Pravastatin Aurobindo: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pravastatin Aurobindo 10 mg tablets, 20 mg tablets, 40 mg tablets

Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Pravastatin Aurobindo is and what it is used for
What you need to know before taking Pravastatin Aurobindo
How to take Pravastatin Aurobindo
Possible side effects
How to store Pravastatin Aurobindo
Contents of the pack and other information

1. What Pravastatina Aurobindo is and what it is used for

Pravastatina Aurobindo belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and therefore reduces levels of cholesterol and other fats (triglycerides) in the body. If cholesterol levels in the blood are too high, cholesterol builds up on the walls of blood vessels and blocks them.
This condition is known as hardening of the arteries or atherosclerosis and can lead to:

chest pain (angina pectoris), when a blood vessel of the heart is partially blocked,
a heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked,
a stroke (cerebrovascular accident), when a blood vessel in the brain is completely blocked.

This medicine is used in 3 situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravastatina Aurobindo is used to reduce high levels of "bad" cholesterol and to increase levels of "good" cholesterol in the blood when they have not been adequately reduced through diet or exercise.
In the prevention of heart and blood vessel diseases

If you have high levels of cholesterol in the blood and risk factors that contribute to these diseases (if you smoke, are overweight, have high blood sugar levels or high blood pressure, or are physically inactive), Pravastatina Aurobindo is used to reduce the risk of heart and blood vessel diseases and to reduce the risk of death due to these conditions.
If you have already had a stroke or have chest pain (unstable angina), even if your cholesterol levels are normal, Pravastatina Aurobindo is used to reduce the risk of having another heart attack or stroke in the future, and to reduce the risk of death due to these diseases.

After an organ transplant
If you have had an organ transplant and are taking medicines that prevent your body from rejecting the transplant, Pravastatina Aurobindo is used to reduce high levels of fats in the blood.

2. What you need to know before taking Pravastatin Aurobindo

Do not take Pravastatin Aurobindo and inform your doctor:

if you are allergic to pravastatin or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant, planning a pregnancy, or breastfeeding (see Pregnancy and breastfeeding);
if you have liver disease (active liver disease);
if repeated blood tests have shown abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and precautions
Check with your doctor or pharmacist before taking this medicine if:
Before starting this treatment, you must inform your doctor if you have or have had any of the following health conditions:

kidney disease;
underactive thyroid (hypothyroidism);
liver disease or alcohol-related problems (if you drink large amounts of alcohol);
muscle disorders caused by an inherited disease;
muscle problems caused by another medicine belonging to the group of statins (HMG-CoA reductase inhibitors) or to the group known as fibrates (see Taking other medicines).
Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
if you have taken or are currently taking, within the last 7 days, an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and Pravastatin Aurobindo may lead to serious muscle problems (rhabdomyolysis).

If you have experienced any of these conditions, or if you are over 70 years old, your doctor will need to perform a blood test before and possibly during treatment. These blood tests will be used to assess your risk of muscle-related adverse effects.
If you experience unexplained muscle cramps or pain during treatment, inform your doctor immediately.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.
Check with your doctor or pharmacist before taking Pravastatin Aurobindo if you:

suffer from severe respiratory failure

Other medicines and Pravastatin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
When taken together with this medicine, the following medicines may increase the risk of developing muscle problems (see Possible side effects). It is important that you inform your doctor if you are already taking:

a medicine that lowers cholesterol levels in the blood (fibrates, for example gemfibrozil, fenofibrate);
a medicine that reduces the body's immune defenses (cyclosporine);
a medicine used to treat bacterial infections (an antibiotic such as erythromycin or clarithromycin);
another medicine that lowers cholesterol levels in the blood (nicotinic acid).
If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart Pravastatin Aurobindo. Taking Pravastatin Aurobindo with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). See further information on rhabdomyolysis in section 4.

If you are also taking a medicine used to lower blood lipid levels (such as bile acid sequestrants, for example cholestyramine or colestipol), this treatment should be taken at least 1 hour before or 4 hours after the bile acid sequestrant, because the sequestrant may interfere with the absorption of Pravastatin Aurobindo if both medicines are taken at the same time.
If you are taking a medicine used to treat and prevent blood clots known as “warfarin-like medicines”, inform your doctor before taking Pravastatin Aurobindo, as using warfarin-like medicines together with Pravastatin Aurobindo may increase the results of blood tests used to monitor treatment with warfarin-like medicines.

Pravastatin Aurobindo with food and drink
This medicine can be taken with or without food, with half a glass of water.
You should always keep your alcohol consumption to a minimum. If you are concerned about how much alcohol you can drink while taking this medicine, discuss it with your doctor.

Pregnancy
Do not take Pravastatin Aurobindo during pregnancy. If you discover you are pregnant, inform your doctor immediately. Consult your doctor or pharmacist before taking any medicine.

Breast-feeding
Do not take Pravastatin Aurobindo if you intend to breastfeed, as this medicine passes into breast milk.

Driving and using machines
Pravastatin Aurobindo usually does not affect your ability to drive or operate machinery. However, if you experience dizziness, blurred or double vision during treatment, make sure you are able to drive or operate machinery safely before doing so.

Pravastatin Aurobindo contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Pravastatin Aurobindo

Take this medicine exactly as directed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
Your doctor will recommend a low-fat diet which you should continue to follow throughout the entire
treatment period.
Pravastatin Aurobindo can be taken with or without food, with half a glass of water.
Dosage
Adults:

For the treatment of high levels of cholesterol and fats in the blood: the usual dose is 10–40 mg once daily, preferably in the evening.
For the prevention of heart or blood vessel disease: the usual dose is 40 mg once daily, preferably in the evening.

The maximum daily dose of 40 mg of Pravastatin Aurobindo must not be exceeded. Your doctor will tell you
which dose is most suitable for you.
Paediatric patients (8–18 years) with an inherited condition causing high blood cholesterol levels:
The usual dose is 10–20 mg once daily for children aged 8 to 13 years, and 10–40 mg once daily for those aged 14 to 18 years.
After organ transplantation:
Your doctor may prescribe an initial dose of 20 mg once daily. The dose may be adjusted by your doctor up to 40 mg.
If you are also taking a medicine that suppresses the body's immune system (cyclosporine), your doctor may prescribe an initial dose of 20 mg once daily. The dose may be adjusted by your doctor up to 40 mg.
If you have severe kidney or liver disease, your doctor may prescribe a lower dose of Pravastatin Aurobindo.
If you feel that the effect of this treatment is too strong or too weak, discuss it with your doctor or pharmacist.
Duration of treatment
Your doctor will advise you on how long to take Pravastatin Aurobindo. This medicine must be taken regularly and for the full duration recommended by your doctor, even if this is a long period. Do not stop treatment on your own.
If you take more Pravastatin Aurobindo than you should
If you have taken too many tablets or if someone accidentally ingests any tablets, contact your doctor or the nearest hospital for assistance.
If you forget to take Pravastatin Aurobindo
If you miss a dose, simply take the next dose as usual.
Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Stop taking Pravastatin Aurobindo and contact your doctor immediately if you develop unexplained and persistent muscle pain, tenderness, weakness or cramps, especially if you also feel unwell or have a fever.
In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to a life-threatening kidney disease.
Sudden severe allergic reactions including swelling of the face, lips, tongue or throat, which may cause severe breathing difficulties. This is a very rare but potentially serious reaction. Inform your doctor immediately if this occurs.

The following side effects are uncommon and may affect more than 1 in 1,000 people:

Nervous system effects: dizziness, fatigue, headache or sleep disorders, including insomnia;
Vision effects: double or blurred vision;
Digestive effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhoea, constipation and flatulence;
Skin and hair effects: itching, pimples, hives, rash, scalp and hair problems (including hair loss);
Urinary and genital effects: bladder problems (painful and more frequent urination, nocturnal urination) and sexual difficulties;
Muscle and joint effects: muscle and joint pain.

The following side effects are very rare and may affect less than 1 in 10,000 people:

Nervous system effects: sensory disturbances, including burning sensations, tingling or numbness, which may indicate nerve damage;
Skin effects: a severe skin disease (lupus-like syndrome);
Liver effects: inflammation of the liver or pancreas; jaundice (recognisable by yellowing of the skin and whites of the eyes); very rapid death of liver cells (fulminant hepatic necrosis);
Muscle and joint effects: inflammation of one or more muscles leading to muscle pain and weakness (myositis or polymyositis); muscle weakness or pain, inflammation of tendons which may be complicated by tendon rupture.
Abnormal blood test results: increased transaminases (a group of enzymes naturally present in the blood), which may be a sign of blood-related problems. Your doctor will want to carry out periodic blood tests to monitor these values.

Side effects with unknown frequency:

Muscle and joint effects: persistent muscle weakness
Dermatomyositis (a condition characterised by inflammation of the muscles and skin)

Possible side effects

nightmares
memory loss
depression
respiratory problems including persistent cough and/or shortness of breath or fever
diabetes. This is more likely if you have high levels of sugar and fats in your blood, if you are overweight, or if you have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Pravastatin Aurobindo

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, bottle, and blister pack after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Blister pack: Store in the original packaging to protect from moisture.
HDPE bottle: Keep the container tightly closed to protect from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Pravastatina Aurobindo contains:

The active substance is pravastatin sodium. Each tablet contains 10 mg, 20 mg or 40 mg of pravastatin sodium.

The other components are: microcrystalline cellulose, monohydrate lactose, heavy magnesium oxide,
sodium croscarmellose, yellow iron oxide (E172), povidone K30, magnesium stearate.
Description of the appearance of Pravastatina Aurobindo and pack contents
Pravastatina Aurobindo 10 mg tablets:
10 mg tablet: yellow, capsule-shaped, biconvex, mottled, uncoated tablets with double bisector notched edges, imprinted with a "Y" on one side and "60" on the other side. The tablet can be divided into two equal doses.
Pravastatina Aurobindo 20 mg tablets:
20 mg tablet: yellow, capsule-shaped, biconvex, mottled, uncoated tablets with double bisector notched edges, imprinted with a "Y" on one side and "61" on the other side.
The tablet can be divided into two equal doses.
Pravastatina Aurobindo 40 mg tablets:
40 mg tablet: yellow, capsule-shaped, biconvex, mottled, uncoated tablets with double bisector notched edges, imprinted with a "Z" on one side and "18" on the other side.
The tablet can be divided into two equal doses.
Pravastatina Aurobindo tablets are available in blisters made of Polyamide / Aluminium / PVC / Aluminium and in HDPE bottles with polypropylene closure.
Pack sizes:
Blister packs: 1, 10, 14, 20, 28, 30, 50, 60, 84, 100 and 500 tablets.
HDPE bottle packs: 30, 100, 500 and 1000 tablets (hospital pack).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy
Responsible manufacturer for batch release
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000.
Malta
Milpharm Limited
Ares, Odyssey Business Park, West End Road, South Ruislip HA4 6QD.
United Kingdom
This medicinal product is authorized in the European Economic Area countries under the
following names:
France: PRAVASTATINE ARROW 10 mg/ 20 mg tablet
PRAVASTATINE ARROW 40 mg tablet
Ireland: Pravastatin sodium Aurobindo 10 mg/ 20 mg/ 40 mg tablets
Italy: Pravastatina Aurobindo
Malta: Pravastatin sodium Aurobindo 10 mg/ 20 mg/ 40 mg tablets
Netherlands: Pravastatine natrium Aurobindo 10 mg/ 20 mg/ 40 mg, tabletten
Portugal: Pravastatina Aurobindo
Spain: PRAVASTATINA AUROBINDO 10 mg/ 20 mg/ 40 mg tablets
United Kingdom: Pravastatin sodium 10 mg/ 20 mg/ 40 mg Tablets
This patient information leaflet was last approved on