Patient Leaflet Updated 03-Nov-2023 | Organon Pharma (UK) Limited
Zocor 10mg, 20mg and 40mg film-coated tablets
Zocor® 10, 20, 40 mg Film-coated Tablets
Simvastatin
1. What Zocor is and what it is used for
2. What you need to know before you take Zocor
3. How to take Zocor
4. Possible side effects
5. How to store Zocor
6. Contents of the pack and other information
Zocor contains the active substance simvastatin. Zocor is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Zocor raises levels of “good” cholesterol (HDL cholesterol). Zocor is a member of the class of medicines called statins.
Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol.
LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brain. This blocking of blood flow can result in a heart attack or stroke.
HDL cholesterol is often called “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease.
Triglycerides are another form of fat in your blood that may increase your risk for heart disease.
You should stay on a cholesterol-lowering diet while taking this medicine.
Zocor is used in addition to your cholesterol-lowering diet if you have:
In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol, and discuss your goals with your doctor.
Do not take more than 40 mg Zocor if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Ask your doctor if you are not sure if your medicine is listed above.
Tell your doctor:
Your doctor should do a blood test before you start taking Zocor and if you have any symptoms of liver problems while you take Zocor. This is to check how well your liver is working.
Your doctor may also want you to have blood tests to check how well your liver is working after you start taking Zocor.
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.
Tell your doctor if you have severe lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage; and very rare deaths have occurred.
The risk of muscle breakdown is greater at higher doses of Zocor, particularly the 80 mg dose. The risk of muscle breakdown is also greater in certain patients. Talk with your doctor if any of the following applies:
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.
Safety and effectiveness of Zocor have been studied in 10-17 year old boys and in girls who had started their menstrual period (menstruation) at least one year before (see section 3: How to take Zocor). Zocor has not been studied in children under the age of 10 years. For more information, talk to your doctor.
Tell your doctor if you are taking, have recently taken or might take any other medicine(s) with any of the following active ingredients. Taking Zocor with any of the following medicines can increase the risk of muscle problems (some of these have already been listed in the above section “Do not take Zocor”).
As well as the medicines listed above, tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicine(s) with any of the following active ingredients:
You should also tell any doctor who is prescribing a new medicine for you that you are taking Zocor.
Grapefruit juice contains one or more components that alter how the body uses some medicinal products, including Zocor. Consuming grapefruit juice should be avoided.
Do not take Zocor if you are pregnant, trying to get pregnant or think you may be pregnant. If you get pregnant while taking Zocor, stop taking it immediately and contact your doctor. Do not take Zocor if you are breast-feeding, because it is not known if the medicine is passed into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Zocor is not expected to interfere with your ability to drive or to use machinery. However, it should be taken into account that some people get dizzy after taking Zocor.
Zocor tablets contain a sugar called 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.
Your doctor will determine the appropriate tablet strength for you, depending on your condition, your current treatment and your personal risk status.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
You should stay on a cholesterol-lowering diet while taking Zocor.
Dosage:
The recommended dose is simvastatin 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg by mouth once a day.
Adults:
The usual starting dose is 10, 20 or, in some cases, 40 mg a day. Your doctor may adjust your dose after at least 4 weeks to a maximum of 80 mg a day. Do not take more than 80 mg a day.
Your doctor may prescribe lower doses, particularly if you are taking certain medicinal products listed above or have certain kidney conditions.
The 80 mg dose is only recommended for adult patients with very high cholesterol levels and at high risk of heart disease problems who have not reached their cholesterol goal on lower doses.
Use in children and adolescents:
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.
Method of administration:
Take Zocor in the evening. You can take it with or without food. Keep taking Zocor unless your doctor tells you to stop.
If your doctor has prescribed Zocor along with another medicine for lowering cholesterol containing any bile acid sequestrant, you should take Zocor at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Zocor can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects have been reported:
If any of the below mentioned serious side effects happen, stop taking the medicine and tell your doctor immediately or go to the emergency room at your nearest hospital.
The following rare serious side effects were reported:
The following very rare serious side effects were reported:
The following side effects have also been reported rarely:
The following side effects have also been reported but the frequency cannot be estimated from the available information (frequency not known):
Additional possible side effects reported with some statins:
Laboratory Values
Elevations in some laboratory blood tests of liver function and a muscle enzyme (creatine kinase) have been observed.
If you get any side effects, talk to your doctor or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the container.
Do not store above 25°C. Keep blister in outer carton in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is simvastatin (10 mg, 20 mg or 40 mg)
The other ingredients are: butylated hydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose (E460), pregelatinised starch, magnesium stearate (E572), and lactose monohydrate. The tablet coating contains hypromellose (E464), hydroxypropylcellulose (E463), titanium dioxide (E171), and talc (E553b). The 10 mg and 20 mg tablets also contain yellow ferric oxide (E172) and red ferric oxide (E172). The 40 mg tablets also contain red ferric oxide.
10 mg simvastatin tablet: Peach, oval film-coated tablet marked ‘MSD 735’ on one side and plain on the other side.
20 mg simvastatin tablet: Tan, 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.
Zocor Tablets are available in packs containing 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium, Finland, France, Germany, Greece, Ireland, Luxembourg, Netherlands, Norway, Portugal, Spain, United Kingdom: ZOCOR.
Austria, Sweden: ZOCORD.
Italy: SINVACOR.
This leaflet was last revised in December 2022.
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