Serova™ belongs to a group of medicines called statins.
You have been prescribed Serova™ because:
• You have a high cholesterol level. This means you are at risk from a
heart attack or stroke. Serova™ 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 Serova™.
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 it is important to keep taking Serova™
Serova™ 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).
• Serova™ 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 Serova™, 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.

Do not take Serova™
• If you have ever had an allergic reaction to Serova™, or to any of its
ingredients.
• If you are pregnant or breast-feeding. If you become pregnant while
taking Serova™ stop taking it immediately and tell your doctor. Women
should avoid becoming pregnant while taking Serova™ 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 Serova™ 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 Serova™.
• 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 Serova
™”.
• 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 Serova™ can lead to serious muscle
problems (rhabdomyolysis), please see “Other medicines and
Serova™”.
• If you are over 70 (as your doctor needs to choose the right start dose of
Serova™ 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 Serova™ to suit you.
If any of the above applies to you (or if you are not sure):
• Do not take Serova™ 40 mg (the highest dose) and check with your
doctor or pharmacist before you actually start taking any dose of Serova™.

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 Serova™.
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: Serova™ should not be given to
children younger than 6 years.
• If the patient is below 18 years of age: The Serova™ 40 mg tablet is
not suitable for use in children and adolescents below 18 years of age.
Other medicines and Serova™
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),
• 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, ombitasvir, paritaprevir,
dasabuvir, velpatasvir, grazoprevir, elbasvir, glecaprevir, pibrentasvir.
The effects of these medicines could be changed by Serova™ or they could change the effect of Serova™.

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 Serova™. Taking Serova™ 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 Serova™ if you are pregnant or breast-feeding. If you
become pregnant while taking Serova™ stop taking it immediately and
tell your doctor. Women should avoid becoming pregnant while taking
Serova™ 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 Serova™
– it will not affect their ability. However, some people feel dizzy during treatment with Serova™. If you feel dizzy, consult your doctor before attempting to drive or use machines.
Serova™ 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 Serova™.
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 Serova™ for high cholesterol:
Starting dose
Your treatment with Serova™ 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 levels.
• 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 Serova™
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 Serova™ 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 Serova™ 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 Serova™ 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 Serova™ for
you. The maximum daily dose of Serova™ 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. Serova™ 40 mg tablet should not be used by
children.
Taking your tablets
Swallow each tablet whole with a drink of water.
Take Serova™ 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 Serova™ that is right for you.
If you take more Serova™ 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 Serova™.
If you forget to take Serova™
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 Serova™
Talk to your doctor if you want to stop taking Serova™. Your cholesterol levels might increase again if you stop taking Serova™.
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 Serova™ 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 Serova™ 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 Serova™ tablets
(only Serova™ 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 Serova™ tablets
(only Serova™ 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 Serova™ and seek medical help immediately.
• Muscle damage in adults – as a precaution, stop taking Serova™ 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.
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), 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 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 side effects not listed in this leaflet. By reporting side effects you can
help provide more information on the safety of this medicine.

Keep out of the sight and reach of children.
Do not store above 30°C.
Store in the original package in order to protect from moisture.
Do not use this medicine after the expiry date which is stated on the box
and blisters after EXP.
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.