20 mg, 40 mg tablets
Pravastatin sodium
What Pravastatin Sandoz is and what it is used for
Pravastatin Sandoz is a cholesterol-lowering drug that belongs to the group of HMG-CoA reductase inhibitors (or statins), which work by reducing the body’s production of ‘bad cholesterol’ ( LDL ) and increasing the levels of ‘good’ cholesterol ( HDL ). Cholesterol is a fat that can cause coronary heart disease by clogging the blood vessels that supply the heart with blood. This condition, called atherosclerosis or arteriosclerosis, can lead to chest pain ( angina pectoris ), a heart attack (myocardial infarction), or stroke.
If you have had a heart attack or have chest pain while resting (labile angina pectoris ), Pravastatin Sandoz helps reduce the risk of a new heart attack or stroke, regardless of your cholesterol levels.
If you have high cholesterol levels but have not had any coronary heart disease, Pravastatin Sandoz will help reduce the risk of you getting coronary heart disease or heart attack in the future.
When using Pravastatin Sandoz, your doctor will recommend other measures as part of your treatment, such as a low-fat diet, exercise, and weight loss.
If you have had an organ transplant and are receiving medication to prevent your body from rejecting the transplant, Pravastatin Sandoz lowers the increased fat levels.
Pravastatin sodium contained in Pravastatin Sandoz may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Pravastatin Sandoz
Do not use Pravastatin Sandoz
- if you are allergic to pravastatin sodium or any of the other ingredients of this medicine (listed in section 6)
- if several blood tests have shown liver dysfunction (high levels of liver enzymes in the blood)
- if you are pregnant or there is a possibility that you will become pregnant
- if you are breast-feeding (see section “Pregnancy and breast-feeding”)
- if you have liver problems (see section 2: “Warnings and precautions”).
Ask your doctor if you are not sure if you can take Pravastatin Sandoz.
Warnings and cautions
If you have or have had any of the following, talk to your doctor or pharmacist before taking Pravastatin Sandoz:
- Kidney disease or an underactive thyroid gland
- Alcohol problems (regular drinking of a lot of alcohol)
- You or a close relative have a hereditary muscle disease
- Muscle side effects caused by another cholesterol-lowering drug such as a statin or a drug that belongs to the group of fibrates
- If you have had any liver problems
- If you have severe lung impairment
- If you are taking a medicine called fusidic acid (medicine for bacterial infections) by mouth or as an injection or have been taking it for the last 7 days. A combination of fusidic acid and Pravastatin Sandoz can cause severe muscle problems ( rhabdomyolysis ).
If you have had any of these conditions, your doctor will need to take a blood test before and possibly during treatment with Pravastatin Sandoz. The blood tests will be used to assess your risk of muscle-related side effects. A blood sample may also be needed if you are over 70 years old to determine your risk of muscle side effects.
Go back to your doctor as soon as possible for a discussion and follow the advice you receive.
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
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.
In a small number of people, statins can affect the liver. This is detected with a simple test that identifies increased levels of liver enzymes in the blood. For this reason, your doctor will usually prescribe this blood test (liver function test) before and during treatment with Pravastatin Sandoz.
If you have unexplained muscle aches, soreness, weakness, or cramps and are taking statins, contact your doctor immediately.
Also, tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to diagnose and treat this.
Children and adolescents (8-18 years) with a hereditary disease that increases blood cholesterol levels (heterozygous familial hypercholesterolemia):
In children before puberty, the benefit/risk of treatment should be carefully evaluated by a physician before starting treatment.
Other medicines and Pravastatin Sandoz
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
You must tell your doctor if you are already being treated with any of the following:
- other cholesterol-lowering drugs called fibrates (eg gemfibrozil or fenofibrate) and nicotinic acid ). The combination can increase the risk of muscle problems.
- drugs used to adjust or adapt the immune system e.g. cyclosporine. The combination may increase the risk of side effects.
- antibiotics erythromycin, clarithromycin, and roxithromycin. The combination can lead to an increased risk of developing muscle problems.
- if you are also taking a resin-type lipid-lowering drug, which contains cholestyramine or colestipol, Pravastatin Sandoz should usually be taken at least one hour before or four hours after taking the resin. This is because the resin may reduce the uptake of pravastatin if the two medicines are taken too close to each other.
- rifampicin ( antibiotic ). The combination may lead to increased pravastatin levels. Pravastatin Sandoz should usually be taken at least two hours before taking rifampicin.
- colchicine (medicine for gout ). The combination can increase the risk of muscle problems.
- lenalidomide (medicines that affect the function of the immune system). The combination can increase the risk of muscle problems.
If you are taking medicines used to treat and prevent blood clots, so-called vitamin K antagonists, you should tell your doctor before taking Pravastatin Sandoz, as concomitant use of vitamin K antagonists with Pravastatin Sandoz may increase the results of blood tests used to monitor treatment with vitamin K antagonists.
If you need to take fusidic acid by mouth to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when you can safely start taking Pravastatin Sandoz again. Concomitant use of Pravastatin Sandoz and fusidic acid may in rare cases cause muscle weakness, tenderness, or pain ( rhabdomyolysis ). See section 4 for more information on rhabdomyolysis.
Pravastatin Sandoz with food, drink, and alcohol
Pravastatin Sandoz can be taken with or without food. Tell your doctor if you regularly drink large amounts of alcohol.
If you are not sure about this, follow your doctor’s advice.
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.
Pravastatin Sandoz should not be used during pregnancy. Physicians will pay particular attention to this when prescribing the drug to young women who may become pregnant and carefully explain the risks associated with pravastatin treatment. If you are planning to become pregnant or have become pregnant, you must inform your doctor and stop treatment immediately (see section 2: Do not use Pravastatin Sandoz).
Pravastatin Sandoz should not be used during breastfeeding, as Pravastatin Sandoz is excreted in human milk (see section 2: Do not use Pravastatin Sandoz).
Driving and using machines
Pravastatin Sandoz does not usually affect your ability to drive and use machines. However, when driving or using machines, keep in mind that dizziness, blurred vision, or double vision may occur during treatment.
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 Sandoz contains lactose and sodium
Pravastatin Sandoz contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Pravastatin Sandoz contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.
How to use Pravastatin Sandoz
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Adults
The usual dose of Pravastatin Sandoz is 10-40 mg once daily, preferably in the evening.
Pravastatin Sandoz can be taken with or without food. The tablet should be taken with half a glass of water.
The tablet can be divided into two equal doses.
Use in children and adolescents (8 to 18 years) with heterozygous familial hypercholesterolemia
Use in children and adolescents (8-13 years): The recommended dose range is 10-20 mg once daily.
Use in children and adolescents (14-18 years): The recommended dose range is 10-40 mg once daily.
Impaired kidney and liver function
The usual dose is 10 mg once daily for patients with renal or hepatic impairment.
Organ transplantation
The usual starting dose is 20 mg once a day. Your doctor may increase the dose from one to 40 mg.
Other drugs
Pravastatin Sandoz should usually be taken at least one hour before or four hours after taking cholestyramine or colestipol.
The usual starting dose for people who use medicines that regulate or adapt the immune system (eg cyclosporine ) is 20 mg once a day. Your doctor may increase the dose from one to 40 mg.
Duration of treatment
Your doctor will tell you how long the treatment with this medicine should last. This medicine should be used regularly for as long as your doctor prescribes it, and this can be a very long time. Do not stop taking this medicine without your doctor’s permission.
If you have the impression that the effect of Pravastatin Sandoz is too strong or too weak, talk to your doctor or pharmacist.
If you take more Pravastatin Sandoz than you should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Pravastatin Sandoz
If you miss a dose, you do not need to worry. Then only take the usual dose one at the next dose. Do not take a double dose to make up for a forgotten dose.
If you stop using Pravastatin Sandoz
Always tell your doctor if you want to stop treatment.
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.
Stop taking Pravastatin Sandoz and contact your doctor as soon as possible if you experience symptoms such as:
- swelling of the face, lips, mouth, tongue, eyes, or throat, difficulty swallowing, hives and difficulty breathing, and dizziness. These are symptoms of a severe allergic reaction ( angioedema, anaphylaxis ) that must be treated immediately, usually in a hospital.
- unexplained or persistent muscle aches, soreness, weakness, or cramps, especially if you feel sick or have a fever at the same time. In very rare cases, muscle problems can be serious ( rhabdomyolysis ) and lead to a serious and possibly life-threatening kidney disease.
- yellowing of the skin or whites of the eyes and/or poor appetite and general malaise, abdominal pain. These are symptoms of severe liver and/or pancreatitis and rapid deterioration of liver function.
Other side effects are
Uncommon (may affect up to 1 in 100 people):
- dizziness, headache, sleep disorders, insomnia
- visual impairment (such as blurred vision and double vision)
- gastrointestinal problems such as indigestion, heartburn, abdominal pain or abdominal discomfort, nausea, vomiting, diarrhea or constipation, and flatulence
- skin reactions such as rash and itching, hives ( urticaria ) or scalp, and hair changes including hair loss
- altered urination (such as difficulty emptying the bladder, frequent urination, nocturnal urination)
- impaired sexual function
- fatigue
- muscle and joint pain
- tendonitis that can be aggravated due to tendon stretching.
Rare (may affect up to 1 in 1,000 people):
- increased skin sensitivity to sunlight.
Very rare (may affect up to 1 in 10,000 people):
- tingling or numbness in the hands and feet (which may be due to the nerve endings being affected)
- allergic condition with joint pain, rash, and fever ( lupus erythematosus )
- muscle pain or weakness ( myopathy ), inflammation of muscles (myositis or polymyositis)
- Abnormal blood tests: increased amount of transaminases (a group of enzymes found naturally in the blood), which can be a sign of liver problems. Your doctor may want to do tests at regular intervals to check this
- dermatitis and muscle inflammation ( dermatomyositis ).
Has been reported (occurs in an unknown number of users):
- persistent muscle weakness
- rash, i.a. lichenoid rash.
The following side effects have been reported with certain statins (medicines of the same type):
- nightmares
- memory loss
- Depression
- difficulty breathing including persistent cough and/or shortness of breath or fever
- diabetes – is more likely if you have high blood sugar and high blood fat levels, are overweight, and have high blood pressure. Your doctor will check you while you are taking this medicine.
How to store Pravastatin Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. or EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
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.
20 mg: Each tablet contains 20 mg of pravastatin sodium
40 mg: Each tablet contains 40 mg of pravastatin sodium.
The other ingredients are microcrystalline cellulose, lactose monohydrate, anhydrous disodium phosphate, croscarmellose sodium, sodium lauryl sulfate, povidone K25, iron oxide (brown) (E172), colloidal anhydrous silica and magnesium stearate.
What the medicine looks like and the contents of the pack
20 mg tablets :
Light brown, speckled, oval, notched on both sides, and marked with “P 20” on one side.
40 mg tablets :
Light brown, speckled, oval, notched on both sides, and marked with “P 40” on one side.
Al / Al blister:
1, 7, 10, 14, 20, 21, 28, 30, 50, 60, 90, 98, 100, 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals, Verovskova 57, SI-1526 Ljubljana, Slovenia
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
LEK SA, ul. Domaniewska 50 C, 02-672 Warsaw, Poland
or
Lek Pharmaceuticals dd Trimline 2 D, 9220 Lendava, Slovenia