Kolitarda belongs to a group of medicines called statins.
You have been prescribed Kolitarda because:
• You have a high cholesterol level. This means you are at
risk from a heart attack or stroke. Kolitarda 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 Kolitarda.
• You have other factors that increase your risk of having a
heart attack, stroke or related health problems.
A disease called atherosclerosis can cause heart attack, stroke
and other problems. Atherosclerosis is due to build-up of fatty
deposits in your arteries.
Why it is important to keep taking Kolitarda
Kolitarda 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).
• Kolitarda 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
leadling 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 Kolitarda, even if it has 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.

Do not take Kolitarda:
• If you have ever had an allergic reaction to Kolitarda, or to
any of its ingredients (listed in section 6).
If you are pregnant or breast-feeding. If you become
pregnant while taking Kolitarda, stop taking it
immediately and tell your doctor. Women should avoid
becoming pregnant while taking Kolitarda 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 any of the above applies to you (or you are in doubt), please
go back and see your doctor.
In addition, do not take 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 Kolitarda.
• 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 have ever developed a severe skin rash or skin
peeling, blistering and/or mouth sores after taking
Kolitarda or other related medicines.
• 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 Kolitarda”.
• 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 Kolitarda can lead to serious muscle
problems (rhabdomyolysis), please see “Other medicines
and Kolitarda”.
• If you are over 70 (as your doctor needs to choose the right
start dose of Kolitarda to suit you)
If any of the above applies to you (or if you are not sure):
• Do not take 40 mg (the highest dose) and check with your
doctor or pharmacist before you actually start taking any
dose of Kolitarda.
Serious skin reactions including Stevens-Johnson syndrome
and drug reaction with eosinophilia and systemic symptoms
(DRESS) have been reported in association with Kolitarda
treatment. Stop using Kolitarda and seek medical attention
immediately if you notice any of the symptoms described in
section 4.
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 Kolitarda. 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: Kolitarda should not be
given to children younger than 6 years.
• If the patient is below 18 years of age: 40 mg tablet is not
suitable for use in children and adolescents below 18 years
of age.
Other medicines and Kolitarda:
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines, including medicines
obtained without a prescription.
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,
ombitasvir, paritaprevir, dasabuvir, velpatasvir, grazoprevir,
elbasvir, glecaprevir, pibrentasvir.
The effects of these medicines could be changed by Kolitarda
or they could change the effect of Kolitarda.
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
Kolitarda. Taking Kolitarda with fusidic acid may rarely lead
to muscle weakness, tenderness or pain (rhabdomyolysis).
See more information regarding rhabdomyolysis in Section 4.
Kolitarda with food and drink
You can take Kolitarda with or without food.
Pregnancy, breastfeeding and fertility:
Do not take Kolitarda tablets if you are pregnant or
breast-feeding. If you become pregnant while taking Kolitarda
tablets stop taking it immediately and tell your doctor. Women
should avoid becoming pregnant while taking Kolitarda tablets
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 Kolitarda – it will not affect their ability. However, some
people feel dizzy during treatment with Kolitarda. If you feel
dizzy, consult your doctor before attempting to drive or use
machines.
Kolitarda contains lactose or any other ingredient:
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 Kolitarda. For a full list of
ingredients, please see Contents of the pack and other
information.

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 Kolitarda for high cholesterol:
Starting dose
Your treatment with Kolitarda tablets 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 Kolitarda tablets 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 Kolitarda 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 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 Kolitarda 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 start dose is 5 mg per day,
and your doctor may gradually increase your dose to find the
right amount of Kolitarda for you. The maximum daily dose of
Kolitarda 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. Children should not use 40 mg Dose.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Kolitarda 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 Kolitarda that is right for you.
If you take more Kolitarda 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 Kolitarda.
If you forget to take Kolitarda
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 Kolitarda
Talk to your doctor if you want to stop taking Kolitarda. Your
cholesterol levels might increase again if you stop taking
Kolitarda.
If you have any further questions on the use of this medicine,
ask your doctor or pharmacist.

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 Kolitarda 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).
• Reddish non-elevated, target-like or circular patches on
the trunk, often with central blisters, skin peeling, ulcers
of mouth, throat, nose, genitals and eyes. These serious
skin rashes can be preceded by fever and flu-like symptoms
(Stevens-Johnson syndrome).
• Widespread rash, high body temperature and enlarged
lymph nodes (DRESS syndrome or drug hypersensitivity
syndrome).
Also, stop taking Kolitarda 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.
• If you experience muscle rupture.
• If you have lupus-like disease syndrome (including rash,
joint disorders and effects on blood cells).
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 Kolitarda tablets (only 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 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 Kolitarda tablets (10 mg and 20 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 Kolitarda and seek medical help immediately.
• Muscle damage in adults – as a precaution, stop taking
Kolitarda 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 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 and breast enlargement in men
(gynaecomastia).
Side effects of unknown frequency may include:
• Diarrhoea (loose stools), 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 and 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.
To report any side effect(s):
• Saudi Arabia:
• The National Pharmacovigilance Centre (NPC)
• Fax: +966-11-205-7662
• SFDA Call Center: 19999
• E-mail: npc.drug@sfda.gov.sa
• Website: https://ade.sfda.gov.sa
• Other GCC States:
Please contact the relevant competent authority.

• Keep this medicine out of the sight and reach of children
and in original packages
• 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 30°C
• 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.