Skip to Content

UK Edition. Click here for US version.

ROSUVASTATIN 20 MG FILM-COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM / ROSUVASTATIN CALCIUM

View full screen / Print PDF » Download PDF ⇩
Transcript
PACKAGE LEAFLET: INFORMATION FOR THE USER

Rosuvastatin 20 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 only. Do not pass it on to others. It may harm them, even if their
signs of illness 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.
What is in this leaflet
1. What Rosuvastatin is and what it is used for
2. What you need to know before you take Rosuvastatin
3. How to take Rosuvastatin
4. Possible side effects
5. How to store Rosuvastatin
6. Contents of the pack and other information





1. WHAT ROSUVASTATIN IS AND WHAT IT IS
USED FOR



Rosuvastatin belongs to a group of medicines called
statins.



You have been prescribed Rosuvastatin because:


You have a high cholesterol level. This means you
are at risk from a heart attack or stroke.
Rosuvastatin is used in adults, adolescents and
children 6 years or older to treat high cholesterol.



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 fight the HIV infection e.g.
ritonavir with lopinavir and/or atazanavir, please see
Other medicines and Rosuvastatin.
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 Rosuvastatin can lead to serious
muscle problems (rhabdomyolysis).
If you are over 70 (as your doctor needs to choose the
right start dose of Rosuvastatin 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 Rosuvastatin to
suit you.

You have been advised to take a statin, because
changing your diet and taking more exercise were not
enough to correct your cholesterol levels. You should
continue with your cholesterol-lowering diet and exercise
while you are taking Rosuvastatin.




Or

Children and adolescents:
• If the patient is under 6 years old: Rosuvastatin should
not be given to children younger than 6 years.
• If the patient is below 18 years of age: The
Rosuvastatin 40 mg tablets are not suitable for use in
children and adolescents below 18 years of age.



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 you arteries.
Why is it important to keep taking Rosuvastatin?
Rosuvastatin 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).
• Rosuvastatin 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 Rosuvastatin, 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 ROSUVASTATIN
Do not take Rosuvastatin:
• if you are allergic 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 Rosuvastatin stop taking it
immediately and tell your doctor. Women should
avoid becoming pregnant while taking Rosuvastatin by
using suitable contraception.
• If you have liver disease.
• If you have severe kidney problems.
• If you have repeated or unexplained muscle aches or
pains.
• If you 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 Rosuvastatin 40 mg (the
highest dose):
• If you have moderate kidney problems (if in doubt,
please ask your doctor).
• If your thyroid gland is not working properly
• If you 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.
• If you regularly drink large amounts of alcohol.
• If you are of Asian origin (Japanese, Chinese, Filipino,
Vietnamese, Korean and Indian).
• If you 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
Rosuvastatin
• 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.

If any of the above applies to you (or if you are not sure):
• Do not take Rosuvastatin 40 mg (the highest
dose) and check with your doctor or pharmacist
before you actually start taking any dose of
Rosuvastatin.
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
Rosuvastatin.
While you are on this medicine 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.
Other medicines and Rosuvastatin
Tell your doctor or pharmacist if you are taking, or 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),
• an oral contraceptive (the pill),
• hormone replacement therapy,
• antiviral medications such as ritonavir with lopinavir
and/or atazanavir or simeprevir (used to treat infections,
including HIV or hepatitis C infection – please see
Warnings and precautions),
• 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 Rosuvastatin. Taking Rosuvastatin with fusidic
acid may rarely lead to muscle weakness, tenderness
or pain (rhabdomyolysis). See more information
regarding rhabdomyolysis in section 4.
The effects of these medicines could be changed by
Rosuvastatin or they could change the effects of
Rosuvastatin.
Rosuvastatin with food and drink
You can take Rosuvastatin with or without food.
Pregnancy and breast-feeding
Do not take Rosuvastatin if you are pregnant or
breast-feeding. If you become pregnant while taking
Rosuvastatin stop taking it immediately and tell your
doctor. Women should avoid becoming pregnant while
taking Rosuvastatin 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 Rosuvastatin – it will not affect their ability.
However, some people feel dizzy during treatment with
Rosuvastatin. If you feel dizzy, consult your doctor before
attempting to drive or use machines.
Rosuvastatin 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 this medicinal product.

3. HOW TO TAKE ROSUVASTATIN
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.

Usual doses in adults
If you are taking Rosuvastatin for high cholesterol:
Starting dose
Your treatment with Rosuvastatin 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 level.
• 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 Rosuvastatin will best suit you.
Your doctor may decide to give you the lowest 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 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 Rosuvastatin 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, 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 Rosuvastatin 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 Rosuvastatin 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 usual start dose is 5 mg. Your doctor may increase
your dose to find the right amount of Rosuvastatin for
you. The maximum daily dose of Rosuvastatin is 10 mg
for children aged 6 to 9 years and 20 mg for children
aged 10 to 17 years. Take your dose once a day.
Rosuvastatin 40 mg tablet should not be used by
children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Rosuvastatin 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 Rosuvastatin that is right
for you.
If you take more Rosuvastatin 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’re taking
Rosuvastatin.



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 possible side effects (these 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 Rosuvastatin tablets (only doses 520 mg).
Rare possible side effects (these 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 Rosuvastatin and seek medical help
immediately
• Muscle damage in adults – as a precaution, stop taking
Rosuvastatin 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.
Very rare possible side effects (these 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:
• Diarrhoea (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 you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE ROSUVASTATIN
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 packaging after EXP. The expiry date refers
to the last day of that month.
This medicinal product does not require any special
temperature storage conditions.
Store in the original package in order to protect from
moisture.

If you forget to take Rosuvastatin
Don’t worry, just take your next scheduled dose at the
correct time. Do not take a double dose to make up for a
forgotten dose.

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.

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

6. CONTENTS OF THE PACK AND OTHER
INFORMATION

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 Rosuvastatin 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 Rosuvastatin and talk to your
doctor immediately if you have any unusual aches
or pains in your muscles which 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.
Common possible side effects (these may affect
between 1 in 10 and 1 in 100 patients):
• Headache
• Stomach pain
• Constipation
• Feeling sick
• Muscle pain
• Feeling weak
• 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 Rosuvastatin tablets (only the 40 mg
dose).

What Rosuvastatin contains
• The active substance is rosuvastatin.
Each film-coated tablet contains 20 mg rosuvastatin
(as rosuvastatin calcium).
• The other ingredients are anhydrous lactose,
microcrystalline cellulose, crospovidone (type A),
magnesium stearate and colloidal anhydrous silica in
the tablet core and poly vinyl alcohol, titanium dioxide
(E171), macrogol 3350, talc, iron oxide yellow (E172) in
the film coating.
What Rosuvastatin looks like and contents of the
pack
Rosuvastatin 20 mg film-coated tablets are white or
almost white, round, slightly biconvex film-coated tablets
with bevelled edges, engraved with number 20 on one
side of the tablet (diameter: 10 mm).
Rosuvastatin is available in boxes containing 10, 14, 15,
20, 28, 30, 56, 60, 90, 98 and 100 film-coated tablets in
blisters.
Rosuvastatin is available in boxes containing 10 x 1, 14 x
1, 15 x 1, 20 x 1, 28 x 1, 30 x 1, 56 x 1, 60 x 1, 90 x 1,
98 x 1 and 100 x 1 film-coated tablets in perforated unit
dose blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
HCS bvba, H Kennisstraat 53,
B 2650 Edegem,
Belgium
Manufacturer
Krka, d.d., Novo mesto, Šmarješka cesta 6,
8501 Novo mesto,
Slovenia
TAD Pharma GmbH, Heinz-Lohmann - Strasse 5,
27472 Cuxhaven,
Germany
Distributed by:
Consilient Health (UK) Limited.
No.1 Church Road, Richmond upon Thames,
Surrey. TW9 2QE
This leaflet was last revised in November 2016
P0574

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide