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DEXCEL CHOLESTEROL LOWERING 10MG TABLETS

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PATIENT INFORMATION LEAFLET

Dexcel Cholesterol Lowering 10mg Tablets
(Simvastatin)

Please read all of this leaflet carefully before
you start taking this medicine because it
contains important information for you.
This medicine is available without prescription.
Nevertheless you still need to use Dexcel
Cholesterol Lowering 10mgTablets carefully to
get the best results from it.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information
or advice.
- If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What Dexcel Cholesterol Lowering 10mg
Tablets are and what they are used for
2. Before you take Dexcel Cholesterol Lowering
10mg Tablets
3. How to take Dexcel Cholesterol Lowering 10mg
Tablets
4. Possible side effects
5. How to store Dexcel Cholesterol Lowering
10mg Tablets
6. Further information

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1. WHAT DEXCEL CHOLESTEROL LOWERING
10mg TABLETS ARE AND WHAT THEY ARE
USED FOR
The active ingredient in Dexcel Cholesterol
Lowering 10mg Tablets is simvastatin which
belongs to a group of medicines known as
'statins'. These significantly reduce the amount of
cholesterol in your blood.
Dexcel Cholesterol Lowering 10mg Tablets
reduce the level of LDL "bad" cholesterol and
fatty substances called triglycerides in your blood.
LDL cholesterol is called "bad" because it is the
cholesterol that clogs your coronary arteries.
These tablets also raise the HDL "good"
cholesterol. HDL is called "good" cholesterol
because it helps to protect against heart disease.
Too much cholesterol in your blood builds up in
the walls of the coronary arteries causing plaques
to form. This leads to a narrowing of the coronary
arteries, just like hard water furs up a water pipe.
Heart attacks can then happen when a blood clot
forms in a narrowed coronary artery.
Taking these tablets can significantly reduce
cholesterol levels and help to reduce build up
of artery-narrowing plaques. In order to get the
maximum benefit from treatment, these tablets
should be taken regularly on a long-term basis.
The risk of heart attacks increases as you age
because of the build up of plaques. Reducing
this risk with these tablets and changes to your
lifestyle needs to be a lifelong effort.
Section 6 includes information on what you can
do to help reduce your risk of heart attack.
Dexcel Cholesterol Lowering 10mg Tablets
reduces the levels of "bad" cholesterol in the
blood by around 27%. Studies show that reducing
cholesterol by this much can reduce the risk of
first heart attack by about one third after 3 years
of treatment.
Dexcel Cholesterol Lowering 10mg tablets can
reduce the risk of a first heart attack in people
who have a moderate risk of coronary heart
disease (heart disease because of build up of
plaques in the coronary arteries). Moderate risk
means your chances of having a heart attack in
the next 10 years are at least 1 in 10.
This medicine is for use by adults only.
You are likely to be at moderate risk of
coronary heart disease if you are:
• a man aged 55 or over.
• a man aged between 45 and 54 or a woman
aged 55 or over and answers yes to one or more
of the questions below:
- Do you have a parent, brother or sister who
suffered a heart attack younger than 55 for
men or 65 for women?
- Do you smoke or have you smoked within the
past 5 years?
- Are you overweight? This means you have a
body mass index over 25 kg/m2 (your weight
in kilos divided by your height in meters
squared), or your waist is greater than 40
inches or 102 cm (for men), or 35 inches or 88
cm (for women). Your pharmacist can help you
answer this question.
- Are you of South Asian origin, i.e. from the
Indian subcontinent that includes India,
Bangladesh, Pakistan or Sri Lanka?
If, in addition, you take no physical exercise other
than normal daily activities, your risk of a heart
attack is further increased.
2. BEFORE YOU TAKE DEXCEL
CHOLESTEROL LOWERING 10mg TABLETS
Do not take this medicine if:
• you have ever had an allergic reaction to
simvastatin or similar medicines or to any of the
other ingredients in this medicine;
• you know you have liver disease or you have
been told you have abnormal liver function
blood tests;
• you are pregnant or breast-feeding;
• you are already taking prescription drugs to
lower your cholesterol (such as gemfibrozil,
bezafibrate);
• you have had muscle problems in the past
after taking a cholesterol lowering medicine;
• you are taking one of the following medicines:
- oral antifungal medicines (drugs taken
by mouth which are used to treat fungal
infections such as itraconazole, ketoconazole,
posaconazole or voriconazole).
- antibiotics called erythromycin, telithromycin
or clarithromycin.
- medicines for HIV infections called protease
inhibitors such as indinavir, nelfinavir, ritonavir
or saquinavir.
- the antidepressant nefazodone.
- ciclosporin an immunosuppressant medicine
(used in organ transplant patients)
- danazol (a steroid often used to treat
endometriosis, a condition in which the lining
of the uterus grows outside the uterus and for
breast cysts in women.

- boceprevir or telaprevir (medicines for hepatitis
C virus infection)
- if you are taking or, in the last 7 days, have
taken or been given a medicine called fusidic
acid (used to treat bacterial infection)
Take special care with this medicine if:
• you have severe respiratory failure.
• you have an under active thyroid gland
(hypothyroidism).
• you have kidney problems.
• You have ever had liver disease. Dexcel
Cholesterol Lowering 10mg Tablets may not be
right for you.
• you have a family or personal history of
muscle disorders.
• your doctor has told you that you have high
blood pressure, check with your doctor before
taking.
• you are aged over 65.
• you are female.
• If you drink more than 4 units of alcohol a day
(for men) or 3 units a day (for women). One unit
is 1/2 pint of lager, a small glass of wine or one
short.
• you have your cholesterol levels checked
and you find that you have a fasting LDL
cholesterol measurement greater than 5.5
mmol/l, you should talk to your doctor because
you may need more than these tablets to reduce
your cholesterol levels.
• you go into hospital for surgery, you should tell
your doctor you are taking Dexcel Cholesterol
Lowering 10mg Tablets as you will need to stop
taking it a few days beforehand.
Your doctor should do a blood test before you start
taking Dexcel Cholesterol Lowering 10mg Tablets
and if you have any symptoms of liver problems
while you take Dexcel Cholesterol Lowering 10mg
Tablets. This is to check how well your liver is
working.
Your doctor may also want you to have blood tests
to check how well your liver is working after you
start taking Simvastatin Tablets.
Tell your doctor if you have severe lung disease.
Tell your doctor immediately if you experience
symptoms such as muscle pain, tenderness
or weakness, unless it is clearly the result of
flu, unaccustomed exercise or recent strain
or injury. This is because on rare occasions,
there is a risk of muscle problems which may
be severe, including muscle breakdown which
can result in kidney damage; and very rarely,
deaths have occurred. The doctor may perform
a blood test to check the condition of your muscles
before and after starting treatment.
You are at a higher risk of coronary heart disease
if you are in one of the groups below. You should
discuss your condition with your doctor since
you are likely to need more than these tablets to
reduce your risk.
• You already have angina or have had a heart
attack.
• You have diabetes.
• You have had a stroke.
• You have disease of the arteries of your legs
or neck (peripheral vascular disease).
• You have inherited (it runs in the family) very
high blood cholesterol levels.
If you think any of these apply to you or you are
unsure that you have one of these conditions, go
and talk to your pharmacist or doctor first.
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.
Taking other medicines
• Please tell your doctor or pharmacist if you
are taking or have recently taken any other
medicines, including medicines obtained without
a prescription. Your pharmacist may advise you
to check with your doctor before taking Dexcel
Cholesterol Lowering 10mg Tablets. If your
doctor prescribes a new medicine for you while
you are taking this product (for example, if you
develop an infection and your doctor decides
to give you a course of antibiotics), you should
mention that you are taking these tablets.
• Take special care if you are taking medicines
for thinning the blood, such as warfarin,
phenprocoumon or acenocoumarol, as they
may cause problems when you take them with
these tablets.
• In addition to the medicines listed in the section
'Do not take these tablets if', this medicine can
react with the following drugs to cause muscle
problems:
- Fluconazole (a medicine used to treat fungal
infections).
- Lipid-lowering medicines (such as fenofibrate,
high doses of niacin or nicotinic acid (more
than 1000mg/day)).
- Amiodarone (a medicine used for irregular
heart beat).
- Verapamil, amlodipine or diltiazem (drugs
used to treat high blood pressure, chest pain
associated with heart disease, or other heart
conditions).
- Colchicine (a medicine used to treat gout).
- Rifampicin (a medicine used to treat
tuberculosis).
If you are taking any of these or any other
medicines talk to your pharmacist or doctor
before taking Dexcel Cholesterol Lowering 10mg
Tablets.
Taking tablets with food and drink:
Grapefruit juice contains one or more components
that alter the metabolism of some medications,
including Dexcel Cholesterol Lowering 10mg
Tablets. Do not drink grapefruit juice while you
are taking Dexcel Cholesterol Lowering 10mg
Tablets as it increases the chance of muscle
damage (see above under ‘Take special care’ and
section 4 ‘Possible side effects’).

Pregnancy and Breast-feeding
Do not take if:
• you could become pregnant, are pregnant,
are planning to become pregnant or are
breastfeeding;
• discover you are pregnant while taking these
tablets. In this case, you should stop taking
these tablets immediately and contact your
doctor.

• Inflammation of the lungs causing breathing
problems including persistent cough and/or
shortness of breath or fever
• Tendon problems, sometimes complicated by
rupture of the tendon.
• Bursitis (inflammation of the fluid filled sacs
around different joints. You might feel pain,
tenderness, redness, warmth, swelling and/or
stiffness near the affected area).

Driving and using machines:
Dexcel Cholesterol Lowering 10mg Tablets can
cause dizziness. If affected, do not drive or
operate machinery.

Additional possible side effects reported with
some statins:
• Sleep disturbances, including nightmares
• Sexual difficulties
• Diabetes. This is more likely if you have high
blood pressure, high levels of sugar or fats in
your blood or if you are overweight (have a
body mass index of more than 30kg/m2). Your
doctor will monitor you while you are taking this
medicine.

Important information about some of the
ingredients
This medicine contains a sugar called 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.
3. HOW TO TAKE DEXCEL CHOLESTEROL
LOWERING 10mg TABLETS
Adults and the elderly:
Take one tablet every evening. Swallow the tablet
with a drink of water.
The evening is the best time because it means
that your medicine will be working when your
body is producing the most cholesterol. Tablets
should be taken regularly and on a long-term
basis in order to gain the full benefits of treatment.
Never take more than one tablet each day. If you
have any further questions on the use of this
product, ask your doctor or pharmacist.
Children (under 18 years):
This medicine is not recommended for children
under 18 years of age.
If you take more Dexcel Cholesterol Lowering
10mg Tablets than you should:
If anyone has taken too many Dexcel Cholesterol
Lowering 10mg Tablets, contact a doctor or your
nearest Accident and Emergency Department
(Casualty) taking this leaflet and pack with you.
If you forget to take Dexcel Cholesterol
Lowering 10mg Tablets:
You should only take this medicine as required
following the dosage instructions above carefully.
If you forget a dose, just take one dose the next
evening you remember. Do not take an extra one
to make up for a forgotten tablet.

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If you stop taking Dexcel Cholesterol Lowering
10mg Tablets:
Your cholesterol may rise again.
Checking Your Cholesterol:
If you have a moderate risk of heart disease,
reducing the level of cholesterol in your blood
will reduce your risk. Your pharmacist can
arrange to check your cholesterol level, but it
is not necessary to know this before you start
using Dexcel Cholesterol Lowering 10mg
Tablets. Checking your cholesterol can provide
additional information and can be helpful to show
your progress while taking Dexcel Cholesterol
Lowering 10mg Tablets. If your fasting LDLcholesterol measurement is above 5.5 mmol/l,
you should talk to your doctor as it may mean that
you need more than Dexcel Cholesterol Lowering
10mg Tablets to reduce your cholesterol.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, these tablets can cause side
effects, although not everybody gets them.
The following terms are used to describe how
often side effects have been reported:
Rare (may affect up to 1 of 1000 patients)
Very rare (may affect up to 1 of 10,000 patients)
Not known (frequency cannot be estimated from
the available data)
The following serious side effects were reported.
If any of these serious side effects happen,
stop taking the tablets and contact your
doctor immediately or go to the emergency
room at your nearest hospital:
• Muscle pain, cramps, tenderness or weakness.
On rare occasions, these muscle problems
can be serious, including muscle breakdown
resulting in kidney damage; and very rare
deaths have occurred.
• Hypersensitivity (allergic) reactions including:
- swelling of the face, tongue and throat which
may cause difficulty in breathing
- severe muscle pain usually in the shoulders
and hips
- rash with weakness of limbs and neck muscles
- pain or inflammation of the joints (polymyalgia
rheumatic)
- inflammation of the blood vessels (vasculitis)
- unusual bruising, skin eruptions and swelling
(dermatomyositis), hives, itchiness, skin
sensitivity to the sun fever, flushing
- shortness of breath (dyspnoea) and feeling
unwell
- lupus-like disease picture (including rash, joint
disorders, and effects on blood cells)
• Inflammation of the liver with the following
symptoms: yellowing of the eyes and/or skin,
itching, dark-coloured urine or pale-coloured
stool, feeling tired or weak, loss of appetite, liver
failure (very rare).
• Pancreatitis (inflammation of the pancreas)
often with severe abdominal pain.
The following side effects have also been reported
rarely:
• Low red blood cell count (anaemia)
• Numbness or weakness of the arms and legs
• Headache, tingling sensation (pins and
needles), dizziness
• Digestive disturbances (abdominal pain,
constipation, flatulence, indigestion, diarrhoea,
nausea, vomiting)
• Rash, itching, hair loss
• Weakness
• Trouble sleeping (very rare)
• Poor memory (very rare), memory loss,
confusion
The following side effects have also been reported
but the frequency cannot be estimated from the
available information (frequency not known):
• Erectile dysfunction
• Depression

Laboratory values
Elevations in some laboratory blood tests of liver
function and a muscle enzyme (creatine kinase)
have been observed.
If you experience any side effects not included in
this leaflet or are not sure about anything, talk to
your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
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. STORING DEXCEL CHOLESTEROL
LOWERING 10mg TABLETS
Keep your medicine out of the reach and sight
of children.
Do not use after the expiry date stated on the
label.
Do not store above 25°C. Store in the original
package.
If your doctor tells you to stop taking the tablets,
please take them back to the pharmacist.
6. FURTHER INFORMATION
What else can I do to reduce my risk of a heart
attack?
At the same time as taking the tablets, try to
reduce your risk of coronary heart disease by
doing the following:
• Stop smoking - there is strong evidence to
link cigarette smoking with heart disease. The
risks increase with the number of cigarettes you
smoke each day, but risks still exist even if you
smoke as little as five a day. It is better to stop
smoking altogether rather than just cut down
on how much you smoke. Your pharmacist can
advise you on a suitable programme to help you
stop smoking.
• Eat a healthy diet - a healthy diet will not only
help towards preventing coronary heart disease,
but has also been shown to reduce the risk of
stroke and a number of cancers. Try to increase
the amount of fruit and vegetables in your diet
and reduce the amount of sugar, salt and fat.
• Lose weight - being overweight can cause a
rise in your blood pressure, increases your risk
of developing diabetes and increases the risk of
developing heart disease due to high cholesterol
levels. Change your diet as described above and
take more exercise.
• Exercise - a brisk walk to the shops can help.
Swimming is a good all round exercise that you
could consider doing, as it is something you can
gradually build up without overdoing it to start
with. You could try adding the following to your
daily routine: vigorous housework, walk upstairs
more often (and don’t take the lift or escalator
when you are out), and gardening.
Your pharmacist can provide details of a Healthy
Heart Programme to help you.
What Dexcel Cholesterol Lowering 10mg
Tablets contain:
Each film-coated tablet contains 10mg simvastatin
as the active ingredient.
The other ingredients are: lactose monohydrate,
pregelatinised maize starch, ascorbic acid (E300),
citric acid monohydrate (E330), microcrystalline
cellulose (E460(i)), butylhydroxyanisole (E320),
croscarmellose sodium, magnesium stearate
(E572).
The
film
coating
materials
contain
hydroxypropylcellulose (E463), hypromellose
15cP (E464), titanium dioxide (E171), talc
(E553(b)), iron oxide yellow (E172), iron oxide red
(E172) and iron oxide black (E172).
What Dexcel Cholesterol Lowering 10mg
Tablets look like:
Dexcel Cholesterol Lowering 10mg Tablets can
be identified as peach coloured, film coated, oval
shaped tablets.
Content of the pack:
Dexcel Cholesterol Lowering 10mg Tablets come
in calendar packs containing 28 film coated
tablets.
Marketing Authorization Holder/Manufacturer:
Dexcel- Pharma Laboratories Limited
Ashacres House, Ashacres Industrial Part,
Draycott in the Clay, Ashbourne,
Derbyshire, DE6 5GX, UK
This leaflet was last revised in July 2014.

+ 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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