Simvastatin 20mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER Simvastatin 10mg Tablets Simvastatin 20mg Tablets Simvastatin 40mg 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 if you:
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
Lactose - if you know you have an intolerance to some sugars, consult 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.
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 in crease again if you stop taking them.
If ypu uave any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Simavastatin Tablets can cause side effects, although not everybody gets them. If any? of the following side effects c ome on soon after taking these tablets, stop the tablets and tell your doctor immediately:
hypersensitivity (allergic) reactions including:
H swelling of the face, tongue and throat which may cause difficulty in breathing
T severe muscle pain usually in the shoulders and hips
H rash with weakness of limbs and neck muscles m pain or inflammation of the j oints e inflammation of the blood 'vessels
H unusual bruising, skin eruptions and swelling, hives, skin sensitivity to the sun,
fevef, flushing shortness of breath and fedling unwed HI topus-like di sease picture (including rash, joint disorders, andeffects on blood
cells)
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
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 rarely: tow red blood cel l 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 weaknes s thas is constant.
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 ary of the side effects gets serious, or if you notice ary side effects rot listed ir this leaflet, please tell your doctor or pharmacist.
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: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide information on the safety of this medicine.
Keep out; of the reach and sight of children.
This medicinal product does not require any special storage conditions.
Do not use the tablets after the expiry date stated on the label.
Medicines should not be nispose d of vi a wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the
environment.
6. FURTHER INFORMATION
What Simvastatin Tablets contain
The active substance is sii^vasoatin, 10mg, 20mg or 40mg.
The other ingredienss are lactose anhydrous, microcrystalline cellulo se, pregelatinised maize starch, butylhydroxyanisole, magnesium soearate, talc, hydroxypropylcellulose, hydroxypropyl methylcellulose and titanium dioxi de (El7 l).(See also end ofSecdon 2 'I mportant information about some of the ingredients of Simvastatin Tablets').
What Sim vastatin Tablets look like and contents of the nack
Simvastatin Tab le!c are white, oblong, biconvex film-coated, scored/embossed tablets.
They are available in blister packs of 2x 14 tablets of lOmg, 20mg or 40mg strength.
Marketing Authorisation Holder :
Medley Pharma Limited
Unit 2A, Olympic Way
Sefton Business dark
Liverpool
L30IRD
UK
Distributed by:
Zanza Laboratori es Limited, Liverpool, U.K.
343/03
Thie leaflet was re-vised s December 2015