Sortis 20

Package Leaflet: Information for the User

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.

SORTIS 20 (Lipitor), 20 mg, film-coated tablets

Atorvastatin
SORTIS 20 and Lipitor are different trade names for the same medicine.

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is SORTIS 20 and what is it used for
• 2. Important information before taking SORTIS 20
• 3. How to take SORTIS 20
• 4. Possible side effects
• 5. How to store SORTIS 20
• 6. Contents of the pack and other information

1. What is SORTIS 20 and what is it used for

SORTIS 20 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
SORTIS 20 is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective on their own. SORTIS 20 can also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking SORTIS 20

When not to take SORTIS 20:

• if the patient is allergic to atorvastatin or any other ingredient of this medicine (listed in section 6),
• if the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective contraception methods,
• in pregnant or 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 20, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Taking fusidic acid with SORTIS 20 can lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding in the brain 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 recurring or unexplained muscle pain or muscle problems in the past, or similar problems in relatives,
• 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 old.

In patients with any of the above conditions, the doctor will order a blood test before starting treatment with SORTIS 20 and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken at the same time (see section 2 "SORTIS 20 and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medicines may be necessary.
During treatment with SORTIS 20, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

SORTIS 20 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of SORTIS 20 or the effect of these medicines may be changed by SORTIS 20.

• This type of interaction can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe muscle damage known as rhabdomyolysis, described in section 4:
• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungals, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with SORTIS 20, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine),

cimetidine (used to treat heartburn and stomach ulcers), phenazone (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used for indigestion, containing aluminum or magnesium),

• over-the-counter medicines: St. John's Wort,
• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking SORTIS 20. The doctor will inform the patient when it is safe to restart treatment with SORTIS 20. Taking SORTIS 20 with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

SORTIS 20 with food, drink, and alcohol

Information on taking SORTIS 20 can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may change the effect of SORTIS 20.
Alcohol
Avoid excessive alcohol consumption while taking SORTIS 20.
More detailed information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking SORTIS 20 during pregnancy or if planning to become pregnant is contraindicated.
Taking SORTIS 20 in women of childbearing age is contraindicated if they do not use effective contraception methods.
Taking SORTIS 20 during breastfeeding is contraindicated.
The safety of taking SORTIS 20 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult a doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive or use machines if the medicine affects their ability to do so.

SORTIS 20 contains lactose monohydrate

Patients who have been informed by their doctor about intolerance to some sugars should contact their doctor before taking this medicine.

SORTIS 20 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

SORTIS 20 contains benzoes acid

This medicine contains 0.00008 mg of benzoes acid per tablet.

3. How to take SORTIS 20

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 20.
SORTIS 10 (10 mg), SORTIS 20 (20 mg), SORTIS 40 (40 mg), and SORTIS 80 (80 mg) are available.
The usual starting dose of SORTIS for adults and children over 10 years old is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of SORTIS is 80 mg once daily.
SORTIS 20 tablets should be swallowed whole with water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
This medicine should always be taken as directed by the doctor or pharmacist. If in doubt, consult the doctor or pharmacist.

The duration of treatment with SORTIS 20 is determined by the doctor.

If the patient feels that the effect of SORTIS 20 is too strong or too weak, they should consult their doctor.

Taking more than the recommended dose of SORTIS 20

In case of accidental ingestion of more than the recommended dose of SORTIS 20 (more than the usual daily dose), the patient should contact their doctor or the nearest hospital for advice.

Missing a dose of SORTIS 20

If a dose is missed, the patient should simply take the next dose at the scheduled time. Do not take a double dose to make up for the missed dose.

Stopping treatment with SORTIS 20

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SORTIS 20 can cause side effects, although not everybody gets them.

If the patient experiences any of the following serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: may occur in up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters, and fever. Skin rash with pink-red spots, especially on the palms or soles, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or brownish discoloration of the urine. If accompanied by malaise or high fever, it may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and may be life-threatening and cause kidney problems.

Very rare: may occur in up to 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. They should consult their doctor as soon as possible.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects of SORTIS 20:

Common: may occur in up to 1 in 10 people

• nasal congestion, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon: may occur in up to 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (in diabetic patients, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling of fingers and toes, reduced sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• liver inflammation
• skin rash, skin lesions, and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine

Rare: may occur in up to 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 up to 1 in 10,000 people

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness

Other possible side effects reported during treatment with some statins (medicines of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the risk of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health
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 side effects will help gather more information on the safety of this medicine.

5. How to store SORTIS 20

Keep the 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 month.
There are no special storage requirements.
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 20 contains

• The active substance is atorvastatin. Each film-coated tablet contains 20 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 20 contains hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (sorbitan trioleate, polyoxyethylated oleic acid, glycerides), thickening agents (methylcellulose, xanthan gum), benzoes acid, sorbic acid, and sulfuric acid.

What SORTIS 20 looks like and contents of the pack

White, round, film-coated tablets with a diameter of 7.1 mm, with "20" embossed on one side and "ATV" on the other side.
Polyamide/Al/PVC blisters in a cardboard box.
SORTIS 20 is available in blisters containing 28 film-coated tablets.
For more detailed information, consult the marketing authorization holder or parallel importer.

Marketing authorization holder in the UK, country of export:

Upjohn UK Limited
Ramsgate Road, Sandwich
Kent, CT13 9NJ
United Kingdom

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg, Mooswaldallee 1, D-79090 Freiburg, Germany

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
UK license number: PL 50622/0039

Parallel import license number: 69/17

Translation of day symbols on the blister pack:

MON

• Monday TUE
• Tuesday WED
• Wednesday THUR
• Thursday FRI
• Friday SAT
• Saturday SUN
• Sunday

Leaflet approval date: 01.03.2022
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