Patient Information Leaflet: Product Characteristics

Pritadol 10 mg Tablets

Pravastatin Sodium

Read this leaflet carefully before you start to take this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms 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

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

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

• The treatment ofprimary hypercholesterolemia and mixed dyslipidemia, diseases characterized by increased 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 Pritadol

• If you are allergic to pravastatina sodium or any of the other components of this medication (listed in section 6)
• If you have any active liver disease or have elevated transaminases (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 Pritadol

• If you are taking or have taken in the last 7 days a medication that contains fusidic acid (used for the treatment of bacterial infection) by mouth or injection. The combination of fusidic acid and Pritadol may produce severe muscle problems (rhabdomyolysis).

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

Moderate increases in liver transaminases levels may occur, which in most cases return to normal without the need to suspend treatment

• You must also inform your doctor if you have kidney insufficiency, hypothyroidism, if you have a family history or have previously had muscle alterations or if you normally consume alcohol

• 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 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 may sometimes worsen the disease or cause myasthenia (see section 4)

Your doctor may recommend blood tests to determine the state of your muscles before starting treatment and during treatment, to consider starting, continuing, or suspending treatment

Inform your doctor if you are taking other medications that can cause muscle alterations, such as:

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

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

Consult your doctor or pharmacist before taking Pritadol if you:

• Have severe respiratory insufficiency

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

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

Taking Pritadol with other medications

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

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

Certain medications may interact with Pritadol; in these cases, you may need to change the dose or interrupt treatment with one of them

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

• Colestiramine or colestipol (may lower pravastatina levels in the blood) and fibrates (may increase the risk of muscle adverse reactions), which are other medications used to lower cholesterol levels
• Ciclosporin, a medication used to prevent transplant rejection (administered with pravastatina, ciclosporin increases pravastatina levels in the blood)
• Antibiotics such as erythromycin or clarithromycin (may increase pravastatina levels in the blood)
• If you are taking a medication used in the treatment and prevention of blood clot formation called "vitamin K antagonists," inform your doctor before taking pravastatina because the concomitant use of vitamin K antagonists with pravastatina 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 consume alcohol, consult your doctor before taking this medication

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication

Pregnancy

Pritadol is contraindicated during pregnancy. If you become pregnant or suspect you may be pregnant, you must suspend treatment and inform your doctor as soon as possible

Breastfeeding:

Pritadol is contraindicated during the breastfeeding period as it passes into breast milk

Driving and operating machinery

At the recommended doses, Pritadol does not affect the ability to drive or operate machinery. However, if you experience symptoms of dizziness, do not drive or operate machinery until you know how the medication affects you

Pritadol contains lactose

This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Pritadol. Do not discontinue treatment before.

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

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

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

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 there are other risk factors.

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

If you estimate that the action of Pritadol is too strong or too weak, inform 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 Toxicological Information Service, phone 91 562 04 20 indicating the medication and the amount taken.

If you forgot to take Pritadol

In case of a missed dose, wait for the next one. Do not take a double dose to compensate for the missed doses.

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

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

Contact your doctor immediately if you develop any of these symptoms during the use of Pritadol because muscle disorders can be severe 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 may 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 service immediately:

Allergic reactions (angioedema, anaphylaxis) such as severe allergic reactions with facial swelling, tongue, or trachea (edema), which may cause breathing difficulties. It is a very rare reaction that can be severe if it occurs.

Other side effects that may occur:

Common: may affect up to 1 in 10 people

• Increased production of liver enzymes.
• Muscle and bone sensitivity, joint pain (arthralgia), muscle cramps, muscle pain, and weakness.

Uncommon: may affect up to 1 in 100 people

• Dizziness,
• Headache
• Sleep disturbances,
• Difficulty sleeping
• Visual disturbances (blurred vision or double vision).
• Digestive problems or slow digestion (dyspepsia)/heartburn
• Abdominal pain
• Nausea/vomiting
• Constipation
• Diarrhea
• Gas.
• Itching, hives, urticaria
• Problems with the scalp and hair (including hair loss).
• Abnormal urination, e.g. pain, frequency, frequent need to urinate at night (dysuria).
• Sexual function problems.
• Fatigue.

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

• Sensory problems including burning/tingling, numbness, or tingling (paresthesia) that may be a sign of nerve damage (peripheral neuropathy).
• Pancreatitis (inflammation of the pancreas).
• Yellowing of the skin (jaundice), tissues, and body fluids.
• Acute liver failure (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 muscle pain or weakness (myositis or polymyositis)
• In some cases, tendon problems associated with rupture.

Unknown: the frequency cannot be estimated from 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 muscles and skin)
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Muscle rupture.
• Consultyour 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.

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 type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the 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 CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30 °C.

Medications should not be disposed of through drains or in the 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Pritadol

• The active ingredient is pravastatina sodium. Each tablet contains 10 mg of pravastatina.
• The other components are: Lactose monohydrate, povidone 30, magnesium oxide, microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Appearance of the product and contents of the packaging

Pritadol are white, round, and scored tablets.

The tablet can be divided into equal doses.

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

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: April 2024

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