Pravastatin Alter 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pravastatin Alter 20 mg tablets EFG

(Sodium pravastatin)

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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pravastatina Alter is and what it is used for

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

Pravastatina Alter, together with an appropriate diet, is indicated for:

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

• 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).

• 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).

• 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 Pravastatin Alter

Do not take Pravastatin Alter

• If you are allergic to sodium pravastatin 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 that you might be pregnant.
• If you are breastfeeding.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Pravastatin Alter:

• 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 Pravastatin Alter 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 baseline 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), since 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 Pravastatin Alter if you:

• Have severe respiratory insufficiency.

While taking this medicine, your doctor will monitor whether you have diabetes or are at 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 have persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Taking Pravastatin Alter with other medicines

Inform 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 must stop taking this medicine. Your doctor will advise you when you can restart treatment with Pravastatin Alter. Using Pravastatin Alter with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Certain medicines may interact with Pravastatin Alter; in such cases, it may be necessary to adjust the dose or interrupt treatment with one of the medicines.

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

• Colestyramine or colestipol (may reduce blood levels of pravastatin) 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 taken with pravastatin, cyclosporine increases blood levels of pravastatin).
• Antibiotics such as erythromycin or clarithromycin (may increase blood levels of pravastatin).
• If you are taking a medicine used to treat and prevent 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 Pravastatin Alter with food and drinks

Pravastatin Alter can be taken with or without food.

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

Pregnancy, breastfeeding, and fertility

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

Pregnancy:

Pravastatin Alter is contraindicated during pregnancy. If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor as soon as possible.

Breastfeeding:

Pravastatin Alter is contraindicated during breastfeeding as it passes into breast milk.

Driving and using machines

At the recommended doses, Pravastatin Alter 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.

Pravastatin Alter contains lactose

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

3. How to take Pravastatina Alter

Follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Remember to take your medication.

Your doctor will tell you how long to continue treatment with Pravastatina Alter. Do not stop treatment prematurely.

The tablets should be swallowed with water and may be taken with or without food, preferably in the evening.

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.

Concomitant treatment: 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 as needed. For patients receiving pravastatin and a bile acid sequestrant resin (e.g., cholestyramine, colestipol), Pravastatina Alter should be administered either 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 impairment or significant hepatic dysfunction, treatment should be initiated at a dose of 10 mg.

If you think that the effect of Pravastatina Alter is too strong or too weak, inform your doctor or pharmacist.

If you take more Pravastatina Alter than you should

If you have taken more Pravastatina Alter than prescribed, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at 91 562 04 20, indicating the medication and the amount taken.

If you forget to take Pravastatina Alter

If you miss a dose, simply take the next dose at the usual time. Do not take a double dose to make up for the missed dose.

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 can cause adverse effects, although not everyone experiences them.

Immune system disorders:

Very rare (may affect up to 1 in 10,000 people): allergic reactions, angioedema (swelling of the arms, legs, face, lips, tongue and/or throat), lupus-like syndrome (skin inflammation).

Nervous system disorders:

Uncommon (may affect up to 1 in 100 people): dizziness, headache, sleep disorders, insomnia.

Very rare (may affect up to 1 in 10,000 people): peripheral polyneuropathy, particularly when used for a prolonged period, and tingling sensation.

Frequency not known (frequency cannot be estimated from the available data): myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Eye disorders:

Uncommon (may affect up to 1 in 100 people): vision disturbances (including blurred vision and double vision).

Frequency not known (frequency cannot be estimated from the available data): ocular myasthenia (a disease causing weakness of the eye muscles).

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.

Gastrointestinal disorders:

Uncommon (may affect up to 1 in 100 people): indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhoea, flatulence.

Very rare (may affect up to 1 in 10,000 people): pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders:

Very rare (may affect up to 1 in 10,000 people): jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

Skin and subcutaneous tissue disorders:

Uncommon (may affect up to 1 in 100 people): itching, skin rash, blistering accompanied by itching, abnormalities of hair and scalp (including hair loss).

Musculoskeletal and connective tissue disorders:

Very rare (may affect up to 1 in 10,000 people): rhabdomyolysis (destruction of muscle fibres), which may be associated with kidney disorders, myopathy (muscle abnormalities).

Tendon disorders, sometimes complicated by rupture.

Frequency not known (frequency cannot be estimated from the available data): muscle rupture.

Renal and urinary disorders:

Uncommon (may affect up to 1 in 100 people): disturbances in urine elimination (such as difficulty urinating, increased frequency of urination, and increased frequency of night-time urination).

Reproductive system and breast disorders:

Uncommon (may affect up to 1 in 100 people): sexual dysfunction.

General disorders:

Uncommon (may affect up to 1 in 100 people): fatigue.

Sleep disorders, including insomnia and nightmares.

Memory loss.

Sexual dysfunction.

Depression.

Respiratory problems including persistent cough and/or difficulty breathing or fever.

Diabetes mellitus: frequency will depend on the presence or absence of risk factors (fasting blood glucose levels of 5.6 mmol/L, BMI > 30 kg/m², elevated triglycerides, history of hypertension). Your doctor will monitor you while you are taking this medicine.

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 levels of creatine kinase (an enzyme indicating muscle damage).

Frequency not known (frequency cannot be estimated from the available data): Persistent muscle weakness.

Hepatic disorders:

elevations in serum transaminases (enzymes indicating liver disease).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may 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 Pravastatin Alter

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

Do not use this medicine after the expiry date stated on the container. 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. Instead, return unused medicines and their containers to the SIGRE collection point (or any other medicine waste collection system) at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Pravastatin Alter

• The active substance is sodium pravastatin. Each tablet contains 20 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 pack

Pravastatin Alter 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 of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/