Sortis 20

Package leaflet: Information for the user

Warning! Keep this leaflet. Information on the immediate packaging is 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.
Please read the entire leaflet carefully before taking this 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 doubts, 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 others, even if their symptoms appear identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform the doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

SORTIS 20 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
SORTIS 20 is used to reduce blood levels of lipids known as cholesterol and triglycerides when a low-fat diet and lifestyle changes alone are not effective. SORTIS 20 may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before using SORTIS 20

When not to use SORTIS 20:

• 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 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 20, discuss this with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• 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 20 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,
• 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.

In patients with any of the above conditions, the doctor may order blood tests before starting treatment with SORTIS 20 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, increases when certain medicines are used concomitantly (see section 2 "SORTIS 20 and other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be necessary 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 blood sugar and lipid levels, overweight, and high blood pressure may be more susceptible to developing diabetes.

SORTIS 20 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 20 or their effects may be altered by SORTIS 20. Such interactions 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 infection,
• 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 combination medicines containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with SORTIS 20 include ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant used in the treatment of epilepsy), 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,
• if the patient needs to take oral fusidic acid to treat a bacterial infection, treatment with SORTIS 20 should be temporarily discontinued. Your doctor will inform you when it is safe to restart SORTIS 20. Taking SORTIS 20 together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information about rhabdomyolysis is provided in section 4.

SORTIS 20 with food, drink, and alcohol
Information on the use of SORTIS 20 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 20.

Alcohol
Avoid excessive alcohol consumption while taking this medicine. More detailed information is provided in section 2 "Warnings and precautions".

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

Driving and operating machinery
SORTIS 20 usually does not affect the ability to drive or operate machinery. However, patients should not drive if the 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 20 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 20 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

SORTIS 20 contains benzoic acid
This medicine contains 0.00008 mg of benzoic acid per tablet.

3. How to use SORTIS 20

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 20.
The following are available on the market: SORTIS 10 (10 mg), SORTIS 20 (20 mg), SORTIS 40 (40 mg), SORTIS 80 (80 mg).
The usual initial dose of SORTIS in 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 20 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 directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with SORTIS 20 is determined by your doctor.
If you feel that the effect of SORTIS 20 is too strong or too weak, consult your doctor.
Taking more SORTIS 20 than recommended
If you accidentally take too many SORTIS 20 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
Missing a dose of SORTIS 20
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 treatment with SORTIS 20
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the patient experiences any of the serious adverse effects 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 lead to severe breathing difficulties.
• Severe illness characterized by peeling and swelling of the skin, skin blisters, and fever, with sores in the mouth, eyes, genitals. 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 rhabdomyolysis (breakdown of striated muscle). Rhabdomyolysis may not always resolve even after discontinuation of atorvastatin, may be life-threatening, and may lead to 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 skin rash, joint disorders, and effects on blood cells).

Other possible adverse effects of SORTIS 20:
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, flatulence, 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 and feet, 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 of the ankles), elevated body temperature
• Presence of white blood cells in urine analysis

Rare: may occur in no more than 1 in 1,000 people

• Visual 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 men)

Frequency not known: cannot be estimated from the available data

• Persistent muscle weakness

Other possible adverse effects 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 diabetes 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 effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Adverse effects 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 effects helps to provide more information on the safety of the medicine.

5. How to store SORTIS 20

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 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 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, monohydrate lactose, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate. The coating of SORTIS 20 tablets contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (polyethylene glycol sorbitan tristearate, polyoxyl stearate, glycerides), thickening agents (methylcellulose, xanthan gum), benzoic 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, embossed with "20" on one side and "ATV" on the other.
Packaged in poliamide/Al/PVC blisters covered with an Al/vinyl layer, in a cardboard box.
SORTIS 20 is available in blister packs containing 28 film-coated tablets.
For more detailed information, please contact the responsible entity or the parallel importer.
Marketing Authorisation Holder in the United Kingdom, 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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
UK Marketing Authorisation Number: PL 50622/0039
Parallel Import Licence Number: 69/17
Translation of weekday symbols on the blister:
MON - Monday
TUE - Tuesday
WED - Wednesday
THUR - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday