Simvahexal 20

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

SimvaHEXAL 20 (Simvastatin – 1 A Pharma 20 mg Film-coated Tablets)

20 mg, film-coated tablets

Simvastatinum
SimvaHEXAL 20 and Simvastatin – 1 A Pharma 20 mg Film-coated Tablets are different trade names
for the same medicine.

You should carefully read the contents of the 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 necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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 tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is SimvaHEXAL 20 and what is it used for
• 2. Important information before taking SimvaHEXAL 20
• 3. How to take SimvaHEXAL 20
• 4. Possible side effects
• 5. How to store SimvaHEXAL 20
• 6. Contents of the packaging and other information

1. What is SimvaHEXAL 20 and what is it used for

SimvaHEXAL 20 contains the active substance simvastatin. SimvaHEXAL 20 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 20 increases the level of HDL cholesterol (so-called "good" cholesterol).
SimvaHEXAL 20 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 plaques can cause narrowing of the arteries.
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, 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, a low-cholesterol diet should be followed.
SimvaHEXAL 20 is used (in addition to diet) in patients:

• with high blood cholesterol levels (primary hypercholesterolemia) or high blood lipid levels (mixed hyperlipidemia);
• with a genetic disorder (homozygous familial hypercholesterolemia), in which blood cholesterol levels are elevated. The 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 20 may prolong the patient's life, reducing the risk of developing heart disease, regardless of the amount of cholesterol in the blood.

In most people, high cholesterol levels do not cause symptoms immediately. The doctor can 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.

2. Important information before taking SimvaHEXAL 20

When not to take SimvaHEXAL 20

• 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 disorder related to cholesterol), they should not take SimvaHEXAL 20 in a dose greater than 40 mg per day.
In case of doubt about whether the patient is taking any of the above-mentioned medicines, they should consult their doctor.

Warnings and precautions

Before starting treatment with SimvaHEXAL 20, 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 previously had liver disease (SimvaHEXAL 20 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 20 can cause severe muscle disorders (rhabdomyolysis);
• the patient is going to have surgery (it may be necessary to stop taking this medicine for a short time);
• the patient is of Asian origin (it may be advisable to use a different dose of the medicine).

The doctor should recommend a blood test before starting treatment with SimvaHEXAL 20 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 20.
Patients with diabetes or at risk of developing diabetes will be closely monitored by their doctor while taking SimvaHEXAL 20. The risk of developing diabetes may concern 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 weakness, they should immediately consult their doctor. In rare cases, muscle disorders can be severe, including muscle breakdown leading to kidney damage

and have also been reported to be fatal.
The patient should also tell their doctor or pharmacist about persistent muscle weakness. Additional tests may be necessary to diagnose it, and appropriate medicines may be necessary for treatment.
The risk of muscle breakdown increases with the dose of simvastatin (especially 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:

• drinking large amounts of alcohol
• kidney function disorders
• thyroid function disorders
• age 65 or older
• female sex
• previous muscle problems while taking cholesterol-lowering medicines (statins or fibrates)
• a genetic 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 had started menstruating at least a year earlier), see section 3 "How to take SimvaHEXAL 20". The use of simvastatin has not been evaluated in children under the age of 10. The doctor will provide more information.

SimvaHEXAL 20 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 20 with any of the mentioned medicines can increase the risk of side effects from the muscles (some of these medicines have already been mentioned above in the "When not to take SimvaHEXAL 20" 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 20. The doctor will inform when it can be safely resumed. Concurrent use of SimvaHEXAL 20 and fusidic acid can rarely cause muscle weakness, muscle tenderness, or pain (rhabdomyolysis). More information about this condition can be found in section 4.

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:

• blood thinners, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medicines)
• 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 20 if their doctor prescribes a new medicine for them.

SimvaHEXAL 20 with food, drinks, and alcohol

Grapefruit juice contains one or more ingredients that can change the effect of some medicines, including SimvaHEXAL 20. 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 20 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 20, they should stop taking the medicine immediately and contact their doctor.
SimvaHEXAL 20 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 20 should not interfere with 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 20 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 SimvaHEXAL 20

The doctor will determine the appropriate tablet strength based on the patient's health condition, current treatment, and individual risk.
SimvaHEXAL 10 (10 mg), SimvaHEXAL 20 (20 mg), and SimvaHEXAL 40 (40 mg) are available on the market.
This medicine should always be taken according to the doctor's recommendations. In case of doubt, the patient should consult their doctor or pharmacist.
During treatment, a low-cholesterol diet should be followed.
The recommended dose isone tablet taken orally once a day.
Adults
The usual starting 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 the target cholesterol level while taking the medicine in lower doses.
Use in children and adolescents
In 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 the doctor recommends stopping it.
The tablets can be divided into equal doses.
If the doctor has prescribed SimvaHEXAL 20 with another cholesterol-lowering medicine containing a bile acid sequestrant, SimvaHEXAL 20 should be taken at least 2 hours before or at least 4 hours after taking that medicine.

Taking a higher dose of SimvaHEXAL 20 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 20

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

Stopping treatment with SimvaHEXAL 20

The patient should discuss this with their doctor or pharmacist, as their blood cholesterol levels may increase again.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, SimvaHEXAL 20 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, tenderness, weakness, or cramps. In rare cases, these symptoms can be severe, including muscle breakdown leading to kidney damage, and very rarely have been fatal.
• 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
• vasculitis
• unusual bruising, skin changes, and swelling, hives, increased sensitivity of the skin to the sun, fever, sudden flushing of the skin
• shortness of breath and malaise
• changes resembling lupus erythematosus (including rash, joint disorders, and effects on blood cells)
• hepatitis 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 rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid changes)
• 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)
• 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 the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store SimvaHEXAL 20

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. The expiry date refers to the last day of the month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: see imprint – batch number/expiry date: see imprint
Do not store above 30°C. Store blisters in the outer 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 20 contains

• The active substance of the medicine is simvastatin. Each film-coated tablet contains 20 mg of simvastatin.
• The other ingredients are: butylhydroxyanisole (E 320), microcrystalline cellulose, citric acid monohydrate, lactose monohydrate, magnesium stearate, maize starch, film coating: hypromellose, talc, titanium dioxide (E 171), iron oxide red (E 172), iron oxide yellow (E 172).

What SimvaHEXAL 20 looks like and contents of the pack

SimvaHEXAL 20 film-coated tablets are orange, oval, biconvex, with a score line on both sides, marked "20" on one side.
PVC/Aluminum blisters contain 30 or 90 film-coated tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Germany, the country of export:

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturer:

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben
Germany
Lek Pharmaceuticals d.d.
Verovskova 57
1526 Ljubljana
Slovenia
Lek S.A.
ul. Podlipie 16
95-010 Stryków
Poland
S.C. SANDOZ S.R.L.
7° “Livezeni” Street
540472 Targu Mures, Mures County
Romania

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Germany, the country of export:52556.02.00

Parallel import authorization number: 109/22 Date of leaflet approval: 24.02.2022

[Information about the trademark]