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ROSUVASTATIN ARISTO 5MG FILM-COATED TABLETS

Active substance(s): ROSUVASTATIN CALCIUM / ROSUVASTATIN CALCIUM

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Package leaflet: Information for the patient

Rosuvastatin Aristo 5 mg film-coated tablets
Rosuvastatin Aristo 10 mg film-coated tablets
Rosuvastatin Aristo 20 mg film-coated tablets
Rosuvastatin Aristo 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 Aristo is
and what it is used for
2. What you need to know before
you take Rosuvastatin Aristo
3. How to take Rosuvastatin Aristo
4. Possible side effects
5. How to store Rosuvastatin Aristo
6. Contents of the pack and other
information

1. What Rosuvastatin
Aristo is and what it is
used for
Rosuvastatin Aristo belongs to a
group of medicines called statins.
You have been prescribed
Rosuvastatin Aristo because:
• You have a high cholesterol
level. This means you are at
risk from a heart attack or
stroke. Rosuvastatin Aristo 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
Rosuvastatin Aristo.
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 Aristo
Rosuvastatin Aristo 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 Aristo 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 Aristo, 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 Aristo
Do not take Rosuvastatin Aristo:
• If you have ever had an allergic
reaction to Rosuvastatin Aristo
or to any of its ingredients
• If you are pregnant or
breast-feeding. If you become
pregnant while taking
Rosuvastatin Aristo stop taking
it immediately and tell your
doctor. Women should avoid
becoming pregnant while
taking Rosuvastatin Aristo 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 Aristo 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 Aristo:
• 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 Rosuvastatin
Aristo.
• 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
Aristo can lead to serious muscle
problems (rhabdomyolysis),
please see “Other medicines
and Rosuvastatin Aristo”.
• If you are over 70 (as your
doctor needs to choose the
right start dose of Rosuvastatin
Aristo 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
Aristo to suit you.
If any of the above applies to you
(or if you are not sure):
• Do not take Rosuvastatin
Aristo 40 mg (the highest dose)
and check with your doctor or
pharmacist before you actually
start taking any dose of this
medicine.

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 Aristo.
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 Aristo should
not be given to children
younger than 6 years.
• If the patient is below 18 years
of age: The Rosuvastatin Aristo
40 mg tablet is not suitable for
use in children and adolescents
below 18 years of age.
Other medicines and
Rosuvastatin Aristo
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”),
an oral contraceptive (the pill),
hormone replacement therapy
anti-viral medications such as
ritonavir with lopinavir and/or
atazanavir or simeprevir (used
to treat infections, including HIV
infection or hepatitis C – please see
“Warnings and precautions”). The
effects of these medicines could be
changed by Rosuvastatin Aristo or
they could change the effects of
Rosuvastatin Aristo.
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 Aristo. Taking
Rosuvastatin Aristo 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 Rosuvastatin Aristo if
you are pregnant or
breast-feeding. If you become
pregnant while taking this
medicine, stop taking it
immediately and tell your
doctor. Women should avoid
becoming pregnant while taking
Rosuvastatin Aristo 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 taking
this medicine – it will not affect
their ability to drive or operate
machinery. However, some people
feel dizzy during treatment
with Rosuvastatin Aristo. If you
feel dizzy, consult your doctor
before attempting to drive or use
machines.
Rosuvastatin Aristo contains
lactose monohydrate.
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 Aristo.
For a full list of ingredients please
see “Contents of the pack and
other information”.

3. How to take
Rosuvastatin Aristo
Always take this medicine as your
doctor has told you. Check with
your doctor or pharmacist if you
are not sure.
Usual doses in adults:
If you are taking Rosuvastatin
Aristo for high cholesterol:
Starting dose
Your treatment with Rosuvastatin
Aristo 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 starting dose of
Rosuvastatin Aristo 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 Aristo 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 Aristo 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
Aristo 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 in children and
adolescents aged 6 to 17 years is
5 to 20 mg once daily. The usual
starting dose is 5 mg per day and
your doctor may gradually increase
your dose to find the right amount
of Rosuvastatin Aristo for you. The
maximum daily dose is 10 mg or
20 mg for children aged 6 to
17 years depending on your
underlying condition. Take your
dose once a day. Rosuvastatin
Aristo 40 mg tablets should not be
used by children.
Taking your tablets
Swallow each tablet whole with a
drink of water.
Take Rosuvastatin Aristo 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.
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 Aristo that is right
for you.
If you take more Rosuvastatin
Aristo 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 Rosuvastatin Aristo.
If you forget to take
Rosuvastatin Aristo
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.
If you stop taking
Rosuvastatin Aristo
Talk to your doctor if you want to
stop taking Rosuvastatin Aristo.
Your cholesterol levels might
increase again if you stop taking
the tablets.
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
Aristo 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
Aristo 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 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 tablets (only
Rosuvastatin Aristo 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 possible side
effects (these may affect up to
1 in 100 people 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 tablets (only
Rosuvastatin Aristo 5 mg, 10 mg
and 20 mg).
Rare possible side effects
(these may affect between 1
in 1,000 people 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 Aristo and
seek medical help immediately.
• Muscle damage in adults –
as a precaution, stop taking
Rosuvastatin Aristo 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 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 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 side effects not listed
in this leaflet. You can also report
side effects directly via the Yellow
Card Scheme at:
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 Aristo
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 blister after “EXP”.
The expiry date refers to the last
day of that month.
Do not store above 30ºC.
Store in the original package in
order to protect from light.
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 Aristo
contains
• The active substance is
rosuvastatin.
Each film-coated tablet contains
5 mg, 10 mg, 20 mg or 40 mg
rosuvastatin as rosuvastatin
calcium, respectively.
• The other ingredients are:
cellulose microcrystalline PH-101,
silica colloidal anhydrous,
crospovidone Type A, cellulose
microcrystalline PH-102, lactose
monohydrate, magnesium
stearate.
The tablet coating contains:
5 mg tablets: Opadry II
Yellow 33K12488 containing:
hypromellose, titanium dioxide
(E171), lactose monohydrate,
triacetin, iron oxide yellow (E172).
10 mg tablets: Opadry II
Pink 33K94423 containing:
hypromellose, titanium dioxide
(E171), lactose monohydrate,
triacetin, iron oxide red (E172).
20 mg tablets: Opadry II
Pink 33K94423 containing:
hypromellose, titanium dioxide
(E171),lactose monohydrate,
triacetin, iron oxide red (E172).
40 mg tablets: Opadry II
Pink 33K94424 containing:
hypromellose, titanium dioxide
(E171), lactose monohydrate,
triacetin, iron oxide red (E172).
What Rosuvastatin Aristo
looks like and contents of the
pack
5 mg tablets: Yellow, round,
biconvex, coated tablet, embossed
‘ROS’ over ‘5’ on one side and
nothing on the other, with
diameter 7 mm.
10 mg tablets: Pink, round,
biconvex, coated tablet, embossed
‘ROS’ over ‘10’ on one side and
nothing on the other, with
diameter 7 mm.
20 mg tablets: Pink, round,
biconvex, coated tablet, embossed
‘ROS’ over ‘20’ on one side and
nothing on the other, with
diameter 9 mm.
40 mg tablets: Pink, oval,
biconvex, coated tablet, embossed
‘ROS’ on one side and ‘40’ on the
other side, with dimensions 6.8 x
11.4 mm.
Tablets are packed in OPA-Al-PVC/
Al blisters.
Pack sizes contain 28, 30,
90 and 100 tablets.
Not all pack sizes may be
marketed.
Marketing Authorisation
Holder
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer
Medochemie Ltd- Central Factory
1-10 Constantinoupoleos Str.,
Limassol, 3011, Cyprus.
This leaflet was last revised in
May 2017.

Expand Transcript

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.

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