SIMVASTATIN 10 MG TABLET

Active substance: SIMVASTATIN

View full screen / Print PDF » Download PDF ⇩

Transcript


• headache, dizziness, weakness, numbness or loss of
sensation in the arms and legs
• hair loss, rash, itchiness
• Muscle aches and pains, tenderness, weakness or
cramps, dark coloured urine, pale coloured stools
(see above and section 2)
• liver disease (possibly presenting as yellowing of the
eyes and/or skin)
• increase in blood levels of liver enzymes
The following side effects were reported very rarely
(less than 1 user in 10,000)
• Liver failure
• Trouble sleeping
• Poor memory
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
• Tendonitis
• Tendon problems, sometimes complicated by
rupture of the tendon
Additional possible side effects reported with some
statins:
• Sleep disturbances, including sleeplessness and
nightmares
• Memory loss
• Sexual dysfunction
• 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.
Laboratory Values
Elevations in some laboratory blood tests of liver
function and a muscle enzyme (creatine kinase) have
been observed.
If any of the side effects gets serious, of if you notice
any side effects not listed in this leaflet, please tell your
doctor or pharmacists

6 Contents of the pack and other

information

What Simvastatin contains:

The active substance is: Simvastatin, 10mg, 20mg or
40mg The other ingredients are:
Tablet core: Lactose monohydrate, microcrystalline
cellulose (E460), Starch (maize) pregelatinised 1500
butylhydroxyanisole (E320), ascorbic acid (E300), Citric
acid, anhydrous (E330), silica, colloidal anhydrous
(E551), talc (E553b), magnesium stearate (E470b).
Film-coating: Hypromellose (E464), iron oxide, red
(E172), iron oxide, yellow (E172), triethylcitrate (E1505),
titanium dioxide (E171), talc (E553b), povidone K-30.

Simvastatin 10mg,
20mg and 40mg 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.
Do not pass it on to others. It may harm them,
even if their symptoms 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.

What Simvastatin looks like and contents of
pack

Simvastatin 10mg is a peach-coloured, oval, biconvex,
film-coated tablet, scored on one side; The tablets can
be divided into equal halves along the score line.
Simvastatin 20mg is a tan-coloured, oval, biconvex,
film-coated tablet, scored on one side; The tablets can
be divided into equal halves along the score line.
Simvastatin 40mg is a brick red-coloured, oval,
biconvex, film-coated tablet, scored on one side; The
tablets can be divided into equal halves along the
score line.
The tablets are packed in blisters in a carton box,
containing 28 tablets.

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

In this leaflet:
1 What Simvastatin is and what it is used
for.
2 What you need to know before you take
Simvastatin.
3 How to take Simvastatin.
4 Possible side effects.
5 How to store Simvastatin.
6 Contents of the pack and other
information.

Marketing Authorisation Holder and Manufacturer
Actavis Group PTC ehf.
Reykjavíkurvegur 76-78
220 Hafnarfjörður
Iceland
Manufacturer
Actavis UK Ltd
Barnstaple
EX32 8NS
UK

1 What Simvastatin is and what it is used

for

Simvastatin belongs to a group of medicines known
as statins. These work by reducing the amount of total
cholesterol, ‘bad’ cholesterol (LDL cholesterol), and
certain fatty substances called triglycerides in your
blood. In addition, simvastatin raises levels of ‘good’
cholesterol (HDL cholesterol). You should stay on a
cholesterol-lowering diet while taking this medicine.

This leaflet was last revised in: March 2013

5 How to store Simvastatin?

Simvastatin is used:

Keep this medicine out of the reach and sight of
children.
Store the tablets in the original package, in order to
protect from light and moisture. Do not store above
30°C.
Do not use the tablets after the expiry date which is
stated after ¨do not use after¨ or ¨exp¨. date stated
on the packaging. The wording ¨exp¨ means: ”expiry
date”. The first 2 digits denote the month, the last
digits the year.
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 to protect
the environment.

• to lower cholesterol and triglycerides in the blood
when a low fat diet and other measures (such
as exercise, weight loss) have failed (primary
hypercholesterolaemia or mixed hyperlipidaemia).
• to lower inherited high levels of cholesterol in your
blood (homozygous familial hypercholesterolemia),
together with dieting and other treatments (e.g.
LDL-apheresis), or when such treatments are not
appropriate.
• to reduce the risk of coronary heart disease if you
have hardening of the arteries (arteriosclerosis) or
diabetes, even if your cholesterol levels are normal,
together with dieting and other treatments.

AAAE3475 50693167

Simvastatin

Do not take Simvastatin:

• if you are allergic (hypersensitive) to simvastatin or
to any of the other ingredients this medicine (listed
in section 6).
• if you currently have liver problems or a continuous
high level of certain liver enzymes (serum
transaminases)
• if you are pregnant or breast-feeding
• if you are taking one or more of the following
medicines at the same time:
- ketoconazole, itraconazole or posaconazole
(medicines for fungal infections)
- HIV-protease inhibitors, such as indinavir, nelfinavir,
ritonavir and saquinavir (medicines used for HIV
infections)
- erythromycin, clarithromycin or telithromycin
(antibiotics for infections)
- nefazodone (an antidepressant)
- gemofibrozil (a medicine for lowering cholesterol)
- ciclosporin (a medicine often used in organ
transplant patients)
- danazol (a man-made hormone used to treat
endometriosis)

Take special care with Simvastatin:

• Tell your doctor about all your medical conditions
including allergies.
• Tell your doctor if you drink large amounts of alcohol.
• Tell your doctor if you have ever had liver disease.
Simvastatin may not be right for you.
• Tell your doctor if you are due to have an operation.
You may need to stop taking Simvastatin tablets for
a short time.
• Your doctor should do a blood test before you start
taking Simvastatin. 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.
• Tell your doctor if you have severe lung disease.
Contact your doctor immediately if you experience
unexplained muscle pain, sensitivity to pressure or
muscle weakness. This is because on rare occasions,

AAAE3475 50693167

page 4



page 1

Simvastatin 10mg, 20mg & 40mg 28 Tablets PIL - UK

colours/plates:
1.

296x210 reel fed

item no: AAAE3475 50693167

dimensions:

print proof no: 5

pharmacode: 7967

origination date: 24.09.12

min pt size: 8pts

originated by: sa
approved for print/date

2.
3.
4.
5.

M.cort (BST Technical)

6.
Non Printing Colours

revision date: 21.03.13

Technical Approval

revised by: SA

date sent:

21/09/12

supplier: Actavis UK

technically app. date:

21/09/12

1.
2.
3.



muscle problems can be serious, including muscle
breakdown resulting in kidney damage; and very rare
deaths have occurred.
You may have a greater risk of muscle breakdown at
higher doses of simvastatin, particularly the 80mg
dose. The risk of muscle breakdown is also greater
in certain patients. Talk with your doctor if any of the
following applies to you:
• you are more than 65 years old
• you have kidney problems
• you have thyroid problems
• you or close family members have a hereditary
muscle disorder
• you are female
• you have ever had muscle problems during
treatment with cholesterol-lowering medicines
called ‘statins’ or fibrates
• if you consume large amounts of alcohol
Consult your doctor if any of the above applies to you
or has applied to you in the past.

Using other medicines

Please note that the following statements may also
apply to products you took some time ago or may take at
some time in the future.
It is particulary important to tell your doctor if you are
taking any of the following drugs. The risk of muscle
problems can be greater if simvastatin is taken with
the following medicines: (some of these have already
been listed in the above section “Do not take the
Simvastatin”)
• Fibrates (other cholesterol-lowering medicines, such
as gemfibrozil, bezafibrate)
• Ciclosporin (drug used to suppress the immune
system)
• Medicines like itraconazole, ketoconazole,
fluconazole, posaconazole (antifungals)
• Erythromycin, clarithromycin and telithromycin
(antibiotics)
• Certain medicines for the treatment of HIV infections
(HIV protease inhibitors such as indinavir, nelfinavir,
ritonavir and saquinavir)
• Danazol (medicine used to treat endometriosis and
breast cysts in women)
• Nefazodone (medicine for depression)
• Amiodarone, a medicine used for irregular heart beat
• Verapamil, diltiazem or amlodipine (medicine used
to treat high blood pressure, chest pain associated
with heart disease, or other heart conditions).
• Fusidic acid as a tablet or infusion (a medicine used
to treat bacterial infections)
• Colchicine (a medicine to treat gout)
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.
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, you should also tell your doctor if you
take
• medicines that prevent blood clots (anticoagulants,
such as acenocoumarol and warfarin). Simvastatin
may increase the effect of these medicines.
• Fenofibrate (another medicine for lowering
cholesterol)
• Niacin (another medicine for lowering cholesterol)
• Rifampicin (antibiotic used to treat tuberculosis)

If you forget to take Simvastatin:

3 How to take Simvastatin?

If you realise you have forgotten to take a dose soon
after its due time, take it as soon as possible. However,
if it is almost time to take the next dose, omit the
forgotten dose and take the next one when it is due.
Ask your doctor or pharmacist in case of doubt.
Do not take a double dose to make up for a forgotten
tablet.

Always take your tablets exactly as your doctor has
instructed you. You should check with your doctor
or pharmacist if you are unsure. You should stay on a
cholesterol lowering diet while taking Simvastatin.
The dose is 1 Simvastatin 5mg, 10mg, 20mg 40mg or
80mg tablet by mouth once a day in the evening.

If you stop taking Simvastatin:

The 80mg dose is only recommended in adult
patients with very high cholesterol levels and at high
risk of heart disease problems who have not reached
their cholesterol goal on lower doses.

Also tell your doctor if you are taking niacin (nicotinic
acid) or a niacin-containing product and are Chinese.
You should also tell any doctor who is prescribing a
new medicine for you that you are taking Simvastatin.

If you suddenly stop taking this medicine, your
cholesterol may rise again. It is therefore important
that you consult a doctor before stopping treatment,
even if you suffer from physical complaints. He/she
can tell you if you can stop and the best way to do so.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

Your doctor will determine the appropriate tablet
strength for you, depending on your condition, your
current treatment and your personal risk status.

Please inform your doctor or pharmacist if you are
taking, or have recently taken any other medicines,
including medicines obtained without a prescription.

Take Simvastatin in the evening. You can take it with
or without food. 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 a
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. Keep taking Simvastatin
unless your doctor tells you to stop.

Taking Simvastatin with food and drink:

Grapefruit juice contains one or more components
which may increase the amount of simvastatin in the
blood. Therefore, you should not drink grapefruit juice
as it could increase the risk of muscle damage.

Pregnancy and breast-feeding

Do not take simvastatin if you are pregnant, trying
to become pregnant or suspect you may be
pregnant, as the safety in pregnant women has not
been established. If you become pregnant while
using simvastatin, you must stop taking the tablets
immediately and contact your doctor.
No data on the excretion of simvastatin in breast milk
are available. Because many medicinal products are
excreted in human milk and because of the potential
for serious side effects, you must not breast-feed your
infant while taking simvastatin.

4 Possible side effects

If your doctor has prescribed a bile acid sequestrant
(another medicine for lowering cholesterol such as
colestyramine) along with simvastatin you should
take simvastatin at least two hours before or four
hours after taking the bile acid sequestrant.

Children and adolescents (10-17 years of
age)

Ask your doctor or pharmacist for advice before taking
any medicine.

For children (10 -17 years old) with a hereditary
illness called familial hypercholesterolaemia, the
recommended usual starting dose is 10mg a day in
the evening. The maximum recommended dose is
40mg a day.

Children

Elderly patients

Safety and effectiveness have been studied in 1017 year old boys and in girls who had started their
menstrual period at least one year before (see 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.

The dose of simvastatin does not need to be changed
for elderly patients.

Instructions for use

Simvastatin tablets should be taken with water.
Take the tablets either on an empty stomach or after
a meal.

Driving and using machines:

Simvastatin is not expected to interfere with your
ability to drive or use machines.
However, there have been rare cases of dizziness
reported in patients taking simvastatin tablets (see
section 4). Do not drive vehicles or operate machines
that require attention if you experience this sideeffect.

Duration of treatment:

You will have to take simvastatin over a long period
of time. Your doctor will tell you how long you need
to take simvastatin. If you have the impression that the
effect of simvastatin is too strong or too weak, talk to
your doctor or pharmacist.

If you take more Simvastatin than you
should:

Important information about some of the
ingredients of Simvastatin:

If you take too many tablets by mistake, contact a
doctor or pharmacist immediately.

Amongst other ingredients, Simvastatin tablets
contain lactose monohydrate. If your doctor has
informed you that you cannot tolerate certain sugars,
contact your doctor before taking this medicine.

page 2

Like all medicines, Simvastatin can have side effects,
although not everybody will have them.
For the most part side effects have been mild and
short lived.
If any of the following serious side effects happen,
stop taking the medicine and tell your doctor
immediately or go to the emergency room at your
nearest hospital:
• muscle aches and pains, tenderness, weakness or
cramps. This is because on rare occasions, muscle
damage can be serious, including muscle breakdown
resulting in kidney damage and very rare deaths
have occured (see section 2 “Take special care with
Simvastatin”).
• 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
- inflammation of the blood vessels
- unusual bruising, skin eruptions and swelling, hives,
skin sensitivity to the sun, fever, flushing
- shortness of breath and feeling unwell
- lupus-like disease picture (including rash, joint
disorders, and effects on blood cells)
• inflammation of the liver with yellowing of the
skin and eyes, itching, dark-coloured urine or palecoloured stool, liver failure (very rare)
• inflammation of the pancreas often with severe
abdominal pain.
The following side effects were reported rarely
(1 to 10 users in 10,000):
• low red blood cells (anaemia)
• stomach upsets (such as sickness, constipation,
abdominal pain, flatulence, nausea, indigestion,
diarrhoea, vomiting, abdominal pain)
• inflammation of the pancreas (severe abdominal
pain radiating to the back, nausea and vomiting)



page 3

Simvastatin 10mg, 20mg & 40mg 28 Tablets PIL - UK

colours/plates:
1.

296x210 reel fed

item no: AAAE3475 50693167

dimensions:

print proof no: 5

pharmacode: 7967

origination date: 24.09.12

min pt size: 8pts

originated by: sa
approved for print/date

2.
3.
4.
5.

M.cort (BST Technical)

6.
Non Printing Colours

revision date: 21.03.13

Technical Approval

revised by: SA

date sent:

21/09/12

supplier: Actavis UK

technically app. date:

21/09/12

1.
2.
3.

Expand view ⇕

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.

Hide
(web5)