Simorion

Patient Information Leaflet: Read this leaflet carefully before taking this medicine, as it contains important information for you.

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
Please read all of this leaflet carefully before you start taking this medicine, because 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 you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Simorion is and what it is used for
2. What you need to know before you take 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 Simorion is and what it is used for

Simorion contains the active substance simvastatin. Simorion is used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simorion increases the level of "good" cholesterol (HDL cholesterol). Simorion belongs to a class of medicines known as statins.
Cholesterol is one of several fatty substances present in the blood. Total cholesterol levels are mainly determined by LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the arteries, forming atherosclerotic plaque. The buildup of atherosclerotic plaque may eventually lead to narrowing of the arteries. This narrowing can slow down or block 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 buildup of "bad" cholesterol in the arteries and protects against heart disease.
Triglycerides are another form of fat in the blood that may increase the risk of heart disease.
While taking this medicine, you should follow a cholesterol-lowering diet.
Simorion is used as an addition to a cholesterol-lowering diet in patients who have:
elevated blood cholesterol levels (primary hypercholesterolemia), or
elevated blood fat levels (mixed hyperlipidemia),
a genetic condition (homozygous familial hypercholesterolemia) causing high blood cholesterol levels (patients may also be undergoing other treatments),
coronary heart disease or a high risk of developing this disease (due to diabetes, history of stroke, or other vascular diseases). Simvastatin may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.
In most people, high blood cholesterol does not cause any immediate symptoms. Your doctor can measure your cholesterol levels with a simple blood test. You should visit your doctor regularly to monitor your cholesterol levels and discuss your target levels with them.

2. Important information before using Simorion

When not to use Simorion:
if the patient is allergic (hypersensitive) to simvastatin or any of the other
components 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 medicines containing any of the following active substances simultaneously:

• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections),
• erythromycin, clarithromycin, or telithromycin (used to treat infections),
• HIV protease inhibitors, e.g. indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used in the treatment of HIV infections),
• boceprevir or telaprevir (medicines used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol levels),
• 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 uterine cavity),
• or if the patient is currently taking or has taken within the last 7 days oral or injectable fusidic acid (used to treat bacterial infections).
  Taking fusidic acid together with Simorion may lead to serious muscle problems (rhabdomyolysis).
  Do not take Simorion at a dose higher than 40 mg if the patient is taking lomitapide (used to treat a severe and rare genetic disorder affecting cholesterol levels).
  If in doubt whether a medicine currently taken by the patient is listed above, consult a doctor.

Warnings and precautions
Before starting Simorion, tell your doctor or pharmacist:
about all medical conditions, including allergies;
if you consume large amounts of alcohol;
if you currently have or have had liver disease (taking Simorion may be contraindicated);
if you are scheduled for surgery (temporary discontinuation of Simorion tablets may be necessary);
if you are of Asian descent, as a different dose may be appropriate for you;
if you have or have had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), as statins may occasionally worsen symptoms or lead to the development of myasthenia (see section 4).

Your doctor should perform a blood test before starting Simorion treatment and whenever liver-related symptoms occur during treatment. This allows monitoring of liver function.
Your doctor may also wish to perform blood tests to monitor liver function after starting Simorion therapy.

Your doctor will closely monitor you during treatment with this medicine if you have diabetes or are at risk of developing diabetes. You are at increased risk of developing diabetes if you have high blood sugar and fat levels, are overweight, and have high blood pressure.

Inform your doctor if you have a severe form of lung disease.

If you experience unexplained muscle pain, tenderness, or weakness, seek medical advice immediately. This is essential because, although rare, muscle disorders can be serious—for example, muscle breakdown leading to kidney damage. Deaths have occurred very rarely.

The risk of muscle breakdown is higher with higher doses of Simorion, especially at the 80 mg dose. The risk is also higher in certain patients. You should contact your doctor immediately in the following cases:
if you consume large amounts of alcohol;
if you have kidney problems;
if you have thyroid problems;
if you are over 65 years of age;
if you are female;
if you have previously experienced muscle problems during treatment with cholesterol-lowering medicines known as statins or fibrates;
if you or a close family member suffer from an inherited muscle disease.

You should also inform your doctor if you experience persistent muscle weakness. Additional diagnostic tests and further treatment may be necessary.

Children and adolescents
The safety and efficacy of Simorion have been studied in boys aged 10–17 years and in girls who have had their first menstrual period at least one year prior (see section 3 "How to take Simorion"). Simorion has not been studied in children under 10 years of age. For additional information, consult your doctor.

Simorion and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, especially those containing any of the following active substances. Taking Simorion with any of these medicines may increase the risk of muscle disorders (some of which are already listed under "When not to use Simorion"):

If oral fusidic acid is required to treat a bacterial infection, temporary discontinuation of Simorion will be necessary. Your doctor will advise when it is safe to restart Simorion.
Concomitant use of Simorion 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 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 uterine cavity)
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, e.g. 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 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 related to heart disease, or other heart conditions)
lomitapide (used to treat a severe and rare genetic disorder affecting cholesterol levels)
daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). Muscle-related adverse effects may be increased when this medicine is taken during simvastatin treatment. Your doctor may decide to temporarily discontinue Simorion
colchicine (used to treat gout)
ticagrelor (an antiplatelet medicine).

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take, including those available without a prescription. In particular, inform your doctor if you are taking medicines containing the following active substances:
medicines containing substances that prevent blood clotting, e.g. warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
fenofibrate (also used to lower cholesterol levels)
niacin (also used to lower cholesterol levels)
rifampicin (used to treat tuberculosis).

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

Simorion with food and drink
Grapefruit juice contains at least one component that alters how the body processes certain medicines, including Simorion. Grapefruit juice should be avoided.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before using this medicine. If you become pregnant while taking Simorion, stop treatment immediately and contact your doctor. Do not use Simorion during breastfeeding, as it is not known whether the medicine is excreted in breast milk.

Before taking any medicine, consult your doctor or pharmacist.

Driving and using machines
Simorion is not expected to affect your ability to drive or operate machinery. However, consider that dizziness may occur in some individuals after taking Simorion.

Simorion contains lactose
Simorion contains lactose (monohydrate) in the following amounts: approximately 66.5 mg per 10 mg tablet, 132.9 mg per 20 mg tablet, 265.9 mg per 40 mg tablet, and 531.8 mg per 80 mg tablet. If you have been previously diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Simorion

Your doctor will determine the appropriate strength of the medicine based on your condition, any other medications you are currently taking, and your individual risk status.
This medicine should always be used exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
While taking Simorion, you should follow a cholesterol-lowering diet.

Dosage:
The recommended dose is one tablet of Simorion 10 mg, 20 mg, 40 mg, or 80 mg taken orally once daily.

Adults:
The usual 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, up to a maximum dose of 80 mg once daily. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose, especially if you are taking certain of the medicines mentioned above, or if you have certain kidney diseases.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and high risk of heart disease, in whom adequate cholesterol control could not be achieved with lower doses.

Use in children and adolescents:
For children (aged 10–17 years), the usual recommended starting dose is 10 mg once daily in the evening. The maximum recommended daily dose is 40 mg.

Method of administration and duration of treatment:
Simorion should be taken in the evening. It can be taken with or without food. Simorion should be taken continuously unless your doctor advises otherwise.
If your doctor has prescribed Simorion to be taken together with another cholesterol-lowering medicine containing bile acid sequestrants, Simorion should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Overdose of Simorion
If you (or someone else) accidentally take too much of this medicine, contact your doctor or hospital immediately.

Missed dose of Simorion
Do not take a double dose to make up for a missed dose. Take the next dose at the usual time the following day.

Stopping Simorion
Consult your doctor or pharmacist before stopping, as cholesterol levels may rise again.
If you have any further 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 everybody will experience them.

The following serious, rarely observed adverse effects have been reported (may occur in up to 1 in 1,000 people):

If any of the following serious adverse effects occur, stop taking the medicine immediately and contact your doctor or go to the nearest hospital emergency department.

• muscle pain, tenderness, weakness or cramps. In rare cases, muscle disorders may be severe, including rhabdomyolysis leading to kidney damage; deaths have been reported very rarely.

• hypersensitivity reactions, including:

  • swelling of the face, tongue and throat, which may cause difficulty in breathing (angioedema)
  • severe muscle pain, usually in the shoulder and hip joints
  • rash with weakness of limbs and neck muscles
  • joint pain or inflammation (rheumatoid-type muscle pain)
  • inflammation of blood vessels
  • unusual bruising, skin rashes and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes
  • shortness of breath and malaise
  • symptoms resembling systemic lupus erythematosus (including rash, joint problems and effects on blood cells)
  • liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare)

• pancreatitis, often with severe abdominal pain.

The following serious adverse effects have been reported very rarely (may occur in up to 1 in 10,000 people):

• severe allergic reactions which may cause difficulty in breathing or dizziness (anaphylactic reaction)
• rash, which may appear on the skin or in the mouth (lichenoid drug eruptions)
• muscle rupture
• gynaecomastia (enlargement of breasts in men).

The following adverse effects have been reported rarely (may occur in up to 1 in 1,000 people):

• low number of red blood cells (anaemia)
• numbness or weakness of the hands and feet
• headache, ringing in the ears, dizziness
• gastrointestinal disturbances (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• fatigue
• memory loss, confusion
• blurred vision and visual disturbances.

The following adverse effects have been reported very rarely (may occur in up to 1 in 10,000 people):

• sleep disorders
• memory disorders.

The following adverse effects have also been reported, but their frequency cannot be estimated from the available data (frequency unknown):

• erectile dysfunction
• depression
• lung inflammation causing breathing problems, including persistent cough and/or shortness of breath or fever
• tendon problems, sometimes complicated by tendon rupture
• myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease causing weakness of eye muscles).

You should speak to your doctor if you experience weakness in the hands or feet that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Additional possible adverse effects reported during the use of some statins include:

• sleep disorders, including nightmares
• sexual dysfunction
• diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, overweight and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.
• muscle pain, tenderness or persistent muscle weakness, which may not resolve after discontinuation of Simorion (frequency unknown).

Laboratory tests: Elevated results in certain liver function tests and liver enzymes (creatine kinase) have been observed.

Reporting of adverse effects

If any adverse effects occur, including any adverse effects not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 responsible entity.

Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Simorion

Keep this medicine out of the sight and reach of children.
No special precautions for storage of the medicinal product are required.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Simorion contains

• The active substance is simvastatin. Each tablet contains 10, 20, 40 or 80 mg of simvastatin.
• The other ingredients of the tablet core are: Acidum ascorbicum, lactose monohydrate, microcrystalline cellulose, pregelatinised starch, maize, 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) (for 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, embossed with the mark “SI” on one side and “10” on the other.
• 20 mg tablet: Light pink, round, biconvex, film-coated tablets, embossed with the mark “SI” on one side and “20” on the other.
• 40 mg tablet: Pink, round, biconvex, film-coated tablets, embossed with the mark “SI” on one side and “40” on the other.
• 80 mg tablet: Pink, capsule-shaped, biconvex, film-coated tablets, embossed with the mark “SI” on one side and “80” on the other.

Pack sizes: 28 or 98 tablets. Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Finland: Simvastatin Orion
Poland: Simorion