10 mg, 20 mg, and 40 mg film-coated tablets
simvastatin
What Zocor is and what it is used for
Zocord contains the active substance simvastatin. Zocord is a drug that is used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL – cholesterol ), and blood fats known as triglycerides. Zocord also increases the levels of “good” cholesterol ( HDL cholesterol ). Zocord belongs to a group of drugs called statins.
Cholesterol is one of several fats found in your blood. Your total cholesterol consists mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it causes fatty deposits in your vessel walls and forms plaque. This plaque deposit can eventually lead to a narrowing of your vessels. This narrowing can reduce or block blood flow to vital organs such as the heart and brain. Blockage of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called the “good” cholesterol because it helps prevent the “bad” cholesterol from being stored in blood vessels and protects against heart disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
You should continue with a cholesterol-lowering diet while taking this medicine.
Zocord is used in addition to your cholesterol-lowering diet if you have:
- elevated cholesterol levels in the blood (primary hypercholesterolemia ) or elevated blood fats (combined hyperlipidemia ),
- a hereditary disease ( homozygous familial hypercholesterolemia ) that produces elevated cholesterol levels in the blood. You can also receive other treatments,
- coronary artery disease or if you are at risk of developing coronary artery disease (because you have diabetes, previous stroke, or other vascular diseases). Treatment with Zocord can lead to prolonged survival by reducing the risk of cardiovascular disease, regardless of the amount of cholesterol in your blood.
In most people, high cholesterol does not cause immediate symptoms. Your doctor can measure your cholesterol level with a simple blood test. Visit your doctor regularly, monitor your cholesterol level, and discuss your goals with your doctor.
What you need to know before you take Zocord
Do not take Zocord
- if you are allergic (hypersensitive) to simvastatin or any of the other ingredients in this medicine (specified in section 6: Contents of the package and other information),
- if you have liver problems,
- if you are pregnant or breastfeeding,
- if you take medicines with one or more of the following active ingredients:
- itraconazole, ketoconazole , posaconazole or voriconazole (used to treat fungal infections),
- erythromycin, clarithromycin, or telithromycin (used to treat infections ),
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir ( HIV protease inhibitors are used in HIV infection ),
- boceprevir or telaprevir (used to treat hepatitis C virus infection),
- nefazodone (used to treat depression),
- cobicistat,
- gemfibrozil (used to lower cholesterol levels),
- ciclosporin (often used in organ transplant patients),
- danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
- if you are taking or in the last 7 days have taken a medicine called fusidic acid (a medicine against a bacterial infection ) either by mouth or by injection. The combination of fusidic acid and Zocord can lead to serious muscle problems ( rhabdomyolysis ).
Do not take more than 40 mg of Zocord if you are taking
lomitapide (used to treat a serious and rare genetic cholesterol condition).
Consult a doctor if you are unsure whether your medicine is listed above.
Warnings and precautions
Inform the doctor:
- about all your medical problems, including allergies,
- if you have high alcohol consumption,
- if you have or have previously had any liver disease. Zocord may not be the right drug for you,
- if you are going to undergo a surgical procedure. Treatment breaks with Zocord may need to be done for a shorter period,
- if you are of Asian origin, then a different dose may apply to you.
Your doctor should do a blood test before you start taking Zocord, and if you have any symptoms of liver problems while taking Zocord. This blood test is taken to check your liver function.
Your doctor may also need to do a blood test to check your liver function after you start taking Zocord.
During treatment with this medicine, the doctor will check you carefully if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk of diabetes if you have high blood sugar and blood fat levels, are overweight, and have high blood pressure.
Tell your doctor if you have any serious lung disease.
Contact a doctor immediately if you experience unexplained muscle pain, tenderness or weakness. The reason for this is that in rare cases, muscle problems can be serious and involve the breakdown of muscles with kidney damage as a result, and in very rare cases, deaths have occurred.
The risk of muscle breakdown is greater with higher doses of Zocord, especially for doses of 80 mg. The risk of muscle breakdown is also greater in some patients. Talk to your doctor if any of the following apply to you:
- you have a high alcohol consumption,
- you have kidney problems,
- you have problems with the thyroid gland,
- you are 65 years of age or older,
- you are a woman
- if you have ever had muscle problems during treatment with cholesterol-lowering medicines called “statins” or fibrates,
- you or a close relative have a hereditary muscle disease.
Tell your doctor or pharmacist if you have persistent muscle weakness. Additional tests and medications may be needed to investigate and treat this.
Children and young people
The safety and effectiveness of Zocord have been studied in boys aged 10-17 years and in girls who have had periods for at least one year (see section 3: How to take Zocord). Zocord has not been studied in children under 10 years of age. For further information, consult a doctor.
Other drugs and Zocord
Tell your doctor if you are taking, have recently taken, or may be taking other medicines with any of the following active ingredients. Taking Zocord with any of the following medicines may increase the risk of muscle problems (some of these have already been listed in the section above “Do not take Zocord”).
- If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will tell you when it is safe to start taking Zocord again. Taking Zocord together with fusidic acid can rarely lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information about rhabdomyolysis in section 4.
- ciclosporin (often used by patients who have undergone organ transplantation),
- danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
- medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used in the treatment of fungal infections),
- fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to lower cholesterol levels),
- erythromycin, clarithromycin, or telithromycin (used in the treatment of bacterial infections ),
- HIV – protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used in the treatment of AIDS ),
- medicines for Hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection),
- nefazodone (used to treat depression),
- medicines containing the active ingredient cobicistat,
- amiodarone (used to treat irregular heart rhythms),
- verapamil, diltiazem, or amlodipine (used to treat high blood pressure, and chest pain associated with cardiovascular disease or other heart conditions),
- lomitapide (used to treat a serious and rare genetic cholesterol condition),
- daptomycin (a medicine used in the treatment of complicated skin and soft tissue infections and bacteremia (presence of bacteria in the blood)). The risk of side effects affecting the muscles may be higher when this medicine is taken during treatment with simvastatin (eg Zocord). Your doctor may decide that you should stop taking Zocord for some time.
- colchicine (used in the treatment of gout ),
- ticagrelor (blood thinners).
Also tell your doctor or pharmacist if you are taking or have recently taken any other medicines in addition to those mentioned above, even those without a prescription. It is especially important to tell the doctor if you are taking medicines with any of the following active ingredients:
- blood clotting prevention drugs with an active ingredient such as warfarin, phenprocoumon, or acenocoumarol ( anticoagulants ),
- fenofibrate (also used to lower cholesterol levels),
- niacin (also used to lower cholesterol levels),
- rifampicin (used in the treatment of tuberculosis ).
Tell any doctor who prescribes a new drug for you that you are taking Zocord.
Zocord with food and drink
Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain medications, including Zocord. Consumption of grapefruit juice should be avoided.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. If you become pregnant while taking Zocord, stop treatment immediately and tell your doctor.
Do not take Zocord if you are breastfeeding because it is unknown if the drug passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving ability and use of machinery
Zocord is not expected to affect your ability to drive or operate machinery. However, keep in mind that some people get dizzy after taking Zocord.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with your doctor or pharmacist if you are unsure.
Zocord contains lactose
Zocord contains a type of sugar called lactose. If your doctor has told you that you have an intolerance to some sugars, you should contact your doctor before taking this medicine.
How to take Zocord
Your doctor will decide which dose is appropriate for you depending on your symptoms, your current treatment, and your risk profile.
Always take this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
You should continue with a cholesterol-lowering diet while taking Zocord.
Dosage:
The recommended dose is simvastatin 5mg, 10mg, 20mg, 40mg, or 80mg once daily.
Adults:
The most common starting dose is 10, 20, or in some cases 40 mg daily. Your doctor may, after at least 4 weeks, need to adjust your dose to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose for you, especially if you take certain medicines listed above or have certain kidney problems.
A dose of 80 mg is only recommended for adult patients with very high cholesterol levels who are at high risk of cardiovascular disease and who have not achieved their treatment goals on a lower dose.
Use for children and adolescents
The recommended starting dose for children (10 – 17 years) is usually 10 mg in the evening. The highest recommended dose is 40 mg daily.
Method of administration:
Take Zocord in the evening. Zocord can be taken with or without food.
Keep taking Zocord unless your doctor tells you to stop.
If your doctor has prescribed Zocord along with another cholesterol-lowering drug that contains bile acid sequestrants, you should take Zocord at least 2 hours before or 4 hours after you take the bile acid sequestrant.
If you have taken too much Zocord
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
If you forget to take Zocord
Do not take a double dose to make up for a missed tablet. Just take your usual dose of Zocord at your usual time the next day.
If you stop taking Zocord
Talk to your doctor or pharmacist as your cholesterol levels may rise again.
If you have further questions about this medicine, contact your doctor or pharmacist.
Possible side effects
Like all medicines, Zocord can cause side effects, although not everybody gets them.
The following division is used to describe how often side effects have been reported:
- Rare (may affect up to 1 in 1,000 users).
- Very rare (may affect up to 1 in 10,000 users).
- Not known frequency (cannot be calculated from available data).
If any of the following serious side effects occur, stop taking your medicine and contact your doctor immediately or visit an emergency department at the nearest hospital.
The following rare serious side effects have been reported:
- muscle pain, soreness, weakness, or cramps. In rare cases, muscle problems can be serious and involve the breakdown of muscles resulting in kidney damage, and very rare cases, death has occurred
- hypersensitivity (allergic reactions) including:
- swelling of the face, tongue, and throat, which can cause breathing difficulties ( angioedema ),
- severe muscle pain, usually in the shoulders and hips,
- rash with weakness in arms, legs, and neck muscles,
- pain or inflammation in the joints (polymyalgia rheumatic),
- inflammation of blood vessels ( vasculitis ),
- bruises of unknown cause, skin rash, and swelling ( dermatomyositis ), hives, skin sensitivity to sunlight, fever, redness,
- shortness of breath ( dyspnoea ) and general malaise,
- lupus-like disease picture (including rash, joint problems, and effects on blood cells ),
- inflammation of the liver with the following symptoms: the yellowish color of the skin and eyes, itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare),
- inflammation of the pancreas, often with severe abdominal pain.
The following very rare serious side effects have been reported:
- a severe allergic reaction causing difficulty breathing or dizziness ( anaphylaxis ),
- rash that may appear on the skin or mouth sores (drug-related lichenoid rash),
- muscle spasms,
- gynecomastia (breast enlargement in men).
The following side effects have also been reported in rare cases:
- the low number of red blood cells (anemia),
- numbness or weakness in arms and legs,
- headache, “ant crawls”, dizziness,
- blurred vision, visual impairment,
- indigestion (abdominal pain, constipation, flatulence, dyspepsia, diarrhea, nausea, vomiting),
- rash, itching, hair loss,
- weakness,
- difficulty sleeping (very rare),
- poor memory (very rare), amnesia, and confusion.
The following side effects have also been reported, but the frequency cannot be determined 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,
- problems with tendons, sometimes complicated by rupture of the tendon.
Additional possible side effects that have been reported with some statins:
- sleep disturbances including nightmares,
- sexual problems,
- diabetes. This is more likely if you have high blood sugar and high blood fat levels, are overweight, and have high blood pressure. The doctor will check you while you are taking this medicine,
- muscle pain, soreness, or weakness that is persistent and may not go away after stopping treatment with Zocord (frequency not known).
Laboratory values
In some blood samples, elevations in liver function values and a muscle enzyme (creatine kinase) have been observed.
How to store Zocord
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton or packaging after the Expiration date. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substance is simvastatin 10 mg, 20 mg, and 40 mg respectively.
Other ingredients are butyl hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinized corn starch, magnesium stearate (E572) and lactose monohydrate. The film coating contains hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), talc (E553b), and red iron oxide (E172). The 10 mg and 20 mg tablets also contain yellow iron oxide (E172).
Appearance and package sizes of the medicine
The appearance of the drug
10 mg simvastatin tablet: Peach-coloured, oval film-coated tablet, marked MSD 735 on one side and plain on the other side.
20 mg simvastatin tablet: Light brown, oval film-coated tablet, marked MSD 740 on one side and plain on the other side.
40 mg simvastatin tablet: Brick red, oval film-coated tablet, marked MSD 749 on one side and plain on the other side.
Package sizes:
Film-coated tablets 10 mg: Blister pack of 1, 4, 10, 14, 15, 20, 28, 30, 50, 60, 98, 100, 49 (49 x 1), and 500 (500 x 1) tablets. Can packaging with 30, 50, and 100 tablets.
Film-coated tablets 20 mg: Blister pack of 1, 4, 10, 14, 15, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 168, 28 (28 x 1), 49 (49 x 1), 84 (84 x 1), 98 (98 x 1) and 500 (500 x 1) tablets. Can packaging with 30, 50, and 100 tablets.
Film-coated tablets 40 mg: Blister pack of 1, 4, 7, 10, 14, 15, 20, 28, 30, 49, 50, 56, 60, 84, 90, 98, 100, 168, 28 (28 x 1), 49 (49 x 1), 98 (98 x 1) and 100 (100 x 1) tablets. Can packaging with 30, 50, and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
NV Organon
Kloosterstraat 6
5349 AB Us
Netherlands
Manufacturer
Schering-Plough Labo NV
Industriepark 30
Heist-op-den-Berg, 2220
Belgium
This medicine is approved in the European Economic Area under the names:
Belgium, Finland, France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain, United Kingdom: ZOCOR.
Sweden, Austria: ZOCORD.
Italy: SINVACOR.