PRAVASTATIN KERN PHARMA 40 mg TABLETS
How to use PRAVASTATIN KERN PHARMA 40 mg TABLETS
Translated with AI
This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
Show originalContents of the leaflet
Introduction
Package Leaflet: Information for the Patient
Pravastatin Kern Pharma 40 mg Film-Coated Tablets
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
- What is Pravastatin Kern Pharma and what is it used for
- What you need to know before you take Pravastatin Kern Pharma
- How to take Pravastatin Kern Pharma
- Possible side effects
- Storage of Pravastatin Kern Pharma
- Contents of the pack and other information
1. What is Pravastatin Kern Pharma and what is it used for
Pravastatin belongs to a group of medicines known as statins, which lower the levels of LDL cholesterol (a type of harmful cholesterol) and triglycerides (a type of fat) in the blood.
Pravastatin Kern Pharma is indicated in:
Hyperlipidaemia:
If you have high levels of cholesterol and/or triglycerides in your blood, pravastatin is indicated to lower, in addition to diet, high levels of cholesterol (total and LDL) and triglycerides in patients with primary hypercholesterolaemia (elevated levels of cholesterol in the blood) and mixed dyslipidaemia (elevated levels of cholesterol and triglycerides in the blood) when diet or other non-drug treatments have not worked.
Primary prevention of coronary heart disease (obstruction or hardening of blood vessels that carry oxygen and nutrients to the heart):
If you are a male patient over 45 years of age, without a history of coronary heart disease, with moderate to severe hypercholesterolaemia and other cardiovascular risk factors such as smoking, diabetes mellitus, family history of premature coronary heart disease, minimal electrocardiographic changes, hypertension, or low levels of HDL (a type of beneficial cholesterol); pravastatin is indicated, in addition to a suitable diet, to prevent myocardial infarction.
Coronary heart disease:
If you have coronary heart disease and have moderate or high levels of cholesterol, Pravastatin Kern Pharma 40 mg is indicated, in addition to a suitable diet, to:
- prevent the risk of suffering a myocardial infarction,
- slow the progression of arteriosclerotic disease (obstruction and hardening of the arteries).
If you have had a myocardial infarction or unstable angina and have normal or high levels of cholesterol, Pravastatin Kern Pharma 40 mg is indicated to:
- reduce the risk of death,
- reduce the risk of death from coronary causes,
- reduce the risk of death from cardiovascular causes,
- prevent the risk of suffering a myocardial infarction,
- reduce the risk of stroke or transient ischaemic attack,
- reduce the need for surgical intervention to increase blood flow to the heart,
- reduce the need for hospitalization.
2. What you need to know before you take Pravastatin Kern Pharma
Do not take Pravastatin Kern Pharma
- if you are allergic to pravastatin sodium or any of the other ingredients of this medicine,
- if you have active liver disease or elevated transaminases (enzymes indicative of liver disease),
- if you are pregnant,
- if you are breast-feeding.
Warnings and precautions
Consult your doctor or pharmacist before taking this medicine.
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 (see section 4).
If you have had liver disease or have a history of alcoholism. Your doctor may perform a blood test to check liver function before and during treatment. If you notice any changes, your doctor may recommend stopping treatment.
Like other medicines that lower cholesterol levels, some patients may experience muscle pain, sensitivity, weakness, or cramps during treatment. If you experience any of these symptoms, you should inform your doctor immediately. 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.
You should also inform your doctor if you have kidney problems, hypothyroidism, a family history of or have previously had muscle disorders, or if you regularly consume alcohol.
Consult your doctor or pharmacist before taking Pravastatin Kern Pharma if you:
- have severe respiratory failure
- 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 Pravastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).
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 sugars and fats in the blood, are overweight, and have high blood pressure.
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 stopping treatment.
Inform your doctor if you are taking other medicines that can also cause muscle problems, such as:
- fibrates (lower cholesterol levels)
- nicotinic acid (lowers cholesterol levels)
- cyclosporin (prevents transplant rejection).
Consult your doctor if any of the above circumstances occur.
Use of other medicines
Inform your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription.
It is important that you inform your doctor if you are taking the following medicines:
- other medicines used to lower cholesterol levels, such as colestyramine, colestipol, or fibrates
- cyclosporin (a medicine used to prevent transplant rejection)
- warfarin (an oral anticoagulant).
Although no clinically significant interactions have been observed with pravastatin, it is advisable to inform your doctor if you are taking gemfibrozil; nicotinic acid; acetylsalicylic acid; antacids; cimetidine; probucol; phenytoin; quinidine; diuretics; medicines used to treat high blood pressure and other cardiovascular disorders, such as ACE inhibitors, digitalis, calcium antagonists, or nitroglycerin.
Also, although no clinically significant interactions have been observed when pravastatin was administered with medicines that are metabolized through the cytochrome P450 system (liver metabolic pathway), it is also advisable to inform your doctor if you are taking: certain heart medicines (diltiazem, verapamil), antifungal medicines (itraconazol, ketoconazol, fluconazol), HIV medicines (protease inhibitors), grapefruit juice, and certain antibiotics (erythromycin and clarithromycin).
If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Pravastatin Kern Pharma. The use of Pravastatin Kern Pharma with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Taking Pravastatin Kern Pharma with food and drinks
Pravastatin can be taken with or without food.
Pregnancy and breast-feeding
Pregnancy
Consult your doctor or pharmacist before taking a medicine.
Do not take this medicine during pregnancy. If you become pregnant or think you may be pregnant, stop taking the medicine and inform your doctor as soon as possible.
Breast-feeding
Consult your doctor or pharmacist before taking a medicine.
Do not take this medicine during breast-feeding.
Driving and using machines
At the recommended doses, this medicine does not affect the ability to drive or use machines.
3. How to take Pravastatin Kern Pharma
Follow exactly the instructions of administration of this medicine indicated by your doctor. If you are in doubt, consult your doctor or pharmacist again.
Your doctor will indicate the duration of the treatment. Do not stop the treatment without consulting your doctor.
The tablets should be swallowed with water and can be taken with or without food, preferably at bedtime.
The usual 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 10 mg of pravastatin once a day; patients treated with pravastatin and a resin (e.g. colestyramine), pravastatin should be administered 1 hour before or 4 hours after the resin.
Children:the administration of pravastatin is not recommended in individuals under 18 years of age, as its efficacy and safety have not been established in this age group.
Elderly patients; patients with renal impairment; patients with hepatic impairment:in patients with significant renal or hepatic impairment, as well as in the elderly, it is recommended to start treatment with a dose of 10 mg.
If you think that the action of this medicine is too strong or too weak, inform your doctor or pharmacist.
If you take more Pravastatin Kern Pharma than you should
If you have taken more pravastatin than you should, consult your doctor or pharmacist immediately.
In case of overdose or accidental ingestion, consult the Toxicological Information Service, telephone: 91 562 04 20.
If you forget to take Pravastatin Kern Pharma
Do not take a double dose to make up for forgotten doses.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
These side effects have been shown to be mild and short-lived.
The most frequently reported side effects are:
Nervous system disorders
Common: headache.
Frequency not known: severe myasthenia* (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
Eye disorders:
Frequency not known: ocular myasthenia* (a disease that causes 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: nausea, vomiting, diarrhoea.
Skin and subcutaneous tissue disorders
Common: skin rash.
Musculoskeletal, connective tissue and bone disorders
Common: muscle pain.
Uncommon: musculoskeletal pain, including joint pain, muscle cramps.
Frequency not known: constant muscle weakness, muscle rupture.
General disorders
Common: chest pain.
Uncommon: fatigue.
During the marketing of the medicine, very rare cases have been reported:
Immune system disorders
Very rare: hypersensitivity reactions accompanied by one or more of the following disorders: anaphylaxis, angioedema (swelling of the arms, legs, face, lips, tongue and/or throat), lupus-like syndrome (skin inflammation), photosensitivity, changes in blood cell count and modification of some parameter in your blood test, vasculitis (inflammation of blood vessels), dermatomyositis.
Musculoskeletal, connective tissue and bone disorders
Very rare: myopathy (muscle disorders), rhabdomyolysis (destruction of muscle fibers) with kidney disorders.
Nervous system disorders
Very rare: tingling sensation, cramps or numbness in arms or legs.
Pravastatin has been administered in combination with colestyramine, colestipol, nicotinic acid, and probucol. No adverse reactions due to combination therapy or additional to those described for each medicine alone have been reported.
The administration of pravastatin has not been associated with the development of cataracts.
Other possible side effects:
- Sleep disorders, including insomnia and nightmares
- Memory loss
- Sexual dysfunction
- Depression
- Respiratory problems, including persistent cough and/or difficulty breathing or fever.
Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
If you experience any side effect that is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.
Reporting of side effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) at www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Pravastatin Kern Pharma
Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package, protected from light and moisture.
Do not use this medicine after the expiry date which is stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.
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 Pravastatin Kern Pharma
- The active substance is pravastatin sodium.
- The other ingredients are: povidone, microcrystalline cellulose, yellow iron oxide E-172, disodium phosphate, magnesium stearate, trometamol, anhydrous calcium hydrogen phosphate, and sodium starch glycolate.
Appearance and packaging of the product
Each tablet contains 40 mg of pravastatin.
It is presented in the form of yellow tablets. Each pack contains 28 tablets.
Other presentations:
Pravastatin Kern Pharma 10 mg film-coated tablets
Pravastatin Kern Pharma 20 mg film-coated tablets
Marketing authorisation holder and manufacturer
Marketing authorisation holder
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Manufacturer
Kern Pharma, S.L.
Venus, 72 - Pol. Ind. Colón II
08228 Terrassa - Barcelona
Spain
Date of last revision of this leaflet: February 2024
Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es
- Country of registration
- Average pharmacy price16.3 EUR
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to PRAVASTATIN KERN PHARMA 40 mg TABLETSDosage form: TABLET, 10 mgActive substance: pravastatinManufacturer: Esteve Pharmaceuticals S.A.Prescription requiredDosage form: TABLET, 20 mgActive substance: pravastatinManufacturer: Esteve Pharmaceuticals S.A.Prescription requiredDosage form: TABLET, 40 mgActive substance: pravastatinManufacturer: Esteve Pharmaceuticals S.A.Prescription required
Online doctors for PRAVASTATIN KERN PHARMA 40 mg TABLETS
Discuss questions about PRAVASTATIN KERN PHARMA 40 mg TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.
Frequently Asked Questions
