Simvahexal 40

Leaflet accompanying the packaging: patient information

SimvaHEXAL 10, 10 mg, film-coated tablets

SimvaHEXAL 20, 20 mg, film-coated tablets

SimvaHEXAL 40, 40 mg, film-coated tablets

Simvastatin

You should carefully read the contents of this 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.
• If you have any doubts, you should 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is SimvaHEXAL and what is it used for

SimvaHEXAL contains the active substance simvastatin. SimvaHEXAL is a medicine used to lower the level of total cholesterol, LDL cholesterol (so-called "bad" cholesterol), and a type of fat called triglycerides in the blood. Additionally, SimvaHEXAL increases the level of HDL cholesterol (so-called "good" cholesterol). SimvaHEXAL belongs to a group of medicines called statins. Cholesterol is one of the fatty substances present in the blood. Total cholesterol is mainly made up of LDL and HDL cholesterol. LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of arteries, forming a plaque, and the accumulation of plaque can cause the arteries to narrow. The consequence of narrowing may be a slowing or blockage of blood flow to vital organs, such as the heart and brain. Blockage of blood flow can lead to a 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 - they can increase the risk of heart disease. While taking the medicine, you should follow a low-cholesterol diet. SimvaHEXAL is used (in addition to diet) in patients:

• with high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of lipids in the blood (mixed hyperlipidemia);
• with a hereditary disease (homozygous familial hypercholesterolemia), in which the level of cholesterol in the blood is elevated. Your doctor may also prescribe other medicines.
• with coronary heart disease or a risk of its development (due to diabetes, a history of stroke or other vascular disease). SimvaHEXAL may prolong the life of the patient, reducing the risk of developing heart disease, regardless of the amount of cholesterol in the blood. In most people, elevated cholesterol levels do not cause symptoms immediately. Your doctor may assess them by examining a blood sample. You should regularly visit your doctor, have your cholesterol levels checked, and discuss your treatment goals and results with your doctor.

SimvaHEXAL is used to reduce the risk of heart disease in patients with high levels of cholesterol in the blood. It is also used to reduce the risk of heart disease in patients with coronary heart disease or a risk of its development.

2. Important information before taking SimvaHEXAL

When not to take SimvaHEXAL

if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6); if you currently have liver function disorders; if you are pregnant or breastfeeding; if you are taking medicines containing one or more of the following active substances:

• itraconazole, ketoconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
• erythromycin, clarithromycin, or telithromycin (medicines used to treat infections)
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines 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 used in patients who have undergone organ transplantation)
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).

If you are taking lomitapide (a medicine used to treat a rare, severe genetic disorder related to cholesterol), you should not take SimvaHEXAL in a dose greater than 40 mg per day. If you are unsure whether you are taking any of the above medicines, you should consult your doctor.

Warnings and precautions

Before starting to take SimvaHEXAL, you should discuss it with your doctor or pharmacist if: you have any diseases, including allergies; you consume large amounts of alcohol; you have ever had liver disease (SimvaHEXAL may not be suitable for you); you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Taking fusidic acid with SimvaHEXAL may cause serious muscle disorders (rhabdomyolysis); you are going to have surgery (it may be necessary to stop taking this medicine for a short time); if you have or have had muscle weakness (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or eye muscle weakness (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to the development of muscle weakness (see section 4). if you are of Asian origin (it may be recommended to use a different dose of the medicine). Your doctor should recommend a blood test before starting to take SimvaHEXAL and during treatment if you experience any symptoms of liver function disorders. These tests are intended to monitor liver function. Your doctor may also recommend checking liver function indicators in the blood after starting to take SimvaHEXAL. Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking SimvaHEXAL. The risk of developing diabetes may affect people with high levels of sugar and fat in the blood, with excess weight and high blood pressure. You should inform your doctor if you have severe lung disease.

If you experience unexplained muscle pain, increased sensitivity to touch (tenderness) or weakness, you should immediately consult your doctor. In rare cases, muscle disorders can be severe, including muscle breakdown leading to kidney damage, and very rarely, death has been reported.

You should also tell your doctor or pharmacist about persistent muscle weakness. To diagnose it, additional tests may be necessary, and appropriate medicines may be administered. The risk of muscle breakdown increases with the dose of simvastatin (mainly at a dose of 80 mg). It is also higher in some patients. You should consult your doctor if any of the following applies to you: consuming large amounts of alcohol; kidney function disorders; thyroid function disorders; age 65 or older; female sex; previous muscle disorders during treatment with cholesterol-lowering medicines (statins or fibrates); a hereditary muscle disease diagnosed in you or a close relative.

Children and adolescents

The safety and efficacy of simvastatin have been studied in 10-17-year-old boys and girls (who have started menstruating at least a year ago), see section 3 "How to take SimvaHEXAL". The use of simvastatin has not been evaluated in children under the age of 10. Your doctor will provide more information.

SimvaHEXAL and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Taking SimvaHEXAL with any of the above medicines may increase the risk of side effects affecting the muscles (some of these medicines have already been listed above in the "When not to take SimvaHEXAL" section).

SimvaHEXAL with food, drinks, and alcohol

Grapefruit juice contains one or more ingredients that can change the effect of some medicines, including SimvaHEXAL. You should avoid drinking it during treatment. You should inform your doctor about consuming large amounts of alcohol.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. You should not take SimvaHEXAL if you are pregnant, trying to become pregnant, or suspect you may be pregnant. If you become pregnant while taking SimvaHEXAL, you should stop taking the medicine immediately and consult your doctor. You should not take SimvaHEXAL if you are breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

SimvaHEXAL should not affect your ability to drive or use machines. However, you should take into account the possibility of dizziness after taking the medicine.

SimvaHEXAL contains lactose

If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take SimvaHEXAL

Your doctor will determine the appropriate tablet strength based on your health condition, current treatment, and individual risk. You should always take this medicine exactly as your doctor has told you. If you are unsure, you should consult your doctor or pharmacist. While taking the medicine, you should follow a low-cholesterol diet. The recommended dose is one tablet taken orally once a day. AdultsThe usual starting dose is 10, 20, or sometimes 40 mg per day. Your doctor may adjust the dose of the medicine after at least 4 weeks to a maximum dose of 80 mg per day. You should not take more than 80 mg per day.Your doctor may prescribe a lower dose, especially if you are already taking certain medicines listed above or have a certain kidney disease. A dose of 80 mg is recommended only for adult patients with very high levels of cholesterol and a high risk of developing heart disease who have not achieved the target cholesterol level while taking the medicine in lower doses. Use in children and adolescentsIn children and adolescents (aged 10-17), the recommended starting dose is usually 10 mg per day, taken in the evening. The maximum recommended dose is 40 mg per day. Method of administration and duration of treatment The medicine should be taken in the evening, regardless of meals. The medicine should be taken until your doctor advises you to stop. The tablets can be divided into equal doses. If your doctor has prescribed SimvaHEXAL with another cholesterol-lowering medicine containing a bile acid sequestrant, you should take SimvaHEXAL at least 2 hours before or at least 4 hours after taking the other medicine.

Taking a higher dose of SimvaHEXAL than recommended

You should immediately consult your doctor. In case of overdose, your doctor will administer symptomatic and supportive treatment.

Missing a dose of SimvaHEXAL

You should not take a double dose to make up for a missed dose, but continue treatment according to the recommended dosage regimen.

Stopping treatment with SimvaHEXAL

You should discuss this with your doctor or pharmacist, as your cholesterol levels may rise again. If you have any further doubts about taking this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, SimvaHEXAL can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, you should stop taking the medicine and immediately consult your doctor or go to the emergency department of the nearest hospital.

The following rare but serious side effects have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms can be severe, including muscle breakdown leading to kidney damage, and very rarely, death has been reported.
• allergic reactions (hypersensitivity), including: swelling of the face, tongue, and throat, which can make breathing difficult (angioedema) severe muscle pain, usually in the shoulders and hips rash with muscle weakness in the arms and neck joint pain or inflammation kidney inflammation blood vessel inflammation unusual bruising, skin changes, and swelling, hives, skin sensitivity to sunlight, fever, sudden flushing of the skin breathing difficulties and feeling unwell changes resembling lupus erythematosus (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 pale stools, feeling tired or weak, loss of appetite, and very rarely, liver failure
• pancreatitis, often with severe abdominal pain

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

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• a rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid reactions)
• muscle damage

The following side effects have also been reported: Rare(may occur in less than 1 in 1000 people):

• low red blood cell count (anemia)
• numbness or weakness in the arms and legs
• headache, tingling sensation, dizziness
• blurred vision; vision disturbances
• digestive disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• increased values of some liver function tests and increased activity of the enzyme present in muscles (creatine kinase)
• memory loss, confusion

Very rare(may occur in less than 1 in 10,000 people):

• difficulty sleeping
• memory disorders

Frequency not known(frequency cannot be estimated from the available data):

• 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
• persistent muscle weakness

Additional possible side effects that have been reported during the use of some statins:

• sleep disorders, including nightmares
• sexual disorders
• diabetes. Its occurrence is more likely in patients with high levels of sugar and fat in the blood, with excess weight and high blood pressure. Your doctor will monitor your condition while taking this medicine.

Reporting side effects If you experience any side effects, including those not listed in this leaflet, you should tell your 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, you can help provide more information on the safety of this medicine.

5. How to store SimvaHEXAL

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the blister, tablet container, and carton after EXP. The expiry date refers to the last day of the month. Do not store above 30°C. Blisters should be stored in the carton to protect from light. Tablet container The tablets should be stored in the original packaging to protect from light. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 SimvaHEXAL contains

• The active substance of the medicine is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• The other ingredients are: SimvaHEXAL 10: ascorbic acid, butylhydroxyanisole (E 320), microcrystalline cellulose, citric acid monohydrate, hypromellose 5 cps, hypromellose 15 cps, lactose monohydrate, magnesium stearate, pregelatinized starch, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172). SimvaHEXAL 20: butylhydroxyanisole (E 320), microcrystalline cellulose, citric acid monohydrate, hypromellose 5 cps, hypromellose 15 cps, lactose monohydrate, magnesium stearate, pregelatinized starch, talc, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172). SimvaHEXAL 40: butylhydroxyanisole (E 320), microcrystalline cellulose, citric acid monohydrate, hypromellose 5 cps, hypromellose 15 cps, lactose monohydrate, magnesium stearate, pregelatinized starch, talc, titanium dioxide (E171), iron oxide red (E172).

What SimvaHEXAL looks like and contents of the pack

SimvaHEXAL 10 film-coated tablets are pale pink, oval, convex, with a notch, marked "SIM 10" on one side. SimvaHEXAL 20 film-coated tablets are orange, oval, biconvex, with a dividing line on both sides, marked "20" on one side. SimvaHEXAL 40 film-coated tablets are reddish-brown, oval, biconvex, with a dividing line on both sides, marked "40" on one side. Blisters of PVC/Aluminum or polyethylene containers with a screw cap contain 28, 30, or 90 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria Manufacturer Salutas Pharma GmbH Otto-von-Guericke-Allee 1 D-39179 Barleben, Germany LEK S.A. ul. Domaniewska 50 C 02-672 Warsaw LEK S.A. ul. Podlipie 16 95-010 Stryków Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia Lek Pharmaceuticals d.d. Trimlini 2D 9220 Lendava, Slovenia S.C. Sandoz, S.R.L. Livezeni Street no 7A 540472 Targu Mures, Romania

To obtain more detailed information about the medicine and its names in other EU member states, you should contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. +48 22 209 70 00 Date of last revision of the leaflet:04/2023 Sandoz logo