Skip to Content

ROSUVASTATIN10 MG FILM-COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM

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

SZ00000LT000

Rosuvastatin 5 mg film-coated tablets
Rosuvastatin 10 mg film-coated tablets
Rosuvastatin 20 mg film-coated tablets
Rosuvastatin 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 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.
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
• 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 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
and end of section 2)
• 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 medicine 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 you take medicines used to treat the HIV
infection e.g. ritonavir with lopinavir, atazanavir
and/or tipranavir, please see Other medicines and
Rosuvastatin .
• If you take antibiotics containing fusidic acid,
please see Other medicines and Rosuvastatin
• 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.
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.
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 tablet is not suitable for
use in children and adolescents below 18 years
of age.
Other medicines and Rosuvastatin
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 and other lipid-lowering
products (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 Warnings and precautions),
an oral contraceptive (the pill), hormone replacement
therapy or ritonavir with lopinavir, atazanavir and/
or tipranavir (used to treat the HIV infection – please
see Warnings and precautions). The effects of these
medicines could be changed by Rosuvastatin or they
could change the effects of Rosuvastatin.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor or pharmacist for advice before taking this
medicine.
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.
Driving and using machines
Most people can drive a car and operate machinery
while taking 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 Rosuvastatin.

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:

Warnings and precautions

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.

Talk to your doctor or pharmacist before taking
Rosuvastatin .

Please check with your doctor or pharmacist which start
dose of Rosuvastatin will best suit you.

• 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.

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).

If any of the above applies to you (or you are in doubt),
please go back and see your doctor.

Continued on the next page >>

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.
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.

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 the 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 carton and on the blister after EXP. The
expiry date refers to the last day of that month.
The shelf-life after first opening of the HDPE bottles is
100 days.
Store in the original package in order to protect from
moisture.
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

Contents of the pack and
other information

What Rosuvastatin contains
• The active substance is rosuvastatin.
Rosuvastatin 5 mg film-coated tablets
Each film-coated tablet contains 5 mg rosuvastatin (as
rosuvastatin calcium).
Rosuvastatin 10 mg film-coated tablets
Each film-coated tablet contains 10 mg rosuvastatin (as
rosuvastatin calcium).
Rosuvastatin 20 mg film-coated tablets
Each film-coated tablet contains 20 mg rosuvastatin (as
rosuvastatin calcium).
Rosuvastatin 40 mg film-coated tablets
Each film-coated tablet contains 40 mg rosuvastatin (as
rosuvastatin calcium).
The other ingredients are:

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.

Tablet contents:
Anhydrous lactose, colloidal anhydrous silica,
microcrystalline cellulose, maize starch, talc, sodium
stearyl fumarate

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

Tablet coat:
Hypromellose, mannitol (E421), macrogol 6000, talc,
titanium dioxide (E171), yellow ferric oxide (E172), red
ferric oxide (E172)

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 side effects (may affect up to 1 in
10 people):
• 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
Rosuvastatin 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 up to 1 in
100 people):
• 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
Rosuvastatin 5 mg, 10 mg and 20 mg).

What Rosuvastatin looks like and contents of
the pack
Film-coated tablets
Rosuvastatin 5 mg film-coated tablets
Brown, round, film-coated tablets with a diameter of
5 mm.
Rosuvastatin 10 mg film-coated tablets
Brown, round, film-coated tablets, with a diameter of
7 mm, with “RSV 10”debossed on one side.
Rosuvastatin 20 mg film-coated tablets
Brown, round, film-coated tablets, with a diameter of
9 mm, with “RSV 20”debossed on one side.
Rosuvastatin 40 mg film-coated tablets
Brown, round, film-coated tablets, with a diameter of
11 mm, with “RSV 40”debossed on one side.
Rosuvastatin 5, 10, 20, and 40 mg film-coated tablets
are available in:
OPA_Al-PVC/Al blister: 7, 10, 14, 20, 21, 28, 30, 40,
42, 50, 60, 70, 84, 90, 98, 100 film-coated tablets
HDPE bottles with PP cap and silica gel desiccant: 28,
30, 50, 84, 90, 100 film-coated tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
Sandoz Ltd,
Frimley Business Park,
Frimley,
Camberley,
Surrey,
GU16 7SR, UK
Manufacturer:
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
Sachsen-Anhalt, 39179 Barleben
Germany
This leaflet was last revised in 10/2015

Rare side effects (may affect up to1 in 1,000
people):
• 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
• Unusual bruising and bleeding due to low level of
blood platelets.
Very rare side effects (may affect up to 1 in
10,000 people):
• 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 not known frequency
(frequency cannot be estimated from the
available data):
• 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 disorders, sometimes complicated by rupture
• Muscle weakness that is constant

SZ00000LT000

draft: 00000000
laetus code: 00000000
mat.no.: 00000000

Artwork Proof Box
Ref: Licence application
Proof no.
001.0

Date prepared:
29/10/2015

Colours:
Black
Dimensions: 148 x 620 mm

Font size:
9pt
Fonts:
FuturaCEEF

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