Simvastatin Genoptim

PATIENT INFORMATION LEAFLET

Enclosed leaflet: patient information

Simvastatin Genoptim, 10 mg, film-coated tablets

Simvastatin Genoptim, 20 mg, film-coated tablets

Simvastatin Genoptim, 40 mg, film-coated tablets

Simvastatin
This medication is absolutely contraindicated in pregnancy
Read the leaflet carefully before taking the medication because 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 medication has been prescribed to a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including any possible 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 Simvastatin Genoptim and what is it used for
• 2. Important information before taking Simvastatin Genoptim
• 3. How to take Simvastatin Genoptim
• 4. Possible side effects
• 5. How to store Simvastatin Genoptim
• 6. Contents of the pack and other information

1. What is Simvastatin Genoptim and what is it used for

Simvastatin Genoptim contains the active substance simvastatin. Simvastatin Genoptim is a medication used to lower the level of total cholesterol, so-called "bad" cholesterol (LDL cholesterol fraction) and fats called triglycerides in the blood. Additionally, Simvastatin Genoptim increases the level of "good" cholesterol (HDL cholesterol fraction).
Simvastatin Genoptim belongs to a group of medications called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate on the walls of arteries, forming a plaque. Eventually, this accumulated plaque can lead to narrowing of the arteries.
This narrowing can slow down or block the flow of blood to vital organs, such as the heart and brain. Blocking the flow of blood can lead to a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol on the walls of arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that can increase the risk of heart disease.
A low-cholesterol diet should be followed during treatment with Simvastatin Genoptim.
Simvastatin Genoptim is used in combination with a low-cholesterol diet in people:

• who have been diagnosed with high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• with a hereditary disease (homozygous familial hypercholesterolemia) that is associated with high cholesterol levels in the blood. In these patients, other treatments may also be used;
• with coronary heart disease (coronary artery disease) or who are at high risk of developing coronary heart disease (due to diabetes, a history of stroke or other vascular diseases). Simvastatin Genoptim may help reduce the risk of developing heart disease, regardless of cholesterol levels in the blood, and thus prolong life for these patients.

In most people, there are no direct symptoms of high cholesterol levels. A doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of cholesterol levels in the blood, and discussion of treatment goals with a doctor are necessary.

2. Important information before taking Simvastatin Genoptim

When not to take Simvastatin Genoptim:

• If the patient is allergicto simvastatin or any of the other ingredients of this medication (listed in section 6).
• If the patient currently has liver problems.
• If the patient is pregnantor breastfeeding.
• If the patient is taking a medication containing one or more of the following active substances:
• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, or saquinavir (used to treat HIV infections),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol levels),
• cyclosporine (used in patients after organ transplants),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus),
• if the patient is taking or has taken within the last 7 days a medication called fusidic acid (used to treat bacterial infections).
• Do not take more than 40 mg of Simvastatin Genoptim if you are taking lomitapide (a substance used to treat serious, rare, hereditary cholesterol disorders).

In case of doubt about whether a medication taken by the patient is listed above, consult a doctor.

Warnings and precautions

Tell your doctor:

• about all current and past illnesses, including allergies,
• about consuming large amounts of alcohol,
• about having had liver disease in the past. In such cases, Simvastatin Genoptim may be contraindicated,
• about planned surgery. In such cases, it may be necessary to discontinue Simvastatin Genoptim for a period of time.
• about being of Asian origin. In such cases, a different dose of the medication may be used.

Before starting treatment, your doctor should order a blood test to check liver function. Also, during treatment with Simvastatin Genoptim, your doctor may consider it necessary to perform blood tests to check liver function.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medication. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Tell your doctor if you have severe lung disease.
Also, inform your doctor or pharmacist if you experience persistent muscle weakness. To diagnose and treat this condition, additional tests and medications may be necessary.

Immediately consult a doctor if you experience unexplained muscle pain, tenderness, or weakness, as in rare cases, this can lead to serious muscle problems, including muscle tissue breakdown, which can cause kidney damage; very rarely, deaths have been reported.

Muscle tissue breakdown can cause kidney damage; very rarely, deaths have been reported.
The risk of muscle tissue breakdown is higher in patients taking Simvastatin Genoptim in higher doses, especially 80 mg. The risk of muscle tissue breakdown is also higher in certain patient groups. Consult your doctor if:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are 65 years of age or older,
• you are female,
• you have had muscle problems while taking cholesterol-lowering medications, including statins or fibrates,
• you or a close relative have been diagnosed with hereditary muscle disorders.

Children and adolescents

The safety and efficacy of simvastatin have been studied in boys aged 10-17 years and in girls who had their first menstrual period at least one year earlier (see section 3 "How to take Simvastatin Genoptim"). No studies have been conducted in children under the age of 10. For more information, consult a doctor.
Disorders of liver proteins (OATP transport proteins) that occur in patients with a specific gene may increase the risk of muscle disease and kidney damage. If necessary, your doctor may recommend genetic testing before prescribing a dose of 80 mg of simvastatin.

Simvastatin Genoptim and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those that are available without a prescription. In particular, tell your doctor if you are taking medications containing the following active substances:

• cyclosporine (often used in patients after organ transplants),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus)
• medications containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates, medications containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol levels),
• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take simvastatin while taking these medications. See also section 4 of this leaflet.
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS),
• boceprevir or telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medications containing the active substance cobicistat,
• amiodarone (used to treat heart rhythm disorders),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases),
• lomitapide (used to treat serious, rare, hereditary cholesterol disorders)
• colchicine (used to treat gout).

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those that are available without a prescription. In particular, tell your doctor if you are taking medications containing the following active substances:

• medications containing active substances that prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medications),
• fenofibrate (used to lower cholesterol levels),
• niacin (used to lower cholesterol levels),
• rifampicin (used to treat tuberculosis).

Also, tell the doctor who prescribes a new medication that you are taking Simvastatin Genoptim.

Simvastatin Genoptim with food and drink

Grapefruit juice contains one or more compounds that affect the action of certain medications in the body, including Simvastatin Genoptim. Avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Simvastatin Genoptim if you are pregnant, plan to have a child, or suspect you may be pregnant. If you become pregnant while taking Simvastatin Genoptim, stop taking the medication and consult your doctor. If you are breastfeeding, do not take Simvastatin Genoptim, as it is not known whether the medication is excreted in breast milk.
Before taking any medication, consult a doctor or pharmacist.

Driving and using machines

Simvastatin Genoptim does not affect the ability to drive or operate machines.
However, consider that some people may experience dizziness after taking Simvastatin Genoptim.

Important information about some ingredients of Simvastatin Genoptim

Simvastatin Genoptim tablets contain a sugar called lactose. If you have been diagnosed with intolerance to some sugars, consult your doctor before taking this medication.

3. How to take Simvastatin Genoptim

Your doctor will determine the appropriate dose of the medication based on your condition, previous treatment, and risk factors.
Always take this medication exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
A low-cholesterol diet should be followed during treatment with Simvastatin Genoptim.

Dosage

The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg taken orally once a day.
Adults
Typically, the initial dose is 10 mg, 20 mg, or, in some cases, 40 mg per day. Your doctor may adjust the dose after at least 4 weeks to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking certain medications listed above or have certain kidney problems.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of developing heart disease, who have not achieved the target cholesterol level with lower doses.
Children and adolescents
For children (aged 10-17 years), the recommended initial dose is 10 mg once a day in the evening. The maximum recommended dose is 40 mg per day.
Method of administration and duration of treatment
Simvastatin Genoptim should be taken in the evening. The medication can be taken with or without food. Simvastatin Genoptim should be taken until your doctor tells you to stop.
If your doctor has prescribed taking Simvastatin Genoptim with another cholesterol-lowering medication that binds bile acids, take Simvastatin Genoptim at least 2 hours before or 4 hours after taking the bile acid-binding medication.

Taking a higher dose of Simvastatin Genoptim than recommended

If you have taken too much Simvastatin Genoptim, consult your doctor or pharmacist.

Missing a dose of Simvastatin Genoptim

Do not take a double dose to make up for a missed dose, just take the normal dose at the usual time the next day.

Stopping treatment with Simvastatin Genoptim

Consult your doctor or pharmacist because cholesterol levels may increase again.
If you have any further questions about taking this medication, consult your doctor or pharmacist.

4. Possible side effects

Like all medications, Simvastatin Genoptim can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects are reported:

• rare (occurred in at least 1 in 10,000 but less than 1 in 1,000 patients),
• very rare (occurred in less than 1 in 10,000 patients),
• frequency not known (cannot be estimated from the available data)

The following are rare but serious side effects.

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

• muscle pain, tenderness, or weakness. In rare cases, these conditions can be severe and associated with muscle tissue breakdown, which can cause kidney damage; very rarely, deaths have been reported;
• allergic reactions (including anaphylaxis) such as:
• swelling of the face, tongue, and throat that may cause difficulty breathing,
• severe muscle pain, usually in the shoulder and hip area,
• rash with muscle weakness in the arms and neck,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, increased sensitivity of the skin to the sun, fever, hot flashes,
• shortness of breath and malaise,
• symptoms of lupus-like disease (including rash, joint pain, and changes in blood cells),
• liver inflammation with symptoms such as yellowing of the skin and eyes, itching, dark urine, or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare);
• pancreatitis, often with severe abdominal pain.

Rarely, the following side effects have also been reported:

• decreased red blood cell count (anemia),
• numbness or weakness in the arms or legs,
• headache, tingling, dizziness,
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• sleep disorders (very rare),
• poor memory (very rare), memory loss, confusion.

The following side effects have been reported, but their frequency cannot be estimated from the available data (frequency not known):

• erectile dysfunction,
• depression,
• inflammation of the lungs causing breathing problems, including prolonged cough and (or) shortness of breath or fever,
• tendon disorders, sometimes complicated by tendon rupture.
• persistent muscle weakness.

Other possible side effects reported during treatment with some statins:

• sleep disorders, including nightmares,
• sexual disorders.
• Diabetes. The risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition while taking this medication.
• Persistent muscle pain, tenderness, or weakness, which in very rare cases may not resolve after stopping Simvastatin Genoptim.

Laboratory test results
In some laboratory blood tests, increased liver enzyme activity and muscle enzyme activity (creatine kinase) have been observed.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring, 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
e-mail: ndl@urpl.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to store Simvastatin Genoptim

Store the medication out of sight and reach of children.
Do not store above 25°C.
Do not use this medication after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Simvastatin Genoptim contains

• The active substance is simvastatin; each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• The other ingredients are: butylhydroxyanisole (E320), microcrystalline cellulose (E460i), maize starch, lactose anhydrous, magnesium stearate (E572), hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), talc (E553B).

What Simvastatin Genoptim looks like and contents of the pack

Simvastatin Genoptim 10 mg, film-coated tablets are:

• white, oval, biconvex, with a score line and engraved with "10" on one side and "SVT" on the other.

Simvastatin Genoptim 20 mg, film-coated tablets are:

• white, oval, biconvex, with a score line and engraved with "20" on one side and "SVT" on the other.

Simvastatin Genoptim 40 mg, film-coated tablets are:

• white, oval, biconvex, with a score line and engraved with "40" on one side and "SVT" on the other.

The tablets are packaged in boxes containing 28, 30, 60, and 90 tablets (in blisters).
Not all pack sizes may be marketed.

Marketing authorization holder

Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw

Manufacturer:

PSI supply n.v.
Axxes Business Park
Guldensporenpark 22
Block C
9820 Merelbeke
Belgium
Galex d.d.
Tišinska ulica 29g
9000 Murska Sobota
Slovenia

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland:
Simvastatin Genoptim
Date of last revision of the leaflet:08.2015