Package Leaflet: Information for the User

PravastatinQualigen20mg film-coated tablets EFG

(pravastatin sodium)

Read this 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. Do not pass it on to others even if their symptoms are the same as yours, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist. See section 4.

Pravastatina Qualigen are tablets that contain pravastatina as the active ingredient.

Pravastatina Qualigen belongs to a group of medications known as HMG-CoA reductase inhibitors (or statins). This group of medications 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 suffering a heart attack if you have high cholesterol levels but do not have coronary heart disease.
• Pravastatina Qualigen reduces high lipid levels if you are receiving immunosuppressive treatment.

If you are taking pravastatina, your doctor will inform you of other complementary aspects of your treatment, such as following a low-fat diet and exercising.

Do not take Pravastatina Qualigen

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

if you have liver disease or have high levels of liver enzymes in the blood.

Warnings and precautions

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

If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

• if you have liver disease or have high levels of liver enzymes in the blood. In this case, contact your doctor as pravastatina may increase the concentration of these enzymes.
• if you have kidney disease, as the effects of pravastatina may be potentiated.
• in case of unexplained muscle aches, consult your doctor as pravastatina may cause muscle symptoms, such as pain, hypersensitivity, weakness or cramps.
• in the case of elderly patients, it may be necessary to perform tests to evaluate the risk of possible adverse reactions.
• if you have reduced thyroid activity.
• in the case of children under 18 years, the doctor must evaluate the risk-benefit ratio of treatment before starting it.
• in the case of familial hypercholesterolemia.

Consult your doctor or pharmacist before taking Pravastatina Qualigen if you:

• have severe respiratory failure.

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

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this condition. Or if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Pravastatina Qualigen may cause severe muscle problems (rhabdomyolysis).

Use of Pravastatina Qualigen with other medicines

It is essential to inform your doctor if you are receiving treatment with medicines to reduce cholesterol (fibrates, for example, gemfibrozil or fenofibrate), with immunosuppressants after an organ transplant (ciclosporin) or with antibiotics (erythromycin or clarithromycin), as the combination of these medicines may increase the risk of developing muscle problems. If you are also taking medicines to reduce lipids (grasas) (cholestyramine or colestipol), pravastatina should be taken normally at least one hour before or four hours after taking the resin. The reason is that the resin may affect the absorption of pravastatina if the two medicines are taken in a very short time interval.

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

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

If you are taking a medicine used to treat and prevent the formation of blood clots called "vitamin K antagonist," consult your doctor before taking pravastatina because the use of vitamin K antagonists concomitantly with pravastatina may increase the results of blood tests used to monitor treatment with vitamin K antagonists.

If you need to take fusidic acid to treat a bacterial infection, you will need to stop taking this medicine. Your doctor will indicate when you can restart the treatment with Pravastatina Qualigen. The use of Pravastatina Qualigen with fusidic acid may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Use of Pravastatina Qualigen with food, drinks and alcohol

Pravastatina Qualigencan be taken with or without food.

Patients who consume large amounts of alcohol regularly 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 should not be used during pregnancy.

If a patient plans to become pregnant or becomes pregnant, she must inform the doctor immediately and must interrupt the treatment with pravastatina, due to the possible risk to the fetus.

It is recommended to take special care with adolescents of childbearing age to ensure that they understand the possible risk associated with treatment with pravastatina during pregnancy.

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

Consult your doctor or pharmacist before using any medicine.

Driving and operating machinery

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

Pravastatina Qualigen contains lactose

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

Pravastatina Qualigen contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.

The usual dose of Pravastatina Qualigen is 10-40 mg once a day, preferably 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 to 40 mg).

Use in children and adolescents

In children and adolescents with hypercholesterolemia aged 8 to 13 years, the recommended dose is between 10 and 20 mg, once a day, and in children and adolescents aged 14 to 18 years, the recommended dose is between 10 and 40 mg, once a day (in adolescents at risk of 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.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forget to take Pravastatina Qualigen

Take the next dose when it is due. Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Pravastatina Qualigen

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

Like all medicines, Pravastatina Qualigen can cause side effects, although not everyone will experience them.

They are infrequent (occurring in 1 to 10 patients out of every 1000), although some people experience dizziness, headache, sleep disturbances, insomnia, visual disturbances, mild digestive disorders (heavy and painful digestion, abdominal pain, stomach burning, nausea, vomiting, constipation, diarrhea, flatulence), itching, rash, urticaria, hair and scalp abnormalities, urinary disorders, sexual dysfunction, and fatigue.

It may also appear as an increase in liver enzymes in the serum, muscle pain, weakness, hypersensitivity, or muscle cramps. Very rarely, this can lead to a serious and potentially fatal condition called rhabdomyolysis.

In very rare cases (less than 1 patient in 10,000), it is possible for adverse reactions of the nervous system to appear, such as an abnormal sensation of tingling, sensations of numbness or tingling (which may indicate nerve 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 inflammation or hepatobiliary disease, such as jaundice (yellowing of the skin and white of the eyes) and hepatitis.

Adverse reactions of unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Myasthenia gravis (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Muscle rupture.

With some statins, the following adverse reactions have been reported:

- Sleep disturbances, including insomnia and nightmares

- Memory loss

- Difficulty with sexual practice

- Depression

- Respiratory problems, including persistent cough or shortness of breath or fever

Adverse effects of unknown frequency: Constant muscle weakness.

Other possible adverse effects:

- Diabetes mellitus: the frequency will depend on the presence or absence of risk factors (fasting glucose at 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 that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not store at a temperature above 25°C. Store in the original packaging well closed.

Expiration Date:

Do not usethis medicationafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Pravastatina Qualigen 20 mg tablets

• The active ingredient is pravastatina.

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

Appearance of the product and contents of the packaging

Pravastatina Qualigen is presented in the form of white, oblong, convex, and scored tablets on both faces, packaged in high-density polyethylene bottles, opaque and white in color; with a silica stopper and safety closure.

Each package contains 7, 20, 28, 30, 50, 60, and 100 tablets.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization and responsible manufacturer

Holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua da Tapada Grande, nº 2, 2710-089 Abrunheira, Sintra

Portugal

Last review date of this leaflet: May 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/