Package leaflet: Information for the patient Pravastatin sodium 30mg Tablets

What is in this leaflet:

1.    What this medicine 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 this medicine is and what it is used for

Pravastatin belongs to a group of medicines called statins (HMG-CoA reductase inhibitors). These

work by helping to reduce cholesterol and fats (triglycerides) in the blood by inhibiting an enzyme

called HMG-CoA reductase, which controls cholesterol production in the liver.

Pravastatin is used to treat the following:

•    Primary hypercholesterolaemia, an inherited condition in which the level of cholesterol in the blood is higher than normal from birth. Pravastatin is used to treat this condition when diet, exercise and weight reduction have been insufficient to correct the condition

•    High levels of triglycerides, cholesterol and other fats in the blood (mixed dyslipidaemia). Pravastatin is used to treat this condition when diet, exercise and weight reduction have been insufficient to correct the condition

•    To prevent heart-related illness or death in patients with moderate to severely high cholesterol levels who are at high risk for first-time heart problems (primary prevention)

•    To prevent heart-related illness or death in patients with a history of heart problems (secondary prevention)

•    To reduce high concentration of triglycerides (fats) or cholesterol in the blood (hyperlipidaemia) in patients who have had an organ transplant and are taking medication to reduce the body’s immunity (immunosuppressants)

2    What you need to know before you take Pravastatin

Do not take Pravastatin if:

•    You are allergic (hypersensitive) to Pravastatin, other HMG-CoA reductase inhibitors or any of the other ingredients of this medicine (see section 6 “Contents of the pack and other information”)

•    You suffer from liver problems

•    You are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby (see “Pregnancy and breast-feeding” section)

Warnings and precautions

•    If you suffer from an inherited condition that causes high levels of cholesterol in the blood (homozygous familial hypercholesterolaemia)

•    If you are taking medicines to lower cholesterol known as fibrates (such as gemfibrozil or fenofibrate) (see “Other medicines and Pravastatin” section)

•    If you are a pre-pubescent child

•    If you suffer from liver problems or have a history of liver disease

•    If you regularly drink a large amount of alcohol

•    If you develop symptoms of interstitial lung disease; difficulty in breathing (dysponea), nonproductive cough, tiredness, weakness or lack energy (fatigue), weight loss or fever as your treatment should be discontinued (see section 4 “Possible side effects”)

•    If you have unexplained symptoms such as muscle pain or tenderness, muscle weakness, or muscle cramps (these symptoms usually resolve following discontinuation of treatment with Pravastatin)

•    If you have kidney problems

•    If you have an underactive thyroid (hypothyroidism)

•    If you have a history of muscle problems associated with taking other medicines used to lower cholesterol, such as statins or fibrates (see “Other medicines and Pravastatin” section).

•    If you have a personal or family history of suffering from hereditary muscular disorders

•    If you are over 70 years of age

•    If you are diabetic

•    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).

•

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.

Other medicines and Pravastatin

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.

Medicines which may interact with or be affected by Pravastatin:

•    Other medicines used to lower cholesterol known as fibrates (such as gemfibrozil or fenofibrate) or nicotinic acid

•    Medicines used to lower cholesterol such as cholestyramine and colestipol (bile acid-binding resin medicines). You should take Pravastatin at least 1 hour before or at least 4 hours after taking a bile acid-binding resin medicine

•    Erythromycin, clarithromycin, medicines used to treat bacterial infections (antibiotics)

•    Ciclosporin, a medicine used to reduce the body’s immunity when receiving organ transplant (immunosuppressant), as treatment with Pravastatin should begin with 20mg once daily and slow increase to 40mg should be performed with caution

•    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.

•    If you are taking a drug used to treat and prevent formation of blood clots called “vitamine 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.

Taking Pravastatin with food and drink and alcohol

•    During treatment with Pravastatin, a low-fat diet should be followed

•    These tablets may be taken with or without food

•    You should avoid or limit your intake of alcohol whilst being treated with Pravastatin 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 for advice before taking this medicine.

Pregnancy

Do not take Pravastatin if you are pregnant, trying to become pregnant or think you may be pregnant. If you plan to become pregnant or become pregnant, inform your doctor immediately as Pravastatin should be discontinued because of the potential risk to the baby.

Breast-feeding

Do not take Pravastatin if you are breast-feeding as Pravastatin is passed into breast milk.

Driving and using machines

Although unlikely, you may feel dizzy or experience visual disturbances whilst taking this medicine. If either of these symptoms are experienced, it may be necessary to avoid driving or operating machinery or pursuing any activity in which full attention is required.

3 How to take Pravastatin

Always take Pravastatin exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Before taking Pravastatin, secondary causes of very high cholesterol levels in the blood (hypercholesterolemia) should be excluded and your doctor should put you on a standard low-fat diet, which should be continued during treatment.

•    These tablets are to be taken orally, in the evening

•    These tablets may be taken with or without food

•    The score line on the tablet is only to facilitate breaking for ease of swallowing and not to divide the tablet into equal doses

Treatment of very high cholesterol levels in the blood (hypercholesterolemia)

•    The recommended dose range is 10-40mg, once daily

•    Your doctor will do periodic blood tests and adjust your dose if necessary. The response to treatment is seen within a week, with full effect of a given dose within four weeks

•    The maximum daily dose is 40mg

Prevention of heart problems

The starting and maintenance dose is 40mg daily

After organ transplantation

The recommended starting dose is 20mg daily and may be increased up to 40mg daily, under close medical supervision.

Use in children

To treat an inherited condition that causes high levels of cholesterol in the blood (heterozygous familial hypercholesterolaemia):

•    The recommended dose range is 10-20mg once daily for children of between 8 and 13 years of age

•    The recommended dose range is 10-40mg daily for children and adolescents of between 14 and 18 years of age

Patients with kidney or liver problems

•    The recommended starting dose is 10mg daily in patients with moderate to severe kidney or liver problems

•    Your doctor will adjust the dose according to your response to treatment If you take more Pravastatin than you should

If you accidentally take too many tablets, contact your doctor or nearest hospital emergency department immediately for advice. Remember to take this leaflet or any remaining tablets with you.

If you forget to take Pravastatin

Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.

If you stop taking Pravastatin

It is important that you keep taking Pravastatin for as long as your doctor has told you to.

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.

Seek medical advice immediately if you develop the following symptoms:

•    Allergic reactions: swelling of the face, throat or tongue, fever, difficulty in breathing, dizziness

•    Inflammation of the pancreas (pancreatitis)

•    Yellowing of the skin or whites of the eyes (jaundice)

•    Inflammation of the liver (hepatitis)

•    Liver failure or damage (fulminant hepatic necrosis)

•    Muscle weakness (myopathy), inflammation of the muscles (myositis), chronic inflammation of the muscles (polymyositis). This can progress to a serious life-threatening condition (called rhabdomyolysis) which is associated with kidney failure. If you have muscle weakness, tenderness or pain and at the same time you feel unwell of have a high temperature, stop taking pravastatin tablets and tell your doctor immediately

•    Swelling of the deeper layers of the skin caused by a build-up of fluid (angioedema)

•    Condition which causes joint pain, skin rashes and fever (lupus erythematous-like syndrome)

Uncommon side effects (may affect up to 1 in 100 people)

•    Dizziness

•    Headache

•    Disturbed sleep or difficulty in sleeping (insomnia)

•    Visual disturbances including blurred vision or double vision (diplopia)

•    Runny nose (rhinitis)

•    Cough

•    Indigestion (dyspepsia) or heartburn

•    Abdominal pain

•    Feeling or being sick (nausea or vomiting)

•    Constipation

•    Diarrhoea

•    Feeling bloated/wind (flatulence)

•    Severe itching (pruritus)

•    Skin rashes

•    Skin rashes with the formation of wheals (urticaria)

•    Scalp or hair problems including hair loss (alopecia)

•    Painful urination (dysuria), increased frequency or urination or a need to wake and pass urine at night (nocturia)

•    Sexual difficulties

•    Tiredness, weakness or lack energy (fatigue)

Very rare side effects (may affect up to 1 in 10,000 people)

•    Disorders of the nervous system e.g. “creeping” sensation and other sensory disorders affecting hands &/or feet (peripheral polyneuropathy), particularly if taken for a long period of time

•    Tingling or numbness in the hands or feet (paraesthesia)

•    Condition in which damaged skeletal muscle tissue breaks down (rhabdomyolysis)

•    Tendon disorders including rupturing

Other possible side effects that have been reported

•    Pain or swelling in the joints (arthralgia)

•    Changes in blood test results

•    Abnormal liver function

•    Nightmares

•    Memory loss

•    Depression

•    Interstitial lung disease (especially with long-term treatment); difficulty in breathing (dysponea), non-productive cough, tiredness, weakness or lack energy (fatigue), weight loss or fever (see section 2 “Warnings and precautions”)

•    Diabetes mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose at 5.6 mmol/L, BMI>30kg/m 2, raised triglycerides, history of hypertension).

•    Dermatomyositis (condition characterized by an inflammation of the muscles and the skin).

•    Muscle weakness that is constant

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 internet 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

•    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 packaging after EXP. The expiry date refers to the last day of the month.

•    All foil blister: Do not store above 30°C. Store in the original package.

Plastic foil backed blister: Do not store above 25°C. Store in the original package.

•    Container: Keep the tablet container tightly closed.

•    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 to protect the environment.

6 Contents of the pack and other information What Pravastatin contains:

Each 30mg tablet contains 30mg of pravastatin sodium

The other ingredients are: anhydrous calcium hydrogen phosphate, sodium starch glycolate, microcrystalline cellulose, trometamol, disodium phosphate dihydrate, povidone, magnesium stearate and yellow ferric oxide (E172).

What Pravastatin looks like and contents of the pack:

Pravastatin 30mg are yellow, oblong, convex, side wall scored tablets encoded P30 with an approximate size of 5.8 x 11.5 mm

Pravastatin is available in:

Pravastatin Tablets are available in packs of:

Blister packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 98, 100x1 or 100 tablets Containers of 28, 30, 98, 100 or 250 tablets

Not all pack sizes or pack types may be marketed.

Product Licence Number:

Pravastatin sodium 30mg Tablets: PL 11311/0497

Marketing Authorisation Holder and Manufacturer:

Tillomed Laboratories Ltd

3 Howard Road

Eaton Socon

St Neots

Cambridgeshire

PE19 8ET

UK

This leaflet was last revised in December 2015

TiU-Ver.10s