SIMVASTATIN BLUEFISH

Patient Information Leaflet

Simvastatin Bluefish, 40 mg, film-coated tablets
(Simvastatinum)
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of contents:

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 levels of cholesterol in the blood, "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 consists mainly of LDL cholesterol and HDL cholesterol fractions.
LDL cholesterol is often called "bad" cholesterol because it can deposit on the walls of arteries, forming atherosclerotic plaques. Eventually, these plaques can narrow the arteries, thereby restricting or blocking blood flow to vital organs such as the heart and brain. Blocked blood flow may lead to heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the deposition of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that may contribute to an increased risk of heart disease.
While taking this medicine, you should follow an appropriate diet to help lower cholesterol levels.
Simvastatin Bluefish is used together with diet in the following cases:

• Elevated cholesterol levels in the blood (primary hypercholesterolemia) or elevated fat levels in the blood (mixed hyperlipidemia);
• An inherited disease (homozygous familial hypercholesterolemia), which causes high cholesterol levels in the blood. Other treatment methods may also be used;
• Ischemic heart disease (IHD) or high risk of IHD (due to diabetes, previous stroke, or other blood vessel diseases). Simvastatin Bluefish may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

Most people do not have direct symptoms of high cholesterol levels. Your doctor can determine your cholesterol level with a simple blood test. You should attend regular check-ups with your doctor, monitor your cholesterol levels, and discuss your treatment goals with your doctor.

2. Important information before taking Simvastatin Bluefish
When not to take Simvastatin Bluefish

• If you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).
• If you currently have liver problems.
• During pregnancy or breastfeeding.
• If you are 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),
  • protease inhibitors of HIV virus, such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors used in the treatment of HIV infection),
  • boceprevir and telaprevir (used in the treatment of hepatitis C),
  • nefazodone (used to treat depression),
  • cobicistat,
  • gemfibrozil (used to reduce cholesterol levels),
  • cyclosporine (used in organ transplant patients),
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).
• if you are currently taking or have taken within the last 7 days the medicine fusidic acid (a medicine used to treat bacterial infections) orally or by injection. Taking fusidic acid together with Simvastatin Bluefish may lead to serious muscle problems (rhabdomyolysis).

Do not take Simvastatin Bluefish in doses higher than 40 mg if you are taking lomitapide (used to treat a severe and rare genetic cholesterol disorder).
If you are unsure whether you are taking any of the medicines listed above, please consult your doctor.

Warnings and precautions
Tell your doctor:

• about all your medical conditions, including allergies,
• if you consume large amounts of alcohol,
• if you have had liver disease in the past. Taking Simvastatin Bluefish may not be appropriate,
• if you are scheduled for surgery. You may need to temporarily stop taking Simvastatin Bluefish,
• if you are of Asian descent, as a different dose may be suitable for you.

Your doctor should perform a blood test before starting Simvastatin Bluefish and during treatment if you have any liver disorders. The test will assess liver function.
Your doctor may also perform blood tests to evaluate liver function after starting Simvastatin Bluefish.
While taking this medicine, your doctor will closely monitor whether you have diabetes or are at risk of developing diabetes. The risk of developing diabetes is higher if you have high blood sugar and fat levels, overweight, or high blood pressure.
Inform your doctor if you have serious lung diseases.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. In rare cases, muscle-related symptoms may be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.
The risk of muscle damage is greater when taking higher doses of Simvastatin Bluefish, particularly the 80 mg dose. The risk of muscle tissue breakdown is also higher in certain patients. Talk to your doctor if:

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid disorders,
• you are 65 years of age or older,
• you are female,
• you have previously experienced muscle problems during treatment with cholesterol-lowering medicines called statins or fibrates,
• you or a close relative have been diagnosed with inherited muscle disorders.

Inform your doctor or pharmacist 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 in girls who have started menstruation at least one year earlier (see section 3 "How to take Simvastatin Bluefish"). Studies on the use of Simvastatin Bluefish in children under 10 years of age have not been conducted. For further information, please consult your doctor.

Simvastatin Bluefish and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, especially those containing any of the following active substances. Taking simvastatin together with the medicines listed below increases the risk of muscle-related problems (some of which were mentioned in the previous section "When not to take Simvastatin Bluefish"):

• If oral fusidic acid is necessary for the treatment of a bacterial infection, you must temporarily stop taking this medicine. Your doctor will inform you when it is safe to restart Simvastatin Bluefish. Taking Simvastatin Bluefish together with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). Additional information on rhabdomyolysis is provided in section 4.
• Cyclosporine (often used in organ transplant patients).
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the tissue lining 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 reduce cholesterol levels).
• Erythromycin, clarithromycin or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir and saquinavir (used in the treatment of AIDS).
• Antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C).
• 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 related to heart disease, or other heart conditions).
• Lomitapide (used to treat a severe and rare genetic cholesterol disorder).
• Colchicine (used to treat gout).

Similarly, tell your doctor or pharmacist about all medicines you are currently taking, including those available without a prescription. It is especially important to inform your doctor about any of the following medicines you are currently taking, containing any of the following active substances:

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

Inform any doctor prescribing a new medicine that you are taking Simvastatin Bluefish.

Simvastatin Bluefish with food and drink
Grapefruit juice contains one or more compounds that affect the action of certain medicines in the body, including Simvastatin Bluefish. You should avoid drinking grapefruit juice.

Pregnancy and breastfeeding
Do not take Simvastatin Bluefish if you are pregnant, planning a pregnancy, or suspect you may be pregnant. If you become pregnant while taking Simvastatin Bluefish, stop taking it immediately and contact your doctor.
Do not breastfeed while taking Simvastatin Bluefish, as it is not known whether the medicine passes into breast milk.

Before starting any new medicine, consult your doctor or pharmacist.

Driving and using machines
You should not expect Simvastatin Bluefish to affect your ability to drive or operate machinery. However, bear in mind 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 previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Simvastatin Bluefish

Your doctor will determine the appropriate dose of this medicine for you, depending on your current treatment and individual risk factors.
This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you have any doubts,
you should consult your doctor or pharmacist.
While being treated with Simvastatin Bluefish, you should follow a standard cholesterol-lowering diet.

Dosage:
The recommended dose of Simvastatin Bluefish is 1 tablet of 10 mg, 20 mg, 40 mg or 80 mg taken once daily by mouth.

Adults:
The starting dose is 10 mg, 20 mg or, in some cases, 40 mg once daily. Your doctor may adjust the dose after at least 4 weeks of treatment up to a maximum of 80 mg once daily. Do not take more than 80 mg per day.
Your doctor may recommend lower doses, especially if you are taking any of the medicines listed above or have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and high risk of heart and vascular disease, in whom the target cholesterol level has not been achieved with a lower dose.

Use in children and adolescents:
For children (aged 10–17 years), the usual starting 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. It can be taken with or without food. Simvastatin Bluefish should be taken continuously until your doctor advises you to stop.
If your doctor has prescribed Simvastatin Bluefish together with another cholesterol-lowering medicine containing any bile acid-binding agent, Simvastatin Bluefish should be taken at least 2 hours before or 4 hours after taking the bile acid-binding medicine.

Taking more Simvastatin Bluefish than prescribed
Contact your doctor or pharmacist immediately.

If you miss a dose of Simvastatin Bluefish
Do not take a double dose to make up for the missed dose.
Take the next dose of Simvastatin Bluefish at the usual time the following day.

Stopping Simvastatin Bluefish
You should consult your doctor or pharmacist before stopping, as cholesterol levels may rise again.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

The following terms have been used to describe the frequency of occurrence of adverse 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 adverse effects, occurring rarely, have been observed.
If any of the following serious adverse effects occur, stop taking the medicine immediately and consult a doctor or go to the nearest hospital emergency department:

• Muscle pain, tenderness, weakness, or cramps, muscle rupture (very rare). In rare cases, muscle problems may have serious consequences, including breakdown of muscle tissue leading to kidney damage; in very rare cases, death has occurred.
• Hypersensitivity (allergic) reactions including:
• swelling of the face, tongue, and throat, which may cause difficulty in breathing (angioedema),
• severe muscle pain, usually in the shoulders and hips,
• rash with muscle weakness in the limbs and neck,
• rash which may affect the skin or ulceration of the oral mucosa (lupus-like lesions) (very rare),
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels,
• abnormal bruising, skin rash, and swelling (dermatomyositis), urticaria, photosensitivity, fever, redness,
• difficulty breathing (dyspnoea) or malaise,
• symptoms of lupus-like syndrome (including rash, joint disorders, and blood cell abnormalities).
• Hepatitis with symptoms such as yellowing of the skin and eyes, itching, dark-coloured urine or pale-coloured stools, fatigue or weakness, loss of appetite, liver failure (very rare).
• Pancreatitis, often with severe abdominal pain.

The following very rare serious adverse effects have been reported:

• Severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis).
• Gynaecomastia (enlargement of breasts in males).

The following adverse effects have also been observed rarely:
Low number of red blood cells (anaemia).
Numbness or weakness in arms and legs.
Headache, tingling sensation, dizziness.
Blurred vision and visual disturbances.
Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
Rash, itching, hair loss.
Weakness.
Sleep disorders (very rare).
Poor memory (very rare), memory loss, confusion.

The following adverse effects have also been observed, however, their frequency cannot be determined from the available data (frequency not known):

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

Possible adverse effects observed during use of other statins:

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

Laboratory test results:
Elevated results in certain blood tests assessing liver function and increased activity of muscle enzymes (creatine kinase) have been observed.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Simvastatin Bluefish

Keep this medicine out of the sight and reach of children.
No special precautions for storage are required.
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 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 protect
the environment.

6. Contents of the pack and other information

What Simvastatin Bluefish contains
The active substance is simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
Other components of the medicine are:
Tablet core:
Butylated hydroxyanisole (E 320)
Ascorbic acid
Monohydrate citric acid
Microcrystalline cellulose
Pregelatinized starch, corn
Lactose monohydrate
Magnesium stearate
Film coating:
Opadry Pink 20A54211:
Hypromellose 6 cP
Hydroxypropylcellulose
Titanium dioxide (E 171)
Talc
Iron oxide red (E 172)

What Simvastatin Bluefish looks like and contents of the pack
Film-coated tablets.
Round, biconvex, pink film-coated tablets, marked with "A" on one side and "03" on the other side.
Simvastatin Bluefish 40 mg film-coated tablets are available in blister packs containing 10, 14, 28, 30,
50, 56, 84, 98 or 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder / Manufacturer
Marketing Authorisation 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 authorised in the European Economic Area countries under the following names:
Austria: Simvastatin Bluefish 40 mg Filmtabletten
Netherlands: Simvastatine Bluefish 40 mg filmomhulde tabletten
Ireland: Simvastatin Bluefish 40 mg film-coated tablets
Iceland: Simvastatin Bluefish 40 mg filmuhúðaðar töflur
Germany: Simvastatin Bluefish 40 mg Filmtabletten
Norway: Simvastatin Bluefish 40 mg tabletter, filmdrasjerte
Poland: Simvastatin Bluefish
Portugal: Simvastatina Bluefish
Sweden: Simvastatin Bluefish 40 mg filmdragerade tabletter