Pravastatin Teva-Ratio 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Pravastatin Teva-ratio 10 mg tablets EFG

Pravastatin sodium

Read the 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, and you should 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 they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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 is Pravastatina Teva-ratio and what is it used for

Pravastatin belongs to a group of medicines known as statins (or HMG-CoA reductase inhibitors). It prevents the production of cholesterol by the liver 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 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 doing little physical activity), Pravastatin 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 with normal cholesterol levels, Pravastatin is indicated to reduce the risk of having another heart attack or stroke in the future, and reduces the risk of dying from these conditions.

After an organ transplant

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

2. What you need to know before starting to take 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).
• If you are pregnant, planning to become pregnant, or breastfeeding (see Pregnancy and breastfeeding).
• 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 condition
• Muscle problems caused by another medicine belonging to the statin group (HMG-CoA reductase inhibitor medicines) or to the group known as fibrates (see Use of other medicines).
• 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 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 you start 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 used to treat bacterial infections), combining it with Pravastatin may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor before taking Pravastatin.

Consult 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 reduces 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 Pravastatin treatment. 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 tuberculosis)
• Lenalidomide (a medicine used to treat a type of blood cancer called multiple myeloma).
• If you are taking a medicine used for the treatment and prevention of 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 vitamin K antagonist therapy.
• If you are also using 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 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 discover 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 use machines until you are certain you are fit to do so.

Pravastatin Teva-ratio contains lactose and sodium

If your doctor has diagnosed you with an intolerance to certain sugars, consult him 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 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 your treatment.

Pravastatin may 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 disease: 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 an inherited condition causing high blood cholesterol levels:

The recommended dose for children aged 8 to 13 years is 10–20 mg once daily, and for adolescents aged 14 to 18 years, the recommended dose is 10–40 mg once daily.

After an organ transplant:

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 medicine is too strong or too weak, tell your doctor or pharmacist.

Duration of treatment

Your doctor will tell you how long to 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 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 go to 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 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 tell your doctor immediately if you experience unexplained or persistent muscle pain, pain on palpation, weakness or cramps, especially if at the same time you 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.

Severe 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, 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 frequency of urination at night) and sexual problems.
• Muscle and joint 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:

• 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 (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 rupture.
• Abnormal blood test results: increased transaminases (a group of blood enzymes), which may indicate liver problems. Your doctor may wish to carry out 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 blood sugar and fat levels, 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 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 directly via the Spanish Pharmacovigilance System for Human Medicinal Products: 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the container and other information

Composition of Pravastatina Teva-ratio 10 mg

• The active substance is sodium pravastatin. Each tablet contains 10 mg of sodium pravastatin.

• The other components are: lactose, povidone (PVP K-30), crospovidone, calcium hydrogen phosphate (E341), sodium stearyl fumarate, microcrystalline cellulose (E460), sodium croscarmellose (E466), red iron oxide (E172).

Appearance of the product and contents of the container

• Tablet.
• Round, mottled, pink, slightly convex tablets, scored on both sides. The tablet can be divided into equal doses.
• Pravastatina Teva-ratio 10 mg is available in pack sizes of 20, 28, 30, 50, 60, 84, 90 and 100 tablets and clinical packs of 50 tablets in unit-dose packaging.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization 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.,
Polígono Malpica, Calle C, No. 4,
50016 Zaragoza, Spain

or

Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren, Germany

This medicinal product is registered in the Member States of the EEA under the following names:

Germany: Pravastatin-ratiopharm 10 mg Tabletten
Netherlands: Pravastatinenatrium ratiopharm 10 mg Teva, tabletten
Portugal: Pravastatina ratiopharm 10mg Comprimidos
Spain: Pravastatina Teva-ratio 10 mg comprimidos EFG

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

“Detailed and up-to-date information on this medicinal product 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 about this medicinal product by scanning with your mobile phone (smartphone) the QR code included on the outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74544/P_74544.html