Simvastatin 40mg Film-Coated Tablets
24 mm
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8 mm
8 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER_
_SIMVASTATIN 10 MG, 20 MG, 40 MG and 80 MG FILM-COATED TABLETS_
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 lo 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 Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. Howto take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. _Contents of the pack and other information._
1. What Simvastatin Tablets are and what they are used for
Simvastatin Tablets belongs to a group of medicines known as 'statins' or 'HMG-CoA reductase inhibitors'. Simvastatin Tablets are used to lower levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvastatin Tablets raises levels of "good" cholesterol (HDL cholesterol). You should stay on a cholesterol-lowering diet while taking this medicine. 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. Nearly all the cholesterol in our body is made by our own liver. The body produces most cholesterol at night, which is why it is recommended that Simvastatin Tablets are taken in the evening or at night.
Simvastatin Tablets are used along with diet if you have:
• A raised cholesterol levels in your blood (Primary hypercholesterolaemia) or elevated fat levels in your blood (mixed hyperlipidaemia). Simvastatin should lower these levels. It is generally accepted that high cholesterol levels in your blood adds to the risk of heart disease. The higher the level, the greater the risk.
• A hereditary illness (homozygous familial hypercholesterolaemia) that increases the cholesterol levels 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 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._
2. What you needto know befOre you take Simvastatin Tablets |
Do not take Simvastatin Tablets if you:
• are allergic to simvastatin or to any other ingredients (these are listed in Section 6, contents of the pack and other information)
• are pregnant or breast feeding.
• are taking an antifungal drug called itraconazole, voriconazole, posaconazole or ketoconazole.
• are taking the antibiotics erythromycin or clarithromycin, or telithromycin.
• are taking the antidepressant nefazodone, gemfibrozil (used to lower cholesterol), cidosporin (used in organ transplant patients), danazol (a man made hormone used to treat endometriosis), cobicistat
• are taking a medicine for the treatment of HIV infections (HIV protease inhibitor) such as indinavir, nelfinavir, ritonavir or saquinavir.
• boceprevir or telaprevir (used to treat hepatitis C virus infection)
• have liver problems
• are taking or, in the last 7 days, have taken or been given fusidic acid ( used to treat bacterial infections)
• Do not take more than 40 mg simvastatin 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 taking Simvastatin Tablets. Tell your doctor if you:
• have allergies and other medical conditions
• regularly drink large amount of alcohol.
• have ever had liver disease. Your doctor may conduct some blood tests to check your liver before and after starting treatment
• are due to have an operation - you might need to stop taking simvastatin.
• have high blood pressure or high levels of fats and sugars in your blood or if you have a body mass index of more than 30kg/m2. You may be more at risk of developing diabetes. Your doctor will monitor you closely if this applies to you.
• have severe lung disease.
• are Asian, because a different dose may be applicable to you.
Contact your doctor immediately ifyou 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, particularly the 80-mg 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 a woman
• 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 ifyou have a muscle weakness that is constant. Additional tests and medicines may be needed to diagnose and treat this.
Other medicines and Simvastatin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking simvastatin with any of these drugs can increase the risk of muscle problems (some of these have already been listed in Do not take Simvastatin)
• fibrates like gemfibrozil and bezafibrate (medicines for lowering cholesterol)
• medicines for fungal infections (such as itraconazole, ketoconazole, voriconazole, fluconazole, or posaconazole)
• medicines for bacterial infections (erythromycin, telithromycin, clarithromycin and fusidic acid). Do not take fusidic acid while using this medicine (see section 4).
• antidepressants (e.g. nefazodone)
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (medicines for AIDS)
• boceprevir or telaprevir ( used to treat hepatitis C virus infection)
• a medicine often used in organ transplant patients (e.g. cidosporin)
• medicine used for irregular heart beat (e.g. amiodarone)
• a man-made hormone used to treat endometriosis (e.g. danazol)
• medicines used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions (such as verapamil, diltiazem or amlodipine)
• medicines used to treat gout (e.g. colchicine), medicines with the active ingredient cobicistat
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 any of the following:
• medicines to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (another medicine for lowering cholesterol)
• niacin (another medicine for lowering cholesterol)
• rifampian (a medicine used to treat tuberculosis).
Also tell your doctor if you are taking niacin (nicotinic acid) or a niacin-containing product and are Chinese.
Pregnancy and Breast-feeding Pregnancy and breast-feeding
• Do NOT take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking these tablets.
• Always ask your doctor or pharmacist for advice before taking any medicine.
• Do not take Simvastatin Tablets if you are breast-feeding, because it is not known if the medicine is passed into breast milk. Consult your doctor before taking the tablets if you are breast-feeding or planning to breast-feed.
Use in Children
• Safety and effectiveness has been studied in 10-17 years old boys and in girls who had started their menstrual period at least one year before (see section 3: How to take Simvastatin). Simvastatin has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Simvastatin Tablets with food, drink and alcohol
• Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Simvastatin. Consuming grapefruit juice should be avoided
Driving and using Machines
Simvastatin is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking simvastatin.
Simvastatin Tablets contain Lactose
If you have been previously told by your doctor that you have intolerance to some sugars (such as lactose), contact your doctor before taking this medicine.
130 mm
Simvastatin (POM) 430 mm
10,20 40 mg Insert
Front
5mh
24 mm
8 mm
| 3. How to take Simvastatin Tablets
• Always take these tablets exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.
• You should check the label to see how often you should take your tablets.
• Ensure that you do not run out of your tablets.
• The tablets should be swallowed whole with a glass of water.
The usual dosages are as follows:
Adults:
• You should stay on a cholesterol-lowering diet while taking Simvastatin Tablets.
• The dose is 1 Simvastatin 10mg, 20mg, 40mg or 80mg tablets by mouth once a day.
Children (10-17 years old):
• The recommended usual starting dose is 10mg a day in the evening. The maximum recommended dose is 40 mg 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.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status. Take Simvastatin Tablets in the evening. You can take it with or without food. The usual starting dose is 10mg, 20mg or in some cases 40mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80mg a day. Do not take more than 80mg a day. Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions. Keep taking Simvastatin Tablets unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Tablets along with any bile acid sequestrant (medicines for lowering cholesterol), you should take Simvastatin Tablets at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin Tablets than you should Please contact your doctor or pharmacist If you forget to take Simvastatin Tablets
If you miss a dose, do not worry. Simply take your normal dose when it is next due.
DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A FORGOTTEN DOSE.
If you stop taking Simvastatin Tablets
• your cholesterol may rise again.
If you have any farther questions on the use of this product, ask your doctor or pharmacist._
| 4. Possible Side Effects |
Like all medicines, Simvastatin Tablets can cause side effects, although not everybody gets them.
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 thejoints (polymyalgia rheumatica)
- inflammation of the blood vessels (vasculitis)
- unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun, fever, flushing
- shortness of breath and feeling unwell
- lupus-like disease picture (including rash, joint disorders, and effects on blood cells)
• inflammation of the liver with yellowing of the skin and eyes, itching, dark coloured urine or pale-coloured stool, liver failure (very rare)
• inflammation of the pancreas often with severe abdominal pain.
The following side effects have also been reported:
Rare (may affect up to 1 in 1,000 people)
• low red blood cell count (anaemia)
• numbness or weakness of the arms and legs
• headache, tingling sensation, dizziness, memory loss, numbness or loss of sensation in the arms and legs
• digestive disturbances (abdominal pain, sickness, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting)
• rash, itching, hair loss, weakness
• increase in blood levels of liver enzymes Very Rare (may affect up to 1 in 10,000 people)
• trouble sleeping (very rare)
• poor memory (very rare), confusion, memory loss.
• liver failure
Not Known (frequency cannot be estimated from the available data)
• 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 tendons.
• tendonitis
• Muscle weakness that is constant
Additional possible side effects reported with some statins:
• Sexual difficulties
• sleep disturbances, including nightmares
• Diabetes: This is more likely if you have high blood pressure, high levels of sugar or fats in your blood, are overweight or if you have a body mass index of more than 30kg/m2. Your doctor will monitor you more closely.
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 yellow card scheme at www.mhra.gov.uk/yellowcard. By reporting side effects, you can help provide more information on the safety of this medicine._
I 5. How to Store Simvastatin Tablets |
• Keep out of the sight and reach of children
• Do not use Simvastatin Tablets after the expiry date which is stated on the carton (EXP.). The expiry date refers to the last day of that month.
• Store below 250C. Store in the original package.
• 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 your environment.
| 6. Contents of the pack and other information |
What Simvastatin Tablets contain
• The active substance is simvastatin.
• Simvastatin Tablets come in four strengths 10 mg, 20 mg, 40 mg and 80 mg. Each tablet contains either 10 mg, 20mg, 40 mg or 80 mg of the active ingredient.
• The other ingredients are lactose monohydrate, maize starch, pregelatinised starch, sodium starch glycollate, colloidal anhydrous silica, Butylated hydroxytoulene (E321), Citric acid monohydrate, Ascorbic acid, microcrystalline cellulose, magnesium stearate, hypromellose 5cps, purified talc, titanium dioxide, ferric oxide yellow, ferric oxide red, macrogol 400.
What Simvastatin Tablets look like and contents of the pack
• Simvastatin 10mg Film-coated Tablets are pinkish-brown coloured, oval, biconvex, film-coated tablets with 'BL' embossing on one side and '10' embossing on the other side.
• Simvastatin 20mg Film-coated Tablets are peach coloured, oval, biconvex, film-coated tablets with 'BL' embossing on one side and '20' embossing on the other side.
• Simvastatin 40mg Film-coated Tablets are dull pink coloured, oval, biconvex, film-coated tablets with 'BL' embossing on one side and '40' embossing on the other side.
• Simvastatin 80mg Film-coated Tablets are pink coloured, capsule shaped, biconvex, film-coated tablets with 'BL' embossing on one side and '80' embossing on the other side.
• Simvastatin Tablets come in blister packs containing 14, 28 or 56 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Name and address: Bristol Laboratories Ltd, Unit 3, Canalside, Northbridge Road, Berkhamsted, Hertfordshire, HP4 1EG, United Kingdom
Telephone: 0044 (0)1442 200922
Fax: 0044 (0)1442 873717
Email: info@bristol-labs.co.uk
Simvastatin 10mg Film-coated Tablets; PL 17907/0060, Simvastatin 20mg Film-coated Tablets; PL 17907/0061 Simvastatin 40mg Film-coated Tablets; PL 17907/0062, Simvastatin 80mg Film-coated Tablets; PL 17907/0205 This leaflet was last revised in September 2015
To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.
V12 18-09-15 DO 3
130 mm
-8-mm
SAME SIZE ARTWORK Back
430 mm