Pravastatin Qualigen 20 mg tablets EFG

Patient Information Leaflet

Introduction

Package leaflet: Information for the user

PravastatinaQualigen 20 mg tablets EFG

(pravastatin sodium)

Read this entire leaflet carefully before you start taking this medicine, as 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.

Leaflet contents

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

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

Pravastatina Qualigen are tablets containing pravastatin as the active substance.

Pravastatina Qualigen belongs to a group of medicines known as HMG-CoA reductase inhibitors (or statins). This group of medicines reduces the production of LDL-cholesterol (bad cholesterol) and increases the concentrations of HDL-cholesterol (good cholesterol).

Pravastatina Qualigen is used in the following situations:

• Pravastatina Qualigen reduces the risk of cardiovascular events (myocardial infarction, stroke).
• Pravastatina Qualigen prevents the risk of having a heart attack, if you have high cholesterol levels but do not have coronary heart disease.
• Pravastatina Qualigen reduces elevated lipid levels if you are receiving immunosuppressive treatment.

If you are taking pravastatin, your doctor will advise you on additional measures to complement your treatment, such as following a low-fat diet and engaging in physical exercise.

2. What you need to know before taking Pravastatina Qualigen

Do not take Pravastatina Qualigen

• if you are allergic to pravastatin or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or planning to become pregnant.
• if you are breastfeeding.

if you have liver disease or elevated serum liver enzymes.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting Pravastatina Qualigen.

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).

• if you have liver disease or elevated serum liver enzymes. In this case, contact your doctor, as pravastatin may increase the levels of these enzymes.
• if you have kidney disease, as the effects of pravastatin may be enhanced.
• if you experience unexplained muscle disorders, consult your doctor, as pravastatin may cause muscle-related symptoms such as pain, tenderness, weakness, or cramps.
• in elderly patients, tests may be necessary to assess the risk of possible adverse reactions.
• if you have reduced thyroid activity.
• in children under 18 years of age, the doctor must evaluate the risk/benefit ratio of treatment before starting therapy.
• in cases of homozygous familial hypercholesterolemia.

Talk to your doctor or pharmacist before taking Pravastatina Qualigen if you:

• suffer from 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 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 issue. Or if you are taking or have taken within the last 7 days an oral or injectable medication containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Pravastatina Qualigen may cause serious muscle problems (rhabdomyolysis).

Taking Pravastatina Qualigen with other medicines

It is important that you inform your doctor if you are being treated with medicines to lower cholesterol (fibrates, for example, gemfibrozil or fenofibrate), immunosuppressants after organ transplantation (cyclosporine), or antibiotics (erythromycin or clarithromycin), as combining these medicines may increase the risk of developing muscle problems. If you are also taking lipid-lowering (fat-reducing) medicines (cholestyramine or colestipol), pravastatin should usually be taken at least one hour before or four hours after taking the resin. This is because the resin may affect the absorption of pravastatin if both medicines are taken too close together.

Pravastatin does not interact with the following medicines: antacids, acetylsalicylic acid (anti-inflammatory), diltiazem (antihypertensive), verapamil (antihypertensive and antiarrhythmic), fluconazole, itraconazole, and ketoconazole (antifungals).

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

If you are taking a medicine used to treat and prevent blood clots called a “vitamin K antagonist,” consult your doctor before taking pravastatin, as using vitamin K antagonists together with pravastatin may increase the results of blood tests used to monitor vitamin K antagonist therapy.

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

Taking Pravastatina Qualigen with food, drinks, and alcohol

Pravastatina Qualigen may be taken with or without food.

Patients who regularly consume large amounts of alcohol should not take Pravastatina Qualigen.

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.

Pravastatina Qualigen must not be used during pregnancy.

If a patient plans to become pregnant or becomes pregnant, she must inform her doctor immediately and discontinue treatment with pravastatin due to the potential risk to the fetus.

Special care should be taken with fertile adolescents to ensure they understand the potential risks associated with pravastatin treatment during pregnancy.

It is recommended not to take Pravastatina Qualigen if you plan to breastfeed, as pravastatin passes into breast milk.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pravastatina Qualigen normally does not affect the ability to drive or operate machinery. However, if you drive or operate machinery, remember that dizziness may occur during treatment.

Pravastatina Qualigen contains lactose

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

Pravastatina Qualigen contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; thus, it is essentially “sodium-free.”

3. How to take Pravastatina Qualigen

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

The usual dose of Pravastatina Qualigen is 10–40 mg once daily, preferably taken at night.

After an organ transplant, your doctor will prescribe the appropriate dose (usually an initial dose of 20 mg/day, which may be adjusted up to 40 mg).

Use in children and adolescents

In children and adolescents with hypercholesterolemia aged 8 to 13 years, the recommended dose is 10 to 20 mg once daily. In children and adolescents aged 14 to 18 years, the recommended dose is 10 to 40 mg once daily (in adolescents with potential for pregnancy, see "Pregnancy and breastfeeding").

If you take more Pravastatina Qualigen than you should

If you have taken too many tablets, or if someone accidentally swallows some, contact your doctor or go to the nearest hospital immediately.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Pravastatina Qualigen

Take the next dose at the scheduled time. Do not take a double dose to make up for a missed dose.

If you stop taking Pravastatina Qualigen

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

4. Possible adverse effects

Like all medicines, Pravastatin Qualigen may cause adverse effects, although not everyone experiences them.

Uncommon (occurring in 1 to 10 out of 1,000 patients), although some people may experience dizziness, headache, sleep disorders, insomnia, visual disturbances, mild digestive disorders (indigestion, abdominal pain, stomach burning, nausea, vomiting, constipation, diarrhoea, flatulence), itching, rash, urticaria, hair and scalp abnormalities, urinary disorders, sexual dysfunction, and fatigue.

Elevated liver enzymes in the blood, muscle pain, weakness, hypersensitivity, or cramps may also occur. Very rarely, this may lead to a serious and potentially fatal condition called rhabdomyolysis.

Very rarely (less than 1 in 10,000 patients), adverse reactions affecting the nervous system may occur, such as abnormal burning sensations, tingling or numbness (which may indicate nerve ending damage); severe allergic reactions, including localized swelling of the face, lips, or tongue, arms and legs, severe skin rash; or gastrointestinal disorders such as pancreatitis, or hepatobiliary disorders such as jaundice (yellowing of the skin and whites of the eyes) and hepatitis.

Adverse reactions with unknown frequency:

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).

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.

Muscle rupture.

The following adverse reactions have been reported with some statins:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Difficulties with sexual performance
• Depression
• Respiratory problems including persistent cough, shortness of breath, or fever

Adverse effects of unknown frequency: Persistent muscle weakness.

Other possible adverse effects:

• Diabetes mellitus: frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/l, BMI > 30 kg/m², elevated triglycerides, history of hypertension).
  • Dermatomyositis (a condition characterized by inflammation of the muscles and skin).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 Medicinal Products: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatin Qualigen

Keep this medicine out of sight and reach of children.

Do not store above 25°C. Store in the original container, tightly closed.

Expiry:

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatin Qualigen 20 mg tablets

• The active substance is pravastatin.

The other components are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc and anhydrous disodium phosphate.

Appearance of the medicine and contents of the pack

Pravastatin Qualigen is presented as white, oblong, convex tablets, scored on both sides, packed in opaque white high-density polyethylene bottles with a silica-containing cap and child-resistant closure.

Each pack contains 7, 20, 28, 30, 50, 60 or 100 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua da Tapada Grande, nº 2, 2710-228 Abrunheira, Sintra
Portugal

Date of the most recent review of this leaflet: May 2022

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