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 (Lipitor), 10 mg, film-coated tablets
Atorvastatin
Sortis 10 and Lipitor are different brand names for the same medicine.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Sortis 10 is and what it is 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 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 sufficient. Sortis 10 may also be used to reduce the risk of heart disease, even when cholesterol levels are within the normal range. During treatment, you should continue to follow a standard low-cholesterol diet.

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 age who are not using effective methods of contraception,
• in pregnant women or women planning to become pregnant,
• in breastfeeding women,
• if the patient is concurrently taking glecaprevir with pibrentasvir for the treatment of hepatitis C virus infection.

Warnings and precautions
Before starting treatment with Sortis 10, discuss the following with your doctor, pharmacist, or
nurse:

• if the patient has severe respiratory insufficiency,
• if the patient is taking or has taken, within the last 7 days, fusidic acid (a medicine used to treat bacterial infections) orally or by injection. 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,
• in case of recurrent or unexplained muscle pain or muscle problems in the past, or similar problems in family members,
• 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 previous 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), as 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, as appropriate, 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 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 their effect on the body may be altered by Sortis 10.
This type of interaction may reduce the 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 hypertension, 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 medicines 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 in epilepsy treatment), 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 oral fusidic acid to treat a bacterial infection, treatment with this medicine should be temporarily discontinued. Your doctor will inform you 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 about rhabdomyolysis is provided in section 4.
• daptomycin (a medicine used to treat complicated skin and skin tissue infections and bacteraemia).

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 consume more than one or two small glasses of grapefruit juice per day, as larger quantities may alter the effect of Sortis 10.
Alcohol
While taking this medicine, avoid excessive alcohol consumption.
Further details on this are provided in section 2 “Warnings and precautions”.

Pregnancy and breastfeeding
Use of Sortis 10 in women who are pregnant or planning to become pregnant is contraindicated.
Use of Sortis 10 in women of childbearing age is contraindicated if they are not using effective methods of contraception.
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 using machines
Usually, this medicine does not affect the ability to drive or operate machinery. However, patients should not drive if this medicine affects their ability to do so. Do not use any tools or machines if taking this medicine affects your ability to operate them.

Sortis 10 contains lactose monohydrate
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 in adults and children aged 10 years or older is 10 mg once daily. This dose may be increased by your doctor as needed, up 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; they 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. In case of doubt, consult your doctor or pharmacist.
The duration of treatment with Sortis 10 is determined by your doctor.
If you feel that the effect of Sortis 10 is too strong or too weak, consult your doctor.
Taking more Sortis 10 than recommended
If you accidentally take too many Sortis 10 tablets (more than the usual daily dose), contact your doctor or nearest hospital for advice.
Missing a dose of Sortis 10
If you forget to take your dose, simply take the next dose at the scheduled time. Do not take a double dose to make up for the 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 will experience 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 without delay.

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

• Severe allergic reaction causing swelling of the face, tongue and throat, which may lead to severe breathing difficulties.
• A serious condition characterized by skin peeling and swelling, skin blisters, blisters in the mouth, eyes, genitals, and fever. Skin rash with pink-red spots, particularly on the palms or soles, possibly with blisters.
• Muscle weakness, tenderness, muscle pain or muscle rupture, or red-brown discoloration of urine. If the patient also feels unwell or has a high fever, this may be due to breakdown of striated muscles (rhabdomyolysis). Breakdown of striated muscles does not always resolve even after the patient stops taking atorvastatin, and may be life-threatening and lead to kidney problems.

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

• Unexpected or unusual bleeding or bruising, which may indicate liver abnormalities. Medical advice should be sought as soon as possible.
• Lupus-like syndrome (including rash, joint disorders, and effects on blood cells).

Other possible adverse reactions 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, flatulence, indigestion, diarrhoea
• Joint pain, muscle pain and back pain
• Blood test results indicating abnormal liver function

Uncommon: may occur in up to 1 in 100 people

• Anorexia (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 fingers, hands or feet, reduced sensitivity to pain and touch, altered taste, memory loss
• Blurred vision
• Ringing in the ears and (or) in the 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 up to 1 in 1,000 people

• Visual disturbances
• 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 up to 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).

Talk to your doctor if the patient experiences 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 this condition is higher in patients with high levels of blood sugar and fat, overweight patients, and those with high blood pressure. During treatment with this medicine, the doctor will perform appropriate tests on the patient.

Reporting of adverse reactions
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 the 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. Such measures 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 (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 10 tablets contains: hypromellose, polyethylene glycol 8000, titanium dioxide (E 171), talc, simethicone emulsion containing simethicone, emulsifying stearates (polysorbate 65, polyglyceryl 40 stearate, 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 coated tablets with a diameter of 5.6 mm, embossed with "10" on one side and "ATV" on the other side.
Packaged in poliamide/Al/PVC blisters covered with an Al/vinyl layer, in a cardboard box.
Sortis 10 is available in blisters containing 28 coated tablets.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Ireland, 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
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
Irish Marketing Authorisation Number (country of export): PA 23055/017/001
Parallel Import Authorisation Number: 188/20
Translation of some texts appearing on the blister:
MON - Monday
TUE - Tuesday
WED - Wednesday
THUR - Thursday
FRI - Friday
SAT - Saturday
SUN - Sunday