Corr 20

Package leaflet: Information for the patient

CORR 20, 20 mg, film-coated tablets
CORR 40, 40 mg, film-coated tablets
Simvastatinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. 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 any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What CORR is and what it is used for
2. What you need to know 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 blood levels of 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 consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries, forming plaque. The accumulation of plaque may lead to narrowing of the arteries.
This narrowing may slow down or block blood flow to vital organs such as the heart and brain. Blocked blood flow may result in a heart attack or stroke.
HDL cholesterol is often called "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 – they may 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 blood cholesterol levels (primary hypercholesterolemia) or high blood lipid levels (mixed hyperlipidemia);
• with an inherited condition (homozygous familial hypercholesterolemia) causing high blood cholesterol levels. Your doctor may also prescribe other medicines;
• with ischemic heart disease or at risk of developing it (due to diabetes, previous stroke, or other blood vessel disease). CORR may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

In most people, elevated cholesterol levels do not cause immediate symptoms. Your doctor can assess them by testing a blood sample. You should attend regular check-ups, have your cholesterol levels measured, and discuss treatment goals and results with your doctor.

2. Important information before using CORR

When not to use 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 abnormalities;
if the patient is pregnant or breastfeeding;
if the patient is 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 reduce cholesterol levels)
• cyclosporine (a medicine used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition 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 affecting cholesterol), CORR should not be used at a dose higher than 40 mg daily.
If in doubt whether the patient is taking any of the above-mentioned medicines, consult a doctor.

Warnings and precautions
Before starting treatment with CORR, discuss this with a doctor or pharmacist if:
the patient has any medical conditions, including allergies;
the patient consumes large amounts of alcohol;
the patient has ever had liver disease (CORR may not be suitable for them);
the patient is currently taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used to treat bacterial infection). Concomitant use of fusidic acid with CORR may cause severe muscle problems (rhabdomyolysis);
the patient is due to undergo surgery (temporary discontinuation of this medicine may be necessary);
the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), because statins may sometimes worsen symptoms or lead to the development of myasthenia (see section 4);
the patient is of Asian origin (a different dose of the medicine may be recommended).

The doctor should order blood tests before starting treatment with CORR and during treatment if the patient develops any symptoms of liver dysfunction. These tests are intended to monitor liver function.
The doctor may also recommend checking liver function markers in the blood after starting treatment with CORR.

Patients with diabetes or at risk of developing diabetes will remain under close medical supervision during treatment with CORR. Risk of developing diabetes may affect individuals with high blood sugar and fat levels, 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 contact a doctor immediately. In rare cases, muscle disorders may be severe, including muscle breakdown leading to kidney damage. Very rare cases of death have also been reported.

Also inform the doctor or pharmacist about persistent muscle weakness. Additional tests may be needed for diagnosis, and appropriate medicines may be required for treatment.

The risk of muscle breakdown increases with higher doses of simvastatin (particularly the 80 mg dose). The risk is also higher in certain patients. Consult a doctor if any of the following apply to the patient:

• consumption of large amounts of alcohol
• kidney function abnormalities
• thyroid gland dysfunction
• age 65 years or older
• female gender
• previous muscle problems during treatment with cholesterol-lowering medicines (statins or fibrates)
• inherited muscle disease diagnosed in the patient or a close relative.

Children and adolescents
The safety and efficacy of simvastatin have been studied in boys and girls aged 10–17 years (and in girls who have had their first menstrual period at least one year prior), see section 3 "How to take CORR". Simvastatin has not been evaluated in children under 10 years of age. More information can be obtained from the doctor.

CORR and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.

Taking CORR with any of the listed medicines may increase the risk of muscle-related adverse effects (some of these medicines have already been mentioned above in the section "When not to use CORR").

Fusidic acid: if the patient needs to take fusidic acid orally to treat a bacterial infection, temporary discontinuation of CORR is necessary. The doctor will advise when it is safe to resume taking CORR. Concurrent use of CORR and fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information about this condition can be found in section 4.

• cyclosporine (a medicine commonly used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, a condition 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 containing gemfibrozil or 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
• nefazodone (a medicine used to treat depression)
• medicines containing the active substance cobicistat
• amiodarone (a medicine used for heart rhythm disorders)
• verapamil, diltiazem or amlodipine (medicines used to treat high blood pressure, chest pain due to heart disease, or other heart conditions)
• lomitapide (a medicine used to treat a rare, severe genetic disorder affecting cholesterol)
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). Muscle-related adverse effects may be more pronounced when this medicine is taken during simvastatin treatment. The doctor may decide to temporarily discontinue simvastatin.
• colchicine (a medicine used to treat gout)
• ticagrelor (used in patients after heart attack or with unstable angina or chest pain not well controlled). If the patient is taking ticagrelor, do not take more than 40 mg of CORR daily.

In addition to the medicines listed above, inform the doctor or pharmacist about all medicines currently taken or taken recently, including over-the-counter medicines. Especially inform the doctor about medicines containing any of the following active substances:

• anticoagulants such as warfarin, phenprocoumon or acenocoumarol
• fenofibrate (also used to reduce cholesterol levels)
• niacin (also used to reduce cholesterol levels)
• rifampicin (a medicine used to treat tuberculosis).

Also inform any doctor prescribing a new medicine that the patient is taking CORR.

CORR with food, drink and alcohol
Grapefruit juice contains one or more components that may alter the action of certain medicines, including CORR. Grapefruit juice should be avoided during treatment.
Inform the doctor about consumption of large amounts of alcohol.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
CORR must not be used if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with CORR, the patient must stop taking the medicine immediately and contact her doctor.
CORR must not be used if the patient is breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and operating machinery
CORR should not impair the ability to drive or operate machinery. However, dizziness may occur in some individuals after taking the medicine, which should be taken into account.

CORR contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking this medicine.

3. How to use CORR

The doctor determines the appropriate tablet strength depending on the patient's health condition, current treatment, and individual risk.
This medicine should always be taken as directed by the doctor. If in doubt, consult a doctor or pharmacist.
While taking this medicine, a low-cholesterol diet should be followed.
The recommended dose is one tablet taken orally once daily.
Adults
The usual starting dose is typically 10, 20, or sometimes 40 mg once daily. The doctor may adjust the dose after at least 4 weeks up to a maximum dose of 80 mg daily. Do not take more than 80 mg daily.
The doctor may prescribe a lower dose, especially if the patient is already taking certain medicines listed above or has a specific kidney disease.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease who have not achieved target cholesterol levels with lower doses.
Use in children and adolescents
In children and adolescents (aged 10–17 years), the usual recommended starting dose is 10 mg once daily, taken in the evening. The maximum recommended dose is 40 mg daily.
Method of administration and duration of treatment
The medicine should be taken in the evening, regardless of meals. Treatment should continue for as long as the doctor recommends.
Tablets may be divided into equal doses.
If the doctor has prescribed CORR together with another cholesterol-lowering medicine containing a bile acid-binding substance, CORR should be taken at least 2 hours before or at least 4 hours after taking that medicine.
Taking more CORR than recommended
Seek immediate medical advice. In case of overdose, the doctor will administer symptomatic and supportive treatment.
Missing a dose of CORR
Do not take a double dose to make up for a missed dose; continue treatment according to the prescribed schedule.
Stopping CORR
Discuss this with your doctor or pharmacist, as blood cholesterol levels may rise again.
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 everybody will experience them.
If the patient experiences any of the following serious adverse reactions, the medicine must be discontinued immediately and the patient should seek medical advice from a doctor or go immediately to the nearest hospital emergency department:

The following rare but serious adverse reactions have been reported:

• muscle pain, tenderness, weakness or cramps. In rare cases, these symptoms may be severe, including muscle breakdown (rhabdomyolysis) leading to kidney damage, and very rarely resulting in death.
• hypersensitivity reactions (allergic reactions), including:
• swelling of the face, tongue and throat, which may cause difficulty in breathing (angioedema)
• severe muscle pain, usually in the shoulders and hips
• rash with muscle weakness in the limbs and neck
• joint pain or inflammation
• inflammation of blood vessels
• unusual bruising, skin lesions and swelling, urticaria, photosensitivity, fever, sudden redness of the skin
• shortness of breath and malaise
• lupus-like reactions (including rash, joint disorders and effects on blood cells)
• hepatitis with the following symptoms: yellowing of the skin and eyes (jaundice), 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 serious adverse reactions have been reported:

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis)
• gynaecomastia (enlargement of breasts in males)
• skin rash which may also affect the mucous membranes of the mouth (lichenoid mucosal lesions)
  Muscle damage has also been reported with the following adverse reactions:

Rare (may occur in fewer than 1 in 1,000 people):

• low number of red blood cells (anaemia)
• numbness or weakness in arms and legs
• headache, tingling sensation, dizziness
• blurred vision; visual disturbances
• gastrointestinal disturbances (abdominal pain, constipation, bloating, dyspepsia, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• fatigue
• increased values in certain liver function tests and increased activity of an enzyme present in muscle (creatine kinase)
• memory loss, confusion

Very rare (may occur in fewer than 1 in 10,000 people):
difficulty in sleeping
memory disorders

Frequency not known (frequency cannot be estimated from the available data):
erectile dysfunction
depression
lung inflammation 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 causing generalised muscle weakness, including in some cases muscles involved in breathing)
ocular myasthenia (a disease causing weakness of the eye muscles).

Patients should consult a doctor if they experience weakness in the arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Additional possible adverse reactions reported during the use of some statins:
sleep disorders, including nightmares
sexual dysfunction
diabetes. The risk of developing diabetes is higher in patients with high levels of blood sugar and fats, overweight and high blood pressure. Your doctor will monitor your health while you are taking this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any 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 at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store CORR

Keep the 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 cardboard box after "EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Store blisters in the cardboard box to protect from light.
Tablet container
Keep tablets in the original packaging to protect from light.
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 CORR contains

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

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

What CORR looks like and contents of the pack
CORR 20 coated tablets are orange, oval-shaped, biconvex, with a breakline on both sides, marked "20" on one side.
CORR 40 coated tablets are brownish-red, oval-shaped, biconvex, with a breakline on both sides, marked "40" on one side.
Blister packs made of PVC/Aluminium foil contain 28, 30, 60 or 90 coated tablets.
Polyethylene containers with screw caps contain 28 or 30 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturers
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia
LEK S.A.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Lek S.A.
ul. Podlipie 16
95-010 Stryków, Poland
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

For further information about the medicinal product and its names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
tel. 22 209 70 00