Pravastatin Sodium 10mg Tablets
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PRAVASTATIN SODIUM 10MG, 20MG AND 40MG TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 further questions, please ask your doctor or your 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.
• Your doctor may have given you this medicine before from another company and it may have looked slightly different. Either brand will have the same effect.
What is in this leaflet:
1. What Pravastatin is and what it is used for
2. What you need to know before you take Pravastatin
3. How to take Pravastatin
4. Possible side effects
5. How to store Pravastatin
6. Contents of the pack and other information
1.WHAT PRAVASTATIN IS AND WHAT IT IS USED FOR
The name of your medicine is Pravastatin Sodium 10mg, 20mg, and 40mg Tablets. Each tablet contains 10mg, 20mg or 40mg of pravastatin sodium (referred to as pravastatin throughout this leaflet).
Pravastatin belongs to a group of medicines called HMG-CoA reductase inhibitors. They work by reducing the level of cholesterol and fats (triglycerides) in your blood.
It is used:
• To lower higher than normal levels of fats in the blood (hyperlipidaemia) where diet, exercise and/or weight reduction alone have not lowered these levels
•To lower the risk of having a further heart attack or stroke, whether or not you have high cholesterol levels, if you have already had a heart attack or have unstable angina.
•To lower your risk of having coronary heart disease, a heart attack or a stroke in the future if you have raised levels of cholesterol but do not have coronary heart disease at the moment
• To lower levels of fats in the blood if you have had an organ transplant and are taking medication to stop your body rejecting the transplant
Having too much cholesterol in your blood can lead to coronary heart disease. It can clog blood vessels, leading to hardening of the arteries (atherosclerosis). Hardened arteries are less able to carry blood to the heart and around the body. This can lead to chest pain (angina) and heart attacks. Pravastatin can both prevent hardening of the arteries and slow it down.
If you have high levels of cholesterol you are more likely to get heart disease if you also:
• Have high blood pressure (hypertension) or high blood sugar (diabetes)
• Take little exercise
• Smoke
• Are overweight or eat a high fat diet
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Ask your doctor or pharmacist if you would like advice about any of the above factors.
2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRAVASTATIN
Do not take pravastatin if:
• You are allergic (hypersensitive) to pravastatin or any of the other ingredients of this medicine (listed in section 6)
• You have liver problems
• You are pregnant or breast-feeding (see the section “Pregnancy, breast-feeding and fertility” below)
• You are a woman of child-bearing age and you are not using a reliable method of contraception (see the section “Pregnancy, breast-feeding and fertility” below).
If you are not sure about taking pravastatin, talk to your doctor
Warnings and precautions
Talk to your doctor or pharmacist before taking pravastatin if:
• You have kidney disease
• You have an under-active thyroid gland
• You regularly drink a large amount of alcohol
• You have had liver problems in the past
• You or any members of your family suffer from hereditary muscle disorders
• You have previously had problems with your muscles as a result of the use of statins or fibrates (medicines used to reduce fat levels in the blood)
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• You have severe respiratory failure
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking pravastatin. Do this even if they have applied in the past.
Tests
If you have suffered from any of the problems listed above (under "Warnings and precautions"), your doctor will need to carry out a blood test before and possibly during pravastatin treatment to assess your risk of developing muscle-related side effects. You may also need this blood test if you are older than 70 years.
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.
Other medicines and pravastatin
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines. This includes medicines you can buy without a prescription, including herbal medicines. This is because pravastatin can affect the way some other medicines work. Also, some medicines can affect the way pravastatin works.
In particular, check with your doctor if you are taking any of the following as taking any of these medicines with pravastatin may increase the risk of muscle problems:
• Ciclosporin ( a medicine that suppresses the immune system)
• Other medicines to lower cholesterol known as fibrates (such as bezafibrate, fenofibrate or gemfibrozil)
• Erythromycin or clarithromycin (antibiotics)
• Colestyramine and colestipol for lowering cholesterol (see "How to take Pravastatin" over the page).
Pravastatin with food and drink
Pravastatin can be taken with or without food.
Pregnancy, breast-feeding and fertility
Do not take pravastatin 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. Tell your doctor straightaway if you become pregnant while taking pravastatin.
• You are breast-feeding as pravastatin can pass into the mother’s milk
Driving and using machines
Pravastatin may cause dizziness in rare cases. If this happens, do not drive or operate any machines or tools.
3.HOW TO TAKE PRAVASTATIN
Always take pravastatin exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Remember to keep to a low-fat diet and to exercise regularly while taking pravastatin The usual doses are:
Adults
The usual dose is 10mg to 40 mg once a day, preferably in the evening.
Following organ transplantation, the usual dose is 20 mg each day.
Children and teenagers with inherited high levels of fat in the blood Ages 8-13 years
The usual dose is 10mg to 20mg once a day.
Ages 14-18 years
The usual dose is 10mg to 40mg once a day.
If you take more pravastatin than you should:
If you take more pravastatin than you should, tell your doctor or go to your nearest hospital straight away. Take the carton and any tablets left with you so that the doctors know what you have taken.
If you forget to take pravastatin:
If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a forgotten dose.
Taking another medicine for lowering your cholesterol at the same time as pravastatin
Your doctor may ask you to take another medicine for lowering your cholesterol at the same time as pravastatin This includes medicines such as colestyramine or colestipol (known as resin-type medicines). This type of medicine can affect the way pravastatin works. You should take pravastatin at least one hour before or four hours after you have taken the resin-type medicine.
If you stop taking taking pravastatin
Keep taking pravastatin until your doctor tells you to stop.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4.POSSIBLE SIDE EFFECTS
Like all medicines, pravastatin can cause side effects, although not everybody gets them.
Stop taking pravastatin and see a doctor or go to a hospital straight away if:
• You get swelling of the hands, feet, ankles, face, lips or throat which may cause difficulty in swallowing or breathing. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria).
This may mean you are having an allergic reaction to pravastatin
• You get unexplained pain, tenderness or weakness in the muscles or pain in your joints. You may also have a high temperature or tiredness. This could be a rare, but possibly life-threatening illness called rhabdomolysis.
• You get a lumpy rash or flushing of the skin
• You get liver problems, such as yellowing of the skin or eyes (jaundice/hepatitis)
• You get severe stomach pain which may reach through to your back. This could be a sign of pancreatitis
The side effects listed above are serious but very rare (affecting less than 1 in 10,000 people)
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts longer than a few days:
Common (affects less than 1 in 10 people)
• Pain in your muscles or joints
Uncommon (affects less than 1 in 100 people)
• Skin rash or itchy skin
• Hair problems including hair loss (alopecia)
• Dizziness, tiredness, headache or sleep problems
• Having to pass water (urine) more often than usual, having to get up at night to pass water or pain when you pass water
• Sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm
• Stomach or bowel problems such as pain, indigestion/heartburn, being sick (vomiting), feeling sick (nausea), diarrhoea, constipation or wind
• Eyesight problems such as blurred or double vision Very rare (affects less than 1 in 10,000 people)
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• Loss of feeling, weakness or problems using your legs, feet, arms or hands. Pain, burning, tingling or numbness in any part of the body. The burning pain may get worse at night. This could be a very rare but serious condition called polyneuropathy.
Other side effects include:
• Nightmares
• Memory loss
• 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
5.HOW TO STORE PRAVASTATIN
• 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 pack.
• Do not use Pravastatin after the expiry date which is stated on the carton and blister after "Exp". The expiry date refers to the last day of that month.
• Do not store above 30°C. Store in the original package in order to protect from light and moisture.
• If you notice any of the tablets are broken or chipped, talk to your pharmacist before taking them.
• 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 Pravastatin Sodium 10mg, 20mg, and 40mg Tablets contain:
Each tablet contains 10mg, 20mg or 40 mg pravastatin sodium as the active substance.
Each tablet also contains mannitol, microcrystalline cellulose, hydrogenated castor oil, calcium lactate pentahydrate, calcium carbonate, crospovidone, red iron oxide (E172) and magnesium stearate.
What Pravastatin Sodium 10mg, 20mg, and 40mg Tablets look like and the contents of the pack
Pravastatin sodium 10mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked 10 on one side.
Pravastatin sodium 20mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked 20 on one side.
Pravastatin sodium 40mg tablets are pale mauve-coloured, marbled, flat bevelled edged round tablets, marked 40 on one side.
They are supplied in blister packs of 28 tablets.
The Marketing Authorisation holder is: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK. The Manufacturer is: Chinoin Pharmaceutical & Chemical Works Co Ltd, H-2112 Veresegyhaz, Levai u. 5, Hungary Date of last revision of the leaflet March 2012.
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything ask your doctor or pharmacist.
Zentiva is a registered trademark. © 2012 Zentiva.
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