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
Atorvastatin
Sortis 80 and Sortis 80 mg are different brand names for the same medicine.
Please read the entire leaflet carefully before using 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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, 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.

Table of contents of the leaflet

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 diet low in fat 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. During treatment, a standard low-cholesterol diet should be continued.

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 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 insufficiency,
• if the patient is taking or has taken oral or injectable 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 previously experienced muscle problems while being treated 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 has or has 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 affected by any of the above conditions, the doctor will 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 greater 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 treatment with other medicines may be necessary to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor you for the development of diabetes or risk factors for diabetes. Patients with high blood sugar and lipid levels, overweight, and 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, have recently taken, or plan to take. Some medicines may alter the effect of Sortis 80 or their effects may be altered by Sortis 80. This type of interaction may reduce the effectiveness of one or both medicines and may 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 fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Sortis 80 include ezetimibe (a cholesterol-lowering agent), warfarin (a blood thinner), oral contraceptives, stiripentol (an anticonvulsant used in epilepsy treatment), cimetidine (used to treat indigestion and stomach ulcers), phenazone (a painkiller), colchicine (used to treat gout), and antacids (medicines 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. Your doctor will inform you 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 on rhabdomyolysis can be found in section 4.

Sortis 80 with food, drink, and alcohol
Information on the use of Sortis 80 is provided in section 3. However, please note 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 details are provided in section 2 "Warnings and precautions".

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

Driving and operating machinery
This medicine 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 tools or machinery if taking this medicine impairs your ability to operate them safely.

Sortis 80 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 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

The following products are available in commerce: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), Sortis 80 (80 mg).
Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 80.
The usual initial dose of Sortis in adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by the doctor, if necessary, 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 80 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 used exactly as prescribed by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 80 is determined by the doctor.
If you feel that the effect of Sortis 80 is too strong or too weak, consult your doctor.
Taking more Sortis 80 than recommended
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 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.

Rare: may occur in less 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, blisters 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 indicate breakdown of skeletal muscle (rhabdomyolysis). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare: may occur in less than 1 in 10,000 people

• Unexpected or unusual bleeding or bruising, which 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 80:
Common: may occur in less than 1 in 10 people

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be carefully monitored), 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 diabetic patients, blood glucose levels should continue to be carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers, hands, and feet, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Tinnitus and (or) noise 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 of 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

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, facial, lip, oral cavity, tongue or throat swelling, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive growth of glandular breast 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 the eye muscles). Consult a doctor if the patient experiences weakness in the 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 certain 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. The doctor will perform appropriate tests during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform a 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 Sortis 80

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 required. These measures will 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 (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 80 contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (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 80 looks like and contents of the pack
White, round, film-coated tablets with a diameter of 11.9 mm, embossed with "80" on one side and "ATV" on the other side.
Packaged in poliamide/Al/PVC-Al/vinyl blisters in a cardboard carton.
Sortis 80 is available in blisters containing 28 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible party in Lithuania, 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:
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, country of export: LT/1/98/3805/059
LT/1/98/3805/061
LT/1/98/3805/063
LT/1/98/3805/066
LT/1/98/3805/067
LT/1/98/3805/069
Marketing authorisation number for parallel import: 14/24