Document: Simvastatin Morningside film-coated tablet ENG PL change

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• Simvastatin Morningside film-coated tablet ENG PL

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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.

• 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:

1. What Simvastatin Morningside is and what it is used for

2. Before you take Simvastatin Morningside

3. How to take Simvastatin Morningside

4. Possible side effects

5. How to store Simvastatin Morningside

6. 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:

• 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.

• 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

• 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:

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:

• 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;

• 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;

- 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 AuthorisationHolder

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