Simvastatin Bluefish 10 mg, 20 mg, 40 mg, 80 mg film-coated tablets
What Is Simvastatin Bluefish, And What Simvastatin Bluefish Used For
Simvastatin Bluefish contains the active substance simvastatin. Simvastatin bluefish used for lower cholesterol, “bad” cholesterol ( LDL – cholesterol ), and fats called triglycerides in the blood. In addition, Simvastatin Bluefish increases “good” cholesterol ( HDL – cholesterol ). Simvastatin Bluefish 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 simvastatin bluefish.
Simvastatin Bluefish is used with diet if you have:
- An elevated blood cholesterol (primary hypercholesterolemia ) or fat blood levels (mixed hyperlipidemia ).
- An inherited disease ( homozygous familial hypercholesterolemia ) that increases blood cholesterol levels. You can also get other treatments.
- Coronary heart disease or are at high risk of getting coronary heart disease (because you have diabetes, previous strokes, or another disease of the blood vessels). Simvastatin Bluefish can prolong your life by reducing the risk of heart disease, regardless of your blood cholesterol level.
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 levels and discuss your goals with your doctor.
Simvastatin contained in Simvastatin Bluefish 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 Bluefish
Do Not Take Simvastatin Bluefish
- If you are allergic to simvastatin or any of the other ingredients of simvastatin bluefish (listed in section 6.1),
- 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 (used to treat HIV )
- Gemfibrozil (used to lower cholesterol)
- Cyclosporine (often used in organ transplant patients)
- Danazol (a synthetic hormone used to treat endometriosis, a condition there
- The uterine lining grows outside the uterus)
- If you take or have taken a medicine called fusidic acid (a medicine for bacterial infections ) either by mouth or by injection for the last 7 days. The combination of fusidic acid and Simvastatin Bluefish can lead to severe muscle problems ( rhabdomyolysis ).
Do not take more than 40 mg of Simvastatin Bluefish if you take 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
Tell your doctor:
- About all your medical ailments, including allergies
- If you have a high alcohol consumption and if you have or have had a history of liver disease. Simvastatin Bluefish may not be the right medicine for you.
- If you are going to have surgery. Discontinuation of treatment with Simvastatin Bluefish may need to be done quickly.
- 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 Bluefish, and if you have any symptoms of liver problems during treatment with Simvastatin Bluefish. 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 Bluefish. When you take simvastatin bluefish, your doctor will closely monitor you if you have diabetes or are at risk of developing diabetes.
The risk of developing diabetes is high if you have high levels of sugar or fat in your blood, 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 with higher doses of Simvastatin Bluefish, especially for a dose 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 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 Bluefish 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 Bluefish). Simvastatin Bluefish has not been studied in children under 10 years of age. For further information, consult a doctor.
Other Medicines And Simvastatin Bluefish
Tell your doctor or pharmacist if you have recently taken or might take any other medicines with the following active ingredients. Taking Simvastatin Bluefish with any of these medicines may increase the risk of muscle problems (some of these have already been mentioned above in the section “Do not take Simvastatin Bluefish” above).
- If you need to take fusidic acid by mouth to treat a bacterial infection, you will need to temporarily stop using simvastatin bluefish. Your doctor will tell you when it is safe to start taking Simvastatin Bluefish again. Taking Simvastatin Bluefish 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, telithromycin (used to treat bacterial infections )
- HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS )
- Hepatitis C medicines 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)
- Colchicine (used to treat gout )
Also tell your doctor or pharmacist if you are taking or have recently taken 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 that you are prescribing a new medicine to take Simvastatin Bluefish.
Simvastatin Bluefish With Food And Drink
Grapefruit juice contains one or more substances that can affect the body’s breakdown of certain drugs, including Simvastatin Bluefish. Intake of grapefruit juice should be avoided.
Pregnancy And Breastfeeding
Do not take Simvastatin Bluefish if you are pregnant, trying to conceive, or think you may be pregnant.
If you become pregnant while taking Simvastatin Bluefish, stop taking the medicine immediately and contact your doctor. Do not take Simvastatin Bluefish if you are breastfeeding as it is known that the medicine passes into breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving And Using Machines
Simvastatin Bluefish 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 Bluefish.
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 Bluefish Contains Lactose
Simvastatin Bluefish contains lactose monohydrate (milk sugar). If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking simvastatin bluefish.
How To Take Simvastatin Bluefish?
- Your doctor will decide which dose is right for you depending on your ailments, your ongoing treatment, and your risk profile.
- Always take simvastatin bluefish exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- You should continue with a cholesterol-lowering diet during treatment with Simvastatin Bluefish.
- Dosage:
- The recommended dose is one Simvastatin 10 mg, 20 mg, 40 mg, or 80 mg tablet once daily. The tablet should be swallowed.
- 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 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, who are at high risk for cardiovascular disease, and who have not achieved their treatment goals at lower doses.
- Use in 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 Bluefish in the evening. You can take it with or without food.
- Continue to take Simvastatin Bluefish unless your doctor tells you to stop.
- If your doctor has prescribed Simvastatin Bluefish together with another cholesterol-lowering medicine that contains bile acid sequestrants, you should take Simvastatin Bluefish at least 2 hours before or 4 hours after taking the bile acid sequestrant.
If You Take More Simvastatin Bluefish Than You Should
If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If You Forget To Take Simvastatin Bluefish
Do not take a double dose to make up for a forgotten dose. Just take your usual dose of Simvastatin Bluefish at the usual time the next day.
If You Stop Taking Simvastatin Bluefish
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 Simvastatin Bluefish Side Effects
Like all medicines, simvastatin bluefish can cause side effects, although not everybody gets them. The following terms describe how often side effects have been reported.
The following rare serious side effects have been reported. If these serious side effects occur, stop taking medicine, contact a doctor immediately, or go to the nearest emergency department.
- Pain, tenderness
- Weakness or muscle cramps and muscle strain (very rare)
- In rare cases, these muscle problems can become serious, i.a. degradation of muscle tissue leading to kidney damage and in very rare cases death.
- Hypersensitivity (allergic reactions) including:
- Swelling of the face, tongue, and throat that can cause difficulty breathing ( angioedema )
- Severe muscle pain
- Usually, in the shoulders and hips
- Rash with weakness in arms, legs, and neck muscles
- Rash that may occur on the skin or sores in the mouth (drug-related lichenoid rash) (very rare)
- Joint pain or inflammation (rheumatic polymyalgia)
- Inflammation of the blood vessels ( vasculitis )
- Unusual bruising, rash, and swelling ( dermatomyositis )
- Hives
- Sun-sensitive skin
- Fever
- Redness
- Shortness of breath ( dyspnoea )
- Malaise
- Lupus-like disease picture (eg rash, joint problems, and effects on blood cells )
- Inflammation of the liver with the following symptoms:
- Yellowish skin and yellowish eyes
- Itching
- Dark-colored urine or light-colored stools
- 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:
- A severe allergic reaction that causes difficulty breathing or dizziness ( anaphylaxis )
- Gynecomastia (breast augmentation in men)
The following side effects have also been reported rarely:
- Low red blood cell count ( anemia )
- Numbness or weakness in the arms and legs
- Headache
- Tingling
- Dizziness
- Blurred vision and impaired vision
- Digestive problems:
- Abdominal pain
- Constipation
- Flatulence
- Stomach upset
- Diarrhea
- Nausea
- Vomiting
- Rash
- Itching
- Hair loss
- Weakness
- Difficulty sleeping (very rare)
- Poor memory (very rare)
- Memory loss
- Confusion
The following side effects have also been reported, but the frequency cannot be calculated from available information (no known frequency):
- Erectile dysfunction
- Depression
- Inflammation of the lungs leads to difficulty breathing with persistent cough, shortness of breath, or fever.
- Problems with tendons, sometimes aggravated by tendon rupture.
Additional possible side effects that have been reported with certain statins:
- Difficulty sleeping, including nightmares
- Sexual disorders
- Diabetes. This is more likely if you have high blood sugar and fat levels, are overweight and have high blood pressure. Your doctor will check if you are taking simvastatin bluefish.
- Muscle pain, tenderness, or persistent weakness may not go away after stopping treatment with Simvastatin Bluefish (no known frequency).
Laboratory values
Elevated values for certain blood tests regarding liver function and a muscle enzyme (creatine kinase) have been observed.
How To Store Simvastatin Bluefish?
- Keep simvastatin bluefish out of sight and reach of children.
- No special storage instructions.
- Do not use simvastatin bluefish after the expiry date which is stated on the label and carton after EXP. 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 that are no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Content Declaration
- The active substance is simvastatin.
- Each film-coated tablet contains 10 mg of simvastatin.
- Each film-coated tablet contains 20 mg of simvastatin.
- Each film-coated tablet contains 40 mg of simvastatin.
- Each film-coated tablet contains 80 mg of simvastatin
- Other ingredients are:
- Tablet core:
- Butylhydroxyanisole (E320)
- Ascorbic acid (E300)
- Citric acid monohydrate (E330)
- Microcrystalline cellulose (E460a)
- Pregelatinized corn starch
- Lactose monohydrate
- Magnesium stearate (E470B)
- Drag:
- Hypromellose
- Hydroxypropylcellulose (E464)
- Titanium dioxide (E171)
- Talk (E553b).
- Yellow iron oxide (E172) – for 10 and 20 mg
- Red iron oxide (E172) – for 10, 20, 40 and 80 mg
- Tablet core:
What The Medicine Looks Like And The Contents Of The Pack
- Film-coated tablet.
- Simvastatin Bluefish 10 mg film-coated tablets:
- Light pink, round, and biconvex with “A” embossed on one side and “01” on the other side.
- Simvastatin Bluefish 20 mg film-coated tablets:
- Light pink, round, and biconvex with “A” embossed on one side and “02” on the other side.
- Simvastatin Bluefish 40 mg film-coated tablets:
- Pink, round, and biconvex with “A” embossed on one side and “03” on the other side.
- Simvastatin Bluefish 80 mg film-coated tablets:
- Pink, capsule-shaped, and biconvex with “A” embossed on one side and “04” on the other side.
- Simvastatin Bluefish 10, 20, 40 and 80 mg film-coated tablets are available in blister packs of 10, 14, 28, 30, 50, 56, 84, 98 and 100 tablets.
- Not all pack sizes may be marketed.
Marketing Authorisation Holder
- This medicinal product is authorized under the European Economic Area under the names:
- Austria: Simvastatin Bluefish 10/20/40 mg Film Tablet
- Finland: Simvastatin Bluefish 10/20/40/80 mg tablet, calvapäällysteine
- Germany: Simvastatin Bluefish 10/20/40/80 mg Film Tablet
- Ireland: Simvastatin Bluefish 10/20/40 mg film-coated tablets
- Norway: Simvastatin Bluefish 10/20/40/80 mg tablets, film-coated
- Poland: Simvastatin Bluefish
- Portugal: Simvastatin Bluefish
- Sweden: Simvastatin Bluefish 10/20/40/80 mg film-coated tablets
- Netherlands: Simvastatin Bluefish 10/20/40/80 mg film-coated tablet
- Iceland: Simvastatin Bluefish 10/20/40/80 mg film-coated tablets