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PC - 6999

•    Bladder problems (painful or frequent urination, having to urinate at night)

•    Sexual dysfunction

Very rare side effects (less than 1 in every 10,000 patients):

•    Joint or muscle pain

•    Tendon problems

Unknown frequency

•    Memory loss

•    Depression

•    Lung disease

•    Liver enzyme increases which may have an effect on some medical tests

If any of these side effects get serious or if you notice any side effects not mentioned in this leaflet, tell your doctor or pharmacist.

5.    How to store Pravastatin Tablets

Keep Pravastatin tablets out of the reach and sight of children.

Do not store above 25°C. Store in the original package Do not use Pravastatin tablets after the expiry date on the labelling. Medicines should not be disposed off via waste water or house hold waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6.    Further Information

What Pravastatin tablets contain

For I0mg Tablets: each tablet contains I0mg of Pravastatin Sodium For 20mg Tablets: each tablet contains 20mg of Pravastatin Sodium For 40mg Tablets: each tablet contains 40mg of Pravastatin Sodium

The other ingredients in Pravastatin Sodium I0mg, 20mg and 40mg tablets are: Croscarmellose Sodium, lactose monohydrate, light magnesium oxide, magnesium stearate, microcrystalline cellulose, povidone and talc.

The tablets are white to off white capsule shaped tablets. The I0mg tablets are marked “PV|I0” on one side. The 20mg tablets are marked “PV|20” on one side. The 40mg tablets are marked “PV 40” on one side.

Pravastatin Sodium I0mg and 20mg tablets are available in blister packs of I0, 20, 28, 30, 50, 56, 98, I00 and 500 (5xI00) tablets and containers of 30, 250 and I000 Tablets. ^{1 2}

Pravastatin Sodium 40mg tablets are available in blister packs of I0, 20, 28, 30, 50, 56, 98,I00 and 500 (5xI00) tablets and containers of 30, 250 and 750 Tablets. ²

*Not all pack sizes may be marketed

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder and company responsible for Manufacture:

MEDREICH PLC

Warwick House, Plane Tree Crescent, Feltham TWI3 7HF, UK E-mail : info@medreich.co.uk

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pravastatin Sodium 10mg, 20mg and 40mg Tablets

Read all of this leaflet carefully before taking your 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 get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

In this leaflet:

1.    What Pravastatin Tablets are and what they are used for

2.    Before you take Pravastatin Tablets

3.    How to take Pravastatin Tablets

4.    Possible side effects

5.    How to store Pravastatin Tablets

6.    Further information

1. What Pravastatin Tablets are and what they are used for

Pravastatin Sodium belongs to a group of medicines known as Statins (or HMG-CoA reductase inhibitors). It is used to treat high cholesterol and works by reducing the amount of cholesterol your body makes.

Pravastatin Tablets are used to treat:

•    High levels of cholesterol in the blood (Hypercholesterolemia)

•    High blood levels of other “fatty substances”

(Mixed dyslipidaemia)

Pravastatin tablets can be prescribed if you have high cholesterol levels and are taking medication to stop your body rejecting a recent organ transplant. It may also be prescribed if you have previously suffered a heart attack or suffer from angina, and your cholesterol levels are normal or only slightly raised.

When you use Pravastatin tablets your doctor will recommend other actions as part of your treatment such as a low-cholesterol diet, exercise and weight reduction. Pravastatin is used to treat long term conditions so it is important that you take your Pravastatin tablets every day.

Head - PDC	Head TT	Head - QC	Head Tech. Services	Head CQA/QA
Prepared by:	Checked by:	Approved by:	Approved by:	Authorized by:
Date:	Date:	Date:	Date:	Date:

MED/PRA/PIL/01

R-1/22.09.14(RA)

•    have a history of liver disease

•    have a type of high cholesterol caused by HDL - Cholesterol

•    have a type of inherited high cholesterol

Tell your doctor immediately if you experience unexplained muscle pain, tenderness or weakness.

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

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.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medication, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following:

•    Other medicines used to treat high cholesterol called colestyramine, colestipol or Fibrates (e.g. gemfibrozil, fenofibrate)

•    Medicines that suppress the immune system especially after organ transplant e.g. cyclosporine

•    The antibiotics erythromycin or clarithromycin

•    Anticoagulants or medicines that thin the blood (such as Warfarin or nicotinic acid)

Taking Pravastatin Tablets with alcohol

Pravastatin tablets should not be taken by patients who regularly drink large amounts of alcohol. Alcohol intake should be kept within guidelines suggested by your doctor as alcohol can increase your cholesterol level. If you are not sure about this please talk to your doctor.

Pregnancy and breastfeeding

You must not take Pravastatin during pregnancy. If you discover that you are pregnant tell your doctor immediately.

Do not breast feed whilst taking Pravastatin as it can be passed in to the child through the mother’s milk.

Driving and using machines

Do not drive or use any tools or machines if you feel dizzy or weak after taking the tablets. This is more likely to happen at the start of your treatment.

3. How to take Pravastatin Tablets

Always take your medicine exactly as told to by your doctor. Ask your doctor or pharmacist if you are not sure.

Taking the tablets

Take your Pravastatin tablets once a day at bedtime. Swallow the tablets whole with a glass of water. The tablets can be taken with or without food.

Pravastatin tablets should not be taken by children or adolescents under the age of 18 years.

Usual dose in adults for lowering cholesterol

The normal starting dose is I0mg once a day. This dose may be increased by your doctor to 40mg once a day.

Usual dose in adults following organ transplantation

The normal dose is 20mg once a day.

If taking other high cholesterol medicines with these tablets

If you are also taking a resin-type lipid-lowering agent such as colestyramine or colestipol, Pravastatin tablets 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

1211401

absorption of Pravastatin if the two medicines are taken too closely together.

If you take more Pravastatin Tablets than you should

If you take too many tablets contact your doctor immediately or go to the nearest hospital casualty department. Take this leaflet or some tablets with you so your doctor will know what you have taken.

If you forget to take Pravastatin Tablets

If you have forgotten to take your Pravastatin tablets wait until it is time to take the next dose and then continue as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pravastatin Tablets

Do not discontinue the treatment without talking to your doctor first. It is important that you take Pravastatin tablets as long as your doctor prescribes it. ³

Head - PDC	Head TT	Head - QC	Head Tech. Services	Head CQA/QA
Prepared by:	Checked by:	Approved by:	Approved by:	Authorized by:
Date:	Date:	Date:	Date:	Date:

MED/PRA/PIL/01

R-1/22.09.14(RA)

WIN:\\192.168.1.33\PDC\Artworks\Medreich\Pravastatin\Sodium Tablets\PIL\1211401.ai

Internal Approval Issued on 22/24.09/01.10.14(RA)    CD Issued on 22/24.09/01.10.14(RA)

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2. Before you take Pravastatin Tablets

Do not take Pravastatin Tablets if you:

•    are allergic (hypersensitive) to Pravastatin or any of the other ingredients listed in Section 6

•    are pregnant or planning to become pregnant

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4. Possible side effects

Like all medicines, Pravastatin tablets can have side effects.

Stop taking Pravastatin and tell your doctor immediately

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 (rhabdomylosis) and can lead to a serious, life threatening kidney disease.

Serious Allergic Reactions

Uncommonly an allergic reaction may occur with symptoms of:

•    Swelling of the face, throat, lips or tongue

•    Severe skin rashes

•    Abdominal pain

Other serious side effects

•    Pain in the lower back associated with the kidneys

•    Problems with touch including burning/tingling sensations or numbness

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

•    Inflammation of the liver or pancreas (pancreatitis or hepatitis). Symptoms may include abdominal pain, loss of appetite and tiredness

3

   Very rapid death of liver cells (fulminant hepatic necrosis) 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 experience any of these side effects contact your doctor IMMEDIATELY or go to your nearest hospital casualty department.

If you experience any unexplained muscle pain, muscle tenderness, weakness or cramp and feel tired, have a fever or your urine looks unusually dark you must contact your doctor straight away. In very rare cases this has progressed to become a serious and potentially life-threatening condition called rhabdomyolysis.

Other possible side effects

Uncommon side effects (between I in 100 and lin 1000 patients)

•    Headache

•    Dizziness

•    Fatigue (tiredness)

•    Sleeping problems

•    Sight problems such as blurred or double vision

•    Minor stomach upsets (indigestion, heart burn, constipation, wind, diarrhoea)

•    Nausea (feeling sick) or vomiting (being sick)

•    Itching or rashes

•    Scalp and hair problems including hair loss

This section is continued overleaf ——