SIMVASTATIN 40 MG TABLETS - patient leaflet, side effects, dosage

Simvastatin 10mg Tablets

(simvastatin)

Read all of this leaflet carefully before you start taking this medicine.

• – 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• – If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

• 1. What Simvastatin Tablets are and what they are used for

• 2. Before you take Simvastatin Tablets

• 3. How to take Simvastatin Tablets

• 4. Possible side effects

• 5. How to store Simvastatin Tablets

• 6. Further information

1. WHAT SIMVASTATIN TABLETS ARE AND WHAT THEY ARE USED FOR

Simvastatin belongs to a group of medicines called ‘HMG-CoA reductase inhibitors’ which reduce the amount of cholesterol and fatty substances called triglycerides in the blood.

Cholesterol is vital to the normal functioning of the body but if levels in the bloodstream are too high, it can be deposited on the walls of the arteries and build up to form plaques which can eventually block the blood vessel.

Simvastatin Tablets are used to:

lower levels of cholesterol (and triglycerides) in the blood, thereby reducing the risk of heart disease

slow or reduce the progression of :

o atherosclerosis (clogging of blood vessels by cholesterol) which can lead to angina (chest pain) and heart attack.

o coronary heart disease (CHD) – Simvastatin Tablets can help to lessen the risk of a

heart attack.

2. BEFORE YOU TAKE SIMVASTATIN TABLETS

DO NOT take Simvastatin Tablets

are allergic (hypersensitive) to simvastatin or any of the other ingredients in the product (see Section 6 and end of section 2)

have liver problems or continual raised transaminase levels (liver enzymes) in your blood are taking any of the following medicines: itraconazole, ketoconazole, HIV protease inhibitors, erythromycin, clarithromycin, telithromycin or nefazodone (see ‘Taking other medicines ’)

are pregnant or breast-feeding

Take special care with Simvastatin Tablets

When taking this medicine, it is important that you tell your doctor if you have persistent muscle aches or pain.

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.

Your doctor will monitor your blood levels for the enzyme creatine kinase before, during and after taking these tablets especially if you:

are over 70 years

have problems with your kidneys.

have uncontrolled thyroid problems

have repeated or unexplained muscle aches or pains (either personal or family history of muscle problems)

have a history of muscle problems when taking other cholesterol lowering medicines You regularly drink large amounts of alcohol.

Tell your doctor if you have severe lung disease

It is important to stay on a low-fat diet as well as taking this medicine.

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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

You must not take any of the following medicines with Simvastatin Tablets. If you need to take any of these medicines, treatment with Simvastatin Tablets must be stopped:

itraconazole, ketoconazole – for the treatment of fungal infection

HIV protease inhibitors (indinavir, nelfinavir, ritonavir or saquinavir) for the treatment of HIV infection erythromycin, clarithromycin, telithromycin – antibiotics nefazodone – for the treatment of depression.

Simvastatin Tablets may occasionally interact with the following medicines:

digoxin (for heart conditions)

warfarin (for thinning the blood)

two other kinds of lipid-lowering agents: fibric acid derivatives (e.g. benzafibrate, fenofibrate, gemfibrozil) and large doses of niacin or nicotinic acid.

ciclosporin (an immunosuppressant medicine) amiodarone, verapamil or diltiazem (heart drugs).

Taking Simvastatin Tablets with food and drink

Do not drink grapefruit juice while you are taking this medicine as it can increase the level of simvastatin in your blood.

Also avoid alcoholic drinks as too much alcohol during treatment with simvastatin can increase your cholesterol level.

Pregnancy and breastfeeding

Do not take Simvastatin Tablets if you are pregnant, planning to become pregnant or are breastfeeding.

Ask your doctor for advice before taking any medicine.

Children

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

Driving and use of machines

Although Simvastatin Tablets are not expected to affect your ability to drive or operate machinery, dizziness has been reported rarely. If you feel dizzy after taking these tablets, do not drive or operate machinery.

Important information about some of the ingredients of Simvastatin Tablets

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. how to take simvastatin tablets

Always take Simvastatin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

It is important you should stay on a low-fat diet as well as taking simvastatin tablets.

The dose is one simvastatin 5mg, 10mg, 20mg, 40mg or 80mg Tablet by mouth once a day.

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

For high cholesterol levels: the usual starting dose is 10–20mg per day.

For coronary heart disease: the usual starting dose is 20–40mg per day, given as a single dose in the evening.

Your doctor may adjust your dose (maximum 80mg) in order to have the best effect. The 80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems.

Keep taking Simvastatin Tablets for as long as your doctor has told you to.

If you notice muscle pain , weakness or cramps whilst taking these tablets, tell your doctor immediately so that your blood levels can be monitored. Your doctor may decide to stop the treatment and re-introduce the tablets at a lower dose with close monitoring. Always speak to your doctor before stopping any medication.

If you have need to have surgery

If you are going to hospital for an operation, please tell the doctor as Simvastatin Tablets should be temporarily stopped a few days before the operation. Your doctor will advise you when to stop and restart taking them.

If you take more Simvastatin Tablets than you should

If you or someone else swallows several of these tablets together, contact your doctor or nearest hospital emergency department immediately (taking any remaining tablets as well as the box with you if possible).

If you forget to take Simvastatin Tablets

If you miss a dose, take one as soon as you can then carry on as before. Do not take an extra dose to make up for a forgotten dose.

If you stop taking Simvastatin Tablets

Talk to your doctor if you want to stop taking these tablets. Your cholesterol levels might 5nc rease agyio if you stos tMdnA tTem.

KIfeyeopuohutavoef tahneyrfeuarcth earnqduseisgthiot nosf ocnhitlhdereunse of this product, ask your doctor or pharmacist.

4. POSSIBL E

Like all medicines, Simavastatin Tablets can cause side effects, although not everybody gets tMhe mdi.cIifneasnysho­ofutlhde nfo ltlobwe idnigspsiodse­edeffoefcvtsi­acowmaestoenwsa­oteornoarfthe­or utaskehinogldthwe­saesttea.bAlet­ssk, syto uprthpeha­tarmblaectsist and tell youpdoctor iimmed iately:

hypersensitivity (allergic) reactions including:

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

y sev^remMAly poin usually in the shoulders and hips

rash with weakness of limbs and neck muscles

What fimvastat pi an inT oa rb il net fls ac mo mnt aa tin on of the joints

The active substiannfcla­emismsaimtiov­nasotafttihne, 1b0lomogd, v2e0smseglsor 40mg.

The other ingreduineunstsua lrebrluacistionsge, asnkhinyder ouupsti,omnis­caroncdrsywste­allin ge, cheilvluelso,s ek,in­prseegnesliat­tiivniitsyetdom­thaeizseun, starch, butylhydrfoex­vyear,nfilsuos­lhe,inmgasghno­erstinuemss sotfeabrraeta­et,htaalncd, hfyeedlrionxgy­upnrowpeyll cellulose, hydroxypropyl methylcellulose launpdutsi-tlainkieumdis­deiaosxeidpeic(tE­u1re71() i. n( cS le ue d ia nls go re an shd , o jf oS ine tc t dio isn o r2 d‘ eI rm s,p ao nr dta n eft fi en cf to srm ona t bio lon o d cell s)

muscle pain, tenderness, weakness, or cramps. On rare occasions, these muscle problems Wha ct anfi bm e v sa ers it oa uti sn , iT nca lb ul de it ns glo mo uk s l ci lk ee ba ren ad kdcon wt nen rt es uo lf tit nh ge ip n a kc ik dney damage; and very rare

deaths hTve occurred

inflammation of the siver with yel2owing of the skin and eyes,itching, dark-coloured urine or pale-coloured stool, liver failure (very rare)

inflammation of th e pancreas often with severe abdominal pain.

Uhe 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.

Side effects of unknown frequency:

Muscle weakness t hat is c onstant.

Other possible side effects:

sleep disturbances, including nightmares

memory loss

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.

If any of the tide effectt gett teriout, or if you notice any tide effectt not litted in thit leaflet, pleate tell your doctor or pharmacitt.

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 via the Yellow Card Scheme at:

. By reporting side effects you can help provide information on the safety of this medicine.

5. how to store simvastatin tablets

KIfeyeopuohutavoef tahneyrfeuarcth earnqduseisgthiot nosf ocnhitlhdereuns.e of this product, ask your doctor or pharmacist.

Th is medicinal prodD Ct does not require any special storage conditions.

Do not use the tablets after the expiry date stated on the label.

Like all medicines, Simavastatin Tablets can cause side effects, although not everybody gets tMhe mdi.cIifneasnysho­ofutlhde nfo ltlobwe idnigspsiodse­edeffoefcvtsi­acowmaestoenwsa­oteornoarfthe­or utaskehinogldthwe­saesttea.bAlet­ssk syto uprthpeha­tarmblaectsist ahnodwtetlol ydoiusrpodsoec­to rf i mm ede icd ina et sely n: o longer required. These measures will help to protect the environment.

6. FURTHER INFORMATION

What Simvastat pi an inT oa rb il net fls ac mo mnt aa tin on of the joints

The active substiannfcla­emismsaimtiov­nasotafttihne, 1b0lomogd, v2e0smseglsor 40mg.

The other ingreduineunstsua lrebrluacistionsge, asnkhinyder ouupsti,omnis­caroncdrsywste­allin ge, cheilvluelso, ssek,inprseeg­nesliattiivni­itsyetdomthae­izseun starch, butylhydrfoex­vyear,nfilsuos­lhe,inmgasghno­erstinuemss sotfeabrraeta­et,htaalncd, hfyeedlrionxgy­upnrowpeyll cellulose, hydroxypropyl methylcellulose launpdutsi-tlainkieumdis­deiaosxeidpeic(tE­u1re71() i. n( cS le ue d ia nls go re an shd , o jf oS ine tc t dio isn o r2 d‘ eI rm s,p ao nr dta n eft fi en cf to srm ona t bio lon about some of th ce ei ln lsg )redients of Simvastatin Tablets’ ).

What Sim v

Simvdaesattah­tsinhTavaeblo­ectscuar reedwhite, oblong, biconvex film-coated, scored/embossed tablets.

They are available in blister packs of 2× 14 tablets of 10mg, 20mg or 40mg strength.

Marketing.Authoris

STphecfioalloC­wonincgepstid­Deeevfefelocptsmhe­anvte(UalKso) bLeiemnitredpot/ra­teRd xrafraerlmy:a ,

Units 1–7 Colonial Way, Watford, Hertfordshire, WD24 4YR

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Manufacturer:

Medley Pharma Ltd-

Unit 2A, Olym pic Way, Sefton Business Park, Liverpool, L30 1RD, UK

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