Sortis 10

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
SORTIS 10, 10 mg, film-coated tablets
Atorvastatin
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of contents

1. What SORTIS 10 is and what it is used for
2. What you need to know before taking SORTIS 10
3. How to take SORTIS 10
4. Possible side effects
5. How to store SORTIS 10
6. Contents of the pack and other information

1. What SORTIS 10 is and what it is used for

SORTIS 10 belongs to a group of medicines called statins, which regulate lipid (fat) metabolism in the body.
SORTIS 10 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 10 may also be used to reduce the risk of heart disease, even when cholesterol levels are normal. A cholesterol-lowering diet should be maintained during treatment.

2. Important information before using SORTIS 10

When not to use SORTIS 10:

• 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 taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with SORTIS 10, discuss this with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory failure,
• 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 10 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 has previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g. other statins or fibrates),
• if the patient regularly drinks 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 has 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 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 may order a blood test before starting treatment with SORTIS 10 and, where 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 10 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.
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 fats, overweight patients, and those with high blood pressure may be at increased risk of developing diabetes.

SORTIS 10 and 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 10 or the effect of those medicines may be altered by SORTIS 10.
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 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 products containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,

• other medicines known to interact with SORTIS 10 include ezetimibe (which lowers 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 fusidic acid orally 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 10. Taking SORTIS 10 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 structure infections and bloodstream infections caused by bacteria).

SORTIS 10 with food, drink and alcohol
Information on the use of SORTIS 10 can be found in section 3. However, please note the following:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts may alter the effect of SORTIS 10.
Alcohol
Avoid drinking excessive amounts of alcohol while taking this medicine.
Further information on this is provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
The use of SORTIS 10 in women who are pregnant or planning to become pregnant is contraindicated.
The use of SORTIS 10 in women of childbearing potential is contraindicated if they are not using effective methods of contraception.
The use of SORTIS 10 during breastfeeding is contraindicated.
The safety of SORTIS 10 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, the patient should not drive if this 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 10 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 10 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

SORTIS 10 contains benzoic acid (E 210)
This medicine contains 0.00004 mg of benzoic acid per tablet.

3. How to use SORTIS 10

Available in the market are: 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 10.
The usual initial dose of SORTIS 10 for adults and children aged 10 years or older is 10 mg once daily. If necessary, your doctor may increase this dose gradually to the dose appropriate for the patient. Your doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of SORTIS 10 is 80 mg once daily.
SORTIS 10 tablets should be swallowed whole with water and 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 used exactly as prescribed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
The duration of treatment with SORTIS 10 is determined by the doctor.
If you feel that the effect of SORTIS 10 is too strong or too weak, consult your doctor.
Taking more SORTIS 10 than prescribed
If you accidentally take too many SORTIS 10 tablets (more than the usual daily dose), contact your doctor or the nearest hospital for advice immediately.
Missing a dose of SORTIS 10
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 10
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 experiences 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 fewer 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 breakdown of striated muscles (rhabdomyolysis). Rhabdomyolysis may not resolve even after the patient stops taking atorvastatin, may be life-threatening, and may lead to kidney problems.

Very rare: may occur in fewer 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 reactions of SORTIS 10:
Common: may occur in fewer than 1 in 10 people

• Inflammation of nasal passages, 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, bloating, indigestion, diarrhoea
• Joint pain, muscle pain, and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in fewer 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 of the ankles, elevated temperature
• Presence of white blood cells in urine analysis

Rare: may occur in fewer 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 fewer 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 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).

Patients should speak to their doctor if they experience 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 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 symptoms 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 of Monitoring Adverse Drug Reactions, 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 SORTIS 10

Keep this medicine out of 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 10 contains

• The active substance is atorvastatin. Each coated tablet contains 10 mg of atorvastatin (in the form of atorvastatin calcium trihydrate).
• Other ingredients are: calcium carbonate, microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, polysorbate 80, hydroxypropylcellulose, and magnesium stearate. The coating of SORTIS 10 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone and emulsifying stearates (polysorbate 65, polyglycol stearate 400, glyceryl monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What SORTIS 10 looks like and contents of the pack
White, round, film-coated tablets with a diameter of 5.6 mm, embossed with "10" on one side and "ATV" on the other side.
Packaged in PA/Al/PVC//Al/vinyl blisters in cardboard boxes.
SORTIS 10 is available in blister packs containing 30 film-coated tablets.
For more detailed information, please contact the marketing authorisation holder or 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
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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź, Poland
Marketing authorisation number in the Czech Republic, country of export: 31/233/99-C
Parallel import authorisation number: 352/21