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DEXACHOL 10MG TABLETS

Active substance(s): SIMVASTATIN

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Package leaflet: Information for the patient

SIMVASTATIN 10 mg, 20 mg and 40 mg TABLETS
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 Simvastatin Tablets are and what they are used for
2. What you need to know before you take Simvastatin Tablets
3. How to take Simvastatin Tablets
4. Possible side effects
5. How to store Simvastatin Tablets
6. Contents of the pack and other information
1. What Simvastatin Tablets are and what they are used for
Simvastatin Tablets are used to lower levels of total cholesterol, “bad”
cholesterol (LDL cholesterol), and fatty substances called
triglycerides in the blood. In addition, Simvastatin Tablets raise
levels of “good” cholesterol (HDL cholesterol). You should stay on a
cholesterol-lowering diet while taking this medicine. Simvastatin is
a member of the class of drugs called statins.
Cholesterol is one of several fatty substances found in the
bloodstream. Your total cholesterol is made up mainly of LDL and
HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can
build up in the walls of your arteries forming plaque. Eventually
this plaque build-up can lead to a narrowing of the arteries. This
narrowing can slow or block blood flow to vital organs such as the
heart and brain. This blocking of blood flow can result in a heart
attack or stroke.
HDL cholesterol is often called ”good” cholesterol because it helps
keep the bad cholesterol from building up in the arteries and
protects against heart disease.
Triglycerides are another form of fat in your blood that may increase
your risk for heart disease.
You should stay on a cholesterol-lowering diet while taking this medicine.
Simvastatin Tablets are used in addition to your cholesterol-lowering diet
if you have:
• a raised cholesterol level in your blood (primary hypercholesterolaemia)
or elevated fat levels in your blood (mixed hyperlipidaemia)
• a hereditary illness (homozygous familial hypercholesterolaemia) that
increases the cholesterol level in your blood. You may also receive other
treatments.
• coronary heart disease (CHD) or at high risk of CHD (because you have
diabetes, history of stroke, or other blood vessel disease).
Simvastatin Tablets may prolong your life by reducing the risk of heart
disease and blood vessels problems, regardless of the amount of
cholesterol in your blood.
In most people, there are no immediate symptoms of high cholesterol.
Your doctor can measure your cholesterol with a simple blood test. Visit
your doctor regularly, keep track of your cholesterol, and discuss your
goals with your doctor.
2. What you need to know before you take Simvastatin Tablets
Do not take Simvastatin Tablets:
• If you are allergic (hypersensitive) to simvastatin, to similar medicines
or to any of the other ingredients of Simvastatin Tablets (see section 6
"Contents of the pack and other information");
• If you currently have liver problems;
• If you are pregnant, plan to become pregnant or are breastfeeding;
• If you are taking medicine(s) with one or more than one of the following
active ingredients:
-itraconazole, ketoconazole, posaconazole or voriconazole (used to treat
fungal infections)
-erythromycin, clarithromycin or telithromycin (used to treat infections);
-HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and
saquinavir (HIV protease inhibitors are used for HIV infections)
-boceprevir or telaprevir (used to treat hepatitis C virus infection)
-nefazodone (used to treat depression)
-cobicistat
-gemfibrozil (used to lower cholesterol)
-ciclosporin (used in organ transplant patients)
-danazol (a man-made hormone used to treat endometriosis, a condition
in which the lining of the uterus grows outside the uterus)
Do not take more than 40 mg Simvastatin if you are taking lomitapide
(used to treat a serious and rare genetic cholesterol condition)
If you think any of these apply to you, do not take the tablets, go and talk
to your doctor first and follow the advice given.
Warnings and precautions:
Talk to your doctor, pharmacist or nurse before taking Simvastatin
Tablets:
• 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 Simvastatin Tablets can lead to serious
muscle problems (rhabdomyolysis).

• About all your medical conditions including allergies;
• If you drink large amounts of alcohol;
• If you have ever had liver disease. Simvastatin Tablets may not be right
for you;
• If you are due to have an operation. You may need to stop taking
Simvastatin Tablets for a short time.
• If you are Asian, because a different dose may be applicable to you.
Your doctor should do a blood test before you start taking Simvastatin
Tablets and if you have any symptoms or liver problems while you take
Simvastatin 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.
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.
Take your doctor if you have severe lung disease.
Contact your doctor immediately if you experience unexplained
muscle pain, tenderness or weakness. This is because on rare
occasions, muscle problems can be serious, including muscle
breakdown resulting in kidney damage; and very rare deaths
have occurred.
The risk of muscle breakdown is greater at higher doses of
Simvastatin Tablets, particularly the 80-mg dose. The risk of muscle
breakdown is also greater in certain patients. Talk with your doctor
if any of the following applies:
• You consume large amounts of alcohol;
• You have kidney problems;
• You have thyroid problems;
• You are 65 years of age or older;
• You are a female;
• You have ever had muscle problems during treatment with
cholesterol-lowering medicines called “statins” or fibrates;
• You or a close family member have a hereditary muscle disorder.
Also tell your doctor or pharmacist if you have a muscle weakness
that is constant. Additional tests and medicines may be needed to
diagnose and treat this.
Children and adolescents
Safety and effectiveness of Simvastatin have been studied in 10-17 year
old boys and in girls who had started their menstrual period (menstruation)
at least one year before (see section 3: How to take Simvastatin).
Simvastatin has not been studied in children under the age of 10 years.
For more information, talk to your doctor.
Other medicines and Simvastatin Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
It is particularly important to tell your doctor if you are taking, have recently
taken or might take any other medicine(s) with any of the following active
ingredients. Taking Simvastatin Tablets with any of the following medicines
can increase the risk of muscle problems .Some of these have already
been listed in the above section “Do not take Simvastatin Tablets”).
- 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 Simvastatin. Taking Simvastatin
with fusidic acid may rarely lead to muscle weakness, tenderness
or pain (rhabdomyolysis). See more information regarding
rhabdomyolysis in section 4.
-ciclosporin (often used in organ transplant patients)
-danazol (a man-made hormone used to treat endometriosis, a condition
in which the lining of the uterus grows outside the uterus)
-medicines with an active ingredient like itraconazole, ketoconazole,
fluconazole, posaconazole or voriconazole (used to treat fungal
infections)
-fibrates with an active ingredient like gemfibrozil and bezafibrate (used
to lower cholesterol)
-erythromycin, clarithromycin or telithromycin (used to treat bacterial
infections).
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and
saquinavir (used to treat AIDS)
- Hepatitis C antiviral agents such as boceprevir, telaprevir, elbasvir or
grazoprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
- medicines with the active ingredient cobicistat
- amiodarone (used to treat an irregular heart beat)
- verapamil, diltiazem or amlodipine (used to treat high blood pressure,
chest pain
- associated with heart disease, or other heart conditions)
- lomitapide (used to treat a serious and rare genetic cholesterol
condition)
- colchicine (used to treat gout).
As well as the medicines listed above, tell your doctor or pharmacist if you
are taking or have recently taken any other medicines, including those
obtained without a prescription. In particular, tell your doctor if you are
taking medicine(s) with any of the following active ingredients:
- medicines with an active ingredient to prevent blood clots, such as
warfarin, phenprocoumon or
- acenocoumarol (anticoagulants)

- fenofibrate (also used to lower cholesterol)
- niacin (also used to lower cholesterol)
- rifampicin (used to treat tuberculosis).
You should also tell any doctor who is prescribing a new medicine for you
that you are taking Simvastatin Tablets.
Simvastatin Tablets with food, drink and alcohol
Grapefruit juice contains one or more components that alter how the
body uses some medicinal products, including Simvastatin Tablets.
Consuming grapefruit juice should be avoided.
Alcohol can affect the action of simvastatin and your doctor should have
advised you to always keep your alcohol intake to a minimum while you
are on these tablets. If you are concerned about how much alcohol you
may drink while taking simvastatin, discuss this with your doctor.
Pregnancy and breast-feeding
Do not use Simvastatin Tablets if you are pregnant, trying to become
pregnant or think you may be pregnant.
If you become pregnant while taking Simvastatin Tablets, stop taking them
immediately and contact your doctor.
Do not take Simvastatin Tablets if you are breastfeeding, because it is not
known if the medicine is passed into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin Tablets are not expected to interfere with your ability to drive
or to use machinery. However, it should be taken into account that
some people get dizzy after taking Simvastatin Tablets.
Simvastatin contains lactose
Simvastatin Tablets contain a milk 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 Simvastatin Tablets
Your doctor will determine the appropriate tablet strength for you,
depending on your condition, your current treatment and your
personal risk status.
Always take Simvastatin Tablets exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking
Simvastatin Tablets.
Dosage:
The recommended dose is Simvastatin 10mg, 20mg, 40mg, or
80mg by mouth once a day.
Adults:
The usual starting dose is 10, 20 or, in some cases, 40mg a day. Your
doctor may adjust your dose after at least 4 weeks to a maximum of 80mg
per day. Do not take more than 80mg a day.
Your doctor may prescribe lower doses, particularly if you are taking
certain medicinal products listed above or have certain kidney conditions.
The 80mg dose is only recommended for adult patients with very high
cholesterol levels and at high risk of heart and blood vessels disease
problems who have not reached their cholesterol goal on lower doses.
Use in children and adolescents:
For children (10-17 years old), the recommended usual starting dose is
10mg a day in the evening. The maximum recommended dose is 40mg
a day.
Method and duration of administration:
Take Simvastatin Tablets in the evening. You can take it with or without
food. Keep taking Simvastatin Tablets unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Tablets along with another
medicine for lowering cholesterol containing any bile acid sequestrant,
you should take Simvastatin Tablets at least 2 hours before or 4 hours
after taking the bile-acid sequestrant.
If you take more Simvastatin Tablets than you should
Please contact your doctor or pharmacist.
If you forget to take Simvastatin Tablets
Do not take an extra dose; just take the normal amount of Simvastatin
Tablets at the usual time the next day.
If you stop taking Simvastatin Tablets
Talk to your doctor or pharmacist because your cholesterol may rise again.
If you have any further questions on the use of this product, ask your
doctor or pharmacist.
4. Possible side effects
Like all medicines, Simvastatin 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 rare 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, tenderness, weakness, or cramps. 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 (angioedema)

- 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 very rare serious side effect was reported:
• a serious allergic reaction which causes difficulty in breathing or
dizziness (anaphylaxis)
The following side effects have also been reported but the frequency
cannot be estimated from the available information (frequency not
known):
• Erectile dysfunction
• Depression
• 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).
Additional possible side effects reported with some statins:
• Sleep disturbances, including nightmares
• Sexual difficulties
• Diabetes. This is more likely if you have high levels of sugar and
fats in your blood, are overweight and have high blood pressure. Your
doctor will monitor you while you are taking this medicine.
• Muscle pain, tenderness, or weakness that is constant that may not go
away after stopping Simvastatin (frequency not known).
Laboratory values
Elevations in some laboratory blood tests of liver function and a muscle
enzyme (creatine kinase) have been observed.
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. You can also report
side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/
yellowcard or search for MHRA Yellow Card in the Google Play or Apple
App Store
By reporting side effects, you can help provide more information on the
safety of this medicine.
5. How to store Simvastatin Tablets
Keep this medicine out of the sight and reach of children.
Do not use Simvastatin Tablets after the expiry date which is stated on
the label.
Do not store above 25oC. Store in the original package.
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. Content of the pack and other information
What Simvastatin Tablets contain
Simvastatin 10, 20 & 40mg Film-coated Tablets contain the active
substance simvastatin 10mg, 20mg or 40mg.
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 Simvastatin Tablets look like and contents of the pack
Simvastatin 10mg Tablets are peach coloured, film coated, oval shaped
tablets.
Simvastatin 20mg Tablets are tan coloured, film coated, oval shaped
tablets.
Simvastatin 40mg Tablets are salmon-pink coloured, film coated, oval
shaped tablets.
Simvastatin Tablets are available in calendar packs containing 28 tablets
in a carton.
Marketing Authorization Holder and Manufacturer
Dexcel® Pharma Ltd.,7 Sopwith Way, Drayton Fields, Daventry,
Northamptonshire, NN11 8PB, United Kingdom.
This leaflet was last revised in February 2018.
V-1421

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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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