LIPLAT 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

LIPLAT 20 mg tablets

Pravastatin sodium

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Liplat is and what it is used for
2. What you need to know before you take Liplat
3. How to take Liplat
4. Possible side effects
5. Storing Liplat
6. Package contents and further information

1. What Liplat is and what it is used for

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

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

• Chest pain (angina), when a blood vessel of the heart is partially blocked.
• Heart attack (myocardial infarction), when a blood vessel of the heart is completely blocked.
• Stroke (cerebral infarction), when a blood vessel of the brain is completely blocked.

This medicine is indicated in three situations:

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

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

The 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 you suffering from a heart or blood vessel problem, and decreases the risk of dying from these diseases.

• If you have already suffered a stroke or suffer from chest pain (unstable angina), even with normal cholesterol levels, Liplat is indicated to reduce the risk of you 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 taking medication to prevent your body from rejecting the transplant, Liplat is indicated to reduce high levels of fat in the blood.

2. What you need to know before you take Liplat

Do not take Liplat

• If you are allergic (hypersensitive) to pravastatin sodium or any of the other components of this medicine (see Further information).

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

Warnings and precautions

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

• Kidney disease
• Decreased thyroid gland activity (hypothyroidism)
• Liver disease or alcohol problems (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 Using other medicines).

Your doctor will perform a blood test before you start taking Liplat 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 Liplat 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 Liplat can rarely 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 evaluate the risk of you suffering from muscle side effects.

If you experience unexplained muscle cramps or 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 blood sugar and fat levels, 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 problem.

Consult your doctor before taking Liplat.

Consult your doctor or pharmacist before taking Liplat if you

• Have severe respiratory failure.
• 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 (see section 4).

Other medicines and Liplat

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

Taking Liplat 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).
• An antibiotic (e.g., erythromycin or clarithromycin) used to treat bacterial infections.
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to restart treatment with Liplat. Taking Liplat with fusidic acid can rarely cause serious muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medicine used to treat gout)
• Nicotinic acid (a medicine used to treat high cholesterol)
• Rifampicin (a medicine used to treat tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).

If you are also using a medicine to lower your blood fat levels (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 Liplat if these two medicines are taken simultaneously.

Taking Liplat with food and drinks

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, consult your doctor.

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

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

Driving and using machines

Liplat normally does not affect your 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.

Important information about some of the ingredients of Liplat

Liplat contains lactose.

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

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

3. How to take Liplat

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

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

Liplat 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 sodium. Your doctor will determine the appropriate 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 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 severe kidney or liver disease, your doctor may prescribe a lower dose of Liplat.

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 your treatment with Liplat. 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 Liplat than you should

If you have taken more Liplat 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Liplat

If you forget to take a dose, simply take your normal dose when your next dose is due.

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

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

4. Possible side effects

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

Stop taking Liplat and inform your doctor immediatelyif you notice unexplained muscle pain or persistent weakness, 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.

Severe allergic reactions and sudden 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 (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, rash, blistering accompanied by itching,

abnormalities of the hair and scalp (including hair loss).

• Urinary and genital disorders:changes in urination (such as pain when urinating, frequent urination, and increased urination at night) and sexual problems.

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 touch sensation, including burning or tingling, or numbness, which indicates nerve damage.

Skin disorders:severe skin disorder (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 or dermatomyositis), pain or weakness in muscles, sprains, muscle strains, and muscle tears, tendon inflammation, sometimes complicated by rupture.
• Abnormal 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.

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

Constant muscle weakness, muscle rupture, liver failure.

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 any of the side effects get worse 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.
• Diabetes: it is more likely if you have high blood sugar and fat levels, are overweight, and have high blood pressure. Your doctor will monitor you during treatment with this medicine.

Reporting of side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, 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: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Liplat

Keep out of the sight and reach of children.

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

Do not store above 30°C.

Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Packaging Contents and Additional Information

Liplat Composition

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

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

Product Appearance and Packaging Contents

Liplat 20 mg tablets are presented in the form of a yellow, oblong, biconvex tablet, with a small lateral notch, anagram "LIPLAT-20" on one face, anonymous on the other. Each package contains 28 tablets.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Esteve Pharmaceuticals, S.A.

Passeig de la Zona Franca, 109

08038 Barcelona

Spain

Manufacturer:

TOWA Pharmaceutical Europe, S.L.

c/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Date of the Last Revision of this Leaflet: March 2023

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