Simcovas

Leaflet accompanying the packaging: patient information

Simcovas, 20 mg, film-coated tablets

Simcovas, 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 as yours.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell 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 raises 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 arteries, forming plaque. If this 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 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 supplementary measure to diet to reduce cholesterol levels in cases of:

• high blood cholesterol (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 heart 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. The doctor may assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of blood cholesterol levels, and discussion of intended treatment goals with the doctor are necessary.

2. Important information before taking Simcovas

When not to take Simcovas

• during pregnancy and breastfeeding
• 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 virus infection)
• nefazodone (an antidepressant)
• cobicistat
• gemfibrozil (a medicine used to lower blood 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 greater than 40 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 by the patient is listed above, the patient should consult their doctor.

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 such cases, it may be necessary to stop taking Simcovas for a while.

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

Immediate medical attention is required 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 patient deaths 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 medicines to lower lipid levels belonging to the statin or fibrate group,
• they or their close relatives have been diagnosed with hereditary muscle disorders.

The patient should also inform their 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 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 bacterial infections, it will be necessary to temporarily stop taking Simcovas. The doctor will inform the patient when it will be safe to restart taking Simcovas.

Taking Simcovas with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information about 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 blood cholesterol levels),
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections),
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV),
• 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 related to heart disease, or other heart diseases),
• lomitapide (used to treat a rare genetic disorder of high cholesterol levels),
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be greater when this medicine is used during treatment with simvastatin (e.g., Simcovas). The doctor may decide to stop taking Simcovas for a while,
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medicine)

Similarly, the patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. In particular, the patient should inform their doctor if they are taking medicines containing any of the following active substances:

• medicines that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines),
• fenofibrate (also used to lower cholesterol),
• niacin (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis).

The patient should inform the doctor who prescribes a new medicine that they are taking Simcovas.

Simcovas with food and drink

Grapefruit juice contains one or more components that affect the action of some medicines in the body, including Simcovas. The patient should avoid consuming grapefruit juice.

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 patient's ability to drive or use machines. However, the patient should consider 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 the patient's condition, treatment, and individual risk assessment.
This medicine should always be taken according to the doctor's or pharmacist's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.
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 dose after at least 4 weeks 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 achieved 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 containing 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 patient should contact their doctor or pharmacist. Missing a dose of Simcovas-
• The patient should not take a double dose to make up for a missed dose. The next dose of Simcovas should be taken at the usual time the following day.

Stopping treatment with Simcovas

• The patient should consult their doctor or pharmacist, as their 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 100 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 patient deaths 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 mouth ulcers (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, hot flushes
• shortness of breath and malaise
• symptoms of lupus-like disease (including rash, joint pain, and blood cell changes)
• inflammation of the liver with symptoms such as yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or 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
• headaches, 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)
• myasthenia gravis (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.

Additional possible side effects 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 not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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, 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 this medicine.

5. How to store Simcovas

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after: EXP. The expiry date refers to the last day of the month stated.
Do not store above 30°C.
Store in the original packaging to protect from light and moisture.
HDPE containers: after first opening, store below 25°C and use within 6 months.
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 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, povidon K-30.

What Simcovas looks like and contents of the pack

Simcovas, 20 mg, are oval, biconvex, film-coated tablets in a beige 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 in a terracotta 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.
Pack 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