PRAVASTATINA 10 mg Coated Tablet

Зміст інструкції

1. Pravastatina Aurobindo 10 mg tablets, 20 mg tablets, 40 mg tablets
   1. What is Pravastatina Aurobindo and what is it used for
   2. What you need to know before taking Pravastatina Aurobindo
   3. How to take Pravastatina Aurobindo
   4. Possible side effects
   5. How to store Pravastatina Aurobindo
   6. Package contents and other information

Pravastatina Aurobindo 10 mg tablets, 20 mg tablets, 40 mg tablets

Equivalent Medicine

Read this leaflet carefully before taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pravastatina Aurobindo is and what it is used for
• 2. What you need to know before you take Pravastatina Aurobindo
• 3. How to take Pravastatina Aurobindo
• 4. Possible side effects
• 5. How to store Pravastatina Aurobindo
• 6. Contents of the pack and other information.

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

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

• chest pain (angina pectoris), when a blood vessel in the heart is partially blocked,
• a heart attack (myocardial infarction), when a blood vessel in 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 cholesterol and fat levels 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 decreased adequately through diet or exercise.
In the prevention of heart and blood vessel diseases

• If you have high cholesterol levels in the blood and risk factors that promote these diseases (if you smoke, are overweight, have high blood sugar levels or high blood pressure, if you do little exercise), Pravastatina Aurobindo is used to reduce the risk of heart and blood vessel diseases and to reduce the risk that you die as a result of these diseases.
• If you have already had a stroke or if you have chest pain (unstable angina), and even if you have normal cholesterol levels, Pravastatina Aurobindo is used to reduce the risk that you have another heart attack or stroke in the future, to reduce the risk that you die as a result of these diseases.

After an organ transplant
If you have had an organ transplant and are taking medicines that stop the 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 Pravastatina Aurobindo

Do not take Pravastatina Aurobindo and tell your doctor:

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

Warnings and precautions
Check with your doctor or pharmacist before taking this medicine if:
Before taking this treatment, you must inform your doctor if you have or have had health problems
such as:

• kidney disease;
• thyroid with poor activity (hypothyroidism);
• a liver disease or alcohol problems (drink large amounts of alcohol);
• muscle disorders caused by a hereditary disease;
• muscle problems caused by another medicine that belongs to the statin group (HMG-CoA reductase inhibitors) or that belongs to the group known as fibrates (see Taking other medicines).
• Also, inform your doctor or pharmacist if you have a constant muscle weakness. Additional tests and medicines may be necessary to diagnose and treat it.
• if you have taken or are taking in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections) orally or by injection. The combination of fusidic acid and Pravastatina Aurobindo can lead to serious muscle problems (rhabdomyolysis).

If you have suffered from any of these problems, 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 the risk of side effects related to the muscles.
If you experience cramps or unexplained muscle pain during treatment, tell your doctor immediately.
During the intake of this medicine, the doctor will carefully check 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 the blood, if you are overweight and have high blood pressure.

Check with your doctor or pharmacist before taking Pravastatina Aurobindo if you:

• suffer from severe respiratory failure

Other medicines and Pravastatina Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or may take
any other medicine.
When combined with this medicine, the medicines listed below may increase the risk of
developing muscle problems(see Possible side effects). It is important that you inform
your doctor if you are already being treated with:

• a medicine that reduces cholesterol levels in the blood (fibrates, for example gemfibrozil, fenofibrate);
• a medicine that reduces the body's defenses (cyclosporine);
• a medicine that treats infections caused by bacteria (an antibiotic such as erythromycin or clarithromycin);
• another medicine that reduces cholesterol levels in the blood (nicotinic acid).
• If you need to take fusidic acid orally 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 Pravastatina Aurobindo. Taking Pravastatina Aurobindo with fusidic acid can rarely lead to weakness, tenderness or muscle pain (rhabdomyolysis). See more information regarding rhabdomyolysis in section 4.

If you are also using a medicine that reduces the level of fats in the blood (such as resins, for example
cholestyramine or colestipol) this treatment must be taken at least 1 hour before or 4 hours after the
resin, because the resin can affect the absorption of Pravastatina Aurobindo if the two
medicines are taken together.
If you are taking a medicine used to treat and prevent the formation of blood clots
called "warfarin-type medicines", tell your doctor before taking Pravastatina Aurobindo
because the use of warfarin-type medicines simultaneously with Pravastatina Aurobindo may increase
the results of blood tests used to monitor treatment with warfarin-type medicines.

Pravastatina Aurobindo with food and drink
This treatment 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 the amount of alcohol
you can drink while taking this medicine, you should discuss it with your doctor.

Pregnancy
Do not take Pravastatina Aurobindo during pregnancy. If you discover that you are pregnant, tell your
doctor immediately. Ask your doctor or pharmacist for advice before taking any
medicine.

Breastfeeding
Do not take Pravastatina Aurobindo if you intend to breastfeed, as this treatment passes into
breast milk.

Driving and operating machinery
Usually Pravastatina Aurobindo does not affect your ability to drive or operate machinery. If
you experience dizziness, blurred vision or double vision during treatment, make sure you are able to
drive and use machinery before doing so.

Pravastatina Aurobindo contains lactose.If your
doctor has diagnosed you with intolerance to
some sugars, contact him before taking this medicine.

3. How to take Pravastatina Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Your doctor will advise you on a low-fat diet that you should continue to follow throughout the
treatment period.
Pravastatina Aurobindo can be taken with or without food, with half a glass of water.

Dosage
Adults:

• In the treatment of high cholesterol and fat levels in the blood: the usual dose is 10-40 mg once a day, preferably in the evening.
• In the prevention of heart or blood vessel disease: the usual dose is 40 mg once a day, preferably in the evening.

You should not exceed the maximum daily dose of 40 mg of Pravastatina Aurobindo. Your doctor will tell you
which dose is most suitable for you.
Paediatric patients (8-18 years) with an inherited condition that increases cholesterol levels in the blood:
The usual dose is 10-20 mg once a day between 8 and 13 years of age and 10-40 mg once a day between 14 and 18 years of age.
After organ transplantation:
Your doctor may prescribe an initial dose of 20 mg once a day. The dose may be adjusted
by your doctor up to 40 mg.
If you are also taking a medicine that reduces the body's immune system (cyclosporine), your
doctor may prescribe an initial dose of 20 mg once a day. The dose may be adjusted
by your doctor up to 40 mg.
If you suffer from kidney disease or severe liver disease, your doctor may prescribe a lower dose of Pravastatina Aurobindo.
If you feel that the effect of this treatment is too strong or too weak, talk to your
doctor or pharmacist.

Duration of treatment
Your doctor will tell you how long to take Pravastatina Aurobindo. This medicine should
be used very regularly and for the entire time your doctor has advised you, even if it is
a long period. Do not stop treatment on your own.

If you take more Pravastatina Aurobindo than you should
If you have taken too many tablets or if someone accidentally ingests some tablets, contact your
doctor or the nearest hospital for assistance.

If you forget to take Pravastatina Aurobindo
If you miss a dose, simply take the next dose as usual.
Do not take a double dose to make up for a missed dose.
If you have any doubts about 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 Pravastatina Aurobindo and contact your doctor immediatelyif you develop unexplained, persistent muscle pain, tenderness, weakness or cramps, especially if you feel unwell or have a fever.
In very rare cases, muscle problems can be severe (rhabdomyolysis) and can lead to a life-threatening kidney disease.
Sudden, severe allergic reactions including swelling of the face, lips, tongue or throat which can cause great difficulty in breathing. This is a very rare reaction which can be serious when it occurs. Tell your doctor about it immediately if it happens.
The following side effects are uncommon and may affect more than 1 in 1,000 people:

• Effects on the nervous system: dizziness, fatigue, headache or sleep disturbances, including insomnia;
• Effects on vision: double or blurred vision;
• Digestive effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhoea or constipation and flatulence;
• Effects on the skin and hair: itching, pimples, hives, rash, problems with the scalp and hair (including hair loss);
• Urinary and genital effects: bladder problems (painful and more frequent urination, urination at night) and sexual difficulties;
• Effects on muscles and joints: muscle and joint pain.

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

• Effects on the nervous system: problems with sensation, including burning or tingling or numbness which may indicate nerve damage;
• Effects on the skin: a severe skin disease (lupus erythematosus-like syndrome);
• Effects on the liver: inflammation of the liver or pancreas; jaundice (recognisable by a yellowing of the skin and the whites of the eyes; very rapid death of liver cells (fulminant hepatic necrosis);
• Effects on muscles and joints: inflammation of one or more muscles leading to pain and muscle weakness (myositis or polymyositis); muscle pain or weakness, inflammation of tendons which may be complicated by tendon rupture.
• Abnormal blood tests: increased transaminases (a group of enzymes that are naturally found in the blood) which may be a sign of blood problems. Your doctor will want to carry out blood tests periodically to check these values.

Side effects with frequency not known:

• Effects on muscles and joints: persistent muscle weakness
• Dermatomyositis (a condition characterized by inflammation of the muscles and skin)

Possible side effects

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

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 through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more information on the safety of this medicine.

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

6. Package contents and other information

What Pravastatina Aurobindo contains:

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

The other ingredients are: microcrystalline cellulose, lactose monohydrate, heavy magnesium oxide,
sodium croscarmellose, yellow iron oxide (E172), povidone K30, magnesium stearate.

Description of the appearance of Pravastatina Aurobindo and package contents
Pravastatina Aurobindo 10 mg tablets:
10 mg tablet: yellow, capsule-shaped, biconvex, mottled, uncoated tablets with dented edges with a double bisect, with a “Y” imprinted 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 dented edges with a double bisect, with a “Y” imprinted 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 dented edges with a double bisect, with a “Z” imprinted on one side and “18” on the other side.
The tablet can be divided into two equal doses.
Pravastatina Aurobindo tablets are available in Polyamide / Aluminum / PVC /
Aluminum blisters and HDPE bottles with a polypropylene closure .
Packs:
Blister pack: 1, 10, 14, 20, 28, 30, 50, 60, 84, 100 and 500 tablets.
HDPE bottle pack: 30, 100, 500 and 1000 tablets (hospital pack).
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer
Aurobindo Pharma (Italia) S.r.l.
Via S. Giuseppe 102
21047 Saronno (VA)
Italy

Manufacturer responsible 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 authorised in the Member States of the European Economic Area under the
following denominations:
France: PRAVASTATINE ARROW 10 mg/ 20 mg sécable 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, tablets
Portugal: Pravastatina Aurobindo
Spain: PRAVASTATINA AUROBINDO 10 mg/ 20 mg/ 40 mg tablets
United Kingdom: Pravastatin sodium 10 mg/ 20 mg/ 40 mg Tablets