SUZASTOR 10mg x 30 tabl

SUZASTOR 10mg x 30 tabl

LEAFLET: INFORMATION FOR THE USER

Suzastor 5 mg film-coated tablets

Suzastor 10 mg film-coated tablets

Suzastor 20 mg film-coated tablets

Rosuvastatin ( Rosuvastatin )

In this leaflet :

1. What Suzastor is and what it is used for

2. Before taking Suzastor

3. How to take Suzastor

4. Possible side effects

5. How to store Suzastor

6. Additional information

1. WHAT SUZASTOR IS AND WHAT IT IS USED FOR

Suzastor belongs to a group of medicines called statins (HMG-CoA reductase inhibitors).

Suzastor has been prescribed to you because:

• You have an elevated cholesterol level. This means you are at risk of a heart attack or stroke .

You have been advised to take a statin because changing your diet and getting more exercise has not been enough to correct your cholesterol levels. You should continue your cholesterol-lowering diet and exercise while taking Suzastor.

Or

• There are other factors that increase the risk of heart attack, stroke, or other similar health problems.

Heart attack, stroke and other problems can be caused by a disease called atherosclerosis. Atherosclerosis is caused by the accumulation of fatty deposits in the arteries.

Why is it important to keep taking Suzastor?
Suzastor is used to correct the levels of fatty substances in the blood called lipids, the most common of which is cholesterol.
There are different types of cholesterol in the blood - "bad" cholesterol (low-density lipoprotein cholesterol or LDL cholesterol) and "good" cholesterol (high-density lipoprotein cholesterol or HDL cholesterol).

• Suzastor can lower levels of "bad" cholesterol and increase levels of "good" cholesterol.
• It works by helping to block the formation of "bad" cholesterol in your body and improving your body's ability to remove it from your blood.

For most people, high cholesterol doesn't affect how they feel because it doesn't cause any symptoms. However, if cholesterol is left untreated, fatty deposits can form on the walls of your blood vessels, causing them to narrow.

• Sometimes narrowed blood vessels can become blocked and this will stop blood flow to the heart or brain, leading to a heart attack or stroke. By lowering your cholesterol levels, you can reduce your risk of heart attack, stroke or other similar health problems.

It is necessary to continue taking Suzastor even if your cholesterol has reached normal levels, because this medicine prevents your cholesterol from rising again. However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. BEFORE YOU TAKE SUZASTOR

Do not take Suzastor

• if you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of Suzastor
• if you have liver disease
• if you have severe kidney disease
• if you have repeated or unexplained muscle aches or pains (myopathy)
• if you are taking a medicine called cyclosporine (used for example after an organ transplant)
• if you are pregnant or breastfeeding (see section "Pregnancy and breastfeeding"). If any of the above applies to you (or you are in doubt), consult your doctor.

Take special care when using Suzastor

• if you have kidney problems
• if you have liver problems
• if you have severe lung failure
• if you have repeated or unexplained muscle aches or pains (myopathy), a personal or family history of muscle problems, or if you have had muscle problems in the past while taking other cholesterol-lowering medicines. Tell your doctor immediately if you experience unexplained muscle aches or pains and, especially, if you feel unwell or have a fever
• if you regularly consume large amounts of alcohol
• if your thyroid gland is not functioning normally
• if you are taking other medicines called fibrates to lower your cholesterol
• if you are taking medicines for HIV infection (for example, lopinavir, ritonavir), see section "Taking other medicines"
• if you are over 70 years of age (as your doctor must choose the right starting dose of Suzastor according to your needs)
• if you are of Asian descent (these are Japanese, Chinese, Filipino, Vietnamese, Korean and Indian). Your doctor should choose the right starting dose of Suzastor based on your needs
• If the patient is under 10 years of age: Suzastor should not be given to children under 10 years of age
• If the patient is under 18 years of age: Suzastor 40 mg is not suitable for use in children and adolescents under 18 years of age.

If any of the above apply to you (or if you're not sure):
Talk to your doctor or pharmacist before taking rosuvastatin.

In a few people, statins can affect the liver. This is determined by a test that measures the levels of liver enzymes in the blood. Therefore, your doctor will usually do this blood test (liver function test) before and during treatment with Suzastor.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor if you are taking any of the following medicines:

• cyclosporine (used for example after an organ transplant)
• warfarin or any other blood-thinning medicine
• fibrates and other lipid-lowering products (such as gemfibrozil, fenofibrate)
• any other medicine to lower cholesterol (such as ezetimibe)
• indigestion treatments (used to neutralize acid in your stomach)
• erythromycin (antibiotic)
• oral contraceptive (birth control pills)
• hormone replacement therapy or lopinavir and ritonavir (to treat HIV infection).

- please see “Take special care when using Suzastor”

Suzastor may change the way these medicines work, or they may change the way Suzastor works.

Taking Suzastor with food and drink

You can take Suzastor with or without food.

Pregnancy and breastfeeding

Do not take Suzastor if you are pregnant or breast-feeding. If you become pregnant while taking Suzastor, you should stop taking the medicine immediately and tell your doctor. Women should avoid becoming pregnant while taking Suzastor by using appropriate contraception.

Driving and using machines

Most people can drive and operate machinery while taking Suzastor, as the medicine does not affect their ability to do so. However, some people feel dizzy during treatment with Suzastor. If you feel dizzy, consult your doctor before driving or using machines.

Important information about some of the ingredients of Suzastor

If your doctor has told you that you have an intolerance to certain types of sugar (lactose or milk sugar), you should consult your doctor before taking Suzastor.

3. HOW TO TAKE SUZASTOR

Before starting treatment, your doctor will put you on a cholesterol-lowering diet, which should continue during the treatment period.

Your doctor will determine the most suitable dose for you.

Always take Suzastor exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Usual doses in adults

If you take Suzastor for high cholesterol:

Starting dose

Your treatment with Suzastor should start with a dose of 5 mg or 10 mg , even if you have already taken a higher dose of another statin. Choosing your starting dose will depend on:

The dose depends on:

• your cholesterol level
• your level of risk of heart attack or stroke
• whether you have a factor that makes you more sensitive to possible side effects

Please consult your doctor or pharmacist which starting dose of Suzastor is most suitable for you.

Your doctor may consider prescribing the lowest starting dose (5 mg) if:

• are of Asian descent (Japanese, Chinese, Filipino, Korean and Indian)
• you are over 70 years old
• you have moderate kidney problems
• you are at risk of developing muscle pains or painful sensations (myopathy).

Dose escalation and maximum daily dose

Your doctor may decide to increase your dose. This is so that you take the dose of Suzastor that is right for you. If you start with a dose of 5 mg, your doctor may decide to double it to 10 mg, then to 20 mg, and then to 40 mg if necessary. If you started with 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg if necessary. A 4-week break is made between each dose change.

The maximum daily dose of Suzastor is 40 mg. It is only for patients with high cholesterol levels and a high risk of heart attack or stroke, whose cholesterol levels cannot be lowered sufficiently with the 20 mg dose.

If you are taking Suzastor to reduce the risk of heart attack, stroke or related health problems:
The recommended dose is 20 mg daily. However, your doctor may decide to use a lower dose if you have any of these factors listed above.

Usual doses for children aged 10 - 17 years
The usual starting dose is 5 mg. Your doctor may increase your dose to the most suitable dose of Suzastor for you. The maximum daily dose of Suzastor is 20 mg. Take your dose once a day.

Taking the tablet

Swallow each tablet whole with water.

Take Suzastor once a day. You can take it at any time of the day. Try taking the tablet at the same time each day to help you remember.

Regular cholesterol tests

It's important to see your doctor for regular cholesterol tests to make sure your cholesterol has reached and stays in the normal range.

Your doctor may decide to increase your dose so that you are taking the amount of Suzastor that is right for you.

If you have taken more Suzastor than you should

Contact your doctor or nearest hospital.

If you go to hospital or are being treated for another illness, tell the medical staff that you are taking Suzastor.

If you forget to take Suzastor

Don't worry, just take the next scheduled dose at the right time. Do not take a double dose to make up for a missed tablet.

If you have stopped taking Suzastor

Consult your doctor if you wish to stop taking Suzastor. Your cholesterol levels may rise again if you stop taking Suzastor.

If you have any other questions about the use of this product, ask your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Suzastor can cause side effects, although not everybody gets them.

It is important to be aware of what these side effects may be. They are usually mild and disappear after a short period of time.

Stop taking Suzastor and get medical help right away if you have any of the following allergic reactions:

• difficulty breathing, with or without swelling of the face, lips, tongue and/or throat
• swelling of the face, lips, tongue and/or throat which may cause difficulty in swallowing
• severe itching of the skin (with blisters)

Also, stop taking Suzastor and tell your doctor right away if you experience unusual muscle pain or soreness that lasts for a long time. Muscular symptoms are more common in children and adolescents than in adults.

As with other statins, very few people experience unpleasant effects in the muscles, and these rarely last long and turn into potentially life-threatening muscle damage called rhabdomyolysis .

Common possible side effects ( may affect between 1 in 10 and 1 in 100 patients )

• headache
• vertigo
• constipation
• malaise
• stomach ache
• muscle pain
• feeling weak
• diabetes, especially in those with blood sugar at the upper end of the normal range.

Uncommon possible side effects ( may affect between 1 in 10 and 1 in 1,000 patients)

• rash, itching or other skin reaction
• increased amount of protein in the urine (abnormal kidney function test results) - usually normalizes on its own without having to stop taking your Suzastor tablets.

Rare possible side effects (may affect between 1 in 10 and 1 in 10,000 patients)

• serious allergic reaction - signs are swelling of the face, lips, tongue and/or throat, difficulty swallowing and breathing, severe itching of the skin (with blisters). If you think you are having an allergic reaction, stop taking Suzastor and seek medical help immediately.
• muscle damage in adults - as a precaution , stop taking Suzastor and consult your doctor immediately if you have unusual muscle pain or soreness that lasts for a long time
• severe stomach pain (inflammation of the pancreas)
• increased liver enzymes in the blood.

Very rare possible side effects ( may affect less than 1 in 10,000 patients)

• Jaundice (yellowing of the skin and eyes)
• hepatitis (inflammation of the liver)
• traces of blood in your urine
• nerve damage in your legs and arms (such as cramping)
• joint pain
• memory loss.

H Adverse reactions with an unknown frequency include

• diarrhea (poor stools)

• Stevens-Johnson syndrome (severe blistering of the skin, mouth, eyes and genitals)
• cough
• out of breath
• edema (swelling)
• sleep disturbances, including insomnia and nightmares
• disorders of sexual function
• depression
• breathing problems, including a persistent cough and/or shortness of breath, or a high fever.

If any of the side effects become worrying, or you experience other side effects not described in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE SUZASTOR

Keep out of the reach of children.

Do not use Suzastor after the expiry date which is stated on the carton and blister. The expiration date corresponds to the last day of the specified month.

Store in original packaging to protect from moisture.

The shelf life after opening the HDPE bottles is up to three months.

Medicines should not be disposed of down the drain or in the household waste container. Ask your pharmacist how to dispose of your unwanted medicines. These measures will help protect the environment.

6. ADDITIONAL INFORMATION

What Suzastor contains

• The active substance is rosuvastatin.

Suzastor 5 mg film-coated tablets

Each film-coated tablet contains 5 mg of rosuvastatin (as rosuvastatin calcium).

Suzastor 10 mg film-coated tablets

Each film-coated tablet contains 10 mg of rosuvastatin (as rosuvastatin calcium).

Suzastor 20 mg film-coated tablets

Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium).

• The other ingredients are:

The tablet contains: anhydrous lactose, silicon dioxide, colloidal anhydrous, silicified microcrystalline cellulose, corn starch, talc, sodium stearyl fumarate

Tablet coating: hypromellose, mannitol E 421, macrogol 6000, talc, titanium dioxide E 171, iron oxide, yellow E 172, iron oxide, red E 172

What Suzastor looks like and contents of the pack

Film-coated tablet

Suzastor 5 mg film-coated tablets

Light brown, round, film-coated tablets, debossed with “RSV 5” on one side.

Suzastor 10 mg film-coated tablets

Brown, round, film-coated tablets, debossed with “RSV 10” on one side.

Suzastor 20 mg film-coated tablets

Brown, round, film-coated tablets, debossed with “RSV 20” on one side.

Suzastor is available in:

OPA-Al-PVC/Al blisters. Types of packaging: 7, 10, 14, 15, 20, 28, 30, 42, 50, 56, 60, 84, 98, 100 film-coated tablets

HDPE bottles with PP cap and silica gel desiccant. Types of packaging: 30, 100 film-coated tablets.

Not all types of packaging can be put on sale.

License holder

Sandoz dd

Verovskova 57, 1000 Ljubljana, Slovenia

Manufacturers

Lek Pharmaceuticals dd

with place of manufacture:

Verovskova 57, 1526 Ljubljana, Slovenia

and

Trimlini 2D, 9220 Lendava, Slovenia

Lek SA

with place of manufacture:

Ul. Podlipie 16, 95-010 Strykow, Poland

and

Ul. Domaniewska 50c, 02-672 Warsaw, Poland

Salutas Pharma GmbH

with place of manufacture:

Otto-von-Guericke-Allee 1, 39179 Barleben, Germany

and

Dieselstrasse 5, 70839 Gerlingen, Germany

This medicinal product is authorized for use in the EEC member states under the following names:

Czech Republic: Rosumop 5 mg

Rosumop 10 mg

Rosumop 20 mg

Denmark: Rosuvastatin Sandoz

Estonia: Roxardio 10 mg

Roxardio 20 mg

Finland: Rosuvastatin Sandoz 5 mg tabletti, kalvovärvementinen

Rosuvastatin Sandoz 20 mg tabletti, kalvovärvementinen

Rosuvastatin Sandoz 10 mg tabletti, kalvovärvementinen

Hungary: Rosuvastatin Sandoz 5 mg filmtabletta

Rosuvastatin Sandoz 10 mg filmtabletta

Rosuvastatin Sandoz 20 mg filmtabletta

Lithuania: Roxardio 5 mg plėvele dengtos tabletės

Roxardio 10 mg plėvele dengtos tabletės

Roxardio 20 mg plėvele dengtos tabletės

Poland Suvardio

Portugal: Rosuvastatina Sandoz

Romania: ROXARDIO 5 mg comprimate filmate

ROXARDIO 10 mg tablet filmate

ROXARDIO 20 mg tablet filmate

Slovak Republic: Rosuvastatin Sandoz 5 mg filmom obalené tablety

Rosuvastatin Sandoz 10 mg filmom obalené tablets

Rosuvastatin Sandoz 20 mg filmom obalené tablets

Slovenia Coupet 5 mg filmsko obložene Tablete

Coupet 10 mg film-coated tablets

Coupet 20 mg film-coated tablets

Date of last approval of leaflet

11/2010

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