Simvahexal 10

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

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 side effects not listed in this leaflet, they should tell their 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
reduce 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 composed of LDL and HDL cholesterol.
LDL cholesterol is often referred to as "bad" cholesterol, as it can accumulate in the walls of arteries, forming a plaque, and the accumulation of plaque can cause narrowing of the arteries.
The consequence of narrowing may be a slowdown 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, as 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.
During treatment with the medicine, a low-cholesterol diet should be followed.
SimvaHEXAL is used (in addition to diet) in patients:

• with elevated blood cholesterol levels (primary hypercholesterolemia) or elevated blood lipid levels (mixed hyperlipidemia);
• with a hereditary disease (homozygous familial hypercholesterolemia), in which blood cholesterol levels are elevated. The doctor may also prescribe other medicines.
• with ischemic heart disease or at risk of its development (due to diabetes, a history of stroke

or other vascular disease). SimvaHEXAL may prolong the patient's life, reducing the risk of developing heart disease, regardless of the amount of cholesterol in the blood.
Most people with elevated cholesterol levels do not experience symptoms immediately. The doctor can assess them by examining a blood sample. Patients should regularly visit their doctor, have their cholesterol levels checked, and discuss their treatment goals and results with their doctor.

2. Important information before taking SimvaHEXAL

When not to take SimvaHEXAL

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 liver function disorders;
if the patient is pregnant or breastfeeding;
if the patient is 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 reduce cholesterol levels)
• cyclosporine (a medicine used in patients after organ transplantation)
• danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterus).

If the patient is taking lomitapide (a medicine used to treat a rare, severe genetic cholesterol disorder), they should not take SimvaHEXAL in a dose greater than 40 mg per day.
In case of doubt about whether the patient is taking any of the above medicines, they should consult their doctor.

Warnings and precautions

Before starting treatment with SimvaHEXAL, the patient should discuss it with their doctor or pharmacist if:
the patient has any diseases, including allergies;
the patient consumes large amounts of alcohol;
the patient has a history of liver disease (SimvaHEXAL may not be suitable for them);
the patient is taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infections). Taking fusidic acid with SimvaHEXAL can cause severe muscle disorders (rhabdomyolysis);
the patient is going to have surgery (it may be necessary to stop taking the medicine for a short time);
If the patient has or has had muscle weakness (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 patient is of Asian origin (a different dose of the medicine may be recommended).
The doctor should recommend a blood test before starting treatment with SimvaHEXAL and during treatment if the patient experiences any symptoms of liver function disorders.
These tests are intended to monitor liver function.
The doctor may also recommend checking liver function indicators in the blood after starting treatment with 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 blood sugar and fat levels, with overweight and high blood pressure.
The patient should inform their doctor if they have severe lung disease.

If the patient experiences unexplained muscle pain, increased muscle sensitivity to touch (tenderness) or muscle weakness, they should immediately consult their doctor. In rare cases, muscle disorders can be severe, including muscle breakdown leading to kidney damage

and, in very rare cases, death.
The patient should also tell their doctor or pharmacist about persistent muscle weakness. Additional tests may be necessary to diagnose it, and appropriate medications may be necessary for treatment.
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. The patient should consult their doctor if any of the following apply to them:
consumption of 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 the patient 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. The doctor will provide more information.

SimvaHEXAL 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.
Taking SimvaHEXAL with any of the listed 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).
Fusidic acid: if the patient must take oral fusidic acid to treat a bacterial infection, it will be necessary to temporarily stop taking

SimvaHEXAL. The doctor will inform the patient when it is safe to resume taking it.

Concomitant use of SimvaHEXAL and fusidic acid may rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information about this condition can be found in section 4.

cyclosporine (a medicine often used in patients after organ transplantation)
danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterus)
medicines containing the active substances itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (medicines used to treat fungal infections)
fibrates with the active substance gemfibrozil and bezafibrate (used to reduce cholesterol levels)
erythromycin, clarithromycin, or telithromycin (medicines used to treat bacterial infections)
HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infection)
medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (medicines used to treat hepatitis C)
nefazodone (a medicine used to treat depression)
medicines containing the active substance cobicistat
amiodarone (a medicine used to treat heart rhythm disorders)
verapamil, diltiazem, or amlodipine (medicines used to treat high blood pressure, chest pain caused by heart disease, or other heart conditions)
lomitapide (a medicine used to treat a rare, severe genetic cholesterol disorder)
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 taken during simvastatin treatment. The doctor may decide to stop taking simvastatin for a while.
colchicine (a medicine used to treat gout)
tikagrelor (used in patients after a heart attack, or with angina pectoris or chest pain that is not well controlled). If the patient is taking tikagrelor, they should not take more than 40 mg of SimvaHEXAL per day.
In addition to the medicines listed above, the patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, including those available without a prescription. The patient should especially inform their doctor about taking medicines containing any of the following active substances:
anticoagulants, such as warfarin, phenprocoumon, or acenocoumarol (medicines that prevent blood clotting)
fenofibrate (also used to reduce cholesterol levels)
niacin (also used to reduce cholesterol levels)
rifampicin (a medicine used to treat tuberculosis).
The patient should also inform their doctor about taking SimvaHEXAL when their doctor prescribes a new medicine for them.

SimvaHEXAL with food, drink, and alcohol

Grapefruit juice contains one or more components that can alter the action of some medicines, including SimvaHEXAL. The patient should avoid drinking it during treatment.
The patient should inform their doctor about consuming large amounts of alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
SimvaHEXAL 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 SimvaHEXAL, they should stop taking the medicine immediately and contact their doctor.
SimvaHEXAL should not be taken if the patient is breastfeeding, as it is not known whether the medicine passes into breast milk.

Driving and using machines

SimvaHEXAL should not affect the patient's ability to drive or operate machines.
However, the patient should take into account the possibility of dizziness after taking the medicine.

SimvaHEXAL contains lactose

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

3. How to take SimvaHEXAL

The doctor will determine the appropriate tablet strength based on the patient's health, current treatment, and individual risk.
This medicine should always be taken according to the doctor's recommendations. If the patient has any doubts, they should consult their doctor or pharmacist.
During treatment, the patient should follow a low-cholesterol diet.
The recommended dose isone tablet taken orally once a day.
Adults
The usual initial dose is 10, 20, or sometimes 40 mg per day. The doctor may adjust the dose of the medicine after at least 4 weeks to a maximum dose of 80 mg per day. Do not take more than 80 mg per day.
The doctor may prescribe a lower dose, especially if the patient is already taking certain medicines listed above or has a certain kidney disease.
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 their target cholesterol level while taking the medicine in lower doses.
Use in children and adolescents
In children and adolescents (aged 10-17), the recommended initial 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 the doctor recommends stopping it.
The tablets can be divided into equal doses.
If the doctor has prescribed SimvaHEXAL with another cholesterol-lowering medicine containing a bile acid sequestrant, SimvaHEXAL should be taken at least 2 hours before or at least 4 hours after taking that medicine.

Taking a higher dose of SimvaHEXAL than recommended

The patient should immediately consult their doctor. In case of overdose, the doctor will provide symptomatic and supportive treatment.

Missing a dose of SimvaHEXAL

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

Stopping treatment with SimvaHEXAL

The patient should discuss this with their doctor or pharmacist, as their cholesterol levels may increase again.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

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

The following rare, serious side effects have been reported:

• muscle pain, muscle tenderness, muscle weakness, or cramps. In rare cases, these symptoms can be severe, including muscle breakdown leading to kidney damage, and very rarely, death.
• allergic reactions (hypersensitivity), including: o swelling of the face, tongue, and throat, which can make breathing difficult (angioedema) o severe muscle pain, usually in the shoulders and hips o skin rash with muscle weakness in the limbs and neck o joint pain or inflammation o blood vessel inflammation o unusual bruising, skin changes, and swelling, hives, skin sensitivity to sunlight, fever, and sudden flushing of the skin o shortness of breath and malaise o 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 of fatigue or weakness, loss of appetite, and very rarely, liver failure
• pancreatitis, often with severe abdominal pain

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

• a severe allergic reaction that causes difficulty breathing or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• a skin rash that can occur on the skin or mouth ulcers (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, dizziness
• blurred vision; vision disturbances
• digestive disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• skin 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
• interstitial lung disease 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 blood sugar and fat levels, with 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 side effects not listed in the leaflet, the patient should tell 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.
Reporting side effects will help gather more information on the safety of the 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 pack, tablet container, and carton after EXP. The expiry date refers to the last day of the month.
Do not store above 30°C.
Blister packs should be stored in the carton to protect from light.
Tablet container
Tablets should be stored in the original packaging to protect from light.
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 SimvaHEXAL contains

• The active substance of the medicine is simvastatin. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of simvastatin.
• 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.
Blister packs 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 European Economic Area member states, please 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
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