Sortis 80

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Sortis 80, 80 mg, Film-Coated Tablets

Atorvastatin

It is essential to carefully read the content of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept to be re-read if necessary.
• In case of any doubts, the patient 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 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 taking Sortis 80
• 3. How to take Sortis 80
• 4. Possible side effects
• 5. How to store Sortis 80
• 6. Contents of the pack 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.
The medicine 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 on their own. Sortis 80 can also be used to reduce the risk of heart disease, even if the cholesterol level is normal. During treatment, a standard low-cholesterol diet should be continued.

2. Important information before taking Sortis 80

When not to take 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. Taking fusidic acid with Sortis 80 can 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.

In patients with any of the above conditions, the doctor will order 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 simultaneously (see section 2 "Sortis 80 and other medicines").
The doctor or pharmacist should also be informed if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.
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 those 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 can lead to reduced efficacy of one or both medicines. At the same time, it can increase the risk of serious side effects, including severe 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 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 for 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 can 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 taking 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 may change the effect of Sortis 80.
Alcohol
Patients should avoid excessive alcohol consumption while taking Sortis 80.
More detailed information can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Sortis 80 during pregnancy or when planning to become pregnant is contraindicated.
Taking Sortis 80 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Sortis 80 during breastfeeding is contraindicated.
The safety of taking Sortis 80 during pregnancy and breastfeeding has not been established.
Before taking 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 some 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 essentially "sodium-free".

Sortis 80 contains benzonic acid (E 210)

This medicine contains 0.00032 mg of benzonic acid per tablet.

3. How to take Sortis 80

Before starting treatment, the doctor will recommend a low-cholesterol diet, which should be continued during treatment with Sortis 80.
Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg) are available.
The usual starting dose of Sortis for adults and children over 10 years of age is 10 mg once daily. This dose may be increased by the doctor if necessary, up to a dose suitable for the patient. The doctor will adjust the dose at intervals of at least 4 weeks. The maximum dose of Sortis is 80 mg once daily.
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 taken 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.

Taking a higher dose of Sortis 80 than recommended

In case of accidental ingestion of more tablets 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 further doubts about taking 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 following serious side effects or symptoms, they should stop taking the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

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

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can lead to severe breathing difficulties.
• Severe skin disease characterized by peeling and swelling of the skin, blisters, and fever. Rash with reddish-purple spots, especially on the hands or feet, with possible blisters.
• Muscle weakness, tenderness, or pain, or muscle rupture, or brownish discoloration of the 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 affect 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 affect up to 1 in 10 people

• nasopharyngitis, sore throat, nosebleeds
• allergic reactions
• increased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels closely), 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 affect up to 1 in 100 people

• loss of appetite, weight gain, decreased blood glucose levels (patients with diabetes should continue to monitor their blood glucose levels closely)
• nightmares, insomnia
• dizziness, numbness or tingling of fingers and toes, reduced sensitivity to pain and touch, changes in taste, memory loss
• blurred vision
• ringing in the ears and/or head
• vomiting, belching, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• rash, skin rash, and itching, hives
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine test.

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

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

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

• allergic reactions - symptoms may include sudden wheezing, 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: frequency cannot be estimated from the available data

• persisting muscle weakness.

Other possible side effects 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 likelihood of developing this disease is higher in patients with high blood sugar and lipid levels, patients who are overweight, and those with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, 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 this 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 they no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Sortis 80 contains

• The active substance is atorvastatin. Each film-coated tablet contains 80 mg of atorvastatin (as 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), benzonic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 80 looks like and contents of the pack

White, round, film-coated tablets with a diameter of 11.9 mm, with the inscription "80" on one side and "ATV" on the other.
Sortis 80 is available in blisters of polyamide/Al/PVC-Al/vinyl in a cardboard box.
The pack contains 30 film-coated tablets.
For more detailed information, patients should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Latvia, 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:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:03-0502

Parallel import authorization number: 209/23

Date of leaflet approval: 27.09.2023

[Information about the trademark]