10 mg, 20 mg, 40 mg, and 80 mg film-coated tablets
simvastatin
What Simvastatin Orion is and what it is used for
Simvastatin Orion contains the active substance simvastatin. Simvastatin Orion is a drug used to lower the levels of total cholesterol in the blood, the “bad” cholesterol ( LDL – cholesterol ), and blood fats called triglycerides. Simvastatin Orion also increases the levels of the “good” cholesterol ( HDL – cholesterol ). Simvastatin Orion belongs to a group of medicines 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 the “bad” cholesterol because it causes fat storage in your vessel walls and forms plaque. This plaque storage can eventually lead to a narrowing of your vessels. This narrowing can reduce or block blood flow to important 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 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 you are taking this medicine.
Simvastatin is used as a supplement to your cholesterol-lowering diet if you have:
- elevated blood cholesterol levels (primary hypercholesterolemia ) or elevated blood fats (combined hyperlipidemia )
- an inherited disease ( homozygous familial hypercholesterolemia ) that causes elevated cholesterol levels in the blood. You can also receive other treatments.
- coronary heart disease or if you are at risk of developing coronary heart disease (because you have diabetes, previously had a stroke, or other vascular diseases). Simvastatin treatment 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 levels, and discuss your goals with your doctor.
Simvastatin contained in Simvastatin Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Simvastatin Orion
Do not take Simvastatin Orion:
- if you are allergic (hypersensitive) to simvastatin or any of the other ingredients of this medicine (listed in section 6 Contents of the pack and other information)
- if you have liver problems
- if you are pregnant or breastfeeding
- if you are taking medicines containing 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 used in HIV infections )
- boceprevir or telaprevir (used to treat hepatitis C virus infection)
- nefazodone (used to treat depression)
- cobicistat
- gemfibrozil (used to lower cholesterol)
- cyclosporine (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 have taken a medicine called fusidic acid (a medicine for bacterial infections ) over the last 7 days, either by mouth or by injection. The combination of fusidic acid and Simvastatin Orion can lead to severe muscle problems ( rhabdomyolysis ).
Do not take more than 40 mg of Simvastatin Orion if you are taking lomitapide (used to treat a serious and rare genetic cholesterol condition).
Consult a doctor if you are unsure if your medicine is listed above
Warnings and cautions
Talk to your doctor before taking Simvastatin Orion:
- about all your medical ailments, including allergies
- if you have high alcohol consumption, or if you have or have had any liver disease. Simvastatin Orion may not be the right medicine for you.
- if you are going to have an operation. Discontinuation of treatment with Simvastatin Orion may need to be done for a short time.
- if you are of Asian descent, then another dose may apply to you.
Your doctor should take a blood sample before you start taking Simvastatin Orion, and if you get any symptoms of liver problems during treatment with Simvastatin Orion. This blood test is taken to check your liver function.
Your doctor may also need to take a blood test to check your liver function after you start taking Simvastatin Orion.
During treatment with this medicine, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes. You are more likely to be at risk for 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 aches, soreness, 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 at higher doses of Simvastatin Orion and is especially true for an 80 mg dose. 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 thyroid problems
- you are 65 years or older
- you are a woman
- if you have ever had muscle problems during treatment with cholesterol-lowering drugs called “statins” or fibrates
- you or a close relative has 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 efficacy of Simvastatin Orion have been studied in boys 10 to 17 years of age and in girls who have been menstruating for at least one year (see section 3 “How to take Simvastatin Orion”). Simvastatin Orion has not been studied in children under 10 years of age. For further information, consult a doctor.
Other medicines and Simvastatin Orion
Tell your doctor if you have recently taken, or might take any other medicines with any of the following active ingredients. Taking Simvastatin Orion 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 Simvastatin Orion”).
- 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 Simvastatin Orion again. Taking Simvastatin Orion with fusidic acid may in rare cases lead to muscle weakness, tenderness, or pain ( rhabdomyolysis ). See more information on rhabdomyolysis in section 4.
- ciclosporin (often used by patients who have had an organ transplant)
- danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
- medicines containing an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
- fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to lower cholesterol)
- erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections )
- HIV – protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat 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 substance cobicistat
- amiodarone (used to treat irregular heartbeat)
- verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with cardiovascular disease or other heart problems)
- lomitapide (used to treat a serious and rare genetic cholesterol condition)
- daptomycin (a medicine used to treat 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. Your doctor may decide to stop you from taking Simvastatin Orion for a while.
- colchicine (used to treat gout )
- ticagrelor (blood-thinning drug).
Also tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. It is especially important to tell your doctor if you are taking medicines with any of the following active ingredients:
- anticoagulants with an active ingredient such as warfarin, phenprocoumon or acenocoumarol ( anticoagulants )
- fenofibrate (also used to lower cholesterol)
- niacin (also used to lower cholesterol)
- rifampicin (used to treat tuberculosis ).
Tell your doctor who is prescribing a new medicine to you that you are taking Simvastatin Orion.
Simvastatin Orion with food and drink
Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin Orion. Intake 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 taking this medicine. If you become pregnant while taking Simvastatin Orion, stop treatment immediately and tell your doctor.
Do not take Simvastatin Orion if you are breastfeeding as it is unknown if the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Simvastatin Orion is not expected to affect your ability to drive or use machines. However, keep in mind that some people get dizzy when they take Simvastatin Orion.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Simvastatin Orion contains lactose monohydrate
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine. The content of lactose monohydrate in Simvastatin Orion is approximate: 70 mg in a 10 mg tablet, 140 mg in a 20 mg tablet, 280 mg in a 40 mg tablet, and 560 mg in an 80 mg tablet.
How to use Simvastatin Orion
Your doctor will decide which dose is right for you depending on your symptoms, your current treatment, and your risk profile.
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
While you are taking Simvastatin Orion, you should be on a cholesterol-lowering diet.
Dosage:
The recommended dose is one tablet of Simvastatin Orion 10 mg, 20 mg, 40 mg, or 80 mg once daily. The tablet should be swallowed.
Adults:
The most common starting dose is 10 mg, 20 mg, 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 are taking 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 and who are at high risk for cardiovascular disease and who have not achieved their treatment goals at lower doses.
Use for children and adolescents:
The recommended starting dose for children (10–17 years) is usually 10 mg in the evening. The maximum recommended dose is 40 mg daily.
Method of administration:
Take Simvastatin Orion in the evening. Simvastatin Orion can be taken with or without food. Continue to take Simvastatin Orion unless your doctor tells you to stop.
If your doctor has prescribed Simvastatin Orion with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin Orion at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If you take more Simvastatin Orion than you should
If you have ingested too much medicine or if e.g. a child accidentally ingested the drug
contact a doctor or hospital for risk assessment and advice.
If you forget to take Simvastatin Orion
Do not take a double dose to make up for a forgotten tablet. Just take your usual dose of Simvastatin Orion at the time you usually take the next day.
If you stop taking Simvastatin Orion
Talk to your doctor or pharmacist as your cholesterol levels may rise again.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following rare serious side effects have been reported (may affect up to 1 in 1,000 people) :
If any of these serious side effects occur, stop taking your medicine and contact your doctor immediately or see an emergency department at the nearest hospital.
- muscle aches, soreness, weakness, or cramps. 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.
- hypersensitivity (allergic reactions) including:
- swelling of the face, tongue, and throat, which may cause difficulty breathing ( angioedema )
- severe muscle pain, usually in the shoulders and hips
- rash with weakness in arms, legs, and neck muscles
- joint pain or inflammation (rheumatic polymyalgia)
- inflammation of blood vessels ( vasculitis )
- bruising of unknown cause, skin rash, and swelling ( dermatomyositis ), hives, skin sensitivity to sun exposure, 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 of tiredness or weakness, 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 ( may affect up to 1 in 10,000 people ):
- a severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis )
- rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash)
- muscle strain
- gynecomastia (breast augmentation in men).
The following side effects have also been reported in rare cases ( may affect up to 1 in 1,000 people ):
- low red blood cell count ( anemia )
- numbness or weakness in the arms and legs
- headache, and crawling, dizziness
- indigestion (abdominal pain, constipation, flatulence, dyspepsia, diarrhea, nausea, vomiting)
- rash, itching, hair loss
- weakness
- memory loss, confusion
- blurred vision and impaired vision.
The following very rare side effects have been reported ( may affect up to 1 in 10,000 people ):
- difficulty sleeping
- bad memory.
The following side effects have also been reported, but the frequency cannot be determined with the available data ( occurs in an unknown number of users) :
- erectile dysfunction
- Depression
- inflammation of the lungs that causes breathing problems including persistent cough and/or shortness of breath or fever
- problems with tendons, sometimes aggravated by tendon rupture.
Additional possible side effects that have been reported with certain statins:
- sleep disorders 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. Your doctor will check you while you are taking this medicine.
- muscle pain, tenderness, or weakness that is persistent and may not go away after stopping treatment with Simvastatin Orion (no known frequency).
Laboratory values
In some blood tests, elevations in liver function values and a muscle enzyme (creatinine kinase) have been observed.
How to store Simvastatin Orion
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Do not use this medicine after the expiry date which is stated on the label, carton, and blister. The expiration date is the last day of the specified month.
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.
Contents of the pack and other information
Content declaration
- The active substance is simvastatin and each tablet contains 10 mg, 20 mg, 40 mg, and 80 mg respectively.
- The other ingredients in the tablet core are ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, magnesium stearate, citric acid monohydrate, butyl hydroxyanisole (E320).
- The other ingredients in the film coating are hydroxypropylcellulose, hypromellose, titanium dioxide (E171), talc, red iron oxide (E172), and yellow iron oxide (E173) (10 mg and 20 mg tablets). For 40 mg and 80 mg tablets, the ingredients are the same, except for the absence of yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
- 10 mg tablet: light pink, round, biconvex, film-coated tablet debossed with ‘SI’ on one side and ’10’ on the other.
- 20 mg tablet: light pink, round, biconvex, film-coated tablet debossed with ‘SI’ on one side and ’20’ on the other.
- 40 mg tablet: pink, round, biconvex, film-coated tablet debossed with ‘SI’ on one side and ’40’ on the other.
- 80 mg tablet: pink, capsule-shaped, biconvex, film-coated tablet debossed with ‘SI’ on one side and ’80’ on the other.
Pack sizes:
Blister: 28 and 98 tablets.
HDPE can:
Simvastatin Orion 10 mg, 20 mg and 40 mg: 30, 100, 250, 500 and 1,000 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
02200 Espoo
Finland
For further information on this medicine, please contact your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com