20 mg and 40 mg tablets
(pravastatin sodium)
What Pravastatin Rivopharm is and what it is used for
The active substance in this medicine is pravastatin sodium, which belongs to a group of medicines called statins or ‘HMG-CoA reductase inhibitors’. These drugs work by reducing the levels of cholesterol and other fats, called triglycerides, in the blood.
Cholesterol is important for the body to function, but if the cholesterol level is too high ( hypercholesterolemia ), it can accumulate on the artery walls and lead to the blood vessels clogging. This in turn can cause angina (severe chest pain) and heart attack.
High cholesterol in the blood can be due to many factors, including high cholesterol and fatty diets, certain diseases, hereditary diseases, and too little exercise.
Your doctor may have prescribed Pravastatin Rivopharm tablets as a supplement to your diet for any of the following reasons:
- You have high levels of cholesterol or fats in your blood, which have not dropped after measures in the form of diet, weight loss, or exercise.
- You have coronary heart disease or you are at risk of developing coronary heart disease because you have diabetes, have had a stroke, or other vascular disease or chest pain ( unstable angina pectoris). Pravastatin sodium can reduce the risk of heart disease and thereby prolong life by helping to keep your arteries open, even if you have normal cholesterol levels.
- You have high cholesterol and are taking medication to prevent your body from rejecting a newly transplanted organ.
Your doctor will also advise you on how to lower your blood cholesterol levels by eating a low-fat diet throughout your treatment with Pravastatin Rivopharm tablets.
What you need to know before you use Pravastatin Rivopharm
Do not use Pravastatin Rivopharm
- if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or planning to become pregnant
- if you are breast-feeding
- if you have liver problems
Warnings and cautions
Pravastatin Rivopharm in some patients may increase the risk of myopathy, which causes muscle aches, sore muscles, and decreased muscle strength. Your doctor may take blood samples to check the condition of your muscles before and after you start treatment with Pravastatin Rivopharm.
Talk to your doctor BEFORE you take the tablets if any of the following apply to you as you may be at greater risk of developing myopathy.
- If you get unexplained muscle aches, sore muscles, or decreased muscle strength, or if you have ever had a disease called myopathy (muscle disease).
- If you have ever had muscle problems during treatment with cholesterol-lowering medicines called statins (eg simvastatin or atorvastatin) or fibrates (eg gemfibrozil and fenofibrate).If you are taking, or within the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infections ) by mouth or by injection. The combination of fusidic acid and Pravastatin Rivopharm can lead to severe muscle problems ( rhabdomyolysis ).
- If you drink a lot of alcohol or have had liver disease. Your doctor may take some blood samples to examine your liver before and after starting treatment.
- If you or close family members have a hereditary muscle disease.
- If you have kidney or thyroid problems.
- If you are over 70 years old.
- If you have had liver disease.
Ask your doctor or pharmacist for advice before taking Pravastatin Rivopharm if you:
- have a severe pulmonary impairment.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to get diabetes if you have high blood sugar and high blood fat levels, are overweight and have high blood pressure.
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
Other medicines and Pravastatin Rivopharm
The risk of muscle problems may increase if Pravastatin Rivopharm is taken with other medicines. Tell your doctor if you are taking, have recently taken, or might take any of the following medicines:
- If you are taking medicines called fibrates, e.g. gemfibrozil or fenofibrate (cholesterol-lowering drugs).
- If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop using this medicine. Your doctor will tell you when it is safe to start taking Pravastatin Rivopharm again. Pravastatin Rivopharm taken with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). For more information on rhabdomyolysis, see section 4.
Other medicines can be affected by Pravastatin Rivopharm. They in turn can affect the way pravastatin sodium works. Tell your doctor if you are taking any of the following medicines:
- Drugs used to inhibit the immune system, e.g. cyclosporine.
- Niacin or nicotinic acid in doses higher than or equal to 1 g per day (used as a cholesterol-lowering drug).
- Drugs that contain cholestyramine or colestipol (often used as cholesterol-lowering drugs).
- Antibiotics such as erythromycin or clarithromycin.
Talk to your doctor before taking Pravastatin Rivopharm if you are taking a medicine that is used to treat and prevent the formation of blood clots, a so-called “vitamin K antagonist”, as the use of vitamin K antagonist together with pravastatin Rivopharm may affect the results. of blood samples used to monitor treatment with vitamin K antagonist er.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pravastatin Rivopharm with food and drink
Pravastatin Rivopharm tablets can be taken with or without food.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. If you become pregnant while taking Pravastatin Rivopharm, stop taking them immediately and consult a doctor.
Do not take Pravastatin Rivopharm if you are breastfeeding as this medicine passes into breast milk.
Driving and using machines
This medicine may make you dizzy. If this happens, do not drive or use machines until you feel better.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Pravastatin Rivopharm contains lactose
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Pravastatin Rivopharm.
How to use Pravastatin Rivopharm
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Pravastatin Rivopharm tablets should be taken as a single dose in the evening or at night. Swallow the tablets whole with a glass of water. The recommended dose is:
Adults (18 years and older):
The recommended starting dose for lowering cholesterol is 10 mg once a day. Your doctor may increase this dose to 40 mg once a day.
The starting and maintenance dose for the prevention of coronary heart disease is 40 mg.
The starting dose after organ transplantation is 20mg once a day. Your doctor may increase the dose from one to 40 mg.
The starting dose for patients with moderate or severe kidney disease or significant liver problems is 10 mg daily. Your doctor may change your dose depending on how you react to the treatment.
Use in children and adolescents, 8–13 years:
The recommended starting dose for lowering cholesterol is 10 mg once a day. Your doctor may increase this dose to 20 mg once a day.
Young people 14–18 years:
The recommended starting dose for lowering cholesterol is 10 mg once a day. Your doctor may increase this dose to 40 mg once a day.
If you are taking a medicine that contains cholestyramine or colestipol (to lower your cholesterol), Pravastatin Rivopharm tablets should be taken at least one hour before or four hours after you have taken such medicines. The reason for this is that these drugs can affect the absorption of pravastatin if taken too close to each other.
If you take more Pravastatin Rivopharm than you should
If you take more Pravastatin Rivopharm than you should, or if you accidentally swallow any tablets, contact your doctor or pharmacist as soon as possible or go to the nearest emergency room immediately. Remember to bring the pack and any remaining tablets.
If you forget to take Pravastatin Rivopharm
If you forget to take Pravastatin Rivopharm tablet (s), do not worry. Only take the next dose when it is time for it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Pravastatin Rivopharm
If you stop taking Pravastatin Rivopharm tablets, your cholesterol level may rise again. Keep taking the tablets for as long as your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of these serious side effects occur, stop taking this medicine and contact your doctor immediately or go to the nearest emergency department.
- Muscle aches, decreased muscle strength, sore muscles or muscle aches, and especially if you also feel sick or have a fever. In very rare cases, muscle problems can be serious ( rhabdomyolysis ) and can lead to serious, life-threatening kidney disease.
- Sudden severe allergic reactions include sudden wheezing, difficulty breathing, swollen eyelids, lips, tongue or throat, skin rash or itching (especially if the whole body is affected), joint pain, inflammation of joints and blood vessels, abnormal bruising, rash, swelling, hives, skin becomes sensitive to sunlight if you get a fever or hot flashes.
- Inflammation of the liver with yellowing of the skin and whites of the eyes, itching, dark-colored urine, or pale-colored stools (liver failure).
- Inflammation of the pancreas often with severe abdominal pain.
The following side effects have been reported with pravastatin:
Uncommon side effects ( affects up to 1 in 100 people):
- dizziness
- headache
- difficulty sleeping
- sleep disorders (insomnia)
- visual disturbances, such as blurred vision or double vision
- stomach upset (such as nausea or vomiting, constipation, diarrhea, flatulence, indigestion, and stomach pain)
- hair loss
- rash
- itching
- impotence
- fatigue
- impotence
- the way your liver works
- heartburn
- bladder problems (painful or dense bladder emptying)
Very rare side effects ( affects up to 1 in 10,000 people, including occasional reports)
- numbness or loss of sensation in the arms and legs
- crawling or tingling ( paresthesia )
- muscle and joint pain
Has been reported (occurs in an unknown number of users):
- Persistent muscle weakness.
Other possible side effects that have been reported with certain statins are:
- Sleep disorders including insomnia and nightmares
- Memory loss
- Impaired sexual ability
- Depression
- Respiratory problems including persistent cough and/or shortness of breath or fever
- Diabetes Mellitus: The frequency depends on the presence or absence of risk factors (fasting glucose ≥5.6 mmol / l, BMI > 30 kg / m 2, elevated triglycerides, high blood pressure in the history of the disease).
- Dermatomyositis (a condition characterized by an inflammation of the muscles and skin).
Reporting of side effects If
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to side effects that are not mentioned in this information. You can also report side effects directly via the Medical Products Agency, Box 26, SE-751 03 Uppsala. Website: www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
How to store Pravastatin Rivopharm
Keep this medicine out of the sight and reach of children.
Pravastatin Rivopharm tablets should not be stored above 25 ° C. Close the package tightly. Store in the original package
Do not use this medicine after the expiry date which is stated on the carton and each blister pack of tablets. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substance is pravastatin sodium.
Each tablet contains 20 mg or 40 mg of pravastatin sodium.
The other ingredients are lactose monohydrate, microcrystalline cellulose, magnesium aluminum silicate, croscarmellose sodium, povidone, talc, and magnesium stearate.
What the medicine looks like and the contents of the pack
Pravastatin Rivopharm 20 mg tablets are white to off-white capsule-shaped tablets marked with “6” on one side of the tablet and “PV 20” on the other side. The breaking slot allows the tablet to be divided into two equal doses.
Pravastatin Rivopharm 40 mg tablets are white to off-white capsule-shaped tablets marked with “6” on one side of the tablet and “PV 40” on the other side.
Pravastatin Rivopharm 20 mg tablets are available in blister packs of 10, 20, 28, 30, 50, 56, 60, 98, 100 and 500 (5×100) tablets and jars of 30, 250 and 1000 tablets.
Pravastatin Rivopharm 40 mg tablets are available in blister packs of 10, 14, 20, 28, 30, 50, 56, 60, 98, 100 and 500 (5×100) tablets and jars of 30, 250 and 750 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer:
• Arrow Pharm (Malta) Ltd, HF 62, Hal Far Industrial Estate, Birzebbugia BBG 06, Malta
• Juta Pharma GmbH, Gutenbergstrasse 13, 24941 Flensburg, Germany
• Quality (Burnley) Limited, Talbot Street, Briercliffe, Burnley, Lancashire, BB10 2JY
UK
• Actavis Ltd, BLB 016, Bulebel Industrial Estate, Zejtun, ZTN 3000, Malta
Agent:
SanoSwiss UAB
Love 25-701
LT-09320 Vilnius
Lithuania
info@sanoswiss.com