Simvastatin Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Simvastatina Zentiva 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Simvastatina Zentiva 40 mg is and what it is used for
2. What you need to know before taking Simvastatina Zentiva 40 mg
3. How to take Simvastatina Zentiva 40 mg
4. Possible side effects
5. How to store Simvastatina Zentiva 40 mg
6. Contents of the pack and other information

1. WHAT SIMVASTATIN ZENTIVA 40 mg IS AND WHAT IT IS USED FOR

Simvastatin Zentiva is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Zentiva increases levels of "good" cholesterol (HDL cholesterol). Simvastatin Zentiva belongs to a group of medicines called statins.

Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in the blood that may increase the risk of heart disease.

You must follow a cholesterol-lowering diet while taking this medicine. Simvastatin Zentiva is used in addition to diet to reduce cholesterol if you have:

• Elevated levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
• An inherited disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood. You may also be receiving other treatments.
• Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). Simvastatin Zentiva may prolong survival by reducing the risk of heart-related problems, regardless of cholesterol levels in the blood.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can check your cholesterol levels with a simple blood test. Visit your doctor regularly, keep track of your cholesterol values, and discuss cholesterol targets with your doctor.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SIMVASTATIN ZENTIVA 40 mg

Do not take Simvastatin Zentiva 40 mg
if:

• You are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this
  medicinal product (listed in section 6 “Contents of the pack and other information”);
• You currently have liver problems;
• You are pregnant or breastfeeding (see section 2 "Pregnancy, breastfeeding and fertility");
• You are taking a medicine(s) containing any 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 and saquinavir (HIV protease inhibitors are used for HIV infections);
  • boceprevir or telaprevir (used to treat hepatitis C virus infection);
  • nefazodone (used to treat depression);
  • cobicistat;
  • gemfibrozil (used to lower cholesterol);
  • cyclosporine (used in patients who have undergone organ transplantation);
  • danazol (an artificial hormone used to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).
• You are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Simvastatin Zentiva may lead to serious muscle problems (rhabdomyolysis).
  Do not take more than 40 mg of Simvastatin Zentiva if you are taking lomitapide (used to treat a rare, serious genetic cholesterol condition).
  Ask your doctor for advice if you are unsure whether the medicine you are taking is one of those listed above.

Warnings and precautions
Inform your doctor:

• About all your medical conditions, including allergies.
• If you consume large amounts of alcohol.
• If you have ever had liver disease. In this case, Simvastatin Zentiva may not be suitable for you.
• If you are due to undergo surgery. You may need to stop taking Simvastatin Zentiva temporarily.
• If you are of Asian origin, as a different dose may be appropriate for you.

Inform your doctor if you have a severe lung disease.
Your doctor will perform a blood test before you start taking Simvastatin Zentiva and if you develop symptoms of liver problems while taking Simvastatin Zentiva. This test is performed to determine whether your liver is functioning properly.
Your doctor may also order blood tests to monitor liver function after starting treatment with Simvastatin Zentiva.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness of unknown cause. This is because, rarely, muscle problems can be serious and may include damage to muscle tissue leading to kidney damage; very rarely, cases of death have occurred.
The risk of muscle injury is higher at higher doses of Simvastatin Zentiva, particularly with the 80 mg dose. The risk of muscle injury is also increased in certain patients.
Talk to your doctor if any of the following conditions apply to you:

• You are 65 years of age or older.
• You are a woman.
• You have thyroid problems.
• You or members of your family have inherited muscle disorders.
• You consume large amounts of alcohol.
• You have kidney problems.
• You have previously experienced muscle problems during treatment with cholesterol-lowering medicines known as “statins” or fibrates.
• You or a close family member have an inherited muscle disease.
• You have or have had myasthenia (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or cause its onset (see section 4).

Talk to your doctor and pharmacist if you experience persistent muscle weakness. Further tests may be needed to diagnose and treat this condition.

Children and adolescents
Safety and efficacy have been studied in adolescents aged between 10 and 17 years, and in girls who have had regular menstrual cycles for at least one year (see section 3 “How to take Simvastatin Zentiva 40 mg”). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatin Zentiva 40 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Taking Simvastatin Zentiva with any of the following medicines may increase the risk of muscle problems (some of which have already been listed in section “Do not take Simvastatin Zentiva 40 mg”):

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Simvastatin Zentiva. Taking Simvastatin Zentiva with fusidic acid may rarely lead to muscle weakness, pain or tenderness (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• Cyclosporine (often used in patients who have undergone organ transplantation).
• Danazol (an artificial hormone used to treat endometriosis, 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 containing active substances such as gemfibrozil and bezafibrate (used to reduce cholesterol).
• Erythromycin, clarithromycin and telithromycin (used to treat bacterial infections).
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS).
• Boceprevir or telaprevir (used to treat hepatitis C virus infections).
• Nefazodone (used to treat depression).
• Medicines containing the active substance cobicistat.
• Amiodarone (used to treat irregular heartbeat).
• Amlodipine, verapamil and diltiazem (used to treat high blood pressure, chest pain associated with heart disease or other heart conditions).
• Lomitapide (used to treat a rare, serious genetic cholesterol condition).
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g. Simvastatin Zentiva). Your doctor may decide to temporarily stop treatment with Simvastatin Zentiva.
• Colchicine (used to treat gout).

As with the medicines listed above, you must always inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription. In particular, tell your doctor if you are taking a medicine(s) containing any of the following active substances:

• Medicines with active substances used to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants).
• Fenofibrate (also used to lower cholesterol).
• Niacin (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (used to prevent heart attack or stroke).

You should also inform any doctor who is prescribing you a new medicine that you are taking Simvastatin Zentiva.

Simvastatin Zentiva 40 mg with food and drink
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatin Zentiva. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not use Simvastatin Zentiva if you are pregnant, intend to become pregnant, or suspect you are pregnant. If you become pregnant while taking Simvastatin Zentiva, stop treatment immediately and contact your doctor.
Do not use Simvastatin Zentiva during breastfeeding, as it is not known whether the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Simvastatin Zentiva is not expected to affect your ability to drive or use machines. However, you should be aware that dizziness has been reported after taking Simvastatin Zentiva.

Simvastatin Zentiva 40 mg contains lactose
The simvastatin tablets contain milk sugar known as lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

3. HOW TO TAKE SIMVASTATIN ZENTIVA 40 mg

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Always take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
During treatment with Simvastatin Zentiva, you must follow a cholesterol-lowering diet.
Take the tablet or half tablet with water, either before or after a meal.

Dosage:
The recommended dose is one tablet of Simvastatin Zentiva 10 mg, 20 mg, or 40 mg orally once daily.

Adults:
The usual starting dose is 10 mg, 20 mg, or in some cases, 40 mg 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 prescribe a lower dose, especially if you are taking any of the medicines listed above or have certain kidney problems.
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 reached their target cholesterol levels with lower doses.

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

Method of administration:
Take Simvastatin Zentiva in the evening. It may be taken with or without food.
Continue taking Simvastatin Zentiva unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Zentiva together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatin Zentiva at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatin Zentiva 40 mg than you should
Contact your doctor or pharmacist immediately.

If you forget to take Simvastatin Zentiva 40 mg
Do not take a double dose to make up for the missed tablet; take only your usual dose of Simvastatin Zentiva at the usual time the next day.

If you stop taking Simvastatin Zentiva 40 mg
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Simvastatin Zentiva can cause adverse effects, although not everybody gets them.
The following terms are used to describe how often adverse effects occur:
• Rare (may affect up to 1 in 1,000 people),
• Very rare (may affect up to 1 in 10,000 people),
• Not known (frequency cannot be estimated from the available data).

The following serious adverse effects have been reported in rare cases.
If you experience any of the following serious adverse effects, you must stop treatment and contact your doctor immediately or go to the nearest hospital emergency department.

• Pain, tenderness, weakness, muscle breakdown (very rare), or muscle cramps. In rare cases, these muscle problems can be severe and may include breakdown of muscle tissue leading to kidney damage; and very rarely, cases of death have been reported.
• Hypersensitivity reactions (allergies) including:
• Swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema).
• Severe muscle pain, usually in the shoulders or hips.
• Skin rash with weakness in the limbs and neck muscles.
• Skin rash which may occur on the skin or mouth ulcers (drug-induced lichenoid eruptions) (very rare).
• Joint pain or inflammation (polymyalgia rheumatica).
• Inflammation of blood vessels (vasculitis).
• Unusual bruising, skin rash and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes.
• Shortness of breath (dyspnoea) and feeling unwell.
• A group of lupus-like symptoms (including skin rash, joint problems, and effects on blood cells).
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare).
• Inflammation of the pancreas, often associated with severe abdominal pain.

The following very rare serious adverse effect has been reported:

• A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis).

The following adverse effects have also been reported rarely:

• Decrease in red blood cell count (anaemia).
• Numbness or weakness in arms and legs.
• Headache, tingling sensation, dizziness.
• Digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Difficulty sleeping (very rare).
• Poor memory (very rare), memory loss, confusion.
• Blurred vision and impaired vision.

The following very rare adverse effect has been reported:

• Gynaecomastia (enlargement of the breast in men).

The following adverse effects have also 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 persistent cough and/or shortness of breath or fever.
• Problems with tendons, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience worsening weakness in arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.

Other possible adverse effects reported with some statins:
• Sleep disorders, including nightmares.
• Sexual difficulties.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• Muscle pain, tenderness or weakness that is persistent and, in very rare cases, may not resolve after stopping treatment with Simvastatin Zentiva (frequency not known).

Laboratory findings
Increases in certain blood test values indicating liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SIMVASTATIN ZENTIVA 40 mg

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Simvastatina Zentiva 40 mg contains
The active substance is simvastatin.
The other components are: anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch,
butylhydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose and titanium
dioxide (E171).
Description of the appearance of Simvastatina Zentiva 40 mg and packaging contents
The film-coated tablets of Simvastatina Zentiva 40 mg are white or almost white, oblong, biconvex tablets, with a score line on both sides, marked with "SVT" on one side and "40" on the other.
Simvastatina Zentiva 40 mg is available in blister packs containing 10, 14, 20, 28, 30, 50, 56 or 100 tablets.
Simvastatina Zentiva 40 mg is also available in a pack of 50 tablets (unit-dose divisible packaging, for hospital use).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Manufacturer:
Zentiva, k.s.
U kabelovny 130
120 37 Praha 10 – Dolní Měcholupy
Czech Republic
This leaflet was last updated on:
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Simvastatin Zentiva 20 mg film-coated tablets

Generic medicinal product
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Simvastatin Zentiva 20 mg is and what it is used for
2. What you need to know before taking Simvastatin Zentiva 20 mg
3. How to take Simvastatin Zentiva 20 mg
4. Possible side effects
5. How to store Simvastatin Zentiva 20 mg
6. Contents of the pack and other information

1. WHAT SIMVASTATIN ZENTIVA 20 mg IS AND WHAT IT IS USED FOR

Simvastatin Zentiva is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. In addition, Simvastatin Zentiva increases levels of "good" cholesterol (HDL cholesterol). Simvastatin Zentiva belongs to a group of medicines called statins.

Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in the blood that may increase the risk of heart disease.

You must follow a cholesterol-lowering diet while taking this medicine.

Simvastatin Zentiva is used in addition to diet to reduce cholesterol when you have:

• Elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia).
• An inherited disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
• Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). Simvastatin Zentiva can prolong survival by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can check your cholesterol levels with a simple blood test. Visit your doctor regularly, keep track of your cholesterol values, and discuss cholesterol targets with your doctor.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SIMVASTATIN ZENTIVA 20 mg

Do not take Simvastatin Zentiva 20 mg
if:

• You are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this medicine (listed in section 6 “Contents of the pack and other information”);
• You currently have liver problems;
• You are pregnant or breastfeeding (see section 2 “Pregnancy, breastfeeding and fertility”);
• You are taking a medicine(s) containing any 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, and saquinavir (HIV protease inhibitors are used for HIV infections);
  • boceprevir or telaprevir (used to treat hepatitis C virus infection);
  • nefazodone (used to treat depression);
  • cobicistat;
  • gemfibrozil (used to lower cholesterol);
  • cyclosporine (used in patients who have undergone organ transplantation);
  • danazol (an artificial hormone used to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus);
  • if you are taking or have taken within the last 7 days, fusidic acid (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin Zentiva may lead to serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatin Zentiva if you are taking lomitapide (used to treat a rare, serious genetic cholesterol condition).

Ask your doctor for advice if you are unsure whether the medicine you are taking is one of those listed above.

Warnings and precautions

Tell your doctor:

• About all your medical conditions, including allergies;
• If you consume large amounts of alcohol;
• If you have ever had liver disease. In this case, Simvastatin Zentiva may not be suitable for you;
• If you are scheduled for surgery. You may need to temporarily stop taking Simvastatin Zentiva;
• If you are of Asian origin, as you may require a different dose.

Inform your doctor if you have a serious lung disease.

Your doctor will perform a blood test before you start taking Simvastatin Zentiva and if you develop symptoms of liver problems while taking it. This test checks whether your liver is functioning properly.

Your doctor may also order periodic blood tests to monitor liver function after starting treatment with Simvastatin Zentiva.

While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, rarely, muscle problems can be serious and may include muscle tissue damage leading to kidney damage; very rarely, cases of death have occurred.

The risk of muscle injury is higher at higher doses of Simvastatin Zentiva, particularly at the 80 mg dose. The risk of muscle injury is also increased in certain patients.

Talk to your doctor if any of the following conditions apply to you:

• You are 65 years of age or older;
• You are female;
• You have thyroid problems;
• You or your family members have inherited muscle disorders;
• You consume large amounts of alcohol;
• You have kidney problems;
• You have previously experienced muscle problems while taking cholesterol-lowering medicines known as “statins” or fibrates;
• You or a close family member has an inherited muscle disease;
• You have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or cause its onset (see section 4).

Talk to your doctor and pharmacist if you experience persistent muscle weakness. Further tests may be needed to diagnose and treat this condition.

Children and adolescents

Safety and efficacy have been studied in adolescents aged 10 to 17 years, and in girls who have had their menstrual periods for at least one year (see section 3 “How to take Simvastatin Zentiva 20 mg”). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatin Zentiva 20 mg

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking Simvastatin Zentiva with any of the following medicines may increase the risk of muscle problems (some of which have already been listed in the section “Do not take Simvastatin Zentiva 20 mg”):

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Simvastatin Zentiva. Taking Simvastatin Zentiva with fusidic acid may rarely cause muscle weakness, pain, or tenderness (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• Cyclosporine (commonly used in patients who have undergone organ transplantation);
• Danazol (an artificial hormone used to treat endometriosis, 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 containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol);
• Erythromycin, clarithromycin, and telithromycin (used to treat bacterial infections);
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS);
• Boceprevir or telaprevir (used to treat hepatitis C virus infections);
• Nefazodone (used to treat depression);
• Medicines containing the active substance cobicistat;
• Amiodarone (used to treat irregular heartbeat);
• Amlodipine, verapamil, and diltiazem (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions);
• Lomitapide (used to treat a rare, serious genetic cholesterol condition);
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g., Simvastatin Zentiva). Your doctor may decide to temporarily stop Simvastatin Zentiva;
• Colchicine (used to treat gout).

As with the medicines listed above, you must always inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription. In particular, tell your doctor if you are taking a medicine containing any of the following active substances:

• Medicines with active substances used to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants);
• Fenofibrate (also used to lower cholesterol);
• Niacin (also used to lower cholesterol);
• Rifampicin (used to treat tuberculosis);
• Ticagrelor (used to prevent heart attack or stroke).

You must also inform any doctor who prescribes a new medicine that you are taking Simvastatin Zentiva.

Simvastatin Zentiva 20 mg with food and drink

Grapefruit juice contains one or more substances that alter how your body processes certain medicines, including Simvastatin Zentiva. Consumption of grapefruit juice should be avoided.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Do not use Simvastatin Zentiva if you are pregnant, intend to become pregnant, or suspect you are pregnant. If you become pregnant while taking Simvastatin Zentiva, stop taking it immediately and contact your doctor.

Do not use Simvastatin Zentiva during breastfeeding, as it is not known whether the medicine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin Zentiva is not expected to affect your ability to drive or use machines. However, you should be aware that dizziness has been reported after taking Simvastatin Zentiva.

Simvastatin Zentiva 20 mg contains lactose

Simvastatin tablets contain milk sugar known as lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO TAKE SIMVASTATIN ZENTIVA 20 mg

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
During treatment with Simvastatin Zentiva, you must follow a diet aimed at reducing cholesterol levels.
Take the tablet or half tablet with water, with or without food.

Dosage:
The recommended dose is one tablet of Simvastatin Zentiva 10 mg, 20 mg, or 40 mg orally once daily.

Adults:
The usual starting 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, up to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose, especially if you are taking any of the medicines listed above or have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk of heart disease who have not reached their target cholesterol levels with lower doses.

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

Method of administration:
Take Simvastatin Zentiva in the evening. It can be taken with or without food.
Continue taking Simvastatin Zentiva unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Zentiva together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatin Zentiva at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatin Zentiva 20 mg than you should
Contact your doctor or pharmacist immediately.

If you forget to take Simvastatin Zentiva 20 mg
Do not take a double dose to make up for the missed tablet; simply take your usual dose of Simvastatin Zentiva at the regular time the next day.

If you stop taking Simvastatin Zentiva 20 mg
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Simvastatin Zentiva can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects occur:
• Rare (may affect up to 1 in 1,000 people),
• Very rare (may affect up to 1 in 10,000 people),
• Not known (frequency cannot be estimated from the available data).

The following serious side effects have been reported in rare cases.
If you experience any of the following serious side effects, you must stop treatment and contact your doctor immediately or go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, muscle breakdown (very rare), or muscle cramps. In rare cases, these muscle problems can be severe and may include breakdown of muscle tissue leading to kidney damage; and very rarely, cases of death have been reported.
• Hypersensitivity reactions (allergies) including:
• Swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema).
• Severe muscle pain, usually in shoulders or hips.
• Skin rash with weakness in the limbs and neck muscles.
• Skin rash which may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (very rare).
• Joint pain or inflammation (polymyalgia rheumatica).
• Inflammation of blood vessels (vasculitis).
• Unusual bruising, skin rash, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes.
• Shortness of breath (dyspnoea) and feeling unwell.
• A set of symptoms resembling lupus (including skin rash, joint problems, and effects on blood cells).
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare).
• Inflammation of the pancreas, often associated with severe abdominal pain.

The following very rare serious side effect has been reported:

• A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis).

The following side effects have also been reported rarely:

• Decrease in red blood cell count (anaemia).
• Numbness or weakness in arms and legs.
• Headache, tingling sensation, dizziness.
• Digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Difficulty sleeping (very rare).
• Poor memory (very rare), memory loss, confusion.
• Blurred vision and impaired vision.

The following very rare side effect has been reported:

• Gynaecomastia (enlargement of breast tissue in men).

The following side effects have also been reported, but their frequency cannot be determined from the available data (frequency not known):
• Erectile dysfunction.
• Depression.
• Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.
• Problems with tendons, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease causing generalized muscle weakness, including in some cases the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).

Contact your doctor if you experience weakness in arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.

Additional possible side effects reported with some statins:
• Sleep disorders, including nightmares.
• Sexual difficulties.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• Muscle pain, tenderness, or weakness that is persistent and, in very rare cases, may not resolve after stopping treatment with Simvastatin Zentiva (frequency not known).

Laboratory findings
Increases in certain blood test values related to liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SIMVASTATIN ZENTIVA 20 mg

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Simvastatina Zentiva 20 mg contains
The active substance is simvastatin.
The other components are: anhydrous lactose, microcrystalline cellulose, pregelatinized corn starch,
butylhydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose and
titanium dioxide (E171).

Description of the appearance of Simvastatina Zentiva 20 mg and pack contents
Simvastatina Zentiva 20 mg film-coated tablets are white or off-white, oblong, biconvex tablets, with a score line on both sides, marked “SVT” on one side and “20” on the other.
Simvastatina Zentiva 20 mg is available in packs of 10, 14, 20, 28, 30, 50, 56 or 100 tablets in blisters.
Simvastatina Zentiva 20 mg is also available in a pack of 50 tablets (unit-dose divisible pack, for hospital use).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturers
Marketing Authorisation Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy

Manufacturer:
Zentiva, k.s.
U kabelovny 130
120 37 Praha 10 – Dolní Měcholupy
Czech Republic

This leaflet was last updated on:

PATIENT INFORMATION LEAFLET

Simvastatina Zentiva 10 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Simvastatina Zentiva 10 mg is and what it is used for
2. What you need to know before taking Simvastatina Zentiva 10 mg
3. How to take Simvastatina Zentiva 10 mg
4. Possible side effects
5. How to store Simvastatina Zentiva 10 mg
6. Contents of the pack and other information

1. WHAT SIMVASTATIN ZENTIVA 10 mg IS AND WHAT IT IS USED FOR

Simvastatin Zentiva is a medicine used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Zentiva increases levels of "good" cholesterol (HDL cholesterol). Simvastatin Zentiva belongs to a group of medicines called statins.

Cholesterol is one of several types of fats present in the bloodstream. Total cholesterol consists mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. Blockage of blood flow can cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in the blood that may increase the risk of heart disease.

You must follow a cholesterol-lowering diet while taking this medicine. Simvastatin Zentiva is used in addition to diet to reduce cholesterol if you have:

• Elevated cholesterol levels in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia).
• An inherited disease (homozygous familial hypercholesterolemia) that increases your blood cholesterol levels. You may also be receiving other treatments.
• Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). Simvastatin Zentiva may prolong survival by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can check your cholesterol levels with a simple blood test. Visit your doctor regularly, keep track of your cholesterol values, and discuss with your doctor the goals you should aim to achieve.

2. WHAT YOU SHOULD KNOW BEFORE TAKING SIMVASTATIN ZENTIVA 10 mg

Do not take Simvastatin Zentiva 10 mg
if:

• You are allergic (hypersensitive) to simvastatin or to any of the other ingredients of this
  medicinal product (listed in section 6 “Contents of the pack and other information”);
• You currently have liver problems;
• You are pregnant or breast-feeding (see section 2 “Pregnancy, breast-feeding and
  fertility”);
• You are taking a medicine(s) containing any 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, and saquinavir (HIV
    protease inhibitors are used for HIV infections);
  • boceprevir or telaprevir (used to treat hepatitis C virus infection);
  • nefazodone (used to treat depression);
  • cobicistat;
  • gemfibrozil (used to lower cholesterol);
  • ciclosporin (used in organ transplant patients);
  • danazol (an artificial hormone used to treat endometriosis, a condition in which the
    tissue lining the uterus grows outside the uterus).
• You are taking or have taken, within the last 7 days, an oral or injectable medicine called fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Simvastatin Zentiva may lead to serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of Simvastatin Zentiva if you are taking lomitapide (used to treat a rare, serious genetic cholesterol condition).
Ask your doctor for advice if you are unsure whether the medicine you are taking is included in the list above.

Warnings and precautions
Inform your doctor:

• about all your medical conditions, including allergies.
• if you consume large amounts of alcohol.
• if you have ever had liver disease. In this case, Simvastatin Zentiva may not be suitable for you.
• if you are due to undergo surgery. You may need to stop taking Simvastatin Zentiva for a short period.
• if you are of Asian origin, as you may require a different dose.

Inform your doctor if you have a severe lung disease.
Your doctor will perform a blood test before you start taking Simvastatin Zentiva and if you develop symptoms of liver problems while taking it. This test is performed to check whether your liver is functioning properly.
Your doctor may also prescribe periodic blood tests to monitor liver function after starting treatment with Simvastatin Zentiva.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, rarely, muscle problems can be serious and may include muscle tissue damage leading to kidney damage; very rarely, cases of death have occurred.

The risk of muscle injury is higher at higher doses of Simvastatin Zentiva, particularly at the 80 mg dose. The risk of muscle injury is also increased in certain patients.
Talk to your doctor if any of the following conditions apply to you:

• You are 65 years of age or older.
• You are female.
• You have thyroid problems.
• You or members of your family have inherited muscle disorders.
• You consume large amounts of alcohol.
• You have kidney problems.
• You have previously experienced muscle problems during treatment with cholesterol-lowering medicines known as “statins” or fibrates.
• You or a close family member has an inherited muscle disease.
• You have or have had myasthenia gravis (a disease characterized by generalized muscle weakness, including in some cases the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen myasthenia or trigger its onset (see section 4).

Talk to your doctor and pharmacist if you experience persistent muscle weakness. Further tests may be needed to diagnose and treat this condition.

Children and adolescents
Safety and efficacy have been studied in adolescents aged between 10 and 17 years, and in girls who have had regular menstruation for at least one year (see section 3 “How to take Simvastatin Zentiva 10 mg”). Simvastatin has not been studied in children under 10 years of age. For further information, consult your doctor.

Other medicines and Simvastatin Zentiva 10 mg
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Taking Simvastatin Zentiva with any of the following medicines may increase the risk of muscle problems (some of which have already been listed in the section “Do not take Simvastatin Zentiva 10 mg”):

• If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Simvastatin Zentiva. Taking Simvastatin Zentiva with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• Ciclosporin (commonly used in organ transplant patients).
• Danazol (an artificial hormone used to treat endometriosis, 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 containing active substances such as gemfibrozil and bezafibrate (used to reduce cholesterol).
• Erythromycin, clarithromycin, and telithromycin (used to treat bacterial infections).
• 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 irregular heartbeat).
• Amlodipine, verapamil, and diltiazem (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions).
• Lomitapide (used to treat a rare, serious genetic cholesterol condition).
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g., Simvastatin Zentiva). Your doctor may decide to temporarily discontinue Simvastatin Zentiva.
• Colchicine (used to treat gout).

As with the medicines listed above, you must always inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those not requiring a prescription. In particular, tell your doctor if you are taking a medicine(s) containing any of the following active substances:

• Medicines containing active substances used to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).
• Fenofibrate (also used to lower cholesterol).
• Niacin (also used to lower cholesterol).
• Rifampicin (used to treat tuberculosis).
• Ticagrelor (used to prevent heart attack or stroke).

You must also inform any doctor who prescribes you a new medicine that you are taking Simvastatin Zentiva.

Simvastatin Zentiva 10 mg with food and drink
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatin Zentiva. Consumption of grapefruit juice should be avoided.

Pregnancy and breast-feeding
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Do not use Simvastatin Zentiva if you are pregnant, intend to become pregnant, or suspect you are pregnant. If you become pregnant while taking Simvastatin Zentiva, stop taking it immediately and contact your doctor.
Do not use Simvastatin Zentiva during breast-feeding, as it is not known whether the medicine passes into breast milk.
Consult your doctor or pharmacist before taking any medicine.

Driving and using machines
Simvastatin Zentiva is not expected to affect your ability to drive or use machines. However, you should be aware that dizziness has been reported after taking Simvastatin Zentiva.

Simvastatin Zentiva 10 mg contains lactose
The simvastatin tablets contain lactose, a milk sugar. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. HOW TO TAKE SIMVASTATIN ZENTIVA 10 mg

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
During treatment with Simvastatin Zentiva, you must follow a diet aimed at reducing cholesterol levels.
Take the tablet or half tablet with water, either before or after a meal.

Dosage:
The recommended dose is one tablet of Simvastatin Zentiva 10 mg, 20 mg, or 40 mg orally once daily.

Adults:
The usual starting 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, up to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may prescribe lower doses, especially if you are taking any of the medicines listed above or have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk of heart disease who have not reached their target cholesterol levels with lower doses.

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

Method of administration:
Take Simvastatin Zentiva in the evening. It can be taken with or without food.
Continue taking Simvastatin Zentiva unless your doctor tells you to stop treatment.
If your doctor has prescribed Simvastatin Zentiva together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatin Zentiva at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatin Zentiva 10 mg than you should
Contact your doctor or pharmacist immediately.

If you forget to take Simvastatin Zentiva 10 mg
Do not take a double dose to make up for the missed tablet; simply take your usual dose of Simvastatin Zentiva at the regular time the next day.

If you stop taking Simvastatin Zentiva 10 mg
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, Simvastatin Zentiva can cause adverse effects, although not everybody gets them.
The following terms are used to describe how often adverse effects occur:
• Rare (may affect up to 1 in 1,000 people),
• Very rare (may affect up to 1 in 10,000 people),
• Not known (frequency cannot be estimated from the available data).

The following serious adverse effects have been reported in rare cases.
If you experience any of the following serious adverse effects, you must stop treatment and contact your doctor immediately or go to the nearest hospital emergency department.

• Pain, tenderness, weakness, muscle breakdown (very rare), or muscle cramps. In rare cases, these muscle problems can be severe and may include breakdown of muscle tissue leading to kidney damage; and death has very rarely occurred.
• Hypersensitivity reactions (allergies) including:
• Swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema).
• Severe muscle pain, usually in the shoulders or hips.
• Rash with weakness in the limbs and neck muscles.
• Rash which may appear on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (very rare).
• Joint pain or inflammation (polymyalgia rheumatica).
• Inflammation of blood vessels (vasculitis).
• Unusual bruising, skin rash and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes.
• Shortness of breath (dyspnoea) and feeling unwell.
• A group of lupus-like symptoms (including skin rash, joint problems, and effects on blood cells).
• Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare).
• Inflammation of the pancreas, often associated with severe abdominal pain.

The following very rare serious adverse effect has been reported:

• A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis).

The following adverse effects have also been reported rarely:

• Decrease in red blood cell count (anaemia).
• Numbness or weakness in arms and legs.
• Headache, tingling sensation, dizziness.
• Digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Difficulty sleeping (very rare).
• Poor memory (very rare), memory loss, confusion.
• Blurred vision and impaired vision.

The following very rare adverse effect has been reported:

• Gynaecomastia (enlargement of the breast in men).

The following adverse effects have also been reported, but their frequency cannot be determined from the available data (frequency not known):
• Erectile dysfunction.
• Depression.
• Inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever.
• Tendon problems, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases may include the muscles used for breathing).
• Ocular myasthenia (a disease causing weakness of the eye muscles).
Contact your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or laboured breathing.
Additional possible adverse effects reported with some statins:
• Sleep disorders, including nightmares.
• Sexual difficulties.
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• Muscle pain, tenderness or weakness that is persistent and, in very rare cases, may not resolve after stopping treatment with Simvastatin Zentiva (frequency not known).
Laboratory findings
Increases in certain blood test values related to liver function and a muscle enzyme (creatine kinase) have been observed.
Reporting of adverse effects
If you experience any adverse effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report adverse effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SIMVASTATIN ZENTIVA 10 mg

Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the packaging after “Exp.”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. PACK CONTENTS AND OTHER INFORMATION

What Simvastatina Zentiva 10 mg contains
The active substance is simvastatin.
The other components are: anhydrous lactose, microcrystalline cellulose, pregelatinized maize starch,
butylhydroxyanisole (E320), magnesium stearate, talc, hydroxypropylcellulose, hypromellose and titanium
dioxide (E171).
Description of the appearance of Simvastatina Zentiva 10 mg and pack contents
Simvastatina Zentiva 10 mg film-coated tablets are white or almost white, oblong, biconvex tablets, with a score line on both sides, marked with "SVT" on one side and "10" on the other.
Simvastatina Zentiva 10 mg is available in blister packs containing 10, 14, 20, 28, 30, 50, 56 or 100 tablets.
Simvastatina Zentiva 10 mg is also available in a pack of 50 tablets (unit dose divisible pack, for hospital use).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder:
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milan, Italy
Manufacturer:
Zentiva, k.s.
U kabelovny 130
120 37 Praha 10 - Dolní Měcholupy
Czech Republic
This leaflet was last updated on: