Pravastatin Teva-Ratio 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pravastatin Teva-ratio 40 mg tablets EFG

Sodium pravastatin

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

• 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 only; do not give it to other people, 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 these effects are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Pravastatina Teva-ratio is and what it is used for

Pravastatin belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the liver from producing cholesterol, thereby reducing levels of cholesterol and other fats (triglycerides) in your body. When excessive levels of cholesterol are present 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), 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:

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

Pravastatin 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 cholesterol levels in the blood and risk factors that contribute to these diseases (such as smoking, being overweight, having high blood sugar or hypertension, or lack of physical activity), pravastatin is indicated to reduce the risk of developing heart and blood vessel problems, and reduces the risk of dying from these conditions.
• If you have already had a stroke or suffer from chest pain (unstable angina), pravastatin is indicated to reduce the risk of future heart attack or stroke, even if your cholesterol levels are normal, and reduces the risk of death from these conditions.

After organ transplantation

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

2. What you need to know before taking Pravastatin Teva-ratio

Do not take Pravastatin if:

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

Warnings and precautions

Before taking this medicine, 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 problems related to alcohol (drinking large amounts of alcohol)
• Muscle disorders caused by an inherited condition
• Muscle problems caused by another medicine in the statin group (HMG-CoA reductase inhibitor medicines) or in the group known as fibrates (see Use with other medicines).
• 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), 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 Pravastatin 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 Pravastatin to monitor your liver function.

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

If you are taking or have taken within the last 7 days, orally or by injection, a medicine called fusidic acid (a medicine for bacterial infections), combining it with Pravastatin may cause serious muscle problems (rhabdomyolysis).

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

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

If you have diabetes or are at risk of developing it, your doctor will closely monitor you during treatment with this medicine. You may be at risk of developing diabetes if you have high levels of sugar and fats in the blood, are overweight, or have hypertension.

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.

Talk to your doctor before taking Pravastatin.

Talk to your doctor or pharmacist before taking Pravastatin if you:

• Have severe respiratory insufficiency.

Other medicines and Pravastatin

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

Taking Pravastatin together 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 must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart Pravastatin. 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 lower high cholesterol levels in the blood).
• Rifampicin (a medicine used to treat an infection called tuberculosis).
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).
• If you are taking a medicine used to treat and prevent blood clots known as a “vitamin K antagonist,” inform your doctor before taking pravastatin, as concomitant use of vitamin K antagonists with pravastatin may increase the results of blood tests used to monitor treatment with vitamin K antagonists.
• 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 affect the absorption of Pravastatin if these two medicines are taken simultaneously.

Taking Pravastatin 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 and breastfeeding

Do not take Pravastatin during pregnancy. If you find out you are pregnant, inform your doctor immediately.

Consult your doctor or pharmacist before using any medicine.

Do not take Pravastatin during breastfeeding, as this medicine passes into breast milk.

Driving and using machines

Pravastatin usually 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.

Pravastatin Teva-ratio contains lactose and sodium

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

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

3. How to take Pravastatin Teva-ratio

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

The recommended dose is:

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 pravastatin must not be exceeded. Your doctor will determine the appropriate dose for you.

Children (8–13 years) and adolescents (14–18 years) with a hereditary condition causing high blood cholesterol levels:

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 (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 pravastatin.

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

Duration of treatment

Your doctor will indicate 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 earlier on your own.

If you take more pravastatin than you should

If you have taken more pravastatin than you should, or if someone accidentally swallowed some tablets, contact your doctor or 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 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take pravastatin

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 product, 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 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 trachea 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 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, diarrhoea, constipation, and flatulence.
• Skin and hair disorders: itching, acne, skin rash, blistering accompanied by itching, and abnormalities of hair and scalp (including hair loss).
• Urinary and genital disorders: changes in urination (such as pain when urinating, increased frequency of urination, and increased frequency of urination at night) and sexual problems.
• Musculoskeletal disorders: muscle and joint pain, tendon inflammation which may lead to tendon rupture.

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

• Increased sensitivity of the skin 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 disorder (lupus-like syndrome).
• Liver disorders: inflammation of the liver or pancreas, jaundice (recognised by 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Possible adverse effects

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

Adverse effects of unknown frequency: Persistent muscle weakness, liver failure, muscle rupture.

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).

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.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can 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 Teva-ratio

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

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

Do not store above 30 °C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to 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 Pravastatin Teva-ratio 40 mg

• The active substance is pravastatin sodium. Each tablet contains 40 mg of pravastatin sodium.
• The other components are: lactose, povidone (PVP K-30), crospovidone, calcium hydrogen phosphate (E341), sodium stearyl fumarate, microcrystalline cellulose (E460), sodium croscarmellose (E466), quinoline yellow (E104), brilliant blue FCF (E133).

Appearance of the medicine and contents of the pack

• Tablet.
• Round, bright green, slightly convex tablets, biconvex and scored on both sides. The tablet may be divided into equal doses.
• Pravastatin Teva-ratio 40 mg is available in pack sizes of 14, 20, 28, 30, 50, 56, 84, 98, 100 and 200 tablets, and in clinical packs of 50 tablets in unit doses.
• Only some pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation Holder:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11. Edificio Albatros B, 1st Floor.

28108 Alcobendas (Madrid), Spain.

Manufacturer:

Pharmachemie B.V.,

Swensweg 5, Postbus 552,

2003 RN Haarlem, The Netherlands

or

Teva Pharmaceutical Works Private Ltd. Co.,

Pallagi út 13, 4042 Debrecen, Hungary

or

Teva Czech Industries s.r.o.,

Ostravská 29, c.p. 305, 747 70

Opava–Komárov, Czech Republic

or

Teva Pharma S.L.U.,

Poligono Malpica, Calle C, No. 4,

50016 Zaragoza, Spain

or

Merckle GmbH,

Ludwig-Merckle-Str. 3,

89143 Blaubeuren, Germany

This medicine is registered in the EEA Member States under the following names:

Germany: Pravastatin- ratiopharm 40 mg Tabletten

Netherlands: Pravastatine natrium ratiopharm 40 mg Teva, tabletten

Portugal: Pravastatina ratiopharm 40 mg Comprimidos

Spain: Pravastatina Teva-ratio 40 mg comprimidos EFG

Date of the most recent revision of this leaflet: April 2023

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

You can access detailed and up-to-date information on this medicine by scanning with your mobile phone (smartphone) the QR code included on the packaging. You may also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74542/P_74542.html