ПРАВАСТАТИНА 20 mg Таблетка

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

Pravastatina Sandoz GmbH 10 mg tablets, 20 mg tablets, 40 mg tablets

Generic medicine
Read this leaflet carefully before you start 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 Sandoz GmbH is and what it is used for
• 2. What you need to know before you take Pravastatina Sandoz GmbH
• 3. How to take Pravastatina Sandoz GmbH
• 4. Possible side effects
• 5. How to store Pravastatina Sandoz GmbH
• 6. Contents of the pack and other information

1. What is Pravastatina Sandoz GmbH and what is it used for

Pravastatina Sandoz GmbH belongs to a group of medicines called HMG-CoA reductase inhibitors (or statins), which work by reducing the production of “bad” cholesterol and increasing the levels of “good” cholesterol. Cholesterol is a lipid that can cause coronary heart disease by narrowing the blood vessels that supply blood to the heart. This condition, called hardening of the arteries or atherosclerosis, can cause chest pain (angina pectoris), heart attack (myocardial infarction) or stroke.
If you have already suffered a heart attack or suffer from chest pain at rest (unstable angina pectoris), Pravastatina Sandoz GmbH reduces the risk of another heart attack or stroke in the future, regardless of cholesterol levels.
If you have high cholesterol levels, but do not suffer from coronary disorders, Pravastatina Sandoz GmbH reduces the risk of these occurring or of a heart attack occurring in the future.
When using Pravastatina Sandoz GmbH, your doctor will recommend other precautions as part of the treatment, such as a low-fat diet, exercise and weight reduction.
If you have undergone an organ transplant and are taking medicines to prevent rejection, Pravastatina Sandoz GmbH reduces the increase in lipid levels.

2. What you need to know before taking Pravastatina Sandoz GmbH

Do not take Pravastatina Sandoz GmbH:

• if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or if there is a possibility of becoming pregnant;
• if you are breastfeeding;
• if you suffer from liver disorders;

Ask your doctor if you have any doubts whatsoever, before taking Pravastatina Sandoz GmbH.

Warnings and precautions
Tell your doctor before taking Pravastatina Sandoz GmbH if you have ever suffered from any of the
following conditions:

• kidney disease or hypothyroidism;
• problems with alcohol (i.e. if you regularly drink a large amount of alcohol);
• an inherited muscle disorder in you or in a relative;
• muscle-related side effects when taking another medicine to lower cholesterol, such as statins or fibrates;
• if you have previously had liver problems.
• if you have severe respiratory failure
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic) orally or by injection. The combination of fusidic acid and Pravastatina Sandoz GmbH may lead to serious muscle problems (rhabdomyolysis).

If you have suffered from any of these conditions, your doctor will need to perform a blood test before and
possibly during treatment with Pravastatina Sandoz GmbH, in order to assess the risk of
muscle-related side effects. A blood test may also be necessary in the case of
patients over 70 years of age.
Consult your doctor as soon as possible: discuss any concerns with him/her and follow his/her
instructions.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be necessary for the diagnosis and treatment of this condition.
While you are taking this medicine, your doctor will carefully monitor whether you have diabetes or are at risk
of developing diabetes. If you have high levels of sugar and fats in your blood, are overweight and have high
blood pressure, you are likely to be at risk of developing diabetes.

Children and adolescents
In children before puberty, the benefit/risk ratio of treatment must be carefully
evaluated by doctors before starting treatment.

Other medicines and Pravastatina Sandoz GmbH
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
If you are taking any of the following medicines, it is important that you inform your doctor:

• other medicines that lower cholesterol, called fibrates (for example gemfibrozil, fenofibrate) and nicotinic acid. The combination may increase the risk of side effects;
• medicines used to modify or adjust the immune response, for example cyclosporine. The combination may increase the risk of side effects;
• the antibiotics erythromycin or clarithromycin. The combination may result in an increased risk of developing muscle problems;
• a lipid-lowering resin-type agent, such as cholestyramine or colestipol. Generally, Pravastatina Sandoz GmbH should be taken at least one hour before or four hours after taking the resin,

because the latter may impair the absorption of Pravastatina Sandoz GmbH if the two
medicines are taken close together in time.
If you are taking a medicine used to treat and prevent blood clot formation
called a “vitamin K antagonist”, tell your doctor before taking Pravastatina Sandoz
GmbH, as the use of vitamin K antagonists together with Pravastatina Sandoz GmbH may increase the
results of blood tests used to monitor treatment with vitamin K antagonists.

If you need to take oral fusidic acid to treat a bacterial infection, it is
necessary to temporarily stop using this medicine. Your doctor will tell you when it is
safe to resume taking Pravastatina Sandoz GmbH. Taking Pravastatina Sandoz
GmbH with fusidic acid can rarely cause muscle weakness, soreness or pain
(rhabdomyolysis). You can find more information about rhabdomyolysis in section 4.
Pravastatina Sandoz GmbH with food, drinks and alcohol
Pravastatina Sandoz GmbH can be taken with or without food. Tell your doctor if you regularly consume
large amounts of alcohol.
If you have any doubts about this, follow your doctor's instructions.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor
or pharmacist for advice before taking this medicine.
You must not take Pravastatina Sandoz GmbH during pregnancy. Doctors will pay particular
attention when prescribing the medicine to young women who may become pregnant and will explain
adequately the potential risks associated with pravastatin therapy during pregnancy.
If you are planning to become pregnant or are already pregnant, stop taking
Pravastatina Sandoz GmbH and inform your doctor immediately (see section 2: Do not take
Pravastatina Sandoz GmbH).

You must not take Pravastatina Sandoz GmbH during breastfeeding, because Pravastatina Sandoz GmbH
passes into breast milk (see section 2: Do not take Pravastatina Sandoz GmbH).

Driving and using machines
Generally, Pravastatina Sandoz GmbH does not affect the ability to drive or operate
machinery; however, if you experience symptoms such as dizziness, blurred or double vision, make sure you are
able to drive and use machinery before performing these activities.

Pravastatina Sandoz GmbH contains lactose
If your doctor has diagnosed you with intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take Pravastatina Sandoz GmbH

Always take Pravastatina Sandoz GmbH following strictly the instructions of your doctor or pharmacist; if you have any doubts, consult your doctor or pharmacist. The tablet can be divided into equal doses.

Adults
The normal dose of Pravastatina Sandoz GmbH is 10-40 mg once a day, preferably in the evening. Pravastatina Sandoz GmbH can be taken with or without food, with half a glass of water. The tablet can be divided into equal doses.

Use in children and adolescents (8 to 18 years of age) with heterozygous familial hypercholesterolemia
Use in children and adolescents (8-13 years of age): the recommended dosage range is 10-20 mg once a day.
Use in children and adolescents (14-18 years of age): the recommended dosage range is 10-40 mg once a day.

Renal and hepatic insufficiency
In patients with renal or hepatic insufficiency, the normal dose is 10 mg once a day.

After organ transplantation
The usual starting dose is 20 mg once a day. The dose may be increased by your doctor up to 40 mg.

Other medicines
Generally, Pravastatina Sandoz GmbH should be taken at least one hour before or four hours after taking cholestyramineor colestipol.
The usual starting dose for those taking medicines that regulate or modify the immune response (e.g.

cyclosporine) is 20 mg once a day. The dose may be increased by your doctor up to 40 mg.
If you feel that the effects of Pravastatina Sandoz GmbH are too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatina Sandoz GmbH than you should
If you have taken an excessive number of tablets, or if someone else has accidentally swallowed some tablets, consult your doctor or the nearest hospital healthcare staff.

If you forget to take Pravastatina Sandoz GmbH
If you forget a dose, do not worry. Simply take the next dose as usual. Do not take a double dose to make up for a forgotten dose.

If you stop taking Pravastatina Sandoz GmbH
Always inform your doctor if you wish to stop treatment.
If you have any further questions on 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.
manifest.

Side effects that occur very rarely (may affect up to 1 in 10,000 patients)

Contact your doctor as soon as possible and stop taking Pravastatina Sandoz GmbHif
you develop any unexplained or persistent muscle pain, tenderness, weakness or cramps,
especially if accompanied by general malaise or a high temperature. In very rare cases, muscle
problems can be severe (rhabdomyolysis) and can lead to serious and potentially life-threatening
kidney disease.

Stop taking Pravastatina Sandoz GmbH and consult your doctor immediatelyif
you experience symptoms such as:

• swelling of the face, tongue or throat;
• difficulty swallowing;
• hives and difficulty breathing.
• dizziness These are symptoms of serious allergic reactions (angioedema, anaphylaxis) that require immediate treatment, usually in hospital

Other side effects:

Uncommon side effects(may affect up to 1 in 100 patients):

• dizziness, headache, sleep disturbances, insomnia
• visual disturbances, such as blurred or double vision
• stomach and intestinal disorders, such as indigestion, heartburn, stomach pain or discomfort, nausea, vomiting, diarrhea or constipation and flatulence
• skin reactions such as itching and rash, hives or problems with the scalp and hair, including hair loss
• urinary problems (painful or more frequent urination, needing to urinate at night)
• sexual dysfunction
• fatigue
• muscle and joint pain.

Very rare side effects(may affect up to 1 in 10,000 patients):

• problems with the sense of touch, including a burning/tingling or numbness sensation, which may indicate damage to the nerve endings
• an allergic condition causing joint pain, rash and fever (lupus erythematosus)
• inflammation of the liver (which can cause yellowing of the skin or whites of the eyes) or the pancreas (which can cause stomach pain)
• muscle pain or weakness (myopathy), muscle inflammation (myositis, polymyositis)
• isolated cases of tendon disorders, sometimes complicated by rupture
• changes in blood tests: increased transaminases (a group of enzymes naturally present in the blood) which may be a sign of liver problems. Your doctor may decide to perform periodic tests to check these values.

Side effects with unknown frequency(frequency cannot be estimated on the basis of the available
data)

• persistent muscle weakness
• dermatomyositis (a condition characterized by inflammation of the muscles and skin)

The following side effects have been reported with some statins (medicines of the same type):

• 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 levels of sugars and fats in your blood, are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting of side effects
Tell your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.agenziafarmaco.gov/it/it/resonsabili.

5. How to store Pravastatina Sandoz GmbH

Keep this medicine out of the sight and reach of children.
Store in the original packaging, to protect it from moisture.
Do not use Pravastatina Sandoz GmbH after the expiry date, which is stated on the packaging, after the
wording 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. Package contents and other information

What Pravastatina Sandoz GmbH contains
The active ingredient is pravastatin sodium.

10 mg tablets:
Each tablet contains 10 mg of pravastatin sodium

20 mg tablets:
Each tablet contains 20 mg of pravastatin sodium

40 mg tablets:
Each tablet contains 40 mg of pravastatin sodium
The excipients are: microcrystalline cellulose, lactose monohydrate, anhydrous dibasic sodium phosphate,
sodium croscarmellose, sodium lauryl sulfate, povidone, iron oxide (brown) E172, anhydrous colloidal silica,
magnesium stearate.

Description of the appearance of Pravastatina Sandoz GmbH and package contents
Pravastatina Sandoz GmbH 10 mg tablets are presented in the form of light brown, mottled,
oval tablets, with a score line on both sides and imprinted with “P 10” on one side.
Pravastatina Sandoz GmbH 20 mg tablets are presented in the form of light brown, mottled,
oval tablets, with a score line on both sides and imprinted with “P 20” on one side.
Pravastatina Sandoz GmbH 40 mg tablets are presented in the form of light brown, mottled,
oval tablets, with a score line on both sides and imprinted with “P 40” on one side.
Alu/Alu blisters
10 mg: 1, 7, 10, 14, 20, 21, 28, 30, 50, 60, 98, 100, 100x1
20 mg: 1, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 98, 100, 100x1
40 mg: 1, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 98, 100, 100x1
Not all pack sizes may be marketed

Marketing Authorisation Holder
Sandoz GmbH - Biochemiestrasse 10 - A-6250 Kundl – Austria

Representative for Italy:
Sandoz Spa – Largo U. Boccioni, 1 – 21040 Origgio (VA) – Italy

Manufacturer
Lek Pharmaceuticals d.d. - Verovskova 57 - 1526 Ljubljana – Slovenia
Salutas Pharma GmbH - Otto-von-Guericke-Allee 1 – 39179 Barleben – Germany
Salutas Pharma GmbH - Dieseltrasse 5 – 10 839 Gerlingen - Germany
Lek SA ul. Domaniewska 50 C – 02 - 672 Warszawa - Poland

This medicinal product is authorised in the member states of the EEA under the following designations:
Belgium: Pravastatine Sandoz 20 mg tabletten
Pravastatine Sandoz 30 mg tabletten
Pravastatine Sandoz 40 mg tabletten
Denmark: Pravastatin Sandoz
Finland: Pravastatin Sandoz 20 mg tabletti
Pravastatin Sandoz 40 mg tabletti
France: PRAVASTATINE GNR DEVELOPPEMENT 10mg, comprimé sécable
PRAVASTATINE GNR DEVELOPPEMENT 20mg, comprimé sécable
PRAVASTATINE GNR DEVELOPPEMENT 40mg, comprimé
Germany: Pravastatin Sandoz10 mg Tabletten
Pravastatin Sandoz 20 mg Tabletten
Pravastatin Sandoz 40 mg Tabletten
Italy: PRAVASTATINA Sandoz GmbH 10 mg compresse
PRAVASTATINA Sandoz GmbH 20 mg compresse
PRAVASTATINA Sandoz GmbH 40 mg compresse
Netherlands: Pravastatinenatrium Sandoz 10
Pravastatinenatrium Sandoz 20
Pravastatinenatrium Sandoz 40
Norway: Pravastatin Sandoz 20 mg Tabletter
Pravastatin Sandoz 40 mg Tabletter
Portugal: Pravastatina Sandoz
Spain: PRAVASTATINA SANDOZ 10 MG COMPRIMIDOS EFG
PRAVASTATINA SANDOZ 20 MG COMPRIMIDOS EFG
PRAVASTATINA SANDOZ 40 MG COMPRIMIDOS EFG
Slovenia: Pravastatin Lek 10 mg tablete
Pravastatin Lek 20 mg tablete
Pravastatin Lek 40 mg tablete
Sweden: Pravastatin Sandoz 20 mg Tabletter
Pravastatin Sandoz 40 mg Tabletter
United Kingdom: Pravastatin sodium 10 mg tablets
Pravastatin sodium 20 mg tablets
Pravastatin sodium 40 mg tablets