Suzator 10 mg. 30 tablets

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 high cholesterol. This means that you are at risk of a heart attack or stroke. Suzastor is used in adults, adolescents and children over 6 years of age to treat high cholesterol.
You have been told to take a statin because changing your diet and getting more exercise have not been enough to control your cholesterol levels. You should continue your cholesterol-lowering diet and exercise while you are taking Suzastor.

Why is it important to continue taking Suzastor?
There are other factors that increase the risk of a heart attack, stroke or other related health problems.
Heart attack, stroke and other problems can be caused by a condition called atherosclerosis. Atherosclerosis is caused by the build-up of fatty deposits in the arteries.
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-C cholesterol) and "good" cholesterol (high-density lipoprotein cholesterol or HDL-C cholesterol).

Suzastor can reduce 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 does not affect the way they feel because it does not cause any symptoms. However, if cholesterol is not treated, fatty deposits can form on the walls of your blood vessels, narrowing them. Sometimes narrowed blood vessels can become blocked and this can stop the blood flow to the heart or brain, which will lead to a heart attack or stroke. By lowering your cholesterol levels, you can reduce the risk of heart attack, stroke or other similar health problems.

You need to continue taking Suzastor even if your cholesterol has reached normal levels, as this medicine prevents your cholesterol from rising again and from the appearance of fatty deposits. However, you should stop taking it if your doctor tells you to or if you become pregnant.

2. What you need to know before you take Suzastor
Do not take Suzastor
if you are allergic (hypersensitive) to rosuvastatin or any of the other ingredients of this medicine (listed in section 6). 
if you are pregnant or breast-feeding. If you become pregnant while taking Suzastor, stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Suzastor by using appropriate contraception. 
if you have liver disease
if you have severe kidney disease
if you have repeated or unexplained muscle pain or tenderness (myopathy)
if you are taking the combination medicine sofosbuvir/velpatasvir/voxilaprevir (used for a viral infection of the liver called hepatitis C). 
if you are taking a medicine called ciclosporin (used, for example, after an organ transplant)
If any of the above apply to you (or you are not sure), talk to your doctor.

In addition, do not take 40 mg of Suzastor (the maximum dose)

if you have repeated or unexplained muscle pain or tenderness (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

if you have moderate kidney problems (if in doubt, consult your doctor)

if your thyroid gland is not working properly

if you regularly drink large amounts of alcohol

if you are taking other medicines called fibrates to lower your cholesterol

if you are of Asian origin (this includes Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).

If any of the above applies to you (or you are in doubt), please consult your doctor.

Warnings and precautions
Talk to your doctor before taking Suzastor:

If you have kidney problems

If you have liver problems

If you have a severe respiratory disorder

If you have recurrent or unexplained muscle pain or tenderness (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 pain or tenderness, and especially if you feel unwell or have a fever. Also tell your doctor or pharmacist if you have muscle weakness that is persistent.

If you have or have ever had myasthenia gravis (a disease of the
general muscle weakness, including in some cases the breathing muscles) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins can sometimes make these conditions worse or lead to the development of myasthenia gravis (see section 4). 
If you regularly drink large amounts of alcohol
If your thyroid gland is not working properly
If you are taking other medicines called fibrates to lower your cholesterol
If you are taking medicines for HIV infection (for example ritonavir with lopinavir, atazanavir and/or tipranavir). see section “Other medicines and Suzastor”
If you are taking or have taken in the last 7 days a medicine called fusidic acid (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and rosuvastatin can lead to serious muscle problems (rhabdomyolysis).
If you are over 70 years of age (as your doctor should choose the right starting dose of Suzastor for your needs)
If you are of Asian origin - these are Japanese, Chinese, Filipino, Vietnamese, Korean and Indian. Your doctor should choose the right starting dose of Suzastor for your needs. 
If you have ever had a severe skin rash or peeling skin, blistering and/or mouth ulcers after taking Suzastor or other related medicines.
Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with Suzastor treatment. Stop taking Suzastor and seek medical help immediately if you notice any of the symptoms described in section 4.

Children and adolescents
If the patient is under 6 years of age: Suzastor should not be given to children under 6 years of age
If the patient is under 18 years of age: the Suzastor 40 mg dose is not suitable for use in children and adolescents under 18 years of age.

If any of the above applies to you (or you are not sure):

Do not take Suzastor 40 mg (the highest dose) and talk to your doctor or pharmacist before taking any dose of Suzastor.

In a small number of people, statins can affect the liver. This is detected by a test that checks the levels of liver enzymes in the blood. Therefore, your doctor will routinely do this blood test (liver function test) before and during treatment with Suzastor.

While taking this medicine, your doctor will monitor you carefully if you have diabetes or if you are likely to develop diabetes. The risk of developing diabetes is higher if you have high blood sugar and lipid levels, if you are overweight and have high blood pressure.

Other medicines and Suzastor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

If you need to take fusidic acid to treat bacterial infections, you will need to temporarily stop taking this medicine. Your doctor will tell you when it is safe to start taking Suzastor again. Taking Suzastor together with fusidic acid may rarely lead to muscle weakness, limpness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Tell your doctor if you are taking any of the following medicines:
ciclosporin (used for example after an organ transplant)
warfarin, ticagrelor or clopidogrel or any other blood thinner
fibrates and other lipid-lowering products (such as gemfibrozil, fenofibrate)
any other cholesterol-lowering medicine (such as ezetimibe)
indigestion treatments (used to neutralise the acid in your stomach)
erythromycin (an antibiotic)
oral contraceptives (birth control pills) or hormone replacement therapy
regorafenib (used to treat cancer)
darolutamide (used to treat cancer)
any of the following medicines used to treat viral infections including HIV or hepatitis C infection, alone or in combination (see also Warnings and precautions): ritonavir, lopinavir, atazanavir, sofosbuvir, voxilaprevir, ombitasvir, paritaprevir, dizabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
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 breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

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 use machines 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.

Suzastor contains lactose and sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, i.e. it can be said to be essentially sodium-free.

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

Usual adult doses
If you are taking Suzastor for high cholesterol:

Starting dose
Your treatment with Suzastor should start with a dose of 5 mg or 10 mg, even if you are already taking a higher dose of another statin. The choice of your starting dose will depend on:

your cholesterol level

your risk of heart attack or stroke

whether you have any factors that make you more sensitive to possible side effects
Please consult your doctor or pharmacist about the starting dose of Suzastor that is most suitable for you.

Your doctor may decide to start you on the lowest starting dose (5 mg) if:
you are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian)
you are over 70 years of age
you have moderate kidney problems
you are at risk of developing muscle pain or tenderness (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is to ensure that you are taking 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 needed. If you started with 10 mg, your doctor may decide to double the dose to 20 mg and then to 40 mg if needed. There is a 4-week break 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 enough 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 the factors listed above.

Use in children and adolescents aged 6-17 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 10 mg for children aged 6-9 years and 20 mg for children aged 10-17 years. 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 with or without food. Try to take your tablet at the same time each day to help you remember.

Regular cholesterol tests
It is important to see your doctor for regular cholesterol tests to make sure that your cholesterol has reached and remains within 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 take more Suzastor than you should
Contact your doctor or the nearest hospital.
If you go into 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 your next dose at the right time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Suzastor
Talk to your doctor if you want to stop taking Suzastor. Your cholesterol levels may increase again if you stop taking Suzastor.

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

4. Possible side effects
Like all medicines, this medicine 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 go away after a short period of time.

Stop taking Suzastor and seek medical help immediately 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)
reddish, flat, target-like or circular spots on the body, often with central blisters, peeling skin, ulcers in the mouth, throat, nose, genitals and eyes. These serious skin rashes
may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome). 
widespread rash, high body temperature and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome). 
In addition, stop taking Suzastor and tell your doctor immediately if:
you experience unusual pain or tenderness in your muscles that lasts longer than expected. Muscle symptoms are more common in children and adolescents than in adults. As with other statins, very few people experience unpleasant effects on the muscles, and they rarely last long and develop into a potentially life-threatening muscle damage called rhabdomyolysis.
Lupus-like syndrome (including rash, joint damage and blood cell damage)
muscle breakdown
Common side effects (may affect up to 1 in 10 people)
headache
dizziness
constipation
nausea
stomach ache
muscle pain feeling weak
diabetes - more likely if you have high blood sugar and lipid levels, if you are overweight and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
Uncommon side effects (may affect up to 1 in 100 people)
rash, itching or other skin reaction
increased protein in the urine (abnormal kidney function test results) - this usually returns to normal on its own without you having to stop taking your Suzastor tablets (for Suzastor 5 mg, 10 mg and 20 mg).
Rare side effects (may affect up to 1 in 1,000 people)
serious allergic reaction - the 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 pain or tenderness in your muscles that lasts longer than expected
severe pain in the abdomen (inflammation of the pancreas)
increased liver enzymes in the blood.
unusual bruising and bleeding due to low blood platelet levels
Very rare side effects (may affect up to 1 in 10,000 people)
jaundice (yellowing of the skin and eyes)
hepatitis (inflammation of the liver)
traces of blood in your urine
damage to the nerves in your legs and arms (such as numbness)
joint pain
memory loss
gynaecomastia (breast enlargement in men and women)
Side effects with unknown frequency include (frequency cannot be estimated from the available data)
diarrhoea (loose stools)
cough shortness of breath
oedema (swelling)
sleep disturbances including insomnia and nightmares sexual dysfunction depression
breathing problems including persistent cough and/or shortness of breath or high fever
tendon damage, sometimes complicated by rupture, muscle weakness that is permanent.
Myasthenia gravis (a disease that causes general muscle weakness, including in some cases the breathing muscles).
Myasthenia gravis (a disease that causes weakness of the eye muscles).
Talk to your doctor if you experience weakness in your arms or legs that gets worse after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
5. How to store Suzastor
Keep out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton, label or blister after “EXP”. The expiry date refers to the last day of that month.
Store in the original package in order to protect from moisture.
The shelf life after first opening the HDPE bottles is 100 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment.

6. Contents of the pack and other information
What Suzastor contains
The active substance is rosuvastatin.
Each film-coated tablet contains 5 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 10 mg rosuvastatin (as rosuvastatin calcium).
Each film-coated tablet contains 20 mg of rosuvastatin (as rosuvastatin calcium). 
The other ingredients are:
The tablet contains: lactose, silica, colloidal anhydrous, silicified microcrystalline cellulose, maize 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
Suzastor 5 mg film-coated tablets Brown, round film-coated tablets.

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 supplied in cartons containing OPA-A1-PVC/A1 blisters or HDPE bottles with PP caps and silica gel desiccant.

Pack sizes:
Blisters: 7, 10,14, 15, 20,28, 30,42, 50, 56, 60, 84, 90, 98, 100 film-coated tablets
Bottles: 30, 100 film-coated tablets.

Not all pack sizes may be marketed.

 

 

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