PRAVASTATIN NORMON 20 mg TABLETS

2. Before taking Pravastatina NORMON

Do not take Pravastatina NORMON

• If you are allergic (hypersensitive) to pravastatine sodium or any of the other components of Pravastatina NORMON (see Additional Information).
• If you are pregnant, plan 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).

Be careful with Pravastatina NORMON

Before taking this treatment, you should consult your doctor if you have or have had 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 other medicines).
• 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 Pravastatina NORMON can cause serious muscle problems (rhabdomyolysis).

If you have had 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 assess the risk of you suffering from muscle side effects.

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

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 or pharmacist before taking Pravastatina NORMON if you:

• Have severe respiratory failure.
• 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).

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

Use of other medicines

When combined with this treatment, the following medicines may increase the risk of muscle problems(see Possible side effects). It is essential that you inform your doctor if you are being treated with:

• a medicine that lowers cholesterol levels in the blood (fibrates, for example, gemfibrozil, fenofibrate);
• a medicine that lowers the body's defenses (cyclosporine);
• a medicine that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin);
• any other medicine that lowers cholesterol levels in your blood (nicotinic acid).

If you are also using a medicine to lower fat levels 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 Pravastatina NORMON if these two medicines are taken simultaneously.

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

Inform your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

Taking Pravastatina NORMON 20 mg with food and drinks

This medicine can be administered 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, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Do not take Pravastatina NORMON during pregnancy. If you discover that you are pregnant, inform your doctor immediately.

Breastfeeding

Pravastatina NORMON should not be administered during breastfeeding, as this treatment passes into breast milk.

Driving and using machines

Pravastatina NORMON does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are sure you can do so safely.

Pravastatina NORMON contains lactose

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

Pravastatina NORMON contains sodium

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

3. How to take Pravastatina NORMON

Your doctor will advise you on a low-fat diet, which you should continue until the end of treatment.

Follow the administration instructions of this Pravastatina NORMON exactly as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

Dose:

Adults:

• In the treatment of high cholesterol and fat levels 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 pravastatine sodium. Your doctor will determine 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 (cyclosporine), 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 severe kidney or liver disease, your doctor may prescribe a lower dose of Pravastatina NORMON.

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

Duration of treatment

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

If you take more Pravastatina NORMON than you should

If you have taken more Pravastatina NORMON 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, phone: 915 620 420, indicating the medicine and the amount taken.

If you forget to take Pravastatina NORMON

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 interrupt treatment with Pravastatina NORMON

Always consult your doctor if you want to interrupt treatment.

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

4. Possible side effects

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

Stop taking Pravastatina NORMON 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 kidney disease that can be life-threatening.

Severe 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 more than 1 in 1000 people:

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders
• Eye disorders:blurred vision or double vision;
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.

• Hepatobiliary disorders:Very rare: jaundice (yellowing of the skin), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).
• Skin and hair disorders:itching, rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:changes in urination (such as difficulty urinating, frequent urination, and increased urination at night) and sexual problems.
• Muscle and joint disorders:muscle and joint pain.

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

• Nervous system disorders: alterations in touch sensation, including burning or tingling, or numbness, which indicates nerve damage;
• Skin disorders: severe skin alteration (lupus-like syndrome);
• Liver disorders: liver inflammation or pancreatitis; jaundice (recognized by yellowing of the skin and whites of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Muscle and bone disorders: inflammation of one or more muscles causing pain or muscle weakness (myositis or polymyositis); pain or weakness in muscles, tendon inflammation, sometimes complicated by rupture.

Altered blood tests: increased transaminases (a group of blood enzymes) that may be a sign of liver problems. Your doctor may want to perform periodic tests to monitor this.

Frequency not known: Muscle weakness, 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 experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

If you consider that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 sugar and fat levels 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 type of side effect, consult your doctor or pharmacist, even if it is a side effect not mentioned in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Pravastatina NORMON

Keep out of the reach and sight of children.

Do not store above 30°C.

Do not use Pravastatina NORMON after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packaging and medicines you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Additional information

Composition of Pravastatina NORMON

The active ingredient is pravastatine sodium. Each tablet contains 20 mg of pravastatine sodium.

The other components are: lactose monohydrate (see section 2: 'Pravastatina NORMON contains lactose'), microcrystalline cellulose, yellow iron oxide (E-172), sodium croscarmellose (see section 2: 'Pravastatina NORMON contains sodium'), magnesium stearate, colloidal silica, and heavy magnesium carbonate.

Appearance of the product and packaging content

Pravastatina NORMON 20 mg is presented in tablet form. The tablets are yellow, round, biconvex, and scored. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

OTHER PRESENTATIONS

Pravastatina NORMON 10 mg tablets.

Pravastatina NORMON 40 mg tablets.

Date of the last revision of this leaflet: March 2024

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.gov.es/.