Pravastatin Pharma Combix 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

PRAVASTATIN PHARMA COMBIX 40 mg TABLETS EFG

Sodium Pravastatin

1. What is this medication and what is it used for?

The active substance in this medication is sodium pravastatin, which belongs to a group of medications called HMG-CoA reductase inhibitors (statins). These medications reduce the production of cholesterol in the body.

This medication is used to:

• Reduce total cholesterol and low-density lipoprotein (LDL) cholesterol levels in the blood when diet, physical exercise, and other non-pharmacological measures have not been sufficient.
• Reduce total cholesterol and LDL cholesterol levels in adolescents from 8 years of age with heterozygous familial hypercholesterolemia (a hereditary condition causing high cholesterol), when diet and other non-pharmacological measures have not been sufficient.
• Reduce the risk of heart attack, need for revascularization procedures, stroke, and death from cardiovascular causes in patients with high cholesterol and other risk factors for cardiovascular disease.

This medication works by reducing the amount of cholesterol produced by the liver, thereby reducing the amount of cholesterol circulating in the blood. It mainly reduces "bad" cholesterol (LDL) and increases "good" cholesterol (HDL).

When not to use this medication

Do not use this medication if:

• You are allergic to pravastatin sodium or any of the components of this medication.
• You have or have had liver disease.
• You are pregnant or breastfeeding.

Warnings and Precautions

Talk to your doctor or pharmacist before taking this medication if:

• You consume large amounts of alcohol.
• You have a history of liver or kidney disease.
• You have hypothyroidism (underactive thyroid).
• You have a history of muscle disorders or have experienced muscle problems with other lipid-lowering medications.
• You have severe respiratory failure.
• You have experienced muscle problems with other lipid-lowering medications.
• You are over 70 years old.
• You are taking other medications that may interact with pravastatin.

Muscle Problems (Myopathy/Rhabdomyolysis)

This medication may cause muscle problems, which in rare cases can lead to a serious condition called rhabdomyolysis, potentially resulting in kidney failure and death. The risk increases at higher doses and in patients with kidney disease, hypothyroidism, or who consume large amounts of alcohol.

Contact your doctor immediately if you experience:

• Unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or malaise.
• Dark-colored urine.

Liver Function

Liver function tests should be performed before starting treatment and periodically thereafter. If signs or symptoms of liver disease appear, the medication should be discontinued.

Interactions with Other Medications

This medication may interact with other medications, including:

• Cyclosporine
• Erythromycin
• Clarithromycin
• Itraconazole
• Ketoconazole
• Gemfibrozil
• Niacin
• Warfarin
• Digoxin
• Oral antidiabetics or insulin

Inform your doctor or pharmacist about all medications you are taking.

Pregnancy and Breastfeeding

This medication is contraindicated during pregnancy and breastfeeding. If you become pregnant while taking this medication, stop immediately and contact your doctor.

Driving and Operating Machines

This medication may cause dizziness. Exercise caution when driving or operating machinery.

How to use this medication

Use this medication exactly as prescribed by your doctor.

Dosage

• Adults: The usual dose is 10 to 40 mg once daily, preferably in the evening.
• Adolescents from 8 years of age: The usual dose is 10 to 20 mg once daily, preferably in the evening.

The dose may be adjusted based on cholesterol levels and response to treatment.

Administration

• Take the tablet whole with water.
• Can be taken with or without food.
• Preferably taken in the evening.

Missed Dose If you forget to take a dose, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular schedule. Do not take a double dose to make up for a missed one.

Overdose In case of overdose, seek medical attention immediately. Symptoms may include nausea, vomiting, abdominal pain, and muscle weakness.

What are the possible side effects?

Like all medications, this medication may cause side effects, although not everyone experiences them.

Common side effects (may affect up to 1 in 10 people):

• Headache
• Dizziness
• Insomnia
• Nausea
• Abdominal pain
• Constipation
• Diarrhea
• Flatulence
• Muscle pain

Uncommon side effects (may affect up to 1 in 100 people):

• Rash
• Pruritus (itching)
• Increased liver enzymes
• Increased creatine kinase
• Joint pain
• Fatigue

Rare side effects (may affect up to 1 in 1,000 people):

• Allergic reactions (rash, hives, swelling)
• Liver disorders (hepatitis, jaundice)
• Muscle disorders (myopathy, rhabdomyolysis)
• Pancreatitis
• Depression
• Memory impairment

Very rare side effects (may affect up to 1 in 10,000 people):

• Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Autoimmune hepatitis
• Interstitial lung disease

Reporting of side effects If you experience any side effects, including those not listed in this leaflet, inform your doctor or pharmacist.

How to store this medication

• Keep out of sight and reach of children.
• Do not use after the expiry date stated on the packaging.
• Store below 30°C, in the original packaging.
• Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medications you no longer use.

Contents of the packaging and other information

Active substance:

• Sodium pravastatin

Other components:

• Lactose monohydrate
• Microcrystalline cellulose
• Croscarmellose sodium
• Magnesium stearate
• Hypromellose
• Triacetin
• Titanium dioxide (E171)
• Iron oxide (E172)

Available presentations:

• Tablets of 10 mg, 20 mg, and 40 mg.

Marketing Authorization Holder: [Company Name]

Manufactured by: [Manufacturer Name]

This information is valid as of [Date].

For more information, consult your doctor or pharmacist.

Package 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. How to store Pravastatina Pharma Combix
6. Further information

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

Pravastatina Pharma Combix 40 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 levels of cholesterol and other fats (triglycerides) in your body. When there is an excess of cholesterol in the blood, it accumulates in the walls of blood vessels, causing them to become narrowed or blocked.

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:

Treatment of high levels of cholesterol and fats in the blood.

Pravastatina Pharma Combix is indicated to lower 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 blood cholesterol levels 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 to reduce the risk of dying from these conditions.

• 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 attacks or strokes, and to reduce the risk of death from these diseases.

After organ transplantation.

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplanted organ, Pravastatina Pharma Combix 40 mg is indicated to reduce elevated levels of fats in the blood.

2. Before taking Pravastatina Pharma Combix

Do not take Pravastatina Pharma Combix 40 mg:

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

Take special care with Pravastatina Pharma Combix 40 mg:

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

• kidney disease;
• 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 (HMG-CoA reductase inhibitor medicines) or to the group known as fibrates (see Taking other medicines).
• If you are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. 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.

If you 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), since statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

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

Use of other medicines:

When used together with this medicine, 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 taking this medicine. Your doctor will advise you when you can restart treatment with Pravastatina Pharma Combix. Taking Pravastatina Pharma Combix with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information about 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 medicine 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 at the same time.

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

Taking Pravastatina Pharma Combix 40 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 can drink while taking this medicine, consult your doctor.

Pregnancy:

Do not take Pravastatina Pharma Combix 40 mg during pregnancy. If you find out you are pregnant, inform your doctor immediately.

Consult your doctor or pharmacist before using any medicine.

Breastfeeding:

Pravastatina Pharma Combix 40 mg should not be administered during breastfeeding, as this medicine passes into breast milk.

Driving and using machines:

Pravastatina Pharma Combix 40 mg normally 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 operate machinery until you are certain you are able to do so safely.

Important information about some of the components of Pravastatina Pharma Combix 40 mg:

This medicine contains lactose.

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

3. How to take Pravastatina Pharma Combix 40

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

Always follow your doctor's instructions for taking this medicine exactly. If you have any doubts, consult your doctor or pharmacist.

Pravastatina Pharma Combix 40 mg can be taken with or without food, with half a glass of water.

Dosage:

Adults

• For the treatment of high levels of cholesterol and fat 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 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 is 10–20 mg once daily. The recommended dose for adolescents aged 14 to 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 up to 40 mg by your doctor.

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

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

Duration of treatment:

Your doctor will advise you on how long to 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 40 mg than you should:

If you have taken more Pravastatina Pharma Combix 40 mg than you should have, or if someone has accidentally swallowed some tablets, contact your doctor, pharmacist, or the nearest hospital immediately.

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 40 mg

If you forget to take a dose, simply take your next scheduled 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 40 mg can have adverse effects, although not everyone experiences them.

Stop taking Pravastatina Pharma Combix 40 mg and tell your doctor immediately if you experience unexplained or persistent muscle pain, tenderness, 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.

Serious and sudden allergic reactions such as swelling of the face, lips, tongue, or throat 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 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, diarrhea, 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 itchy blisters, abnormalities of hair and scalp (including hair loss)
• Urinary and genital disorders: disturbances in urination (such as pain during urination, 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 (recognized 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, tendon inflammation, sometimes complicated by rupture.
• Abnormal blood test results: increased transaminases (a group of blood enzymes) which may be a sign of liver problems. Your doctor may want to perform 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.
• 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 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 pack after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

Medicines should not be disposed of via wastewater or household waste. Return unused medicines and their containers to 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. Additional Information

Composition of Pravastatina Pharma Combix 40 mg:

• The active substance is sodium pravastatin. Each Pravastatina Pharma Combix tablet contains 40 mg of sodium pravastatin.
• 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 40 mg tablets are yellow, rectangular-shaped, biconvex tablets with rounded edges, uncoated, marked with the initials “PDT” on one side and the number “40” on the other.

Pravastatina Pharma Combix 40 mg tablets are packed in blister strips in packs of 28 tablets.

Marketing Authorization Holder:

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer:

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/