Sortis 40

Package leaflet: Information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Sortis 40 (Lipitor), 40 mg, film-coated tablets
Atorvastatin
Sortis 40 and Lipitor are different brand names of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, 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 others, 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 40 is and what it is used for
2. Important information before taking Sortis 40
3. How to take Sortis 40
4. Possible side effects
5. How to store Sortis 40
6. Contents of the pack and other information

1. What Sortis 40 is and what it is used for

Sortis 40 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
Sortis 40 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 40 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 cholesterol-lowering diet.

2. Important information before taking Sortis 40

When not to take Sortis 40:

• 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 potential 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 40, 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 40 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 aged over 70 years.

For patients affected by any of the above conditions, the doctor may order blood tests before starting treatment with Sortis 40 and, as appropriate, 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 taken concomitantly (see section 2 "Sortis 40 with other medicines").
Inform your doctor or pharmacist if muscle weakness persists. Additional tests and additional medicines may be necessary to diagnose and treat this condition.
While taking this medicine, your doctor will closely monitor you for the development of diabetes or risk of developing diabetes. Patients with high levels of blood sugar and lipids, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

Sortis 40 with 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 40 or their effect on the body may be altered by Sortis 40.
This type of interaction may reduce the 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:

• immunomodulating 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, colestyramine,
• 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 fixed-dose combinations containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines known to interact with Sortis 40 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 pain-relieving medicine),
• colchicine (a medicine used to treat gout), and acid-reducing medicines (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. Your doctor will inform you when it is safe to restart treatment with Sortis 40. Taking Sortis 40 together with fusidic acid may, in rare cases, lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Sortis 40 with food, drink, and alcohol
Information on how to take Sortis 40 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 amounts may alter the effect of Sortis 40.
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 40 in women who are pregnant or planning to become pregnant is contraindicated.
The use of Sortis 40 in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
The use of Sortis 40 during breastfeeding is contraindicated.
The safety of using Sortis 40 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and operating machinery
Generally, this medicine 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 40 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 40 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

Sortis 40 contains benzoic acid
This medicine contains 0.00016 mg of benzoic acid per tablet.

3. How to use Sortis 40

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 40.
Available on the market are: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg).
The usual starting 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 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 40 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. In case of doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 40 is determined by the doctor.
If you feel that the effect of Sortis 40 is too strong or too weak, consult your doctor.
Taking more Sortis 40 than prescribed
If you accidentally take too many Sortis 40 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice.
If you forget to take Sortis 40
If you miss 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 40
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 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 sores in the mouth, eyes, and genital area, accompanied by 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 these symptoms occur together with malaise or high fever, this may be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis may not 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

• 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 40:
Common: may occur in no more than 1 in 10 people

• Nasopharyngitis, sore throat, nosebleeds
• Allergic reactions
• Increased blood glucose levels (in patients with diabetes, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• Headache
• 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 closely monitored)
• 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 eruptions 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: frequency cannot be estimated from available data

• Persistent muscle weakness.

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 diabetes 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 your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring of 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 provide more information on the safety of the medicine.

5. How to store the medicine Sortis 40

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the specified month.
No special storage instructions apply.
Medicines must 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. Package contents and other information

What Sortis 40 contains

• The active substance is atorvastatin. Each coated tablet contains 40 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 40 contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc,
simeticone emulsion containing simeticone, stearate emulsifiers (polysorbate 65, polyglyceryl 400 stearate, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 40 looks like and contents of the pack

White, round, film-coated tablets with a diameter of 9.5 mm, embossed with "40" on one side and "ATV" on the other side.

Sortis 40 is available in blisters made of PA/Al/PVC//Al/vinyl foil, packed in a cardboard box. The pack contains 28 film-coated tablets.

For more detailed information, please contact the marketing authorisation holder or parallel importer.

Marketing Authorisation Holder in Ireland, 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

Marketing Authorisation Number in Ireland, country of export: PA 23055/017/003
Parallel Import Authorisation Number: 208/21

Translation of the abbreviations for days of the week printed next to each tablet on the immediate packaging:
MON – Monday, TUE – Tuesday, WED – Wednesday, THUR – Thursday, FRI – Friday,
SAT – Saturday, SUN – Sunday.