PRITADOL 40 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Pritadol 40 mg Tablets

Pravastatin Sodium

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. See section 4.

Contents of the pack

1. What is Pritadol and what is it used for
2. What you need to know before you take Pritadol
3. How to take Pritadol
4. Possible side effects
5. Storage of Pritadol
6. Contents of the pack and other information

1. What is Pritadol and what is it used for

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

Pritadol, in combination with a suitable diet, is indicated in:

• Treatment of primary hypercholesterolemia and mixed dyslipidemia, diseases characterized by increased cholesterol and/or triglyceride levels 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 Pritadol

Do not take Pritadol

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pritadol.

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

• 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 will return to their initial level without the need to discontinue 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.

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes exacerbate the disease or cause myasthenia to appear (see section 4).

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

Inform 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).

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

Consult your doctor or pharmacist before taking Pritadol if you:

• Have severe respiratory failure.

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 sugar and fat in the blood, are overweight, and have high blood pressure.

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.

Taking Pritadol with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• If you need to take oral fusidic acid to treat a bacterial infection, you will have to stop taking this medicine. Your doctor will tell you when you can restart treatment with Pritadol. The use of Pritadol with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

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

• Colestyramine or colestipol (can decrease pravastatin levels in the blood) and fibrates (can increase the risk of adverse muscle reactions), which are other medicines used to lower cholesterol levels.
• 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 are taking a medicine used in the treatment and prevention of blood clot formation called "vitamin K antagonists", 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.

Taking Pritadol with food and drinks

Pritadol can be taken with or without food.

If you normally drink alcohol, consult your doctor before taking this medicine.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Pritadol is contraindicated during pregnancy. If you become pregnant or think you may be pregnant, you should stop treatment and inform your doctor as soon as possible.

Breastfeeding:

Pritadol is contraindicated during breastfeeding as it passes into breast milk.

Driving and using machines

At the recommended doses, Pritadol 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.

Pritadol contains lactose

This medicine 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 Pritadol

Follow exactly the administration instructions of this medicine given by your doctor. If you are in doubt, consult your doctor or pharmacist again.

Follow these instructions unless your doctor has given you other different instructions.

Remember to take your medicine.

Your doctor will tell you the duration of your treatment with Pritadol. Do not stop treatment before.

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

The normal 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., colestyramine, colestipol), Pritadol should be administered 1 hour before or 4 hours after the sequestrant.

Children and adolescents (8-18 years) with heterozygous familial 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:it is not necessary to adjust the dose in these patients unless there are other risk factors.

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

If you think the action of Pritadol is too strong or too weak, tell your doctor or pharmacist.

If you take more Pritadol than you should

If you have taken more Pritadol than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Pritadol

In case of forgetting a dose, wait for the next one. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately if you develop any of these symptomsduring the use of Pritadol because muscle disorders can be serious in exceptional cases (see also section 2 "Warnings and precautions"):

Very rare (may affect up to 1 in 10,000 people)

• Muscle inflammation, destruction of skeletal muscle fibers (rhabdomyolysis) that can be associated with acute kidney failure.

If you experience one or more of the following symptoms, contact your doctor or go to the nearest emergency department immediately:

Hypersensitivity reactions (angioedema, anaphylaxis) such as severe allergic reactions with swelling of the face, tongue, or trachea (edema), which can cause breathing difficulties. It is a very rarereaction that can be serious if it occurs.

Other side effects that may occur:

Common: may affect up to 1 in 10 people

• Increased production of liver enzymes.
• Sensitivity in muscles and bones, pain in the joints (arthralgia), muscle cramps, muscle pain, and weakness.

Uncommon: may affect up to 1 in 100 people

• Dizziness,
• Headache
• Sleep disorders,
• Difficulty sleeping
• Visual disturbances (blurred or double vision).
• Digestive problems or slow digestion (dyspepsia)/heartburn
• Abdominal pain
• Nausea/vomiting
• Constipation
• Diarrhea
• Gas.
• Itching, rash, urticaria
• Scalp and hair problems (including hair loss).
• Urination problems, e.g., pain, frequency, need to urinate frequently at night (dysuria).
• Sexual function problems.
• Fatigue.

Very rare: may affect up to 1 in 10,000 people

• Sensory disturbances including burning sensation/tremor, numbness, or tingling that could be a sign of nerve damage (peripheral neuropathy).
• Pancreatitis.
• Yellowing of the skin, tissues, and body fluids (jaundice).
• Hepatitis, sudden destruction of liver tissue (fulminant hepatic necrosis).
• A type of chronic skin disorder (lupus-like syndrome).
• Inflammation of one or more muscles leading to pain or weakness in the muscles (myositis or polymyositis)
• In some cases, tendon problems associated with rupture.

Not known: frequency cannot be estimated from the available data

• Nightmares
• Memory loss
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever.
• Constant muscle weakness.
• Dermatomyositis (a disease characterized by inflammation of the muscles and skin)
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing)
• Ocular myasthenia (a disease that causes weakness of the eye muscles)
• Muscle rupture.
• Consult 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.

Possible side effects reported with some statins (medicines of the same type):

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).

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 via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pritadol

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

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 shown.

Do not store above 30°C.

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 Pritadol

• The active substance is pravastatin sodium. Each tablet contains 40 mg of pravastatin.
• The other ingredients are: lactose monohydrate, povidone 30, magnesium oxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of the product and pack contents

Pritadol are white, round, and scored tablets.

The tablet can be divided into equal doses.

They are presented in Al/Al blisters, which are packaged in boxes of 28 tablets.

Marketing authorization holder and manufacturer:

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of last revision of this leaflet: April 2024

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/