Uncommon

5. How to store Simvastatin Tablets

PACKAGE LEAFLET: INFORMATION FOR THE USER

• Sleep disturbances, including

Simvastatin 10 mg film-coated tablets

insomnia and nightmares

Keep this medicine out of the sight and

Simvastatin 20 mg film-coated tablets

• Memory loss

reach of children.

Simvastatin 40 mg film-coated tablets

• Sexual difficulties

Simvastatin 80 mg film-coated tablets

• Depression

Do not use Simvastatin Tablets after the

Simvastatin

expiry date which is stated on the carton

Side effects of unknown frequency

after EXP. The expiry date refers to the

Read all of this leaflet carefully

blood vessels. There it builds up

• Muscle weakness that is constant.

last day of that month.

before you start taking this

to form plaque, which can

medicine because it contains

eventually block the blood vessel.

Contact your doctor promptly if you

There are no special storage precautions

important information for you.

experience unexplained muscle pain,

for Simvastatin Tablets.

•

Keep this leaflet. You may

Simvastatin Tablets are used in:

tenderness, weakness or cramps.

need to read it again.

• Patients with too high a level

Do not throw away any medicines via

•

If you have any further

of cholesterol in their blood

In rare cases Simvastatin Tablets can

wastewater or household waste. Ask your

questions, ask your doctor or

(hypercholesterolaemia),

cause an allergic reaction. The allergic

pharmacist how to throw away any

pharmacist.

when the combination of diet,

reaction may include some of the

medicines you no longer use. These

•

This medicine has been

physical exercise and weight

following: swelling of the face, tongue or

measures will help to protect the

prescribed for you only. Do

loss has not lowered the

throat,joint pains,joint and blood vessel

environment.

not pass it on to others. It

cholesterol level adequately.

inflammation, skin eruptions, swelling,

may harm them, even if their

• Patients with existing heart

hives, skin sensitivity to the sun, fever,

6. Contents of the pack and other

signs of illness are the same

problems (arterosclerotic

flushing, difficulty in breathing, or

information

as yours.

cardiovascular disease) or

tiredness. Stop taking Simvastatin

•

If you get any side effects,

diabetes, to lower a normal or

Tablets and contact your doctor

What Simvastatin Tablets contains

talk to your doctor or

raised cholesterol level and

immediately, if you experience swelling

The active substance is Simvastatin.

pharmacist.

thereby reduce the risk of

of the face, tongue and/or throat and/or

The other ingredients are lactose

This includes

complications.

difficulties in swallowing, or ifhives and

anhydrous, microcrystalline cellulose,

■ ■ any possible

breathing difficulties occur.

pregelatinised maize starch,

— — side effects not

2. What you need to know

butylhydroxyanisole, magnesium

■ ■ listed in this

before you take Simvastatin

In very rare cases breathing problems

stearate and talc. The film coat contains

leaflet. See

Tablets

including persistent cough and/ or

hydroxypropylcellulose, hypromellose,

section 4.

shortness ofbreath or fever or effect on

talc and titanium dioxide (E171).

Children

some blood tests such as elevated serum

In this leaflet:

Safety and effectiveness have

transaminase, elevated alkaline

What Simvastatin Tablets look like

1.

What Simvastatin Tablets are

been studied inlO-17 year old

phosphatase, elevated creatinine kinase

and contents of the pack

and what they are used for

boys and in girls who had started

levels may occur.

White, oblong, biconvex film-coated

2.

What you need to know

their menstrual period at least one

tablets scored on one side, embossed

before you take Simvastatin

year before (see - How to take

Diabetes

with “10”, “20”, “40” or “80” on the

Tablets

Simvastatin Tablets).

This is more likely if you have high

scored side and with “SVT” on the

3.

How to take Simvastatin

Simvastatin has not been studied

levels of sugars and fats in your blood,

opposite side.

Tablets

in children under the age oflO

are overweight and have high blood

4.

Possible side effects

years. For more information, talk

pressure. Your doctor will monitor you

Pack size: Blisterpacks of7, 10, 14, 15,

5.

How to store Simvastatin

to your doctor.

while you are taking this medicine.

28, 30, 50, 56, 60, 98 and 100 tablets.

Tablets

6.

Contents of the pack and

Do not take Simvastatin Tablets

Reporting of side effects

Not all pack sizes may be marketed.

other information

• If you are allergic to

If you get any side effects, talk to your

simvastatin or any of the

doctor or pharmacist. This includes any

Marketing Authorisation Holder

1.

What Simvastatin Tablets

other ingredients of this

possible side effects not listed in this

Momingside Healthcare Ltd

are and what they are used

medicine (listed in section 6);

leaflet. You can also report side effects

115 Narborough Road, Leicester,

for

• If you are pregnant or breast-

directly via the Yellow Card Scheme at:

LE3 0PA, UK

feeding (see section 2);

www.mhra.eov.uk/vellowcard. Bv

Simvastatin Tablets belong to a

• If you have liver disease;

reporting side effects you can help

Manufacturer

group of medicines called statins.

• If you are taking the

provide more information on the safety

Momingside Pharmaceuticals Limited

These medicines inhibit the

antifungal agents called

of this medicine.

5 Pavillion Way, Loughborough,

production of cholesterol in the

itraconazole or ketoconazole,

LEU 5GW,UK

liver and lower the cholesterol

fluconazole, posaconazole;

and fat content in the blood.

• If you are taking the

This leaflet was last revised in March

Cholesterol is vital to the normal

antibiotics called

2015.

functioning of the body, but if the

erythromycin, clarithromycin

levels of cholesterol in the

or telithromycin;

bloodstream are too high it can

• If you are taking the

be deposited on the walls of the

antidepressant called

nefazodone;

• If you are taking medicines

breakdown which can result in

• Medicines against heart rhythm

The dose is one 5mg, 10mg, 20mg, 40mg

for the treatment of HIV

kidney damage. The doctor may

disturbances and/or high blood

or 80mg Simvastatin Tablet by mouth

infections (HIV protease

perform a blood test to check the

pressure (containing amiodarone,

once a day.

inhibitors) such as indinavir,

condition of your muscles before

verapamil, amlodipine or diltiazem).

For children (10-17 years old), the

nelfinavir, ritonavir or

and after starting treatment.

• Drugs such as danazol used in the

recommended usual starting dose is 10

saquinavir.

treatment of endometriosis,

mg a day in the evening. The maximum

Also tell your doctor or

colchicine used in the treatment of

recommended dose is 40 mg a day.

Warnings and precautions

pharmacist if you have a muscle

gout.

Check with your doctor or

weakness that is constant.

The 80 mg dose is only recommended in

pharmacist before taking

Additional tests and medicines

If you are taking these medicines you

for adult patients with very high

Simvastatin Tablets if you:

may be needed to diagnose and

should talk to your doctor before taking

cholesterol levels and at high risk of

• Have severe respiratory

treat this.

simvastatin tablets.

heart disease problems.

failure.

While you are on this medicine

Simvastatin Tablets with food and

Keep taking the tablets as long as your

Simvastatin Tablets can

your doctor will monitor you

drink

doctor has asked you to.

occasionally cause muscle

closely if you have diabetes or

Do not drink grapefruitjuice when you

problems manifested as muscle

are at risk of developing diabetes.

are taking Simvastatin Tablets.

If you take more Simvastatin Tablets

pain, tenderness or weakness.

You are likely to be at risk of

Grapefruitjuice increases the effects of

than you should

The risk of muscle problems is

developing diabetes if you have

this medicine, which may lead to side

It is important to stick to the dose on the

greater at higher doses of

high levels of sugars and fats in

effects.

label of the medicine. If you or someone

Simvastatin Tablets and in certain

your blood, are overweight and

else swallows several of these tablets all

groups ofpatients.

have high blood pressure.

Pregnancy and breast-feeding

together, contact your doctor, pharmacist

Ask your doctor or pharmacist before

or hospital emergency

Tell your doctor:

Other medicines and

taking any medicine.

department immediately.

• If you are over 70 years of

Simvastatin Tablets

Always take any tablets left

age;

Simvastatin tablets may

Simvastatin should not be used during

over with you and also the ■ ■

• If you have kidney problems;

occasionally interfere with other

pregnancy. Simvastatin may only be used

box, as this will allow easier

• If you have thyroid problems;

medicines, so it is important that

by women of childbearing age, if

identificationofthetablets. — —

• If you have ever had muscle

you tell your doctor about all the

pregnancy has been excluded. If you

■ ■

problems during treatment

medicines you are taking,

wish to become pregnant or suspect that

If you forget to take

with simvastatin or other

including those obtained without

you may be pregnant, you should

Simvastatin Tablets

statins (such as fluvastatin,

a doctor's prescription. These are;

immediately stop using simvastatin and

If you miss a dose,just carry on with the

atorvastatin, pravastatin or

• Medicines for thinning the

consult your doctor.

next one as normal. Do not take a double

rosuvastatin), or cholesterol-

blood, e.g. warfarin.

dose to make up for a forgotten dose.

lowering medicines called

• Two other kinds of lipid

It is not known whether simvastatin

fibrates (such as gemfibrozil,

lowering agents; fibric acid

passes into breast milk. Therefore, you

If you stop taking Simvastatin Tablets

bezafibrate);

derivatives (e.g.

should not use this medicine if you are

If you have any further questions on the

• If you or close family

benzafibrate, fenofibrate,

breast-feeding.

use of this product, ask your doctor or

members have a hereditary

gemfibrozil) and large doses

pharmacist.

muscle disorder;

of niacin or nicotinic acid.

Driving and using machines

• If you consume substantial

• Immunosuppressant

Simvastatin Tablets have no or negligible

4. Possible side effects

quantities of alcohol or if you

medicines e.g. ciclosporin.

influence on the ability to drive and use

have liver problems or a

• An antifungal medicine

machines. However, simvastatin may

Like all medicines, this medicine can

continuous high level of

called itraconazole,

cause dizziness in rare cases.

cause side effects, although not

certain liver enzymes (serum

ketoconazole, fluconazole,

everybody gets them.

transaminases).

posaconazole.

Simvastatin Tablets contains lactose

• An antibiotic medicine

If you have intolerance to some sugars,

The following side effects were reported

If you are going to hospital for an

containing erythromycin,

contact your doctor before taking this

rarely (in less than 1 person out of 1000):

operation, tell the doctor that you

clarithromycin,

medicinal product.

Stomach upsets (such as sickness,

are taking simvastatin.

telithromycin, fusidic acid,

constipation, diarrhoea, flatulence,

rifampicin.

3. How to take Simvastatin Tablets

indigestion and abdominal pain),

Tell your doctor immediately if

• An antidepressant medicine

anaemia, weakness, headache, dizziness,

you experience unexplained

nefazodone.

Always take Simvastatin Tablets exactly

numbness or loss of sensation in the

muscle pain, tenderness or

• Drugs such as indinavir,

as your doctor has told you. You should

arms and legs, hair loss, rash, itchiness,

weakness. This is because on

nelfinavir, ritonavir or

check with your doctor or pharmacist if

liver disease (possibly presenting as

rare occasions, there is a risk of

saquinavir (HIV protease

you are not sure.

yellowing of the eyes and/or skin,

muscle problems which may be

inhibitor) for the treatment of

You should stay on a cholesterol-

itchiness of the skin, dark coloured urine,

serious, including muscle

HIV infections.

lowering diet while taking Simvastatin

pale coloured stools), muscle pain,

Tablets.

tenderness or weakness.