Simvastatin 10 Mg Film-Coated Tablets
Text to appear on the Patient Information Leaflet (combined)
Simvastatin 10mg, 20mg, and 40mg film-coated tablets
Active substance: 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 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.
In this leaflet:
1. What SIMVASTATIN is and what it is used for
2. Before you take SIMVASTATIN
3. How to take SIMVASTATIN
4. Possible side effects
5. How to store SIMVASTATIN
6. Further information
1. What SIMVASTATIN is and what it is used for
SIMVASTATIN is a medicinal product to lower elevated cholesterol levels in blood (HMG-CoA reductase inhibitor, lipid-lowering agent).
SIMVASTATIN is used:
• in elevated blood lipid values
- Treatment of elevated blood lipid values which are not attributable to another disease (primary hypercholesterolaemia or mixed hyperlipidaemia), additionally to diet when response to diet and other non-pharmacological measures (e.g. physical exercise, weight reduction) are not sufficient.
- To treat hereditary elevated blood lipid values (homozygous familial hypercholesterolaemia). SIMVASTATIN is used as an adjunct to diet and other lipid-lowering measures (e.g. LDL apheresis) or if such measures are not appropriate.
• to prevent cardiovascular events
Reduction in the frequency of cardiovascular induced deaths and events (mortality and morbidity) in patients with manifest atherosclerotic heart disease or diabetes mellitus whose cholesterol values are normal or elevated. As an adjunct to correct other risk factors and cardioprotective therapy.
2. Before you take SIMVASTATIN Do not take SIMVASTATIN
• if you are hypersensitive (allergic) to simvastatin or to any of the other ingredients of
SIMVASTATIN
• if you have an active liver disease or suffer from an unexplained, persistent elevation of certain liver enzymes in blood (transaminases)
• if you are pregnant or breast-feeding
• if you concomitantly take medicinal products which inhibit the enzyme cytochrome P450 3A4 e.g. itraconazole, ketoconazole, posaconazole or voriconazole [medicinal products against
pathogenic fungi], HIV protease inhibitors e.g. nelfinavir [medicinal products in HIV infection], erythromycin, clarithromycin, telithromycin [antibiotics], boceprevir or telaprevir (medicinal products treat hepatitis C virus infection) and nefazodone [antidepressant] (see section “Taking other medicines”).
Take special care with SIMVASTATIN
• If you experience muscle pain, weakness or cramps during therapy with SIMVASTATIN, please inform your doctor immediately. SIMVASTATIN occasionally causes a disease of skeletal muscle (myopathy). In rare cases SIMVASTATN can cause severe muscle problems that can produce renal impairment (rhabdomyolysis). The risk is higher in patients who take high doses of SIMVASTATIN or who take it with certain medicines (see section “Taking other medicines”)
• Inform your doctor if you are older than 65 years, if you experience renal dysfunction, untreated thyroid hypofunction (untreated hypothyroidism), if you have familial history or have previously suffered from muscular disorders or if you regularly consume alcohol, since these factors can increase the risk of muscle disorders.
• 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.
• If you have had some liver disease. Moderate increases of transaminase levels are likely to occur and usually return to baseline without discontinuing SIMVASTATIN treatment. Persistent increases in serum transaminases usually fall slowly to pre-treatment levels when SIMVASTATIN is discontinued or interrupted.
• 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.
Your doctor may want to carry out blood/liver function tests to check that liver and muscles are working
properly before and during treatment with SIMVASTATIN.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription.
The following medicines can interact with SIMVASTATIN and can increase the risk of muscle adverse
reactions. In these cases dosage adjustment or discontinuation of SIMVASTATIN can be necessary:
• itraconazole, ketoconazole, posaconazole or voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (e.g. nelfinavir), boceprevir or telaprevir and nefazodone.
These medicinal products must therefore not be taken concomitantly with SIMVASTATIN (see section "Do not take SIMVASTATIN")
• fibrates (other cholesterol-lowering medicines such as gemfibrozil, bezafibrate)
• niacin or nicotinic acid (cholesterol-lowering medicines) in large doses (> 1 g/day), especially if you are Chinese
• ciclosporin (medicine to prevent transplant rejection)
• verapamil, diltiazem or amlodipine (medicinal products to treat high blood pressure or chest tightness) and amiodarone (medicinal product to treat arrhythmias)
• danazol (synthetic hormone, gonadotrophin inhibitor)
• fusidic acid (medicine for bacterial infections)
• colchicine (medicine to treat gout)
• medicines to prevent the blood from clotting such as warfarin
• fluconazole (medicine for fungal infections)
Tell your doctor if you are taking any of the above.
If you are taking the following medicine, you should have your cholesterol levels monitored and the dose of SIMVASTATIN may need to be adjusted:
• Rifampicin (medicine to treat tuberculosis)
It is also important to tell your doctor if you are taking or have taken within the last 4 weeks:
• Medicinal products for oral intake which inhibit blood coagulation (oral anticoagulants), since the anticoagulant effect is increased if they are taken with SIMVASTATIN
Taking SIMVASTATIN with food and drink
Grapefruit juice can increase the concentration of simvastatin in blood. Avoid a consumption of grapefruit juice during therapy with SIMVASTATIN.
Alcohol: Inform your doctor if you consume large quantities of alcohol.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Pregnancy
Do not use SIMVASTATIN if you are pregnant, trying to become pregnant or suspect that you are 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 (see ‘Do not take SIMVASTATIN’).
Breast-feeding
It is not known whether SIMVASTATIN passes into mother’s milk. On account of the risk of serious adverse reactions in infants, SIMVASTATIN must not be used in the lactation period. If therapy is indispensable, breastfeeding must be stopped.
Driving and using machines
You are allowed to drive and use machines.
SIMVASTATIN has no or only negligible influence on the ability to drive and to operate machines. However, when driving or operating machines, it should be taken into account that dizziness has rarely been reported in the post-marketing period.
Important information about some of the ingredients of SIMVASTATIN
This medicinal product contains 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
Always take SIMVASTATIN exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Take the tablets with sufficient liquid (a glass of water) as single dose in the evening. You may take SIMVASTATIN irrespective of meals. The tablet can be divided into equal halves.
You should stay on a cholesterol-lowering diet while taking SIMVASTATIN.
Usual dose: The dose is 1 SIMVASTATIN 5mg, 10mg, 20mg, 40mg, or 80mg tablet by mouth once a
day. See table below:
Maximum dose: 80mg a day
Your doctor will increase the dose, if required, at intervals of at least 4 weeks. The 80mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems.
|
Usual initial Dose |
Patients who require a large starting dose | |
|
In case of elevated blood lipid values |
10mg to 20mg once daily |
20mg to 40mg once daily |
|
In case of hereditary elevated blood lipid values (homozygous familial hypercholesterolaemia) |
40mg once daily, or 20mg in the morning, 20mg at noon and 40mg in the evening | |
|
To prevent cardiovascular events |
20mg to 40mg once daily |
Concomitant administration with other medicinal products
SIMVASTATIN is effective alone or together with bile acid sequestrants (medicines for lowering cholesterol) such as colestyramine, colestipol.
SIMVASTATIN should be taken at least 2 hours before or at least 4 hours after taking a bile acid sequestrant.
In patients taking ciclosporin, danazol, fibrates (except fenofibrate) or lipid-lowering doses of niacin (nicotinic acid; > 1 g/day) concomitantly with SIMVASTATIN, a dose of 10mg a day should not be exceeded.
In patients taking amiodarone or verapamil concomitantly with SIMVASTATIN, a dose of 20mg a day should not be exceeded.
Elderly patients
No dose adjustment is necessary for elderly patients.
Children and adolescents (age < 18 years)
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.
Efficacy and safety of SIMVASTATIN in children younger than 10 years has not been studied. For this reason, SIMVASTATIN is not recommended for use in children younger than 10 years, pre- puberty or pre-menstrual girls.
If you have kidney problems
No dose adjustment is usually necessary in patients with moderate kidney problems. In patients with severe kidney problems (creatinine clearance below 30 ml/min), doses above 10mg a day should be carefully considered and, if necessary, prescribed with caution.
The attending doctor will decide on the duration of treatment.
If you take more SIMVASTATIN than you should
Please consult your doctor without delay. In case of overdose, your doctor should take symptomatic and supportive measures.
If you forget to take SIMVASTATIN
Do not take a double dose to make up for a forgotten dose, but continue treatment with the dose prescribed.
4. Possible side effects
Like all medicines, SIMVASTATIN can cause side effects, although not everybody gets them.
Serious side effects
If you have any of the following rare side effects, stop taking SIMVASTATIN and tell your doctor or go to your nearest hospital immediately:
• Muscle pain, tenderness or weakness. On rare occasions, these muscle problems can be serious, including muscle breakdown resulting in kidney damage and very rarely deaths have occurred (see section 2, ‘Take special care’)
• Inflammation of the liver with yellowing of the skin and eyes, itching, dark-coloured urine or pale coloured stool, liver failure (very rare)
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (Pancreatitis)
• Shortness of breath, non-productive cough, tiredness, weight loss and fever (Intestinal lung disease)
• Symptoms of an allergic reaction such as:
- swelling of the face or throat
- rash, joint disorders and effects on blood cells (Lupus-like syndrome)
- severe muscle pain, stiffness and tenderness in the shoulders and hips
- skin rash with weakness of limbs and neck muscles
- inflammation of blood vessels, often with skin rash
- reduction in blood platelets, which increases risk of bleeding or bruising
- increase in certain type of white blood cells, which may cause frequent wheezing and breathlessness, abdominal pain, diarrhoea, fever, cough and rashes (diagnosed through blood test)
- joint pain and inflammation
- itchy rash, increased sensitivity of the skin to sunlight, fever, flushing
- breathlessness and general feeling of being unwell
Rare side effects (affects less than 1 user in 1,000)
• Skin rash
• Itchy skin (Pruritus)
• Feeling weak (Asthenia)
• Hair loss (Alopecia)
• Dizziness
• Constipation
• Passing wind (Flatulence)
• Abdominal pain
• Indigestion (Dyspepsia)
• Diarrhoea
• Nausea (Feeling sick)
• Vomiting (Being sick)
• Headache
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness (Anaemia)
• Tingling or numbness in the hands or feet (Paraesthesia)
• Tingling, numbness or burning pain of the skin (Peripheral neuropathy)
Very rare side effects (affects less than 1 user in 10,000)
• Difficulty sleeping
• Poor memory
Other side effects (frequency not known)
• Muscle weakness that is constant
• Difficulty having an erection
• Depression
Other side effects reported with some statins
• Sleep disturbances, including nightmares
• Memory loss
• Sexual difficulties
and fats in your blood, are overweight and you are taking this medicine.
increase in serum creatine kinase levels
• Diabetes. This is more likely if you have high levels of sugars have high blood pressure. Your doctor will monitor you while
Investigations
Increases in serum transaminases, elevated alkaline phosphatase,
(see section “Take special care with SIMVASTATIN“).
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 . By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store SIMVASTATIN
Children: Keep out of the sight and reach of children.
Use by Date: Do not use SIMVASTATIN after the expiry date which is stated on the blister and on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Blister: Keep the blister in the outer carton to protect from light.
Tablet container: Store in the original container to protect from light.
Disposal: 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 contains
The active substance is: simvastatin.
One film-coated tablet contains 10mg, 20mg, or 40mg simvastatin.
The other ingredients are ascorbic acid, butyl hydroxyanisole (Ph.Eur.) (E 320), microcrystalline cellulose, citric acid monohydrate, hypromellose, lactose monohydrate, magnesium stearate (Ph.Eur.), pregelatinized starch (maize), talc, colouring agents: titanium dioxide (E 171).
SIMVASTATIN 10mg and 20mg also contains iron oxide, yellow (E172) and iron oxide, red (E172). SIMVASTATIN 40mg also contains iron oxide, red (E172).
What SIMVASTATIN looks like and contents of the pack
SIMVASTATIN 10mg is a pale pink coated, oval, scored, convex tablet coded SIM 10 on one side. SIMVASTATIN 20mg is an orange coated, oval, scored, convex tablet coded SIM 20 on one side. SIMVASTATIN 40mg is a pink coated, oval, scored, convex tablet coded SIM 40 on one side.
All are available in the following packs:
Blister (Aluminium/PVC)
Pack sizes: 10, 20, 28, 30, 40, 49, 50, 50 x 1, 98 and 100 film-coated tablets.
Polyethylene tablet container with screw cap
Pack sizes: 10, 20, 28, 30, 40, 50, 100 and 250 film-coated tablets.
Not all packs sizes or pack types may be marketed.
Marketing Authorisation Holder
Imperial Worldwide Limited 1st Floor, 61-63 Alexandra Road,
Walsall, WS1 4DX United Kingdom
Manufacturer
Tillomed Laboratories Ltd 3 Howard Road,
Eaton Socon, St Neots, Cambridgeshire PE19 8ET UK
Product Licence Numbers
SIMVASTATIN 10mg Tablets: PL 45994/0001 SIMVASTATIN 20mg Tablets: PL 45994/0002 SIMVASTATIN 40mg Tablets: PL 45994/0003
This leaflet was last revised in