Sortis 10

Leaflet attached to the packaging: information for the user

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

Sortis 10 (Sortis), 10 mg, film-coated tablets

Atorvastatin
Sortis 10 and Sortis are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed to a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Sortis 10 and what is it used for
• 2. Important information before taking Sortis 10
• 3. How to take Sortis 10
• 4. Possible side effects
• 5. How to store Sortis 10
• 6. Contents of the packaging and other information

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

Sortis 10 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
The medicine Sortis 10 is used to reduce the levels of lipids known as cholesterol and triglycerides in the blood, when a low-fat diet and changes in lifestyle are not effective. Sortis 10 may 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 10

When not to take Sortis 10:

• in women of childbearing age who do not use effective methods of contraception,
• in pregnant or breastfeeding women,

Warnings and precautions

Before starting treatment with Sortis 10, the patient should discuss it with their doctor, pharmacist, or nurse:

• in patients over 70 years of age,

In patients who are in any of the above situations, the doctor will order a blood test before starting treatment with Sortis 10 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 at the same time (see section 2 "Sortis 10 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 10, 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 10 and other medicines

The patient should tell 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 10 or the effect of these medicines on the body may be changed by Sortis 10.
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:

• medicines that modify the immune system, 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, cholestyramine,
• 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 10, 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,

Sortis 10 with food, drink, and alcohol

Information on taking Sortis 10 can be found in section 3. However, the following information should be noted:
Grapefruit juice
Do not drink more than one or two small glasses of grapefruit juice per day, as larger amounts of grapefruit juice can change the effect of Sortis 10.
Alcohol
While taking Sortis 10, the patient should avoid consuming excessive amounts of alcohol.
More detailed information on this can be found in section 2 "Warnings and precautions".

Pregnancy and breastfeeding

Taking Sortis 10 during pregnancy or breastfeeding is contraindicated.
Taking Sortis 10 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
Taking Sortis 10 during breastfeeding is contraindicated.
The safety of taking Sortis 10 during pregnancy and breastfeeding has not been established.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, the patient should not drive if the medicine affects their ability to do so. The patient should not use any tools or machines if taking the medicine affects their ability to use them.

Sortis 10 contains lactose monohydrate

Patients who have been informed by their doctor about intolerance to certain sugars should contact their doctor before taking Sortis 10.

Sortis 10 contains sodium

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

Sortis 10 contains benzoic acid

This medicine contains 0.00004 mg of benzoic acid per tablet.

3. How to take Sortis 10

Before starting treatment, the doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 10.
Sortis 10 (10 mg), Sortis 20 (20 mg), Sortis 40 (40 mg), and Sortis 80 (80 mg) are available.
Typically, the initial dose of Sortis for adults and children over 10 years old 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 at intervals of at least 4 weeks. The maximum dose of Sortis is 80 mg once a day.
Sortis 10 tablets should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, the patient should try to take the tablet at the same time every day.
This medicine should always be taken according to the doctor's or pharmacist's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.

The duration of treatment with Sortis 10 is determined by the doctor.

If the patient feels that the effect of Sortis 10 is too strong or too weak, they should consult their doctor.

Taking a higher dose of Sortis 10 than recommended

If the patient accidentally takes too many Sortis 10 tablets (more than the usual daily dose), they should contact their doctor or the nearest hospital for advice.

Missing a dose of Sortis 10

If the patient forgets to take a dose, they should simply take the next dose at the scheduled time. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Sortis 10

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Sortis 10 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 the medicine and contact their doctor or go to the emergency department of the nearest hospital immediately.

Rare: may occur in up to 1 in 1000 people

• A severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• A severe disease characterized by skin peeling and swelling, blisters on the skin, mouth, eyes, genitals, and fever. A 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 the patient also feels unwell or has a high fever, it may be due to muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if the patient stops taking atorvastatin, and it can 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. The patient should consult their doctor as soon as possible.
• A condition similar to lupus (including rash, joint disorders, and effects on blood cells).

Other possible side effects of Sortis 10:

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
• 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 patients with diabetes, blood glucose levels should continue to be closely monitored)
• nightmares, insomnia
• dizziness, numbness or tingling in the 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, upper and lower abdominal pain, pancreatitis (causing abdominal pain)
• hepatitis
• skin rash, skin rash and itching, hives, hair loss
• neck pain, muscle fatigue
• fatigue, malaise, weakness, chest pain, swelling, especially of the ankles, elevated temperature
• presence of white blood cells in the urine.

Rare: may occur in up to 1 in 1000 people

• vision disorders
• unexpected bleeding or bruising (bruises)
• cholestasis (yellowing of the skin and whites of the 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: frequency 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). Ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient 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 10 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 patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
By reporting side effects, more information can be gathered on the safety of the medicine.

5. How to store Sortis 10

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 instructions.
Medicines should not be disposed of via wastewater or household waste. The patient 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 10 contains

• The active substance of Sortis 10 is atorvastatin. Each film-coated tablet contains 10 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 10 contains: hypromellose, macrogol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearyl alcohol (polysorbate 65, macrogol 400 stearyl alcohol, glycerol monostearate 40-55), thickening agents (methylcellulose, xanthan gum), benzoic acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 10 looks like and what the packaging contains

White, round, film-coated tablets with a diameter of 5.6 mm, with the inscription "10" on one side and "ATV" on the other side.
Sortis 10 is available in blisters of PA/Al/PVC//Al/vinyl in a cardboard box.
The packaging contains 30 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, the country of export:

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

Manufacturer:

Pfizer Manufacturing Deutschland GmbH
Site 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 the Czech Republic, the country of export:31/233/99-C
Parallel import authorization number:282/21

Date of leaflet approval: 21.12.2023

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