Simvastatin Mylan Generics

PACKAGE LEAFLET

Package leaflet: Information for the patient

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

Generic Medicine
Please read this entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 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

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

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

• high cholesterol levels in the blood (primary hypercholesterolemia) or elevated levels of fats in the blood (mixed hyperlipidemia), when physical exercise and weight loss have not been effective.
• an inherited disease called homozygous familial hypercholesterolemia, which causes increased cholesterol levels in the blood. You may also be taking other medicines for this condition.
• coronary heart disease or a high risk of developing coronary heart disease. You are more likely to have coronary heart disease if you have diabetes, have previously had a stroke, or have other blood vessel diseases.

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

• have high blood pressure (hypertension)
• have diabetes (high blood sugar levels)
• exercise too little
• smoke
• are overweight or eat a diet high in fats.

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

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

Do not take Simvastatin Mylan Generics:

• if you are allergic to simvastatin or to 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 containing 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 Simvastatin”).
• if you are taking gemfibrozil (a medicine used to lower cholesterol).
• if you are taking cyclosporine (a medicine often used in patients who have had an organ transplant).
• if you are taking danazol (a hormone used to treat endometriosis).

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

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

• have any medical condition, including allergies.
• have previously had liver problems. Simvastatin Mylan Generics may not be suitable for you.
• have high blood pressure, high levels of fats and sugars in your blood, or a body mass index (BMI) above 30 kg/m². You may be at higher risk of developing diabetes. Your doctor will monitor you closely for this.
• regularly drink large amounts of alcohol.
• are taking, or have taken within the last 7 days, a medicine called fusidic acid (used for bacterial infections), taken orally or by injection. The combination of fusidic acid and simvastatin can lead to serious muscle problems (rhabdomyolysis).

Children and adolescents
The safety and efficacy of Simvastatin Mylan Generics have been studied in adolescents aged 10–17 years, including girls who have had their first menstrual period at least one year prior (see section “How to take Simvastatin Mylan Generics”). Simvastatin has not been studied in children under 10 years of age. For further information, please consult your doctor.

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

During treatment
While being treated 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 sugars and fats in your blood, 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 and may lead to kidney damage; in very rare cases, death has occurred.
You are at higher risk of muscle breakdown if you are taking high doses of Simvastatin Mylan Generics, particularly 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 to you:

• you drink large amounts of alcohol.
• you have kidney problems.
• you have thyroid problems.
• you are aged 65 or older.
• you are a woman.
• you are of Asian origin, as you may require a different dose.
• you have previously experienced muscle problems while taking cholesterol-lowering medicines such as statins or fibrates.
• you or a close family member has a hereditary muscle disorder.

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.
If you develop breathing difficulties or a persistent cough, you should see your doctor.
If you are scheduled for hospitalization and surgery, you may need to temporarily stop taking simvastatin.

Other medicines and Simvastatin Mylan Generics
Many medicines affect how Simvastatin Mylan Generics works. Inform 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, vitamin supplements, and any of the following active substances:

• Cyclosporine – used to prevent organ rejection in transplant patients.
• A hormone called danazol, used to treat heavy or painful periods.
• Antifungal medicines such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole.
• Fibrates such as gemfibrozil, fenofibrate, and bezafibrate, used to lower high cholesterol.
• Niacin or nicotinic acid, or acipimox in high doses, used to treat high cholesterol.
• Antibiotics such as erythromycin, clarithromycin, telithromycin.
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, or saquinavir (medicines for HIV infection), or medicines containing cobicistat (also used to treat HIV infection).
• Medicines used to treat hepatitis C (boceprevir, telaprevir).
• An antidepressant called nefazodone.
• Medicines such as amiodarone (a medicine for irregular heartbeat), verapamil, diltiazem, or 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 Simvastatin Mylan Generics with some of these medicines may increase the risk of muscle problems (some of which are already listed in the previous section “Do not take Simvastatin Mylan Generics”).
If you need to take 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 Simvastatin Mylan Generics. Taking Simvastatin Mylan Generics and fusidic acid together may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Check with your doctor if you are taking any of the following medicines before taking Simvastatin 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 adjustment.

Also inform your doctor if you are taking niacin (nicotinic acid) or products containing niacin, and if you are of Chinese origin.

Simvastatin Mylan Generics with food and drink
Grapefruit juice can alter how your body processes simvastatin. You should avoid consuming grapefruit juice while taking simvastatin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, DO NOT take Simvastatin Mylan Generics. If you become pregnant while taking Simvastatin Mylan Generics, STOP taking the medicine immediately and contact your doctor.
Do not take Simvastatin 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
Simvastatin Mylan Generics is not known to have any significant effect on the ability to drive or operate machinery. However, simvastatin may cause dizziness; therefore, ensure this does not affect you before driving or operating machinery.

Simvastatin Mylan Generics contains lactose (10 mg, 20 mg, 40 mg strengths) and polidextrose (40 mg strength only).
If your doctor has diagnosed you with an intolerance to certain sugars, consult them before taking this medicine.

3. How to take Simvastatin Mylan Generics

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist. Your dose will be determined by your doctor and will depend on the results of
your blood tests. The dose you should take will be indicated on your doctor's prescription.
Remember to maintain a low-fat diet and engage in physical exercise.
Patients with coronary heart disease (CHD)
The recommended dose is 20 mg – 40 mg taken in the evening. Your doctor may increase the dose every 4
weeks. The maximum dose is 80 mg. Your doctor will determine the appropriate dosage for you, depending on your
condition, current treatment, and personal risk status. Continue taking
Simvastatin Mylan Generics unless your doctor tells you to stop.
Patients with high cholesterol/fat levels in the blood (hypercholesterolemia/hyperlipidemia)
The recommended starting dose is 10 mg–20 mg taken in the evening. Your doctor may increase the dose every
4 weeks. The maximum dose is 80 mg.
Patients with inherited high cholesterol (homozygous familial hypercholesterolemia)
The recommended starting dose is 40 mg taken in the evening.
The 80 mg dose is recommended only for adult patients who have very high blood cholesterol levels, are at high risk of developing
heart problems, and have not achieved the desired low cholesterol levels.
Use in children and adolescents (10–17 years)
The recommended starting 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 may require a lower dose, particularly if they are also taking other medicines such as
fibrates or niacin, or if they have severe kidney problems.
Taking Simvastatin Mylan Generics with other cholesterol-lowering medicines
Your doctor may ask you to take a medicine called cholestyramine while you are taking
simvastatin. This medicine may interfere with how simvastatin works. You must take
simvastatin either 2 hours before or 4 hours after taking cholestyramine.
How to take the medicine
Swallow the medicine with plenty of water. For the 10 mg tablets, the score line is only intended to facilitate breaking the tablet if you have difficulty swallowing it whole. The 20 mg tablets may be divided into two equal doses. You may take them with or without food.
If you take more Simvastatin Mylan Generics than you should
Speak to your doctor or go immediately to the nearest emergency department. Take the packaging with you.
If you forget to take Simvastatin Mylan Generics
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed dose.
If you stop taking Simvastatin Mylan Generics
Your doctor will tell you how long you should take the tablets. Do not stop taking the medicine suddenly without first contacting your doctor, 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Don't be alarmed by the list of possible side effects. You may not experience any of them, but it is important that you know what to do if they do occur.
If any of the following serious side effects occur, stop taking the medicine and speak to your doctor immediately or go to the nearest hospital emergency department.

• Unexplained muscle problems such as muscle pain, tenderness, weakness, particularly ongoing muscle weakness or cramps. In rare cases, these muscle problems can be very serious and lead to muscle breakdown and kidney damage. In some cases, these problems may be life-threatening and, very rarely, death has occurred.
• Hypersensitivity reactions (allergies), including:
  • swelling of the face, tongue and throat which may cause difficulty breathing
  • severe muscle pain, usually in the shoulders and hips
  • skin rash with weakness in the limbs and neck muscles
  • joint pain or inflammation
  • inflammation of blood vessels
  • unusual bruising, skin rashes and swelling, hives, skin sensitivity to sunlight, fever, hot flushes
  • shortness of breath and feeling unwell
  • lupus-like illness (including skin rash, joint problems, and effects on blood cells)
  • liver inflammation with yellowing of the skin and eyes (jaundice), itching, dark-coloured urine or pale stools, which may lead to liver failure
  • severe stomach pain which may be associated with abdominal swelling and tenderness, spreading to the back, and feeling unwell with fever due to inflammation of the pancreas
  • lung inflammation 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 due to problems with tendons that attach muscle to bone
  • diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, or have high blood pressure. Your doctor will monitor 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 due to low red blood cell count (anaemia)
• Numbness or weakness in arms and legs
• Headache, tingling sensation, dizziness
• Gastrointestinal disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• Skin rash, itching, hair loss
• Weakness
• Increased levels of substances in the blood indicating liver or muscle function, detected by 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 the available data):

• Inability to get or maintain an erection (erectile dysfunction)
• Depression
• Feeling thirsty, needing to urinate more often, feeling tired due to increased blood sugar levels

Additional side effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual difficulties

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 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 Simvastatin Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use this medicine after the expiry date stated on the carton/blister pack/bottle after "Exp".
The expiry date refers to the last day of that month.
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 Simvastatina Mylan Generics contains
Simvastatina Mylan Generics is available as film-coated tablets in three strengths containing 10 mg,
20 mg, and 40 mg of the active substance simvastatin per tablet. The other ingredients are ascorbic acid,
butylated hydroxyanisole (E320), citric acid monohydrate, lactose monohydrate (see section 2
“Simvastatina contains lactose”), magnesium stearate, microcrystalline cellulose, pregelatinized maize 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 section 2 “Simvastatina
contains polydextrose”) and macrogol 8000.

Description of the appearance of Simvastatina Mylan Generics and package contents
The 10 mg film-coated tablets of Simvastatina Mylan Generics are dark peach to pink in colour, oval-shaped, film-coated tablets with a "G" on one side and "SM" and a break line with "10" on the other.
The 20 mg film-coated tablets of Simvastatina Mylan Generics are dark brown, oval-shaped, film-coated tablets with a "G" on one side and "SM" and a break line with "20" on the other.
The 40 mg film-coated tablets of Simvastatina Mylan Generics are pink, oval-shaped, 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 desiccant) or blisters containing 10, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 250, and 1000 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A.
Via Vittor Pisani 20
20124 Milano
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 authorized in the European Economic Area countries under the following names:
Austria: Simvarcana 20 mg, 40 mg Film Tablets
Belgium: Simvastatine Mylan 20 mg, 40 mg and 80 mg film-coated tablets
Czech Republic: Simvastatin Mylan 10, 20 & 40 mg
Denmark: Simvastatin Generics 10 mg, 20 mg, 40 mg
Germany: Simvastatin dura 10 mg, 20 mg, 40 mg Film Tablets
Greece: Simvastatin/Mylan 10 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 Film-coated tablets
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