PRAVASTATIN TEVA 20 mg TABLETS

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

Do not take Pravastatina Teva:

• 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 any liver disease (active liver disease).
• If several blood tests show abnormal liver function (elevated liver enzyme levels in the blood)

Warnings and precautions

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 Pravastatin to check liver function.

Pravastatin may increase the risk of muscle side effects in some patients, which can lead to muscle pain, sensitivity, and weakness. Your doctor may perform blood tests to check the condition of your muscles before and after starting treatment with pravastatin.

Consult your doctor or pharmacist BEFORE taking pravastatin if you have any of the following situations, as you may have a higher risk for muscle side effects:

• if you have kidney disease
• if you have an underactive thyroid gland (hypothyroidism)
• if you have liver disease or problems with alcohol (drinking large amounts of alcohol)
• if you have a muscle disorder caused by a hereditary muscle disorder or family history of such a disease
• if you have had muscle problems caused by another medicine that belongs to the group of statins (HMG-CoA reductase inhibitors) or one that belongs to the group known as fibrates (see Taking other medicines).
• if you are over 70 years old.
• 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 (see section 4).

Some medicines may increase your risk of muscle side effects, see "Using Pravastatina Teva with other medicines".

If you are taking or have taken in the last 7 days an oral or injectable medicine called fusidic acid (an antibiotic), your combination with Pravastatina may produce 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 muscle pain during treatment, inform your doctor immediately. 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.

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 blood sugar and fat levels, are overweight, and have hypertension.

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.

Statins, like pravastatin, can sometimes cause lung disease, especially when used for a long time. You should stop taking pravastatin and consult your doctor if you experience shortness of breath, dry cough, and your general health worsens, with fatigue, weight loss, and fever.

Using Pravastatina Teva with other medicines

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:

• Fibrates, e.g., gemfibrozil, fenofibrate (a medicine that lowers cholesterol levels in the blood).
• Ciclosporin (a medicine that lowers the body's defenses).
• Antibiotics such as erythromycin or clarithromycin (medicines that treat bacterial infections).
• Colchicine (a medicine used to treat gout)
• Nicotinic acid (a medicine used to treat high cholesterol 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 need to take fusidic acid orally to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start treatment with pravastatin. Taking pravastatin with fusidic acid can rarely cause muscle weakness, sensitivity, or pain (rhabdomyolysis). See more information on rhabdomyolysis in section 4.

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 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 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

Follow exactly the instructions of administration 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, which 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 immune system (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.

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.

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, telephone 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 it is time for your next dose.

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

If you have any other questions 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.

If the following side effects occur, stop taking the tablets and inform your doctor immediately or go to the nearest hospital:

• Allergic reaction (swelling of the face or neck, muscle and joint pain, hives, fever, redness, shortness of breath).

This is a very serious but rare side effect. You may need urgent medical attention or hospitalization.

Contact your doctor as soon as possible and stop taking Pravastatina if you develop:

• Any unexplained muscle pain or persistent sensitivity, weakness, or cramps, especially if you do not feel well or have a high temperature.

In very rare cases, this can progress to a serious and potentially fatal disease called rhabdomyolysis.

The following side effects are uncommon and may affect up to 1 in 100 people:

• dizziness, fatigue, headache, sleep disorders, including insomnia.
• blurred vision or double vision.
• indigestion, nausea, vomiting, stomach pain or discomfort, diarrhea, constipation, and gas.
• itching, acne, skin rash, blistering accompanied by itching, hair and scalp abnormalities (including hair loss).
• urination problems (such as painful urination, frequent urination, and increased urination at night) and sexual problems.
• muscle 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:

• alterations in touch sensation, including burning or tingling, or numbness, which indicates nerve damage.
• severe skin disorder (lupus-like syndrome).
• inflammation of the liver or pancreas, jaundice (recognized by yellowing of the skin and the whites of the eyes), rapid destruction of liver cells (fulminant liver necrosis).
• 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.
• 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.

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

If you consider that 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.

The following side effects have been reported with some statins (medicines of the same type)

• Nightmares
• Memory loss

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report side effects 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. Storing Pravastatina Teva

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 "EXP". The expiry date is the last day of the month indicated.

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

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Package Contents and Additional Information.

Composition of Pravastatina Teva 20 mg

• The active ingredient is sodium pravastatin. Each tablet contains 20 mg of sodium pravastatin.
• The other components are: lactose, povidone (PVP K-30), crospovidone, hydrogenated calcium phosphate (E341), sodium stearyl fumarate, microcrystalline cellulose (E460), sodium croscarmellose (E466), yellow iron oxide (E172).

Appearance of the Product and Package Contents

Tablet.

Yellow, bright, slightly convex, round tablets, scored on both sides. The tablet can be divided into equal doses.

Pravastatina Teva 20 mg is available in package sizes of 10, 20, 28, 30, 50, 56, 84, 98, 100, and 200 tablets, and clinical packages of 50 tablets in unit doses.

Not all package 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.

Alcobendas, 28108 - MADRID

Manufacturer:

Pharmachemie B.V.

Swensweg 5, Postbox 552.

2003 RN Haarlem

Netherlands

or

Teva Pharmaceutical Works Private Ltd. Co.

Pallagi Street 13, 4042 Debrecen

Hungary

or

GALIEN LPS

98 Bellocier Street, 89100 Sens

France

or

Teva Pharma S.L.U.

Malpica Industrial Park, Street C, No. 4, 50016 Zaragoza

Spain

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

Names:

FrancePravastatine Teva 20 mg, tablet

ItalyPravastatina Ratiopharm Tablets

NetherlandsPravastatin sodium 20 mg tablets

NorwayPravastatin Teva 20 mg Tablets

PortugalPravastatina Teva 20 mg Tablets

SpainPravastatina Teva 20 mg, EFG tablets

SwedenPravastatin Teva 20 mg tablets

Date of the last revision of this leaflet: April 2023