Corr 20

Leaflet accompanying the packaging: patient information

CORR 20, 20 mg, film-coated tablets

CORR 40, 40 mg, film-coated tablets

Simvastatin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• 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 or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is CORR and what is it used for
• 2. Important information before taking CORR
• 3. How to take CORR
• 4. Possible side effects
• 5. How to store CORR
• 6. Package contents and other information

1. What is CORR and what is it used for

CORR contains the active substance simvastatin. CORR is a medicine used to reduce the level of total cholesterol, LDL cholesterol (so-called "bad" cholesterol), and fatty substances called triglycerides in the blood. Additionally, CORR increases the level of HDL cholesterol (so-called "good" cholesterol). CORR belongs to a group of medicines called statins. Cholesterol is one of the fatty substances present in the blood. Total cholesterol mainly consists of LDL and HDL cholesterol. LDL cholesterol is often referred to as "bad" cholesterol, as it can accumulate in the walls of arteries, forming a plaque, and the accumulation of plaques can cause the arteries to narrow. The consequence of narrowing may be a slowing or blockage of blood flow to vital organs, such as the heart and brain. Blockage of blood flow can lead to a heart attack or stroke. HDL cholesterol is often referred to as "good" cholesterol, as it helps prevent the accumulation of "bad" cholesterol in the arteries and protects against heart disease. Triglycerides are another type of fat present in the blood - they can increase the risk of heart disease. While taking the medicine, a low-cholesterol diet should be followed. CORR is used (in addition to diet) in patients:

• with high blood cholesterol levels (primary hypercholesterolemia) or high blood lipid levels (mixed hyperlipidemia);
• with a hereditary disease (homozygous familial hypercholesterolemia), in which blood cholesterol levels are elevated. The doctor may also prescribe other medicines.
• with coronary heart disease or a risk of its development (due to diabetes, a history of stroke or other vascular disease). CORR may prolong the patient's life, reducing the risk of developing heart disease, regardless of the amount of cholesterol in the blood.

Most people with high cholesterol do not have symptoms right away. The doctor can assess them by examining a blood sample. Regular check-ups with the doctor, cholesterol level checks, and discussions with the doctor about treatment goals and results are necessary.

2. Important information before taking CORR

When not to take CORR

if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6); if the patient currently has liver function disorders; if the patient is pregnant or breastfeeding; if the patient is taking medicines containing one or more of the following active substances:

• itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
• erythromycin, clarithromycin, or telithromycin (medicines used to treat infections)
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infection)
• boceprevir or telaprevir (medicines used to treat hepatitis C)
• nefazodone (an antidepressant)
• cobicistat
• gemfibrozil (a medicine used to reduce cholesterol levels)
• cyclosporine (a medicine used in patients after organ transplantation)
• danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterus)

If the patient is taking lomitapide (a medicine used to treat a rare, severe genetic disorder related to cholesterol), they should not take CORR in a dose greater than 40 mg per day. In case of doubts about taking any of the above medicines, consult a doctor.

Warnings and precautions

Before starting to take CORR, discuss it with a doctor or pharmacist if: the patient has any diseases, including allergies; the patient consumes large amounts of alcohol; the patient has had liver disease in the past (CORR may not be suitable for them); the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Taking fusidic acid with CORR can cause severe muscle disorders (rhabdomyolysis); the patient is going to have surgery (it may be necessary to stop taking this medicine for a short time); if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4). the patient is of Asian origin (it may be advisable to use a different dose of the medicine). The doctor should recommend a blood test before starting to take CORR and during treatment if the patient experiences any symptoms of liver function disorders. These tests are intended to monitor liver function. The doctor may also recommend checking liver function indicators in the blood after starting to take CORR. Patients with diabetes or at risk of developing diabetes will be under close medical supervision while taking CORR. The risk of developing diabetes may concern people with high blood sugar and fat levels, with overweight and high blood pressure. Inform the doctor if the patient has severe lung disease.

If the patient experiences unexplained muscle pain, increased sensitivity to touch (tenderness) or weakness, they should immediately consult a doctor. In rare cases, muscle disorders can be severe, including muscle breakdown leading to kidney damage.

Very rare cases of death have also been reported.

The patient should also tell the doctor or pharmacist about persistent muscle weakness. To diagnose it, additional tests may be necessary, and appropriate medications may be administered. The risk of muscle breakdown increases with the dose of simvastatin (mainly at a dose of 80 mg). It is also higher in some patients. The patient should consult a doctor if any of the following apply: consuming large amounts of alcohol; kidney function disorders; thyroid function disorders; age 65 or older; female sex; previous muscle disorders during treatment with cholesterol-lowering medicines (statins or fibrates); a hereditary muscle disease diagnosed in the patient or a close relative.

Children and adolescents

The safety and efficacy of simvastatin have been studied in 10-17-year-old boys and girls (who started menstruating at least one year earlier), see section 3 "How to take CORR". The use of simvastatin has not been evaluated in children under the age of 10. The doctor will provide more information.

CORR and other medicines

The patient should tell the doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Taking CORR with any of the listed medicines may increase the risk of side effects affecting the muscles (some of these medicines have already been listed above in the "When not to take CORR" section). Fusidic acid: if the patient needs to take oral fusidic acid to treat a bacterial infection, it will be necessary to temporarily stop taking CORR.

The doctor will inform when it can be safely resumed. Concurrent use of CORR and fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information about this condition can be found in section 4. cyclosporine (a medicine often used in patients after organ transplantation) danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterus) medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (medicines used to treat fungal infections) fibrates with active substances such as gemfibrozil and bezafibrate (used to reduce cholesterol levels) erythromycin, clarithromycin, or telithromycin (medicines used to treat bacterial infections) HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infection) medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (medicines used to treat hepatitis C) nefazodone (an antidepressant) medicines containing the active substance cobicistat amiodarone (a medicine used to treat heart rhythm disorders) verapamil, diltiazem, or amlodipine (medicines used to treat high blood pressure, chest pain caused by heart disease, or other heart conditions) lomitapide (a medicine used to treat a rare, severe genetic disorder related to cholesterol) daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when this medicine is taken with simvastatin. The doctor may decide to stop taking simvastatin for a while. colchicine (a medicine used to treat gout) ticagrelor (used in patients after a heart attack, or with angina pectoris or chest pain that is not well controlled). If the patient is taking ticagrelor, they should not take more than 40 mg of CORR per day. Apart from the medicines listed above, the patient should tell the doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. In particular, the patient should inform the doctor about taking medicines containing any of the following active substances: anticoagulants, such as warfarin, phenprocoumon, or acenocoumarol (medicines that prevent blood clots) fenofibrate (also used to reduce cholesterol levels) niacin (also used to reduce cholesterol levels) rifampicin (a medicine used to treat tuberculosis). The patient should also inform the doctor about taking CORR when a new medicine is prescribed.

CORR with food, drinks, and alcohol

Grapefruit juice contains one or more components that can change the effect of some medicines, including CORR. The patient should avoid drinking it during treatment. The patient should inform the doctor about consuming large amounts of alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. The patient should not take CORR if they are pregnant, trying to become pregnant, or suspect they may be pregnant. If the patient becomes pregnant while taking CORR, they should stop taking the medicine immediately and contact their doctor. The patient should not take CORR if they are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

CORR should not affect the patient's ability to drive or use machines. However, the patient should take into account the possibility of dizziness after taking the medicine.

CORR contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take CORR

The doctor will determine the appropriate tablet strength based on the patient's health condition, current treatment, and individual risk. This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist. While taking the medicine, a low-cholesterol diet should be followed. The recommended dose isone tablet taken orally once a day. AdultsThe usual initial dose is 10, 20, or sometimes 40 mg per day. The doctor may adjust the dose of the medicine after at least 4 weeks to a maximum dose of 80 mg per day. The patient should not take more than 80 mg per day.The doctor may prescribe a lower dose, especially if the patient is already taking certain medicines listed above or has a certain kidney disease. A dose of 80 mg is recommended only for adult patients with very high cholesterol levels and a high risk of developing heart disease who have not achieved the target cholesterol level with lower doses of the medicine. Use in children and adolescentsIn children and adolescents (aged 10-17), the recommended initial dose is usually 10 mg per day, taken in the evening. The maximum recommended dose is 40 mg per day. Method of administration and duration of treatment The medicine should be taken in the evening, regardless of meals. The medicine should be taken until the doctor recommends stopping it. The tablets can be divided into equal doses. If the doctor has prescribed CORR with another cholesterol-lowering medicine containing a bile acid sequestrant, CORR should be taken at least 2 hours before or at least 4 hours after taking that medicine.

Taking a higher dose of CORR than recommended

The patient should immediately consult a doctor. In case of overdose, the doctor will administer symptomatic and supportive treatment.

Missing a dose of CORR

The patient should not take a double dose to make up for a missed dose, but continue treatment according to the recommended schedule. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

Stopping treatment with CORR

The patient should discuss this with a doctor or pharmacist, as blood cholesterol levels may increase again. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following serious side effects, they should stop taking the medicine and immediately consult a doctor or go to the emergency department of the nearest hospital:

The following rare, serious side effects have been reported:

• pain, tenderness, weakness, or cramps in the muscles. In rare cases, these symptoms can be severe, including muscle breakdown leading to kidney damage, and very rarely, they can be fatal.
• allergic reactions (hypersensitivity), including:
• swelling of the face, tongue, and throat, which can make breathing difficult (angioedema)
• severe muscle pain, usually in the shoulders and hips
• rash with muscle weakness in the limbs and neck
• joint pain or inflammation
• vasculitis
• unusual bruising, skin changes, and swelling, hives, increased sensitivity of the skin to the sun, fever, sudden flushing of the skin
• shortness of breath and malaise
• changes resembling lupus erythematosus (including rash, joint disorders, and effects on blood cells)
• hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling of tiredness or weakness, loss of appetite, and very rarely, liver failure
• pancreatitis, often with severe abdominal pain.

The following very rare, serious side effect has been reported:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• a rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid reactions) muscle damage. The following side effects have also been reported:

Rarely(may occur less frequently than in 1 in 1000 people):

• low red blood cell count (anemia)
• numbness or weakness in the arms and legs
• headache, tingling, dizziness
• blurred vision; vision disturbances
• digestive disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• increased values of some liver function tests and increased activity of the enzyme present in muscles (creatine kinase)
• memory loss, confusion

Very rarely(may occur less frequently than in 1 in 10,000 people):
difficulty sleeping
memory disorders
Frequency not known(frequency cannot be estimated from the available data):
erectile dysfunction
depression
inflammation of the lungs causing breathing difficulties, including persistent cough and/or shortness of breath and/or fever
tendon disorders, sometimes complicated by tendon rupture
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 weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects that have been reported during the use of some statins:
sleep disorders, including nightmares
sexual disorders
diabetes. Its occurrence is more likely in patients with high blood sugar and fat levels, with overweight and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

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 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store CORR

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister, tablet container, and cardboard box after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Blisters should be stored in a cardboard box to protect from light. Tablet container The tablets should be stored in the original packaging to protect from light. 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. Package contents and other information

What CORR contains

• The active substance of the medicine is simvastatin. Each film-coated tablet contains 20 mg or 40 mg of simvastatin.
• Other ingredients are: CORR 20: maize starch, lactose monohydrate, microcrystalline cellulose, butylhydroxyanisole (E320), citric acid monohydrate, magnesium stearate, hypromellose 5 cps, hypromellose 15 cps, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172). CORR 40: maize starch, lactose monohydrate, microcrystalline cellulose, butylhydroxyanisole (E320), citric acid monohydrate, magnesium stearate, hypromellose 5 cps, hypromellose 15 cps, talc, titanium dioxide (E171), iron oxide red (E172).

CORR 40: maize starch, lactose monohydrate, microcrystalline cellulose, butylhydroxyanisole (E320), citric acid monohydrate, magnesium stearate, hypromellose 5 cps, hypromellose 15 cps, talc, titanium dioxide (E171), iron oxide red (E172).

What CORR looks like and what the package contains

CORR 20 film-coated tablets are orange, oval, biconvex, with a dividing line on both sides, marked with "20" on one side. CORR 40 film-coated tablets are reddish-brown, oval, biconvex with a dividing line on both sides, marked with "40" on one side. Blisters of PVC/Aluminum foil contain 28, 30, 60, or 90 film-coated tablets. Polyethylene containers with a screw cap contain 28 or 30 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 A-6250 Kundl, Austria Manufacturer Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia LEK S.A. ul. Domaniewska 50 C 02-672 Warsaw, Poland Lek S.A. ul. Podlipie 16 95-010 Stryków Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany S.C. Sandoz, S.R.L. Livezeni Street no 7A 540472 Targu Mures, Romania

To obtain more detailed information about the medicine and its names in other Member States of the European Economic Area, the patient should contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of last revision of the leaflet:04/2023 Sandoz logo