Simvastatin SUN - Simvastatin uses, dose and side effects

Simvastatin SUN contains the active substance simvastatin. Simvastatin SUN is a drug used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL – cholesterol ), and blood fats called triglycerides. Simvastatin SUN also increases the levels of the “good” cholesterol ( HDL – cholesterol ). Simvastatin SUN belongs to a group of medicines called statins.

Cholesterol is one of several fats found in your blood. Your total cholesterol consists mainly of LDL and HDL cholesterol.

LDL cholesterol is often called the “bad” cholesterol because it causes fat storage in your vessel walls and forms plaque. This plaque storage can eventually lead to a narrowing of your vessels. This narrowing can reduce or block blood flow to important organs such as the heart and brain. Blockage of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called the “good” cholesterol because it helps prevent the “bad” cholesterol from being stored in vessels and protects against heart disease.

Triglycerides are another type of fat in the blood that can increase the risk of heart disease.

You should continue with a cholesterol-lowering diet while you are taking this medicine.

Simvastatin SUN is used as a supplement to your cholesterol-lowering diet if you have:

elevated blood cholesterol levels (primary hypercholesterolemia ) or elevated blood lipids (combined hyperlipidemia ),
an inherited disease ( homozygous familial hypercholesterolemia ) that causes elevated cholesterol levels in the blood. You can also get other treatments,
coronary heart disease or if you are at risk of developing coronary heart disease (because you have diabetes, previously had a stroke, or other vascular diseases). Treatment with Simvastatin SUN can lead to prolonged survival by reducing the risk of cardiovascular disease, regardless of the amount of cholesterol in your blood.

In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol level with a simple blood test. Visit your doctor regularly, monitor your cholesterol levels, and discuss your goals with your doctor.

Simvastatin contained in Simvastatin SUN may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Simvastatin SUN

Do not take Simvastatin SUN

if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6: Contents of the pack and other information),
if you have liver problems,
if you are pregnant or breastfeeding,
if you are taking medicines containing one or more of the following active ingredients:
- 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 used in HIV infections ),
- boceprevir or telaprevir (used to treat hepatitis C virus infection),
- nefazodone (used to treat depression),
- cobicistat,
- gemfibrozil (used to lower cholesterol),
- cyclosporine (often used in organ transplant patients),
- danazol (a synthetic 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 a medicine called fusidic acid (a medicine for bacterial infections ) over the last 7 days, either by mouth or by injection. The combination of fusidic acid and Simvastatin SUN can lead to severe muscle problems ( rhabdomyolysis ).

Do not take more than 40 mg of Simvastatin SUN if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).

Consult a doctor if you are unsure if your medicine is listed above.

Warnings and cautions

Tell your doctor:

about all your medical ailments, including allergies,
if you have a high alcohol consumption,
and if you have or have had any liver disease. Simvastatin SUN may not be the right medicine for you,
if you are going to have surgery. Treatment discontinuation with Simvastatin SUN may need to be made for a shorter period,
if you are of Asian descent, then another dose may apply to you.

Your doctor should take a blood sample before you start taking Simvastatin SUN, and if you have any symptoms of liver problems during treatment with Simvastatin SUN. This blood test is taken to check your liver function.

Your doctor may also need to take a blood test to check your liver function after you start taking Simvastatin SUN.

During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to get diabetes if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure.

Tell your doctor if you have any serious lung disease.

Contact a doctor immediately if you experience unexplained muscle aches, soreness, or weakness. The reason for this is that in rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result and in very rare cases, deaths have occurred.

The risk of muscle breakdown is greater with higher doses of Simvastatin SUN, especially for an 80 mg dose. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:

you have a high alcohol consumption,
you have kidney problems,
you have thyroid problems,
you are 65 years or older,
you are a woman,
if you have ever had muscle problems during treatment with cholesterol-lowering drugs called “statins” or fibrates,
you or a close relative has a hereditary muscle disease.

Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.

Children and young people

The safety and efficacy of Simvastatin SUN have been studied in boys 10 to 17 years of age and in girls who have been menstruating for at least one year (see section 3: How to use Simvastatin SUN).

SimvastatinSUN has not been studied in children under 10 years of age. For further information, consult a doctor.

Other medicines and Simvastatin SUN

Tell your doctor or pharmacist if you y taken, or might take any other medicines with any of the following active ingredients. Taking Simvastatin SUN with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the sections above “Do not use Simvastatin SUN”).

If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start taking Simvastatin SUN again. Taking Simvastatin SUN with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4.
ciclosporin (often used by patients who have had an organ transplant),
danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
drugs 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 lower cholesterol),
erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections ),
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS ),
Hepatitis C medicines, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
nefazodone (used to treat depression),
medicinal products 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 cardiovascular disease or other heart problems),
lomitapide (used to treat a serious and rare genetic cholesterol condition),
daptomycin (a drug used in the treatment of complicated skin and soft tissue infections as well as bacteremia (presence of bacteria in the blood)). The risk of side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin (eg Simvastatin SUN). Your doctor may decide to stop you from taking Simvastatin SUN for a while,
colchicine (used in the treatment of gout ).

Also tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking medicines with any of the following active ingredients:

anticoagulants with an active ingredient such as warfarin, phenprocoumon or acenocoumarol ( anticoagulants ),
fenofibrate (also used to lower cholesterol),
niacin (also used to lower cholesterol),
rifampicin (used to treat tuberculosis ).

Tell your doctor who is prescribing a new medicine to you that you are taking Simvastatin SUN.

Simvastatin SUN with food and drink

Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin SUN. Intake of grapefruit juice should be avoided.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Simvastatin SUN, stop treatment immediately and tell your doctor.

Do not take Simvastatin SUN if you are breastfeeding as it is unknown if the medicine passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Simvastatin SUN is not expected to affect your ability to drive or use machines. However, keep in mind that some people get dizzy when they take Simvastatin SUN.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Simvastatin SUN contains lactose

Simvastatin SUN contains a sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to use Simvastatin SUN

Your doctor will decide which dose is right for you depending on your symptoms, your current treatment, and your risk profile.

Always take Simvastatin SUN exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

You should continue your cholesterol-lowering diet while you are taking Simvastatin SUN.

Dosage:

The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg once daily.

Adults:

The most common starting dose is 10, 20, or in some cases 40 mg daily. Your doctor may, after at least 4 weeks, need to adjust your dose to a maximum of 80 mg per day. Do not take more than 80 mg per day.

Your doctor may prescribe a lower dose for you, especially if you are taking certain medicines listed above or have certain kidney problems.

A dose of 80 mg is only recommended for adult patients with very high cholesterol levels and who are at high risk for cardiovascular disease and who have not achieved their treatment goals at lower doses.

Use for children and adolescents

The recommended starting dose for children (10 – 17 years) is usually 10 mg in the evening. The maximum recommended dose is 40 mg daily.

Method of administration:

Take Simvastatin SUN in the evening. Simvastatin SUN can be taken with or without food.

Continue to take Simvastatin SUN unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin SUN together with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin SUN at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin SUN than you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor or hospital for risk assessment and advice.

If you forget to take Simvastatin SUN

Do not take a double dose to make up for a forgotten tablet. Only take your usual dose of Simvastatin SUN at the usual time the next day.

If you stop taking Simvastatin SUN

Talk to your doctor or pharmacist as your cholesterol levels may rise again.

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

Possible side effects

Like all medicines, Simvastatin SUN can cause side effects, although not everybody gets them.

The following classification is used to describe how often side effects have been reported:

Rare (may affect up to 1 in 1,000 people),
Very rare (may affect up to 1 in 10,000 people),
No known frequency (cannot be calculated from the available data).

The following rare serious side effects have been reported.

If any of these serious side effects occur, stop taking your medicine and contact your doctor immediately or see an emergency department at the nearest hospital.

muscle aches, soreness, weakness, or cramps. In rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result, and in very rare cases, deaths have occurred.
hypersensitivity (allergic reactions) including:
- swelling of the face, tongue, and throat, which may cause difficulty breathing ( angioedema ),
- severe muscle pain, usually in the shoulders and hips,
- rash with weakness in arms, legs, and neck muscles,
- joint pain or inflammation (rheumatic polymyalgia),
- inflammation of blood vessels ( vasculitis ),
- bruising of unknown cause, skin rash, and swelling ( dermatomyositis ), hives, skin sensitivity to sun exposure, fever, redness,
- shortness of breath ( dyspnoea ) and general malaise,
- lupus-like disease picture (including rash, joint problems, and effects on blood cells ),
inflammation of the liver with the following symptoms: the yellowish color of the skin and eyes, itching, dark-colored urine or pale stools, feeling of tiredness or weakness, loss of appetite, liver failure (very rare),
inflammation of the pancreas, often with severe abdominal pain.

The following side effects have also been reported rarely:

low red blood cell count ( anemia ),
numbness or weakness in the arms and legs,
headache, “ant crawls”, dizziness,
indigestion (abdominal pain, constipation, flatulence, dyspepsia, diarrhea, nausea, vomiting),
rash, itching, hair loss,
weakness,
difficulty sleeping (very rare),
poor memory (very rare), memory loss, confusion,
blurred vision and impaired vision.

The following very rare serious side effects have been reported:

a severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis ),
rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash),
pain, tenderness, weakness, or muscle cramps, breakdown of muscles, muscle strain,
gynecomastia (breast augmentation in men).

The following side effects have also been reported, but the incidence cannot be determined with available information (no known frequency):

erectile dysfunction,
Depression,
inflammation of the lungs that causes breathing problems including persistent cough and/or shortness of breath or fever,
problems with tendons, sometimes aggravated, with tendon rupture.

Additional possible side effects that have been reported with certain statins:

sleep disorders including nightmares,
sexual problems,
diabetes. This is more likely if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure. Your doctor will check you while you are taking this medicine.
muscle pain, soreness, or weakness that is persistent and that may not go away after stopping treatment with Simvastatin SUN (no known frequency).

Laboratory values

In some blood tests, elevations in liver function values and a muscle enzyme (creatinine kinase) have been observed.

How to store Simvastatin SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

No special storage instructions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is simvastatin. One tablet contains either 10 mg, 20 mg, or 40 mg of simvastatin.
The other ingredients are tablet core: butyl hydroxyanisole (E320), lactose monohydrate, pregelatinized maize starch, partially pregelatinized maize starch (1500), ascorbic acid, citric acid monohydrate, microcrystalline cellulose, magnesium stearate.

The film features :

10 mg: Opadry 20A 54963 pinks, consists of hydroxypropylcellulose, hypromellose, titanium dioxide (E 171), talc, yellow, red, and black iron oxide (E 172).

20 mg: Opadry 20A 56532 brown, consists of hydroxypropylcellulose, hypromellose, titanium dioxide (E 171), talc, yellow, red, and black iron oxide (E 172).

40 mg: Opadry 20A 54964 pink, consists of hydroxypropylcellulose, hypromellose, titanium dioxide (E 171), talc, yellow, red, and black iron oxide (E 172).

What the medicine looks like and the contents of the pack

Film-coated tablet

10 mg: 8.0 mm ± 0.3 mm long and 6.0 mm ± 0.3 mm wide, peach-colored, oval, film-coated tablet marked with “SST” on one side and “10” on the other side.

20 mg: 10.0 mm ± 0.3 mm long and 7.5 mm ± 0.3 mm wide brown, oval, film-coated tablet marked with “SST” on one side and “20” on the other side.

40 mg: 12.0 mm ± 0.3 mm long and 9.0 mm ± 0.3 mm wide, reddish-brown, oval, film-coated tablet marked with “SST” on one side and “40” on the other side.

Blister of PVDC-coated clear, transparent PVC film with the back of hard heat-sealable aluminum foil coated with heat-sealing varnish.

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 film-coated tablets.

Hospital packaging: 10 x 30 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV,

Polarisavenue 87,

2132 JH Hoofddorp,

Netherlands

Manufacturer: