Rastor (10 mg)

RASTOR® 5 mg Film-Coated Tablets
RASTOR® 10 mg Film-Coated Tablets
RASTOR® 20 mg Film-Coated Tablets
RASTOR® 40 mg Film-Coated Tablets
Rosuvastatin
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. (See section 4).
In this leaflet
1. What Rastor is and what it is used for.
2. What you need to know before you take Rastor.
3. How to take Rastor.
4. Possible side effects.
5. How to store Rastor.
6. Further information.
1. What Rastor is and what it is used for
Rastor contains the active substance Rosuvastatin which belongs to a group of
medicines called statins.
You have been prescribed Rastor because:
•You have a high cholesterol level. This means you are at risk from a heart attack or
stroke. Rastor is used in adults, adolescents and children 6 years or older to treat
high cholesterol.
•You have been advised to take a statin, because changing your diet and doing more
exercise were not enough to correct your cholesterol levels. You should continue with
your cholesterol-lowering diet and exercise while you are taking Rastor.
Or
•You have other factors that increase your risk of having a heart attack, stroke or related
health problems.
Heart attack, stroke and other problems can be caused by a disease called
atherosclerosis. Atherosclerosis is due to build-up of fatty deposits in your arteries.
Why it is important to keep taking Rastor
Rastor 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 found in the blood – ‘bad’ cholesterol (LDL-C)
and ‘good’ cholesterol (HDL-C).
Rastor can reduce the ‘bad’ cholesterol and increase the ‘good’ cholesterol.
•It works by helping to block your body’s production of ‘bad’ cholesterol. It also improves
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
produce any symptoms. However, if it is left untreated, fatty deposits can build up in
the walls of your blood vessels causing them to narrow.
•Sometimes, these narrowed blood vessels can get blocked which can cut off the blood
supply to the heart or brain leading to a heart attack or a stroke. By lowering your
cholesterol levels, you can reduce your risk of having a heart attack, a stroke or related
health problems.
You need to keep taking Rastor, even if it has got your cholesterol to the right level, because it prevents your cholesterol levels from creeping up again and causing build-up of fatty deposits. However, you should stop if your doctor tells you to do so, or
you have become pregnant.
2. What you need to know before you take Rastor
Do not take Rastor If you:
•Have ever had an allergic reaction to Rastor, or to any of its ingredients.
•Pregnant or breast-feeding. If you become pregnant while taking Rastor stop taking it
immediately and tell your doctor. Women should avoid becoming pregnant while taking
Rastor by using suitable contraception.
•Have liver disease.
•Have severe kidney problems.
•Have repeated or unexplained muscle aches or pains.
•Take a drug called ciclosporin (used, for example, after organ transplants).
If any of the above applies to you (or you are in doubt), please go back and see
your doctor.
In addition, do not take Rastor 40 mg (the highest dose) If you:
•Have moderate kidney problems (if in doubt, please ask your doctor).
•Your thyroid gland is not working properly.
•Have had any repeated or unexplained muscle aches or pains, a personal or family
history of muscle problems, or a previous history of muscle problems when taking
other cholesterol-lowering medicines.
•Regularly drink large amounts of alcohol.
•Are of Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
•Take other medicines called fibrates to lower your cholesterol.
If any of the above applies to you (or you are in doubt), please go back and see
your doctor.
Warnings and precautions
Talk to your doctor or pharmacist before taking Rastor.
•If you have problems with your kidneys.
•If you have problems with your liver.
•If you have had repeated or unexplained muscle aches or pains, a personal or family
history of muscle problems, or a previous history of muscle problems when taking
other cholesterol-lowering medicines. Tell your doctor immediately if you have
unexplained muscle aches or pains, especially if you feel unwell or have a fever. Also,
tell your doctor or pharmacist if you have a muscle weakness that is constant.
•If you regularly drink large amounts of alcohol.
•If your thyroid gland is not working properly.
•If you take other medicines called fibrates to lower your cholesterol. Please read this
leaflet carefully, even if you have taken other medicines for high cholesterol before.
•If you take medicines used to treat the HIV infection e.g. ritonavir with lopinavir and/or
atazanavir, please see “Other medicines and Rastor”.
•If you are taking or have taken in the last 7 days a medicine called fusidic acid (a
medicine for bacterial infection), orally or by injection. The combination of fusidic acid
and Rastor can lead to serious muscle problems (rhabdomyolysis), please see “Other
medicines and Rastor”.
•If you are over 70 (as your doctor needs to choose the right start dose of Rastor to
suit you)
•If you have severe respiratory failure.
•If you are of Asian origin – that is Japanese, Chinese, Filipino, Vietnamese, Korean and
Indian. Your doctor needs to choose the right start dose of Rastor to suit you.
If any of the above applies to you (or if you are not sure):
•Do not take Rastor 40 mg (the highest dose) and check with your doctor or
pharmacist before you actually start taking any dose of Rastor.
In a small number of people, statins can affect the liver. This is identified by a simple
test which looks for increased levels of liver enzymes in the blood. For this reason,
your doctor will usually carry out this blood test (liver function test) before and during
treatment with Rastor.
While you are on Rastor your doctor will monitor you closely if you have diabetes or
are at risk of developing diabetes. You are likely to be at risk of developing diabetes
if you have high levels of sugars and fats in your blood, are overweight and have high
blood pressure.
Children and adolescents
•If the patient is under 6 years old: Rastor should not be given to children younger than 6 years.
•If the patient is below 18 years of age: The Rastor 40 mg tablet is not suitable for use in children and adolescents below 18 years of age.
Other medicines and Rastor
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines
Tell your doctor if you are taking any of the following:
•Ciclosporin (used for example, after organ transplants),
•Warfarin or clopidogrel (or any other drug used for thinning the blood),
•Fibrates (such as gemfibrozil, fenofibrate) or any other medicine used to lower
cholesterol (such as ezetimibe),
•Indigestion remedies (used to neutralise acid in your stomach),
•Erythromycin (an antibiotic), fusidic acid (an antibiotic – please see below and
Warnings and precautions),
•Oral contraceptive (the pill),
•Regorafenib (used to treat cancer),
•Hormone replacement therapy
•Any of the following drugs used to treat viral infections, including HIV or hepatitis C
infection, alone or in combination (please see Warnings and precautions): ritonavir,
lopinavir, atazanavir, ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir,
elbasvir, glecaprevir, pibrentasvir.
The effects of these medicines could be changed by Rastor or they could change the
effect of Rastor.
If you need to take oral fusidic acid to treat a bacterial infection you will need
to temporarily stop using this medicine. Your doctor will tell you when it is safe
to restart Rastor. Taking Rastor with fusidic acid may rarely lead to muscle
weakness, tenderness or pain (rhabdomyolysis). See more information regarding
rhabdomyolysis in Section 4.
Pregnancy and breast-feeding
Do not take Rastor if you are pregnant or breast-feeding. If you become pregnant while taking Rastor stop taking it immediately and tell your doctor. Women should avoid becoming pregnant while taking Rastor by using suitable contraception.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Most people can drive a car and operate machinery while using Rastor – it will not affect
their ability. However, some people feel dizzy during treatment with Rastor. If you feel
dizzy, consult your doctor before attempting to drive or use machines.
Rastor contains lactose
If you have been told by your doctor that you have an intolerance to some sugars (lactose
or milk sugar), contact your doctor before taking Rastor.
For a full list of ingredients, please see further information.
3. How to take Rastor
Always take this medicine as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Usual dose in adults
If you are taking Rastor for high cholesterol:
Starting dose
Your treatment with Rastor must start with the 5 mg or the 10 mg dose, even if you have taken a higher dose of a different statin before. The choice of your start dose
will depend upon:
•Your cholesterol levels.
•The level of risk you have of experiencing a heart attack or stroke.
•Whether you have a factor that may make you more sensitive to possible side effects.
Please check with your doctor or pharmacist which start dose of Rastor will best suit you.
Your doctor may decide to give you the lowest dose (5 mg) if you:
• Asian origin (Japanese, Chinese, Filipino, Vietnamese, Korean and Indian).
• Are over 70 years of age.
• Have moderate kidney problems.
• Are at risk of muscle aches and pains (myopathy).
Increasing the dose and maximum daily dose
Your doctor may decide to increase your dose. This is so that you are taking the amount
of Rastor that is right for you.
•If you started with a 5 mg dose, your doctor may decide to double this to 10 mg, then
20 mg and then 40 mg if necessary.
•If you started on 10 mg dose, your doctor may decide to double this to 20 mg and then
40 mg if necessary. There will be a gap of four weeks between every dose adjustment.
The maximum daily dose of Rastor is 40 mg. It is only for patients with high cholesterol
levels and a high risk of heart attacks or stroke whose cholesterol levels are not lowered
enough with 20 mg.
If you are taking Rastor to reduce your risk of having a 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 mentioned above.
Use in children and adolescents aged 6-17 years
The dose range is 5 to 20 mg once daily. The usual start dose is 5 mg per day, and your
doctor may gradually increase your dose to find the right amount of Rastor for you. The
maximum daily dose of Rastor is 10 or 20 mg for children aged 6 to 17 years depending
on your underlying condition being treated. Take your dose once a day. Rastor 40 mg tablet should not be used by children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rastor once daily. You can take it at any time of the day with or without food.
Try to take your tablet at the same time every day to help you to remember it.
Regular cholesterol checks
It is important to go back to your doctor for regular cholesterol checks, to make sure your
cholesterol has reached and is staying at the correct level.
Your doctor may decide to increase your dose so that you are taking the amount of
Rastor that is right for you.
If you take more Rastor than you should
Contact your doctor or nearest hospital for advice.
If you go into hospital or receive treatment for another condition, tell the medical staff
that you are taking Rastor.
If you forget to take Rastor
Do not worry; just take your next scheduled dose at the correct time. Do not take a
double dose to make up for a forgotten dose.
If you stop taking Rastor
Talk to your doctor if you want to stop taking Rastor. Your cholesterol levels might
increase again if you stop taking Rastor.
If you have any further questions on the use of this medicine, 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 that you are aware of what these side effects may be. They are usually
mild and disappear after a short time.
Stop taking Rastor and seek medical help immediately if you have any of the following allergic reactions:
•Difficulty in 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 raised lumps).
Also, stop taking Rastor and talk to your doctor immediately If you:
•Have any unusual aches or pains in your muscles that go on for longer than you
might expect. Muscle symptoms are more common in children and adolescents than
in adults. As with other statins, a very small number of people have experienced
unpleasant muscle effects and rarely these have gone on to become a potentially life
threatening muscle damage known as rhabdomyolysis.
•Experience muscle rupture.
•Have lupus-like disease syndrome (including rash, joint disorders and effects on blood
cells).
Common side effects (may affect between 1 in 10 and 1 in 100 patients):
•Headache
•Stomach pain
•Constipation
•Feeling sick or weak
•Muscle pain
•Dizziness
•An increase in the amount of protein in the urine - this usually returns to normal on its
own without having to stop taking your Rastor tablets (only Rastor 40 mg).
•Diabetes. This is more likely if you have high levels of sugars and fats in your blood,
are overweight and have high blood pressure. Your doctor will monitor you while you
are taking this medicine.
Uncommon side effects (may affect between 1 in 100 and 1 in 1,000 patients):
•Rash ,Itching or other skin reactions.
•An increase in the amount of protein in the urine - this usually returns to normal on
its own without having to stop taking your Rastor tablets (only Rastor 5 mg, 10 mg
and 20 mg).
Rare side effects (may affect between 1 in 1,000 and 1 in 10,000 patients):
•Severe allergic reaction – signs include swelling of the face, lips, tongue and/or throat,
difficulty in swallowing and breathing, a severe itching of the skin (with raised lumps).
If you think you are having an allergic reaction, then stop taking Rastor and seek medical help immediately.
•Muscle damage in adults – as a precaution, stop taking Rastor and talk to your doctor immediately if you have any unusual aches or pains in your muscles which go on for longer than expected.
•A severe stomach pain (inflamed pancreas).
•Increase in liver enzymes in the blood.
•Bleeding or bruising more easily than normal due to low level of blood platelets.
•Lupus-like disease syndrome (including rash, joint disorders and effects on blood
cells).
Very rare side effects (may affect less than 1 in 10,000 patients):
•Jaundice (yellowing of the skin and eyes)
•Hepatitis (an inflamed liver)
•Traces of blood in your urine
•Damage to the nerves of your legs and arms (such as numbness)
•Joint pain
•Memory loss
•Breast enlargement in men (gynaecomastia)
Side effects of unknown frequency may include:
•Diarrhea (loose stools),
•Stevens-Johnson syndrome (serious blistering condition of the skin, mouth, eyes and
genitals),
•Cough
•Shortness of breath
•Oedema (swelling)
•Sleep disturbances, including insomnia and nightmares
•Sexual difficulties
•Depression
•Breathing problems, including persistent cough and/or shortness of breath or fever
•Tendon injury
•Muscle weakness that is constant
Reporting of side effects
If any of the side effects gets serious, or if you notice any possible side effects not listed
in this leaflet, please tell your doctor or pharmacist. You can also report side effects
directly (see section 6). By reporting side effects you can help provide more information
on the safety of this medicine.
5. How to store Rastor
•Do not store above 30°C. Store in the original package in order to protect from
moisture.
•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 box after EXP. The
expiry date refers to the last day of the month.
•Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.
6. Further information
What Rastor contains:
The active substance is Rosuvastatin. Each film-coated tablets contain Rosuvastatin Calcium equivalent to 5 mg, 10 mg, 20
mg or 40 mg of Rosuvastatin.
The other ingredients are: Lactose Monohydrate, Microcrystalline Cellulose, Anhydrous Dibasic Calcium Phosphate, Hypromellose, Crospovidone, Magnesium Stearate, Opadry
Yellow (Rastor 5 mg), Opadry Pink (Rastor 10 mg, 20 mg, and 40 mg).
What Rastor looks like and contents of the pack
Rastor 5 mg; Yellow, round, biconvex, film-coated tablets debossed with “CL” on one side and “86” on other side.
Rastor 10 mg; Pink, round, biconvex, film-coated tablets debossed with “CL87” on one side and plain on other side.
Rastor 20 mg; Pink, round, biconvex, film-coated tablets debossed with “CL88” on one side and plain on other side.
Rastor 40 mg; Pink, Oval, biconvex film-coated tablets debossed with “CL89” on one side and plain on other side.
Rastor 5 mg, 10 mg, 20 mg and 40 mg available in blister packs containing 7 tablets and each box contains four blisters (28 tablets).