Package Leaflet: Information for the User

Pravastatina Codramol 20 mg Tablets EFG

Read this leaflet carefully before you start taking the medicine.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others even if their symptoms are the same. It may harm them.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

1. What Pravastatina Codramol 20mg Tablets are and what they are used for

2. Before taking Pravastatina Codramol 20mg Tablets

3. How to take Pravastatina Codramol 20mg Tablets

4. Possible side effects

5. Storage of Pravastatina Codramol 20mg Tablets

6. Further information

Pravastatina Codramol are tablets that contain pravastatina as the active ingredient, available on the market in the following dosages: 10 mg, 20 mg and 40 mg. It is included in the category of anti-dislipidemics.

Therapeutic indications

Hypcholesterolemia

Treatment of primary hypercholesterolemia or mixed dyslipidemia, in conjunction with diet, when the response to diet and other non-pharmacological treatments (e.g., exercise, weight reduction) has failed.

Primary prevention

Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and high risk of a first cardiovascular event, as an additional treatment to diet.

Secondary prevention

Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina and with normal or elevated cholesterol levels, in conjunction with correction of other risk factors.

Post-transplant

Reduction of post-transplant hyperlipidemia (blood lipid levels) in patients receiving immunosuppressive treatment after solid organ transplantation (see the sectionsBefore taking Pravastatina CodramolandHow to take Pravastatina Codramol)

Do not take Pravastatina Actavis:

• If you are allergic (hypersensitive) to pravastatina or any of the excipients of Pravastatina Codramol.
• If you have any active liver disease, including unexplained elevations of serum transaminases above three times the upper limit of normal (see the section Before taking Pravastatina Codramol).
• During pregnancy or breastfeeding.

Be especially careful with Pravastatina Codramol:

In the case of familial hypercholesterolemia, since pravastatina has not been evaluated in patients with this condition.

In cases of liver disease, since, like other similar lipid-lowering drugs, moderate increases in serum transaminases levels may occur, which in most cases return to their initial level without the need to suspend treatment.

As with other statins, treatment with pravastatina has been associated with the appearance of muscle problems: myalgia, myopathy, and, rarely, rhabdomyolysis. The possibility of myopathy should be taken into account in any patient treated with statins who presents unexplained muscle symptoms such as muscle pain or sensitivity, muscle weakness, or muscle cramps.

The risk and severity of muscle problems during treatment with statins increase with the concomitant administration of medications that interact with them. Muscle symptoms, when associated with statins, usually disappear after suspending treatment.

Consult with your doctor or pharmacist before starting to take Pravastatina Codramol:

• If you have severe respiratory failure.
• If you have or have had myasthenia (a disease that involves generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), since statins can sometimes worsen the disease or cause myasthenia (see section 4).

While taking this medication, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Children under 18 years:Pravastatina Codramol is not recommended for use in these patients due to the limited available data on safety and efficacy.

Older adults:In elderly patients with risk factors, it may be necessary to adjust the dose.

Patients with renal or hepatic insufficiency:The dose should be adjusted according to blood lipid levels and under medical supervision.

Before starting treatment:

• It is recommended to determine creatine kinase levels before starting treatment in patients with special predisposing factors and in patients who develop muscle symptoms during treatment with statins.

• Care should be taken in patients with predisposing factors such as renal insufficiency, hypothyroidism, a history of muscle toxicity from a statin or a fibrate, a personal or family history of hereditary muscle diseases, or alcohol abuse. In these cases, creatine kinase levels should be determined before starting treatment. It is also recommended to evaluate creatine kinase levels before starting treatment in people over 70 years old, especially those with other predisposing factors.

During treatment:

• Patients should be advised to report any unexplained muscle pain, sensitivity, weakness, or muscle cramps promptly. In these cases, creatine kinase levels should be determined. If a hereditary muscle disease is suspected in the patient, it is not recommended to resume treatment with statins.

Use of other medications:

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Fibrates:The use of fibrates alone is sometimes associated with the appearance of myopathy. There has been a reported increase in the risk of muscle adverse reactions, including rhabdomyolysis, associated with the concomitant administration of fibrates with other statins. Since the appearance of these adverse reactions cannot be ruled out with pravastatina, it is recommended to avoid the simultaneous use of pravastatina and fibrates (e.g., gemfibrozil, fenofibrate).

Colestiramine/colestipol:The simultaneous administration resulted in a decrease in pravastatina bioavailability. When pravastatina was administered one hour before or four hours after colestiramine or one hour before colestipol and a standard meal, no clinically significant decrease in bioavailability or therapeutic effect was observed (see the section How to takePravastatina Codramol)

Ciclosporina:The simultaneous administration of pravastatina and ciclosporina produces an increase in systemic exposure to pravastatina. It is recommended to perform clinical and biochemical monitoring of patients receiving this combination (see the section How to takePravastatina Codramol).

Warfarina and other anticoagulants:The chronic administration of pravastatina and warfarin does not produce any change in the anticoagulant effect of warfarin.

Drugs metabolized by the cytochrome P450:Specifically, the absence of significant pharmacokinetic interactions with pravastatina and other drugs, especially those that are substrates/inhibitors of CYP3A4, such as diltiazem, verapamil, itraconazole, ketoconazole, protease inhibitors, grapefruit juice, and CYP2C9 inhibitors (e.g., fluconazole), has been demonstrated.

Special caution should be exercised when pravastatina is administered with erythromycin or clarithromycin.

Other drugs:No statistically significant differences in bioavailability were observed when pravastatina was administered in interaction studies with aspirin, antacids (one hour before pravastatina), nicotinic acid, or probucol.

Pravastatina Actavis with food and beverages:

Pravastatina is administered once a day, preferably at night. The tablets can be taken with or without food.

Pravastatina should be administered under strict supervision in patients who consume large amounts of alcohol or have previous liver disease.

Pregnancy, breastfeeding:

Consult your doctor or pharmacist before taking any medication.

Pravastatina is contraindicated during pregnancy.

If a patient plans to become pregnant, she should inform her doctor immediately and discontinue pravastatina treatment due to the potential risk to the fetus.

Pravastatina passes in small amounts into breast milk, so it is contraindicated during breastfeeding.

Driving and operating machinery:

Pravastatina has no or has a negligible effect on the ability to drive and use machines. However, when driving or using machines, it should be taken into account that dizziness may occur during treatment.

Important information about some of the components of Pravastatina Codramol tablets:

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

Follow exactly the administration instructions for Pravastatina Codramol indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Before starting treatment with Pravastatina Codramol, secondary causes of hypercholesterolemia must be ruled out and patients must undergo a standard hypolipidemic diet (diet to reduce blood lipid levels), which should be maintained during treatment.

Pravastatina Codramol is administered orally once a day, preferably at night, with or without food.

Hipercolesterolemia:The recommended dosage interval is 10 to 40 mg once a day. The response to treatment is observed after one week, with maximum effect achieved in four weeks; therefore, periodic determinations of blood lipids should be performed and the dose adjusted accordingly. The maximum dose is 40 mg per day.

Cardiovascular prevention:In all mortality studies (studies that analyze complications and mortality), the only starting and maintenance dose studied was 40 mg per day.

Posology after transplants:After an organ transplant, an initial dose of 20 mg per day is recommended in patients receiving immunosuppressive treatment. Depending on blood lipid levels, the dose may be increased to 40 mg under close medical supervision (see sectionBefore Taking Pravastatina Codramol).

Children:The existing information on safety and efficacy in patients under 18 years is limited; therefore, the use of Pravastatina Codramol is not recommended in these patients.

Elderly patients:No dose adjustment is necessary in these patients unless other risk factors are present (see sectionBefore Taking Pravastatina Codramol).

Renal or hepatic insufficiency:In patients with moderate or severe renal impairment or significant hepatic impairment, an initial dose of 10 mg per day is recommended. The dose should be adjusted according to blood lipid levels and under medical supervision.

Concomitant treatment:The cholesterol-lowering effect of Pravastatina Codramol increases when combined with a bile acid sequestrant (e.g. cholestyramine, colestipol). Pravastatina Codramol should be administered one hour before or at least four hours after the sequestrant (see sectionBefore Taking Pravastatina Codramol).

Patients receiving ciclosporin with or without other immunosuppressive medications should start treatment with 20 mg of pravastatina once a day, and the dose adjustment to 40 mg should be done with caution (see sectionBefore Taking Pravastatina Codramol).

If you estimate that the action of Pravastatina Codramol is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatina Codramol than you should:

There is limited information on pravastatina overdose and its treatment. Therefore, if you have taken more Pravastatina Codramol than you should, contact your doctor or pharmacist or the nearest hospital for appropriate symptomatic treatment.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forget to take Pravastatina Codramol:

Do not take a double dose to compensate for the missed dose, wait for the next scheduled dose.

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

If you stop taking Pravastatina Codramol

Contact your doctor or pharmacist

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

Side effects are classified as: very common (affecting at least 1 in 10 patients), common (affecting at least 1 in 100 patients), uncommon (affecting at least 1 in 1,000 patients), rare (affecting at least 1 in 10,000 patients), very rare (less than 1 in 10,000 patients) and isolated cases.

The side effects found during studies conducted with pravastatina 40 mg have been:

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, insomnia.

Eye disorders:

Uncommon: visual disturbances (including blurred vision and double vision of objects)

Gastrointestinal disorders:

Uncommon: indigestion/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhea, gas

Skin and subcutaneous tissue disorders:

Uncommon: itching, skin rash, appearance of blisters accompanied by itching, hair and scalp abnormalities (including hair loss).

Renal and urinary disorders:

Uncommon: urinary elimination disturbances (such as difficulty urinating, urinating more frequently and urinating more frequently at night).

Reproductive and breast disorders:

Uncommon: sexual disturbances

General disorders:

Uncommon: fatigue

Side effects of special clinical relevance:

Musculoskeletal disorders: muscle and skeletal pain including joint pain, muscle cramps, muscle pain (very common), muscle weakness (common) and elevations of creatine kinase levels (enzyme indicative of muscle damage).

Hepatic disorders: elevations of serum transaminases (enzymes indicative of liver disease).

During post-marketing experienceof pravastatina, the following adverse reactions have been reported:

Nervous system disorders:

Very rare: peripheral neuropathy, particularly when used for a prolonged period and paresthesia (tingling sensation).

Unknown frequency: myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Eye disorders:

Unknown frequency: myasthenic eye disease (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.

Immune system disorders:

Very rare: hypersensitivity reactions such as swelling of the arms, legs, face, lips, tongue and/or throat (angioedema), lupus-like syndrome.

Gastrointestinal disorders:

Very rare: pancreatitis (inflammation of the pancreas)

Hepatobiliary disorders:

Very rare: yellowing of the skin (jaundice), liver inflammation (hepatitis), fulminant hepatic necrosis.

Musculoskeletal and connective tissue disorders:

Very rare: muscle fiber destruction (rhabdomyolysis) that may be associated with acute renal failure secondary to myoglobinuria (red urine) and muscle abnormalities (myopathy), muscle inflammation (myositis), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated with rupture.

Unknown frequency: muscle rupture.

Possible side effects of some statins:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• 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, obesity and high blood pressure. Your doctor will monitor you while taking this medication.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Keep Pravastatina Codramol out of the reach and sight of children.

Do not store at a temperature above 25°C. Store in the original packaging well closed.

Expiration Date:

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

Composition of Pravastatina Codramol 20 mg tablets

The active ingredient is pravastatina. Each tablet contains 20 mg of pravastatina.

The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, talc, and anhydrous disodium phosphate.

Appearance of the product and contents of the package

Pravastatina Codramol is presented in the form of white, oblong, convex, and scored tablets on both faces. Each package contains 7, 20, 28, 30, 50, 60, and 100 tablets in high-density polyethylene bottles.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

FARMALIDER, S.A.

Aragoneses, 15

28108, Alcobendas, Madrid- Spain

Responsible manufacturer:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora (Portugal).

This leaflet was approved in May 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/