Simvastatin Ranbaxy

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Package leaflet: Information for the patient

Simvastatin Ranbaxy10 mg, 20 mg, 40 mg Film-coated Tablets

simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

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

2. What you need to know before you take Simvastatin Ranbaxy

3. How to take Simvastatin Ranbaxy

4. Possible side effects

How to store Simvastatin Ranbaxy

6. Contents of the pack and other information

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

Simvastatin Ranbaxycontains the active substance simvastatin. Simvastatin Ranbaxy is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Ranbaxy raises levels of “good” cholesterol (HDL cholesterol). Simvastatin Ranbaxy is a member of the class of medicines called statins.

Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.

HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat in your blood that may increase your risk for heart disease.

You should stay on a cholesterol-lowering diet while taking this medicine.

Simvastatin Ranbaxyis used in addition to your cholesterol-lowering diet if you have:

• a raised cholesterol level in your blood (primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia)

• a hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol level in your blood. You may also receive other treatments.

• coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease). Simvastatin Ranbaxy may prolong your life by reducing the risk of heart disease problems, regardless of the amount of cholesterol in your blood.

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.

What you need to know before you take Simvastatin Ranbaxy

Do not take Simvastatin Ranbaxy:

- if you are allergic (hypensensitive) 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 breast-feeding.

- if you are taking medicine(s) with one or more than one 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 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)
ciclosporin (used in organ transplant patients)
danazol (a man-made 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 Simvastatin Ranbaxy if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition)

Ask your doctor if you are not sure if your medicine is listed above.

Warnings and precautions

Talk to your doctor or pharmacist before takingSimvastatin Ranbaxy.

Tell your doctor:

about all your medical conditions including allergies.
if you drink large amounts of alcohol.
if you have ever had liver disease. Simvastatin Ranbaxy may not be right for you.
if you are due to have an operation. You may need to stop taking Simvastatin Ranbaxy for a short time.
if you are Asian, because a different dose may be applicable for you.
if you are taking or have taken in the last 7 days a medicine called fusidic acid, (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Simvastatin Ranbaxy can lead to serious muscle problems (rhabdomyolysis).

Your doctor should do a blood test before you start taking Simvastatin Ranbaxyand if you have any symptoms of liver problems while you take Simvastatin Ranbaxy. This is to check how well your liver is working.

Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Simvastatin Ranbaxy.

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Tell your doctor if you have severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

The risk of muscle breakdown is greater at higher doses of Simvastatin Ranbaxy, particularly the 80mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:

you consume large amounts of alcohol
you have kidney problems
you have thyroid problems
you are 65 years or older
you are female
you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates
you or a close family member have a hereditary muscle disorder.

Also tell your doctor or pharmacist if you have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.

Children and adolescents

Safety and effectiveness of Simvastatin Ranbaxy have been studied in 10-17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Simvastatin Ranbaxy). Simvastatin Ranbaxy has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Other medicines and Simvastatin Ranbaxy

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you need to take oral fusidic acid 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 Simvastatin Ranbaxy. Taking Simvastatin Ranbaxy with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

Taking Simvastatin Ranbaxy with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Simvastatin Ranbaxy”):

• ciclosporin (often used in organ transplant patients)

• danazol (a man-made hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)

• medicines with an active ingredient like itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)

• fibrates with an active ingredient like gemfibrozil and bezafibrate (used to lower cholesterol)

• erythromycin, clarithromycin, telithromycin, or fusidic acid (used to treat bacterial infections). Do not take fusidic acid while using this medicine. Also see section 4. of this leaflet.

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)

• boceprevir or telaprevir (used to treat hepatitis C virus infection)

• 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 conditions)

• lomitapide (used to treat a serious and rare genetic cholesterol condition)

• colchicine ( used to treat gout).

As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking 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)

You should also tell any doctor who is prescribing a new medicine for you that you are taking Simvastatin Ranbaxy.

Simvastatin Ranbaxywith food and drink

Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin Ranbaxy. Consuming grapefruit juice should be avoided.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, 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 get pregnant while taking Simvastatin Ranbaxy, stop taking it immediately and contact your doctor.

Do not take Simvastatin Ranbaxy if you are breast-feeding, because it is not known if the medicine is passed into breast milk.

Driving and using machines

Simvastatin Ranbaxyis not expected to interfere withyour ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking Simvastatin Ranbaxy.

Simvastatin Ranbaxycontains lactose

Simvastatin Ranbaxy tablets contain 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 medicinal product.

How to take Simvastatin Ranbaxy

Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You should stay on a cholesterol-lowering diet while taking Simvastatin Ranbaxy.

Dosage:

The recommended dose is Simvastatin Ranbaxy 10 mg, 20 mg, 40 mg, or 80 mg by mouth once a day.

Adults:

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

Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.

Use in children and adolescents:

For children (10 -17 years old), the recommended usual starting dose is 10 mg a day in the evening. The maximum recommended dose is 40 mg a day.

Method of administration:

Take Simvastatin Ranbaxy in the evening. You can take it with or without food. Keep taking Simvastatin Ranbaxy unless your doctor tells you to stop.

If your doctor has prescribed Simvastatin Ranbaxy along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Simvastatin Ranbaxyat least 2 hours before or at least 4 hours after taking the bile acid sequestrant.

If you take more Simvastatin Ranbaxy than you should

Please contact your doctor or pharmacist.

If you forget to take Simvastatin Ranbaxy

Do not take a double dose to make up for a forgetten tablet. Just take your normal amount of Simvastatin Ranbaxyat the usual time the next day.

If you stop taking Simvastatin Ranbaxy

Talk to your doctor or pharmacist because your cholesterol may rise 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.

The following terms are used to describe how often side effects have been reported:

• Rare (may affect up to 1 of 1,000 people)

• Very rare (may affect up to 1 of 10,000 people).

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

The following rare serious side effects were reported.

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

- muscle pain, tenderness, weakness or cramps. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.

- hypersensitivity (allergic) reactions including:

- swelling of the face, tongue and throat which may cause difficulty in breathing

- severe muscle pain usually in the shoulders and hips

- rash with weakness of limbs and neck muscles

- pain or inflammation of the joints (polymyalgia rheumatica)

- inflammation of the blood vessels (vasculitis)

- unusual bruising, skin eruptions and swelling (dermatomyositis), hives, skin sensitivity to the sun, fever, flushing

- shortness of breath (dyspnoea)and feeling unwell

- lupus-like disease picture (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-coloured urine or pale-coloured stool, feeling tired or weak, 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 (anaemia)
numbness or weakness of the arms and legs
headache, tingling sensation, dizziness
digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
rash, itching, hair loss
weakness

trouble sleeping (very rare)
poor memory (very rare), memory loss, confusion

The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):

erectile dysfunction
depression
inflammation of the lungs causing breathing problems including persistent cough and/or shortness of breath or fever
tendon problems, sometimes complicated by rupture of the tendon.

Additional possible side effects reported with some statins:

sleep disturbances, including nightmares
sexual difficulties
diabetes. This is more likely if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
muscle pain, tenderness, or weakness that is constant that may not go away after stopping Simvastatin Ranbaxy (frequency not known).

Laboratory Values

Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Simvastatin Ranbaxy

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 expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Simvastatin Ranbaxycontains

The active substance is simvastatin.

10 mg: Each film-coated tablet contains 10 mg of simvastatin.

The other ingredients are:

Per tablet core: Butylhydroxyanisole, lactose monohydrate, starch pregelatinised (maize starch), partially pregelatinised maize starch, ascorbic acid, citric acid monohydrate, cellulose microcrystalline, magnesium stearate

Per tablet coating: Opadry 20A 54963 Pink: Hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide red (E 172), iron oxide black (E 172)

20 mg: Each film-coated tablet contains 20 mg of simvastatin.

The other ingredients are:

Per tablet coating: Opadry 20A 56532 Brown: Hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172)

40 mg: Each film-coated tablet contains 40 mg of simvastatin.

The other ingredients are:

Per tablet coating: Opadry 20A 54964 Pink: Hydroxypropyl cellulose, hypromellose, titanium dioxide (E171), talc, iron oxide yellow (E172), iron oxide red (E172), iron oxide black (E172)

What Simvastatin Ranbaxy looks like and contents of the pack

Each Simvastatin Ranbaxy 10 mg film-coated tablet is

8.0 mm ± 0.3 mm long and 6.0 mm ± 0.3 mm wide, peach coloured, film coated, oval shaped tablet, debossed with 'SST'on one side and '10'on other side with intact coating.

Each Simvastatin Ranbaxy 20 mg film-coated tablet is

10.0 mm ± 0.3 mm long and 7.5 mm ± 0.3 mm wide, tan coloured, film coated, oval shaped tablet, debossed with 'SST'on one side and '20'on other side with intact coating.

Each Simvastatin Ranbaxy 40 mg film-coated tablet is

12.0 mm ± 0.3 mm long and 9.0 mm ± 0.3 mm wide, brick red coloured, film coated, oval shaped tablet, debossed with 'SST'on one side and '40'on other side with intact coating.

The tablets are supplied in blister strips comprising of PVdC coated PVC clear transparent film. The backing is made of hard tempered heat sealable aluminium foil coated with heat seal lacquer.

The possible pack sizes are:

Simvastatin Ranbaxy 10, 20, 40 mg film-coated tablets:

10, 14, 20, 28, 30, 50, 56, 60, 98, 100 film-coated tablets and 300 (10 x 30) film-coated tablets for hospitals

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Spain Simvastatina Ranbaxy 10/20/40 mg comprimidos EFG

France Simvastatine RPG 10/20/40 mg comprime pelliculé

Italy Simvastatina Ranbaxy 10/20/40 mg compresse rivestite con film

Netherlands Simvastatine 20/40 Ranbaxy, filmomhulde tabletten 20/40 mg

Sweden Simvastatin Ranbaxy 10/20/40 mg filmdragerad tablett

Romania Simvastatin Terapia 10/20/40 mg comprimate filmate

This leaflet was last revised in 2016-05-11

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