sortis 10 and, where 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 possibly additional medicines may be required 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 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 the effect of these medicines 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 hypertension, e.g. amlodipine, diltiazem; and also 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 (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 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.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Sortis 10 with food, drink and alcohol
Information on how to take Sortis 10 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 quantities may alter the effect of Sortis 10.

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 10 in women who are pregnant or planning to become pregnant is contraindicated.
The use of Sortis 10 in women of childbearing potential is contraindicated if they are not using effective contraceptive methods.
The use of Sortis 10 during breastfeeding is contraindicated.
The safety of Sortis 10 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Sortis 10 usually 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 machines if taking this medicine affects your ability to operate them.

Sortis 10 contains lactose monohydrate
Patients who have been advised 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 (E 210)
This medicine contains 0.00004 mg of benzoic acid per tablet.

3. How to take 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 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 taken as prescribed 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.
If you forget to take Sortis 10
If you forget to take a 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 a doctor or go to the emergency department of the
nearest hospital without delay.

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, sores in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly 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 the patient stops taking atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare: may occur in less 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 skin 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
• Headache
• Nausea, constipation, flatulence, 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 in 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 swelling, facial swelling, swelling of the lips, mouth, tongue, or throat, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast tissue in males)

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).

Patients should speak to their doctor if they experience weakness in the arms or legs that worsens
with 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 in the patient.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, the patient should inform their doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions 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 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 conditions are required.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will 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, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, stearic acid emulsifiers (polysorbate 65, polyglyceryl 400 stearate, 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, engraved with "10" on one side and "ATV" on the other side.
Packaged in poliamide/Al/PVC-Al/vinyl blisters in a cardboard box.
Sortis 10 is available in blisters containing 28 coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Marketing Authorisation Holder in Lithuania, 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, 79108 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 Authorisation Numbers in Lithuania, the country of export: LT/1/98/3805/002
LT/1/98/3805/004
LT/1/98/3805/006
LT/1/98/3805/009
LT/1/98/3805/010
LT/1/98/3805/012
Parallel Import Licence Number: 94/24