Pravastatin Pharma Combix 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN PHARMA COMBIX 20 mg TABLETS EFG

Sodium Pravastatin

Contents of the leaflet:

1. What Pravastatina Pharma Combix is and what it is used for
2. Before taking Pravastatina Pharma Combix
3. How to take Pravastatina Pharma Combix
4. Possible side effects
5. Storage of Pravastatina Pharma Combix
6. Additional information

1. What Pravastatina Pharma Combix is and what it is used for

Pravastatina Pharma Combix 20 mg belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol and consequently reduces cholesterol and other fat levels (triglycerides) in your body. When there are excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, causing them to become blocked.

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

• chest pain (angina pectoris), when a blood vessel in the heart is partially blocked
• heart attack (myocardial infarction), when a blood vessel in 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.

Pravastatina Pharma Combix 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 cholesterol levels in the blood and risk factors that contribute to these diseases (such as smoking, being overweight, having high blood sugar or hypertension, or lack of physical activity), Pravastatina Pharma Combix 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 from chest pain (unstable angina), even with normal cholesterol levels, Pravastatina Pharma Combix is indicated to reduce the risk of future heart attack or stroke, and reduces the risk of death due to these conditions.

After organ transplantation.

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Pravastatina Pharma Combix 20 mg is indicated to reduce elevated fat levels in the blood.

2. Before taking Pravastatina Pharma Combix

Do not take Pravastatina Pharma Combix 20 mg:

• If you are allergic (hypersensitive) to pravastatin sodium or to any of the other ingredients of this medicine (see Additional information).
• If you are pregnant, planning to become pregnant, or breastfeeding (see “Pregnancy and breastfeeding”).
• If you have liver disease (active liver disease);
• If repeated blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Take special care with Pravastatina Pharma Combix 20 mg:

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

• kidney disease;
• hypothyroidism;
• liver disease or alcohol-related problems (drinking large amounts of alcohol);
• muscle disorders caused by an inherited disease;
• muscle problems caused by another medicine belonging to the statin group (HMG-CoA reductase inhibitors) or to the group known as fibrates (see Taking other medicines).
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Pravastatina Pharma Combix may cause serious muscle problems (rhabdomyolysis).

If you have had any of these conditions 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 your risk of developing muscle-related adverse effects.

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

Talk to your doctor or pharmacist before taking Pravastatina Pharma Combix 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).

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.

Taking other medicines:

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

• a medicine that lowers cholesterol levels in the blood (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);
• any other medicine that lowers cholesterol levels in your blood (nicotinic acid);
• If you need to take oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Pravastatina Pharma Combix. Using Pravastatina Pharma Combix with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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 Pravastatina Pharma Combix if both medicines are taken simultaneously.

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Taking Pravastatina Pharma Combix 20 mg 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 may drink while taking this medicine, consult your doctor.

Pregnancy:

Do not take Pravastatina Pharma Combix 20 mg during pregnancy. If you discover you are pregnant, inform your doctor immediately.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding:

Pravastatina Pharma Combix 20 mg should not be used during breastfeeding, as this medicine passes into breast milk.

Driving and using machines:

Pravastatina Pharma Combix 20 mg 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 ingredients of Pravastatina Pharma Combix 20 mg:

This medicine contains lactose.

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

3. How to take Pravastatina Pharma Combix 20

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

Follow exactly the instructions for use provided by your doctor. If you have any doubts, consult your doctor or pharmacist.

Pravastatina Pharma Combix 20 mg 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 in the evening.
• For the prevention of heart and blood vessel diseases: the usual dose is 40 mg once daily, preferably in the evening.

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

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

The recommended dose for children aged 8 to 13 years is 10–20 mg once daily. The recommended dose for adolescents aged 14 to 18 years 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 kidney disease or severe liver disease, your doctor may prescribe a lower dose of Pravastatina Pharma Combix.

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

Duration of treatment:

Your doctor will indicate how long you should take Pravastatina Pharma Combix. This medicine should be taken regularly for the length of time recommended by your doctor, even if this is for a long period. Do not stop treatment prematurely on your own.

If you take more Pravastatina Pharma Combix 20 mg than you should:

If you have taken more Pravastatina Pharma Combix 20 mg than you should, or if someone accidentally swallowed some 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, indicating the medicine and the amount ingested.

If you forget to take Pravastatina Pharma Combix 20 mg:

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 a missed dose.

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

4. Possible adverse effects

Like all medicines, Pravastatina Pharma Combix 20 mg can have adverse effects, although not everyone will experience them.

Stop taking Pravastatina Pharma Combix 20 mg and contact your doctor immediately if you experience unexplained or persistent muscle pain, pain on palpation, weakness, or cramps, especially if at the same time you feel unwell or have a fever.

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

Sudden, severe 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 may be serious if it occurs. You must inform your doctor immediately if this happens.

The following adverse effects are uncommon and may affect more than 1 in 1,000 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, diarrhoea, constipation, and flatulence
• 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, 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
• Musculoskeletal disorders: muscle and joint pain

The following adverse effects are very rare and may affect fewer than 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 reactions (lupus-like syndrome);
• Liver disorders: inflammation of the liver or pancreas; jaundice (recognised by yellowing of the skin and whites of the eyes); rapid destruction of liver cells (fulminant hepatic necrosis);
• Musculoskeletal and bone disorders: inflammation of one or more muscles causing muscle pain or weakness (myositis or polymyositis); muscle pain or weakness, inflammation of tendons, sometimes complicated by rupture.
• Abnormal blood test results: increased transaminases (a group of blood enzymes), which may indicate liver problems. Your doctor may wish to carry out periodic tests to monitor this.

Possible adverse effects:

• Nightmares
• Memory loss
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever

Adverse effects of unknown frequency:

• Persistent muscle weakness.
• Severe 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).
• Muscle rupture.

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.

Reporting of adverse effects

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

5. Storage of Pravastatin Pharma Combix

Keep out of the reach and sight 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 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the Sigre Point in your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Additional Information

Composition of Pravastatina Pharma Combix 20 mg:

• The active substance is pravastatin sodium. Each Pravastatina Pharma Combix tablet contains 20 mg of pravastatin sodium.
• The other components are lactose monohydrate, sodium croscarmellose, magnesium stearate, light magnesium oxide, microcelac 100, povidone K-30, and yellow iron oxide (E172).

Appearance of the product and contents of the pack:

Pravastatina Pharma Combix 20 mg tablets are presented as yellow, rectangular, rounded-edge, biconvex uncoated tablets, with the initials “PDT” engraved on one side and the number “20” engraved on the other side.

Pravastatina Pharma Combix 20 mg tablets are packed in blister strips and in packs containing 28 tablets.

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer Responsible for Manufacturing:

Laboratori Fundació DAU

C/ C, 12-14 Pol. Ind. Zona Franca

08040 Barcelona

Spain

Date of the most recent review of this leaflet: March 2024

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.es/