Package Insert: Information for the User

Pravastatina Teva 20 mg Tablets EFG

Pravastatina Sodium

Read this package insert carefully before you start taking this medicine, because

it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Pravastatina Teva

3. How to take Pravastatina Teva

4. Possible side effects

5. Storage of Pravastatina Teva

6. Contents of the pack and additional information

Pravastatina belongs to a group of medications known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and as a result, reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, obstructing them.

This situation is known as hardening of the arteries or atherosclerosis and can lead to:

• Chest pain (angina pectoris), when a coronary artery is partially obstructed.
• Heart attack, when a coronary artery is completely obstructed.
• Stroke, when a cerebral artery is completely obstructed.

This medication is indicated in three situations:

In the treatment of high levels of cholesterol and fats in the blood

Pravastatina is indicated to reduce high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

Prevention of heart and blood vessel diseases

• If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little exercise), Pravastatina is indicated to reduce the risk of suffering a heart and blood vessel problem.
• If you have already suffered a stroke or have unstable chest pain (angina), even with normal cholesterol levels, Pravastatina is indicated to reduce the risk of suffering another heart attack or stroke in the future.

After an organ transplant

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Pravastatina is indicated to reduce elevated levels of blood fat.

Do not take Pravastatina Teva:

• If you are allergic to pravastatina or any of the other components of this medication (listed in section 6).
• If you are pregnant, planning to become pregnant, or breastfeeding (see Pregnancy and breastfeeding).
• If you have any liver disease (active liver disease).
• If several blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and precautions

Your doctor will perform a blood test before starting to take Pravastatina and if you have any liver symptoms or problems during treatment. This is to check if your liver is functioning properly.

Your doctor may also need to perform a blood test after starting treatment with Pravastatina to check your liver function.

Pravastatina may increase the risk of muscle side effects in some patients, which can cause muscle pain, sensitivity, and weakness. Your doctor may perform blood tests to check your muscle state before and after starting treatment with pravastatina.

Consult with your doctor or pharmacist BEFORE taking pravastatina if you experience any of the following situations, as you may be at a higher risk for muscle side effects:

• If you have kidney disease.
• If you have a less active thyroid gland (hypothyroidism).
• If you have liver disease or problems with alcohol (drinking large amounts of alcohol).
• If you have a muscle disorder caused by a hereditary muscle disorder or family history of the disease.
• If you have had muscle problems caused by another medication that belongs to the group of statins (medications that inhibit HMG-CoA reductase) or one that belongs to the group known as fibrates (see Taking other medications).
• If you are over 70 years old.
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Some medications may increase your risk of muscle-related side effects, see “Use of Pravastatina Teva with other medications”.

If you are taking or have taken within the last 7 days orally or by injection a medication called fusidic acid (a medication for bacterial infections), your combination with Pravastatina may cause severe muscle problems (rhabdomyolysis).

If you have experienced any of these problems, or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to evaluate the risk of you experiencing muscle side effects.

If you experience unexplained muscle cramps or muscle pain during treatment, inform your doctor immediately. Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

If you have diabetes or are at risk of developing it, your doctor will perform a careful check during treatment with this medication. You may be at risk of developing diabetes if you have high blood sugar and fat levels, obesity, and hypertension.

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Statins, such as pravastatina, may sometimes cause lung disease, especially when used for a long period of time. Stop taking pravastatina and consult your doctor if you experience shortness of breath, dry and non-productive cough, and overall health deterioration, with fatigue, weight loss, and fever.

Use of Pravastatina Teva with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

The administration of Pravastatina with any of the following medications may increase the risk of muscle problems:

• Fibrates, e.g. gemfibrozil, fenofibrate (medication that lowers cholesterol levels in the blood).
• Ciclosporin (medication that reduces the body's defenses).
• Antibiotics such as erythromycin or clarithromycin (medications that treat bacterial infections).
• Colchicine (a medication used to treat gout)
• Nicotinic acid (a medication used to treat high cholesterol levels in the blood)
• Rifampicin (a medication used to treat tuberculosis infection)
• Lenalidomide (a medication used to treat a type of blood cancer called multiple myeloma).

If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will indicate when it is safe to start treatment with pravastatina. Taking pravastatina with fusidic acid may rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information about rhabdomyolysis in section 4.

If you are taking a medication used to prevent and treat blood clots called “vitamin K antagonist”, inform your doctor before taking pravastatina because the use of vitamin K antagonists concomitantly with pravastatina may increase the results of the blood tests used to monitor treatment with vitamin K antagonist.

If you are also using a medication to lower your fat levels in the blood (of the type resin such as cholestyramine or colestipol), this treatment 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 Pravastatina if these two medications are taken simultaneously.

Pravastatina Teva with food and drinks

This treatment can be taken with or without food, with half a glass of water.

You should reduce your alcohol consumption to a minimum. If you have any doubts about how much alcohol you can drink while taking this medication, consult your doctor.

Pregnancy and breastfeeding

Do not take Pravastatina during pregnancy. If you discover you are pregnant, inform your doctor immediately.

Consult your doctor or pharmacist before using any medication.

Do not take Pravastatina during the breastfeeding period as this medication passes into breast milk.

Driving and operating machinery

Pravastatina usually does not affect your ability to drive or operate machinery. However, if you experience symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or operate machinery until you are sure you are in a condition to do so.

Pravastatina Teva contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will advise you on a low-fat diet that you should continue until the end of treatment.

Pravastatina can be taken with or without food, with half a glass of water.

The recommended dose is:

Adults

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

Do not exceed the maximum daily dose of 40 mg of pravastatina. Your doctor will establish the suitable dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases blood cholesterol levels:

The recommended dose between 8 and 13 years is 10-20 mg once a day, and the recommended dose between 14 and 18 years is 10-40 mg once a day.

After an organ transplant:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medication that reduces the body's immune system (ciclosporina), your doctor may prescribe an initial dose of 20 mg once a day. This dose may be adjusted up to 40 mg by your doctor.

If you have severe kidney or liver disease, your doctor may prescribe a lower dose of pravastatina.

Treatment duration

Your doctor will indicate the duration of your pravastatina treatment. This medication should be taken regularly for the time your doctor recommends, even if it is for a long period of time.

If you take more Pravastatina than you should

If you have taken more Pravastatina than you should, or if someone accidentally swallowed some tablets, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Pravastatina

If you forgotto take a dose, simply take your normal dose when it is due next.

Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If the following side effects occur, stop taking the tablets and inform your doctor immediately or go to the nearest hospital:

• Allergic reaction (swelling of the face or neck, muscle and joint pain, urticaria, fever, redness, shortness of breath).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalization.

Contact your doctor as soon as possible and stop taking Pravastatina if you develop:

• Unexplained or persistent muscle pain, sensitivity, weakness, or cramps, especially if you also feel unwell or have a high temperature.

In rare cases, it may progress to a serious and potentially fatal disease called rhabdomyolysis.

The following side effects are infrequent and may affect up to 1 in 100 people:

• Dizziness, fatigue, headache, sleep disturbances, including insomnia.
• Blurred vision or double vision.
• Indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• Itching, acne, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).
• Changes in urine elimination (such as pain while urinating, urinating more frequently, and urinating more frequently at night) and sexual problems.
• Muscle and joint pain, tendon inflammation, which may be complicated by tendon rupture.

The following side effects are rare and may affect up to 1 in 1,000 people:

• Sensitivity to the sun.

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

• Changes in the sense of touch, including burning or tingling sensations, or numbness, indicating nerve damage.
• Severe skin alteration (lupus erythematosus-like syndrome).
• Inflammation of the liver or pancreas, jaundice (recognized by yellow discoloration of the skin and eyes), rapid destruction of liver cells (fulminant hepatic necrosis).
• Inflammation of one or more muscles causing muscle pain or weakness (myositis, polymyositis, or dermatomyositis), muscle pain or weakness, tendon inflammation, sometimes complicated by rupture.
• Increased transaminases (a group of blood enzymes) that may indicate liver problems. Your doctor may want to perform periodic tests to monitor it.

Side effects of unknown frequency:Constant muscle weakness, liver failure, muscle rupture

Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia ocular (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

• Nightmares
• Memory loss

• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes: it is more likely if you have high blood sugar and fat levels, obesity, and hypertension. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after

the CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C. Store in the original packaging to protect it

from moisture.

Medicines should not be thrown down the drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pravastatina Teva 20 mg

• The active ingredient is pravastatina sodium. Each tablet contains 20 mg of pravastatina sodium.
• The other components are: lactose, povidone (PVP K-30), crospovidone, calcium hydrogen phosphate (E341), sodium stearate fumarate, microcrystalline cellulose (E460), sodium croscarmellose (E466), yellow iron oxide (E172).

Appearance of the product and contents of the packaging

Tablet.

Yellow shiny round tablets, slightly convex, scored on both sides. The tablet can be divided into equal doses.

Pravastatina Teva 20 mg is available in packaging sizes of 10, 20, 28, 30, 50, 56, 84, 98, 100, and 200 tablets and clinical packaging of 50 tablets in single-dose packaging.

Only some packaging sizes may be marketed.

Holder of the Marketing Authorization and responsible for manufacturing:

Holder of the marketing authorization

Teva Pharma, S.L.U

C/Anabel Segura, 11. Edificio Albatros B, 1st floor.

Alcobendas, 28108- MADRID

Responsible for manufacturing:

Pharmachemie B.V,

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

or

Teva Pharmaceutical Works Private Ltd. Co.,

Pallagi út 13, 4042 Debrecen

Hungary

or

GALIEN LPS

98 Rue Bellocier, 89100 Sens

France

or

Teva Pharma S.L.U.

Poligono Malpica, Calle C, N°4, 50016 Zaragoza

Spain

This medicine is registered in the Member States of the EEA with the following names:

names:

France Pravastatine Teva 20 mg, comprimé

Italy Pravastatina Ratiopharm Compresse

Netherlands Pravastatinenatrium 20 mg tabletten

Norway Pravastatin Teva 20 mg Tabletter

Portugal Pravastatina Teva 20 mg Comprimidos

Spain Pravastatina Teva 20 mg, comprimidos EFG

Sweden Pravastatin Teva 20 mg tabletter

Last review date of this leaflet: April 2023