Patient Information Leaflet
Pravastatina Teva-ratio 20 mg Tablets EFG
Pravastatina Sodium
Read this leaflet carefully before you start taking this medicine because it contains important information for you.
Pravastatina belongs to a group of medications 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 excessive levels of cholesterol in the blood, cholesterol accumulates in the walls of blood vessels, obstructing them.
This situation is known as hardening of the arteries or atherosclerosis and can lead to:
This medication is indicated in three situations:
In the treatment of high levels of cholesterol and fats in the blood
Pravastatina is indicated to reduce high levels of "bad" cholesterol and increase levels of "good" cholesterol in the blood when diet and exercise have not been effective.
Prevention of heart and blood vessel diseases
After an organ transplant
If you have undergone an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Pravastatina is indicated to reduce elevated levels of blood fat.
Do not take Pravastatina Teva-ratio:
Warnings and precautions
Before taking this treatment, you must consult your doctor if you have or have had any of the following medical conditions:
Your doctor will perform a blood test before starting to take Pravastatina and if you have any liver symptoms or problems during treatment. This is to check if your liver is functioning correctly.
Your doctor may also need to perform a blood test after starting treatment with Pravastatina to check the functioning of your liver.
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 orally or by injection a medication called fusidic acid (a medication for bacterial infections), your combination with Pravastatina may cause severe 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 evaluate the risk of you experiencing adverse muscle effects.
If you feel inexplicable cramps or muscle pain during treatment, inform your doctor immediately.
If you have diabetes or are at risk of developing it, your doctor will perform a careful control during treatment with this medication. It is likely that you are at risk of developing diabetes if you have high levels of sugar and fats in your blood, overweight, and 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.
Consult your doctor before taking Pravastatina.
Consult your doctor or pharmacist before taking Pravastatina if you
Other medications and Pravastatina
Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.
The administration of Pravastatina with any of the following medications may increase the risk of muscle problems:
Pravastatina with food and drinks
This treatment can be taken with or without food, with half a 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 medication, you should consult your doctor.
Pregnancy and breastfeeding
Do not take Pravastatina during pregnancy. If you discover that you are pregnant, you must inform your doctor immediately.
Consult your doctor or pharmacist before using any medication.
Do not take Pravastatina during the breastfeeding period as this treatment passes into breast milk.
Driving and using machines
Pravastatina usually 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 are in a condition to do so.
Pravastatina Teva-ratio contains lactose and sodium
If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medication.
This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again..
Your doctor will advise you to follow a low-fat diet, which you should continue until the end of treatment.
Pravastatina can be taken with or without food, with half a glass of water.
The recommended dose is:
Adults
Do not exceed the maximum daily dose of 40 mg of pravastatina. Your doctor will establish the suitable dose for you.
Children (8-13 years) and adolescents (14-18 years) with a hereditary disease that increases blood cholesterol levels:
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 medication that reduces the body's immune system (ciclosporina), 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 estimate that the effect of this treatment is too strong or too weak, inform your doctor or pharmacist.
Treatment duration
Your doctor will indicate the duration of your pravastatina treatment. This medication should be taken regularly for the time your doctor recommends, even if it is for a long period of time. 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 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.
If you forgot to take Pravastatina
If you forgotto take a dose, simply take your normal dose when it is due next.
Do not take a double dose to compensate for the missed doses.
If you have any other questions about the use of this product, ask your doctor or pharmacist.
Stop taking Pravastatinaand tell your doctor immediatelyif you notice unexplained or persistent muscle pain, pain on movement, weakness or cramps, especially if you do not feel well or have a fever at the same time.
In rare cases, muscle problems can be severe (rhabdomyolysis) and can cause a kidney disease that can be life-threatening.
Severe and sudden allergic reactions such as swelling of the face, lips, tongue, or throat can cause serious breathing difficulties. This is a very rare reaction that can be serious if it occurs. Inform your doctor immediately if this happens.
The following side effects are infrequent and can affect up to 1 in 100 people:
The following side effects are rare and can affect up to 1 in 1,000 people:
The following side effects are very rare and can affect up to 1 in 10,000 people:
If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.
Possible side effects
Side effects of unknown frequency:constant muscle weakness, liver failure, muscle rupture
Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
Myasthenia ocular (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 eyelid drooping, difficulty swallowing, or difficulty breathing.
Reporting side effects
If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.
Do not store at a temperature above 30 °C. Store in the original packaging to protect it from moisture.
Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.
Composition of Pravastatina Teva-ratio 20 mg
Appearance of the product and contents of the package
Holder of the marketing authorization and responsible for manufacturing:
Holder of the marketing authorization:
Teva Pharma, S.L.U.
C/ Anabel Segura, 11. Edificio Albatros B, 1st Floor.
28108 Alcobendas (Madrid).
Responsible for manufacturing:
Pharmachemie B.V,
Swensweg 5, Postbus 552,
2003 RN Haarlem
Netherlands
or
Teva Pharmaceutical Works Private Ltd. Co.,
Pallagi ùt 13, 4042 Debrecen
Hungary
or
Teva Czech Industries s.r.o.,
Ostravská 29, c.p. 305, 747 70
Opava–Komárov
Republic of Czecha
or
Teva Pharma S.L.U.,
Poligono Malpica, Calle C, N°4,
50016 Zaragoza
Spain
or
Merckle GmbH,
Ludwig-Merckle-Str. 3,
89143 Blaubeuren
Germany
This medicine is registered in the Member States of the EEA with the following names:
Germany:Pravastatin-ratiopharm 20 mg Tabletten
Netherlands:Pravastatinenatrium ratiopharm 20 mg Teva, tabletten
Portugal:Pravastatina ratiopharm 20mg Comprimidos
Spain:Pravastatina Teva-ratio 20 mg comprimidos EFG
Date of the last review of this prospectus:April 2023
“Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ ”
You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the carton. You can also access this information on the following internet address: https://cima.aemps.es/cima/dochtml/p/74543/P_74543.html
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