SIMVASTATINA 40 mg Tabletki Powlekane

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1. Simvastatina Mylan Generics 10 mg, 20 mg, 40 mg film-coated tablets
   1. What Simvastatina Mylan Generics is and what it is used for
   2. What you need to know before taking Simvastatina Mylan Generics
   3. How to take Simvastatina Mylan Generics
   4. Possible side effects
   5. How to store Simvastatina Mylan Generics
   6. Contents of the pack and other information

Simvastatina Mylan Generics 10 mg, 20 mg, 40 mg film-coated tablets

Generic Equivalent Medicine

Read this leaflet carefully before 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 their symptoms are the same as yours, as it could 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 Mylan Generics is and what it is used for
• 2. What you need to know before you take Simvastatina Mylan Generics
• 3. How to take Simvastatina Mylan Generics
• 4. Possible side effects
• 5. How to store Simvastatina Mylan Generics
• 6. Contents of the pack and other information

1. What Simvastatina Mylan Generics is and what it is used for

Simvastatina Mylan Generics is used to lower cholesterol levels and fatty substances called
triglycerides in the blood.
While taking this medicine, you must follow a low-cholesterol diet.
This medicine belongs to the class of drugs called statins.
Simvastatina Mylan Generics is used with a diet in case of:

• high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia) when exercise and weight loss have not worked.
• an inherited condition called homozygous familial hypercholesterolemia that causes increased cholesterol levels in the blood. You may also need to take other medicines for this condition.
• coronary heart disease or a high risk of developing coronary heart disease. You are very likely to have coronary heart disease if you have diabetes, if you have had a stroke before, or have other blood vessel diseases.

Most people will not have any symptoms related to increased cholesterol. Your doctor or
pharmacist can measure your cholesterol levels with a simple blood test. Too high a level of
cholesterol in the blood can lead to coronary heart disease. The blood vessels that carry
hardening of the arteries (atherosclerosis) can become blocked. Hardened arteries are less able to carry blood to the heart and
throughout the body. This can lead to chest pain (angina) and heart attacks.
If you have high cholesterol levels, you are more likely to also suffer from coronary heart disease
if you:

• Have high blood pressure (hypertension)
• Have diabetes (high blood sugar levels)
• Do little physical exercise
• Smoke
• Are overweight or consume a diet rich in fats.

Talk to your doctor or pharmacist if you need advice on any of these factors.

2. What you need to know before taking Simvastatina Mylan Generics

Do not take Simvastatina Mylan Generics:

• if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• if you have liver problems.
• if you are pregnant or breastfeeding.
• if you are taking medicines for fungal infections (such as itraconazole, ketoconazole, posaconazole or voriconazole), medicines used to treat HIV (such as indinavir, nelfinavir, ritonavir and saquinavir), medicines that contain cobicistat (also used to treat HIV), medicines used to treat hepatitis C (boceprevir, telaprevir), antibiotics (such as erythromycin, clarithromycin, telithromycin) or nefazodone which is used to treat depression (see section 2: “Other medicines and Simvastatina”)
• if you are taking gemfibrozil (a medicine to lower cholesterol)
• if you are taking ciclosporin (a medicine often used in patients who have had an organ transplant)
• if you are taking danazol (a human hormone used to treat endometriosis).

Do not take more than 40 mg a day of Simvastatina Mylan Generics if you are taking lomitapide (used to treat
a rare and serious genetic condition related to cholesterol).
If any of these conditions apply to you, do not take this medicine and go back to your doctor to discuss your
treatment.

Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatina Mylan Generics if you:

• Have a medical condition including allergies
• Have previously had liver problems. Simvastatina Mylan Generics may not be suitable for you.
• Have high blood pressure or high levels of fats and sugars in your blood or if your body mass index is greater than 30 kg/m². You may be at increased risk of developing diabetes. Your doctor will monitor you carefully if this applies to you.
• Drink regularly large amounts of alcohol.
• Are taking, or have taken in the last 7 days, a medicine called fusidic acid (used for bacterial infections), by mouth or by injection. The combination of fusidic acid and simvastatin can lead to serious muscle problems (rhabdomyolysis).

Children and adolescents
Safety and efficacy have been studied in boys 10-17 years old and in girls who have had their first
menstrual period at least one year before (see How to take Simvastatina Mylan Generics). The
simvastatin has not been studied in children under 10 years of age. For more information, ask your
doctor.

Blood tests
Before taking Simvastatina Mylan Generics your doctor will perform a blood test to check your
liver function.
Your doctor may also decide to perform blood tests to check your liver function
after you have started taking Simvastatina Mylan Generics.
Once you have started taking this medicine, your doctor will ask you to have regular blood tests to see how the
medicine is working.

During treatment
During treatment with this medicine your doctor will carefully check that you do not have diabetes or
are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of
sugars and fats in your blood, if you are overweight and have high blood pressure.

Important – Keep healthcare professionals informed.
Contact your doctor immediately if you experience any unexplained muscle pain, tenderness
or weakness. This is because in a very small number of patients, muscle problems can be
serious. This can lead to kidney damage and in rare cases death.
You are at increased risk of muscle breakdown if you take high doses of Simvastatina Mylan Generics, in
particular the 80 mg dose. Other patients may also be at increased risk of muscle breakdown. Talk to your
doctor if any of the following apply:

• drink large amounts of alcohol
• have kidney problems
• have thyroid problems
• are 65 years of age or older
• are a woman
• if you are of Asian origin, as you may need a different dose
• have ever had muscle problems while taking medicines that lower cholesterol such as statins or fibrates
• you or a close family member has hereditary muscle disorders.

Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further tests and medicines
may be needed to diagnose and treat this.
If you have difficulty breathing or a persistent cough, you should see your doctor.
If you need to go to hospital for an operation - you may need to stop taking
simvastatin for a short period of time.

Other medicines and Simvastatina Mylan Generics
Many medicines affect the way Simvastatina Mylan Generics works. Tell your doctor or
pharmacist if you are taking, have recently taken or might take any other medicines.
This includes over-the-counter medicines, herbal remedies and vitamin supplements and any of the following
active ingredients:

• Ciclosporin- to prevent rejection in patients who have had an organ transplant
• A hormone called danazolused to treat heavy or painful periods
• Antifungal medicines such as itraconazole, ketoconazole, fluconazole, posaconazole orvoriconazole
• Fibrates such as gemfibrozil, fenofibrate and bezafibrateused to lower high cholesterol
• Niacinor nicotinic acidor acipimox in high doses used to treat high cholesterol
• Antibiotics, such as erythromycin, clarithromycin, telithromycin
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonaviror saquinavir(medicines for HIV infections), or medicines that contain cobicistat (also used to treat HIV infections)
• Medicines used to treat hepatitis C (boceprevir, telaprevir)
• An antidepressant called nefazodone
• Medicines such as amiodarone(a medicine for irregular heartbeat), verapamil,diltiazemor amlodipine(medicines used to treat high blood pressure or heart disease)
• Lomitapide(used to treat a rare genetic cholesterol condition)
• Colchicine(a medicine used to treat gout).

Taking Simvastatina Mylan Generics with some of these medicines can increase the risk of
muscle problems (some of these have already been listed in the previous section “Do not take
Simvastatina Mylan Generics”).
If you need to take fusidic acid to treat a bacterial infection you will need to temporarily stop
this medicine. Your doctor will tell you when you can safely start taking Simvastatina Mylan
Generics again. Taking Simvastatina Mylan Generics and fusidic acid can rarely lead to
muscle weakness, tenderness or pain (rhabdomyolysis). You can find more information about
rhabdomyolysis in section 4.

Check with your doctor if you are taking any of the following medicines before taking Simvastatina
Mylan Generics:

• A medicine used to treat tuberculosis called rifampicin
• Medicines used to treat blood clots, such as warfarin, phenprocoumon or acenocoumarol, as the doses of warfarin, phenprocoumon or acenocoumarol may need to be changed.

Also tell your doctor if you are taking niacin (nicotinic acid) or products containing niacin and if you are
Chinese.

Simvastatina Mylan Generics with food and drink
Grapefruit juice can alter the way the body uses simvastatin. Consumption of grapefruit
juice should be avoided if you are taking simvastatin.

Pregnancy and breastfeeding
If you are pregnant, or suspect you may be pregnant, DO NOTtake Simvastatina Mylan
Generics. If you become pregnant while taking Simvastatina Mylan Generics, STOP
taking the medicine and contact your doctor immediately.
Do not take Simvastatina Mylan Generics 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
There are no known effects of Simvastatina Mylan Generics on the ability to drive and operate
machines. Simvastatina Mylan Generics can cause dizziness and therefore make sure that it does not affect
you before driving and operating machines.

Simvastatina Mylan Generics contains lactose (10 mg, 20 mg, 40 mg strengths) and polydextrose (40 mg
strength only).
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take Simvastatina Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. The dose will be decided by the doctor and will depend on the results of the blood
tests. The dose you need to take will be reported on the doctor's prescription..
Remember to maintain a low-fat diet and to exercise.

Patients with coronary heart disease (CHD)
The recommended dose is 20 mg – 40 mg to be taken in the evening. The doctor may increase the dose every 4
weeks. The maximum dose is 80 mg. The doctor will establish the appropriate dosage for you, depending on
your condition, your current treatment and your personal risk status. Continue to take
Simvastatina Mylan Generics unless your doctor tells you to stop.

Patients with high cholesterol/fat levels in the blood (hypercholesterolemia/hyperlipidemia)
The initial recommended dose is 10 mg-20 mg to be taken in the evening. The doctor may increase the dose every
4 weeks. The maximum dose is 80 mg.

Patients with high inherited cholesterol (familial homozygous hypercholesterolemia)
The initial recommended dose is 40 mg to be taken in the evening.
A dose of 80 mg is recommended only for adult patients who have very high levels of cholesterol in the
blood and are at high risk of developing heart problems and have not reached the desired low levels of
cholesterol.

Use in children and adolescents (10-17 years)
The initial recommended dose for children and adolescents aged 10-17 years is 10 mg.
This dose should normally be taken in the evening. If necessary, the dose may be increased up to
a maximum of 40 mg.
Some patients will need a lower dose, especially if they are also taking other medicines such as
fibrates or niacin, and also if they have severe kidney problems.

Taking Simvastatina Mylan Generics with other medicines that lower cholesterol
Your doctor may ask you to take a medicine called cholestyramine while you are taking
simvastatin. This medicine may interfere with the way simvastatin works. You should
take simvastatin 2 hours before or 4 hours after you have taken cholestyramine.

Taking the medicine
Swallow the medicine with plenty of water. For 10 mg tablets, the score line is only to facilitate
breaking the tablet if you have difficulty swallowing it whole. 20 mg tablets can be divided into
two equal doses. You can take them with or without food.

If you take more Simvastatina Mylan Generics than you should
Talk to your doctor or go immediately to the nearest emergency room. Bring the package with you.

If you forget to take Simvastatina Mylan Generics
If you forget to take a dose, take it immediately as soon as you remember, unless it is too close to the time of the next dose. Do nottake a double dose to make up
for the missed dose.

If you stop taking Simvastatina Mylan Generics
Your doctor will tell you how long you need to take the tablets. Do notsuddenly stop
taking the medicine without first contacting your doctor because your cholesterol level
may increase again.
If you have any doubts about 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 everyone will experience them.
Do not worry about the list of side effects. You may not experience any, but it is important that you know what to do if they occur.

If any of these serious side effects occur, stop taking the medicine and immediately talk to your doctor or go to the nearest hospital emergency room.

• Unexplained muscle problems such as muscle pain, tenderness, weakness, particularly continuous muscle weakness or cramps. In rare cases, these muscle problems can be very serious and cause muscle breakdown and kidney damage. In some cases, these problems can be life-threatening and very rarely death has occurred.
• Hypersensitivity reactions (allergies), include:
• swelling of the face, tongue and throat which can cause difficulty in breathing
• severe muscle pains usually in the shoulders and hips
• skin irritation with weakness of the arms and neck muscles
• pain or inflammation of the joints
• inflammation of the blood vessels
• unusual bruising, skin rashes and swelling, urticaria, skin sensitivity to the sun, fever, hot flushes
• shortness of breath and malaise
• lupus-like illness picture (including skin irritation, joint disorders, and effects on blood cells)
• inflammation of the liver with yellowing of the skin and eyes, itching, dark urine or pale stools, which can lead to liver failure
• severe pain in the abdomen which may be swollen and tender and may spread to the back, and a feeling of being sick with fever caused by inflammation of the pancreas
• inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
• joint pain with weakness and inability to move the arm or leg caused by problems with the tendons that attach the muscle to the bone.
• diabetes. This is more likely if you have high levels of sugars and fats in your blood, if you are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine.

Other possible side effects
Rare (may affect up to 1 in 1,000 people):

• Feeling tired and short of breath with pale skin caused by a low number of red blood cells (anemia)
• numbness or weakness of the arms and legs
• headache, tingling sensation, dizziness
• digestive disorders (abdominal pain, constipation, flatulence, indigestion, diarrhea, nausea, vomiting)
• skin rash, itching, hair loss
• weakness
• increased levels of substances in the blood that indicate how the liver and muscles are working, which are detected in blood tests

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

• sleep disorders
• poor memory, memory loss, confusion.

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

• inability to get and maintain an erection (erectile dysfunction)
• depression
• feeling thirsty, needing to urinate more often, feeling tired due to increased blood sugar.

Further side effects reported with some statins:

• sleep disturbances, including nightmares
• sexual difficulties

Reporting of 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.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Simvastatina Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store at a temperature above 25ºC.
Do not use this medicine after the expiry date which is stated on the package / blister / bottle after 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 eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Simvastatina Mylan Generics contains
Simvastatina Mylan Generics is presented as film-coated tablets in three dosages of 10 mg,
20 mg, 40 mg of the active substance simvastatin per tablet. The other components are ascorbic acid,
butylated hydroxyanisole (E320), citric acid monohydrate, lactose monohydrate (see paragraph 2
“Simvastatina contains lactose”), magnesium stearate, microcrystalline cellulose, pregelatinized corn starch,
hypromellose, talc, titanium dioxide (E171), triacetin, yellow iron oxide (E172) (only for
20 mg and 40 mg) and red iron oxide (E172). The 40 mg film-coated tablets also contain
polydextrose (containing small amounts of glucose and sorbitol (E420) (see paragraph 2 “Simvastatina
contains polydextrose) and macrogol 8000.

Description of the appearance of Simvastatina Mylan Generics and contents of the pack
The film-coated tablets of Simvastatina Mylan Generics 10 mg range from dark peach to
pink in color, have an oval shape, film-coated tablets with a “G” on one side and a “SM” fracture line
“10” on the other.
The film-coated tablets of Simvastatina Mylan Generics 20 mg are dark brown, oval in
shape, film-coated tablets with a “G” on one side and a “SM” fracture line “20” on the other.
The film-coated tablets of Simvastatina Mylan Generics 40 mg are pink, oval in
shape, film-coated tablets with a “G” on one side and “SM40” on the other.
The film-coated tablets of Simvastatina Mylan Generics are available in plastic bottles (with
optional filler) or blisters of 10, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 250, 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milan
Italy

Manufacturer:
Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road
Dublin 13
Ireland
Mylan Hungary Kft.
H-2900, Komárom
Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Austria: Simvarcana 20 mg, 40mg Filmtabletten

Belgium: Simvastatine Mylan 20 mg, 40 mg and 80 mg filmomhulde tabletten

Czech Republic: Simvastatin Mylan 10, 20 & 40 mg

Denmark: Simvastatin Generics 10 mg, 20 mg, 40 mg

Germany: Simvastatin dura 10 mg, 20mg, 40mg Filmtabletten

Greece: Simvastatin/Mylan10 mg, 20 mg, 40 mg

Ireland: Simvastatin 10 mg, 20 mg, 40 mg, 80 mg Film-coated Tablets

Italy: Simvastatina Mylan Generics 10 mg, 20 mg, 40 mg

Luxembourg: Simvastatine Mylan 20 mg, 40 mg, 80 mg

Netherlands: Simvastatine Mylan 10 mg, 20 mg, 40 mg, 80 mg Filmomhulde tabletten

Poland: Simvagen 10 mg, 20 mg, 40 mg, 80 mg

Portugal: Sinvastatina Anova

United Kingdom: Simvastatin 10 mg, 20 mg, 40 mg, 80 mg Film-coated tablets