PRAVASTATIN TARBIS 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

PRAVASTATINA TARBIS 40 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What Pravastatina Tarbis 40 mg tablets are and what they are used for
2. What you need to know before you take Pravastatina Tarbis 40 mg tablets
3. How to take Pravastatina Tarbis 40 mg tablets
4. Possible side effects
5. Storage of Pravastatina Tarbis 40 mg tablets
6. Contents of the pack and other information

1. What PRAVASTATINA TARBIS 40 mg tablets are and what they are used for

Pravastatina Tarbis 40 mg belongs to a group of medicines known as statins, which act by reducing blood lipid, cholesterol, and triglyceride levels.

Pravastatina Tarbis 40 mg is indicated, along with a suitable diet, in:

• Treatment of primary hypercholesterolemia and mixed dyslipidemia, diseases characterized by increased cholesterol and/or triglycerides in the blood, when diet or other measures (exercise or weight loss) have not been effective.
• Prevention of cardiovascular problems (myocardial infarction) and death from cardiovascular causes in patients with high cholesterol levels and a high risk of suffering a first cardiovascular problem (Primary prevention).
• Prevention of cardiovascular problems and death from cardiovascular causes in patients with normal or high cholesterol levels who have already had a cardiovascular problem, such as myocardial infarction or angina pectoris (Secondary prevention).

• Reduction of blood lipid levels in patients undergoing organ transplantation and receiving immunosuppressive treatment.

2. What you need to know before you take PRAVASTATINA TARBIS 40 mg tablets

Do not take Pravastatina Tarbis 40 mg

• If you are allergic (hypersensitive) to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6).
• If you have any active liver disease (liver disease) or have elevated transaminases (enzymes indicative of liver disease).
• If you are pregnant or think you may be pregnant.
• If you are breast-feeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravastatina Tarbis 40 mg.

• 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia to appear (see section 4).
• If you have had any liver disease or have a history of alcoholism.

It is possible that moderate increases in liver transaminase levels may occur, which, in most cases, return to their initial level without the need to suspend treatment.

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

• During treatment, some patients may experience pain, sensitivity, muscle weakness, or muscle cramps. If you experience any of these symptoms, you should immediately inform your doctor.
• 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.
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will indicate when you can restart treatment with Pravastatina Tarbis. The use of Pravastatina Tarbis with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

It is possible that your doctor may recommend blood tests to determine the condition of your muscles before starting treatment and during treatment, to consider starting, continuing, or suspending treatment.

Consult your doctor or pharmacist before taking Pravastatina Tarbis 40 mg if you:

• Have severe respiratory failure.

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

• Fibrates (lower cholesterol levels).
• Nicotinic acid (lowers cholesterol levels).

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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

Use of Pravastatina Tarbis 40 mg with other medicines

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

Certain medicines may interact with Pravastatina Tarbis 40 mg; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is essential that you inform your doctor if you are taking or have recently taken any of the following medicines:

• Other drugs used to lower cholesterol levels, such as cholestyramine or colestipol (can decrease pravastatin levels in the blood), and fibrates (can increase the risk of adverse muscle reactions).
• Cyclosporin, a medicine used to prevent transplant rejection (given with pravastatin, cyclosporin increases pravastatin levels in the blood).
• Antibiotics such as erythromycin or clarithromycin (can increase pravastatin levels in the blood).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will indicate when you can restart treatment with Pravastatina Tarbis. The use of Pravastatina Tarbis with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Pravastatina Tarbis 40 mg with food and drinks

Pravastatina Tarbis 40 mg can be taken with or without food.

Pravastatina Tarbis 40 mg should be administered with caution to patients who consume alcohol. If you drink alcohol regularly, consult your doctor.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pravastatina Tarbis 40 mg should not be taken during pregnancy. If you become pregnant or think you may be pregnant, stop taking the medicine and inform your doctor as soon as possible.

Pravastatina Tarbis 40 mg should not be taken during breast-feeding as it passes into breast milk.

Driving and using machines

At normal doses, Pravastatina Tarbis 40 mg does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how the medicine affects you.

Pravastatina Tarbis 40 mg contains lactose.

If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take PRAVASTATINA TARBIS 40 mg tablets

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Pravastatina Tarbis 40 mg. Do not stop treatment before.

The tablets of Pravastatina Tarbis 40 mg are for oral administration.

The tablets should be swallowed with water and can be administered 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 the necessary adjustments based on your response to the medicine.

Combined treatment:patients treated with pravastatin and cyclosporin should start treatment with 20 mg of pravastatin once a day; your doctor will adjust the dose up to 40 mg. For patients treated with pravastatin and a bile acid sequestrant (e.g., cholestyramine, colestipol), Pravastatina Tarbis 40 mg should be administered 1 hour before or 4 hours after the sequestrant.

Children and adolescents:the administration of pravastatin is not recommended for children under 18 years of age, as its efficacy and safety have not been established in this age group.

Elderly patients:no dose adjustment is necessary in these patients unless there are other risk factors.

Patients with renal or hepatic impairment:in patients with moderate or severe renal impairment or significant hepatic impairment, treatment should be initiated with a dose of 10 mg.

If you think that the action of Pravastatina Tarbis 40 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Pravastatina Tarbis 40 mg than you should

If you have taken more Pravastatina Tarbis 40 mg than you should, 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 Toxicology Information Service, phone: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Pravastatina Tarbis 40 mg:

Do not take a double dose to make up for forgotten doses. Wait for the next dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Pravastatina Tarbis 40 mg can cause side effects, although not everybody gets them.

Frequencies are defined as follows: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); not known (cannot be estimated from the 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 tingling sensation.

Not known: severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

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

Eye disorders:

Uncommon: vision disturbances (including blurred vision and double vision).

Not known: ocular myasthenia (a disease that causes weakness of the eye muscles).

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).

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis (destruction of muscle fibers), which may be associated with kidney disorders, myopathy (muscle disorders).

Tendon disorders, sometimes complicated by rupture.

Not known: constant muscle weakness.

Endocrine disorders:

Not known: diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Psychiatric disorders:

Unknown frequency: depression, nightmares, and memory loss.

Renal and urinary disorders:

Uncommon: changes in urine elimination (such as difficulty urinating, frequent urination, and increased urination at night).

Reproductive system and breast disorders:

Uncommon: sexual disorders.

General disorders:

Uncommon: fatigue.

Not known: isolated cases of interstitial lung disease, especially with prolonged treatment (see section 4.4).

The following adverse effects of special clinical interest have also been reported during clinical studies:

Musculoskeletal and connective tissue disorders:

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), muscle weakness (common), and elevated creatine kinase levels (an enzyme indicative of muscle disorder).

Hepatic disorders:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PRAVASTATINA TARBIS 40 mg tablets

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

Do not store above 25°C.

Store in the original packaging to protect from moisture.

Expiry date

Do not use this medicine after the expiry date which is stated on the carton, after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatina Tarbis 40 mg

• The active ingredient is pravastatin sodium. Each tablet contains 40 mg of pravastatin sodium.
• The other ingredients (excipients) are: anhydrous colloidal silica, lactose, povidone, sodium lauryl sulfate, sodium croscarmellose, microcrystalline cellulose (E 460ii), magnesium stearate, sodium phosphate, and iron oxide (E 172).

Appearance of the product and pack contents

Pravastatina Tarbis 40 mg is presented in the form of scored, light brown tablets. Each pack contains 28 tablets.

Other presentations

Pravastatina Tarbis 10 mg tablets EFG.

Pravastatina Tarbis 20 mg tablets EFG.

Marketing authorization holder and manufacturer

Marketing authorization holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer

Lek Pharmaceutical Company D.D.

Verovskova, 57 (Ljubljana) – 1526 - Slovenia

or

Lek Pharmaceuticals d.d.

Trimlini, 2 D

9220 Lendava - Slovenia

Date of last revision of this leaflet: April 2023

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