PRAVASTATIN CODRAMOL 20 mg TABLETS

2. BEFORE TAKING PRAVASTATINA CODRAMOL 20 mg TABLETS

Do not take Pravastatin Actavis:

• If you are allergic (hypersensitive) to pravastatin or any of the excipients of Pravastatin Codramol.
• If you have any active liver disease (including unexplained elevations of serum transaminases above 3 times the upper limit of normal) (see section Before taking Pravastatin Codramol).
• In case of pregnancy or breastfeeding.

Be careful with Pravastatin Codramol:

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

In case of liver conditions, since, as with other lipid-lowering drugs, moderate increases in serum transaminase levels may occur, which, in most cases, return to their initial level without the need to discontinue treatment.

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

The risk and severity of muscle conditions during statin treatment increase with the concomitant administration of interacting medications. Muscle symptoms, when associated with statins, usually disappear after discontinuing treatment.

Consult your doctor or pharmacist before starting to take Pravastatin Codramol:

• 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), since statins can sometimes worsen the disease or cause the appearance of 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 levels of sugars and fats in the blood, are overweight, and have high blood pressure.

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

Elderly:in elderly patients with risk factors, it may be necessary to adjust the dose.

Patients with renal or hepatic impairment: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 statin treatment.

• Caution should be exercised in patients with predisposing factors such as renal impairment, hypothyroidism, history of muscle toxicity with a statin or fibrate, 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 determine creatine kinase levels before starting treatment in people over 70 years old, especially in those with other predisposing factors.

During treatment:

• Patients should be advised to report any unexplained muscle pain, sensitivity, weakness, or cramps. 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:

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

Fibrates: the use of fibrates alone is occasionally associated with the appearance of myopathy. An increased risk of adverse muscle reactions, including rhabdomyolysis, has been reported with the concomitant administration of fibrates and other statins. Since the occurrence of these adverse reactions cannot be ruled out with pravastatin, the simultaneous use of pravastatin and fibrates (e.g., gemfibrozil, fenofibrate) should be avoided.

Colestyramine/colestipol: concomitant administration resulted in a decrease in the bioavailability of pravastatin. When pravastatin was administered one hour before or four hours after colestyramine or one hour before colestipol and a standard meal, no clinically significant decrease in bioavailability or therapeutic effect was observed (see section How to take Pravastatin Codramol)

Cyclosporine: concomitant administration of pravastatin and cyclosporine results in an increase in systemic exposure to pravastatin. Clinical and biochemical monitoring of patients receiving this combination is recommended (see section How to take Pravastatin Codramol)

Warfarin and other anticoagulants: chronic administration of pravastatin and warfarin does not produce any change in the anticoagulant effect of warfarin.

Drugs metabolized by cytochrome P450: it has been specifically demonstrated that there are no significant pharmacokinetic interactions between pravastatin 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).

Special caution should be exercised when administering pravastatin with erythromycin or clarithromycin.

Other medications: no statistically significant differences in bioavailability were observed when pravastatin was administered in interaction studies with acetylsalicylic acid, antacids (one hour before pravastatin), nicotinic acid, or probucol.

Taking Pravastatin Actavis with food and drinks:

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

Pravastatin should be administered under strict supervision in patients who consume large amounts of alcohol or have pre-existing liver disease.

Pregnancy, breastfeeding

Consult your doctor or pharmacist before taking any medication.

Pravastatin is contraindicated in pregnancy.

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

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

Driving and using machines:

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

Important information about some of the components of Pravastatin Codramol tablets

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

3. HOW TO TAKE PRAVASTATINA CODRAMOL 20 mg TABLETS

Follow the administration instructions of Pravastatin Codramol indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

Hypercholesterolemia:the recommended dosage range is 10 to 40 mg once a day. The response to treatment is observed after one week, reaching its maximum effect at 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 morbidity and mortality studies (studies analyzing complications and mortality), the only studied starting and maintenance dose was 40 mg per day.

Dosage 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 up to 40 mg under close medical supervision (see section Before taking Pravastatin Codramol)

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

Elderly patients:it is not necessary to adjust the dose in these patients unless there are other risk factors (see section Before taking Pravastatin Codramol)

Renal or hepatic impairment: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 Pravastatin Codramol increases when associated with a bile acid sequestrant (e.g., colestyramine, colestipol). Pravastatin Codramol should be administered one hour before or at least four hours after the resin (see section Before taking Pravastatin Codramol)

Patients treated with cyclosporine with or without other immunosuppressive medications should start therapy with 20 mg of pravastatin once a day, and the dose adjustment to 40 mg should be done with caution (see section Before taking Pravastatin Codramol)

If you think the action of Pravastatin Codramol is too strong or too weak, consult your doctor or pharmacist.

If you take more Pravastatin Codramol than you should:

There is not much information about overdose with pravastatin or its treatment. Therefore, if you have taken more Pravastatin Codramol than you should, contact your doctor or pharmacist or the nearest hospital so that they can provide you with the appropriate symptomatic treatment.

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

If you forget to take Pravastatin Codramol:

Do not take a double dose to make up for the forgotten dose, wait for the next dose.

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

If you stop taking Pravastatin Codramol

Contact your doctor or pharmacist

4. Possible side effects

Like all medications, Pravastatin Codramol can cause side effects, although not everyone will experience them.

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

The effects found during the studies conducted with pravastatin 40 mg have been:

Nervous system disorders:

Uncommon: dizziness, headache, sleep disorders, insomnia.

Eyeball disorders:

Uncommon: vision changes (including blurred vision and double vision)

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders:

Uncommon: itching, rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).

Renal and urinary disorders:

Uncommon: changes in urine elimination (such as difficulty urinating, frequent urination, and increased urination at night).

Reproductive system and breast disorders:

Uncommon: sexual disorders

General disorders:

Uncommon: fatigue

Side effects of special clinical relevance:

Musculoskeletal disorders: musculoskeletal 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 experiencewith pravastatin, the following adverse reactions have been reported:

Nervous system disorders:

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

Frequency not known: severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Eyeball disorders:

Frequency not known: ocular myasthenia (a disease that causes weakness of the eye muscles).

Tell 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.

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), hepatitis (inflammation of the liver), fulminant hepatic necrosis (destruction of liver cells).

Musculoskeletal and connective tissue disorders:

Very rare: rhabdomyolysis (destruction of muscle fibers) that can be associated with acute renal failure secondary to myoglobinuria (red urine) and muscle disorders (myopathy), myositis (inflammation of the muscles), significant muscle weakness (polymyositis) (see section 2).

Isolated cases of tendon disorders, sometimes complicated by rupture.

Frequency not known: 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 levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medication.

If you think any of the side effects you are experiencing is serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

5. Storing PRAVASTATINA CODRAMOL 20 mg TABLETS

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

Do not store above 25°C. Store in the original package, tightly closed.

Expiration date:

Do not use this medication after the expiration date shown on the package. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. ADDITIONAL INFORMATION

Composition of Pravastatina Codramol 20 mg tablets

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

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

Appearance of the product and packaging content

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FARMALIDER, S.A.

Aragoneses, 15

28108, Alcobendas, Madrid - Spain

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

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/