SORTIS 80

Package leaflet: Information for the user

Warning! Keep this leaflet. The packaging information in a foreign language.
Sortis 80 (Lipitor)
80 mg, film-coated tablets
Atorvastatinum
Sortis 80 and Lipitor are different trade names for the same medicine.
Please read this leaflet carefully before taking the 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 questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Sortis 80 is and what it is used for
2. What you need to know 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 a low-fat diet 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, you should continue to follow a standard diet low in cholesterol.

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 results of liver function tests,
• 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 taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions

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Before starting treatment with Sortis 80, discuss this 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 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,
• in case of muscle problems during previous treatment with other lipid-lowering medicines (e.g. other statins or fibrates),
• in case of regular excessive alcohol consumption,
• in case of history of liver disease,
• in patients over 70 years of age.

In patients with 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 higher 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 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 levels of blood sugar and lipids, overweight patients, and those with 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 or have recently taken, as well as any medicines you plan to take. Some medicines may alter the effect of Sortis 80 or the effect of these medicines on the body may be altered by Sortis 80. 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, 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 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,

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• other medicines known to interact with Sortis 80 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 (a medicine 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 this medicine should be temporarily discontinued. The doctor will inform the patient 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 is provided in section 4.

Sortis 80 with food, drink, and alcohol
Information on the use of Sortis 80 is provided in section 3. However, please pay attention to the following information:
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 on this 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 methods of contraception.
Use of Sortis 80 during breastfeeding is contraindicated.
The safety of using Sortis 80 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Sortis 80 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 any tools or machines if taking this medicine affects your ability to operate them.

Sortis 80 contains lactose monohydrate
Patients who have been informed 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 take Sortis 80

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 80.
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Available on the market are: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), Sortis 80 (80 mg).
The usual starting 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 four 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 approximately the same time each day.
This medicine should always be taken according to your doctor's or pharmacist's instructions. If you have any doubts, consult your doctor or pharmacist.
The duration of treatment with Sortis 80 is determined by your doctor.
If you feel that the effect of Sortis 80 is too strong or too weak, consult your doctor.
Taking more Sortis 80 than prescribed
If you accidentally take too many Sortis 80 tablets (more than the usual daily dose), contact your doctor or the 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 the 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 without delay.
Rare: may occur in up to 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, genitals, accompanied by fever. Skin rash with pink-red spots, especially on the palms or soles, possibly with blisters.
• Muscle 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 indicate breakdown of skeletal muscle (rhabdomyolysis). Rhabdomyolysis does not always resolve even after the patient stops taking atorvastatin, and may be life-threatening and lead to kidney problems.

Very rare: may occur in up to 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.

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• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Other possible adverse reactions of Sortis 80:

Common: may occur in up to 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 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 up to 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 carefully monitored)
• Nightmares, insomnia
• Dizziness, numbness or tingling in fingers and toes, reduced sensitivity to pain and touch, taste disturbances, 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 up to 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 up to 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 males)

Frequency not known: 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 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 on the patient.

Reporting of adverse reactions
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If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department for 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 to provide more information on the safety of the medicine.

5. How to store Sortis 80

Keep this medicine out of the 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 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 pack 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 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (polysorbate 65, polyglycolized stearate, glycerol monostearate 40-50), 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 blisters sealed with a heat-sealable Al/vinyl layer, in a cardboard box.
Sortis 80 is available in blisters containing 28 film-coated tablets.

For more detailed information, please contact the Marketing Authorisation Holder or the 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
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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

Irish Marketing Authorisation Number (country of export): PA23055/017/004
Parallel Import Licence Number: 281/22

Translation of some blister pack abbreviations:
MON - Monday
TUE - Tuesday
WED - Wednesday
THUR - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday
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