Patient Information Leaflet

PRAVASTATINA DOC Generici 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What PRAVASTATINA DOC Generici is and what it is used for
What you need to know before taking PRAVASTATINA DOC Generici
How to take PRAVASTATINA DOC Generici
Possible side effects
How to store PRAVASTATINA DOC Generici
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 cholesterol production in your body.

If you have already had a heart condition, pravastatin reduces the risk of a second heart attack or stroke, reduces the need for heart surgery, and slows further narrowing of your arteries.
If you do not have a heart condition but have high cholesterol levels, pravastatin reduces the risk of having a heart attack or needing heart surgery. Pravastatin must always be used together with a low-fat diet.
If you have had an organ transplant and are taking medication to prevent rejection of the transplanted organ by your body, pravastatin helps reduce increases 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 to any of the other ingredients of this medicine (listed in section 6).
if you are breastfeeding.
if you are pregnant or there is a possibility that you could become pregnant.
if you have or have had liver problems.

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

you have kidney problems
you have thyroid problems
you have previously had muscle problems with a statin or a fibrate
you have a personal or family history of hereditary muscle disorders
you drink large amounts of alcohol or have a history of alcohol abuse
you have severe respiratory insufficiency
you are taking or have taken in 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 PRAVASTATINA DOC Generici may lead to serious muscle problems (rhabdomyolysis)

Inform your doctor or pharmacist if any of the conditions listed above apply to you. If you have suffered from any of these problems, your doctor will need to perform a blood test before and possibly during treatment with pravastatin, to check whether you are at risk of experiencing muscle-related 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 whether you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.
In addition, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be needed to diagnose and treat this condition.

Children
The use of PRAVASTATINA DOC Generici is recommended in children only when they have an inherited condition called heterozygous familial hypercholesterolemia (which causes high cholesterol levels 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 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 taking PRAVASTATINA DOC Generici. Taking PRAVASTATINA DOC Generici with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). You can find further information on rhabdomyolysis in section 4.
If you are taking a medicine used to treat and prevent blood clots called a “vitamin K antagonist”, talk to your doctor before taking PRAVASTATINA DOC Generici, as using vitamin K antagonists together with PRAVASTATINA DOC Generici may 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 medicines in this category include bezafibrate, ciprofibrate, fenofibrate, and gemfibrozil
Cyclosporine, an immunosuppressant
The antibiotics erythromycin or clarithromycin
Lipid-lowering resin-like agents such as cholestyramine or colestipol. PRAVASTATINA DOC Generici should be taken at least one hour before or four hours after taking the resin; this is because the resin may affect the absorption of pravastatin if both medicines 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 you may be pregnant, plan to become pregnant, or are breastfeeding with breast milk, consult your doctor or pharmacist before taking this medicine.

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

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

3. How to take PRAVASTATINA DOC Generici

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets whole with half a glass of water. It does not matter whether you take the tablets before or during meals. However, it is better to take pravastatin in the evening before going to bed, since your body produces the most cholesterol while you are sleeping, and pravastatin works best when taken at night.
Adults and adolescents (14–18 years): The recommended dose is 10–40 mg once daily in the evening.
Children (8–13 years): with heterozygous familial hypercholesterolemia. The recommended dose is 10–20 mg once daily.
Your doctor may perform a blood test after 4 weeks to check whether 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 emergency department. Remember to bring this leaflet or the remaining tablets with you to the hospital.
If you forget to take PRAVASTATINA DOC Generici
If you have forgotten to take a tablet, do not worry. Take your usual dose at the next scheduled time. Do not take a double dose to make up for the missed dose.
If you stop taking PRAVASTATINA DOC Generici
It is important that you continue taking the tablets until your doctor tells you otherwise. Your doctor will ask you to return for regular check-ups. Attend your appointments with your doctor even if you feel well.
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 gets them.
Contact your doctor immediately if:

You notice signs of a severe allergic reaction including localized swelling of the face, lips and/or tongue, or severe skin rash.
You experience unexplained muscle pain, tenderness, weakness or cramps associated with dark, red or cola-coloured 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, diarrhoea or constipation and flatulence
Skin reactions such as itching and rashes, or hair and scalp problems including hair loss, bladder problems (frequent or painful urination, need to urinate at night) and sexual difficulties
Tiredness.

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

Sensory problems, including burning/tingling sensations or numbness
Liver problems 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 from the available data )

Memory loss
Depression
Breathing problems including persistent cough and/or shortness of breath or fever
Diabetes: frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥5.6 mmol/L, BMI >30 kg/m², elevated 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)
Ongoing muscle weakness.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via 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 below 25°C.
Store the tablets in the original packaging. Remove them from the packaging only when it is time to take the medicine.

Do not use this medicine after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

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

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

Description of the appearance of PRAVASTATINA DOC Generici and contents of the pack
10 mg: light pink, round, unmarked tablet, imprinted with ‘APO’ on one side and ‘PRA’ above ‘10’ on the other side.
20 mg: tablet from almost white to light yellow, round, unmarked, imprinted with ‘APO’ on one side and ‘PRA’ above ‘20’ on the other side.
40 mg: light green, round, unmarked tablet, imprinted with ‘APO’ 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 Milano, Italy

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 European Economic Area Member States under the following names:
Ireland: Pravat
Italy: PRAVASTATINA DOC Generici
Netherlands: Pravastatinenatrium Apotex
Spain: Pravastatina Cinfa