Patient Information Leaflet

Pravastatina Davur 40 mg Tablets EFG

1. What Pravastatina Davur 40 mg Tablets are and what they are used for

2. What you need to know before you start taking Pravastatina Davur 40 mg Tablets

3. How to take Pravastatina Davur 40 mg Tablets

4. Possible side effects

5. Storage of Pravastatina Davur 40 mg Tablets

6. Contents of the pack and additional information

Pravastatina belongs to a group of medications known as statins that act by reducing the levels of lipids, cholesterol, and triglycerides in the blood.

It is indicated, along with an appropriate diet, for:

• The treatment ofprimary hypercholesterolemia and mixed dyslipidemia, diseases characterized by elevated cholesterol and/or triglycerides in the blood, when diet or other measures (exercise or weight reduction) have not been effective.

• The prevention of cardiovascular problems (myocardial infarction) and cardiovascular death in patients with elevated cholesterol levels and a high risk of suffering a first cardiovascular event (Primary Prevention).

• The prevention of cardiovascular problems and cardiovascular death in patients with normal or high cholesterol levels who have already had a cardiovascular event, such as myocardial infarction or angina pectoris (Secondary Prevention).

• Thereduction of lipid levels in the bloodin patients undergoing organ transplantation and receiving immunosuppressive treatment

Do not take Pravastatina Davur

• if you are allergic (hypersensitive) to pravastatin sodium or to any of the other ingredients of this medicine (listed in section 6)
• if you have any liver disease (liver disorder) or have elevated liver enzymes (indicative of liver disease)
• if you are pregnant or there is a possibility that you may be pregnant
• if you are breastfeeding

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravastatina.

• If you have had any liver disease or have a history of alcoholism

It is possible that moderate increases in liver enzymes may occur, which in most cases return to normal without the need to discontinue treatment.

• You should also inform your doctor if you have kidney insufficiency, hypothyroidism, if you have a family history or have previously experienced muscle disorders, or if you normally consume alcohol.

• Consult your doctor or pharmacist before takingPravastatina Davurif you have severe respiratory insufficiency.

• While you are taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

• During treatment, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps. If you experience any of these symptoms, inform your doctor immediately.

• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and pravastatin can cause severe muscle problems (rhabdomyolysis).

• If you have or have had myasthenia (a disease characterized by 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).

Your doctor will perform a blood test before starting to take Pravastatina Davur 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 Davur to check the functioning of your liver.

Your doctor may recommend that you have blood tests to determine the state of your muscles before starting treatment and during treatment, to consider starting, continuing, or discontinuing treatment.

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

Inform your doctor if you are taking other medicines that can cause muscle disorders such as:

• Fibrates (lower cholesterol levels)
• Nicotinic acid (a medicine used to treat high blood cholesterol)
• Colchicine (a medicine used to treat gout)
• Rifampicin (a medicine used to treat a bacterial infection called tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma)

Consult your doctor, even if any of the above circumstances have occurred at any time.

Interaction of Pravastatina Davur with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine.

Certain medicines may interact with Pravastatina; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are using or have used recently any of the following medicines:

• Other medicines used to lower cholesterol levels, such as cholestyramine or cholestipol (may decrease pravastatin levels in the blood) and fibrates (may increase the risk of muscle side effects).
• Ciclosporin, a medicine used to prevent transplant rejection (administered with pravastatin, ciclosporin increases pravastatin levels in the blood).
• Antibiotics such as erythromycin or clarithromycin (may increase pravastatin levels in the blood).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will tell you when you can restart treatment with pravastatin. The use of pravastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking a medicine used to treat and prevent blood clots called an antagonist of vitamin K, inform your doctor before taking pravastatin because the use of vitamin K antagonists concomitantly with pravastatin may increase the results of blood tests used to monitor treatment with vitamin K antagonists.

Pravastatina Davur with food, drinks, and alcohol

Pravastatina can be taken with or without food.

Pravastatina should be administered with caution to patients who consume alcohol. If you normally drink alcohol, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine. Pravastatina should not be administered during pregnancy. If you become pregnant or suspect you may be pregnant, you should discontinue treatment and inform your doctor as soon as possible.

Pravastatina should not be administered during breastfeeding as it passes into breast milk.

Driving and operating machinery

At normal doses,Pravastatinadoes not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medicine.

Pravastatina Davur contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free."

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

The tablets should be swallowed with water and can be taken with or without food, preferably at night.

The recommended dose is between 10-40 mg once a day. Your doctor will establish the suitable dose for you and make any necessary adjustments based on your response to the medication.

Associated treatment:patients taking pravastatina and ciclosporina should start treatment with 20 mg of pravastatina once a day, your doctor will adjust the dose up to 40 mg. Patients taking pravastatina and a bile acid sequestrant (e.g. colestiramina, colestipol) should be given Pravastatina Davur 40 mg one hour before or four hours after the sequestrant.

Use in children and adolescents (8-18 years) with familial heterozygous hypercholesterolemia: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.

Elderly patients:No dose adjustment is necessary in these patients unless other risk factors are present.

Patients with renal or hepatic insufficiency:In patients with moderate or severe kidney function impairment or significant liver function impairment, it is recommended to start treatment with a dose of 10 mg.

If you estimate that the action of Pravastatina Davur 40 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Pravastatina Davur than you should

Contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 915 620 420, indicating the medication and the amount taken.

If you forgot to take Pravastatina Davur

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

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

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

Side effects are classified as:

Very common (affects more than 1 in 10 patients), common (affects between 1 and 10 in 100 patients),

Uncommon (affects between 1 and 10 in 1,000 patients),

Rare (affects between 1 and 10 in 10,000 patients),

Very rare (affects less than 1 in 10,000 patients) and

Unknown frequency (cannot be estimated from available data)

Immune system disorders

Very rare: allergic reactions, angioedema (swelling of the arms, legs, face, lips, tongue, and/or throat), lupus-like syndrome (skin inflammation).

Nervous system disorders

Uncommon: dizziness, headache, sleep disorders, insomnia.

Very rare: peripheral neuropathy, particularly when used for a prolonged period and a sensation of numbness.

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

Eye disorders

Uncommon: visual disturbances (including blurred vision and double vision of objects).

Unknown frequency: ocular myasthenia (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.

Gastrointestinal disorders

Uncommon: indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, gas.

Very rare: pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders

Very rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

Unknown frequency: liver failure.

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, appearance of blisters accompanied by itching, abnormalities of the hair and scalp (including hair loss).

Musculoskeletal and connective tissue disorders

Very rare: rhabdomyolysis (destruction of muscle fibers), which may be associated with kidney disorders, myopathy (muscle alterations), myositis (inflammation of muscle tissue), polymyositis (simultaneous inflammation of multiple muscles).

Unknown frequency: muscle rupture.

Tendon alterations, sometimes complicated by rupture.

Renal and urinary disorders

Uncommon: urinary elimination disorders (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Reproductive and breast disorders

Uncommon: sexual disorders.

General disorders

Uncommon: fatigue.

Also, the following clinically significant adverse effects have been reported during clinical studies:

Musculoskeletal and connective tissue disorders

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), constant muscle weakness (unknown frequency), and elevated creatine kinase levels (enzyme indicative of muscle alteration).

Hepatobiliary disorders

Elevations of serum transaminases (enzymes indicative of liver disease).

The following adverse reactions have been reported with some statins:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes Mellitus: The frequency will depend on the presence or absence of risk factors (fasting glucose at 5.6 mmol/L, BMI>30 kg/m2, elevated triglycerides, history of hypertension). Your doctor will monitor you while taking this medication.
• Dermatomyositis (a disease characterized by inflammation of the muscles and skin).

Reporting of adverse effects

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

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

Do not store at a temperature above30°C

Do not use this medicationafter the expiration date that appears on the packaging after the CAD abbreviation. The expiration date is the last day of the month indicated.

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

Composition of Pravastatina Davur 40 mg tablets

• The active ingredient is pravastatina sodium. Each tablet contains 40 mg of pravastatina sodium.
• The other components (excipients) are: anhydrous lactose, povidone, crospovidone, anhydrous calcium hydrogen phosphate, sodium stearate fumarate, microcrystalline cellulose, sodium croscarmellose, yellow quinoline WS (E – 104), and brilliant blue (E – 133).

Appearance of the product and content of the packaging

Pravastatina Davur 40 mg is presented in the form of tablets. The tablets are round, pale green in color, slightly convex, and scored on both sides. The tablet can be divided into equal doses.

Each package contains 28 tablets.

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 (Spain)

Responsible for manufacturing

Teva Pharma S.L.U.

Polígono Industrial Malpica street C.4

50016-Zaragoza.

Spain

or

Teva Pharmaceutical Works Private Limited Company

Pallagi ut, 13 Debrecen

Hungary

Last review date of this leaflet: March 2024

Other sources of information

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