Pritadol 10 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pritadol 10 mg tablets

Pravastatin sodium

Read the entire leaflet carefully before you start taking 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pritadol is and what it is used for

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

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

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

• The prevention of cardiovascular events (myocardial infarction) and cardiovascular death in patients with high cholesterol levels and a high risk of experiencing a first cardiovascular event (Primary prevention).

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

• The reduction of blood lipid levels in patients who have undergone organ transplantation and are receiving immunosuppressive therapy.

2. What you need to know before taking 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 active liver (hepatic) disease or elevated transaminases (enzymes indicating liver disease)
• If you are pregnant or there is a possibility you could be pregnant
• If you are breastfeeding

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pritadol

• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Pritadol may cause serious muscle problems (rhabdomyolysis).

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

Mild increases in liver transaminase levels may occur, which in most cases return to normal without the need to discontinue treatment.

• You should also inform your doctor if you have renal insufficiency, hypothyroidism, a personal or family history of muscle disorders, or if you regularly consume alcohol.

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

• 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 ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor may recommend blood tests to assess your muscle status before starting and during treatment, to evaluate whether to initiate, continue, or discontinue therapy.

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

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

Consult your doctor, even if any of the above conditions occurred in the past.

Talk to your doctor or pharmacist before taking Pritadol if you:

• Have severe respiratory insufficiency

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Taking Pritadol with other medicines

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

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

Certain medicines may interact with Pritadol; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

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

• Cholestyramine or colestipol (may reduce pravastatin blood levels) and fibrates (may increase the risk of muscle-related adverse reactions), which are other medicines used to lower cholesterol levels.
• Cyclosporine, a medicine used to prevent transplant rejection (when given with pravastatin, cyclosporine increases blood levels of pravastatin).
• Antibiotics such as erythromycin or clarithromycin (may increase pravastatin blood levels).
• If you are taking a medicine used for the treatment and prevention of blood clots known as “vitamin K antagonists,” inform your doctor before taking pravastatin, as concomitant use of vitamin K antagonists with pravastatin may increase the results of blood tests used to monitor vitamin K antagonist therapy.

Taking Pritadol with food and drink

Pritadol can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Pritadol is contraindicated during pregnancy. If you become pregnant or suspect pregnancy, you must 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 operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how the medicine affects you.

Pritadol contains lactose

This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Pritadol

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

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

Remember to take your medicine.

Your doctor will determine the duration of your treatment with Pritadol. Do not stop treatment prematurely.

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

The usual dose ranges from 10–40 mg once daily. Your doctor will determine the appropriate dose for you and will make any necessary adjustments based on your response to the medication.

Combination therapy: patients receiving pravastatin and cyclosporine should start treatment with 20 mg of pravastatin once daily; your doctor will adjust the dose up to 40 mg. For patients receiving pravastatin and a bile acid sequestrant resin (e.g. cholestyramine, colestipol), Pritadol should be administered one hour before or four hours after the resin.

Children and adolescents (8–18 years) with heterozygous familial hypercholesterolemia: the recommended dose for patients aged 8–13 years is 10–20 mg once daily; the recommended dose for patients aged 14–18 years is 10–40 mg once daily.

Elderly patients: dose adjustment is not necessary in these patients unless other risk factors are present.

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

If you think that the effect 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, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20, indicating the medication and amount taken.

If you forget to take Pritadol 10

If you miss a dose, wait until your next scheduled dose. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone gets them.

Contact your doctor immediately if you develop any of these symptoms while taking Pritadol, because muscle disorders can be serious in rare 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), which 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 department immediately:

Hypersensitivity reactions (angioedema, anaphylaxis), such as severe allergic reactions with swelling of the face, tongue, or trachea (edema), which may cause breathing difficulties. This is a very rare reaction, but it may be serious if it occurs.

Other side effects that may occur:

Frequent: may affect up to 1 in 10 people

• Increased production of liver enzymes.
• Muscle and bone tenderness, joint pain (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 vision or double vision)
• Digestive problems or slow digestion (dyspepsia)/heartburn
• Abdominal pain
• Nausea/vomiting
• Constipation
• Diarrhea
• Gas (flatulence)
• Itching, rash, hives
• Scalp and hair problems (including hair loss)
• Abnormal urination, e.g., pain, frequency, frequent need to urinate at night (dysuria)
• Problems with sexual function
• Tiredness

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

• Sensory disturbances including burning sensation/tremor, numbness or tingling (paresthesia), which could be a sign of nerve ending damage (peripheral neuropathy)
• Inflammation of the pancreas (pancreatitis)
• Yellowing of the skin (jaundice), tissues, and body fluids
• Inflammation of the liver (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 sometimes associated with rupture

Not known: frequency cannot be estimated from available data

• Nightmares
• Memory loss
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever
• Persistent muscle weakness
• Dermatomyositis (a disease characterized by inflammation of the muscles and skin)
• Myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing)
• Ocular myasthenia (a disease causing weakness of the eye muscles)
• Muscle rupture
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

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

Diabetes mellitus. The frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 30 kg/m², elevated triglycerides, history of hypertension).

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Do not store above 30 °C.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Pritadol

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

Appearance of the medicinal product and contents of the container

Pritadol are white, round, scored tablets.

The tablet can be divided into equal doses.

They are presented in Al/Al blisters packed in boxes containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the most recent revision of this leaflet: April 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/