Sortis 20

Package leaflet: Information for the user

Warning! Keep this 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.
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 doubts, 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 not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

1. What Sortis 20 is and what it is used for
2. What you need to know 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 diet low in fat 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 normal. Standard diet low in cholesterol should be continued during treatment.

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 the following with your doctor, pharmacist, or nurse:

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken fusidic acid orally or by injection within the last 7 days (a medicine used to treat bacterial infections). Concomitant use of fusidic acid with Sortis 20 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,
• if the patient has kidney problems,
• if the patient has hypothyroidism (underactive thyroid),
• if the patient has a history of recurrent or unexplained muscle pain or muscle problems, or if such problems occurred 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 currently has or previously 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 occasionally worsen symptoms or lead to the development of myasthenia (see section 4).

In patients affected by any of the above conditions, the doctor will order a blood test before starting treatment with Sortis 20 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 used concomitantly (see section 2 “Sortis 20 with 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.
During treatment, 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 patients, and those with high blood pressure may be more susceptible to developing diabetes.

Sortis 20 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 20 or their effects may be altered by Sortis 20. Such interactions may reduce the effectiveness of one or both medicines. They 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, colestipol,

• 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 20 include ezetimibe (which lowers 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 (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 20. Taking Sortis 20 together with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bloodstream infections caused by bacteria).

Sortis 20 with food, drink, and alcohol
Information on how to take Sortis 20 can be found 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.
Further information on this topic 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 potential is contraindicated if they are not using effective methods of contraception.
The use of Sortis 20 during breastfeeding is contraindicated.
The safety of Sortis 20 during pregnancy and breastfeeding has not been established.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Sortis 20 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 machines 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, i.e. the medicine is considered "sodium-free".

Sortis 20 contains benzoic acid (E 210)
This medicine contains 0.00008 mg of benzoic acid (E 210) per tablet.

3. How to use the medicine Sortis 20

The following medicines are available: 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 20.
The usual starting dose of Sortis 20 in adults and children aged 10 years or older is 10 mg once daily. This dose may be adjusted by your doctor as needed, up to the dose appropriate for the individual patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Sortis 20 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 recommended to take the tablet at the same time each day.
This medicine should always be used exactly as your doctor or pharmacist has instructed. If you are unsure, 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 a 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 20
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, 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 skin peeling and swelling, skin blisters, sores 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 be due to rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after the patient stops taking atorvastatin; it may be life-threatening and can cause 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 20:
Common: may occur in no more than 1 in 10 people

• Inflammation of the nasal passages, 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, 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 diabetic patients, 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 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 no more 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
• Rash, which may appear on the skin, or mouth ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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 swelling, facial, lip, oral, 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). If the patient experiences worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath, they should consult their doctor.

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. During treatment with this medicine, the doctor will perform appropriate tests in the patient.

Reporting of adverse reactions
If any adverse symptoms occur, including any possible adverse reactions not listed in this leaflet, the patient should inform their 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 the medicine Sortis 20

Keep this medicine out of the 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 apply.
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 coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate).
• Other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate. Coating: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing: simethicone, stearic acid emulsifiers (polysorbate 65, stearic acid polyethylene glycol 400, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 20 looks like and contents of the pack
White, round coated tablets with a diameter of 7.1 mm, embossed with "20" on one side and "ATV" on the other side.
Blister packs made of polyamide/Al/PVC laminated with Al/vinyl, contained in a cardboard box.
Sortis 20 is available in blisters containing 28 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
Medis International a.s.
výrobní závod Bolatice
Průmyslová 961/16
747 23 Bolatice, Czech Republic
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
Marketing Authorisation Number in Ireland, country of export: PA 23055/017/002
Parallel Import Licence Number: 189/20
Translation of some terms appearing on the blister:
MON - Monday
TUE - Tuesday
WED - Wednesday
THUR - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday