Simvasterol

Leaflet accompanying the packaging: patient information

Simvasterol, 10 mg, film-coated tablets

Simvasterol, 20 mg, film-coated tablets

Simvasterol, 40 mg, film-coated tablets

Simvastatin

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Simvasterol and what is it used for

Simvasterol belongs to a group of medicines called statins.
Simvasterol is used to reduce the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood.
Additionally, Simvasterol increases the level of "good" cholesterol (HDL cholesterol).
Cholesterol is one of several fatty substances present in the blood. Total cholesterol consists mainly 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 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 that can contribute to the increased risk of developing heart disease.
During treatment with Simvasterol, a low-cholesterol diet should be followed.
Simvasterol, in combination with a diet, is used if:

• there is an elevated level of cholesterol in the blood (primary hypercholesterolemia) or an elevated level of fats in the blood (mixed hyperlipidemia);
• there is a family history of high cholesterol (homozygous familial hypercholesterolemia), a genetic disorder that causes high cholesterol levels. Other treatment methods may also be used in this case.
• there is coronary heart disease (ischemic heart disease) or a high risk of developing coronary heart disease (due to diabetes, a history of stroke, or other vascular diseases). Simvasterol may prolong life by reducing the risk of developing heart disease, regardless of cholesterol levels.

In most people, there are no direct symptoms of high cholesterol levels. A doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of cholesterol levels, and discussion of treatment goals with a doctor are necessary.

2. Important information before taking Simvasterol

When not to take Simvasterol

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
• if there are current liver function disorders;
• if the patient is pregnant or breastfeeding;
• if the patient is taking one or more of the following medicines:
• itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections);
• erythromycin, clarithromycin, or telithromycin (antibiotics used to treat bacterial infections);
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections);
• boceprevir, telaprevir (medicines used to treat hepatitis C);
• nefazodone (a medicine used to treat depression);
• cobicistat (used to increase the effect of antiretroviral medicines);
• gemfibrozil (a medicine used to lower cholesterol levels);
• cyclosporine (a medicine used in organ transplant patients);
• 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 taking or has taken fusidic acid (an antibiotic) orally or by injection within the last 7 days. Taking fusidic acid with Simvasterol may lead to severe muscle damage (rhabdomyolysis).

Simvasterol 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 the use of any of the above-mentioned medicines, consult a doctor.

Warnings and precautions

Before starting treatment with Simvasterol, discuss it with a doctor or pharmacist.
Inform the doctor:

• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or myasthenia

gravis (a disease that causes eye muscle weakness), as statins can sometimes exacerbate symptoms of the disease or lead to the development of myasthenia (see section 4).

• about all current and past illnesses, including allergies.
• about excessive alcohol consumption.
• about a history of liver disease. In this case, Simvasterol may be contraindicated.
• about planned surgery. In this case, it may be necessary to discontinue Simvasterol for a period of time.
• if the patient is of Asian origin, as a different dose may be suitable for this patient.

Before starting treatment, the doctor should order a blood test to check liver function.
Also, after starting treatment with Simvasterol, the doctor may consider it necessary to perform blood tests to check liver function.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Inform the doctor if the patient has severe lung disease.

Immediately consult a doctor if the patient experiences unexplained muscle pain, tenderness, or weakness, as in rare cases, this can lead to serious muscle problems, including muscle tissue breakdown, which can cause kidney damage

(rhabdomyolysis), and in very rare cases, can be fatal.
The risk of muscle tissue breakdown is higher in patients taking Simvasterol in higher doses, particularly 80 mg. The risk of muscle tissue breakdown is also higher in some patients. Inform the 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, including statins or fibrates;
• the patient or their close relatives have had a genetic muscle disorder.

Also, inform the 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 have been studied in boys aged 10-17 years and in girls who have had their first menstrual period at least one year earlier (see section 3, "How to take Simvasterol"). Simvastatin has not been studied in children under the age of 10. For more information, consult a doctor.

Simvasterol and other medicines

Inform the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. The following medicines may interact with Simvasterol:

• if it is necessary to treat a bacterial infection with fusidic acid orally or by injection, Simvasterol should be temporarily discontinued. The doctor will inform the patient when it is safe to restart Simvasterol. Taking Simvasterol with fusidic acid can lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

Taking simvastatin with the following medicines increases the risk of muscle problems (some of which are listed in the "When not to take Simvasterol" section):

• cyclosporine (a medicine used in organ transplant patients);
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the lining of the uterus grows outside the uterus);
• medicines such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (medicines used to treat fungal infections);
• fibrates, such as gemfibrozil and bezafibrate (medicines used to lower cholesterol levels);
• erythromycin, clarithromycin, telithromycin, or fusidic acid (antibiotics used to treat bacterial infections). Do not take fusidic acid while taking Simvasterol. More information on rhabdomyolysis can be found in section 4.
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat AIDS);
• boceprevir, telaprevir, elbasvir, or grazoprevir (medicines used to treat hepatitis C);
• nefazodone (a medicine used to treat depression);
• medicines containing the active substance cobicistat (used to increase the effect of antiretroviral medicines);
• amiodarone (a medicine used to treat heart rhythm disorders);
• verapamil, diltiazem, or amlodipine (medicines used to treat high blood pressure, chest pain related to heart disease, or other heart conditions);
• lomitapide (used to treat a rare genetic cholesterol disorder);
• colchicine (a medicine used to treat gout).

Inform the doctor or pharmacist about all recently taken medicines, including those available without a prescription, especially:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, acenocoumarol, or ticagrelor (anticoagulant medicines);
• fenofibrate (another medicine used to lower cholesterol levels);
• niacin (nicotinic acid) (another medicine used to lower cholesterol levels), especially if the patient is of Asian origin;
• rifampicin (a medicine used to treat tuberculosis).

Also, inform any doctor prescribing a new medicine about the use of Simvasterol.

Simvasterol with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medicines in the body, including Simvasterol. Therefore, grapefruit juice should be avoided, as it may increase the risk of muscle damage.

Pregnancy and breastfeeding

Simvasterol is contraindicated in pregnancy.
The safety of simvastatin has not been established in pregnant women.
If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before taking this medicine. If the patient becomes pregnant while taking simvastatin, they should stop taking it and consult a doctor.
There is no data on the excretion of simvastatin into breast milk. Since many medicines are excreted into breast milk and can cause serious side effects, breastfeeding should be avoided while taking simvastatin.

Driving and using machines

Simvasterol does not affect the ability to drive or use machines.
However, rare cases of dizziness have been reported in patients taking simvastatin (see section 4). If such symptoms occur, the patient should not drive or operate machines that require attention.

Simvasterol contains lactose monohydrate

Simvasterol 10 mg: each film-coated tablet contains 65.73 mg of lactose monohydrate.
Simvasterol 20 mg: each film-coated tablet contains 131.46 mg of lactose monohydrate.
Simvasterol 40 mg: each film-coated tablet contains 262.92 mg of lactose monohydrate.
If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take Simvasterol

This medicine should always be taken as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
During treatment with Simvasterol, a low-cholesterol diet should be followed.
Dosage:
The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of Simvasterol, taken orally, once a day.
Adults
The initial dose is 10 mg, 20 mg, 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 prescribe lower doses, especially if the patient is taking certain medicines listed above or has kidney problems.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels and a high risk of developing heart disease, who have not achieved the target cholesterol level with a lower dose.
Children and adolescents
In children (aged 10-17 years with heterozygous familial hypercholesterolemia), the initial dose is 10 mg once a day, in the evening. The maximum recommended dose is 40 mg per day.

Method of administration

Simvasterol should be taken in the evening. Simvasterol tablets should be swallowed with water.
The medicine can be taken with or without food.
If the doctor prescribes taking Simvasterol with bile acid sequestrants, it should be taken at least 2 hours before or at least 4 hours after taking the bile acid sequestrants.

Duration of treatment

Treatment with simvastatin is long-term. The duration of treatment is determined by the doctor.

Taking a higher dose of Simvasterol than recommended

In case of accidental overdose, immediately consult a doctor or pharmacist.
Several cases of overdose have been reported. None of the patients experienced specific symptoms, and all recovered without consequences. In case of overdose, general measures should be taken.

Missing a dose of Simvasterol

If the patient realizes they have missed a dose, they should take it as soon as possible. However, if it is already time for the next dose, the missed dose should be skipped, and the next dose should be taken at the scheduled time.
Do not take a double dose to make up for the missed tablet.

Stopping treatment with Simvasterol

Consult a doctor, as cholesterol levels may increase again.
In case of further doubts about the use of this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvasterol can cause side effects, although not everyone will experience them.
The frequency of possible side effects listed below is defined using the following convention:

• Rare (occurs in less than 1 in 1,000 patients)
• Very rare (occurs in less than 1 in 10,000 patients)
• Unknown (frequency cannot be estimated from available data).

The following rare, serious side effects have been reported:

If any of these serious side effects occur, stop taking the medicine and immediately consult a doctor or go to the emergency department of the nearest hospital:

• muscle pain, tenderness, weakness, or cramps; in rare cases, these symptoms can be severe and associated with muscle tissue breakdown, leading to kidney damage; very rare cases of death have been reported.
• allergic reactions (allergic) in the form of:
• swelling of the face, tongue, and throat, which can cause breathing difficulties (angioedema);
• severe muscle pain, usually in the shoulder and hip area;
• rash with muscle weakness and neck and limb pain;
• joint pain or inflammation (polymyalgia rheumatica);
• inflammation of blood vessels (vasculitis);
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, sun sensitivity, fever;
• shortness of breath (dyspnea) and malaise;
• symptoms of lupus-like disease (including rash, joint pain, and blood cell changes);
• increased eosinophil count - a type of white blood cell;
• increased ESR;
• liver inflammation with symptoms of jaundice, itching, dark urine, or pale stools, fatigue, or loss of appetite;
• pancreatitis, often with severe abdominal pain.

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

• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis).

Other side effects:

Rare:

• decreased red blood cell count (anemia);
• numbness or weakness in the arms or legs;
• headache, tingling, dizziness;
• rash, itching, hair loss;
• weakness;
• memory loss, confusion;
• increased muscle enzyme activity (creatine kinase) in the blood and abnormal liver function test results, increased alkaline phosphatase;
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting);
• blurred vision and visual disturbances.

Very rare:

• insomnia;
• memory disorders;
• liver failure.
• rash that can occur on the skin or mouth ulcers (drug-induced lichenoid reactions);
• muscle damage;
• gynecomastia (breast enlargement in men).

Frequency unknown:

• erectile dysfunction;
• depression;
• inflammation of the lungs, causing breathing difficulties, including persistent cough and (or) shortness of breath or fever;
• tendon disorders, sometimes complicated by tendon rupture;
• persistent muscle weakness
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes eye muscle weakness) If the patient experiences muscle weakness, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath, they should consult a doctor.

The following side effects have also been reported with some statins:

• sleep disturbances, including nightmares;
• sexual disorders;
• diabetes. The risk of developing diabetes is higher in people with high blood sugar and fat levels, overweight, and high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Reporting side effects

If side effects occur, including any not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 can help gather more information on the safety of the medicine.

5. How to store Simvasterol

Store in the original packaging. Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month.
The inscription on the packaging after the abbreviation EXP indicates the expiry date, and after the abbreviation Lot/LOT, it indicates the batch number.
Medicines should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medicines. This will help protect the environment.

6. Contents of the packaging and other information

What Simvasterol contains

• The active substance of Simvasterol is simvastatin in doses of 10 mg, 20 mg, and 40 mg.
• Other ingredients are: tablet core:lactose monohydrate, microcrystalline cellulose, pregelatinized starch, butylhydroxyanisole (E320), ascorbic acid, citric acid, anhydrous colloidal silica, talc, magnesium stearate. tablet coating:hypromellose, hypromellose, iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171), talc, povidone K-30.

What Simvasterol looks like and contents of the packaging

Simvasterol 10 mg is a film-coated tablet, pink-beige in color, oval, and biconvex, with a score line on one side. The tablet can be divided into two halves.
Simvasterol 20 mg is a film-coated tablet, orange in color, oval, and biconvex.
Simvasterol 40 mg is a film-coated tablet, pink in color, oval, and biconvex.
The tablets are packaged in blisters and then in a cardboard box containing:
28 tablets (10 mg and 20 mg tablets)
14 or 28 tablets (40 mg tablets).
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Polpharma S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01
Date of last revision of the leaflet:April 2023