Package Insert: Information for the User

LIPLAT 40 mg Tablets

Pravastatina Sodica

Read this package insert carefully before starting to take the medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others who have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not mentioned in this package insert. See section 4.

1. What is Liplat and what it is used for

2. What you need to know before taking Liplat

3. How to take Liplat

4. Possible adverse effects

5. Storage of Liplat

6. Contents of the package and additional information

Liplat belongs to a group of medications known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver and as a consequence reduces levels of cholesterol and other fats (triglycerides) in the body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, obstructing them.

This situation is known as hardening of the arteries or atherosclerosis and can lead to:

• Chest pain (angina pectoris), when a coronary artery is partially obstructed.
• Heart attack (myocardial infarction), when a coronary artery is completely obstructed.
• Stroke (cerebral infarction), when a cerebral artery is completely obstructed.

This medication is indicated in three situations:

In the treatment of high levels of cholesterol and fats in the blood

Liplat is indicated to reduce high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.

Prevention of heart and blood vessel diseases

• If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little exercise), Liplat is indicated to reduce the risk of suffering a heart and blood vessel problem, and decreases the risk of dying from these diseases.

• If you have already suffered a stroke or have chest pain (unstable angina), even with normal cholesterol levels, Liplat is indicated to reduce the risk of suffering another heart attack or stroke in the future, and decreases the risk of dying from these diseases.

After an organ transplant

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Liplat is indicated to reduce elevated levels of fat in the blood.

Do not take Liplat

• If you are allergic (hypersensitive) to pravastatin sodium or to any of the other components of this medication (see Additional Information).

• If you are pregnant, intend to become pregnant or if you are breastfeeding (see Pregnancy and Breastfeeding).
• If you have any liver disease (active liver disease).
• If several blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and Precautions

Before taking this treatment, you must consult your doctor if you have or have had any of the following medical conditions:

• Kidney disease
• Decreased activity of the thyroid gland (Hypothyroidism)
• Liver disease or problems with alcohol (drinking large amounts of alcohol)
• Muscular alterations caused by a hereditary disease
• Muscle problems caused by another medication belonging to the group of statins

(medications inhibiting HMG-CoA reductase) or belonging to the group known as fibrates (see Use of Other Medications).

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

Your doctor may also need to perform a blood test after starting treatment with Liplat to check the functioning of your liver.

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 medication containing fusidic acid (used for the treatment of bacterial infections) by oral or injection route. The combination of fusidic acid and Liplat may produce severe 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 evaluate the risk of you experiencing adverse muscle 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 perform a careful control during treatment with this medication. You are likely to be at risk of developing diabetes if you have high levels of sugar and fats in your blood, overweight and high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

Consult your doctor before taking Liplat.

Consult your doctor or pharmacist before taking Liplat if you

• Have severe respiratory failure.
• Have or have had myasthenia (a disease that involves 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).

Other Medications and Liplat

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

The administration of Liplat with any of the following medications may increase the risk of muscle problems:

• A medication that lowers cholesterol levels in the blood (fibrates, e.g. gemfibrozil, fenofibrate).
• A medication that lowers the body's defenses (ciclosporin).
• A medication that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medication. Your doctor will indicate when it is safe to resume treatment with Liplat. Taking Liplat with fusidic acid may produce rare muscle weakness, sensitivity or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medication used to treat gout)
• Nicotinic acid (a medication used to treat high cholesterol levels in the blood)
• Rifampicin (a medication used to treat the infection called tuberculosis)
• Lenalidomide (a medication used to treat a type of blood cancer called multiple myeloma).

If you are also using a medication to lower fat levels in your blood (of the type resin such as 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 may affect the absorption of Liplat if these two medications are taken simultaneously.

Taking Liplat with Food and Drinks

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

You should reduce your alcohol consumption to a minimum. If you have any doubts about how much alcohol you can drink while on treatment with this medication, consult your doctor.

Pregnancy

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

Consult your doctor or pharmacist before using any medication.

Lactation

Liplat should not be administered during the lactation period as this treatment passes into breast milk.

Driving and Operating Machines

Liplat usually does not affect your ability to drive or operate machines. However, if you experience symptoms of dizziness, blurred vision or double vision during treatment, do not drive or operate machines until you are sure you are able to do so.

Important Information about Some of the Components of Liplat

Liplat contains lactose.

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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

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

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

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

Dosage

Adults:

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

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

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

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 medication that reduces the body's immune system (ciclosporina), 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 Liplat.

If you estimate that the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.

Treatment duration

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

If you take more Liplat than you should

If you have taken more Liplat than you should, or if someone 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Liplat

If you forgotto take a dose, simply take your normal dose when it is due next.

Do not take a double dose to compensate for the missed doses.

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

Like all medicines, Liplat may cause side effects, although not everyone will experience them.

Stop taking Liplat and tell your doctor immediatelyif you notice unexplained or persistent muscle pain, weakness or cramps, especially if you do not feel well or have a fever at the same time.

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

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

The following side effects are infrequent (may affect up to 1 in 100 people):

• Nervous system disorders:dizziness, fatigue, headache, sleep disorders, including insomnia.
• Eye disorders:blurred vision or double vision.
• Gastrointestinal disorders:indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• Skin and hair disorders:itching, acne, skin rash, appearance of blisters

accompanied by itching, hair and scalp abnormalities (including hair loss).

• Urinary and genital disorders:alterations in urine elimination (such as pain while urinating, urinating more frequently and urinating more frequently at night) and sexual problems.
• Musculoskeletal and connective tissue disorders:muscle and joint pain.

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

• Sensitivity to sunlight

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

• Nervous system disorders:alterations in the sense of touch including sensation of

burning or tingling, or numbness which indicates nerve damage.

• Skin disorders:severe skin alteration(lupus erythematosus-like syndrome),
• Hepatic disorders:inflammation of the liver or pancreas, jaundice (recognized by yellow coloration of the skin and the white of the eyes), rapid destruction of liver cells (fulminant hepatic necrosis).

• Musculoskeletal and connective tissue disorders:inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis or dermatomyositis), muscle pain or weakness,muscle strains, muscle tears,inflammation in tendons, sometimes complicated with rupture.
• Abnormal blood test results:increase in transaminases (a group of blood enzymes) which may be a sign of liver problems. Your doctor may want to perform periodic tests to monitor it.

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

Constant muscle weakness, muscle rupture, liver failure.

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

Myasthenic eye (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 eyelid drooping, difficulty swallowing or difficulty breathing.

If any of the side effects worsen or if you experience any side effect not listed in this leaflet, inform your doctor or pharmacist.

The following adverse reactions have been reported with some statins:

• Nightmares

• Memory loss

• Depression

• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Dyslipidemia: it is more likely if you have high blood sugar and fat levels, obesity, and hypertension. Your doctor will monitor you during treatment with this medication.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse reactions, you can contribute to providing more information on the safety of this medication.

Keep out of sight and reach of children.

Do not use this treatment after the expiration date that appears on the carton and blister pack after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above25°C.

Store in the original packagingto protect it from light and humidity.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. In case of doubtask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Liplat

• The active ingredient is pravastatina sodium. Each tablet contains 40 mg of pravastatina sodium.

• The other components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, povidone, magnesium stearate, heavy magnesium oxide (E-530) and yellow iron oxide (E-172)

Appearance of the product and content of the packaging

Liplat 40 mg tablets are presented in the form of a yellow, oblong, biconvex, anonymous tablet on one side and the anagram “LIPLAT-40” on the other.,Cada envase contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Responsible for manufacturing:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Last review date of this leaflet: March 2023

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/