LIPLAT 20 MG TABLETS

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to other people, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Liplat is and what it is used for
2. What you need to know before taking Liplat
3. How to take Liplat
4. Possible side effects
5. How to store Liplat
6. Contents of the pack and other 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 liver from producing cholesterol and consequently reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol builds up in the walls of blood vessels, causing them to become narrowed.

This condition is known as hardening of the arteries or atherosclerosis and may lead to:

• Chest pain (angina pectoris), 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 (cerebrovascular accident), when a blood vessel in 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 lower 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 promote these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little physical exercise), Liplat is indicated to reduce the risk of developing heart and blood vessel problems, and reduces the risk of dying from these diseases.

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

After organ transplantation

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.

2. What you need to know before taking Liplat

Do not take Liplat

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

• If you are pregnant, planning to become pregnant, or are breastfeeding (see Pregnancy and Breastfeeding).

• If you have any liver disease (active liver disease).

• If repeated blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and precautions

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

• Kidney disease
• Reduced activity of the thyroid gland (hypothyroidism)
• Liver disease or problems related to alcohol (drinking large amounts of alcohol)
• Muscle disorders caused by an inherited disease
• Muscle problems caused by another medicine belonging to the statin group
  (medicines that are HMG-CoA reductase inhibitors) or to the group known as fibrates (see Use of other medicines).

Your doctor will perform a blood test before you start taking Liplat and if you develop any symptoms or liver problems during treatment. This is to check whether your liver is functioning properly.

Your doctor may also need to carry out blood tests after you start treatment with Liplat to monitor your liver function.

The risk of muscle damage is higher in some patients. Consult your doctor in the following cases:

If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Liplat can cause serious muscle problems (rhabdomyolysis).

If you have had any of these problems, or if you are over 70 years of age, your doctor will perform blood tests before and probably during treatment. These blood tests will be used to assess your risk of developing adverse muscle effects.

If you experience 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 monitor you carefully during treatment with this medicine. You may be at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Consult your doctor before taking Liplat.

Consult your doctor or pharmacist before taking Liplat if you

• Have severe respiratory insufficiency.
• Have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Other medicines and Liplat

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

Taking Liplat together 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 suppresses the body's immune defenses (cyclosporine).
• A medicine used to treat bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Liplat treatment. Taking Liplat with fusidic acid may rarely cause muscle weakness, tenderness, 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 blood cholesterol)
• Rifampicin (a medicine used to treat the infection called tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).

If you are also taking a medicine to lower fat levels in your blood (a resin-type 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 interfere with the absorption of Liplat if both medicines are taken at the same time.

Taking Liplat with food and drinks

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

You should minimize your alcohol consumption. If you have any doubts about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy

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

Consult your doctor or pharmacist before using any medicine.

Breastfeeding

Liplat must not be administered during breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Liplat usually does not affect your ability to drive or operate machinery. However, if you experience symptoms such as dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are certain you are able to do so safely.

Important information about some of the components of Liplat

Liplat contains lactose.

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Liplat

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

Always follow exactly the instructions provided by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist.

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

Dosage

Adults:

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

The maximum daily dose of 40 mg of pravastatin sodium must not be exceeded. Your doctor will determine the appropriate dose for you.

Children (8–13 years) and adolescents (14–18 years) with a hereditary condition causing high blood cholesterol levels:

The recommended dose for children aged 8–13 is 10–20 mg once daily. The recommended dose for adolescents aged 14–18 is 10–40 mg once daily.

After organ transplantation:

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

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

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

If you think that the effect of this medicine is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

Your doctor will tell you how long you should take Liplat. This medicine should be taken regularly for the duration recommended by your doctor, even if this is for a long period. Do not stop treatment prematurely 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 any tablets, contact your doctor, pharmacist, or nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Liplat

If you forget to take a dose, simply take your next dose at the usual time.

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

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

4. Possible adverse effects

Like all medicines, Liplat may have adverse effects, although not everyone gets them.

Stop taking Liplat and tell your doctor immediately if you experience unexplained or persistent muscle pain, weakness or cramps, especially if you also feel unwell or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and may lead to kidney disease that can be life-threatening.

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

The following adverse 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 flatulence.

• 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: disturbances in urination (such as pain

when urinating, increased frequency of urination and increased frequency of urination at night) and sexual problems.

• Muscle and joint disorders: muscle and joint pain.

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

• Skin sensitivity to sunlight

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

• Nervous system disorders: disturbances in the sense of touch including burning sensations, tingling, or numbness indicating nerve damage.

• Skin disorders: severe skin reaction (lupus-like syndrome).

• Liver disorders: inflammation of the liver or pancreas, 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 muscle pain or weakness (myositis, polymyositis or dermatomyositis), muscle pain or weakness, sprains, muscle tears and muscle ruptures, tendon inflammation, sometimes complicated by tendon rupture.

• Abnormal blood test results: increased transaminases (a group of blood enzymes) which may indicate liver problems. Your doctor may wish to perform periodic tests to monitor this.

Adverse effects with frequency not known (cannot be estimated from available data):

Persistent muscle weakness, muscle rupture, liver failure.

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

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

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

If any of the side effects worsen or if you experience any side effects 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: more likely if you have high levels of sugar and fats in the blood, are overweight, or have hypertension. Your doctor will monitor you during treatment with this medicine.

Reporting of adverse effects

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

5. Storage of Liplat

Keep out of the sight and reach of children.

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

Do not store above 30°C.

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

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

6. Contents of the pack and other information

Composition of Liplat

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

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

Appearance of the product and contents of the pack

Liplat 20 mg tablets are yellow, oblong, biconvex tablets with a small lateral notch, imprinted with the anagram “LIPLAT-20” on one side and blank on the other. Each pack 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 most recent revision of this leaflet: March 2023

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