Simvastatin Bluefish

Leaflet attached to the packaging: patient information

Simvastatin Bluefish, 10 mg, coated tablets

(Simvastatinum)

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Simvastatin Bluefish and what is it used for.
• 2. Important information before taking Simvastatin Bluefish.
• 3. How to take Simvastatin Bluefish.
• 4. Possible side effects.
• 5. How to store Simvastatin Bluefish.
• 6. Contents of the packaging and other information.

1. What is Simvastatin Bluefish and what is it used for

Simvastatin Bluefish contains the active substance simvastatin. Simvastatin Bluefish is used to lower blood cholesterol levels, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides. Additionally, Simvastatin Bluefish increases the level of "good" cholesterol (HDL cholesterol). Simvastatin Bluefish belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol is mainly composed of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate on the walls of arteries, forming plaques. Eventually, these plaques can cause narrowing of the arteries, resulting in restricted or blocked blood flow to vital organs, such as the heart and brain. Restricted blood flow can lead to a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the accumulation of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood, which can contribute to an increased risk of heart disease.
While taking this medicine, the patient should follow a proper diet to lower cholesterol levels.
Simvastatin Bluefish is used in conjunction with a diet in the following cases:

• high blood cholesterol levels (primary hypercholesterolemia) or high blood fat levels (mixed hyperlipidemia);
• a hereditary disease (homozygous familial hypercholesterolemia) that causes high blood cholesterol levels. Other treatment methods may also be used;
• ischemic heart disease (IHD) or a high risk of IHD (due to diabetes, a history of stroke, or other vascular diseases). Simvastatin Bluefish may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

In most people, there are no direct symptoms of high cholesterol levels. A doctor can determine cholesterol levels with a simple blood test. You should regularly visit your doctor for check-ups, monitor your cholesterol levels, and discuss your goals with your doctor.

2. Important information before taking Simvastatin Bluefish

When not to take Simvastatin Bluefish

• If the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• If the patient currently has liver problems.
• During pregnancy or breastfeeding.
• If the patient is taking one or more of the following medicines, containing at least one of the active substances listed below:
• 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 to treat HIV infection),
• boceprevir and telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol levels),
• cyclosporine (used in patients with transplanted organs),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus).
• if the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. Taking fusidic acid in combination with Simvastatin Bluefish may lead to serious muscle problems (rhabdomyolysis).

Simvastatin Bluefish should not be taken in a dose greater than 40 mg if the patient is taking lomitapide (used to treat a severe and rare genetic cholesterol disorder).
In case of doubt about the use of any of the above-mentioned medicines, you should consult a doctor.

Warnings and precautions

You should inform your doctor:

• about all your ailments, including allergies,
• about consuming large amounts of alcohol,
• about having had liver disease in the past. Taking Simvastatin Bluefish may not be suitable.
• about planned surgery. It may be necessary to interrupt the use of Simvastatin Bluefish for a short time.
• if the patient is of Asian origin, as a different dose may be suitable for this patient.

The doctor should perform a blood test before starting Simvastatin Bluefish and during treatment if the patient has any liver problems. The purpose of the test is to assess liver function.
The doctor may also perform blood tests to assess liver function after starting Simvastatin Bluefish.
While taking this medicine, the doctor will carefully monitor whether the patient has diabetes or is at risk of developing diabetes. The risk of developing diabetes is likely if the patient has high blood sugar and fat levels, is overweight, or has high blood pressure.
You should inform your doctor about serious lung diseases.

You should contact your doctor immediately if you experience:

unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to
kidney damage, and in very rare cases, death.
The risk of muscle damage is higher when taking higher doses of Simvastatin Bluefish, particularly the 80 mg dose. The risk of muscle tissue breakdown is also higher in some patients. You should discuss with your doctor if:

• the patient consumes large amounts of alcohol,
• the patient has kidney problems,
• the patient has thyroid problems,
• the patient is 65 years or older,
• the patient is female,
• the patient has ever had muscle problems while taking cholesterol-lowering medicines called statins or fibrates,
• the patient or a close relative has been diagnosed with a hereditary muscle disorder.

You should also inform your doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Children and adolescents

The safety and efficacy of Simvastatin Bluefish have been studied in boys aged 10-17 years and in girls who have started menstruating (menstruation) at least one year earlier (see section 3 "How to take Simvastatin Bluefish"). No studies have been conducted on the use of Simvastatin Bluefish in children under the age of 10. For further information, you should consult a doctor.

Simvastatin Bluefish and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or plan to take, including those that are available without a prescription. It is particularly important to inform your doctor about all medicines you are currently taking, including those that contain any of the following active substances:

• If it is necessary to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily interrupt the use of this medicine. The doctor will inform you when it is safe to restart Simvastatin Bluefish. Taking Simvastatin Bluefish with fusidic acid may rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.
• Cyclosporine (often used in patients with transplanted organs).
• Danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus).
• Medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol levels).
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors used to treat AIDS).
• Antiviral medicines used to treat hepatitis C virus infection, such as boceprevir, telaprevir, elbasvir, or grazoprevir.
• Nefazodone (used to treat depression).
• Medicines containing the active substance cobicistat.
• Amiodarone (used to treat irregular heart rhythm).
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases).
• Lomitapide (used to treat a severe and rare genetic cholesterol disorder).
• Colchicine (used to treat gout).

You should also tell your doctor or pharmacist about all medicines you have taken recently, including those available without a prescription. It is particularly important to inform your doctor about all medicines you are currently taking, including those that contain any of the following active substances:

• Medicines containing active substances that prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines).
• Fenofibrate (also used to lower cholesterol levels).
• Niacin (also used to lower cholesterol levels). Rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes a new medicine about the use of Simvastatin Bluefish.

Simvastatin Bluefish with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Simvastatin Bluefish. You should avoid consuming grapefruit juice.

Pregnancy and breastfeeding

You should not take Simvastatin Bluefish if you are pregnant, plan to become pregnant, or suspect you are pregnant. If you become pregnant while taking Simvastatin Bluefish, you should stop taking it and consult your doctor.
You should not breastfeed while taking Simvastatin Bluefish, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicines, you should consult a doctor or pharmacist.

Driving and using machines

You should not expect Simvastatin Bluefish to affect your ability to drive or use machines. However, you should take into account that some people may experience dizziness after taking Simvastatin Bluefish.

Simvastatin Bluefish contains lactose

Simvastatin Bluefish contains lactose monohydrate (milk sugar). If you have been informed that you have an intolerance to some sugars, you should consult your doctor before taking this medicine.

3. How to take Simvastatin Bluefish

Your doctor will determine the dose of Simvastatin Bluefish suitable for you, depending on your current treatment and individual risk.
This medicine should always be taken as directed by your doctor or pharmacist. In case of doubt, you should consult your doctor or pharmacist.
While taking Simvastatin Bluefish, you should follow a standard cholesterol-lowering diet.
Dosage:
The recommended dose of Simvastatin Bluefish is one 10 mg, 20 mg, 40 mg, or 80 mg tablet taken once a day, orally.
Adults:
The initial dose is 10, 20, or in some cases 40 mg per day. Your doctor may adjust the dose after at least 4 weeks of treatment to a maximum of 80 mg per day. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking some of the medicines listed above or have certain kidney problems.
A dose of 80 mg is recommended for use only in adult patients with very high cholesterol levels and a high risk of heart and vascular diseases, who have not achieved the target cholesterol level with a lower dose.

Use in children and adolescents:

For children (aged 10-17 years), the recommended initial dose is 10 mg once a day in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Simvastatin Bluefish should be taken in the evening. The medicine can be taken with or without food. Simvastatin Bluefish should be taken continuously until your doctor advises you to stop it.
If your doctor has prescribed Simvastatin Bluefish with another cholesterol-lowering medicine containing a bile acid sequestrant, you should take Simvastatin Bluefish at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simvastatin Bluefish than recommended

You should contact your doctor or pharmacist.

Missing a dose of Simvastatin Bluefish

You should not take a double dose to make up for a missed dose.
You should take the next dose of Simvastatin Bluefish the next day at the usual time.

Stopping the use of Simvastatin Bluefish

You should consult your doctor or pharmacist, as your cholesterol levels may rise again.
In case of any doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvastatin Bluefish can cause side effects, although not everybody gets them.
The following terms have been used to describe the frequency of side effects:
Rare (may affect up to 1 in 1,000 people)
Very rare (may affect up to 1 in 10,000 people)
Unknown (frequency cannot be estimated from the available data)
The following serious side effects have been observed rarely.

In case of the following serious side effects, you should stop taking the medicine and consult your doctor or go to the emergency department of the nearest hospital:

• Muscle pain, tenderness, weakness, or cramps, muscle rupture (very rare). In rare cases, muscle problems can have serious consequences, including muscle breakdown leading to kidney damage; in very rare cases, death has occurred.
• Allergic reactions (allergic) including:
• swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
• severe muscle pain, usually in the shoulders and hips,
• rash with muscle weakness and neck stiffness,
• rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid reactions) (very rare),
• joint pain or inflammation,
• vasculitis,
• abnormal bruising, skin rash, and swelling, photosensitivity, fever, and flushing,
• difficulty breathing (dyspnea) or feeling unwell,
• symptoms of lupus-like syndrome (including rash, joint disorders, and blood disorders).
• Hepatitis with symptoms such as yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare).
• Pancreatitis, often with severe abdominal pain.

The following very rare but serious side effect has been reported:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis).
• Gynecomastia (breast enlargement in men).

The following side effects have been observed rarely:
Low red blood cell count (anemia).
Numbness or weakness in the arms and legs.
Headache, tingling sensation, dizziness.
Blurred vision and vision disturbances.
Gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting).
Rash, itching, hair loss.
Weakness.
Sleep disorders (very rare).
Poor memory (very rare), memory loss, confusion.
The following side effects have also been reported, but their frequency cannot be estimated from the available data (frequency unknown):

• Erectile dysfunction.
• Depression.
• Pneumonia, causing breathing problems, including chronic cough and (or) shortness of breath and fever.
• Tendon disorders, sometimes complicated by tendon rupture.

The following side effects have been observed in the use of other statins:

• Sleep disorders, including nightmares.
• Sexual disorders.
• Diabetes: it is more likely if you have high blood sugar and fat levels, are overweight, or have high blood pressure. Your doctor will monitor your health while taking this medicine.
• Muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simvastatin Bluefish (frequency unknown).

Lab test results:
Increased results of some blood tests assessing liver function and increased muscle enzyme activity (creatine kinase) have been observed.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: + 48 22 49 21 309,
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simvastatin Bluefish

The medicine should be stored out of sight and reach of children.
No special precautions for storage are necessary.
Do not use this medicine after the expiry date stated on the blister pack and carton after "EXP" or "Expiry date". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Simvastatin Bluefish contains

The active substance of Simvastatin Bluefish is simvastatin. Each coated tablet contains 10 mg of simvastatin.
The other ingredients of the medicine are:
Core:
Butylhydroxyanisole (E 320)
Ascorbic acid
Citric acid monohydrate
Microcrystalline cellulose
Maize starch paste
Lactose monohydrate
Magnesium stearate
Coating:
Opadry Pink 20A54239:
Hypromellose 6 cP
Hydroxypropylcellulose
Titanium dioxide (E 171)
Talc
Iron oxide yellow (E 172)
Iron oxide red (E 172)

What Simvastatin Bluefish looks like and contents of the pack

Coated tablets.
Round, biconvex, light pink coated tablets, with the inscription "A" on one side and "01" on the other side.
Simvastatin Bluefish 10 mg coated tablets are available in blisters containing 10, 14, 28, 30, 50, 56, 84, 98, or 100 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder/Manufacturer

Marketing authorization holder

Bluefish Pharmaceuticals AB, P.O. Box 49013, 100 28 Stockholm, Sweden.

Manufacturer

Bluefish Pharmaceuticals AB, Gävlegatan 22, 113 30 Stockholm, Sweden.

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria:
Simvastatin Bluefish 10 mg Filmtabletten
Netherlands:
Simvastatine Bluefish 10 mg filmomhulde tabletten
Ireland:
Simvastatin Bluefish 10 mg film-coated tablets
Iceland:
Simvastatin Bluefish 10 mg filmuhúðaðar töflur
Germany:
Simvastatin Bluefish 10 mg Filmtabletten
Norway:
Simvastatin Bluefish 10 mg tabletter, filmdrasjerte
Poland:
Simvastatin Bluefish
Portugal:
Simvastatina Bluefish
Sweden:
Simvastatin Bluefish 10 mg filmdragerade tabletter
Date of last revision of the leaflet:18.02.2020