Consumer medicine information

What is in this Leaflet

The information in this leaflet will answer some of the questions you may have about PRAVACHOL. This leaflet does not tell you everything about the medicine.

Your doctor and pharmacist have been provided with full information and can answer any questions you may have.

This leaflet is no substitute for talking with your doctor or pharmacist. You should follow all advice from your doctor when being treated with this medicine.

Ask your doctor or pharmacist if you have any concerns about taking this medicine.

You should read this leaflet carefully before starting PRAVACHOL and keep it in a safe place to refer to later.

What is it used for

PRAVACHOL is used to treat people who have had a heart attack or an episode of unstable angina, or who have high blood cholesterol levels. In these people PRAVACHOL can reduce the risk of further heart disease, reduce the possibility of needing a bypass operation, or reduce the risk of having a stroke.

It lowers high blood cholesterol levels (Doctors call this hypercholesterolaemia). It is also used if your cholesterol levels are normal if you have had a heart attack or an episode of unstable angina.

It is used to treat heterozygous familial hypercholesterolaemia in children and adolescent patients aged 8 years and older as an adjunct to diet and lifestyle changes.

If you have had a heart attack, an episode of unstable angina or you have too much cholesterol in your blood, then you have an increased risk of a blood clot forming in your blood vessels and causing a blockage. Blood vessels that become blocked in this way can lead to further heart disease, angina or stroke.

PRAVACHOL may be used to lower lipids in heart or kidney transplant patients, who are also being given immunosuppressive medicine.

It is used to treat long-term (chronic) conditions so it is important that you take your PRAVACHOL every day.

It is not addictive or habit forming.

It is only available upon prescription from your doctor.

How does it work

PRAVACHOL tablets contain pravastatin sodium, a drug that reduces the level of cholesterol in your blood and helps to protect you in other ways from heart attack or stroke. It is more effective if it is taken with a diet low in fat.

Before I take it

Before taking PRAVACHOL, you should be aware of the following:

You should not take it

• if you are or may become pregnant
• if you are breast feeding
• if you have ever had an allergic reaction to pravastatin sodium or any other ingredient listed at the end of this leaflet
• if you have ever had liver disease
• if you have had muscle pain from any other medicine used to treat high cholesterol

Do not give your medicine to any one else even if they have the same condition as you have.

Before you take it

You must tell your doctor if:

• you are taking other medicines or treatment
• you drink alcohol regularly
• you have ever had liver problems
• you have a problem with your kidneys
• you are or may become pregnant
• you are breastfeeding
• you suffer from hormonal disorders
• you suffer from central nervous system vascular lesions
• you suffer from allergies
• you suffer from homozygous familial hypercholesterolaemia, (a doctor will have told you this)
• you have increased triglycerides in your blood (a doctor will have told you this also)
• you suffer from muscle disease (including pain, tenderness or weakness).

Taking other medicines

Some medicines can affect the way PRAVACHOL works.

You should always tell your doctor about any other medicines you take, even those bought without a doctor's prescription.

It is especially important that you tell your doctor if you are taking any of the following:

• any other medicine to lower cholesterol
• cyclosporin
• ketoconazole
• spironolactone
• cimetidine
• gemfibrozil
• cholestyramine and colestipol
• antacids
• Macrolides
• Propanol
• Bile acid sequestrants
• Digoxin
• Warfarin or other Coumarin anticoagulants

Please discuss any of these with your doctor if you need to take any of them.

It generally does not interfere with your ability to drive or operate machinery. However some people may experience dizziness, so you should be sure how you react to PRAVACHOL before you drive a car, or operate machinery.

How to take it

How much to take

PRAVACHOL should only be used as directed by your doctor. Your doctor will decide on the dose, this will depend on many factors including your cholesterol level. The dose for lowering cholesterol is 10 – 80mg, and is 40mg for reducing the possibility of a stroke or heart attack.

The recommended dose is 20 mg once daily for children 8 – 13 years of age and 40 mg once daily in adolescents 14 – 18 years of age, with heterozygous familial hypercholesterolaemia.

How to take it

Take PRAVACHOL once a day in the evening before bed-time.

For best results, take PRAVACHOL on an empty stomach (ie. two or more hours after your last meal).

Take PRAVACHOL at about the same time each day. Taking it at the same time each day will have the best effect and will also help you remember when to take it.

If you forget to take it

If you forget to take a dose of PRAVACHOL, take the next dose normally at your usual time.

Side Effects

All medicines, including PRAVACHOL, can sometimes cause unwanted effects. This is not an exhaustive list.

The most common side effects are:

• upset stomach
• nausea
• diarrhoea
• wind
• constipation
• headache
• dizziness.

Tell your doctor as soon as possible if you have any of these side effects or any other problem while taking PRAVACHOL.

Your doctor may arrange blood tests.

You must tell your doctor immediately, or go to the hospital, if you suffer any of the following:

• unexplained muscle pain
• tenderness
• weakness.

It is also possible to suffer from an allergic reaction to PRAVACHOL, so tell your doctor if you develop a skin rash or itchiness, fever, joint pain or shortness of breath.

In few cases, statins have been reported to induce de novo or aggravate pre-existing myasthenia gravis or ocular myasthenia.

If you take too much (Overdose)

Call your doctor immediately if you or someone else has taken too much PRAVACHOL.

If your doctor is not available call your nearest hospital or a Poisons Information Centre on 13 11 26.

Storage

Store PRAVACHOL in a cool dry place, and keep the tablets in the blister until it is time to take them.

Store PRAVACHOL below 25°C, and protect from light and moisture.

The expiry date is printed on the pack. Do not take it after the expiry date or if the tablets have changed in appearance colour or taste.

Ask your pharmacist about disposal of unused tablets.

Keep all medicines out of reach of children.

Product description

What it looks like

Pravachol 10mg tablet - engraved ‘10’. AUST R 68706

Pravachol 20mg tablet - engraved ‘20’. AUST R 68704

Pravachol 40mg tablet - engraved ‘40’. AUST R 58075

Pravachol 80mg tablet - engraved ‘80’. AUST R 101491

Pravachol tablets are yellow capsule shaped tablets supplied in blister packs containing 30 tablets per pack.

Active ingredients

Pravachol 10mg tablets - 10mg pravastatin sodium

Pravachol 20mg tablets - 20mg pravastatin sodium

Pravachol 40mg tablets - 40mg pravastatin sodium

Pravachol 80mg tablets - 80mg pravastatin sodium

Inactive ingredients

PRAVACHOL tablets also contain lactose, povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, magnesium oxide and iron oxide-yellow.

Contains sugars as lactose.

Sponsor & Distributor

Arrow Pharma Pty Ltd
15 – 17 Chapel Street
Cremorne Victoria 3121

This leaflet was revised in October 2023.

Published by MIMS December 2023

1 Name of Medicine

Pravastatin sodium.

2 Qualitative and Quantitative Composition

Pravachol is one of a new class of lipid-lowering compounds, the HMG-CoA reductase inhibitors, that reduce cholesterol biosynthesis. These agents are competitive inhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase, the enzyme catalysing the early rate limiting step in cholesterol biosynthesis, conversion of HMG-CoA to mevalonate.
Pravastatin sodium is an odourless, white to off-white, fine or crystalline powder. It is a relatively polar hydrophilic compound with a partition coefficient (octanol/ water) of 0.59 at a pH of 7.0. It is soluble in methanol and water (> 300 mg/mL), slightly soluble in isopropanol, and practically insoluble in acetone, acetonitrile, chloroform, and ether.
Pravachol tablets are available in 10 mg, 20 mg, 40 mg and 80 mg.
Excipients of known effect. Lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pravachol is available as yellow capsule shaped biconvex tablets containing 10 mg, 20 mg, 40 mg or 80 mg pravastatin sodium. The 10 mg tablet (8.8 x 4.4 mm) is engraved "10" on one side, the 20 mg tablet (11.0 x 5.5 mm) is engraved "20" on one side, the 40 mg tablet (14.0 x 7.0 mm) is engraved "40" on one side, the 80 mg tablet (17.6 x 8.8 mm) is engraved "80" on one side. The tablets are supplied in blister packs containing 30 tablets.

4 Clinical Particulars

4.9 Overdose

Symptoms. There has been limited experience with overdosage of pravastatin. To date there are two reported cases, both of which were asymptomatic and not associated with clinical laboratory test abnormalities. Of these two cases, one occurred in a clinical trial patient who ingested 3 g pravastatin; the other ingested 280 mg pravastatin, as marketed tablets. Both cases also involved overdose of concomitant medications.
Treatment. Should overdose occur, treat symptomatically and institute supportive measures as required.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In six genetic toxicology studies performed with pravastatin, there was no evidence of mutagenic potential at the chromosomal or gene level.
Carcinogenicity. In a 2-year oral study of rats, a statistically significant increase in the incidence of hepatocellular carcinomas was observed in male rats given 100 mg/kg daily of pravastatin. This change was not seen in male rats given 40 mg/kg or less, or in female rats at doses up to 100 mg/kg daily. Increased incidences of hepatocellular carcinomas were also observed in male and female mice dosed with pravastatin at 250 and 500 mg/kg daily, but not at 100 mg/kg/day or less. An increased incidence of pulmonary adenomas was seen in female mice dosed at 250 mg/kg/day. The AUC value for the serum concentration of pravastatin at the no effect dose level of 100 mg/kg/day in mice was 2 times higher than that in humans receiving 80 mg pravastatin per day.
The hepatocarcinogenic effect of pravastatin in rats is associated with proliferation of hepatic peroxisomes. Other HMG-CoA reductase inhibitors (simvastatin and lovastatin) also induce hepatic peroxisome proliferation and hepatocellular carcinomas in rats and mice. The clinical significance of these findings is unclear.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Pravastatin sodium is designated chemically as:
(3R,5R)-7-[(1S,2S,6S,8S,8aR) -1,2,6,7,8,8a-Hexahydro-6-hydroxy-2-methyl -8-[(S)-2-methylbutyryloxy-1-naphthyl]] -3,5-dihydroxyheptanoic acid, sodium salt, and has the following structure:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPRASOD.gif CAS number. 81131-70-6.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription only medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PRAVCHST.gif