PRAVASTATIN DAVUR 20 mg TABLETS

2. What you need to know before taking Pravastatina Davur

Do not take Pravastatina Davur

• if you are allergic (hypersensitive) to pravastatina sodium or any of the other components of this medicine (listed in section 6)
• if you have any active liver disease (liver) or have elevated transaminases (enzymes indicative of liver disease).
• if you are pregnant or may be pregnant.
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Pravastatina.

• If you have had any liver disease or have a history of alcoholism.

It is possible that moderate increases in liver transaminase levels may occur, which, in most cases, return to their initial level without the need to discontinue treatment.

• You should also inform your doctor if you have kidney failure, hypothyroidism, if you have a family history or have previously suffered from muscle disorders or if you normally consume alcohol.

• Consult your doctor or pharmacist before taking Pravastatina Davur if you have severe respiratory failure.

• While you are taking this medicine, your doctor will check 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.

• During treatment, some patients may experience muscle pain, sensitivity, weakness, or muscle cramps. If you experience any of these symptoms, you should immediately inform your doctor.

• If you are taking or have taken in the last 7 days a medicine that contains fusidic acid, (used to treat bacterial infection) orally or by injection. The combination of fusidic acid and pravastatina can cause serious muscle problems (rhabdomyolysis).

• 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 myasthenia to appear (see section 4).

Your doctor will perform a blood test before you start taking Pravastatina Davur and if you have any symptoms or liver problems during treatment. This is to check if your liver is working properly.

Your doctor may also need to perform a blood test after starting treatment with Pravastatina Davur to check liver function.

It is possible that your doctor may recommend that you have blood tests to determine the condition of your muscles before starting treatment and during treatment, to consider starting, continuing, or discontinuing treatment.

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Inform your doctor if you are taking other medicines that can also cause muscle disorders such as:

• Fibrates (lower cholesterol levels).
• Nicotinic acid (a medicine used to treat high cholesterol in the blood).
• Colchicine (a medicine used to treat gout).
• Rifampicin (a medicine used to treat tuberculosis infection).
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).

.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Interaction of Pravastatina Davur with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Certain medicines may interact with Pravastatina; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you are using or have recently used any of the following medicines:

• Other drugs used to lower cholesterol levels, such as colestyramine or colestipol (can decrease pravastatina levels in the blood) and fibrates (can increase the risk of adverse muscle reactions).
• Cyclosporin, a medicine used to prevent transplant rejection (given with pravastatina, cyclosporin increases pravastatina blood levels).
• Antibiotics such as erythromycin or clarithromycin (can increase pravastatina blood levels).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with pravastatina. The use of pravastatina with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• If you are taking a medicine used in the treatment and prevention of blood clots called "vitamin K antagonist", inform your doctor before taking pravastatina because the use of vitamin K antagonists concomitantly with pravastatina may increase the results in blood tests used to monitor treatment with vitamin K antagonist.

Pravastatina Davur with food, drinks, and alcohol

Pravastatina can be taken with or without food.

Pravastatina should be administered with caution to patients who consume alcohol. If you normally drink alcohol, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Pravastatina should not be taken during pregnancy. In case of pregnancy or suspected pregnancy, treatment should be discontinued and your doctor informed as soon as possible.

Pravastatina should not be taken during breastfeeding as it passes into breast milk.

Driving and using machines

At normal doses, Pravastatina does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how the medicine affects you.

Pravastatina Davur contains lactose and sodium

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

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

3. How to take Pravastatina Davur

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

The tablets should be swallowed with water and can be administered with or without food, preferably at night.

The recommended dose is between 10-40 mg once a day. Your doctor will determine the suitable dose for you and make any necessary adjustments based on your response to the medicine.

Combined treatment:patients treated with pravastatina and cyclosporin should start treatment with 20 mg of pravastatina once a day, your doctor will adjust the dose up to 40 mg. For patients treated with pravastatina and a bile acid sequestrant (e.g., colestyramine, colestipol), Pravastatina Davur 20 mg should be administered 1 hour before or 4 hours after the sequestrant.

Use in children and adolescents (8-18 years) with heterozygous familial hypercholesterolemia:the recommended dose between 8 and 13 years is 10-20 mg once a day and the recommended dose between 14 and 18 years is 10-40 mg once a day.

Elderly patients:no dose adjustment is necessary in these patients unless there are other risk factors.

Patients with renal or hepatic impairment:in patients with moderate or severe kidney function impairment or significant liver function impairment, treatment should be initiated with a dose of 10 mg.

If you think the effect of Pravastatina Davur 20 mg is too strong or too weak, talk to your doctor or pharmacist.

If you take more Pravastatina Davur than you should

Contact your doctor, pharmacist, or call the Toxicological Information Service, phone: 915 620 420, indicating the medicine and the amount taken.

If you forget to take Pravastatina Davur

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

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

4. Possible side effects

Like all medicines, Pravastatina can cause side effects, although not everybody gets them.

Side effects are classified into:

Very common (affects more than 1 in 10 patients), common (affects between 1 and 10 in 100 patients),

Uncommon (affects between 1 and 10 in 1,000 patients),

Rare (affects between 1 and 10 in 10,000 patients),

Very rare (affects less than 1 in 10,000 patients), and

Frequency not known (cannot be estimated from the available data)

Immune system disorders

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

Nervous system disorders

Uncommon: dizziness, headache, sleep disorders, insomnia.

Very rare: peripheral neuropathy, particularly when used for a long time, and tingling sensation.

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

Eye disorders

Uncommon: vision disturbances (including blurred vision and double vision).

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

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

Gastrointestinal disorders

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

Very rare: pancreatitis (inflammation of the pancreas).

Hepatobiliary disorders

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

Frequency not known: liver failure.

Skin and subcutaneous tissue disorders

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

Musculoskeletal and connective tissue disorders

Very rare: rhabdomyolysis (destruction of muscle fibers), which may be associated with kidney disorders, myopathy (muscle disorders), myositis (inflammation of muscle tissue), polymyositis (simultaneous myositis in several muscles).

Frequency not known: muscle rupture.

Tendon disorders, sometimes complicated by rupture.

Renal and urinary disorders

Uncommon: changes in urine elimination (such as difficulty urinating, urinating more frequently, and urinating more frequently at night).

Reproductive system and breast disorders

Uncommon: sexual disorders.

General disorders

Uncommon: fatigue.

The following adverse effects of special clinical interest have also been reported during clinical studies:

Musculoskeletal and connective tissue disorders

Musculoskeletal pain, including joint pain, muscle cramps, muscle pain (very common), constant muscle weakness (frequency not known), and elevated creatine kinase levels (enzyme indicative of muscle disorder).

Hepatobiliary disorders

Elevations of serum transaminases (enzymes indicative of liver disease).

The following adverse reactions have been reported with 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 Mellitus: The frequency will depend on the presence or absence of risk factors (fasting glucose at 5.6 mmol/L, BMI>30 kg/m2, elevated triglycerides, history of hypertension). Your doctor will monitor you while you are taking this medicine.
• Dermatomyositis (a disease characterized by inflammation of the muscles and skin).

Reporting of side effects

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

5. Storage of Pravastatina Davur

Keep this medicine out of the sight and reach of children.

Do not store above 30°C

Do not use this medicine after the expiry date stated on the packaging after the abbreviation EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy's SIGRE Point. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatina Davur 20 mg Tablets

• The active ingredient is pravastatina sodium. Each tablet contains 20 mg of pravastatina sodium.
• The other ingredients (excipients) are: anhydrous lactose, povidone, crospovidone, anhydrous calcium hydrogen phosphate, sodium stearyl fumarate, microcrystalline cellulose, sodium croscarmellose, and yellow iron oxide (E-172).

Appearance of the product and contents of the pack

Pravastatina Davur 20 mg is presented in the form of tablets. The tablets are pale yellow, slightly convex, and scored on both sides. The tablet can be divided into equal doses.

Each pack contains 28 tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer

Teva Pharma S.L.U.

Malpica Industrial Estate, C.4 street

50016-Zaragoza.

Spain

or

Teva Pharmaceutical Works Private Limited Company

Pallagi ut, 13 Debrecen

Hungary

Date of the last revision of this leaflet: March 2024

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/