PRAVASTATIN QUALIGEN 10 mg TABLETS

2. What you need to know before taking Pravastatin Qualigen

Do not take Pravastatin 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 breast-feeding.

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

Warnings and precautions

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

If you have or have had myasthenia (a disease that causes 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 worsen the disease or cause myasthenia to appear (see section 4).

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

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

• have severe respiratory failure.

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 sugar and fat in your blood, are overweight, and have high blood pressure.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Further tests and medication 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) orally or by injection. The combination of fusidic acid and Pravastatin Qualigen can cause serious muscle problems (rhabdomyolysis).

Using Pravastatin Qualigen with other medicines

It is important 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 (cyclosporin) or with antibiotics (erythromycin or clarithromycin), as the combination of these medicines can increase the risk of developing muscle problems. If you are also taking medicines to reduce lipids (fats) (cholestyramine or colestipol), pravastatin should be taken at least one hour before or four hours after taking the resin. The reason is that the resin can affect the absorption of pravastatin if the two medicines are taken in a short time interval.

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

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.

If you are taking a medicine used to treat and prevent blood clot formation called a "vitamin K antagonist", consult your doctor before taking pravastatin, as the use of vitamin K antagonists concomitantly with pravastatin 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 have to stop using this medicine. Your doctor will tell you when you can restart treatment with Pravastatin Qualigen. The use of Pravastatin Qualigen with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Using Pravastatin Qualigen with food, drinks, and alcohol

Pravastatin Qualigen can be taken with or without food.

Patient who regularly consume large amounts of alcohol should not take Pravastatin Qualigen.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pravastatin Qualigen should not be used during pregnancy.

If a patient is planning to become pregnant or becomes pregnant, she should inform her doctor immediately and should stop treatment with pravastatin, due to the possible risk to the fetus.

Special care should be taken with adolescent girls of childbearing age to ensure they understand the possible risk associated with treatment with pravastatin during pregnancy.

Pravastatin Qualigen should not be taken if you are breast-feeding, as pravastatin passes into breast milk.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Pravastatin Qualigen does not normally affect the ability to drive or use machines. However, if you drive or use machines, remember that during treatment, dizziness can occur.

Pravastatin Qualigen contains lactose

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

Pravastatin Qualigen contains sodium

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

3. How to take Pravastatin Qualigen

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The usual dose of Pravastatin Qualigen is 10-40 mg once a day, preferably in the evening.

After an organ transplant, your doctor will prescribe the appropriate dose (usually an initial dose of 20 mg/day, which can 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 10-20 mg once a day, and in children and adolescents aged 14 to 18 years, the recommended dose is 10-40 mg once a day (in adolescents at risk of pregnancy, see "Pregnancy and lactation").

If you take more Pravastatin 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 Toxicology Information Service. Telephone: 91 562 0420.

If you forget to take Pravastatin Qualigen

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

If you stop taking Pravastatin Qualigen

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

4. Possible side effects

Like all medicines, Pravastatin Qualigen can cause side effects, although not everybody gets them.

They are uncommon (affecting 1 to 10 people in every 1000), but some people may experience dizziness, headache, sleep disorders, insomnia, vision changes, mild digestive disorders (indigestion, abdominal pain, heartburn, nausea, vomiting, constipation, diarrhea, flatulence), itching, rash, urticaria, hair and scalp disorders, urinary disorders, sexual dysfunction, and fatigue.

It can also cause an increase in liver enzymes in the blood, muscle pain, weakness, hypersensitivity, or cramps. Very rarely, this can lead to a serious and potentially life-threatening condition called rhabdomyolysis.

In very rare cases (less than 1 person in every 10,000), it is possible to experience adverse reactions of the nervous system, such as abnormal tingling, numbness, or tingling sensations (which can 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 or hepatobiliary disorders, such as jaundice (yellowing of the skin and the whites of the eyes) and hepatitis.

Adverse reactions with unknown frequency:

Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Ocular myasthenia (a disease that causes weakness of the eye muscles).

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

Muscle rupture.

Some statins have reported the following adverse reactions:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual difficulties
• Depression
• Respiratory problems, including persistent cough or shortness of breath or fever

Adverse reactions with unknown frequency: Constant muscle weakness.

Other possible side effects:

• Diabetes mellitus: the frequency will depend on the presence or absence of risk factors (fasting 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 side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

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

5. Storage of Pravastatin Qualigen

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

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

Expiry date:

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Pravastatin Qualigen 10 mg tablets

• The active ingredient is pravastatin.
• The other ingredients are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and anhydrous disodium phosphate.

Appearance of the product and packaging contents

Pravastatin Qualigen is presented in the form of white, oblong, convex, and scored tablets on both sides, packaged in high-density polyethylene bottles, opaque and white in color; with a silicone plug and safety cap.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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, Abrunheira, 2710-228 Sintra

Portugal

Date of last revision of this leaflet: May 2022

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