SIMCOVAS 40 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Simcovas, 20 mg, film-coated tablets
3. Simcovas, 40 mg, film-coated tablets
   1. It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What is Simcovas and what is it used for
5. Important information before taking Simcovas
   1. When not to take Simcovas
   2. Warnings and precautions
   3. Immediate medical attention should be sought if the patient experiences unexplained muscle pain, tenderness, or weakness. In rare cases, serious muscle problems can occur, including muscle tissue breakdown, which can lead to kidney damage; very rare cases of death have been reported.
   4. Children and adolescents
   5. Simcovas and other medicines
   6. Simcovas with food and drink
   7. Pregnancy and breastfeeding
   8. Driving and using machines
   9. Simcovas contains lactose monohydrate
6. How to take Simcovas
   1. Use in children and adolescents
   2. Taking a higher dose of Simcovas than recommended
   3. Stopping treatment with Simcovas
7. Possible side effects
   1. If the patient experiences any of these serious side effects, they should stop taking the medicine and immediately consult their doctor or go to the emergency department of the nearest hospital
   2. Reporting side effects
8. How to store Simcovas
9. Contents of the packaging and other information
   1. What Simcovas contains:
   2. What Simcovas looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder
   5. Manufacturer
   6. To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:
   7. Date of last revision of the leaflet: May 2023

Leaflet accompanying the packaging: patient information

Simcovas, 20 mg, film-coated tablets

Simcovas, 40 mg, film-coated tablets

Simvastatin

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept, so it can be re-read if necessary.
• 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 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 inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Simcovas and what is it used for

The active substance of Simcovas is simvastatin. Simcovas is a medicine used to lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. Additionally, Simcovas increases the level of "good" cholesterol (HDL cholesterol). Simcovas belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances found in the bloodstream. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of the arteries, forming plaque. If the plaque builds up, it can lead to narrowing of the arteries. This narrowing can slow down or block the flow of blood to vital organs, such as the heart and brain. Blocking the flow of blood can lead to a heart attack or stroke.
HDL cholesterol is often referred to as "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the walls of the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
While taking this medicine, the patient should remain on a low-cholesterol diet.
Simcovasis used as a supplement to a cholesterol-lowering diet in cases of:

• high blood cholesterol levels (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• hereditary disorders (homozygous familial hypercholesterolemia) that cause high blood cholesterol levels. Other treatments may also be used;
• ischemic heart disease (coronary artery disease) or a high risk of developing ischemic heart disease (due to diabetes, a history of stroke, or other vascular diseases). Simcovas may prolong the patient's life by reducing the risk of developing heart disease, regardless of their cholesterol level.

In most patients, there are no direct symptoms of high cholesterol levels. The doctor may assess the cholesterol level by ordering a simple blood test. The patient should regularly attend follow-up visits, monitor their blood cholesterol levels, and discuss their treatment goals with their doctor.

2. Important information before taking Simcovas

When not to take Simcovas

• 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 active liver disease
• during pregnancy and breastfeeding
• if the patient is taking any of the following medicines:
• itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors used to treat HIV infection)
• boceprevir or telaprevir (medicines used to treat hepatitis C)
• nefazodone (an antidepressant)
• cobicistat
• gemfibrozil (a medicine used to lower cholesterol levels)
• cyclosporine (a medicine usually 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). Simcovas should not be taken in doses higher than 20 mg if the patient is taking lomitapide (used to treat a rare genetic disorder of high cholesterol levels).

In case of doubt about whether a medicine being taken is listed above, the doctor should be consulted.

Warnings and precautions

Before starting to take Simcovas, the patient should discuss it with their doctor or pharmacist.
The patient should inform their doctor:

• about all their illnesses, including allergies
• about consuming large amounts of alcohol
• about having had liver disease in the past. Taking Simcovas may not be suitable.
• about planned surgery. In this case, it may be necessary to stop taking Simcovas for a while.
• if the patient is of Asian origin, as a different dose may be suitable for this patient.
• if the patient is taking or has taken within the last 7 days a medicine called fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simcovas can lead to serious muscle problems (rhabdomyolysis).
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate the symptoms of the disease or lead to the development of myasthenia (see section 4).

The doctor should perform a blood test before starting to take Simcovas and during treatment if the patient has any liver problems.
The test checks the liver function.
After starting treatment with Simcovas, the doctor may also consider it necessary to perform blood tests to check liver function.
During treatment with this medicine, the doctor will closely monitor the patient for symptoms of diabetes or the risk of developing diabetes. Patients at risk of developing diabetes are those with high blood sugar and fat levels, overweight, and high blood pressure.

Immediate medical attention should be sought if the patient experiences unexplained muscle pain, tenderness, or weakness. In rare cases, serious muscle problems can occur, including muscle tissue breakdown, which can lead to kidney damage; very rare cases of death have been reported.

The risk of muscle tissue breakdown is higher in patients taking Simcovas in higher doses, especially at a dose of 80 mg. The risk of muscle tissue breakdown is also higher in certain groups of people. The patient should consult their doctor if:

• they consume large amounts of alcohol
• they have kidney disease
• they have thyroid function disorders
• they are over 65 years old
• the patient is female
• they have ever had muscle problems while taking lipid-lowering medicines, including statins or fibrates
• they or a close relative have been diagnosed with hereditary muscle disorders.

The doctor or pharmacist should also be informed 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 Simcovas have been studied in boys aged 10-17 years and girls who have been menstruating for at least one year (see section 3: "How to take Simcovas").
No studies have been conducted on the use of Simcovas in children under the age of 10. For more detailed information, the patient should consult their doctor.

Simcovas 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:

• If it is necessary to take fusidic acid orally for the treatment of a bacterial infection, it will be necessary to temporarily stop taking this medicine. The doctor will inform when it is safe to restart taking Simcovas.

Simcovas with food and drink

Grapefruit juice contains one or more ingredients that affect the action of some medicines in the body, including Simcovas. Grapefruit juice should be avoided.

Pregnancy and breastfeeding

Simcovas should not be taken if the patient is pregnant, trying to become pregnant, or suspects they may be pregnant. If the patient becomes pregnant while taking Simcovas, they should stop taking the medicine immediately and consult their doctor.
Simcovas 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

It is unlikely that Simcovas will affect the ability to drive or use machines. However, it should be taken into account that some people may experience dizziness after taking Simcovas.

Simcovas contains lactose monohydrate

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Simcovas

The doctor will determine the appropriate dose of Simcovas for the patient, depending on their condition, treatment, and individual risk assessment.
This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, the doctor or pharmacist should be consulted.
While taking Simcovas, the patient should follow a low-cholesterol diet.
Dosage:
The recommended dose is 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin, taken orally, once a day.
Adults:
The usual starting dose is 10 mg, 20 mg, or in some cases 40 mg per day.
The doctor may adjust the dosage after at least 4 weeks, up to a maximum dose of 80 mg once a day. The patient should not take more than 80 mg per day.
The doctor may prescribe lower doses, especially if the patient is taking any of the medicines listed above or has certain kidney diseases.
A dose of 80 mg is recommended only for adult patients with very high blood cholesterol levels and a high risk of developing heart disease, who have not reached their target cholesterol level with a lower dose.

Use in children and adolescents

The usual starting dose for children (aged 10-17 years) is 10 mg per day in the evening.
The maximum recommended dose is 40 mg per day.
Method of administration:
Simcovas should be taken in the evening. The medicine can be taken with or without food. Simcovas should be taken continuously until the doctor decides to stop it.
If the doctor has prescribed Simcovas with another cholesterol-lowering medicine that contains a bile acid sequestrant, Simcovas should be taken at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simcovas than recommended

• The doctor or pharmacist should be contacted. Missing a dose of Simcovas-
• A double dose should not be taken to make up for a missed dose. The next dose of Simcovas should be taken the next day at the usual time.

Stopping treatment with Simcovas

• The doctor or pharmacist should be consulted, as the cholesterol level may increase again.

If the patient has any questions about using this product, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Simcovas can cause side effects, although not everybody gets them.
The following terms are used to describe how often side effects are reported:

• rare (may affect up to 1 in 1,000 people)
• very rare (may affect up to 1 in 10,000 people)
• frequency not known (frequency cannot be estimated from the available data)

The following serious side effects have been reported rarely.

If the patient experiences any of these serious side effects, they should stop taking the medicine and immediately consult their doctor or go to the emergency department of the nearest hospital

• muscle pain, tenderness, weakness, or cramps, muscle rupture (very rare). In rare cases, these conditions can be severe and lead to muscle tissue breakdown (rhabdomyolysis) and subsequent kidney damage; very rare cases of death have been reported.
• allergic reactions, including:
• swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema)
• severe muscle pain, usually in the arms and hips (polymyalgia rheumatica)
• rash with muscle weakness in the arms and neck
• rash that can occur on the skin or ulcers in the mouth (drug-induced lupus-like reactions) (very rare)
• joint pain or inflammation
• inflammation of blood vessels
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, sensitivity to sunlight, fever, flushing
• shortness of breath and feeling unwell
• symptoms of lupus-like disease (including rash, joint pain, and blood cell changes)
• inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue or weakness, loss of appetite; liver failure (very rare)
• inflammation of the pancreas, often with severe abdominal pain.

The following serious side effect has been reported very rarely:

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men) Rarely, the following side effects have also been reported:
• decreased red blood cell count (anemia)
• numbness or weakness in the hands and feet
• headache, feeling of tingling, dizziness
• blurred vision, vision disturbances
• gastrointestinal disorders (abdominal pain, constipation, bloating with gas, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• sleep disturbances (very rare)
• poor memory (very rare), memory loss, confusion

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 difficulty breathing, including persistent cough and/or shortness of breath or fever
• tendon disorders, sometimes complicated by tendon rupture
• muscle weakness that persists
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

The following possible side effects have been observed with some statins:

• sleep disturbances, including nightmares
• sexual disorders
• diabetes: the risk of developing diabetes is more likely if the patient has high blood sugar and fat levels, is overweight, and has high blood pressure. The doctor will monitor the patient's condition while taking this medicine.

Laboratory test results
Elevated muscle enzyme activity (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should inform their doctor, pharmacist, or nurse. 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 181C, 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, more information can be gathered on the safety of the medicine.

5. How to store Simcovas

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month stated.
The medicine should not be stored at temperatures above 30°C.
The medicine should be stored in its original packaging to protect it from light and moisture.
HDPE containers: after opening, store at a temperature below 25°C and use within 6 months.
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 packaging and other information

What Simcovas contains:

The active substance is simvastatin. Each film-coated tablet contains 20 mg or 40 mg of simvastatin.
The other ingredients of the medicine are:
Tablet core:lactose monohydrate, microcrystalline cellulose, maize starch, butylhydroxyanisole (E 320), ascorbic acid, anhydrous citric acid, colloidal anhydrous silica, talc, magnesium stearate.
Coating:hypromellose (Pharmacoat 606), hypromellose (Methocel E15 LV Premium), red iron oxide (E 172), yellow iron oxide (E 172), triethyl citrate, titanium dioxide (E 171), talc, povidone K-30.

What Simcovas looks like and contents of the pack

Simcovas, 20 mg, are oval, biconvex, film-coated tablets, beige in color, with a score line on one side.
The film-coated tablets can be divided into equal doses along the score line.
Simcovas, 40 mg, are oval, biconvex, film-coated tablets, brick-red in color, with a score line on one side.
The film-coated tablets can be divided into equal doses along the score line.
The film-coated tablets are packaged in blisters in a cardboard box or in HDPE containers.
Package sizes:
Blisters:
Simcovas, 20 mg and 40 mg: 28 and 30 film-coated tablets.
HDPE containers:
Simcovas, 20 mg: 250 and 500 film-coated tablets.
Simcovas, 40 mg: 250 film-coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Actavis Group PTC ehf.
Dalshraun 1, 220 Hafnarfjörður
Iceland

Manufacturer

Balkanpharma-Dupnitsa AD
3, Samokovsko Shosse Str.
2600 Dupnitsa, Bulgaria

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Teva Pharmaceuticals Polska Sp. z o.o., ul. Emilii Plater 53, 00-113 Warsaw, tel. (22) 345 93 00.

Date of last revision of the leaflet: May 2023