Patient Information Leaflet

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

Generic medicine
Please 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Pravastatina Sandoz GmbH is and what it is 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 levels of "good" cholesterol. Cholesterol is a lipid that can cause coronary heart disease by narrowing the blood vessels supplying blood to the heart. This condition, known as hardening of the arteries or atherosclerosis, can lead to chest pain (angina pectoris), heart attack (myocardial infarction), or stroke.
If you have already had a heart attack or suffer from chest pain at rest (unstable angina pectoris), Pravastatina Sandoz GmbH reduces the risk of future heart attacks or stroke, regardless of cholesterol levels.
If you have high cholesterol levels but do not have coronary heart disease, Pravastatina Sandoz GmbH reduces the risk of developing such conditions or having a heart attack in the future.
When taking Pravastatina Sandoz GmbH, your doctor will recommend additional measures as part of your treatment, such as a low-fat diet, physical exercise, and weight reduction.
If you have undergone an organ transplant and are taking medicines to prevent rejection, Pravastatina Sandoz GmbH helps reduce the increase in lipid levels.

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

Do not take Pravastatin Sandoz GmbH:

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

Ask your doctor if you have any doubts whatsoever before taking Pravastatin Sandoz GmbH.
Warnings and precautions
Inform your doctor or pharmacist before taking Pravastatin Sandoz GmbH if you have ever had any of the following conditions:

kidney disease or underactive thyroid;
problems related to alcohol (i.e. if you regularly drink large amounts of alcoholic beverages);
a hereditary muscle disorder in yourself or in a blood relative;
muscle-related side effects when taking another medicine used 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 within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used for bacterial infection). The combination of fusidic acid and Pravastatin Sandoz GmbH can lead to serious muscle problems (rhabdomyolysis).

If you have had any of these conditions, your doctor should perform a blood test before and possibly during treatment with Pravastatin Sandoz GmbH to assess the risk of muscle-related side effects. Blood tests may also be necessary for patients over 70 years of age.
Contact your doctor as soon as possible: discuss any concerns with them and follow their advice.
Additionally, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and treatments may be needed to diagnose and manage this condition.
While 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 at increased risk of developing diabetes.
Children and adolescents
In prepubescent children, the risk-benefit ratio of treatment must be carefully evaluated by doctors before starting therapy.
Other medicines and Pravastatin Sandoz GmbH
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
If you are taking any of the following medicines, it is important that you inform your doctor:

other cholesterol-lowering medicines called fibrates (e.g. gemfibrozil, fenofibrate) or nicotinic acid. The combination may increase the risk of side effects;
medicines used to modify or suppress the immune response, such as ciclosporin. The combination may increase the risk of side effects;
the antibiotics erythromycin or clarithromycin. The combination may increase the risk of developing muscle problems;
a lipid-lowering resin-type agent such as cholestyramine or colestipol. Pravastatin Sandoz GmbH should generally be taken at least one hour before or four hours after taking the resin,

since the resin may interfere with the absorption of Pravastatin Sandoz GmbH if both are taken too close together.
If you are taking a medicine used to treat and prevent blood clots known as a “vitamin K antagonist”, inform your doctor before taking Pravastatin Sandoz GmbH, as using vitamin K antagonists together with Pravastatin 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, you must temporarily stop taking this
medicine. Your doctor will tell you when it is safe to restart taking Pravastatin Sandoz GmbH. Taking
Pravastatin Sandoz GmbH together with fusidic acid may rarely cause muscle weakness, tenderness or
pain (rhabdomyolysis). More information about rhabdomyolysis can be found in section 4.
Pravastatin Sandoz GmbH with food, drinks and alcohol
Pravastatin Sandoz GmbH can be taken with or without food. Inform your doctor if you regularly consume large amounts of alcohol.
If you have any doubts about this, follow your doctor’s advice.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, inform your doctor or pharmacist before taking this medicine.
You must not take Pravastatin Sandoz GmbH during pregnancy. Doctors will exercise particular caution when prescribing this medicine to young women who could become pregnant and will adequately explain the potential risks associated with pravastatin therapy during pregnancy.
If you plan to become pregnant or if you are already pregnant, stop taking Pravastatin Sandoz GmbH and inform your doctor immediately (see section 2: Do not take Pravastatin Sandoz GmbH).
You must not take Pravastatin Sandoz GmbH while breastfeeding, as Pravastatin Sandoz GmbH passes into breast milk (see section 2: Do not take Pravastatin Sandoz GmbH).
Driving and using machines
Generally, Pravastatin Sandoz GmbH has no effect on the ability to drive or use machinery; however, if you experience symptoms such as dizziness, blurred or double vision, make sure you are fit to drive or operate machinery before engaging in such activities.
Pravastatin Sandoz GmbH contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Pravastatin Sandoz GmbH

Always take Pravastatin Sandoz GmbH exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist. The tablet can be divided into equal doses.
Adults
The usual dose of Pravastatin Sandoz GmbH is 10–40 mg once daily, preferably in the evening. Pravastatin 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 (aged 8 to 18 years) with heterozygous familial hypercholesterolemia
Use in children and adolescents (8–13 years of age): the recommended dosage range is 10–20 mg once daily.
Use in children and adolescents (14–18 years of age): the recommended dosage range is 10–40 mg once daily.
Renal and hepatic impairment
In patients with renal or hepatic impairment, the usual dose is 10 mg once daily.
After organ transplantation
The usual starting dose is 20 mg once daily. Your doctor may increase the dose up to 40 mg.
Other medicines
Pravastatin Sandoz GmbH should generally be taken at least one hour before or four hours after taking cholestyramine or colestipol.
The usual starting dose for patients taking medicines that regulate or modify the immune response (e.g. cyclosporine) is 20 mg once daily. Your doctor may increase the dose up to 40 mg.
If you think that the effects of Pravastatin Sandoz GmbH are too strong or too weak, consult your doctor or pharmacist.
If you take more Pravastatin Sandoz GmbH than you should
If you have taken too many tablets, or if someone else has accidentally ingested any tablets, consult your doctor or the medical staff at the nearest hospital.
If you forget to take Pravastatin Sandoz GmbH
If you miss 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 Pravastatin Sandoz GmbH
Always inform your doctor if you wish to discontinue treatment.
If you have any further 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 everybody will get them.

Side effects occurring very rarely (may affect up to 1 in 10,000 patients)
Contact your doctor as soon as possible and stop taking Pravastatin Sandoz GmbH if you develop any unexplained or persistent muscle pain, tenderness, weakness or cramps, especially if associated with general malaise or fever. In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to severe and potentially life-threatening kidney disease.

Stop taking Pravastatin Sandoz GmbH and consult your doctor immediately if you experience symptoms such as:

swelling of the face, tongue or throat;
difficulty swallowing;
hives and breathing difficulties;
dizziness.

These are symptoms of serious allergic reactions (angioedema, anaphylaxis) which must be treated immediately, usually in a hospital setting.

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

dizziness, headache, sleep disorders, insomnia
visual disturbances, such as blurred or double vision
stomach and intestinal problems, such as indigestion, heartburn, stomach pain or discomfort, nausea, vomiting, diarrhoea or constipation and flatulence
skin reactions such as itching and rash, hives or scalp and hair problems, including hair loss
urinary problems (painful or more frequent urination, need to urinate during the 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 sensation or numbness, which may indicate nerve damage
an allergic condition causing joint pain, skin rash and fever (lupus erythematosus)
inflammation of the liver (which may cause yellowing of the skin or whites of the eyes) or of the pancreas (which may cause stomach pain)
muscle pain or weakness (myopathy), inflammation of the muscles (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 carry out periodic tests to monitor these values.

Side effects with unknown frequency (frequency cannot be estimated from the available data):

persistent muscle weakness
dermatomyositis (a condition characterised 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 sugar 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
If you get any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov/it/it/responsabili.

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 word EXP.
The expiry date refers to the last day of that month.
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 Sandoz GmbH contains
The active substance 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 other ingredients (excipients) are: microcrystalline cellulose, monohydrate lactose, anhydrous dibasic sodium phosphate, croscarmellose sodium, sodium lauryl sulfate, povidone, iron oxide (brown) E172, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Pravastatina Sandoz GmbH and contents of the pack
Pravastatina Sandoz GmbH 10 mg tablets are light brown, mottled, oval tablets, scored on both sides with "P 10" engraved on one side.
Pravastatina Sandoz GmbH 20 mg tablets are light brown, mottled, oval tablets, scored on both sides with "P 20" engraved on one side.
Pravastatina Sandoz GmbH 40 mg tablets are light brown, mottled, oval tablets, scored on both sides with "P 40" engraved on one side.

Alu/Alu blister packs
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 Authorization Holder
Sandoz GmbH - Biochemiestrasse 10 - A-6250 Kundl – Austria
Representative in Italy:
Sandoz S.p.A. – 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 - Dieselstrasse 5 – 10 839 Gerlingen - Germany
Lek SA ul. Domaniewska 50 C – 02 - 672 Warszawa - Poland

This medicinal product has been authorised in the EEA Member States under the following names:
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 Sandoz 10 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

This leaflet was last approved on