Simvastatin Sandoz

Package leaflet: Information for the patient

Simvastatina Sandoz 10 mg film-coated tablets, 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 adverse effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

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

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

Simvastatin Sandoz contains the active substance simvastatin.
Simvastatin Sandoz is a medicine used to reduce levels of total cholesterol, "bad" cholesterol (LDL), and fats called triglycerides in the blood.
Additionally, Simvastatin Sandoz increases levels of "good" cholesterol (HDL). Simvastatin Sandoz belongs to a class of medicines known as statins.
Cholesterol is one of many fats found in the blood. Total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is commonly referred to as "bad" cholesterol because it can build up in the walls of arteries and form plaques. Over time, these plaques grow larger and eventually block the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain, thereby causing a heart attack or stroke.
HDL cholesterol is commonly known as "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood. High levels may increase the risk of heart problems.
While being treated with this medicine, you must continue to follow a diet low in cholesterol.
Simvastatin Sandoz is used in addition to a cholesterol-lowering diet in the following cases:

• high 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 cholesterol levels in the blood. You may also need to undergo other treatments.
• coronary heart disease (CHD) or if you are at risk of CHD (due to diabetes, previous stroke, or other blood vessel diseases). Simvastatin Sandoz may prolong your life by reducing the risk of heart problems, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol level with a simple blood test. Have regular check-ups, keep track of your cholesterol levels, and discuss your targets with your doctor.

2. What you should know before taking Simvastatina Sandoz

Do not take Simvastatina Sandoz

• if you are allergic to simvastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you currently have liver problems
• if you are pregnant or breastfeeding
• if you are taking medicines 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, or saquinavir (used to treat HIV infections); boceprevir or telaprevir (used to treat hepatitis C virus infection); nefazodone (used to treat depression); cobicistat or gemfibrozil (used to lower cholesterol); cyclosporine (used in organ transplant patients); or danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus). Do not take more than 40 mg of Simvastatina Sandoz if you are taking lomitapide (used to treat a rare, genetic, severe cholesterol condition). Consult your doctor if you are unsure whether your medicine is listed above.

Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatina Sandoz:

• about your medical conditions, including allergies.
• if you drink large amounts of alcohol.
• if you have ever had liver disease. Simvastatina Sandoz may not be suitable for you.
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a drug for bacterial infections). The combination of fusidic acid and Simvastatina Sandoz can lead to serious muscle problems (rhabdomyolysis).
• if you are scheduled for surgery. You may need to temporarily stop taking Simvastatina Sandoz tablets.
• if you are of Asian origin, as you may require a different dose.

Your doctor will perform a blood test before you start taking Simvastatina Sandoz and if you develop symptoms of liver problems during treatment with Simvastatina Sandoz. This is done to monitor liver function.
Your doctor may also perform blood tests to monitor your liver function after you have started taking Simvastatina Sandoz.
While taking 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 fats in the blood, if you are overweight, or if you have high blood pressure.
Inform your doctor if you suffer from a serious lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness.
This is necessary because, in rare cases, muscle problems can be serious and may include generalized muscle breakdown that can lead to kidney damage; very rarely, cases of death have been reported.
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.
The risk of muscle breakdown is higher with high doses of Simvastatina Sandoz, especially at the 80 mg dose. The risk of muscle breakdown is also increased in certain patients. Consult 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 years or older
• you are female
• you have previously experienced muscle problems while being treated with cholesterol-lowering medicines called "statins" or fibrates
• you or a close family member have a hereditary muscle disease

Children and adolescents
The safety and efficacy of simvastatin have been studied in boys and girls aged between 10 and 17 years, and in girls who had started menstruation at least one year prior – (see section 3: How to take Simvastatina Sandoz). Simvastatin has not been studied in children under 10 years of age.
For further information, consult your doctor.
Other medicines and Simvastatina Sandoz
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Taking Simvastatina Sandoz with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section above "Do not take Simvastatina Sandoz").

• 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 Sandoz. Taking Simvastatina Sandoz with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.
• cyclosporine (often used in organ 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, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• fibrates containing 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 HIV infections)
• antiviral medicines for hepatitis C such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)
• nefazodone (used to treat depression)
• medicines containing 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, genetic, severe cholesterol condition)
• colchicine (used to treat gout)

As with the medicines listed above, inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine, including those obtained without a prescription.
In particular, inform your doctor if you are taking medicines 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).

Inform any doctor who prescribes you a new medicine that you are taking Simvastatina Sandoz.
Simvastatina Sandoz with food, drinks, and alcohol
Grapefruit juice contains one or more components that alter how the body processes certain medicines, including Simvastatina Sandoz. Therefore, grapefruit juice should be avoided.
Inform your doctor if you consume large amounts of alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Do not take Simvastatina Sandoz if you are pregnant, trying to become pregnant, or suspect you are pregnant. If you find out you are pregnant while taking Simvastatina Sandoz, stop taking it immediately and contact your doctor.
Do not take Simvastatina Sandoz if you are breastfeeding, as it is not known whether the medicine passes into breast milk.
Driving and using machines
Simvastatina Sandoz should not affect your ability to drive or use machinery.
However, bear in mind that some people may experience dizziness after taking Simvastatina Sandoz.
Simvastatina Sandoz contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Simvastatin Sandoz

Your doctor will determine the most appropriate tablet dosage for you, based on your medical condition, current treatment, and risk factors.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
While undergoing treatment with Simvastatin Sandoz, you must follow a diet low in cholesterol.
The recommended dose is one tablet taken orally once daily.
Adults:
The usual starting dose is 10, 20, or in some cases, 40 mg/day. Your doctor may adjust the dose after at least 4 weeks have passed, 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 if you have certain kidney diseases.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and at high risk of heart problems who have not achieved target cholesterol levels with lower doses.
Use in children and adolescents
For children (aged 10–17 years), the recommended starting dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.
Method and duration of administration:
Take the medicine in the evening. You may take the tablet with or without food. Continue taking the medicine until your doctor tells you to stop.
The tablet may be divided into equal doses.
If your doctor has prescribed Simvastatin Sandoz together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatin Sandoz at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin Sandoz than you should
Contact your doctor immediately. In case of overdose, your doctor will initiate symptomatic and supportive measures.
If you forget to take Simvastatin Sandoz
Do not take a double dose to make up for the missed dose; instead, continue treatment with your prescribed dosage.
If you stop taking Simvastatin Sandoz
Consult 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 side effects

Like all medicines, this medicine may cause side effects, although not everyone gets them.
If you experience any of the following serious side effects, stop taking the medicine and
contact your doctor immediately or go to the nearest hospital Emergency Department.
The following rare serious side effects have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity (allergic) reactions, including:
• swelling of the face, tongue, and throat which may cause breathing difficulties (angioedema)
• severe muscle pain, usually in the shoulders and hips
• skin rash with weakness of the limbs and neck muscles
• joint pain or inflammation (polymyalgia rheumatica)
• inflammation of blood vessels (vasculitis)
• bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flushes
• shortness of breath (dyspnoea) and malaise
• lupus-like syndrome (including skin rash, joint disorders, 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, and very rare liver failure
• inflammation of the pancreas, often 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 been reported:
Rare (may affect up to 1 in 1,000 people):

• low red blood cell count (anaemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• skin rash, itching, hair loss
• fatigue
• increases in certain blood test values indicating liver function and muscle enzyme (creatine kinase)
• memory loss, confusion

Very rare (may affect up to 1 in 10,000 people):

• sleep disorders
• memory impairment

Not known (frequency cannot be estimated from the available data):

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

Other 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.

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 https://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 Simvastatina Sandoz

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack/bottle and on the outer packaging,
following the word "Exp". The expiry date refers to the last day of that month.
Do not store above 30°C.
Keep blister packs in the outer packaging to protect the medicine from light.
Keep the bottle in the original packaging to protect the medicine from light.
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. Package Contents and Other Information

What Simvastatin Sandoz Contains

• The active substance is simvastatin. One tablet contains 10 mg/20 mg/40 mg of simvastatin.
• The other components are:
  Tablet core for 10 mg: pregelatinized starch, monohydrate lactose, microcrystalline cellulose, butylated hydroxyanisole (E 320), ascorbic acid (E 300), monohydrate citric acid (E 330), magnesium stearate.

Tablet core for 20 mg and 40 mg: pregelatinized starch, monohydrate lactose, microcrystalline cellulose, butylated hydroxyanisole (E 320), monohydrate citric acid (E 330), magnesium stearate.
Film coating for 10 mg and 20 mg tablets: hypromellose, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172).
Film coating for 40 mg tablets: hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172).

Description of the Appearance of Simvastatin Sandoz and Contents of the Package
Simvastatin Sandoz 10 mg film-coated tablets are light pink, oval-shaped, scored, convex, film-coated tablets marked with "SIM 10", available in the following pack sizes:
10 mg:
Blister (Aluminum/PVC)
Packs: 10, 20, 28, 30, 40, 49, 50, 50 x 1, 60, 84, 90, 98 and 100 film-coated tablets.
Polyethylene container with screw cap
Packs: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.
The tablet can be divided into equal doses.

Simvastatin Sandoz 20 mg film-coated tablets are orange, oval-shaped, biconvex, film-coated tablets with a breakline on both sides, marked with "20", available in the following pack sizes:
20 mg:
Blister (Aluminum/PVC)
Packs: 10, 20, 28, 30, 40, 49, 50, 50 x 1, 60, 84, 90, 98 and 100 film-coated tablets.
Polyethylene container with screw cap
Packs: 10, 20, 28, 30, 40, 50, 84, 94, 100, 120 and 250 film-coated tablets.
The tablet can be divided into equal doses.

Simvastatin Sandoz 40 mg film-coated tablets are red-brown, oval-shaped, biconvex, film-coated tablets with a breakline on both sides, marked with "40", available in the following pack sizes:
40 mg:
Blister (Aluminum/PVC)
Packs: 10, 20, 28, 30, 40, 49, 50, 50 x 1, 60, 84, 90, 98 and 100 film-coated tablets.
Polyethylene container with screw cap
Packs: 10, 20, 28, 30, 40, 50, 84, 90, 100, 120 and 250 film-coated tablets.
The tablet can be divided into equal doses.

Not all pack sizes may be marketed.

Marketing Authorization Holder:
Sandoz S.p.A.
Largo U. Boccioni, 1
21040 Origgio - Varese
Italy

Manufacturers:

• Salutas Pharma GmbH - Otto-von-Guericke Allee 1 - D-39179 Barleben - Germany
• LEK S.A. - ul. Domaniewska 50 C - 02-672 Warszawa - Poland
• LEK Pharmaceuticals d.d. - Verovskova 57 - 1526 Ljubljana - Slovenia
• S.C. Sandoz S.r.l. Str. Livezeni nr. 7A 540472 Targu Mures, Jud. Mures - Romania
• LEK S.A. 16, Podlipie Str. 95-010 Strykow Poland

This medicinal product is authorized in the European Economic Area (EEA) Member States under the following names:
DE: Simvastatin Sandoz 10 mg/20 mg/40 mg Filmtabletten
DK: Simvastatin Sandoz
ES: Simvastatina Sandoz 10 mg/20 mg/40 mg comprimidos recubiertos con película EFG
IT: Simvastatina Sandoz 10 mg/20 mg/40 mg compresse rivestite con film
NL: Simvastatine Sandoz 10 mg/20 mg/40 mg filmomhulde tabletten
NO: Simvastatin Sandoz 10 mg/20 mg/40 mg tabletter, filmdrasjerte
PL: CORR 10/20/40
PT: Simvastatina Sandoz
SI: Simvastatin Lek 10 mg/20 mg/40 mg filmsko obložene tablete
UK: Simvastatin 10 mg/20 mg/40 mg film-coated tablets