PRAVASTATIN Aurovitas 10 mg Tablets

2. What you need to know before you take Pravastatina Aurovitas

Do not takePravastatina Aurovitas

• if you are allergic to pravastatin or any of the other components of this medicine (listed in section 6).
• if you are pregnant, trying to become pregnant or are breastfeeding (see Pregnancy and Breastfeeding).
• if you have any liver disease (active liver disease).
• if several blood tests show abnormal liver function (elevated liver enzymes in the blood).

Warnings and precautions

Consult your doctor or pharmacist before starting to take the medicine if:

Before taking this treatment, you should consult your doctor if you suffer or have suffered from any of the following medical problems:

• kidney disease.
• hypothyroidism.
• liver disease or problems with alcohol (drinking large amounts of alcohol).
• muscle disorders caused by a hereditary disease.
• muscle problems caused by another medicine belonging to the group of statins (HMG-CoA reductase inhibitors) or belonging to the group known as fibrates (see Taking Pravastatina Aurovitas with other medicines).

Your doctor will perform a blood test before starting to take pravastatin and if you have any symptoms or liver problems during treatment. This is to check if your liver is working properly.

Your doctor may also need to perform a blood test after starting treatment with pravastatin to check liver function. The risk of muscle failure is higher in some patients. Consult your doctor in the following cases.

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 can cause serious muscle problems (rhabdomyolysis).

If you have suffered from any of these problems, or if you are over 70 years old, your doctor will perform a blood test before and probably during treatment. These blood tests will be used to evaluate the risk of you suffering from adverse muscular effects.

If you feel unexplained cramps or muscle pain during treatment, inform your doctor immediately.

If you have diabetes or are at risk of developing it, your doctor will closely monitor you during treatment with this medicine. You are likely to be at risk of developing diabetes if you have high levels of sugar and fat in the blood, are overweight, and have hypertension.

Also, inform your doctor or pharmacist if you have constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Consult your doctor before taking pravastatin.

• 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 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).

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

• have severe respiratory failure.

Taking Pravastatina Aurovitas with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Taking pravastatin with any of the following medicines may increase the risk of muscle problems:

• a medicine that lowers blood cholesterol levels (fibrates, e.g., gemfibrozil, fenofibrate).
• a medicine that lowers the body's defenses (ciclosporin).
• a medicine that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• colchicine (used to treat gout).
• nicotinic acid (used to treat high cholesterol in the blood).
• rifampicin (used to treat tuberculosis infection).
• lenalidomide (used to treat a type of blood cancer called multiple myeloma).

If you are also using a medicine to lower the levels of fat in your blood (such as a resin like cholestyramine or colestipol), this treatment should be taken at least one hour before or four hours after taking the resin. This is because the resin can affect the absorption of pravastatin if these two medicines are taken simultaneously.

Taking Pravastatina Aurovitas with food, drinks, and alcohol

This treatment can be taken with or without food, with a half glass of water.

You should reduce your alcohol consumption to a minimum. If you have doubts about how much alcohol you can drink while taking this medicine, you should consult your doctor.

Pregnancy, breastfeeding, and fertility

Pregnancy

Do not take pravastatin during pregnancy. If you discover that you are pregnant, you should inform your doctor immediately. Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Pravastatin should not be administered during breastfeeding as this treatment passes into breast milk.

Driving and using machines

Generally, pravastatin does not affect the ability to drive or use machines. However, if you experience dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are sure you can do so safely.

Pravastatina Aurovitas 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.

Pravastatina Aurovitas contains sodium

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

3. How to take Pravastatina Aurovitas

Your doctor will advise you on a low-fat diet, which you should follow throughout treatment.

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist again.

Pravastatin can be taken with or without food, with a half glass of water.

Dose

Adults:

• In the treatment of high levels of cholesterol and fat in the blood: the normal dose is 10-40 mg once a day, preferably at night.
• In the prevention of heart and blood vessel diseases: the normal dose is 40 mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatin. Your doctor will establish the suitable dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases cholesterol levels in the blood:

The recommended dose between 8 and 13 years is 10-20 mg once a day and the recommended dose between 14 and 18 years is 10-40 mg once a day.

After an organ transplant:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medicine that lowers the body's immune system (ciclosporin), your doctor may prescribe an initial dose of 20 mg once a day. This dose may be adjusted up to 40 mg by your doctor.

If you have kidney or severe liver disease, your doctor may prescribe a lower dose of pravastatin.

If you think the action of this treatment is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment

Your doctor will indicate the duration of treatment with pravastatin. This medicine should be taken regularly for the time that your doctor recommends, even if it is for a long period. Do not stop treatment on your own.

If you take more Pravastatina Aurovitas than you should

If you have taken more pravastatin than you should, or if someone has accidentally swallowed some tablets, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pravastatina Aurovitas

If you forget to take a dose, simply take your normal dose when it is time for the next one.

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Stop taking pravastatin and inform your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on palpation, weakness, or cramps, especially if you do not feel well or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and can cause a life-threatening kidney disease.

Serious and sudden allergic reactions such as swelling of the face, lips, tongue, or trachea can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. You should inform your doctor immediately if this happens.

The following side effects are uncommon and may affect up to 1 in 100 people:

• Effects on the nervous system: dizziness, fatigue, headache, sleep disorders, including insomnia.
• Effects on vision: blurred vision or double vision.
• Digestive effects: indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• Effects on the skin and hair: itching, acne, rash, hair and scalp problems (including hair loss).
• Urinary and genital effects: bladder problems (such as pain when urinating, frequent urination, needing to urinate at night) and sexual problems.
• Effects on muscles and joints: muscle and joint pain.

The following side effects are rare and may affect up to 1 in 1,000 people:

• Sensitivity of the skin to the sun

The following side effects are very rare and may affect up to 1 in 10,000 people:

• Effects on the nervous system: alterations in touch sensation, including burning or tingling or numbness, which could be indicative of nerve damage.
• Effects on the skin: a serious skin disease (lupus-like syndrome).
• Effects on the liver: liver or pancreas inflammation, jaundice (recognized by yellowing of the skin and the whites of the eyes), rapid destruction of liver cells (fulminant hepatic necrosis).
• Effects on muscles and bones: inflammation of one or more muscles that causes pain or muscle weakness (myositis, polymyositis, or dermatomyositis), pain or weakness in the muscles, tendon inflammation, which can be complicated by rupture.
• Altered blood tests: increased transaminases (a group of enzymes that occur naturally in the blood), which can be a sign of liver problems. Your doctor may want to perform periodic tests to monitor this.

If you think any of the side effects you are suffering from are serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Possible side effects

• Nightmares.
• Memory loss.
• 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 fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Side effects of unknown frequency (cannot be estimated from the available data):

• Constant muscle weakness, liver failure.
• Muscle rupture.
  • Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

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

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pravastatina Aurovitas

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

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from moisture.

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

6. Packaging Content and Additional Information

Composition ofPravastatina Aurovitas

• The active ingredient is pravastatine sodium. Each tablet contains 10 mg of pravastatine sodium.
• The other components are: microcrystalline cellulose, lactose monohydrate, heavy magnesium oxide, sodium croscarmellose, yellow iron oxide (E172), povidone K30, magnesium stearate.

Appearance of the Product and Packaging Content

Uncoated yellow tablets, capsule-shaped, biconvex, speckled, scored on both sides, with the mark "Y" on one side and "60" on the other. The tablet can be divided into equal doses.

Pravastatina Aurovitas is available in blister packs of 20, 28, 30, 60, and 98 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

or

Generis Farmacêutica, S.A.

Rua João de Deus, nº 19, Venda Nova

2700-487 Amadora

Portugal

This medicinal product is authorized in the Member States of theEconomic European Area under the following names:

Date of the last revision of this leaflet: March 2024

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