Pravastatin Vir 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
PRAVASTATIN VIR 10 mg TABLETS EFG
Read the entire leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you must not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If you think any of the side effects you experience are serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.
Leaflet Contents
- What PRAVASTATIN VIR is and what it is used for
- Before you take PRAVASTATIN VIR
- How to take PRAVASTATIN VIR
- Possible side effects
- How to store PRAVASTATIN VIR
- Further information
1. What PRAVASTATIN VIR is and what it is used for
PRAVASTATIN VIR belongs to a group of medicines known as statins, which work by reducing lipid, cholesterol, and triglyceride levels in the blood. PRAVASTATIN VIR is indicated, together with an appropriate diet, for:
- Treatment of primary hypercholesterolemia and mixed dyslipidemia, conditions characterized by elevated cholesterol and/or triglycerides 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 had 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. Before taking PRAVASTATIN VIR
Do not take PRAVASTATIN VIR:
-
If you are allergic to pravastatin sodium or to any of the other components of
PRAVASTATIN VIR. -
If you have active liver disease or elevated transaminases (enzymes indicating liver disease).
-
If you are pregnant or think you might be pregnant.
-
If you are breastfeeding.
Warnings and precautions
Talk to your doctor or pharmacist before taking PRAVASTATIN VIR if:
- You have severe respiratory insufficiency.
- 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 may cause serious muscle problems (rhabdomyolysis).
- 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).
While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, 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.
Take special care with PRAVASTATIN VIR:
- 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 discontinuing treatment.
- You should also inform your doctor if you have kidney impairment, 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, inform your doctor immediately.
Your doctor may recommend blood tests to assess muscle status before starting treatment and during treatment, to determine 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 (reduce cholesterol levels).
- Nicotinic acid (reduces cholesterol levels).
Consult your doctor, even if any of the above conditions occurred in the past.
Taking PRAVASTATIN VIR with food and drinks:
PRAVASTATIN VIR can be taken with or without food.
PRAVASTATIN VIR should be used with caution in patients who consume alcohol. If you regularly drink alcohol, consult your doctor.
Pregnancy:
Consult your doctor or pharmacist before taking any medicine.
PRAVASTATIN VIR must not be used during pregnancy. If you become pregnant or suspect pregnancy, stop treatment immediately and inform your doctor.
Breast-feeding:
Consult your doctor or pharmacist before taking any medicine.
PRAVASTATIN VIR must not be used during breast-feeding, as it passes into breast milk.
Driving and using machines:
At normal doses, PRAVASTATIN VIR does not affect the ability to drive or
operate machinery. However, if you experience dizziness, do not drive or use machines until you know how you react to the medicine.
Use of other medicines:
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Certain medicines may interact with PRAVASTATIN VIR; 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:
- Other cholesterol-lowering drugs such as cholestyramine or colestipol (which may reduce blood levels of pravastatin) and fibrates (which may increase the risk of muscle-related adverse reactions).
- Cyclosporine, a medicine used to prevent transplant rejection (when given with pravastatin, cyclosporine increases blood levels of pravastatin).
- Antibiotics such as erythromycin or clarithromycin (which may increase blood levels of pravastatin).
If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart pravastatin treatment. Using pravastatin with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.
3. How to take PRAVASTATIN VIR
Follow these instructions unless your doctor has given you different advice.
Remember to take your medicine.
Your doctor will tell you how long to take PRAVASTATIN VIR. Do not stop treatment early.
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.
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 if needed. For patients taking pravastatin and a bile acid sequestrant (e.g. cholestyramine, colestipol), PRAVASTATIN VIR should be administered one hour before or four hours after the resin.
Children and adolescents: Pravastatin administration is not recommended in individuals under 18 years of age, as efficacy and safety have not been established in this age group.
Elderly patients: Dose adjustment is not usually necessary in elderly 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 PRAVASTATIN VIR is too strong or too weak, tell your doctor or pharmacist.
If you take more PRAVASTATIN VIR than you should:
If you have taken more PRAVASTATIN VIR than you should, contact your doctor, pharmacist, or nearest hospital.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.
If you forget to take PRAVASTATIN VIR:
Do not take a double dose to make up for missed doses. Wait until your next scheduled dose.
4. Possible adverse effects
Like all medicines, PRAVASTATINA VIR may have adverse effects.
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 polyneuropathy, particularly when used for a prolonged period, and tingling sensation.
Frequency not known: myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).
Eye disorders:
Uncommon: visual disturbances (including blurred vision and double vision).
Frequency not known: ocular myasthenia (a disease causing weakness of the eye muscles).
Gastrointestinal disorders:
Uncommon: indigestion/heartburn, abdominal pain, nausea, vomiting, constipation, diarrhea, flatulence.
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, abnormalities of the hair and scalp (including hair loss).
Musculoskeletal and connective tissue disorders:
Very rare: rhabdomyolysis (destruction of muscle fibres), which may be associated with kidney disorders, myopathy (muscle disorders). Tendon abnormalities, sometimes complicated by tendon rupture.
Frequency not known: persistent muscle weakness, muscle rupture.
Renal and urinary disorders:
Uncommon: changes in urine elimination (such as difficulty urinating, increased frequency of urination, and increased frequency of urination at night).
Reproductive system and breast disorders:
Uncommon: sexual disturbances.
General disorders:
Uncommon: fatigue.
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).
Hepatic disorders:
elevations in serum transaminases (enzymes indicating liver disease).
Other possible adverse effects
- Sleep disorders, including insomnia and nightmares
- Memory loss
- Sexual dysfunction
- Depression
- Respiratory problems including persistent cough and/or difficulty breathing or fever
Diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.
If you notice any other adverse effects not described in this leaflet, consult your doctor or pharmacist.
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: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of PRAVASTATIN VIR
Keep out of the reach and sight of children.
Storage conditions
Do not store above 30°C.
Store in the original container, protected from light and moisture.
Expiry
Do not use after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater drains or household waste. Return unused medicines and their containers to the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This helps protect the environment.
6. ADDITIONAL INFORMATION
Composition of PRAVASTATIN VIR:
The active substance is sodium pravastatin. Each tablet contains 10 mg of sodium pravastatin.
The other components (excipients) are: monobasic anhydrous calcium phosphate, sodium glycolate starch from potato, microcrystalline cellulose, tromethamine, dibasic sodium phosphate dihydrate, polyvinylpyrrolidone K30, magnesium stearate, yellow iron oxide (E-172).
PRAVASTATIN VIR 10 mg is presented as yellow tablets. Each pack contains 28 tablets.
Other presentations:
PRAVASTATIN VIR 20 mg TABLETS EFG
PRAVASTATIN VIR 40 mg TABLETS EFG
Marketing Authorization Holder and Manufacturer:
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A.
C/ Laguna 66-68-70, Polígono Industrial Urtinsa II - 28923 ALCORCÓN (Madrid)
Manufacturer:
Industria Química y Farmacéutica VIR, S.A.
C/ Laguna 66-70, Polígono Industrial Urtinsa II - 28923 Alcorcón (Madrid)
or
SALUTAS PHARMA GmbH. Otto Von Guericke Alle 1. 39179 Barleben. GERMANY
Date of the most recent review of this leaflet: March 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