Simorion

Leaflet attached to the packaging: information for the user

Simorion, 10 mg, film-coated tablets

Simorion, 20 mg, film-coated tablets

Simorion, 40 mg, film-coated tablets

Simorion, 80 mg, film-coated tablets

Simvastatin

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 passed on 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 Simorion and what is it used for
• 2. Important information before taking Simorion
• 3. How to take Simorion
• 4. Possible side effects
• 5. How to store Simorion
• 6. Contents of the pack and other information

1. What is Simorion and what is it used for

Simorion contains the active substance simvastatin. Simorion is used to reduce the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. Additionally, Simorion increases the level of "good" cholesterol (HDL cholesterol). Simorion belongs to a class of medicines called statins.
Cholesterol is one of several fatty substances present in the blood. The total cholesterol level is mainly due to LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the arteries, forming a plaque. The accumulation of plaque can eventually lead to narrowing of the arteries. This narrowing can cause a reduction or blockage of blood flow to important organs such as the heart and brain. Blockage of blood flow can lead to heart attack and stroke.
HDL cholesterol is often referred to as "good" cholesterol because it limits the buildup of bad cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that can increase the risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simorion is used as a complementary measure to a cholesterol-lowering diet, if the patient has:

high blood cholesterol (primary hypercholesterolemia) or high blood fat (mixed hyperlipidemia),

a congenital disease (homozygous familial hypercholesterolemia) that causes an increase in blood cholesterol levels (the patient may also be undergoing other treatments),

coronary heart disease or a high risk of developing it (due to diabetes, a history of stroke or other blood vessel disease). Simvastatin may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.
Most people do not experience immediate symptoms of high blood cholesterol. The doctor may perform a blood test to measure cholesterol levels, by ordering a simple blood test. You should regularly visit your doctor, monitor your cholesterol levels, and discuss your goals with your doctor.

2. Important information before taking Simorion

When not to take Simorion:

if the patient is 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 the patient currently has liver problems;

if the patient is pregnant or breastfeeding;

if the patient is taking certain medicines at the same time, including:

• 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 infections),
• boceprevir or telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporine (used in patients who have had organ transplants),
• danazol (a synthetic hormone used to treat endometriosis - a condition 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 (used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simorion may lead to serious muscle problems (rhabdomyolysis).
Simorion should not be taken in a dose greater than 40 mg if the patient is taking lomitapide (used to treat a rare genetic cholesterol disorder).
In case of doubt about whether a medicine taken by the patient has been listed above, the patient should consult their doctor.

Warnings and precautions

Before starting to take Simorion, the patient should tell their doctor or pharmacist:

about all their illnesses, including allergies

about consuming large amounts of alcohol

about having liver disease now or in the past (taking Simorion may be contraindicated)

about planned surgery (it may be necessary to temporarily discontinue taking Simorion tablets)

if the patient is of Asian origin, as a different dose may be suitable for this patient

if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).
The doctor should perform a blood test before starting Simorion therapy and when the patient experiences liver symptoms during treatment with this medicine. This is to check liver function.
The doctor may also want to perform a blood test to check liver function after starting Simorion therapy.
During therapy with this medicine, the doctor will closely monitor the patient if they have diabetes or are at risk of developing it. The patient is at risk of developing diabetes if they have high blood sugar and fat levels, are overweight, and have high blood pressure.
The patient should inform their doctor if they have severe lung disease.

In case of unexplained pain, tenderness, or muscle weakness, the patient should immediately consult their doctor. This is necessary because in rare cases, muscle disorders can be serious, such as muscle breakdown leading to kidney damage. Very rarely

deaths have also occurred.

The risk of muscle breakdown is higher with higher doses of Simorion, especially with a dose of 80 mg. The risk of muscle breakdown is also higher in some patients. In the following cases, the patient should immediately talk to their doctor:
if the patient consumes large amounts of alcohol;

if the patient has kidney problems;

if the patient has thyroid problems;

if the patient is over 65 years old;

if the patient is a woman;

if the patient has ever had muscle problems during treatment with cholesterol-lowering medicines called statins or fibrates;

if the patient or their close relative has a hereditary muscle disease.
The patient should also tell their doctor if they experience persistent muscle weakness. Additional diagnostic tests and additional treatment may be necessary.

Children and adolescents

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

Simorion and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take, including those that contain any of the following active substances. Taking Simorion with any of these medicines may increase the risk of muscle disorders (some of which are listed in the "When not to take Simorion" section):

if it is necessary to take fusidic acid orally for the treatment of bacterial infections, it will be necessary to temporarily discontinue taking this medicine. The doctor will inform when it is safe to restart taking Simorion.
The doctor will be informed when it is safe to restart taking Simorion.

Taking Simorion 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 who have had organ transplants)

danazol (a synthetic hormone used to treat endometriosis - a condition 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)

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 (used to treat hepatitis C virus infection)

nefazodone (used to treat depression)

medicines containing the active substance cobicistat

amiodarone (used to treat heart rhythm disorders)

verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)

lomitapide (used to treat a rare genetic cholesterol disorder)

daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that side effects affecting the muscles may be greater when this medicine is taken with simvastatin. The doctor may decide to stop taking Simorion for a while

colchicine (used to treat gout)

tikagrelor (an antiplatelet medicine).
The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This includes medicines that are available without a prescription. In particular, the patient should inform their doctor about taking medicines that contain the following active substances:

medicines that prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)

fenofibrate (also used to lower cholesterol)

niacin (also used to lower cholesterol)

rifampicin (used to treat tuberculosis).
The patient should also inform their doctor about taking Simorion when their doctor prescribes any new medicine.

Simorion with food and drink

Grapefruit juice contains at least one ingredient that changes the way the body uses some medicines, including Simorion. The patient should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine. If the patient becomes pregnant while taking Simorion, they should stop treatment and contact their doctor immediately. Simorion should not be taken during breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Before taking any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

The patient should not expect Simorion to affect their ability to drive or use machines. However, they should take into account that some people may experience dizziness after taking Simorion.

Simorion contains lactose

Simorion contains lactose (in the form of lactose monohydrate) in an amount of approximately: 66.5 mg in a 10 mg tablet, 132.9 mg in a 20 mg tablet, 265.9 mg in a 40 mg tablet, and 531.8 mg in an 80 mg tablet. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Simorion

The doctor will determine the appropriate dose of Simorion for the patient, depending on their condition, the medicines they are currently taking, and their individual risk factors.
This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
While taking Simorion, the patient should follow a cholesterol-lowering diet.
Dosage:
The recommended dose is one Simorion tablet of 10 mg, 20 mg, 40 mg, or 80 mg per day, taken orally.
Adults:
The usual starting dose is 10 mg, 20 mg, or in some cases 40 mg per day. The doctor may change the dose after at least 4 weeks to a maximum dose of 80 mg per day. The patient should not take a dose greater than 80 mg per day.
The doctor may recommend lower doses, especially if the patient is taking certain medicines listed above or if they have certain kidney diseases.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease, who have not been able to achieve adequate cholesterol levels with smaller doses.
Use in children and adolescents:
In children (aged 10-17 years), the recommended starting dose is usually 10 mg once daily, in the evening. The maximum recommended daily dose is 40 mg.
Method and duration of administration:
Simorion should be taken in the evening. The medicine can be taken with or without food. Simorion should be taken continuously until the doctor decides to stop it.
If the doctor has prescribed Simorion to be taken with another cholesterol-lowering medicine that contains an ion-exchange resin, Simorion should be taken at least 2 hours before or 4 hours after taking the ion-exchange resin.

Taking a higher dose of Simorion than recommended

If the patient (or someone else) has accidentally taken too much of this medicine, they should immediately contact their doctor or hospital.

Missing a dose of Simorion

The patient should not take a double dose to make up for a missed dose. They should take the next dose of Simorion at the usual time the next day.

Stopping treatment with Simorion

The patient should consult their doctor or pharmacist, as their cholesterol levels may increase again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Simorion can cause side effects, although not everybody gets them.
The following serious side effects have been reported rarely ( may affect up to 1 in 1,000 people):

In case of any of the following serious side effects, the patient should stop taking Simorion and contact their doctor immediately or go to the nearest hospital emergency department.

muscle pain, tenderness, weakness, or cramps. In rare cases, muscle disorders can be serious, including muscle breakdown leading to kidney damage; very rarely
deaths have also occurred.

allergic reactions, including:

• swelling of the face, tongue, and throat, which can make breathing difficult (angioedema)
• severe muscle pain, usually in the shoulder and hip joints
• rash with weakness of the limbs and neck muscles
• muscle or joint pain (rheumatoid-like muscle pain)
• vasculitis
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, increased sensitivity of the skin to the sun, fever, hot flushes
• shortness of breath (dyspnea) and malaise
• a disease similar to lupus (including rash, joint disorders, and effects on blood cells)

liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark urine, or light-colored stools, feeling of tiredness or weakness, loss of appetite; liver failure (very rare)

pancreatitis, often with severe abdominal pain.
The following serious side effects have been reported very rarely ( may affect up to 1 in 10,000 people):

severe allergic reactions that can cause breathing difficulties or dizziness (anaphylactic reaction)

a rash that can appear on the skin or sores in the mouth (lichenoid eruptions)

muscle rupture

gynecomastia (breast enlargement in men).
The following side effects have been reported rarely ( may affect up to 1 in 1,000 people):

low red blood cell count (anemia)

numbness or weakness of the hands and feet

headache, ringing in the ears, dizziness

digestive disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)

rash, itching, hair loss

weakness

memory loss, confusion

blurred vision and vision disturbances.
The following side effects have been reported very rarely ( may affect up to 1 in 10,000 people):

sleep disorders

memory disorders.
The following side effects have also been reported, but their frequency cannot be estimated from the available data ( frequency not known):

erectile dysfunction

depression

inflammation of the lungs causing breathing problems, including long-term cough and/or shortness of breath or fever;

tendon problems, sometimes complicated by tendon rupture

myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)

myasthenic syndrome (a disease that causes muscle weakness in the eyes).
The patient should talk to their doctor if they experience weakness of the hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects reported during the use of some statins include:

sleep disorders, including nightmares

sexual disorders

diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, are overweight, and have high blood pressure. The doctor will monitor the patient's condition while they are taking this medicine.

muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simorion (frequency not known).
Laboratory tests:
Increased results of some laboratory tests of liver function and liver enzymes (creatine kinase) have been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store Simorion

The medicine should be stored out of sight and reach of children.
There are no special precautions for the storage of this medicinal product.
The patient should not take this medicine after the expiry date stated on the carton and blister. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist 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 Simorion contains

• The active substance of Simorion is simvastatin. Each tablet contains 10, 20, 40, or 80 mg of simvastatin,
• The other ingredients of the tablet core are: ascorbic acid, lactose monohydrate, microcrystalline cellulose, maize starch, magnesium stearate, citric acid monohydrate, butylhydroxyanisole (E 320).
• The other ingredients of the coating are: hydroxypropylcellulose, hypromellose 6cP, titanium dioxide (E 171), talc, iron oxide red (E 172), iron oxide yellow (E 172) (10 mg and 20 mg tablets). For 40 mg and 80 mg tablets, the ingredients are the same, except that iron oxide yellow (E 172) is not present.

What Simorion looks like and contents of the pack

• 10 mg tablet: Light pink, round, biconvex, film-coated tablets with the inscription "SI" on one side and "10" on the other.
• 20 mg tablet: Light pink, round, biconvex, film-coated tablets with the inscription "SI" on one side and "20" on the other.
• 40 mg tablet: Pink, round, biconvex, film-coated tablets with the inscription "SI" on one side and "40" on the other.
• 80 mg tablet: Pink, capsule-shaped, biconvex, film-coated tablets with the inscription "SI" on one side and "80" on the other.

Package sizes: 28 or 98 tablets. Not all package sizes may be marketed.

Marketing authorization holder

Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland

Manufacturer

Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
To obtain more detailed information on this medicine, the patient should contact the local representative of the marketing authorization holder:
Orion Pharma Poland Sp. z o. o.
[email protected]

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

Finland: Simvastatin Orion
Poland: Simorion
Date of last revision of the leaflet:17.05.2023