Corr 40

Package Leaflet: Information for the Patient

CORR 20, 20 mg, Film-Coated Tablets

CORR 40, 40 mg, Film-Coated Tablets

Simvastatin

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

• You should keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet:

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

1. What CORR is and what it is used for

CORR contains the active substance simvastatin. CORR is a medicine used to lower the level of cholesterol in the blood, specifically total cholesterol, LDL cholesterol (so-called "bad" cholesterol), and a type of fat called triglycerides. 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 is mainly made up of LDL and HDL cholesterol. LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of arteries, forming plaques, and the accumulation of plaques can cause the arteries to narrow. The consequence of narrowing can 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 because it helps prevent the buildup of "bad" cholesterol in the arteries and protects against heart disease. Triglycerides are another type of fat present in the blood and can increase the risk of heart disease. While taking this medicine, you should follow a low-cholesterol diet. CORR is used (in addition to diet) in patients with:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of lipids in the blood (mixed hyperlipidemia);
• a hereditary disease (homozygous familial hypercholesterolemia) where the level of cholesterol in the blood is elevated. Your doctor may also prescribe other medicines.
• ischemic heart disease or at risk of developing it (due to diabetes, a history of stroke, or other vascular disease). CORR may prolong life by reducing the risk of heart disease, regardless of the amount of cholesterol in the blood.

Most people with high cholesterol do not have symptoms. Your doctor can assess them by examining a blood sample. You should regularly visit your doctor, have your cholesterol levels checked, and discuss your treatment goals and results with your doctor.

2. Important information before taking CORR

When not to take CORR

if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6); if you currently have liver problems; if you are pregnant or breastfeeding; if you are taking medicines containing any 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 lower cholesterol levels)
• cyclosporine (a medicine used in patients who have had an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, where the lining of the uterus grows outside the uterus)

If you are taking lomitapide (a medicine used to treat a rare, severe genetic disorder related to cholesterol), you should not take CORR at a dose greater than 40 mg per day. If you are unsure whether you are taking any of the above medicines, consult your doctor.

Warnings and precautions

Before starting to take CORR, discuss it with your doctor or pharmacist if: you have any diseases, including allergies; you consume large amounts of alcohol; you have had liver disease in the past (CORR may not be suitable for you); you are taking or have 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 serious muscle disorders (rhabdomyolysis); you are going to have surgery (it may be necessary to stop taking this medicine for a short time); you have had muscle weakness (myasthenia) or eye muscle weakness (ocular myasthenia), as statins can sometimes worsen symptoms or lead to myasthenia (see section 4). you are of Asian origin (a different dose of the medicine may be recommended). Your doctor should recommend a blood test before starting CORR and during treatment if you experience any symptoms of liver problems. These tests are to check liver function. Your doctor may also recommend checking liver function indicators in the blood after starting CORR. Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking CORR. The risk of developing diabetes may affect people with high levels of sugar and fat in the blood, with overweight and high blood pressure. Inform your doctor if you have severe lung disease.

If you experience unexplained muscle pain, tenderness, or weakness, you should immediately consult your 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.

You should also inform your doctor or pharmacist about persistent muscle weakness. Additional tests may be necessary to diagnose it, and appropriate medications may be necessary for treatment. 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. You should consult your doctor if any of the following apply to you: consuming large amounts of alcohol; kidney problems; thyroid problems; age 65 or older; female sex; previous muscle problems while taking cholesterol-lowering medicines (statins or fibrates); a hereditary muscle disease diagnosed in you 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 have had their first period at least one year ago), see section 3 "How to take CORR". The use of simvastatin has not been evaluated in children under the age of 10. Your doctor will provide more information.

CORR and other medicines

Inform your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Taking CORR with any of the mentioned medicines can increase the risk of side effects affecting the muscles (some of these medicines have already been mentioned above in the "When not to take CORR" section). Fusidic acid: if you need to take fusidic acid orally to treat a bacterial infection, it will be necessary to temporarily stop taking CORR.Your doctor will inform you when it is safe to resume taking it. Taking CORR and fusidic acid at the same time can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information about this condition can be found insection 4. cyclosporine (a medicine often used in patients who have had an organ transplant) danazol (a synthetic hormone used to treat endometriosis, where 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 lower 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 side effects affecting the muscles may be greater when this medicine is taken with simvastatin. Your doctor may decide to stop simvastatin for a while. colchicine (a medicine used to treat gout) tikagrelor (used in patients who have had a heart attack, or with angina or chest pain that is not well controlled). If you are taking tikagrelor, you should not take more than 40 mg of CORR per day. Apart from the medicines mentioned above, inform your doctor or pharmacist about all medicines you are currently taking or have recently taken, including those available without a prescription. In particular, inform your doctor about medicines containing any of the following active substances: anticoagulants, such as warfarin, phenprocoumon, or acenocoumarol (medicines that prevent blood clots) fenofibrate (also used to lower cholesterol levels) niacin (also used to lower cholesterol levels) rifampicin (a medicine used to treat tuberculosis). You should also inform your doctor about taking CORR when they prescribe you a new medicine.

CORR with food, drink, and alcohol

Grapefruit juice contains one or more components that can alter the action of some medicines, including CORR. You should avoid drinking it while taking this medicine. Inform your doctor about consuming large amounts of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine. You should not take CORR if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking CORR, you should stop taking it immediately and consult your doctor. You should not take CORR if you are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

CORR is unlikely to affect your ability to drive or use machines. However, you should take into account the possibility of dizziness after taking the medicine.

CORR contains lactose

If you have been diagnosed with an intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take CORR

Your doctor will determine the appropriate tablet strength based on your health condition, current treatment, and individual risk. You should always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist. While taking this medicine, you should follow a low-cholesterol diet. The recommended dose isone tablet taken orally once a day. AdultsThe usual starting dose is 10, 20, or sometimes 40 mg per day. Your doctor may adjust the dose of CORR after at least 4 weeks to a maximum dose of 80 mg per day. You should not take more than 80 mg per day.Your doctor may prescribe a lower dose, especially if you are already taking certain medicines mentioned above or have 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 heart disease who have not reached their target cholesterol level with lower doses. Use in children and adolescentsIn children and adolescents (aged 10-17), the recommended starting 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. You should take CORR for as long as your doctor recommends. The tablets can be divided into equal doses. If your doctor has prescribed CORR with another cholesterol-lowering medicine containing a bile acid sequestrant, you should take CORR at least 2 hours before or at least 4 hours after taking the other medicine.

Taking a higher dose of CORR than recommended

You should immediately consult your doctor. In case of overdose, your doctor will provide symptomatic and supportive treatment.

Missing a dose of CORR

You should not take a double dose to make up for a missed dose, but continue treatment according to the recommended dosage regimen.

Stopping treatment with CORR

You should discuss this with your doctor or pharmacist, as your cholesterol levels may rise again. If you have any further questions about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

If you experience any of the following serious side effects, stop taking CORR and immediately consult your doctor or go to the emergency department of your nearest hospital:

The following rare but serious side effects have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms can be severe, including muscle breakdown leading to kidney damage, and very rarely, they have been 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 arms and neck
• joint pain or inflammation
• vasculitis (inflammation of blood vessels)
• 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 feeling unwell
• 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 tired or weak, loss of appetite, and very rarely, liver failure
• pancreatitis, often with severe abdominal pain.

The following very rare but 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:

Rare(may affect up to 1 in 1000 people):

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

Very rare(may affect up to 1 in 10,000 people):
sleep disorders
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 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).
You should discuss with your doctor if you experience weakness in your 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 with the use of some statins:
sleep disorders, including nightmares
sexual disorders
diabetes. Its onset is more likely in patients with high levels of sugar and fat in the blood, with overweight and high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects

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

5. How to store CORR

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the blister, tablet container, and carton after "EXP". The expiry date refers to the last day of the month. Do not store above 30°C. Store blisters in the carton to protect from light. Tablet container Store tablets in their original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What CORR contains

• The active substance of CORR is simvastatin. Each film-coated tablet contains 20 mg or 40 mg of simvastatin.
• The 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).

What CORR looks like and contents of the pack

CORR 20 film-coated tablets are orange, oval, biconvex, with a score line on both sides, marked with "20" on one side. CORR 40 film-coated tablets are reddish-brown, oval, biconvex, with a score line on both sides, marked with "40" on one side. Blisters of PVC/Aluminum 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 on this medicine and its names in other European Economic Area countries, please 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