Simvastatin Bluefish

Leaflet accompanying the packaging: patient information

Simvastatin Bluefish, 20 mg, coated tablets

(Simvastatin)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet:

• 1. What Simvastatin Bluefish is and what it is 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 pack and other information.

1. What Simvastatin Bluefish is and what it is 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 made up of LDL cholesterol and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up on the walls of arteries, forming plaques. Eventually, these plaques can cause the arteries to narrow, restricting or blocking blood flow to vital organs such as the heart and brain. Restricted blood flow can lead to heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood that can increase the risk of developing heart disease.
While taking this medicine, the patient should follow a standard 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 treatments 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, high cholesterol levels do not cause direct symptoms. The doctor can determine cholesterol levels with a simple blood test. Regular check-ups with the doctor, cholesterol level checks, and discussions with the doctor about goals are necessary.

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 following active substances:
• 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 after organ transplants),
• 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 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 taking any of the above medicines, the doctor should be consulted.

Warnings and precautions

The doctor should be informed:

• about all conditions, including allergies,
• about consuming large amounts of alcohol,
• about a history of liver disease. Taking Simvastatin Bluefish may not be suitable,
• about planned surgery. It may be necessary to stop taking 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 will 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.
Severe lung diseases should be reported to the doctor.

Immediate medical attention is required in case of:

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 breakdown is also higher in some patients. The doctor should be consulted 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 previously experienced 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.

The doctor or pharmacist should also be informed if muscle weakness persists. Additional tests and medications may be necessary to diagnose and treat this condition.

Children and adolescents

The safety and efficacy of Simvastatin Bluefish have been studied in boys aged 10-17 years and girls who have started menstruation (at least one year before treatment). No studies have been conducted in children under the age of 10. For further information, the doctor should be consulted.

Simvastatin Bluefish and other medicines

The doctor or pharmacist should be told about all medicines the patient is currently taking or plans to take, including those containing any of the following active substances. Taking simvastatin with the following medicines increases the risk of muscle problems (some of which are mentioned in the previous section "When not to take Simvastatin Bluefish"):

• If it is necessary to take fusidic acid orally for bacterial infection treatment, Simvastatin Bluefish should be temporarily stopped. The doctor will inform when it is safe to restart Simvastatin Bluefish. Taking Simvastatin Bluefish with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information on rhabdomyolysis can be found in section 4.
• Cyclosporine (often used in patients after organ transplants).
• 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 (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 related to heart disease, or other heart diseases).
• Lomitapide (used to treat a severe and rare genetic cholesterol disorder).
• Colchicine (used to treat gout).

Similarly, the doctor or pharmacist should be informed about all recently taken medicines, including those available without a prescription. It is especially important to inform the doctor about all currently taken medicines, including those containing 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).

The doctor or pharmacist should also be informed about taking Simvastatin Bluefish when prescribing a new medicine.

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. Grapefruit juice should be avoided.

Pregnancy and breastfeeding

Simvastatin Bluefish should not be taken if the patient is pregnant, plans to become pregnant, or suspects they are pregnant. If the patient becomes pregnant while taking Simvastatin Bluefish, they should stop taking it and consult their doctor.
Simvastatin Bluefish should not be taken while breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicines, the doctor or pharmacist should be consulted.

Driving and using machines

No effect of Simvastatin Bluefish on the ability to drive or use machines is expected. However, it should be taken into account that some people may experience dizziness after taking Simvastatin Bluefish.

Simvastatin Bluefish contains lactose

Simvastatin Bluefish contains lactose monohydrate (milk sugar). If the patient has been informed about intolerance to some sugars in the past, they should consult their doctor before taking this medicine.

3. How to take Simvastatin Bluefish

The doctor will determine the suitable dose of Simvastatin Bluefish for the patient, depending on the current treatment and individual risk.
This medicine should always be taken as directed by the doctor or pharmacist. In case of doubt, the doctor or pharmacist should be consulted.
While taking Simvastatin Bluefish, the patient should follow a standard diet to lower cholesterol levels.
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. The 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.
The doctor may recommend lower doses, especially if the patient is taking some of the medicines listed above or has 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 daily 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 the doctor recommends stopping it.
If the doctor has prescribed Simvastatin Bluefish with another cholesterol-lowering medicine containing a bile acid sequestrant, Simvastatin Bluefish should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simvastatin Bluefish than recommended

The doctor or pharmacist should be consulted.

Missing a dose of Simvastatin Bluefish

A double dose should not be taken to make up for a missed dose.
The next dose of Simvastatin Bluefish should be taken the next day at the usual time.

Stopping Simvastatin Bluefish treatment

The doctor or pharmacist should be consulted, as cholesterol levels may rise again.
In case of any doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Simvastatin Bluefish can cause side effects, although not everybody gets them.
The following terms are 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)
Not known (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, treatment should be stopped and a doctor or the emergency department of the nearest hospital should be consulted immediately:

• 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.
• Allergic reactions (anaphylaxis) 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 muscle weakness and neck and limb stiffness,
• rash that may occur on the skin or mouth ulcers (drug-induced lupus-like reactions) (very rare),
• muscle pain or inflammation of the joints (polymyalgia rheumatica),
• inflammation of blood vessels,
• abnormal bruising, skin rash, and swelling (dermatomyositis), hives, skin sensitivity to light, fever, redness,
• breathing difficulties (dyspnea) or general feeling of being unwell,
• symptoms of lupus-like syndrome (including rash, joint disorders, and blood disorders).
• Liver inflammation 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 breathing difficulties or dizziness (anaphylaxis).
• Gynecomastia (breast enlargement in men).

The following side effects have been observed rarely:
A small number of red blood cells (anemia).
Numbness or weakness of the arms and legs.
Headache, tingling, dizziness.
Blurred vision and vision disturbances.
Digestive 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 been reported, but their frequency cannot be estimated from the available data (frequency not known):

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

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

• Sleep disorders, including nightmares.
• Sexual disorders.
• Diabetes: it is more likely if the patient has high blood sugar and fat levels, is overweight, or has high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
• Muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simvastatin Bluefish (frequency not known).

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 any side effects occur, including those not listed in this leaflet, the doctor or pharmacist should be informed. 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.
Reporting side effects will help gather 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.
This medicine should not be taken 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. The pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Simvastatin Bluefish contains

The active substance of Simvastatin Bluefish is simvastatin. Each coated tablet contains 20 mg of simvastatin.
The other ingredients of the medicine are:
Tablet 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
Yellow iron oxide (E 172)
Red iron oxide (E 172)

What Simvastatin Bluefish looks like and contents of the pack

Coated tablets.
Round, biconvex, light pink coated tablets, with "A" engraved on one side and "02" on the other side.
Simvastatin Bluefish 20 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 20 mg Filmtabletten
Netherlands:
Simvastatine Bluefish 20 mg filmomhulde tabletten
Ireland:
Simvastatin Bluefish 20 mg film-coated tablets
Iceland:
Simvastatin Bluefish 20 mg filmuhúðaðar töflur
Germany:
Simvastatin Bluefish 20 mg Filmtabletten
Norway:
Simvastatin Bluefish 20 mg tabletter, filmdrasjerte
Poland:
Simvastatin Bluefish
Portugal:
Simvastatina Bluefish
Sweden:
Simvastatin Bluefish 20 mg filmdragerade tabletter
Date of last revision of the leaflet:18.02.2020