Sinvat

Package leaflet: Information for the patient

SINVAT 20 mg film-coated tablets, 40 mg film-coated tablets

Simvastatin
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, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SINVAT is and what it is used for

SINVAT contains the active substance simvastatin. SINVAT is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fats called triglycerides in the blood.
In addition, SINVAT increases levels of "good" cholesterol (HDL cholesterol). SINVAT belongs to a group of medicines called statins.
Cholesterol is one of several types of fats 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 can increase the risk of heart disease.
You must follow a cholesterol-lowering diet while taking this medicine.
SINVAT is used, in addition to diet, to lower cholesterol if you have:

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia).
• an inherited condition (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). SINVAT 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 with your doctor the target goals to achieve.

2. What you should know before taking SINVAT

Do not take SINVAT if:

• you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6).

• you currently have liver problems.

• you are pregnant or breastfeeding.

• you are 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 (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 (a synthetic hormone used to treat endometriosis, a condition in which uterine lining tissue grows outside the uterus),
  • if you are taking or have taken within the last 7 days, or have been administered, an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and SINVAT may lead to serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of SINVAT if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition).

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

Warnings and precautions
Talk to your doctor or pharmacist before taking SINVAT.

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, SINVAT may not be suitable for you,
• if you suffer from a severe lung disease,
• if you are scheduled for surgery. You may need to temporarily stop taking SINVAT,
• if you are of Asian descent, as a different dose may be appropriate for you,
• if 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), since statins may occasionally worsen myasthenia or trigger its onset (see section 4).

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

Your doctor may also prescribe periodic blood tests to monitor liver function after starting SINVAT therapy.

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 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 SINVAT, 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 consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are aged 65 or older,
• you are female,
• you have previously experienced muscle problems while being treated with cholesterol-lowering medicines known as “statins” or fibrates,
• you or a close family member has a hereditary muscle disease.

Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.

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

Other medicines and SINVAT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

It is particularly important that your doctor knows if you are taking any of the following medicines. Taking SINVAT with any of these medicines may increase the risk of muscle problems (some of these have already been listed above under “Do not take SINVAT”).

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 SINVAT treatment. Taking SINVAT with fusidic acid may rarely cause 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 (a synthetic hormone used to treat endometriosis, a condition in which uterine lining tissue 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 or bezafibrate (used to lower cholesterol),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir (used to treat AIDS),
• antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• medicines containing the active substance cobicistat,
• amiodarone (used to treat irregular heartbeat),
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions),
• lomitapide (used to treat a rare, severe genetic cholesterol condition),
• daptomycin (used to treat complicated skin and soft tissue infections and bacteremia). The risk of muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin (e.g., SINVAT). Your doctor may decide to temporarily stop your treatment with SINVAT,
• colchicine (used to treat gout),
• ticagrelor (an antiplatelet medicine).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicines, 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 an active substance 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),
• ribociclib (used to treat breast cancer),
• palbociclib (used to treat breast cancer).

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Do not take SINVAT if you are pregnant, think you might be pregnant, or are planning a pregnancy. If you become pregnant while taking SINVAT, stop treatment immediately and contact your doctor.

Do not take SINVAT if you are 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
SINVAT is not expected to affect your ability to drive or operate machinery. However, you should be aware that dizziness has been reported after taking SINVAT.

SINVAT contains lactose
SINVAT contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take SINVAT

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
While being treated with SINVAT, you must follow a diet aimed at reducing cholesterol levels.
Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.

Dosage
The recommended dose is SINVAT 10 mg, 20 mg, or 40 mg taken 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 a high risk of heart disease who have not reached their target cholesterol level with lower doses.

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

Method of administration
Take SINVAT in the evening. You may take it with or without food. Continue taking SINVAT unless your doctor tells you to stop.
If your doctor has prescribed SINVAT together with another medicine used to lower cholesterol that contains a bile acid sequestrant, you must take SINVAT at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.
The tablets may be divided into equal parts.

If you take more SINVAT than you should
If you accidentally take too much SINVAT, contact your doctor immediately or go to the nearest hospital.

If you forget to take SINVAT
Do not take a double dose to make up for the missed tablet. Take only your usual dose of SINVAT the next day at the usual time.

If you stop taking SINVAT
Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, SINVAT may cause side effects, although not everybody experiences them.
The following terms are used to describe how frequently 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)

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

• pain, tenderness, weakness, or cramps in the muscles. In rare cases, these muscle problems can be severe and may include muscle tissue damage leading to kidney injury; and very rarely, cases of death have 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
  • skin rash with weakness in the legs and neck muscles
  • joint pain or inflammation (polymyalgia rheumatica)
  • inflammation of blood vessels (vasculitis)
  • unusual bruising, skin rashes, and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, hot flushes
  • shortness of breath (dyspnea) and feeling unwell
  • a group of lupus-like symptoms (including skin rash, joint problems, and effects on blood cells)
• liver inflammation 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 serious very rare side effects have been reported:

• a severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis)
• skin rash which may appear on the skin or mouth ulcers (drug-induced lichenoid eruptions)
• muscle breakdown
• gynecomastia (enlargement of the breast in males).

The following side effects have also been reported, but rarely:

• decrease in red blood cell count (anaemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• blurred vision, visual disturbances
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• skin rash, itching, hair loss
• weakness
• difficulty falling asleep (very rare)
• poor memory (very rare), memory loss, confusion.

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

• erectile dysfunction
• depression
• lung inflammation causing breathing problems including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by tendon rupture
• persistent muscle weakness
• 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 the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects reported with some statins include:

• sleep disorders, including nightmares
• sexual difficulties
• diabetes. This is more likely if you have high levels of sugar and fat 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 may not resolve after stopping treatment with SINVAT (frequency not known).

Laboratory values
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, speak to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at http://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 SINVAT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Store below 25°C.
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. Package Contents and Other Information

What SINVAT Contains
SINVAT 20 mg film-coated tablets

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other components are: monohydrate lactose, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, yellow iron oxide, red iron oxide.

SINVAT 40 mg film-coated tablets

• The active substance is simvastatin. Each tablet contains 40 mg of simvastatin.
• The other components are: monohydrate lactose, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide, talc, red iron oxide.

Description of the Appearance of SINVAT and Contents of the Pack
SINVAT 20 mg film-coated tablets – packs of 10 and 28 tablets: light orange, oblong, film-coated tablet with a break line on one side and the imprint “20 mg” on the other.
SINVAT 40 mg film-coated tablets – packs of 10 and 28 tablets: pink, oblong, film-coated tablet with a break line on one side and the imprint “40 mg” on the other.

MARKETING AUTHORISATION HOLDER
Epifarma S.r.l.
Via San Rocco, 6
85033 Episcopia (PZ)

Manufacturer
Famar Italia S.p.A.
Via Zambeletti, 25
Baranzate (Milan)

Special Product’s Line S.p.a
Via Fratta Rotonda Vado Largo, 1
03012-Anagni (FR)