Simvastatin Doc Generici

Package leaflet: Information for the patient

SIMVASTATINA DOC 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Equivalent 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 effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. WHAT SIMVASTATINA DOC IS AND WHAT IT IS USED FOR

SIMVASTATINA DOC belongs to a group of medicines known as statins.
SIMVASTATINA DOC is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fats known as triglycerides in the blood. In addition, SIMVASTATINA DOC increases levels of "good" cholesterol (HDL cholesterol).
SIMVASTATINA DOC belongs to the group of medicines called statins.
Cholesterol is one of several fatty substances 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 during treatment with this medicine.
SIMVASTATINA DOC is used in addition to diet to reduce cholesterol if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia),

• a hereditary disease (homozygous familial hypercholesterolemia) that increases your cholesterol levels in the blood.

You may also be receiving other treatments, such as for coronary heart disease (CHD) or if you are at high risk of CHD (because you have diabetes, have had a stroke, or have another blood vessel disease). SIMVASTATINA DOC may prolong survival by reducing the risk of heart disease-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 need to know before taking SIMVASTATINA DOC

Do not take SIMVASTATINA DOC

• 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),
• if you currently have liver problems,
• if you are pregnant or breastfeeding,
• if you are taking a medicine(s) containing any of the following active substances:
  o itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections),
  o erythromycin, clarithromycin or telithromycin (used to treat infections),
  o HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections),
  o boceprevir or telaprevir (used to treat hepatitis C virus infection),
  o nefazodone (used to treat depression),
  o cobicistat,
  o gemfibrozil (used to lower cholesterol),
  o cyclosporine (used in organ transplant patients),
  o danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and SIMVASTATINA DOC can cause serious muscle problems (rhabdomyolysis).
Do not take more than 40 mg of SIMVASTATINA DOC 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, pharmacist or nurse before taking SIMVASTATINA DOC:
Inform your doctor:
o about all medical conditions including allergies, if you consume large amounts of alcohol, or if you have ever had liver disease. In such cases, SIMVASTATINA DOC may not be suitable for you.
o if you are due to undergo surgery. You may need to stop taking simvastatin temporarily.
o if you are of Asian origin, as you may require a different dose.
o if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases may include 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 SIMVASTATINA DOC and if you develop symptoms of liver problems while taking SIMVASTATINA DOC. 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 SIMVASTATINA DOC.
During treatment with this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Risk factors for developing diabetes include high blood sugar and fat levels, being overweight, and having high blood pressure.
Inform your doctor if you have a severe lung disease.

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 damage is higher at higher doses of SIMVASTATINA DOC, particularly at the 80 mg dose. The risk of muscle damage 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 65 years of age or older,
• you are female,
• you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates,
• you or a close family member have a hereditary muscle disease.

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

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

Other medicines and SIMVASTATINA DOC
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine containing any of the following active substances. Taking SIMVASTATINA DOC with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in section “Do not take SIMVASTATINA DOC”).

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 SIMVASTATINA DOC. Taking SIMVASTATINA DOC 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 transplant patients),
• danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines containing active substances such as itraconazole or ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates with active substances such as gemfibrozil and bezafibrate (used to reduce cholesterol),
• erythromycin, clarithromycin or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and 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. SIMVASTATINA DOC). Your doctor may decide to temporarily stop your treatment with SIMVASTATINA DOC,
• 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 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 an active substance to prevent blood clotting, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants),
• fenofibrate (also used to lower cholesterol),
• niacin (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis).

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

SIMVASTATINA DOC with food, drinks and alcohol
Grapefruit juice contains one or more components that alter how the body processes certain medicines, including simvastatin. Consumption of grapefruit juice should be avoided.

Pregnancy, breastfeeding and fertility
Do not use SIMVASTATINA DOC during pregnancy, if you are planning a pregnancy, or if you suspect you are pregnant. If you become pregnant while taking SIMVASTATINA DOC, stop treatment immediately and contact your doctor. Do not use SIMVASTATINA DOC during breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and using machines
SIMVASTATINA DOC is not expected to affect your ability to drive or operate machinery. However, you should be aware that dizziness has been reported after taking SIMVASTATINA DOC.

SIMVASTATINA DOC contains lactose
SIMVASTATINA DOC tablets contain a sugar called lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take SIMVASTATIN DOC

Your doctor will determine the appropriate tablet dosage for you, based on your condition,
your current treatment, and your risk profile.
Always take this medicine exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
During treatment with simvastatin, you must follow a cholesterol-lowering diet.

Dosage:
The recommended dose is simvastatin 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 per day. Your doctor may adjust your 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.

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

Method of administration:
Take SIMVASTATIN DOC in the evening. You may take it regardless of meals. Continue taking SIMVASTATIN DOC unless your doctor tells you to stop.
If your doctor has prescribed SIMVASTATIN DOC together with a cholesterol-lowering medicine containing a bile acid sequestrant, you must take SIMVASTATIN DOC at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more SIMVASTATIN DOC than you should

• contact a doctor or pharmacist immediately.

If you forget to take SIMVASTATIN DOC

• Do not take a double dose to make up for the missed dose. Take only your usual dose of SIMVASTATIN DOC at your usual time the next day.

If you stop taking SIMVASTATIN DOC
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 ADVERSE REACTIONS

Like all medicines, SIMVASTATIN DOC may cause adverse reactions, although not everyone experiences them.
To describe how frequently adverse reactions occur, the following terms are used:

• 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 following serious adverse reactions, you must stop treatment and contact your doctor immediately or go to the nearest hospital emergency department.
The following rare serious adverse reactions have been reported:

• Pain, tenderness, weakness, or muscle cramps. In rare cases, these muscle problems can be severe and may include muscle tissue damage leading to kidney injury; very rarely, cases of death have occurred.

• Hypersensitivity reactions (allergies) including:
  o swelling of the face, tongue, and throat, which may cause breathing difficulties (angioedema),
  o severe muscle pain, usually in the shoulders and hips,
  o skin rash with weakness in the legs and neck muscles,
  o joint pain or inflammation (polymyalgia rheumatica),
  o inflammation of blood vessels (vasculitis),
  o unusual bruising, skin rashes (dermatomyositis), swelling, hives, skin sensitivity to sunlight, fever, hot flushes,
  o shortness of breath (dyspnea) and feeling unwell,
  o a group of symptoms resembling lupus (including skin rash, joint disorders, and effects on blood cells).

• Inflammation of the liver, with the following symptoms: yellowing of the skin and eyes (jaundice), 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 reactions have also been reported:

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

The following adverse reactions have been reported rarely:

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

The following adverse reactions 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.

Additional possible adverse reactions reported with some statins:

• Sleep disorders, including nightmares,
• Memory loss,
• Sexual difficulties,
• Diabetes. The risk is higher if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.
• Persistent muscle pain, tenderness, or weakness that may not resolve after stopping treatment with SIMVASTATIN DOC (frequency not known).
• 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.

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

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

5. How to store SIMVASTATIN DOC

Keep this medicine out of the sight and reach of children.
Keep the tablets in the original packaging. Do not store above 25°C.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The first two digits indicate the month, followed by the year. 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 no longer required. This will help protect the environment.

6. Package contents and other information

What SIMVASTATINA DOC contains

• The active substance is simvastatin. Each film-coated tablet of SIMVASTATINA DOC 10 mg, 20 mg and 40 mg contains 10, 20 and 40 mg of simvastatin, respectively.
• The other components are:
  Tablet core: monohydrate lactose, microcrystalline cellulose (E460), pregelatinized corn starch, butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid (E330), anhydrous colloidal silica (E551), talc (E553b), magnesium stearate (E470b).
  Film coating: hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate (E1505), titanium dioxide (E171), talc (E553b), povidone (E1201).

Description of the appearance of SIMVASTATINA DOC and package contents
SIMVASTATINA DOC 10 mg: light orange, oval, biconvex, film-coated tablets,
scored on one side. The 10 mg tablets can be divided into two equal halves. The 10 mg tablets are packaged in blisters, in cardboard boxes containing 20, 28 or 30 tablets.
SIMVASTATINA DOC 20 mg: light brown, oval, biconvex, film-coated tablets. The tablets are packaged in blisters, in cardboard boxes containing 10 or 28 tablets.
SIMVASTATINA DOC 40 mg: red, oval, biconvex, film-coated tablets. The tablets are packaged in blisters, in cardboard boxes containing 10 or 28 tablets.

Marketing Authorization Holder
DOC Generici S.r.l.
Via Turati 40
20121 Milano
Italy

Responsible producer for batch release
FINE FOODS & PHARMACEUTICALS N.T.M. S.p.A.
Via Grignano 43
24041 Brembate (BG)
Italy

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