Pravastatin Sodium 20mg Tablets
Package leaflet: Information for the user Pravastatin sodium 20 mg tablets Pravastatin sodium 40 mg tablets Pravastatin sodium
The name of your medicine is Pravastatin sodium, 20mg or 40mg tablets, which will be referred to as Pravastatin Tablets throughout this leaflet.
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 Tablets are and what they are used for
2. What you need to know before you take Pravastatin Tablets
3. How to take Pravastatin Tablets
4. Possible side effects
5. How to store Pravastatin Tablets
6. Contents of the pack and other information
1. What Pravastatin Tablets are and what they are used for
Pravastatin Tablets contain the active ingredient pravastatin sodium, which is a lipid lowering substance. Pravastatin Tablets are used to lower high levels of cholesterol and other fats (lipids) in the blood. If untreated, these high levels might cause problems later on leading to heart disease or other illnesses.
Pravastatin Tablets are used to:
- Treat high lipid levels (together with a diet) when dieting alone, exercise and weight reduction is not effective.
- Reduce heart disease (together with a diet) in patients with moderate or severely high lipids who are at risk of heart attack.
- Reduce heart disease in patients with a history of heart attack or unstable angina.
- Reduce high lipid levels in patients receiving anti-rejection drugs after an organ transplant.
2. What you need to know before you take Pravastatin Tablets Do not take Pravastatin Tablets:
- if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section
6).
- if you have liver disease
- if you are pregnant or there is a possibility that you may become pregnant
- if you are breast-feeding
Warnings and precautions
Talk to your doctor or pharmacist before using Pravastatin Tablets:
- if you have a high lipid level due to a specific type of cholesterol (HDL-cholesterol).
- if you have a liver disorder or high alcohol consumption
- if you have or get muscle disorders such as pain, tenderness, weakness or cramps.
- if you have a kidney disorder
- if you have an under-active thyroid (hypothyroidism)
- if you have a history or family history of muscle disorders
- 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 Tablets can lead to serious muscle problems (rhabdomyolysis)
- 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.
- 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.
Children
Pravastatin Tablets may not be suitable for children before puberty.
Other medicines and Pravastatin Tablets
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines:
- other treatments that reduce the level of fats in the blood such as fibrates (e.g. bezafibrate, fenofibrate), colestyramine, colestipol
- ciclosporin (used after organ transplants)
- erythromycin or clarithromycin (antibiotics)
- 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 Tablets. Taking Pravastatin Tablets with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.
- 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 Tablets because the use of vitamin K antagonists concomitantly with Pravastatin Tablets might increase the results of blood tests used to monitor the treatment with vitamin K antagonists.
Pregnancy and breast-feeding
You should not take Pravastatin Tablets while pregnant or breast-feeding.
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
You should not drive or operate machinery if you feel unwell or dizzy after taking Pravastatin Tablets.
Pravastatin tablets contain lactose
Pravastatin Tablets contain lactose which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Pravastatin Tablets
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Pravastatin Tablets are taken orally once daily in the evening with or without food.
Adults and Elderly
The recommended dose is 10-40 mg once daily. The maximum daily dose is 40 mg. Patients with liver or kidney disorders need a starting dose of 10 mg per day.
For patients taking ciclosporin (used after organ transplant) treatment should begin with 20 mg of Pravastatin once daily
Use in children and adolescents (8-18 years of age)
Pravastatin Tablets are only recommended for use in children when they have an inherited condition called heterozygous familial hypercholesterolaemia. The recommended dose range is 10-20 mg once daily for children between 8 and 13 years of age, and 10-40mg daily between 14 and 18 years of age
If you take more Pravastatin Tablets than you should:
It is important to stick to the dose on the label of your medicine. If you or someone else takes too many Pravastatin Tablets all together, contact your doctor, pharmacist or hospital emergency department immediately. Always take any tablets left over with you and also the box, as this will allow easier identification of the medicine.
If you forget to take Pravastatin Tablets:
If you forget to take a dose, take it as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking pravastatin straight away and go to your doctor or to the nearest hospital if you feel one of the following:
• Sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) which can be symptoms of states called anaphylaxis and angioedema, (may affect up to 1 in 10 000 people) .
• Facial rash, joint pain, muscle disorder and fever which can be symptoms of a state called lupus erythematous-like syndrome (may affect up to 1 in 10 000 people)
• Severe belly and back pain with feeling very unwell which can be symptoms of a state called pancreatitis (may affect up to 1 in 10 000 people)
• Yellowing of the skin or eyes (jaundice) (may affect up to 1 in 10 000 people)
• Tiredness, pain in abdomen, joints or muscles caused by inflammation of the liver (hepatitis) (may affect up to 1 in 10 000 people) ,
• Feeling of sickness, drowsiness, confusion, masses in belly caused by rapid liver death (fulminant hepatic necrosis) (may affect up to 1 in 10 000 people)
• Muscle disorders such as pain, tenderness, weakness or cramps which can progress to a state called rhabdomyolysis (abnormal muscle breakdown which can lead to kidney problems) (may affect up to 1 in 10 000 people)
• Breathing problems including persistent cough and/or shortness of breath or fever (interstitial lung disease) (frequency of this side effect cannot be estimated from the available data)
• Diabetes mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose at 5.6 mmol/l, BMI>30kg/m2, raised triglycerides, history of hypertension). Your doctor will monitor you while you are taking this medicine.
Pravastatin can cause some other side effects:
Uncommon (may affect up to 1 in 100 people):
- Dizziness,
- Headache,
- Sleep problems, insomnia,
- Vision problems such as blurred vision and double vision,
- Indigestion,
- Tummy pain,
- Feeling sick (nausea),
- Vomiting,
- Constipation,
- Diarrhoea,
- Wind (flatulence),
- Itching,
- Rash,
- Nettle rash which can cover a lot of your body or hives (urticaria)
- Scalp or hair problems including hair loss,
- Problems with urination (painfull or difficult water passing (dysuria), very often water passing, the awakening from sleep at night to pass urine (nocturia),
- Sexual problems,
- Tiredness.
Very rare (may affect up to 1 in 10 000 people):
- Disorder of the nerves which can cause weakness, tingling or numbness (especially if you use pravastatin for a long time)
- Pins and needles
Not known (frequency cannot be estimated from the available data)
- Tendon problems
- Muscle weakness that is constant
The treatment with pravastatin may be associated with
• Depression,
• Nightmare,
• Memory loss
• Breathing problems including persistent cough and/or shortness of breath or fever
skin)
• Dermatomyositis(condition characterized by an inflammation of the muscles and the
Reporting of side effects
side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible not listed in this leaflet. You can also report side effects directly via the 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.
5. How to store Pravastatin Tablets
Do not store above 25°C. Store in the original container.
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 carton. 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.
6. Contents of the pack and other information
What Pravastatin Tablets contain:
The active substance is pravastatin sodium 20mg or 40mg.
The other ingredients are lactose monohydrate, cellulose microcrystalline, calcium hydrogen phosphate dihydrate, croscarmellose sodium, iron oxide yellow (E172), sodium laurilsulfate, povidone, talc, silica colloidal anhydrous, sodium stearyl fumarate.
What Pravastatin Tablets look like and contents of the pack
Pravastatin sodium 20mg Tablets are yellow, round tablets imprinted with ’20’ on one side Pravastatin sodium 40mg Tablets are yellow, round tablets imprinted with ’40’ on one side.
Blister packs of 10 and 28 tablets per carton Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
PLIVA Pharma Ltd., Vision House, Bedford Road, Petersfield, Hampshire, GU32 3QB, United Kingdom
Manufacturer
PLIVA Krakow, Ul. Mogilska 80. 31-456, Krakow, Poland.
This leaflet was last revised in
January 2016