PRAVASTATINA 20 mg Таблетка

Содержание инструкции

1. Pravastatina Mylan 20 mg tablets, 40 mg tablets
   1. What is Pravastatina Mylan and what is it used for
   2. What you need to know before taking Pravastatina Mylan
   3. How to take Pravastatina Mylan
   4. Possible side effects
   5. How to store Pravastatina Mylan
   6. Package Contents and Other Information

Pravastatina Mylan 20 mg tablets, 40 mg tablets

pravastatin sodium

Generic medicine
Read this leaflet carefully before you start taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Pravastatina Mylan is and what it is used for
• 2. What you need to know before you take Pravastatina Mylan
• 3. How to take Pravastatina Mylan
• 4. Possible side effects
• 5. How to store Pravastatina Mylan
• 6. Contents of the pack and other information

1. What is Pravastatina Mylan and what is it used for

Pravastatina, the active substance of Pravastatina Mylan, belongs to a group of medicines called “statins” which
work by reducing high levels of cholesterol in the blood. Cholesterol is a fatty substance (lipid) that
can cause narrowing of the blood vessels of the heart (coronary heart disease).
Pravastatina Mylan is used:

• To reduce high levels of cholesterol in the blood when diet, increased physical exercise, or weight loss have not been sufficient.
• As an addition to diet if you are at risk of narrowing of the blood vessels of the heart caused by excess cholesterol in the blood.
• To lower fat (lipid) levels in the blood after an organ transplant.
• To reduce the risk of having another heart attack if you have already had one or if you suffer from chest pain (unstable angina pectoris).

2. What you need to know before taking Pravastatina Mylan

Do not take Pravastatina Mylan:

• If you are allergic to pravastatin, or to any of the other ingredients of this medicine (listed in section 6);
• If you suffer from liver disorders or if liver function tests show excessively high values without an identifiable reason (your doctor will advise you);
• If you are pregnant or breastfeeding.

Take special care with Pravastatina Mylan:

• If you have kidney problems or have had liver problems;
• If you usually drink large amounts of alcohol;
• If you suffer from reduced thyroid function;
• If you are taking other medicines at the same time (e.g. fibrates) to lower blood fats;
• If you have had muscle problems while taking other medicines that lower cholesterol, or if one of your family members has hereditary muscle problems, especially if you are over 65 years of age.
• If you are taking or have taken in the last 7 days a medicine called fusidic acid (a medicine for bacterial infections), orally or by injection. The combination of fusidic acid and pravastatin sodium can lead to serious muscle problems (rhabdomyolysis).
• If you suffer from severe respiratory failure.

If you have suffered from any of these problems, your doctor will have you undergo a blood test before and during
treatment with pravastatin to ascertain the risks related to undesirable effects on the muscles. A blood test may
also be necessary if you are over 70 years of age.
Consult your doctor immediately if unexplained muscle pain, muscle weakness, muscle cramps or flaccidity occur while using Pravastatina Mylan, particularly if associated with
fatigue, fever and reddish-brown urine (rhabdomyolysis) which may be symptoms of
urinary problems. These disorders may be caused by the use of Pravastatina Mylan.
Also, inform your doctor or pharmacist if you have persistent muscle weakness. Further
tests and medicines may be needed for the diagnosis and treatment of this condition.
During the intake of this medicine, the doctor will carefully check if you have diabetes or are at
risk of developing diabetes. You are very likely to be at risk of developing diabetes if you have high
levels of sugar or fats in your blood, if you are overweight or have high blood pressure.

Children
This medicine is not recommended in children under 8 years of age.

Taking Pravastatina Mylan with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, even those available without a prescription.
If you take Pravastatina Mylan together with certain other medicines, the effect of both Pravastatina Mylan and
other medicines or of both may be affected.
Consult your doctor or pharmacist if you are using or have recently used any of the following medicines:

• Medicines known as fibrates (e.g. gemfibrozil and fenofibrate) which lower blood fat levels or nicotinic acid (a vitamin B). Concomitant use of pravastatin may cause muscle disorders, sometimes severe.
• Medicines such as cholestyramine and colestipol used for the treatment of high cholesterol levels, because they can reduce the effect of pravastatin. Pravastatina Mylan must be taken at least 1 hour before or four hours after you have taken these medicines.
• Cyclosporine (a medicine used to suppress the immune system) because the effect of pravastatin may be increased and your doctor may need to change the dose.
• Antibiotics such as erythromycin, clarithromycin, roxithromycin and rifampicin because they intensify the effects of pravastatin.
• If you are taking a medicine used to treat and prevent blood clot formation called a “vitamin K antagonist”, inform your doctor before taking Pravastatina Mylan because the use of vitamin K antagonists in conjunction with Pravastatina Mylan may increase the results of blood tests used to monitor their treatment with vitamin K antagonists.
• Colchicine (used to treat gout).
• Lenalidomide (used to treat a type of blood cancer called multiple myeloma).

If you need to take oral fusidic acid to treat a bacterial infection, you must temporarily interrupt
this medicine. Your doctor will tell you when it is safe to resume Pravastatina Mylan.
Taking Pravastatina Mylan with fusidic acid can rarely cause muscle weakness,
flaccidity or pain (rhabdomyolysis). For further information regarding rhabdomyolysis see
paragraph 4.

Pravastatina Mylan and alcohol
You should limit alcohol consumption to a minimum. If you are concerned about the amount of alcohol you can drink while
being treated with this medicine, ask your doctor.

Pregnancy and breastfeeding
Do not take Pravastatina Mylan during pregnancy or breastfeeding as pravastatin can
harm your baby.
Before starting to use Pravastatina Mylan, you must inform your doctor if you are pregnant or intend
to become pregnant. If you do become pregnant during treatment, stop taking Pravastatina Mylan and see
your doctor immediately.
Girls and women of childbearing potential must use a reliable contraceptive method.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Usually Pravastatina Mylan does not affect the ability to drive vehicles and operate machinery. However,
dizziness or visual disturbances may occur. If you do not feel well after taking
pravastatin, avoid driving vehicles or operating machinery.

Pravastatina Mylan contains lactose and sodium
If you have intolerance to certain sugars, contact your doctor before taking this medicine. In addition,
this medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free”.

3. How to take Pravastatina Mylan

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.

To lower blood cholesterol levels
The recommended dose is 10 - 40 mg of pravastatin once a day. The maximum daily dose is 40 mg
of pravastatin.

To prevent cardiac and vascular disorders
The recommended dose is 40 mg of pravastatin once a day.

After a transplant
The recommended dose is 20 mg of pravastatin once a day. The dosage may be increased up to
40 mg of pravastatin. Your doctor will tell you how much product to take.

Use in children and adolescents with inherited high blood cholesterol
(heterozygous familial hypercholesterolemia)
The recommended dose is 10-20 mg of pravastatin once a day for children aged 8-13 years and 10-40 mg of
pravastatin once a day, in adolescents aged 14-18 years.

Elderly
No dose adjustment is necessary for this group of patients. The same dose as
adult patients can be used. Your doctor will tell you how much product to take.

Dose adjustment in patients with kidney or liver disorders
The dose is usually 10 mg of pravastatin once a day, but it may also be higher. Your
doctor will tell you how much product to take

Usewith other medicines
If you are taking other medicines containing colestyramine or colestipol (medicines used to treat high cholesterol levels) at the same time, you must take Pravastatina Mylan
at least one hour before or four hours after these medicines.
If you are taking a medicine used to suppress the immune system (cyclosporine) at the same time, your doctor
will prescribe you an initial dose of 20 mg of pravastatin once a day. This dose may be
adjusted by your doctor up to 40 mg of pravastatin. Your doctor will tell you how much product to take.
Pravastatina Mylan should be taken once a day, preferably in the evening, with or without food.
Swallow the tablets with a sufficient amount of liquid (e.g. a glass of water).
20 mg and 40 mg tablets: the tablet can be divided into equal doses.
Your doctor will tell you how long you should continue to use Pravastatina Mylan. This depends on
the disease for which you are taking this medicine.
If you feel that the effect of Pravastatina Mylan is too strong or too weak, talk to your
doctor or pharmacist.

If you take more Pravastatina Mylan than you should
If you have taken too many tablets or if someone has accidentally taken your tablets, contact
your doctor or pharmacist immediately.

If you forget to take Pravastatina Mylan
If you have forgotten to take your dose, do not worry. Simply take the next dose
normally as prescribed.
Do not take a double dose to make up for a missed dose.

If you stop taking Pravastatina Mylan
Take Pravastatina Mylan for the period that your doctor has told you. If you stop taking Pravastatina
Mylan, your cholesterol or lipid levels may rise again.
If you have any questions about the use of Pravastatina Mylan, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor immediately if you experience any of the following side effects during
treatment with Pravastatina Mylan:
Very rare (may affect up to 1 in 10,000 people)

• hypersensitivity reactions or severe allergic reaction causing swelling of the face, throat, tongue and excess fluid in the body which can lead to difficulty breathing or swallowing (angioedema, anaphylaxis). or skin rashes, with possible joint pain (lupus-like syndrome)
• destruction of muscle fibres (rhabdomyolysis) which may be associated with acute kidney failure (see also section 2 “What you need to know before you take Pravastatina Mylan”), muscle/several muscle inflammation (myositis/polymyositis). It can cause muscle pain,

tenderness or muscle weakness not caused by exercise, decreased amount of
urine, dark-coloured urine and an increase in creatine kinase detectable in blood tests.
Presence of myoglobin in the urine which can be detected by urine testing (myoglobinuria).

• severe liver problems including yellowish discoloration of the skin and/or eyes (jaundice), tissues and body fluids, liver inflammation (hepatitis), sudden rapid destruction of liver tissue (fulminant hepatic necrosis). This can cause a feeling or state of unwellness, loss of appetite, general malaise, fever, itching, dark urine, pale stools
• inflammation of the pancreas. This causes moderate-to-severe stomach pain, radiating to the back (pancreatitis)
• problems with sensation, including burning and tingling, numbness and pins and needles (paresthesia) which may be a sign of nerve damage (peripheral neuropathy)
• a condition characterized by inflammation of the skin muscles (dermatomyositis).

Not known (frequency cannot be estimated from the available data)

• diabetes. This is much more likely if you have high blood sugar and fat levels, if you are overweight or have high blood pressure. Your doctor will monitor you closely during treatment with this medicine.
• breathing problems, including persistent cough, shortness of breath and/or fever (interstitial lung disease)
• persistent muscle weakness (immune-mediated necrotizing myopathy)

Other possible side effects include:
Common (may affect up to 1 in 10 people)

• joint pain (arthralgia)
• increased production of liver enzymes which can be detected by blood tests.

Uncommon (may affect up to 1 in 100 people)

• dizziness, headache, sleep disorders, difficulty sleeping
• vision problems, including blurred or double vision
• digestive problems or slow digestion, indigestion/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence
• itching, skin rash, hives, scalp or hair abnormalities (including hair loss)
• abnormal urination, e.g. pain, increased frequency, frequent urination at night
• sexual dysfunction
• fatigue.
• tendon inflammation, sometimes associated with rupture

Rare (may affect up to 1 in 1,000 people)

• increased sensitivity to light (photosensitivity)

The following side effects have been observed with other medicines similar to pravastatin, and may
occur with this medicine
Not known (frequency cannot be estimated from the available data)

• nightmares
• memory loss
• depression

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/content/come-segnalare-una-
sospetta-reazione-avversa . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Pravastatina Mylan

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.”.
The expiry date refers to the last day of the month.
Store in the original package to protect the medicine from moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Pravastatina Mylan contains
The active ingredient is pravastatin sodium.
Pravastatina Mylan 20 mg tablets: each tablet contains 20 mg of pravastatin sodium.
Pravastatina Mylan 40 mg tablets: each tablet contains 40 mg of pravastatin sodium
The other ingredients are:
lactose monohydrate (see section 2 “Pravastatina Mylan contains lactose and sodium”), dihydroxyaluminum
sodium carbonate, sodium stearyl fumarate, iron oxide red (E172) (only for the 40 mg tablets) and iron
oxide yellow (E172) (only for the 20 mg tablets)

Description of the appearance of Pravastatina Mylanand package contents
20 mg tablets
Light yellow, mottled, round tablets, with “20” imprinted on one side and a fracture line on the other. The
tablets can be divided into two equal halves.
40 mg tablets
Light pink, mottled, round tablets, with “40” imprinted on one side and a fracture line on the other. The
tablets can be divided into two equal halves.
Pravastatina Mylan is available in blisters of 10, 14, 20, 28, 30, 50, 60, 84, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Mylan S.p.A., Via Vittor Pisani 20 – 20124 Milan

Manufacturer(s)
Mc Dermott Laboratories Ltd t/a Gerard Laboratories
35, 36, 75, 76, 77, 80, 81 Baldoyle Industrial Estate
Grange Road, Dublin 13, Ireland
Mylan Hungary Kft.
H-2900 Komárom, Mylan utca 1
Hungary

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Belgium Pravastatin Mylan Pharma 10 mg, 20 mg, 40 mg Tablets
France Pravastatine Mylan Pharma 10 mg, 20 mg, 40 mg Tablets
Ireland Pravastatin Mylan 10 mg, 20 mg, 40 mg Tablets
Italy Pravastatina Mylan 20 mg, 40 mg compresse
Netherlands Pravastatinenatrium Mylan 10 mg, 20 mg, 40 mg Tabletten
Portugal Pravastatina Mylan 10 mg, 20 mg, 40 mg comprimidos
Romania Pravastatină Mylan 10 mg, 20 mg, 40 mg comprimate
Spain Pravastatina Mylan Pharmaceuticals 10 mg, 20 mg, 40 mg comprimidos EFG
United Kingdom Pravastatin Sodium 10 mg, 20 mg, 40 mg Tablets