SORTIS 40 mg Tablets

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
3. Sortis 40 (Lipitor), 40 mg, film-coated tablets
   1. You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Sortis 40 and what is it used for
5. Important information before using Sortis 40
   1. When not to use Sortis 40:
   2. Warnings and precautions
   3. Sortis 40 and other medicines
   4. Sortis 40 with food, drink, and alcohol
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Sortis 40 contains lactose monohydrate
   8. Sortis 40 contains sodium
   9. Sortis 40 contains benzoes acid
6. How to use Sortis 40
   1. The duration of treatment with Sortis 40 is determined by your doctor.
   2. Using a higher dose of Sortis 40 than recommended
   3. Missing a dose of Sortis 40
   4. Stopping treatment with Sortis 40
7. Possible side effects
   1. If you experience any of the serious side effects or symptoms, you should stop taking the medicine and contact your doctor or go to the emergency department of the nearest hospital immediately.
   2. Other possible side effects of Sortis 40:
   3. Reporting side effects
8. How to store Sortis 40
9. Contents of the packaging and other information
   1. What Sortis 40 contains
   2. What Sortis 40 looks like and what the packaging contains
   3. Marketing authorization holder in Ireland, the country of export:
   4. Manufacturer:
   5. Parallel importer:
   6. Repackaged by:
   7. Date of leaflet approval: 07.08.2023

Leaflet attached to the packaging: information for the user

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

Sortis 40 (Lipitor), 40 mg, film-coated tablets

Atorvastatin
Sortis 40 and Lipitor are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using 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 specifically for you. 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 40 and what is it used for
• 2. Important information before using Sortis 40
• 3. How to use Sortis 40
• 4. Possible side effects
• 5. How to store Sortis 40
• 6. Contents of the packaging and other information

1. What is Sortis 40 and what is it used for

Sortis 40 belongs to a group of medicines called statins, which regulate lipid metabolism in the body.
The medicine Sortis 40 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 40 may also be used to reduce the risk of heart disease, even if cholesterol levels are normal. During treatment, you should continue a standard low-cholesterol diet.

2. Important information before using Sortis 40

When not to use Sortis 40:

• 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 40, you should discuss it with your doctor, pharmacist, or nurse:

• 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 who are affected by any of the above situations, the doctor will prescribe a blood test before starting treatment with Sortis 40 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 40 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 40, 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 40 and other medicines

You should 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 change the effect of Sortis 40 or the effect of these medicines on the body may be changed by Sortis 40.
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, 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 40, 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 40 with food, drink, and alcohol

Information on the use of Sortis 40 can be found in section 3. However, you should pay attention to the following information:
Grapefruit juice
You 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 40.
Alcohol
While taking Sortis 40, you 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 40 in women who are pregnant or plan to become pregnant is contraindicated.
The use of Sortis 40 in women of childbearing age is contraindicated if they do not use effective methods of contraception.
The use of Sortis 40 during breastfeeding is contraindicated.
The safety of using Sortis 40 during pregnancy and breastfeeding has not been established.
Before using any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Normally, the medicine does not affect the ability to drive or use machines. However, you should not drive if the medicine affects your ability to do so. You should not use any tools or machines if the medicine affects your ability to use them.

Sortis 40 contains lactose monohydrate

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

Sortis 40 contains sodium

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

Sortis 40 contains benzoes acid

This medicine contains 0.00016 mg of benzoes acid per tablet.

3. How to use Sortis 40

Before starting treatment, your doctor will recommend a low-cholesterol diet; this diet should be continued during treatment with Sortis 40.
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 of age is 10 mg per day. This dose may be increased by your 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 40 tablets should be swallowed whole, with a glass of water; they can be taken at any time of day, with or without food. However, you should try to take the tablet at the same time every day.
This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, you should 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.

Using a higher dose of Sortis 40 than recommended

If you accidentally take too many Sortis 40 tablets (more than the usual daily dose), you should contact your doctor or the nearest hospital for advice.

Missing a dose of Sortis 40

If you forget to take a dose, you should simply take the next dose at the scheduled time. You should not take a double dose to make up for the missed dose.

Stopping treatment with Sortis 40

If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Sortis 40 can cause side effects, although not everybody gets them.

If you experience any of the serious side effects or symptoms, you should stop taking the medicine and contact your doctor or go to the emergency department of the nearest hospital immediately.

Rare: may occur in up to 1 in 1000 people

• Severe allergic reaction causing swelling of the face, tongue, and throat, which can cause severe breathing difficulties.
• Severe disease characterized by peeling and swelling of the skin, 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 you also feel unwell or have a high fever, it may be caused by muscle breakdown (rhabdomyolysis). Muscle breakdown may not always resolve, even if you stop 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 you experience unexpected or unusual bleeding or bruising, it may indicate liver problems. You should consult your 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 40:

Common: may occur in up to 1 in 10 people

• nasal passage inflammation, 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 of the hands and feet, 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)
• liver inflammation
• 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 test.

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.

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 patients with high blood pressure. During treatment with this medicine, the doctor will perform the necessary tests on the patient.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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, you can help provide more information on the safety of this medicine.

5. How to store Sortis 40

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. You should ask your 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 40 contains

• The active substance of Sortis 40 is atorvastatin. Each film-coated tablet contains 40 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 40 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), benzoes acid (E 210), sorbic acid, and sulfuric acid.

What Sortis 40 looks like and what the packaging contains

White, round, film-coated tablets with a diameter of 9.5 mm, with the inscription "40" on one side and "ATV" on the other side.
Sortis 40 is available in blisters of PA/Al/PVC//Al/vinyl in a cardboard box.
The packaging contains 28 film-coated tablets.
For more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Ireland, 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 Ireland, the country of export:PA 23055/017/003
Parallel import authorization number:208/21
Translation of day-of-the-week abbreviations on the packaging:
MON– Monday, TUE– Tuesday, WED– Wednesday, THUR– Thursday, FRI– Friday, SAT– Saturday, SUN– Sunday.

Date of leaflet approval: 07.08.2023

[Information about the trademark]