Product Details

Product Information of Rosudex 10mg Tablets

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 breastfeeding. 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 combination of sofosbuvir/velpatasvir/voxilaprevir (used for viral infection of the liver called hepatitis C).
• If you take a drug called ciclosporin (used, for example, after organ transplants)
• If you have ever developed a severe  skin rash or skin peeling, blistering and/
or mouth sores after taking Rosuvastatin or other related medicines.
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. 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”.
• 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), 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.
• Serious skin reactions including
Stevens-Johnson syndrome and drug
reaction with eosinophilia and systemic
symptoms (DRESS) have been reported
in association with Rosuvastatin
treatment. Stop using Rosuvastatin
and seek medical attention immediately
if you notice any of the symptoms
described in section 4.
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 (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),
• regorafenib (used to treat cancer),
• darolutamide (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,
sofosbuvir, voxilaprevir, simeprevir,
ombitasvir, paritaprevir, dasabuvir,
velpatasvir, grazoprevir, elbasvir,
glecaprevir, pibrentasvir.
The effects of these medicines could be
changed by Rosuvastatin or they could
change the effect of Rosuvastatin.
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.
Pregnancy, breast-feeding and fertility
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.
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.
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, contact your
doctor before taking this medicinal product.
Rosuvastatin film-coated tablets contain
allura red AC and sunset yellow FCF, which
may cause allergic reactions.
For a full list of ingredients, please
see Contents of the pack and other information

How to store Turbovas
Keep this medicine out of the sight and
reach of children.
This medicinal product does not require
any special temperature storage conditions.
Store in the original package in order to
protect from light.
Do not use this medicine after the expiry
date which is stated after EXP on the blister
and carton. 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