Sortis 40

Package leaflet: Information for the user

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Sortis 40 (Sortis 40 mg), 40 mg, film-coated tablets
Atorvastatin
Sortis 40 and Sortis 40 mg are different trade names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• 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 reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet 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 reduce 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 normal. During treatment, you should continue to follow a standard low-cholesterol 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 had in the past 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 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 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 consumption of large amounts of alcohol,
• in case of previous liver disease,
• in patients over 70 years of age,
• if the patient has or has had myasthenia gravis (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients with any of the above conditions, the doctor will order a blood test before starting
treatment with Sortis 40 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 taken concomitantly (see section 2 “Sortis 40 and 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.
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 risk of developing diabetes.

Sortis 40 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 40 or the
effect of these medicines may be altered by Sortis 40.
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, 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 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 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 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 a patient needs to take fusidic acid orally to treat a bacterial infection, treatment with Sortis 40 should be temporarily discontinued. The doctor will inform the patient when it is safe to restart treatment with Sortis 40. Taking Sortis 40 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 40 with food, drink and alcohol
Information on how to take Sortis 40 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 amounts of
grapefruit juice may alter the effect of Sortis 40.
Alcohol
While taking this medicine, avoid excessive alcohol consumption.
Further information on this topic is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Use of Sortis 40 in women who are pregnant or planning to become pregnant is contraindicated.
Use of Sortis 40 in women of childbearing age is contraindicated if they are not using effective
contraceptive methods.
Use of Sortis 40 during breastfeeding is contraindicated.
The safety of Sortis 40 during pregnancy and breastfeeding has not been established.
Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Usually, this medicine 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 machinery 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 (E 210)
This medicine contains 0.00016 mg of benzoic acid (E 210) per tablet.

3. How to use Sortis 40

The following products are available in the market: Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), Sortis 80 (80 mg).
Before starting treatment, your doctor will recommend adopting a low-cholesterol diet; this diet should be continued throughout treatment with Sortis 40.
The usual initial dose of Sortis 40 for 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 40 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 taken exactly as prescribed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The duration of treatment with Sortis 40 is determined by your 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 immediately.
If you forget to take Sortis 40
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 40 treatment
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 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 skin peeling and swelling, skin blisters, sores in the mouth, eyes, genitals, and 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 accompanied by malaise or high fever, this may indicate breakdown of striated muscles (rhabdomyolysis). Breakdown of striated muscles 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

• 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 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 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 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 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) in the head
• Vomiting, regurgitation, 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 in the ankles, elevated temperature
• Presence of white blood cells in urine analysis

Rare: may occur in up to 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 oral ulcers (lichenoid drug reaction)
• Purple skin lesions (symptoms of vasculitis)

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, swelling of the eyelids, face, lips, mouth, tongue or throat, breathing difficulties, collapse
• Hearing loss
• Gynaecomastia (excessive development of breast glandular tissue in males)

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 eye muscles).

Talk to your doctor if the patient experiences weakness in the arms or legs, worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
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 levels of blood sugar and fats, overweight, and high blood pressure. Your doctor will perform appropriate tests while you are taking 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 also be reported directly to the Department for Monitoring Adverse Reactions of Medicinal Products at 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 40

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 are required.
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 40 contains

• The active substance is atorvastatin. Each coated tablet contains 40 mg of atorvastatin (in the form of 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 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simeticone emulsion containing simeticone, stearic acid 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.
Packaged in poliamide/Al/PVC-Al/vinyl blisters in a cardboard box.
Sortis 40 is available in blisters containing 28 film-coated tablets.
For more detailed information, please contact the responsible party or parallel importer.
Responsible entity in Romania, country of export:
Upjohn EESV
Rivium Westlaan 142, 2909 LD Capelle aan den Ijssel, Netherlands
Manufacturer:
Medis International a.s.
Průmyslová 961/16, 747 23 Bolatice, Czech Republic
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1, 79108 Freiburg Im Breisgau, Germany
Mylan Hungary Kft.
Mylan utca 1, Komárom, 2900, Hungary
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
Permit number in Romania, country of export: 8194/2015/06
8194/2015/08
Parallel import permit number: 108/26