Sortis 80

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Sortis 80 (Sortis 80 mg), 80 mg, film-coated tablets

Atorvastatin
Sortis 80 and Sortis 80 mg are different trade names for the same medicine.

It is necessary to carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sortis 80 and what is it used for
• 2. Important information before using Sortis 80
• 3. How to use Sortis 80
• 4. Possible side effects
• 5. How to store Sortis 80
• 6. Contents of the packaging and other information

1. What is Sortis 80 and what is it used for

Sortis 80 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
Sortis 80 is used to reduce the levels of lipids, such as cholesterol and triglycerides, in the blood when a low-fat diet and lifestyle changes are not effective. Sortis 80 may also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before using Sortis 80

When not to use Sortis 80:

• if the patient is allergic to atorvastatin or any other ingredient of this medicine (listed in section 6),
• if the patient has or has had liver disease,
• if the patient has unexplained, abnormal liver function test results,
• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or 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 80, the patient should discuss the following with their doctor, pharmacist, or nurse:

• if the patient has severe respiratory failure,
• if the patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Concomitant use of fusidic acid with Sortis 80 may lead to serious muscle problems (rhabdomyolysis),
• in case of a stroke with bleeding in the brain 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 recurring or unexplained muscle pain or muscle problems in the past, or similar problems in relatives,
• 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 a history of liver disease,
• in patients over 70 years of age,
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins may sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).

In patients who are affected by any of the above situations, the doctor will prescribe a blood test before starting treatment with Sortis 80 and, if possible, during treatment to monitor the risk of muscle-related side effects. It is known that the risk of muscle-related side effects, such as rhabdomyolysis, is higher when certain medicines are taken concomitantly (see section 2 "Sortis 80 and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.
During treatment with Sortis 80, the doctor will closely monitor the patient for the development of diabetes or the risk of developing diabetes. Patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure may be at risk of developing diabetes.

Sortis 80 and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Some medicines may change the effect of Sortis 80 or the effect of these medicines on the body may be changed by Sortis 80. This type of interaction may lead to reduced efficacy of one or both medicines. At the same time, it may increase the risk of serious side effects, including serious muscle damage known as rhabdomyolysis, described in section 4:

• immunosuppressants, such as cyclosporine,
• certain antibiotics or antifungal medicines, such as erythromycin, clarithromycin, telithromycin, ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole, rifampicin, fusidic acid,
• other lipid-lowering medicines, such as gemfibrozil, other fibrates, colestyramine,
• certain calcium channel blockers used for angina or high blood pressure, such as amlodipine, diltiazem, as well as medicines that regulate heart rhythm, such as digoxin, verapamil, amiodarone,
• letermovir, a medicine used to prevent cytomegalovirus disease,
• medicines used to treat HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir in combination with ritonavir, etc.,
• certain medicines used to treat hepatitis C virus infection, such as telaprevir, boceprevir, and a combination product containing elbasvir with grazoprevir, ledipasvir with sofosbuvir,
• other medicines that are known to interact with Sortis 80, including ezetimibe (which lowers cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an antiepileptic medicine), cimetidine (used to treat heartburn and stomach ulcers), phenazon (a pain reliever), colchicine (a medicine used to treat gout), and antacids (medicines used to treat indigestion, containing aluminum or magnesium),

Over-the-counter medicines: St. John's Wort,

• if the patient needs to take fusidic acid orally to treat a bacterial infection, they should temporarily stop taking Sortis 80. The doctor will inform the patient when it is safe to restart treatment with Sortis 80. Taking Sortis 80 with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Sortis 80 with food, drink, and alcohol

Information on the use of Sortis 80 can be found in section 3. However, the following information should be noted:
Grapefruit juice
Patients should not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice may change the effect of Sortis 80.
Alcohol
During treatment with Sortis 80, patients should avoid consuming excessive amounts of alcohol.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

The use of Sortis 80 in pregnant or breastfeeding women is contraindicated.
The use of Sortis 80 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of Sortis 80 during breastfeeding is contraindicated.
The safety of using Sortis 80 during pregnancy and breastfeeding has not been established.
Before using any medicine, patients should consult their doctor or pharmacist.

Driving and using machines

Sortis 80 usually does not affect the ability to drive or use machines. However, patients should not drive or use machines if the medicine affects their ability to do so.

Sortis 80 contains lactose monohydrate

Patients who have been informed by their doctor about intolerance to certain sugars should contact their doctor before taking Sortis 80.

Sortis 80 contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is considered "sodium-free".

Sortis 80 contains benzoeic acid (E 210)

This medicine contains 0.00032 mg of benzoeic acid per tablet.

3. How to use Sortis 80

Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg) are available.
Before starting treatment, the doctor will recommend a low-cholesterol diet, which should be continued during treatment with Sortis 80.
Typically, the initial dose of Sortis 80 for adults and children over 10 years of age is 10 mg per day. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose of Sortis 80 at intervals of at least 4 weeks. The maximum dose of Sortis 80 is 80 mg once a day.
Sortis 80 tablets should be swallowed whole with water and can be taken at any time of day, with or without food. However, patients should try to take the tablet at the same time every day.
This medicine should always be used as directed by the doctor or pharmacist. In case of doubts, patients should consult their doctor or pharmacist.

The duration of treatment with Sortis 80 is determined by the doctor.

If the patient feels that the effect of Sortis 80 is too strong or too weak, they should consult their doctor.

Using a higher dose of Sortis 80 than recommended

In case of accidental ingestion of more than the recommended dose of Sortis 80 (more than the usual daily dose), patients should contact their doctor or the nearest hospital for advice.

Missing a dose of Sortis 80

If a dose is missed, patients should simply take the next dose at the scheduled time. They should not take a double dose to make up for the missed dose.

Stopping treatment with Sortis 80

In case of any further doubts about using this medicine, patients should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sortis 80 can cause side effects, although not everybody gets them.

If the patient experiences any of the serious side effects or symptoms, they should stop taking Sortis 80 and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: may occur in up to 1 in 1,000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause difficulty breathing.
• Severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. Skin rash with pink-red spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or reddish-brown urine. If accompanied by malaise or high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and may be life-threatening and cause kidney problems.

Very rare: may occur in up to 1 in 10,000 people

• If the patient experiences unexpected or unusual bleeding or bruising, it may indicate liver problems. They should consult their doctor as soon as possible.
• Systemic lupus erythematosus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible side effects 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 diabetic patients, blood glucose levels should continue to be closely monitored), increased blood creatine kinase levels
• headaches
• nausea, constipation, bloating, indigestion, diarrhea
• joint pain, muscle pain, and back pain
• blood test results indicating abnormal liver function

Uncommon: may occur in up to 1 in 100 people

• 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 of fingers and toes, decreased sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, skin itching, and hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in urine tests

Rare: may occur in up to 1 in 1,000 people

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and eyes)
• tendon rupture

Very rare: may occur in up to 1 in 10,000 people

• allergic reactions - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• hearing loss
• gynecomastia (excessive breast tissue growth in men)

Frequency not known: cannot be estimated from the available data

• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing). Myasthenic syndrome (a disease that causes muscle weakness in the eyes). Patients should talk to their doctor if they experience muscle weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible side effects of Sortis 80 reported during treatment with some statins (medicines of the same type):

• sexual disorders
• depression
• breathing problems, including persistent cough and/or shortness of breath or fever
• diabetes; the risk of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and patients with high blood pressure. During treatment with Sortis 80, the doctor will perform the necessary tests on the patient.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, patients should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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 side effects will help gather more information on the safety of the medicine.

5. How to store Sortis 80

The medicine should be stored 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 month.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Patients should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sortis 80 contains

• The active substance of Sortis 80 is atorvastatin. Each film-coated tablet contains 80 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 80 contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying agents (polysorbate 65, macrogol 400 stearate, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoeic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 80 looks like and what the packaging contains

White, round, film-coated tablets with a diameter of 11.9 mm, with the inscription "80" on one side and "ATV" on the other side.
Polyamide/Al/PVC-Al/vinyl blisters in a cardboard box.
Sortis 80 is available in blisters containing 28 film-coated tablets.
For more detailed information, patients should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Lithuania, the country of export:

Upjohn EESV, Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Netherlands

Manufacturer:

Pfizer Manufacturing Deutschland GmbH, Betriebsstätte Freiburg, Mooswaldallee 1, 79090 Freiburg, 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Lithuanian marketing authorization number, in the country of export: LT/1/98/3805/059
LT/1/98/3805/061
LT/1/98/3805/063
LT/1/98/3805/066
LT/1/98/3805/067
LT/1/98/3805/069

Parallel import authorization number: 14/24

Date of leaflet approval: 15.01.2024

[Information about the trademark]