Sortis 40

Package leaflet: Information for the user

Warning! Keep the leaflet – the information on the immediate packaging is in a foreign language!
SORTIS 40
40 mg, film-coated tablets
Atorvastatinum
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• 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 give it to others. This medicine may harm other people, 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 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 using the medicine SORTIS 40

When not to use 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 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 this with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory failure,
• 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 (underactive thyroid),
• 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,
• if the patient has or has 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 of the disease 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 40 and, where possible, during treatment to monitor the risk of muscle-related adverse reactions. It is known that the risk of muscle-related adverse reactions, such as rhabdomyolysis, is higher when certain medicines are used 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.
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 fats, 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 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 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 reactions, 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 high blood pressure, 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 combination medicines 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 to treat epilepsy), 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. 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 the use of SORTIS 40 can be found in section 3. However, please note the following: S grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of SORTIS 40.
Alcohol
Avoid excessive alcohol consumption while taking this medicine.
Further information on this 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 age is contraindicated if they are not using effective methods of contraception.
The 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
This medicine usually does not affect the ability to drive or use machines. 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
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 the medicine SORTIS 40

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with SORTIS 40.
The usual starting dose of SORTIS 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 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 recommended to take the tablet at the same time each day.
This medicine should always be used exactly as prescribed by your doctor or pharmacist. If in doubt, 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, you should 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.
Missing a dose of 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 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 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, or throat, which may cause 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 indicate rhabdomyolysis (breakdown of skeletal muscle). Rhabdomyolysis does not always resolve even after discontinuation of atorvastatin, and may be life-threatening and 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 problems. Medical advice should be sought immediately.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse effects 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 diabetic patients, blood glucose levels should continue to be carefully monitored), 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 diabetic patients, 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, 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 in 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 oral 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, facial, lip, oral, 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
• Myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing). Ocular myasthenia (a disease causing weakness of eye muscles). If the patient experiences weakness in arms or legs that worsens after periods of activity, double vision, drooping eyelids, difficulty swallowing, or breathlessness, they should speak to their doctor.

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 levels of blood sugar and fats, 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 effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
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 40

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after "EXP".
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 package and other information

What SORTIS 40 contains

• The active substance is atorvastatin. Each coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate).
• Other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate.

The coating of SORTIS 40 contains: Opadry YS-1-7040 white film coating:
hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc; simethicone emulsion containing
simethicone, stearate emulsifiers (polysorbate 65, polyglycol 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 coated tablets with a diameter of 9.5 mm, embossed with "40" on one side and "ATV" on the other side.
Packaged in PA/Al/PVC//Al/vinyl blisters in a cardboard box.
SORTIS 40 is available in blister packs containing 30 coated tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, country of export:
Upjohn EESV
Rivium Westlaan 142
2909 LD Capelle aan den IJssel
The Netherlands

Manufacturer:
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg im Breisgau
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:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Poland
SHIRAZ PRODUCTIONS Sp. z o.o.
ul. Tymiankowa 24/28
95-054 Ksawerów
Poland

Marketing Authorisation Number in the Czech Republic, country of export: 31/235/99-C
Parallel Import Authorisation Number: 278/23