Pravastatin Stada 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pravastatin STADA 10 mg film-coated tablets EFG

Pravastatin STADA 20 mg film-coated tablets EFG

Pravastatin STADA 40 mg film-coated tablets EFG

sodium pravastatin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Pravastatin STADA is and what it is used for
2. What you need to know before taking Pravastatin STADA
3. How to take Pravastatin STADA
4. Possible adverse effects
5. How to store Pravastatin STADA
6. Contents of the pack and other information

1. What Pravastatina Stada is and what it is used for

Pravastatin, the active substance in Pravastatina Stada, 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 are excessive levels of cholesterol in the blood, cholesterol 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 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:

For the treatment of high levels of cholesterol and fats in the blood

This medicine is indicated to lower high levels of "bad" cholesterol and to 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 levels of cholesterol in the blood and risk factors that contribute to these diseases (if you smoke, are overweight, have high blood sugar levels or hypertension, or do little physical activity), this medicine 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 if your cholesterol levels are normal, this medicine is indicated to reduce the risk of having another heart attack or stroke in the future, and reduces the risk of dying from these diseases.

After organ transplantation

If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, this medicine is indicated to reduce elevated levels of fat in the blood.

2. What you need to know before taking Pravastatina Stada

DO NOT take Pravastatina Stada:

• if you are allergic to pravastatin or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, planning to become pregnant, or breastfeeding (see Pregnancy and Breast-feeding).
• if you have any liver disease (active liver disease).
• if repeated blood tests show abnormal liver function (elevated levels of liver enzymes in the blood).

Warnings and precautions

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

• Kidney disease
• Reduced activity of the thyroid gland (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 Other medicines and Pravastatina Stada).
• If you have or have had myasthenia (a disease characterized by generalized muscle weakness, which 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).

Your doctor will perform a blood test before you start taking this medicine and if you develop any symptoms or liver problems during treatment. This is to check whether your liver is functioning properly.

Your doctor may also need to perform blood tests after starting treatment with this medicine to monitor your liver function.

The risk of muscle failure is higher in some patients. Consult your doctor in the following cases:

If you are taking or have taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) by oral or injectable route. The combination of fusidic acid and pravastatin may cause serious muscle problems (rhabdomyolysis).

If you have experienced any of these problems, or if you are over 70 years of age, your doctor will perform blood tests before and probably during treatment. These blood tests will be used to assess your risk of developing adverse muscle effects.

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

While taking this medicine, your doctor will monitor you for diabetes or risk of developing diabetes. This risk increases if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

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.

Consult your doctor before taking this medicine.

Talk to your doctor or pharmacist before taking Pravastatina Stada if you:

• have severe respiratory insufficiency.

Other medicines and Pravastatina Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Taking pravastatin with any of the following medicines may increase the risk of muscle problems:

• 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).
• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with this medicine. Taking pravastatin with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.
• Colchicine (a medicine used to treat gout)
• Nicotinic acid (a medicine used to treat high blood cholesterol)
• Rifampicin (a medicine used to treat the infection called tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).

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 pravastatin if both medicines are taken simultaneously.

Taking Pravastatina Stada with alcohol

You should reduce your alcohol consumption to a minimum. If you have any doubts about how much alcohol you may drink while taking this medicine, consult your doctor.

Pregnancy and Breast-feeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Do not take pravastatin during pregnancy. If you become pregnant, inform your doctor immediately.

Breast-feeding

Do not take pravastatin while breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Pravastatin does not affect your ability to drive or use machines. 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.

Pravastatina Stada contains lactose and sodium

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

Sodium: This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, it is essentially “sodium-free”.

3. How to take Pravastatina Stada

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

Always follow exactly the instructions for use of this medicine as given by your doctor. In case of doubt, please consult your doctor or pharmacist again.

Dosage

Adults

?? In the treatment of high levels of cholesterol and fat in the blood: the usual dose is 10–40 mg once daily, preferably at night.

• In 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 that increases cholesterol levels in the blood

The recommended dose for children aged 8 to 13 years is 10–20 mg once daily, and 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 (ciclosporin), 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 severe kidney or liver disease, your doctor may prescribe a lower dose of pravastatin.

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

Method of administration

This medicine can be taken with or without food, with half a glass of water.

Duration of treatment

Your doctor will tell you how long you should take pravastatin. This medicine should be taken regularly for as long as your doctor recommends, even if this is for a long period of time. Do not stop treatment prematurely on your own.

If you take more Pravastatina Stada than you should

If you have taken more pravastatin than you should, or if someone has accidentally swallowed some tablets, contact your doctor, pharmacist, or the nearest hospital.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 915 620 420, indicating the medicine and the amount ingested.

If you forget to take Pravastatina Stada

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 forgotten doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Stop taking pravastatin and contact 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 may 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 trachea may cause severe 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 up to 1 in 100 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.
• Skin and hair disorders: itching, acne, skin rash, appearance of itchy blisters, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders: changes in urination (such as pain when urinating, increased frequency of urination, and increased nighttime urination) and sexual problems.
• Musculoskeletal disorders: muscle and joint pain.

The following adverse effects are rare and may affect up to 1 in 1,000 people:

• Skin sensitivity to sunlight.

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

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• Persistent muscle weakness
• Liver failure
• Myasthenia gravis (a disease causing generalized muscle weakness that, in some cases, affects the muscles used for breathing)¹
• Ocular myasthenia (a disease causing weakness of the eye muscles)¹
• Muscle rupture

¹ Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Possible adverse effects reported with some statins:

• Nightmares
• Memory loss
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Diabetes: more likely if you have high levels of blood sugar and fats, are overweight, or have hypertension. Your doctor will monitor you during treatment with this medicine.

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 through 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 Stada

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

Do not use this medicine after the expiry date stated on the packaging 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.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE point located at the pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pravastatina Stada

• The active substance is sodium pravastatin.

10 mg: Each tablet contains 10 mg of sodium pravastatin.

20 mg: Each tablet contains 20 mg of sodium pravastatin.

40 mg: Each tablet contains 40 mg of sodium pravastatin.

• The other components are:

Tablet core:

10 mg: microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), red iron oxide (E172), anhydrous colloidal silica (E551).

20 mg: microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), yellow iron oxide (E172), anhydrous colloidal silica (E551).

40 mg: microcrystalline cellulose (E460), sodium croscarmellose (E468), macrogol 8000, copovidone, heavy magnesium carbonate (E504), lactose monohydrate, magnesium stearate (E470b), yellow iron oxide (E172), anhydrous colloidal silica (E551).

Tablet coating: hypromellose (E463), macrogol 400, macrogol 3350, hypromellose (E464).

Appearance of the product and contents of the pack

10 mg: Film-coated tablet, peach-pink in colour, marked with "10" on one side.

20 mg: Film-coated tablet, yellow in colour, marked with "20" on one side.

40 mg: Film-coated tablet, yellow in colour, marked with "40" on one side.

The tablet can be divided into equal doses.

Pravastatina Stada (10 mg and 20 mg) is available in blisters of 7, 10, 20, 28, 30, 48, 50, 56, 98, 100 and 200 tablets.

Pravastatina Stada (40 mg) is available in blisters of 7, 10, 14, 20, 28, 30, 48, 50, 56, 98, 100 and 200 tablets.

Only some pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

[email protected]

Manufacturer:

Dragenopharm Apotheker Püschl GmbH

Göllstrasse 1

84529 Tittmoning

Germany

or

Swiss Caps GmbH

Grassingerstraße 9

83043 Bad Aibling

Germany

or

STADA Arzneimittel AG

Stadastrasse 2-18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31 E,

4814 NE BREDA

The Netherlands

Date of the most recent revision of this leaflet: February 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/