Simvastatin genoptim

Package leaflet: Information for the patient

Simvastatin Genoptim, 10 mg, film-coated tablets
Simvastatin Genoptim, 20 mg, film-coated tablets
Simvastatin Genoptim, 40 mg, film-coated tablets
Simvastatinum
This medicinal product is contraindicated during pregnancy
Please read this leaflet carefully before taking this medicine because 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 give it to others. It may harm them, even if their symptoms are the same as yours.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. See section 4.
Contents of the leaflet:

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

Simvastatin Genoptim contains the active substance simvastatin. Simvastatin Genoptim is a medicine used to lower blood levels of total cholesterol, the so-called "bad" cholesterol (LDL cholesterol fraction), and fats known as triglycerides. In addition, Simvastatin Genoptim increases levels of "good" cholesterol (HDL cholesterol fraction). Simvastatin Genoptim belongs to a group of medicines 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 called "bad" cholesterol because it can deposit on the walls of arteries, forming plaque. Over time, this accumulating plaque can lead to narrowing of the arteries. This narrowing may slow down or block blood flow to vital organs such as the heart and brain. Blocking blood flow may result in a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent bad cholesterol from depositing in artery walls and protects against heart disease.
Triglycerides are another type of fat present in the blood that may increase the risk of heart disease.
While undergoing treatment, you should follow a cholesterol-lowering diet.
Simvastatin Genoptim is used together with a cholesterol-lowering diet in people:

• who have been diagnosed with high blood cholesterol levels (primary hypercholesterolemia) or elevated blood fat levels (mixed hyperlipidemia);
• with an inherited condition (homozygous familial hypercholesterolemia) associated with high blood cholesterol levels. In these patients, additional treatments may also be used;
• with ischemic heart disease (coronary artery disease) or who are at high risk of developing ischemic heart disease (due to diabetes, previous stroke, or other vascular diseases). Simvastatin Genoptim may help reduce the risk of heart disease regardless of blood cholesterol levels, thereby contributing to increased life expectancy in these individuals.

In most people, elevated cholesterol levels do not cause direct symptoms. Your doctor can assess your cholesterol levels by ordering a simple blood test. You should attend regular check-ups, monitor your blood cholesterol levels, and discuss treatment goals with your doctor.

2. Important information before using Simvastatin Genoptim

When not to use Simvastatin Genoptim:

• 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 problems.
• If the patient is pregnant or breast-feeding.
• If the patient is taking a medicine 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 infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (HIV protease inhibitors are used in the treatment of HIV infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol levels),
• cyclosporine (used in patients after organ transplantation),
• danazol (a synthetic hormone used in the treatment of endometriosis, i.e. a condition in which the tissue lining the uterus grows outside the uterus),
• if the patient is taking or has taken or received within the last 7 days a medicine called fusidic acid (used to treat bacterial infections).
• Do not take a dose higher than 40 mg of Simvastatin Genoptim if you are taking lomitapide (a substance used to treat serious, rare, inherited disorders of cholesterol levels).

If in doubt whether a medicine taken by the patient is listed above, consult a doctor.

Warnings and precautions

Tell your doctor:

• about all current illnesses, past diseases, and allergies,
• if you consume large amounts of alcohol,
• if you have a history of liver disease. In such a case, Simvastatin Genoptim may be contraindicated,
• if you are scheduled for surgery. In such a case, temporary discontinuation of Simvastatin Genoptim may be necessary.
• if you are of Asian origin. In such a case, a different dose of the medicine may be used.

Before starting treatment, your doctor should order a blood test to check liver function. After starting treatment with Simvastatin Genoptim, your doctor may also consider it necessary to perform blood tests to monitor liver function.

Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high levels of blood sugar and fats, overweight, and high blood pressure may be at increased risk of developing diabetes.

Inform your doctor if the patient has a severe lung disease.

Inform your doctor or pharmacist if muscle weakness persists. Additional tests and medications may be required to diagnose and treat this condition.

Seek immediate medical advice if unexplained muscle pain, tenderness or weakness occurs,
as in rare cases this may lead to serious muscle problems, including breakdown of muscle tissue,
which may cause kidney damage; very rare cases of patient deaths have been reported.

The risk of muscle tissue breakdown is higher in patients taking Simvastatin Genoptim at higher doses, especially 80 mg. The risk of muscle tissue breakdown is also higher in certain patient groups. Consult your doctor if:

• the patient consumes large amounts of alcohol,
• the patient has kidney problems,
• the patient has thyroid problems,
• the patient is 65 years of age or older,
• the patient is female,
• the patient has ever had muscle problems during treatment with cholesterol-lowering medicines belonging to the statin or fibrate group,
• the patient or a close relative has been diagnosed with inherited muscle disorders.

Children and adolescents

The safety and efficacy of simvastatin have been studied in boys aged 10–17 years and in girls who have had their first menstrual period at least one year earlier (see section 3 “How to use Simvastatin Genoptim”). Simvastatin has not been studied in children under 10 years of age. For additional information, consult your doctor.

Impaired function of liver proteins (OATP transporters), which occur in patients with a specific gene, may increase the risk of muscle disorders and kidney damage. If necessary, your doctor may recommend genetic testing before prescribing an 80 mg dose of simvastatin.

Simvastatin Genoptim and other medicines

Tell your doctor about all medicines currently used or recently taken, as well as any medicines the patient plans to take, containing any of the substances listed below. Taking Simvastatin Genoptim with any of these medicines may increase the risk of muscle problems (some of which are already listed above under “When not to use Simvastatin Genoptim”).

• cyclosporine (often used in patients after organ transplantation),
• danazol (a synthetic hormone used in the treatment of endometriosis, i.e. a condition in which the tissue lining the uterus grows outside the uterus),
• medicines containing active substances such as: itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates, medicines containing active substances such as: gemfibrozil and bezafibrate (lowering cholesterol levels),
• erythromycin, clarithromycin, telithromycin or fusidic acid (used to treat bacterial infections). Do not take simvastatin while using these medicines. 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),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat heart rhythm disorders),
• verapamil, diltiazem or amlodipine (used in hypertension, chest pain related to heart disease or other heart conditions),
• lomitapide (used to treat serious, inherited disorders of cholesterol levels),
• colchicine (used to treat gout).

Tell your doctor or pharmacist about all medicines currently used or recently taken, as well as any medicines the patient plans to take, including those available without a prescription. In particular, inform your doctor if the patient is taking medicines containing the following active substances:

• medicines containing active substances preventing blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulant medicines),
• fenofibrate (also used to lower cholesterol levels),
• niacin (also used to lower cholesterol levels),
• rifampicin (used to treat tuberculosis).

Also, inform any doctor prescribing a new medicine that the patient is taking Simvastatin Genoptim.

Simvastatin Genoptim with food and drink

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

Pregnancy and breast-feeding

Do not use Simvastatin Genoptim if you are pregnant, planning to become pregnant, or suspect you may be pregnant. If you become pregnant while taking Simvastatin Genoptim, stop taking the medicine immediately and contact your doctor. If you are breast-feeding, you must not take Simvastatin Genoptim, as it is not known whether the medicine is excreted in breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines

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

Important information about certain ingredients of Simvastatin Genoptim

Simvastatin Genoptim tablets contain a sugar called lactose. If the patient has been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Simvastatin Genoptim

Your doctor will determine the appropriate dose of the medicine depending on your condition, previous treatment, and risk factors.
This medicine should always be used exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
You should follow a cholesterol-lowering diet during treatment with Simvastatin Genoptim.

Dosage
The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg or 80 mg taken orally once daily.

Adults
The usual starting dose is 10 mg, 20 mg or, in some cases, 40 mg once daily. Your doctor may adjust the dose after at least 4 weeks, up to a maximum of 80 mg daily. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking certain of the medicines listed above or if you have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high blood cholesterol levels and a high risk of heart disease, in whom target cholesterol levels have not been achieved with lower doses.

Children and adolescents
For children (aged 10–17 years), the usual starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg daily.

Method of administration and duration of treatment
Simvastatin Genoptim should be taken in the evening. It can be taken during meals or independently of food. Simvastatin Genoptim should be taken until your doctor advises you to stop.
If your doctor has prescribed Simvastatin Genoptim together with another cholesterol-lowering medicine that binds bile acids, Simvastatin Genoptim should be taken at least 2 hours before or 4 hours after taking the bile acid-binding medicine.

Taking more Simvastatin Genoptim than prescribed
If you take too much Simvastatin Genoptim, contact your doctor or pharmacist immediately.

Missing a dose of Simvastatin Genoptim
Do not take a double dose to make up for a missed dose. Take your next dose at the usual time the following day.

Stopping Simvastatin Genoptim
Talk to your doctor or pharmacist before stopping, as 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 everyone experiences them.
The following terms are used to describe how frequently adverse reactions have been reported:

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

Below are listed rare but serious adverse reactions.
If any of these serious adverse reactions occur, the medicine must be discontinued immediately
and the attending physician should be contacted without delay or the patient should go to the
nearest hospital emergency department.

• muscle pain, tenderness, weakness or cramps. In rare cases, these symptoms may be severe and associated with muscle breakdown leading to kidney damage; deaths have very rarely been reported;
• hypersensitivity (allergic) reactions including:
• swelling of the face, tongue and throat which may cause difficulty in breathing,
• severe muscle pain, usually in the shoulder and hip joints,
• rash with muscle weakness in limbs and neck,
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes,
• shortness of breath and malaise,
• symptoms of lupus-like illness (including rash, joint problems and blood cell changes),
• liver inflammation with the following symptoms: yellowing of the skin and whites of the eyes, itching, dark-coloured urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare);
• pancreatitis, often with severe abdominal pain.

The following adverse reactions have also been reported rarely:

• decreased number of red blood cells (anaemia),
• numbness or weakness in arms or legs,
• headache, tingling sensation, dizziness,
• gastrointestinal disturbances (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting),
• rash, itching, hair loss,
• fatigue,
• sleep disorders (very rare),
• poor memory (very rare), memory loss, confusion.

The following adverse reactions have been reported, but frequency cannot be determined from available data (frequency not known):

• erectile dysfunction,
• depression,
• lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever,
• tendon disorders, sometimes complicated by tendon rupture,
• persistent muscle weakness.

Other possible adverse reactions reported during the use of certain statins:

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

Laboratory test results
In some laboratory blood tests, increased activity of liver enzymes and muscle enzymes (creatine kinase) has been observed.
Reporting of adverse reactions
If any adverse reactions occur, including any 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
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Simvastatin Genoptim

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
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.
Medicines must 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 package and other information

What Simvastatin Genoptim contains

• The active substance is simvastatin; each coated tablet contains 10, 20 or 40 mg of simvastatin.
• The other ingredients are: butylated hydroxyanisole (E320), microcrystalline cellulose (E460i), pregelatinized maize starch, anhydrous lactose, 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, coated tablets are:

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

Simvastatin Genoptim 20 mg, coated tablets are:

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

Simvastatin Genoptim 40 mg, coated tablets are:

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

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

Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Poland

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 authorised in the European Economic Area countries under the following names:
Poland: Simvastatin Genoptim