PRAVASTATINA 10 mg Tabletka

Treść ulotki

1. PRAVASTATINA DOC Generici 10 mg Tablets, 20 mg Tablets, 40 mg Tablets
   1. What PRAVASTATINA DOC Generici is and what it is used for
   2. What you need to know before taking PRAVASTATINA DOC Generici
   3. How to take PRAVASTATINA DOC Generici
   4. Possible side effects
   5. How to store PRAVASTATINA DOC Generici
   6. Contents of the pack and other information

PRAVASTATINA DOC Generici 10 mg Tablets, 20 mg Tablets, 40 mg Tablets

Equivalent Medicinal Product
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 DOC Generici is and what it is used for
• 2. What you need to know before you take PRAVASTATINA DOC Generici
• 3. How to take PRAVASTATINA DOC Generici
• 4. Possible side effects
• 5. How to store PRAVASTATINA DOC Generici
• 6. Contents of the pack and other information

1. What PRAVASTATINA DOC Generici is and what it is used for

Pravastatin belongs to a group of medicines called HMG-CoA reductase inhibitors, also known as statins, which work by reducing the production of cholesterol in your body.

• If you have already had heart disease, pravastatin reduces the risk of a second heart attack or stroke, reduces the need for heart surgery, and reduces any further narrowing of your arteries.
• If you do not have heart disease but have high cholesterol levels, pravastatin reduces the risk that you will have a heart attack or need heart surgery. Pravastatin should always be used in conjunction with a low-fat diet.
• If you have had an organ transplant and are taking a medicine to prevent your body from rejecting the transplant, pravastatin reduces the increase in lipid levels.

2. What you need to know before taking PRAVASTATINA DOC Generici

Do not take PRAVASTATINA DOC Generici:

• if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6).
• if you are breastfeeding.
• if you are pregnant or if there is a possibility that you may become pregnant.
• if you have or have had problems with your liver.

Warnings and precautions
Talk to your doctor or pharmacist before taking PRAVASTATINA DOC Generici if:

• you have problems with your kidneys
• you have problems with your thyroid
• you have had muscle problems in the past while taking a statin or a fibrate
• you have a personal or family history of hereditary muscle problems
• you drink a large amount of alcohol or have a history of alcohol abuse
• you have severe respiratory failure and are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and PRAVASTATINA DOC Generici can lead to serious muscle problems (rhabdomyolysis)

Inform your doctor or pharmacist if any of the above conditions apply to you. If you have suffered from
any of these problems, your doctor will need to have you undergo a blood test before
and possibly during treatment with pravastatin, to check if you are at risk of having
muscle side effects. You may also need this blood test if you are over
70 years of age.
During treatment with this medicine, your doctor will carefully monitor that you do not
have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you
have high levels of sugars and fats in your blood, if you are overweight and have high
blood pressure.
Also, inform your doctor or pharmacist if you have constant muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.

Children
The use of PRAVASTATINA DOC Generici is recommended in children only when they have a
hereditary condition called heterozygous familial hypercholesterolemia (which leads to high levels of
cholesterol in the blood).

Other medicines and PRAVASTATINA DOC Generici
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

If you need to take fusidic acid by mouth to treat a bacterial infection you will
momentarily have to stop taking this medicine. Your doctor will then tell you when it is
safetorestarttakingPRAVASTATINADOCGenerici.Taking
PRAVASTATINA DOC Generici with fusidic acid can lead in rare cases to weakness,
sensitivityormuscle pain (rhabdomyolysis). You can find more information about
rhabdomyolysis in section 4.
If you are taking a medicine used to treat and prevent blood clot formation
called “vitamin K antagonist”, talk to your doctor before taking PRAVASTATINA
DOC Generici because the use of vitamin K antagonists together with PRAVASTATINA DOC
Generici can increase the results of blood tests used to monitor treatment with
vitamin K antagonists.
In particular, inform your doctor if you are currently taking any of the following medicines:

• Fibrates, examples of drugs in this category include bezafibrate, ciprofibrate, fenofibrate and gemfibrozil
• Cyclosporine, an immunosuppressant
• The antibiotics erythromycin or clarithromycin
• Lipid-lowering resins such as cholestyramine or colestipol. PRAVASTATINA DOC Generici must be taken at least one hour before or four hours after you have taken the resin; this is because the resin can affect the absorption of pravastatin if the two drugs are taken too close together.

Pregnancy and breastfeeding
You must not use PRAVASTATINA DOC Generici during pregnancy and/or breastfeeding.
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
PRAVASTATINA DOC Generici has no effects on the ability to drive and use
machinery.
However, if you experience side effects such as dizziness, blurred or double vision, your
ability to drive or use machines may be impaired.

PRAVASTATINA DOC Generici contains lactose monohydrate
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take PRAVASTATINA DOC Generici

Take this medicine following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
Swallow the tablets whole with half a glass of water. It does not matter if you take the tablets
before or during meals. However, it is better to take pravastatina in the evening before going to bed,
because your body produces the largest amount of cholesterol when you sleep and pravastatina
works best when taken at night.

Adults and adolescents(14-18 years): The recommended dose is 10-40 mg once a day in the evening.

Children(8-13 years): with heterozygous familial hypercholesterolemia. The recommended dose is 10-20
mg once a day.
Your doctor may perform a blood test after 4 weeks to check that your
cholesterol has decreased.

If you take more PRAVASTATINA DOC Generici than you should
If you have accidentally taken too many tablets, inform your doctor immediately, or go to the nearest
hospital.

If you forget to take PRAVASTATINA DOC Generici
If you have forgotten to take a tablet, do not worry. Take the normal dose when it is
time for the next one. Do not take a double dose to make up for a missed dose.

If you stop taking PRAVASTATINA DOC Generici
It is important that you continue to take the tablets until your doctor tells you to
otherwise. The doctor will tell you to return for regular check-ups. Attend your
doctor's appointment even if you feel well.
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.

Inform your doctor immediately:

• If you notice the onset of a severe allergic reaction that includes localized swelling of the face, lips and/or tongue, severe skin rash.
• If you experience unexplained muscle pain, tension, weakness or cramps accompanied by dark, red or cola-colored urine (rhabdomyolysis).

These side effects occur very rarely.

Uncommon (may affect up to 1 in 100 people)

• Dizziness, headache, sleep disorders including insomnia and nightmares
• Vision problems, such as blurred or double vision
• Stomach and intestinal problems such as indigestion, nausea, diarrhea or constipation and flatulence
• Skin reactions such as itching and rashes, or problems with hair and scalp, including hair loss, bladder problems (frequent or painful urination, needing to urinate at night) and sexual difficulties
• Fatigue.

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

• Problems with touch, including burning/tingling or numbness
• Liver disorders such as jaundice (yellowing of the skin and/or eyes) and inflammation (swelling) of the liver or pancreas
• Muscle and joint pain.

Not known(frequency cannot be estimated based on available data)

• Memory loss
• Depression
• Breathing problems including persistent cough and/or shortness of breath or fever
• Diabetes: the frequency will depend on the presence or absence of risk factors (fasting blood glucose at 5.6 mmol/L, BMI >30 kg/m², high triglycerides, history of hypertension). Your doctor will monitor you during treatment with this medicine. Dermatomyositis (a condition characterized by inflammation of the muscles and skin)
• Persistent muscle weakness.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. 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 DOC Generici

• Keep this medicine out of the sight and reach of children.
• Store at a temperature below 25°C.
• Keep the tablets in the original package. Only remove them when it is time to take the medicine.

Do not use this medicine after the expiry date which is stated on the box and blister after
“EXP”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your
pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What PRAVASTATINA DOC Generici contains
Pravastatin is available in three different dosages: 10 mg, 20 mg and 40 mg.

• The active ingredient is pravastatin sodium.
• The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, red iron oxide (E172) (for the 10 mg dosage), yellow iron oxide (E172) (for the 20 mg and 40 mg dosages) and brilliant blue FCF aluminium lake (E133) (for the 40 mg dosage).

Description of the appearance of PRAVASTATINA DOC Generici and contents of the pack
10 mg: light pink, round tablet, not scored, with the writing ‘APO’ imprinted on one side and
‘PRA’ above ‘10’ on the other side.
20 mg: almost white to light yellow, round tablet, not scored, with the writing ‘APO’
imprinted on one side and ‘PRA’ above ‘20’ on the other side.
40 mg: light green, round tablet, not scored, with the writing ‘APO’ imprinted on one side and
‘PRA’ above ‘40’ on the other side.
The tablets are available in PVC/PVAC/Aluminium blisters containing 4, 10, 14, 20, 28, 30,
50, 56, 98, 100 and 200 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DOC Generici S.r.l., Via Turati 40, 20121 Milan

Manufacturers
Apotex Nederland BV, Archimedesweg 2, 2333 CN Leiden, The Netherlands
Laboratorios Cinfa, S.A., Crta. Olaz Chipi, 10, Polígono Areta, 31620 Huarte Pamplona, Navarra,
Spain
S.I.I.T. S.r.l., Via Ariosto 50/60, 20090 Trezzano sul Naviglio (MI), Italy
Lamp San Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero S/S Modena, Italy

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Ireland: Pravat
Italy: PRAVASTATINA DOC Generici
Netherlands: Pravastatinenatrium Apotex
Spain: Pravastatina Cinfa