Simvastatin 10mg Film-coated Tablets

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 further questions, please ask your doctor or pharmacist.
  • This medicine has been prescribed for you personally and you should 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 or pharmacist.

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 statins, which are lipid-lowering medicines. Simvastatin lowers the levels of cholesterol and fatty substances known as triglycerides in your blood.

Most cholesterol is produced in our body by the liver. This happens mainly at night, which is why it is recommended that Simvastatin Tablets are taken in the evening or at night. Simvastatin tablets are used, together with diet if you have:

  • Raised cholesterol levels (primary hypercholesterolaemia) or elevated fat levels (mixed hypercholesterolaemia) in your blood.
  • Homozygous familial hypercholesterolaemia (an inherited disease that causes raised levels of cholesterol.)
  • Coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, history of stroke, or other blood vessel disease.) Simvastatin tablets may reduce the risk of heart disease by keeping your arteries clear, even if your cholesterol levels are normal.

It is generally accepted that a high cholesterol level in your blood increases the risk of heart disease. The higher the level, the greater the risk. The presence of other factors, such as existing heart disease, high blood pressure, high blood sugar (diabetes), increased weight, lack of exercise and smoking adds to the risk of getting or worsening of heart disease with high cholesterol.

In most people there are no obvious signs of high cholesterol. Your doctor will measure the levels of cholesterol with a blood test.

2. BEFORE YOU TAKE SIMVASTATIN TABLETS

DO NOT TAKE Simvastatin tablets if:

  • you are hypersensitive (allergic) to simvastatin or any of the other ingredients of the tablets (listed in section 6)
  • you have liver problems
  • you are pregnant or breast-feeding
  • you are taking:
  • antifungal drugs such as itraconazole or ketoconazole
  • antibiotics erythromycin, telithromycin or clarithromycin
  • the antidepressant nefazodone
  • a medicine for the treatment of HIV infections (HIV protease inhibitor) such as indinavir, nelfinavir, ritonavir or saquinavir

If you think any of these apply to you talk to your doctor before taking the tablets.

Before taking Simvastatin tablets, it is important to tell your doctor:

  • if you are taking anticoagulants (drugs that prevent blood clots such as warfarin)
  • if you have an intolerance to some sugars
  • about your present and past health problems, especially muscle problems, diabetes and kidney problems, as well as any allergies.
  • if you consume large quantities of alcohol
  • if you have a history of liver disease
  • if you are due to have major surgery. You may need to stop taking Simvastatin tablets for a while.
  • if you have severe respiratory failure
  • if you have diabetes or are at risk of developing diabetes while you are on this medicine your doctor will monitor you closely . 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.

Muscle problems with Simvastatin

On rare occasions there is a risk of muscle problems, which may be serious. The doctor may perform a blood test to check the condition of your muscles before and after starting treatment.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness

The risk of developing muscle problems is greater with high doses of Simvastatin and in certain patients.

Tell your doctor before you take Simvastatin if any of the following apply to you:

  • you are female
  • you are more than 65 years old
  • you have kidney problems
  • you have thyroid problems
  • you or close family members have a hereditary muscle disease
  • you have ever had muscle problems during treatment with cholesterol lowering medicines called statins (e.g. simvastatin, atorvastatin, pravastatin) or fibrates (e.g. gemfibrozil)
  • you have a history of alcohol abuse
  • you are taking certain other medicines (see ‘Taking other medicines’ below):

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.

It is particularly important that your doctor knows if you are taking any of the following medicines as they may cause an increased risk of muscle problems:

  • ciclosporin, a medicine used to suppress the immune system
  • antifungal agents (such as itraconazole or ketoconazole)
  • medicines for the treatment of HIV infections (such as indinavir, nelfinavir, ritonavir and saquinavir)
  • other cholesterol lowering medicines such as fibric acid derivatives e.g. gemfibrozil, bezafibrate, fenofibrate
  • antibiotic medicines containing erythromycin, telithromycin, fusidic acid or clarithromycin
  • nefazodone (an antidepressant)
  • amiodarone (used to treat irregular heart beat)
  • verapamil diltiazem or amlodipine (used to treat high blood pressure, angina or other heart conditions).
  • danazol (used to treat endometriosis)

Also tell your doctor or pharmacist if you are taking:

  • oral anticoagulants (drugs that prevent blood clots), such as warfarin, phenprocoumon or acenocumarol, as simvastatin may increase the risk of bleeding
  • niacin or nicotinic acid (cholesterol lowering medicines) containing products, especially if you are Chinese.

Taking Simvastatin tablets with food and drink

Grapefruit juice contains substances that change how the body uses some medicines, including Simvastatin tablets. You should not drink grapefruit juice when taking Simvastatin tablets.

Children

Safety and effectiveness have been studied in 10-17 year old boys and in girls who have started their menstrual period at least one year before (see HOW TO TAKE SIMVASTATIN TABLETS). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.

Pregnancy and Breastfeeding

Do not take Simvastatin tablets if you are pregnant, trying to become pregnant or think you might be pregnant. If you become pregnant while taking Simvastatin tablets, stop taking it immediately and contact your doctor.

If you are breastfeeding your baby you should not take Simvastatin tablets. Consult your doctor before taking the tablets if you are breastfeeding or planning to breastfeed.

Driving and using machines

At the recommended doses, Simvastatin tablets are not expected to affect your ability to drive or use machines. However, when driving or operating machinery, it should be taken into account that dizziness has been reported rarely.

Important information about one of the ingredients of Simvastatin:

Simvastatin tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

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. Remember to take your medicine.

Your doctor will tell you how long you have to take Simvastatin tablets. Do not stop treatment early or your cholesterol will rise to pre-treatment levels.

Your doctor will have explained the importance of staying on a cholesterol lowering diet as well as taking the Simvastatin tablets.

Dosage:

  • Your doctor will determine the appropriate tablet strength for you, depending on your condition, current treatment and personal risk status.
  • Take the tablets in the evening with or without food.
  • The usual starting dose is 10, 20 or, in some cases, 40mg a day, by mouth. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80mg a day.
  • The 80mg 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.

If your doctor has prescribed Simvastatin along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin at least 2 hours before or 4 hours after taking the bile-acid sequestrant.

Your doctor may prescribe lower doses, especially if you are taking certain medicines (see above), or suffer from kidney disorders.

If the required dose is 5mg, break the scored 10mg tablet in two.

Do not take more or less than has been prescribed for you by your doctor.

Use in 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.

If you take more Simvastatin tablets than you should talk to a doctor or pharmacist immediately.

If you forget to take Simvastatin tablets

Do not take a double dose to make up for forgotten individual doses.

Continue with the next tablet as usual.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Simvastatin tablets can have side effects in some patients.

In most cases the side effects are mild and of short duration.

Rare, serious side effects (occurring in less than 1 in 1000 people)

Stop taking the tablets and tell your doctor immediately, or go to the nearest hospital casualty department if you have any of the following:

  • muscle pain, tenderness, weakness or cramps. On rare occasions these muscle problems can be serious such as muscle breakdown, resulting in kidney damage, and very rarely deaths have occurred.
  • hypersensitivity (allergic) syndrome which may include:
  • swelling of the face, tongue or throat
  • muscle pain and wasting
  • joint pain and inflammation
  • inflammation of the blood vessels
  • unusual bruising, skin eruptions, swelling
  • skin sensitivity to the sun, raised itchy rash
  • fever, flushing
  • feeling unwell
  • shortness of breath
  • liver problems and jaundice (yellowing of the skin and/or eyes, dark coloured urine, pale coloured stools)
  • inflammation of the pancreas giving severe abdominal pain.

Other rare side effects (occurring in less than 1 in 1000 people)

Tell your doctor or pharmacist if any of the following side effects gets serious:

  • dizziness, headache
  • hair loss
  • rash and itchiness
  • stomach upsets (such as sickness, diarrhoea, stomach pain, indigestion, constipation and flatulence)
  • abnormal sensations in the arms and legs
  • numbness and tingling
  • weakness
  • anaemia
  • trouble sleeping (very rare)
  • poor memory (very rare).

Possible side effects reported with some statins:

  • sleep disturbances, including insomnia and nightmares
  • sexual difficulties
  • depression
  • breathing problems including persistent cough and/or shortness of breath or fever
  • 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.

Laboratory Values

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

If you notice any side effect not mentioned in this leaflet tell your doctor or pharmacist.

5. HOW TO STORE SIMVASTATIN TABLETS

Keep out of reach and sight of children.

Do not store above 25°C.

Store in the original package in order to protect from moisture.

Do not use Simvastatin tablets after the expiry date marked on the pack.

6. FURTHER INFORMATION

What Simvastatin tablets contain

Each tablet contains the active ingredient simvastatin 10mg, 20mg or 40mg.

The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, butylated hydroxyanisole (E320), ascorbic acid, citric acid anhydrous, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171), povidone.

What this medicine looks like and contents of the pack

Simvastatin 10mg Tablets are peach-coloured, film-coated, oval shaped tablets scored on one side.

Simvastatin 20mg Tablets are tan-coloured, film-coated, oval shaped tablets.

Simvastatin 40mg Tablets are brick red-coloured, film-coated, oval shaped tablets.

They are available in packs of 10, 14, 20, 28, 30, 40, 50, 56, 60, 84, 98 or 100 tablets contained in an outer carton. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer:

M & A Pharmachem Ltd, Wigan Road, Westhoughton, Bolton, Lancs, BL5 2AL

Date of approval of the leaflet: 01/2011

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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