Pravastatin Mylan

Package leaflet: Information for the user

Pravastatin Mylan 20 mg tablets, 40 mg tablets

sodium pravastatin
Generic medicine
Read this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Pravastatin, the active substance in Pravastatin 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).
Pravastatin Mylan is used:

• To reduce high cholesterol levels in the blood when diet, increased physical activity, or weight reduction have not provided a sufficient response.
• As an addition to diet if you are at risk of narrowing of the blood vessels of the heart due to high cholesterol levels in the blood.
• To lower fatty substances (lipids) 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 Pravastatin Mylan

Do not take Pravastatin Mylan:

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

Take special care with Pravastatin Mylan:

• If you have kidney problems or have previously had liver problems;
• If you regularly drink large amounts of alcohol;
• If you have an underactive thyroid gland;
• If you are concurrently taking other medicines (e.g. fibrates) to lower blood lipids;
• If you have experienced muscle problems while taking other cholesterol-lowering medicines, or if any of your family members have inherited muscle disorders, especially if you are over 65 years old;
• If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infections). The combination of fusidic acid and sodium pravastatin may lead to serious muscle problems (rhabdomyolysis);
• If you suffer from severe respiratory insufficiency.

If you have experienced any of these conditions, your doctor will perform a blood test before and during treatment with pravastatin to assess the risk of muscle-related side effects. A blood test may also be necessary if you are over 70 years old.
Contact your doctor immediately if, while taking Pravastatin Mylan, you develop unexplained muscle pain, muscle weakness, muscle cramps, or muscle flaccidity, particularly if associated with fatigue, fever, or red-brown discoloration of the urine (rhabdomyolysis), which may be signs of urinary problems. These symptoms may be caused by the use of Pravastatin Mylan.
Additionally, inform your doctor or pharmacist if you have persistent muscle weakness. Further tests and treatments may be required to diagnose and manage this condition.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. Your risk of developing diabetes is higher if you have high levels of sugar or fats in your blood, if you are overweight, or if you have high blood pressure.

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

Taking Pravastatin Mylan with other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.

If you take Pravastatin Mylan together with certain other medicines, the effect of Pravastatin Mylan, the other medicines, or both may be altered.
Talk to 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) that 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 to treat high cholesterol levels, as they may reduce the effect of pravastatin. Pravastatin Mylan should be taken at least 1 hour before or 4 hours after taking these medicines.
• Cyclosporine (a medicine used to suppress the immune system), as the effect of pravastatin may be increased and your doctor may need to adjust the dose.
• Antibiotics such as erythromycin, clarithromycin, roxithromycin, and rifampicin, as they may enhance the effects of pravastatin.
• If you are taking a medicine used to treat and prevent blood clots known as a “vitamin K antagonist”, inform your doctor before taking Pravastatin Mylan, as using vitamin K antagonists together with Pravastatin Mylan may increase the results of blood tests used to monitor your 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 stop taking this medicine. Your doctor will advise you when it is safe to restart Pravastatin Mylan.
Taking Pravastatin Mylan with fusidic acid may rarely cause muscle weakness, flaccidity, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Pravastatin Mylan and alcohol
You should limit alcohol consumption to a minimum. If you are concerned about how much alcohol you can drink while taking this medicine, consult your doctor.

Pregnancy and breastfeeding
Do not take Pravastatin Mylan during pregnancy or breastfeeding, as pravastatin may harm your baby.
Before starting Pravastatin Mylan, inform your doctor if you are pregnant or intend to become pregnant. If you become pregnant while taking this medicine, stop taking Pravastatin Mylan immediately and contact your doctor without delay.
Girls and women of childbearing age must use a reliable method of contraception.
Ask your doctor or pharmacist for advice before taking any medicine.

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

Pravastatin Mylan contains lactose and sodium
If you have an intolerance to certain sugars, consult your doctor before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e., essentially “sodium-free”.

3. How to take Pravastatin Mylan

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
To lower blood cholesterol levels
The recommended dose is 10–40 mg of pravastatin once daily. The maximum daily dose is 40 mg
of pravastatin.
To prevent heart and blood vessel problems
The recommended dose is 40 mg of pravastatin once daily.
After transplantation
The recommended dose is 20 mg of pravastatin once daily. The dose may be increased up to
40 mg of pravastatin. Your doctor will tell you how much medicine 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 daily in children aged 8–13 years and 10–40 mg of
pravastatin once daily in adolescents aged 14–18 years.
Elderly
Dose adjustment is not necessary for this patient group. The same doses as in adult patients may be used.
Your doctor will tell you how much medicine to take.
Dose adjustment in patients with kidney or liver problems
The usual dose is 10 mg of pravastatin once daily, but higher doses may also be used. Your
doctor will tell you how much medicine to take.
Use with other medicines
If you are taking other medicines containing the active substances cholestyramine or
colestipol (medicines used to treat high cholesterol levels), you must take Pravastatin Mylan
at least one hour before or four hours after taking these medicines.
If you are simultaneously taking a medicine used to suppress the immune system (cyclosporine), your doctor
will prescribe an initial dose of 20 mg of pravastatin once daily. This dose may be
adjusted by your doctor up to 40 mg of pravastatin. Your doctor will tell you how much medicine to take.
Pravastatin Mylan should be taken once daily, 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 may be divided into equal doses.
Your doctor will tell you how long you should continue taking Pravastatin Mylan. This depends on
the condition for which you are taking this medicine.
If you feel that the effect of Pravastatin Mylan is too strong or too weak, talk to your
doctor or pharmacist.
If you take more Pravastatin 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 Pravastatin Mylan
If you forget to take your dose, do not worry. Simply take your next dose as prescribed.
Do not take a double dose to make up for the forgotten dose.
If you stop taking Pravastatin Mylan
Take Pravastatin Mylan for the length of time prescribed by your doctor. If you stop taking Pravastatin
Mylan, your cholesterol or lipid levels may rise again.
If you have any questions about the use of Pravastatin Mylan, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if you experience any of the following side effects during treatment with
Pravastatin Mylan:
Very rare (may affect up to 1 in 10,000 people)

• hypersensitivity reactions or severe allergic reactions causing swelling of the face, throat, tongue and fluid accumulation in the body, which may lead to difficulty breathing or swallowing (angioedema, anaphylaxis), or skin rashes, possibly with joint pain (lupus-like syndrome)
• breakdown of muscle fibres (rhabdomyolysis), which may be associated with acute kidney failure (see also section 2 “What you should know before taking Pravastatin Mylan”), muscle inflammation/muscle inflammation affecting multiple muscles (myositis/polymyositis). This may cause muscle pain, tenderness or weakness not caused by physical exercise, reduced urine output, dark-coloured urine and an increase in creatine kinase detectable in blood tests. Presence of myoglobin in the urine, detectable by urine test (myoglobinuria).
• serious liver problems including yellowing of the skin and/or eyes (jaundice), tissues and body fluids, inflammation of the liver (hepatitis), sudden rapid destruction of liver tissue (fulminant hepatic necrosis). This may cause a feeling or state of illness, 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)
• sensory disturbances may occur, including burning sensations and tingling, numbness and pins and needles (paraesthesia), which may be a sign of nerve ending damage (peripheral neuropathy)
• a condition characterised by inflammation of the skin muscles (dermatomyositis).

Not known (cannot be estimated from the available data)

• diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight or have high blood pressure. Your doctor will monitor you closely during treatment with this medicine.
• respiratory 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 may be detected in blood tests.

Uncommon (may affect up to 1 in 100 people)

• dizziness, headache, sleep disorders, difficulty sleeping
• vision disorders, including blurred vision or double vision
• digestive problems or slow digestion, indigestion/heartburn, abdominal pain, nausea/vomiting, constipation, diarrhoea, flatulence
• itching, rash, hives, scalp or hair abnormalities (including hair loss)
• abnormal urination, e.g. pain, increased frequency, frequent nighttime urination
• 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 (cannot be estimated from the available data)

• nightmares
• memory loss
• depression

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Pravastatin 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 packaging to protect the medicine from moisture.
Do not dispose of any medicine via 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 substance 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 components are:
monohydrate lactose (see section 2 “Pravastatina Mylan contains lactose and sodium”), dihydroxyaluminium
sodium carbonate, sodium stearyl fumarate, red iron oxide (E172) (only in 40 mg tablets), and yellow iron
oxide (E172) (only in 20 mg tablets).

Description of the appearance of Pravastatina Mylan and package contents
20 mg tablets
Light yellow, mottled, round tablets, marked “20” on one side and a score line on the other. The tablets can be divided into two equal parts.

40 mg tablets
Light pink, mottled, round tablets, marked “40” on one side and a score line on the other. The tablets can be divided into two equal parts.

Pravastatina Mylan is available in blisters containing 10, 14, 20, 28, 30, 50, 60, 84, 90, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A., Via Vittor Pisani 20 – 20124 Milano, Italy

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 authorized in the European Economic Area Member States under 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 tablets
Netherlands Pravastatine natrium 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