PRAVASTATIN TEVA-RATIO 40 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Pravastatina Teva-ratio 40 mg Tablets EFG

Pravastatin Sodium

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pravastatina Teva-ratio and what is it used for
2. What you need to know before you take Pravastatina Teva-ratio
3. How to take Pravastatina Teva-ratio
4. Possible side effects
5. Storing Pravastatina 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 as a result reduces the levels of cholesterol and other fats (triglycerides) in your body. When there are high levels of cholesterol in the blood, cholesterol accumulates in the walls of the blood vessels, blocking them.

This situation is known as hardening of the arteries or atherosclerosis and can lead to:

• Chest pain (angina), 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:

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

Pravastatin is indicated to lower high levels of "bad" cholesterol and raise levels of "good" cholesterol in the blood when diet and exercise have not been effective.

The prevention of heart and blood vessel diseases

• If you have high levels of cholesterol in the blood and risk factors that favor these diseases (if you smoke, are overweight, have high blood sugar levels or high blood pressure, or do little exercise), Pravastatin is indicated to reduce the risk of you suffering from a heart or blood vessel problem, and reduces the risk of dying from these diseases.
• If you have already had a stroke or suffer from chest pain (unstable angina), and even with normal cholesterol levels, Pravastatin is indicated to reduce the risk of you having another heart attack or stroke in the future, and reduces the risk of dying from these diseases.

After an organ transplant

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

2. What you need to know before you take Pravastatina Teva-ratio

Do not take Pravastatina:

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

Warnings and precautions

Before taking this treatment, you should consult your doctor if you have or have had any of the following medical problems:

• Kidney disease
• Decreased thyroid function (hypothyroidism)
• Liver disease or problems with alcohol (drinking large amounts of alcohol)
• Muscle disorders caused by a hereditary disease
• Muscle problems caused by another medicine belonging to the group of statins (HMG-CoA reductase inhibitors) or belonging to the group known as fibrates (see Use of other medicines).
• 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), as 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 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 to check 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 in the last 7 days orally or by injection a medicine called fusidic acid (an antibiotic), its combination with Pravastatina can 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 a blood test before and probably during treatment. These blood tests will be used to assess the risk of you suffering from muscle side effects.

If you experience unexplained muscle cramps or 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 are likely to be at risk of developing diabetes if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.

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

Consult your doctor before taking Pravastatina.

Consult your doctor or pharmacist before taking Pravastatina if you:

• Have severe respiratory failure.

Other medicines and Pravastatina

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

Taking Pravastatina 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 lowers the body's defenses (ciclosporin).
• A medicine that treats bacterial infections (an antibiotic such as erythromycin or clarithromycin).
• If you need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Pravastatina. Taking Pravastatina with fusidic acid can rarely cause muscle weakness, sensitivity, 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 infection)
• 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 called "vitamin K antagonist", inform your doctor before taking pravastatin because the use of vitamin K antagonists in combination with pravastatin may increase the results in blood tests used to monitor treatment with vitamin K antagonist.
• If you are also using a medicine to lower fat levels in your blood (such as resin like 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 can affect the absorption of Pravastatina if these two medicines are taken simultaneously.

Taking Pravastatina with food and drinks

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

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

Pregnancy and breastfeeding

Do not take Pravastatina during pregnancy. If you discover that you are pregnant, you should inform your doctor immediately.

Consult your doctor or pharmacist before using any medicine.

Do not take Pravastatina during breastfeeding as this treatment passes into breast milk.

Driving and using machines

Pravastatina normally does not affect your ability to drive or use machines. However, if you notice symptoms of dizziness, blurred vision, or double vision during treatment, do not drive or use machines until you are sure you can do so safely.

Pravastatina Teva-ratio contains lactose and sodium

If your doctor has told you that you have an intolerance to certain sugars, consult with 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 Teva-ratio

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

Your doctor will advise you on a low-fat diet that you should continue until the end of treatment.

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

The recommended dose is:

Adults

• In the treatment of high levels of cholesterol and fat in the blood: the normal dose is 10-40 mg once a day, preferably at night.
• In the prevention of heart and blood vessel diseases: the normal dose is 40 mg once a day, preferably at night.

Do not exceed the maximum daily dose of 40 mg of pravastatin. Your doctor will determine the suitable dose for you.

Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases cholesterol levels in the blood:

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.

After an organ transplant:

Your doctor may prescribe an initial dose of 20 mg once a day. Your doctor may adjust the dose up to 40 mg.

If you are also taking a medicine that lowers the body's defenses (ciclosporin), your doctor may prescribe an initial dose of 20 mg once a day. This dose may be adjusted up to 40 mg by your doctor.

If you have severe kidney or liver disease, your doctor may prescribe a lower dose of Pravastatina.

If you think the action of this treatment is too strong or too weak, inform your doctor or pharmacist.

Duration of treatment

Your doctor will indicate the duration of your treatment with pravastatin. This medicine should be taken regularly for the time your doctor recommends, even if it is for a long period. Do not stop treatment on your own.

If you take more Pravastatina than you should

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Pravastatina

If you forget to take a dose, simply take your normal dose when your next dose is due.

Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

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

Stop taking Pravastatinaand inform your doctor immediatelyif you notice unexplained muscle pain or persistent pain, pain on palpation, weakness, or cramps, especially if you do not feel well or have a fever.

In very rare cases, muscle problems can be serious (rhabdomyolysis) and can cause a life-threatening kidney disease.

Serious and sudden allergic reactions such as swelling of the face, lips, tongue, or trachea can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. You should inform your doctor immediately if this happens.

The following side 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 gas.
• Skin and hair disorders:itching, acne, rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).
• Urinary and genital disorders:changes in urination (such as pain when urinating, urinating more frequently, and urinating more frequently at night) and sexual problems.
• Muscle and joint disorders: muscle pain and joint pain, tendon inflammation that can be complicated by tendon rupture.

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

• Sensitivity of the skin to the sun.

The following side effects are very rare and may affect up to 1 in 10,000 people:

• Nervous system disorders:alterations in touch sensation including burning or tingling, or numbness, which indicates nerve damage.
• Skin disorders:severe skin disorder (lupus-like syndrome).
• Liver disorders: liver inflammation or pancreatitis, jaundice (recognized 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 pain or muscle weakness (myositis or polymyositis or dermatomyositis), pain or weakness in muscles, tendon inflammation, sometimes complicated by rupture.
• Blood test alterations:increase in transaminases (a group of blood enzymes) that may be a sign of liver problems. Your doctor may want to perform periodic tests to monitor this.

If you think any of the side effects you are suffering from is serious, or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

Possible side effects

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

Side effects of unknown frequency:Constant muscle weakness, liver failure, muscle rupture

Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).

Ocular myasthenia (a disease that causes weakness of the eye muscles).

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

Reporting of side effects

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

5. Storing Pravastatina Teva-ratio

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

Do not use this medicine after the expiry date that appears on the packaging after CAD. The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Container Content and Additional Information

Composition of Pravastatina Teva-ratio 40 mg

• The active ingredient 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 Product and Container Content

• Tablet.
• Green, slightly convex, round tablets with a notch on both sides. The tablet can be divided into equal doses.
• Pravastatina Teva-ratio 40 mg is available in pack sizes of 14, 20, 28, 30, 50, 56, 84, 98, 100, and 200 tablets, and clinical packs of 50 tablets in unit doses.
• Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura Street, 11. Albatros B Building, 1st Floor.

28108 Alcobendas (Madrid).

Manufacturer:

Pharmachemie B.V,

Swensweg 5, Postbox 552,

2003 RN Haarlem, 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.,

Malpica Industrial Park, Street C, No. 4,

50016 Zaragoza, Spain

or

Merckle GmbH,

Ludwig-Merckle-Str. 3,

89143 Blaubeuren, Germany

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

Germany: Pravastatin-ratiopharm 40 mg Tablets

Netherlands: Pravastatin sodium ratiopharm 40 mg Teva, tablets

Portugal: Pravastatina ratiopharm 40 mg Tablets

Spain: Pravastatina Teva-ratio 40 mg tablets EFG

Date of the Last Revision of this Leaflet:April 2023

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS http://www.aemps.gob.es/”

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/74542/P_74542.html