СИМВАСТАТИНА 10 mg Film-coated tablets

Содержание инструкции

1. Simvastatina Aurobindo 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets
   1. What is Simvastatina Aurobindo and what it is used for
   2. What you need to know before taking Simvastatina Aurobindo
   3. How to take Simvastatina Aurobindo
   4. Possible side effects
   5. How to store Simvastatina Aurobindo
   6. Package Contents and Other Information

Simvastatina Aurobindo 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Simvastatina Aurobindo and what it is used for

Simvastatina Aurobindo is a medicine used to reduce levels of total cholesterol, of “bad” cholesterol (LDL cholesterol) and of fatty substances called triglycerides in the blood. Furthermore, this medicine increases levels of “good” cholesterol (HDL cholesterol). This medicine belongs to a class of medicines called statins.
Cholesterol is one of the various fatty substances found in the bloodstream. Total cholesterol is composed mainly of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can accumulate in the walls of the arteries forming plaques. Over time, this accumulation in the form of plaque can lead to a narrowing of the arteries. This narrowing can slow down or block the flow of blood 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 accumulating in the arteries and protects against heart disease.
Triglycerides are another form of fat present in the blood that can increase the risk of heart disease.
You must follow a diet to reduce cholesterol during therapy with this medicine.
This medicine is used in addition to diet to reduce cholesterol if you have:

• an increased level of cholesterol in the blood (primary hypercholesterolemia) or high levels of triglycerides in the blood (mixed hyperlipidemia);
• an inherited disease (familial homozygous hypercholesterolemia) that increases the level of cholesterol in the blood. You may also receive other treatments;
• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or other vascular diseases). This medicine can prolong your life by reducing the risk of heart disease, regardless of the amount of cholesterol in your blood.

In most of the population, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. See your doctor regularly, keep a record of your cholesterol, and inform your doctor of the results achieved.

2. What you need to know before taking Simvastatina Aurobindo

DO NOT USE Simvastatina Aurobindo

• if you are allergic to simvastatin or 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 any medicine(s) 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 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 lining of the uterus grows outside the uterus).
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatina Aurobindo may cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat a severe and rare genetic cholesterol condition).

Ask your doctor for advice if you are not sure whether the medicine you are taking is among those listed above.

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

• Tell your doctor about your medical conditions, including allergies.
• Tell your doctor if you drink large amounts of alcohol.
• Tell your doctor if you have ever had any liver disease. This medicine may not be right for you.
• Tell your doctor if you are about to have surgery. It may be necessary to stop taking this medicine for a short period.
• If you are Asian, because a different dose may be appropriate for you.

Your doctor will need to have a blood test before giving you Simvastatina Aurobindo and if you have
symptoms of liver problems while taking Simvastatina Aurobindo. This test is done
to make sure your liver is working properly.
Your doctor may also prescribe blood tests to check your liver function after starting
therapy with this medicine.
During therapy with this medicine, your doctor will carefully monitor you if 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
your blood, if you are overweight and have high blood pressure.
Tell your doctor if you have a severe lung disease.

Immediately consult your doctor if you experience muscle pain, tenderness or weakness without
reason. This is because, in rare cases, muscle problems can be serious and include
muscle tissue damage leading to kidney damage; very rarely, deaths have occurred.
The risk of muscle problems is higher at higher doses of this medicine, particularly with the
40 mg dose. The risk of muscle injury is also higher in some patients.
Talk to your doctor if any of the following conditions occur:

• if you drink large amounts of alcohol;
• if you have kidney problems;
• if you have thyroid problems;
• if you are 65 years of age or older;
• if you are a woman;
• if you have or have ever had muscle problems while taking medicines that lower cholesterol, called “statins” or fibrates;
• if you or a close family member have hereditary muscle diseases.

Also, tell your doctor or pharmacist if you have persistent muscle weakness.
Further tests and medicines may be needed to diagnose and treat this condition.

Children and adolescents
The safety and effectiveness of Simvastatina Aurobindo have been studied in boys aged between 10
and 17 years and in girls who have started to have their menstrual period (menstruation) for at least one year
(see section 3, “How to take Simvastatina Aurobindo”). Simvastatina Aurobindo has not
been studied in children under 10 years of age. For more information, ask your doctor.

Other medicines and Simvastatina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription. Taking Simvastatina
Aurobindo with any of these medicines may increase the risk of muscle problems (some
of these have already been listed in the previous section “Do not take Simvastatina Aurobindo”):

• if you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with Simvastatina Aurobindo. Taking Simvastatina Aurobindo with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4;
• cyclosporine (a medicine often used in patients with organ transplantation);
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections);
• fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce cholesterol);
• erythromycin, clarithromycin, 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 infections);
• nefazodone (used to treat depression);
• medicines with the active ingredient cobicistat;
• amiodarone (used to treat an irregular heartbeat);
• verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart problems);
• lomitapide (used to treat a severe and rare genetic cholesterol condition);
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). It is possible that side effects affecting the muscles may be greater when this medicine is taken during treatment with simvastatin. Your doctor may decide to stop taking it for a certain period;
• colchicine (used to treat gout).

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

• medicines with an active ingredient 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 (antiplatelet agent).

You should also tell the doctor who is prescribing you a new medicine that you are taking
Simvastatina Aurobindo.

Simvastatina Aurobindo with food and drink
Grapefruit juice contains one or more substances that alter the way the body uses some
medicines, including Simvastatina Aurobindo. Avoid consuming grapefruit juice.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Do not take this medicine if you are pregnant, are trying to become pregnant or think you might
be pregnant. If you become pregnant while taking this medicine, stop taking it immediately
and contact your doctor.
Do not take this medicine if you are breastfeeding, as it is not known whether the medicine is excreted in breast milk.

Driving and using machines
This medicine is not expected to impair your ability to drive or operate machinery. However, you should be aware that some
people have experienced dizziness after taking this medicine.

Simvastatina Aurobindo contains lactose
Simvastatina Aurobindo tablets contain a sugar called lactose; if your doctor has
diagnosed you with intolerance to some sugars, contact him before taking this medicine.

3. How to take Simvastatina Aurobindo

The doctor will determine the appropriate tablet dosage for you, based on your condition, your current
treatment and your risk profile.
Take this medicine following the doctor's instructions exactly. If you have any doubts, consult your
doctor or pharmacist.
Follow a diet to lower cholesterol while taking this medicine.
Dosage:
The recommended dose is 1 tablet of 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of Simvastatina
Aurobindo, orally once a day.
Adults:
The initial dose is usually 10, 20 or, in some cases, 40 mg per day. The 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.
The doctor may prescribe lower doses, especially if you are taking some 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 the desired cholesterol level with lower doses.

Use in children and adolescents
The recommended initial dose for children (aged 10 to 17 years) is 10 mg per day, in the evening. The
maximum recommended dose is 40 mg per day.
Method of administration:
Take Simvastatina Aurobindo in the evening. You can take it with or without food. Continue to take this
medicine unless your doctor tells you to stop.
If your doctor has prescribed Simvastatina Aurobindo together with another medicine to lower
cholesterol containing a bile acid sequestrant, you must take Simvastatina Aurobindo at least
2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatina Aurobindo than you should

• contact your doctor or pharmacist.

If you forget to take Simvastatina Aurobindo

• do not take an extra dose, just take your usual dose, at the usual time, the next day. Do not take a double dose to make up for a missed tablet.

If you stop taking Simvastatina Aurobindo

• talk to your doctor or pharmacist as your cholesterol may increase again.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
To describe the frequency with which side effects 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 (the frequency cannot be estimated from the available data).

The following serious side effects have been reported as rare.

If any of these serious side effects occur, stop taking the medicine
and immediately consult your doctor or go to the nearest hospital emergency room.
Muscle pain, tenderness, weakness, muscle breakdown or cramps. In rare cases, these
muscle problems can be severe, including breakdown of muscle cells and
resulting kidney damage; cases of death have occurred, although very rarely.
Hypersensitivity reactions (allergies) including:
swelling of the face, tongue and throat which can cause difficulty breathing
(angioedema);
severe muscle pain usually felt in the shoulders and hips;
skin rash with weakness of the arms and neck muscles;
skin rash that can occur on the skin or in the mouth sores (drug-induced
lichenoid eruptions);
pain or inflammation of the joints (polymyalgia rheumatica);
inflammation of blood vessels (vasculitis);
unusual bruising, rash and swelling (dermatomyositis), hives, skin sensitivity
to the sun, fever, redness;
shortness of breath (dyspnea) and feeling unwell;
a lupus-like illness (including rash, joint disorders 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 side effects have been reported rarely:
Low number of red blood cells (anemia).
Numbness or weakness in the arms and legs.
Headache, tingling sensation, dizziness.
Blurred vision, altered vision.
Digestive disorders (abdominal pain, constipation, flatulence, indigestion,
diarrhea, nausea, vomiting).
Skin rash, itching, hair loss.
Weakness.
Difficulty sleeping (very rare).
Poor memory (very rare), memory loss, confusion.
The following very rare serious side effect has been reported:
A severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis).
Gynaecomastia (enlargement of breast tissue in men).
The following adverse effects have also been reported, but the frequency cannot be estimated based on
the available information (frequency not known):

• Erectile dysfunction.
• Depression.
• Inflammation of the lungs causing breathing problems including cough and/or asthma or persistent fever.
• Tendon problems, sometimes complicated by tendon rupture.

Further possible adverse effects reported with some statins:

• Sleep disturbances, including nightmares.
• Sexual problems.
• Diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and if you have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Muscle pain, tenderness or weakness that is constant and may not go away after stopping treatment with this medicine (frequency not known).

Laboratory values
Increases in some values related to liver function
and a muscle enzyme (creatine kinase) have been observed in laboratory tests.

Reportingof side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Simvastatina Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and the cardboard box
after the wording EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 Simvastatina Aurobindo tablets contain

• The active ingredient is simvastatin. Each film-coated tablet contains 10 mg of simvastatin. Each film-coated tablet contains 20 mg of simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
• The other ingredients are: Tablet CoreButylated Hydroxyanisole (E320), Ascorbic Acid (E300), Citric Acid Monohydrate (E330), Microcrystalline Cellulose (E460a), Pregelatinized Starch, Lactose Monohydrate, Magnesium Stearate (E470B)

Film Coating
Hypromellose (E464), Hydroxypropylcellulose (E463), Titanium Dioxide (E171), Talc (E553b), Iron Oxide
Yellow (E172) - For 10 and 20 mg, Iron Oxide Red (E172) - For 10, 20, 40 mg

Description of the appearance of Simvastatina Aurobindo and contents of the pack
Film-coated tablets.
Simvastatina Aurobindo 10 mg film-coated tablets:
light pink, round [diameter 6.1 mm] and biconvex with an “A” imprinted on one side and “01” on the other.
Simvastatina Aurobindo 20 mg film-coated tablets:
light pink, round [diameter 8.1 mm] and biconvex with an “A” imprinted on one side and “02” on the other.
Simvastatina Aurobindo 40 mg film-coated tablets:
pink, round [diameter 10.1 mm] and biconvex with an “A” imprinted on one side and “03” on the other.
Simvastatina Aurobindo film-coated tablets 10, 20 and 40 mg are available in blister packs of
10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102

• 21047 - Saronno (VA) Italy

Manufacturers
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
Great Britain
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
France: SIMVASTATINE ARROW LAB 10/20 /40 mg, comprimés pelliculés
Germany: Simvastatin PUREN 5/10 /20 /40 /80 mg Filmtabletten
Italy: Simvastatina Aurobindo
Poland: Simvastatin Aurovitas
Portugal: Simvastatina Aurobindo
Romania: Simvastatin Aurobindo 10/20 /40 mg comprimat filmat
Spain: Simvastatina Aurovitas 10/20 /40 mg comprimidos recubiertos con película
Netherlands: Simvastatine Aurobindo 5/10 /20 /40 /80 mg filmomhulde tabletten
United Kingdom: Simvastatin 10/20 /40 /80 mg film-coated tablets