Pravastatin Sodium 10 Mg Tablets
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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Pravastatin sodium
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 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. See section 4.
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
Pravastatin belongs to a group of medicines called HMG-CoA reductase inhibitors (or statins) which work by reducing your body’s production of "bad cholesterol” and raising the levels of “good cholesterol”. Cholesterol is a lipid that can cause coronary heart disease by narrowing the vessels that supply the heart with blood. This condition, called hardening of the arteries or atherosclerosis, may lead to chest pain (angina pectoris), a heart attack (myocardial infarction) or stroke.
If you have already had a heart attack or have chest pain at rest (unstable angina pectoris), Pravastatin reduces the risk of having another heart attack or stroke in the future, regardless of your cholesterol levels. If you have raised levels of cholesterol but do not have coronary heart disease, Pravastatin reduces the risk of this occurring or of you having a heart attack in the future.
When you use Pravastatin, your doctor will recommend other actions as part of your treatment, such as a low-fat diet, exercise and weight reduction.
If you have had an organ transplant and are taking medication to stop your body rejecting the transplant, Pravastatin reduces increased lipid levels.
Do not take Pravastatin:
• if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6)
• if you are pregnant or if there is a possibility that you may become pregnant.
• if you are breast-feeding.
• if you have liver problems.
Ask your doctor if you are uncertain whether you can take Pravastatin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Pravastatin if you have ever had any of the following:
• Kidney disease or an underactive thyroid
• Alcohol problems (regularly drinking large amounts of alcohol)
• A hereditary muscle disorder in yourself or a blood relative
• Side effects affecting your muscles when taking another cholesterol-lowering medicine such as a statin or fibrate
• If you have had a history of liver problems
• If you have severe respiratory failure.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infection) orally or by injection. The combination of fusidic acid and Pravastatin can lead to serious muscle problems (rhabdomyolysis).
If you have suffered from any of these problems, your doctor will need to carry out a blood test before and possibly during Pravastatin treatment to assess your risk of muscle-related side effects.
You may also need this blood test if you are aged older than 70 years.
Go back to your doctor as soon as possible to discuss your concerns and follow the advice given.
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.
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
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be at risk of developing diabetes if you have high level of sugars and fats in your blood, are overweight and have high blood pressure.
Children and adolescents
In children before puberty; the benefit/risk of treatment should be carefully evaluated by physicians before treatment initiation.
Other medicines and Pravastatin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is important that you inform your doctor if you are already being treated with any of the following:
• other cholesterol lowering drugs called fibrates (e.g. gemfibrozile, fenofibrate) and nicotinic acid. The combination may increase the risk of side effects.
• medicines used to adjust or adapt the immune response, e.g. ciclosporin. The combination may increase the risk of side effects
• the antibiotics erythromycin or clarithromycin (the combination may result in an increased risk of developing muscle problems)
• a resin-type lipid-lowering agent such as colestyramine or colestipol (Pravastatin should usually be taken at least one hour before or four hours after you have taken the resin. This is because the resin can affect the absorption of Pravastatin if the two medicines are taken too closely together).
If you are taking a drug used to treat and prevent formation of blood clots called “vitamin K antagonist”, tell your doctor before taking Pravastatin because the use of vitamin K antagonists concomitantly with Pravastatin might increase the results of blood tests used to monitor the treatment with vitamin K antagonists.
If you need to take oral fusidic acid to treat a bacterial infection you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart Pravastatin. Taking Pravastatin with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
Pravastatin with food, drink and alcohol
Pravastatin can be taken with or without food. Inform your doctor if you regularly consume large quantities of alcohol.
If you are not sure about this please follow your doctor’s guidelines.
Pregnancy and breast-feeding
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.
You should not take Pravastatin during pregnancy.
Doctors will take special care when prescribing this medicine to young women that might become pregnant and they will properly explain the potential risk associated with Pravastatin therapy during pregnancy. If you have plans to become pregnant or if you have become pregnant, you should stop taking Pravastatin and inform your doctor immediately (see Section 2:
Do not take Pravastatin).
You should not take Pravastatin during breast-feeding as Pravastatin passes into the mother’s milk (see Section 2: Do not take Pravastatin).
Driving and using machines:
Pravastatin does not usually affect your ability to drive but if you experience any dizziness, blurred or double vision make sure you are fit to drive and operate machinery before attempting to do so.
Pravastatin contains lactose
If you have been told by your doctor that you have an intolerance to some
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sugars, contact your doctor before taking this medicinal product.
Always take Pravastatin exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults
The usual dose of Pravastatin is 10 - 40 mg once a day, preferably in the evening. Pravastatin can be taken with or without food, with half a glass of water. The tablet can be divided into equal doses.
Use in children and adolescents (from 8 to 18 years of age) with heterozygous familial hypercholesterolemia
Use in children and adolescents (8 - 13 years of age): The recommended dose range is 10 - 20 mg once a day.
Use in children and adolescents (14 - 18 years of age): The recommended dose range is 10 - 40 mg once a day.
Renal and hepatic impairment:
The usual dose is 10 mg once a day in patients with renal or hepatic impairment.
Following organ transplantation:
The usual starting dose is 20 mg once a day. This dose may be increased by your doctor to 40 mg
Other medicines:
Pravastatin should usually be taken at least one hour before or four hours after you have taken the Colestyramin or Colestipol.
The usual starting dose for a person who uses medicines which adjust or adapt the immune response (e.g. Ciclosporin) is 20 mg once a day. This dose may be increased by your doctor to 40 mg.
If you have the impression that the effect of Pravastatin is too strong or too weak, talk to your doctor or pharmacist.
If you take more Pravastatin than you should
If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or the nearest hospital for advice.
If you forget to take Pravastatin
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 forgotten doses.
If you stop taking Pravastatin
Always tell your doctor if you want to stop the treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
numbness which may indicate damage to nerve endings
• allergic condition which causes joint pain, skin rashes and fever (lupus erythematosus)
• inflammation of the liver (which may cause yellowing of the skin or the whites of the eyes) or pancreas (which may cause stomach pain)
• pain or weakness in muscle (myopathy) , inflammation of the muscles (myositis, polymyositis)
• isolated cases of tendon disorders, sometimes complicated by rupture
• abnormal blood tests: increases in transaminases (a group of enzymes occuring naturally in the blood) which may be a sign of liver problems. Your doctor may want to perform tests periodically to check these.
Side effects of unknown frequency
(frequency cannot be estimated from the available data):
• muscle weakness that is constant
• dermatomyositis (condition characterized by an inflammation of the muscles and the skin).
The following side effects have been reported with some statins (medicines of the same type)
• 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.
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 the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Store in the original package in order to protect from moisture.
Do not use Pravastatin after expiry date which is stated on the outer carton or blister after ‘EXP’. The expiry date refers to the last day of that month.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects which occur very rarely (may affect up to 1 in 10,000 people)
Contact your doctor as soon as possible and stop taking Pravastatin if you develop any unexplained or persistent muscle pain, tenderness, weakness or cramps, especially, if at the same time you feel unwell or have a high temperature. In very rare cases, muscle problems can be serious (rhabdomyolysis) and can lead to a serious and potentially life-threatening kidney disease.
You should stop taking Pravastatin and see your doctor immediately if
you experience symptoms such as:
• swollen face, tongue or pharynx
• difficulty to swallow
• hives and difficulties to breathe
• dizziness.
These are symptoms of a serious allergic reactions (angioedema, anaphylaxis), which must be treated immediately, usually in a hospital.
Other side effects:
Uncommon side effects (may affect up to 1 in 100 people):
• dizziness, headache, sleep disorders, sleeplessness
• problems with sight such as blurred or double vision
• stomach and bowel problems such as indigestion, heartburn, stomach pain or discomfort nausea, vomiting, diarrhoea or constipation and wind
• skin reactions such as itching and rashes, hives (urticaria) or scalp and hair problems including hair loss
• bladder problems (painful or more frequent urination, having to pass water at night)
• sexual difficulties
• tiredness
• muscle and joint pain.
Very rare side effects (may affect up to 1 in 10,000 people):
• problems with touch including burning/tingling sensations or
What Pravastatin contains
• The active substance is: pravastatin sodium. Each tablet contains 10 mg, 20 mg or 40 mg pravastatin sodium.
• The other ingredients are: microcrystalline cellulose, lactose monohydrate, dibasic sodium phosphate anhydrous, croscarmellose sodium, sodium lauryl sulphate, povidone K25, iron oxide (brown) (E172), colloidal anhydrous silica, magnesium stearate
What Pravastatin looks like and contents of the pack
Pravastatin sodium 10 mg Tablets are light brown, mottled, oval, scored on both sides and debossed with "P 10” on one side.
Pravastatin sodium 20 mg Tablets are light brown, mottled, oval, scored on both sides and debossed with "P 20” on one side.
Pravastatin sodium 40 mg Tablets are light brown, mottled, oval, scored on both sides and debossed with "P 40” on one side.
Pack sizes:
Alu/Alu blister:
10 mg: 1,7, 10, 14, 20, 21,28, 30,
50, 60, 98, 100, 100x1
20 mg: 1,7, 10, 14, 20, 21,28, 30,
50, 60, 90, 98, 100, 100x1 40 mg: 1,7, 10, 14, 20, 21,28, 30,
50, 60, 90, 98, 100, 100x1
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sandoz Ltd,
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d.,Verovskova 57, 1526 Ljubljana, Slovenia or Salutas Pharma GmbH, Otto-con-Guericke-Allee 1,39179 Barleben, Germany or Salutas Pharma GmbH,
Dieselstrasse 5, 70839 Gerlingen, Germany or LEK S.A., ul. Domaniewska 50 C, 02-672 Warsaw, Poland
This leaflet was last revised in 06/2016 00000000
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