PACKAGE LEAFLET: INFORMATION FOR THE USER
Simvastatin Morningside 10 mg, film-coated tablet
Simvastatin Morningside 20 mg, film-coated tablet
Simvastatin Morningside 40 mg, film-coated tablet
Simvastatin Morningside 80 mg, film-coated tablet
Simvastatin
Read all of this leaflet carefully before you start taking this medicine.
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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 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:
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6.
What Simvastatin Morningside is and what it is used for
Before you take Simvastatin Morningside
How to take Simvastatin Morningside
Possible side effects
How to store Simvastatin Morningside
Further information
1. WHAT SIMVASTATIN MORNINGSIDE IS AND WHAT IT IS USED FOR
Simvastatin Morningside belongs to a group of medicines called statins. These medicines
inhibit the production of cholesterol in the liver and lower the cholesterol and fat content
in the blood. Cholesterol is vital to the normal functioning of the body, but if the levels of
cholesterol in the bloodstream are too high it can be deposited on the walls of the blood
vessels. There it builds up to form plaque, which can eventually block the blood vessel.
Simvastatin Morningside is used in:
o Patients with too high levels of cholesterol in their blood (hypercholesterolaemia),
when the combination of diet, physical exercise and weight loss has not lowered
the cholesterol level adequately.
o Patients with existing heart problems (arterosclerotic cardiovascular disease) or
diabetes, to lower a normal or raised cholesterol level and thereby reduce the risk
of complications.
2. BEFORE YOU TAKE SIMVASTATIN MORNINGSIDE
Children
Safety and effectiveness have been studied in 10-17 year old boys and in girls
who had started their menstrual period at least one year before (see HOW TO
TAKE SIMVASTATIN MORNINGSIDE).Simvastatin Morningside has not been
studied in children under the age of 10 years. For more information, talk to your
doctor.
Do not take Simvastatin Morningside
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If you are allergic (hypersensitive) to simvastatin or to any of the other
ingredients of Simvastatin Morningside;
If you are pregnant or breast-feeding (see section 2);
If you have liver disease;
If you are taking the antifungal agents called itraconazole or ketoconazole,
fluconazole, posaconazole;
If you are taking the antibiotics called erythromycin, clarithromycin or
telithromycin;
If you are taking the antidepressant called nefazodone;
If you are taking medicines for the treatment of HIV infections (HIV protease
inhibitors) such as indinavir, nelfinavir, ritonavir or saquinavir.
Take special care with Simvastatin Morningside
Check with your doctor or pharmacist before taking Simvastatin Morningside if you:
 Have severe respiratory failure
Simvastatin Morningside can occasionally cause muscle problems manifested as muscle
pain, tenderness or weakness. The risk of muscle problems is greater at higher doses of
Simvastatin Morningside and in certain groups of patients.
Tell your doctor:
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If you are over 70 years of age;
If you have kidney problems;
If you have thyroid problems;
If you have ever had muscle problems during treatment with simvastatin or other
statins (such as fluvastatin, atorvastatin, pravastatin or rosuvastatin), or
cholesterol-lowering medicines called fibrates (such as gemfibrozil, bezafibrate);
If you or close family members have a hereditary muscle disorder;
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If you consume substantial quantities of alcohol or if you have liver problems or a
continuous high level of certain liver enzymes (serum transaminases)
If you are going to hospital for an operation, tell the doctor that you are taking
simvastatin.
Tell your doctor immediately if you experience unexplained muscle pain, tenderness
or weakness. This is because on rare occasions, there is a risk of muscle problems which
may be serious, including muscle breakdown which can result in kidney damage. The
doctor may perform a blood test to check the condition of your muscles before and after
starting treatment.
This medicine contains lactose. If you have been told by your doctor that you have
intolerance to some sugars, contact your doctor before taking this medicinal product.
Taking other medicines
Simvastatin tablets may occasionally interfere with other medicines, so it is important
that you tell your doctor about all the medicines you are taking, including those obtained
without a doctor's prescription. These are;
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Medicines for thinning the blood, e.g. warfarin
Two other kinds of lipid lowering agents; fibric acid derivatives (e.g.
benzafibrate, fenofibrate, gemfibrozil) and large doses of niacin or nicotinic acid
Immunosuppressant medicines e.g. ciclosporin
An antifungal medicine called itraconazole, ketoconazole, fluconazole,
posaconazole
An antibiotic medicine containing erythromycin, clarithromycin, telithromycin,
fusidic acid, rifampicin
An antidepressant medicine nefazodone
Drugs such as indinavir, nelfinavir, ritonavir or saquinavir (HIV protease
inhibitor) for the treatment of HIV infections.
Medicines against heart rhythm disturbances and/or high blood pressure
(containing amiodarone, verapamil, amlodipine or diltiazem).
Drugs such as danazol used in the treatment of endometriosis, colchicine used in
the treatment of gout
If you are taking these medicines you should talk to your doctor before taking simvastatin
tablets.
Taking Simvastatin Morningside with food and drink
Do not drink grapefruit juice when you are taking Simvastatin Morningside. Grapefruit
juice increases the effects of this medicine, which may lead to side effects.
Pregnancy and breast-feeding
Ask your doctor or pharmacist before taking any medicine.
Simvastatin should not be used during pregnancy. Simvastatin may only be used by
women of childbearing age, if pregnancy has been excluded. If you wish to become
pregnant or suspect that you may be pregnant, you should immediately stop using
simvastatin and consult your doctor.
It is not known whether simvastatin passes into breast milk. Therefore, you should not
use this medicine if you are breast-feeding.
Driving and using machines
Simvastatin Morningside has no or negligible influence on the ability to drive and use
machines. However, simvastatin may cause dizziness in rare cases.
Important information about some of the ingredients of Simvastatin Morningside
Simvastatin Morningside contains lactose. If you have intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. HOW TO TAKE SIMVASTATIN MORNINGSIDE
Always take Simvastatin Morningside exactly as your doctor has told you. You should
check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking Simvastatin Morningside.
The dose is 1 Simvastatin Morningside 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg tablet by
mouth once a day.
For children (10-17 years old), the recommended usual starting dose is 10 mg a day in the
evening. The maximum recommended dose is 40 mg a day.
The 80 mg dose is only recommended in for adult patients with very high cholesterol
levels and at high risk of heart disease problems.
Keep taking the tablets as long as your doctor has asked you to.
If you take more Simvastatin Morningside than you should
It is important to stick to the dose on the label of the medicine. If you or someone else
swallows several of these tablets all together, contact your doctor, pharmacist or hospital
emergency department immediately. Always take any tablets left over with you and also
the box, as this will allow easier identification of the tablets.
If you forget to take Simvastatin Morningside
If you miss a dose, just carry on with the next one as normal. Do not take a double dose
to make up for a forgotten dose.
If you stop taking Simvastatin Morningside
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 Morningside can cause side effects, although not
everybody gets them.
The following side effects were reported rarely (affects 1 to 10 users in 10,000):
Stomach upsets (such as sickness, constipation, diarrhoea, flatulence, indigestion and
abdominal pain), anemia, weakness, headache, dizziness, numbness or loss of sensation
in the arms and legs, hair loss, rash, itchiness, liver disease (possibly presenting as
yellowing of the eyes and/or skin, itchiness of the skin, dark coloured urine, pale
coloured stools), muscle pain, tenderness or weakness.
Uncommon (affects 1 to 10 users in 1,000)
 Sleep disturbances, including insomnia and nightmares
 Memory loss
 Sexual difficulties
 Depression
Contact your doctor promptly if you experience unexplained muscle pain, tenderness,
weakness or cramps.
In rare cases Simvastatin Morningside can cause an allergic reaction. The allergic
reaction may include some of the following: swelling of the face, tongue or throat, joint
pains, joint and blood vessel inflammation, skin eruptions, swelling, hives, skin
sensitivity to the sun, fever, flushing, difficulty in breathing, or tiredness. Stop taking
Simvastatin Morningside and contact your doctor immediately, if you experience
swelling of the face, tongue and/or throat and/or difficulties in swallowing, or if hives and
breathing difficulties occur.
In very rare cases (affects less than 1 user in 10,000) breathing problems including
persistent cough and/ or shortness of breath or fever or effect on some blood tests such as
elevated serum transaminase, elevated alkaline phosphatase, elevated creatinine kinase
levels may occur.
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.
5. HOW TO STORE SIMVASTATIN MORNINGSIDE
Keep out of the reach and sight of children.
Do not use Simvastatin Morningside after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
There are no special storage precautions for Simvastatin Morningside.
Medicines should not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Simvastatin Morningside tablet contains
The active substance is Simvastatin.
The other ingredients are lactose anhydrous, microcrystalline cellulose, pregelatinised
maize starch, butylhydroxyanisole, magnesium stearate and talc. The film coat contains
hydroxypropylcellulose, hypromellose, talc and titanium dioxide (E171).
What Simvastatin Morningside tablets looks like and contents of the pack
White, oblong, biconvex film-coated tablets scored on one side, embossed with “10”,
“20”, “40” or “80” on the scored side and with “SVT” on the opposite side.
Pack size: Blister packs of 7, 10, 14, 15, 28, 30, 50, 56, 60, 98 and 100 tablets
Not all pack sizes may be marketed
Marketing Authorisation Holder
Morningside Healthcare Ltd
115 Narborough Road,
Leicester, LE3 0PA
United Kingdom
Manufacturer
Morningside Pharmaceuticals Limited
5 Pavillion Way, Loughborough, UK.
This leaflet was last approved in 2010-10-13