Patient Information Leaflet

Pravastatina Teva-ratio 10 mg Tablets EFG

Pravastatin Sodium

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, 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 you must not give it to others even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Pravastatina Teva-ratio

3. How to take Pravastatina Teva-ratio

4. Possible side effects

5. Storage of Pravastatina Teva-ratio

6. Contents of the pack and additional information

Pravastatin 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 may lead to:

• Chest pain (angina pectoris), when a coronary artery is partially obstructed.
• Heart attack (myocardial infarction), when a coronary artery is completely obstructed.
• Cerebral infarction (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

Pravastatin 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), Pravastatin is indicated to reduce the risk of suffering from a heart and blood vessel problem, and decreases the risk of dying from these diseases.
• If you have already suffered a cerebral infarction or have chest pain (unstable angina), even with normal cholesterol levels, Pravastatin is indicated to reduce the risk of suffering another heart attack or cerebral infarction in the future, and decreases the risk of dying from these diseases.

After an organ transplant

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

Do not take Pravastatina:

• 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

Before taking this treatment, consult your doctor if you have or have had any of the following medical conditions:

• Liver disease
• Decreased activity of the thyroid gland (Hypothyroidism)
• Liver disease or problems with alcohol (drinking large amounts of alcohol)
• Muscle alterations caused by a hereditary disease
• Muscle problems caused by another medication belonging to the group of statins (medications inhibiting HMG-CoA reductase) or belonging to the group known as fibrates (see Use of other medications).
• If you have or have had myasthenia (a disease that courses with generalized muscle weakness that, in some cases, affects the muscles used to breathe) 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).

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 correctly.

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

The risk of muscle failure is higher in some patients. Consult your doctor in the following cases:

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 had 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 adverse muscle effects.

If you feel inexplicable cramps or muscle pain during treatment, inform your doctor immediately.

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

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

Consult your doctor before taking Pravastatina.

Consult your doctor or pharmacist before taking Pravastatina if you

• Have severe respiratory failure.

Other medications and Pravastatina

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:

• A medication that lowers cholesterol levels in the blood (fibrates, e.g. gemfibrozil, fenofibrate).
• A medication that lowers the body's defenses (ciclosporin).
• A medication that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• 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 resume treatment with Pravastatina. Taking Pravastatina with fusidic acid may cause rare muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medication used to treat gout)
• Nicotinic acid (a medication used to lower high cholesterol levels in the blood)
• Rifampicin (a medication used to treat the infection called tuberculosis)
• Lenalidomide (a medication used to treat a type of blood cancer called multiple myeloma).
• If you are taking a medication used to treat and prevent 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 in the blood tests used to monitor treatment with vitamin K antagonist.
• You are also using a medication to lower fat levels in your 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 becausethe resin may affect the absorption of Pravastatina if these two medications are taken simultaneously.

Pravastatina 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 on treatment with this medication, you should consult your doctor.

Pregnancy and breastfeeding

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

Consult your doctor or pharmacist before using any medication.

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

Driving and using machines

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

Pravastatina Teva-ratio contains lactose and sodium

If your doctor has indicated 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 indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Your doctor will advise you to follow a low-fat diet, which 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 appropriate 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.

If you estimate that the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.

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. Do not stop treatment on your own.

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 can cause side effects, although not everyone will experience them.

Stop taking Pravastatinaand inform your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on examination, weakness or cramps, especially if you do not feel well or have a fever at the same time.

In rare cases, muscle problems can be severe (rhabdomyolysis) and can cause a life-threatening kidney disease.

Severe and sudden allergic reactions such as swelling of the face, lips, tongue, or throat can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. Inform your doctor immediately if this happens.

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

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders, including insomnia.
• Eye disorders: blurred vision or double vision.
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• Skin and hair disorders:itching, acne, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:urination alterations (such as pain while urinating, urinating more frequently, and urinating more frequently at night) and sexual problems.
• Muscle and joint disorders: muscle and joint pain, tendon inflammation, which can be complicated by tendon rupture.

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

• Sensitivity to sunlight.

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

• Nervous system disorders:alterations in the sense of touch, including burning or tingling sensations, or numbness, which indicates nerve damage.
• Skin disorders:severe skin alteration (lupus erythematosus-like syndrome).
• Liver disorders: liver or pancreas inflammation, jaundice (recognized by yellow discoloration of the skin and eyes), rapid destruction of liver cells (fulminant hepatic necrosis).
• Muscle and bone disorders: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.
• Altered blood tests:increased transaminases (a group of blood enzymes) that can be a sign of liver problems. Your doctor may want to perform periodic tests to monitor it.

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

Possible side effects

• 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, overweight, and hypertension. Your doctor will perform a check during treatment with this medicine.

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, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not mentioned in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://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 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 humidity.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Pravastatina Teva-ratio 10 mg

• The active ingredient is pravastatina sodium. Each tablet contains 10 mg of pravastatina

sodium.

• The other components are: lactose, povidone (PVP K-30), crospovidone, calcium phosphate dihydrate (E341), sodium stearate fumarate, microcrystalline cellulose (E460), sodium croscarmellose (E466), red iron oxide (E172).

Appearance of the product and contents of the package

• Tablet.
• Round, speckled, pink, slightly convex, scored on both sides. The tablet can be divided into equal doses
• Pravastatina Teva-ratio 10 mg is available in package sizes of 20, 28, 30, 50, 60, 84, 90, and 100 tablets and clinical packs of 50 tablets in single-dose packaging.

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.

28108 Alcobendas (Madrid).

Responsible for manufacturing:

Pharmachemie B.V,

Swensweg 5, Postbus 552,

2003 RN Haarlem

Netherlands

or

Teva Pharmaceutical Works Private Ltd. Co.,

Pallagi ùt 13, 4042 Debrecen

Hungary

or

Teva Czech Industries s.r.o.,

Ostravská 29, c.p. 305, 747 70

Opava–Komárov, Czech Republic

or

Teva Pharma S.L.U.,

Poligono Malpica, Calle C, N°4,

50016 Zaragoza, Spain

or

Merckle GmbH,

Ludwig-Merckle-Str. 3,

89143 Blaubeuren, Germany

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

Germany:Pravastatin-ratiopharm 10 mg Tabletten

NetherlandsPravastatinenatrium ratiopharm 10 mg Teva, tabletten

Portugal:Pravastatina ratiopharm 10mg Comprimidos

Spain:Pravastatina Teva-ratio 10 mg comprimidos EFG

Date of the last review of this prospectus:April 2023

“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”

You can access detailed and updated information on this medicine by scanning the QR code included in the packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74544/P_74544.html