Simvahexal 20

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
SimvaHEXAL 20 (Simvastatin – 1 A Pharma 20 mg Film Tablets)
20 mg, film-coated tablets
Simvastatinum
SimvaHEXAL 20 and Simvastatin – 1 A Pharma 20 mg Film Tablets are different brand names
of the same medicine.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What SimvaHEXAL 20 is and what it is 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 pack and other information

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

SimvaHEXAL 20 contains the active substance simvastatin. SimvaHEXAL 20 is a medicine
used to reduce blood levels of total cholesterol, LDL cholesterol (so-called "bad" cholesterol), and
fats known as triglycerides.
Additionally, SimvaHEXAL 20 increases HDL cholesterol levels (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 consists mainly of
LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can deposit in the walls of arteries,
forming plaques, and the accumulation of plaques may lead to narrowing of the arteries.
Arterial narrowing may slow down or block blood flow to vital organs such as the heart and brain.
Blocked blood flow may result in a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from
depositing in the arteries and protects against heart disease.
Triglycerides are another type of fat present in the blood – they may increase the risk of heart disease.
A low-cholesterol diet should be followed during treatment.
SimvaHEXAL 20 is used (in addition to diet) in patients:

• with elevated blood cholesterol levels (primary hypercholesterolemia) or elevated blood lipid levels (mixed hyperlipidemia);
• with an inherited condition (homozygous familial hypercholesterolemia) characterized by high blood cholesterol levels. Your doctor may also prescribe other medicines.
• with ischemic heart disease or at risk of developing it (due to diabetes, previous stroke, or other vascular disease). SimvaHEXAL 20 may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.

In most people, elevated cholesterol levels do not cause immediate symptoms. Your doctor can
assess them by analyzing a blood sample. You should regularly visit your doctor, monitor cholesterol
levels, and discuss treatment goals and results with your doctor.

2. Important information before using SimvaHEXAL 20

When not to use SimvaHEXAL 20

• 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 medicine)
• cobicistat
• gemfibrozil (a medicine used to reduce cholesterol levels)
• cyclosporine (a medicine used in organ transplant patients)
• 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 affecting cholesterol), SimvaHEXAL 20 should not be used at a dose higher than 40 mg daily.
If in doubt whether the patient is taking any of the above-mentioned medicines, consult a doctor.
Warnings and precautions
Before starting SimvaHEXAL 20, discuss with a doctor or pharmacist if:

• the patient has any medical conditions, including allergies;
• the patient consumes large amounts of alcohol;
• the patient has ever had liver disease (SimvaHEXAL 20 may not be suitable for them);
• the patient is currently taking or has taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). Taking fusidic acid together with SimvaHEXAL 20 may cause severe muscle problems (rhabdomyolysis);
• the patient is due to undergo surgery (temporary discontinuation of this medicine may be necessary);
• the patient is of Asian origin (a different dose may be recommended).

The doctor should order a blood test before starting SimvaHEXAL 20 and during treatment if the patient develops any symptoms of liver dysfunction. These tests are intended to monitor liver function.
The doctor may also recommend checking liver function markers in the blood after starting SimvaHEXAL 20.
Patients with diabetes or at risk of developing diabetes will remain under close medical supervision while taking SimvaHEXAL 20. The risk of developing diabetes may affect individuals with high levels of blood sugar and fats, overweight, and high blood pressure.
Inform the doctor if the patient has severe lung disease.
If the patient experiences unexplained muscle pain, increased tenderness (sensitivity) to touch, or weakness, they should seek immediate medical advice. In rare cases, muscle disorders may be severe, including muscle breakdown leading to kidney damage. Very rare cases of death have also been reported.
The patient should also inform the doctor or pharmacist about persistent muscle weakness. Additional tests may be needed for diagnosis, and appropriate medicines may be required for treatment.
The risk of muscle breakdown increases with higher doses of simvastatin (particularly the 80 mg dose).
The risk is also higher in certain patients. Consult a doctor if any of the following apply:

• drinking large amounts of alcohol
• kidney function disorders
• thyroid function disorders
• age 65 years or older
• female gender
• previous muscle problems during treatment with cholesterol-lowering medicines (statins or fibrates)
• a family history of muscle disease in the patient or a close relative.

Children and adolescents
The safety and efficacy of simvastatin have been studied in boys and girls aged 10–17 years (in girls who have had menstruation for at least one year), see section 3 “How to use SimvaHEXAL 20”. Simvastatin has not been evaluated in children under 10 years of age. More information is available from the doctor.
SimvaHEXAL 20 and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Taking SimvaHEXAL 20 with any of the following medicines may increase the risk of muscle-related side effects (some of these medicines have already been listed above in the section “When not to use SimvaHEXAL 20”).

• fusidic acid: if the patient must take fusidic acid orally to treat a bacterial infection, temporary discontinuation of SimvaHEXAL 20 is required. The doctor will advise when it is safe to resume treatment. Concurrent use of SimvaHEXAL 20 and fusidic acid may rarely cause muscle weakness, muscle tenderness or pain (rhabdomyolysis). More information about this condition is provided in section 4.
• cyclosporine (a medicine commonly used in organ transplant patients)
• danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterus)
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (medicines used to treat fungal infections)
• fibrates containing gemfibrozil or 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 virus, 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 for heart rhythm disorders)
• verapamil, diltiazem or amlodipine (medicines used to treat high blood pressure, chest pain due to heart disease or other heart conditions)
• lomitapide (a medicine used to treat a rare, severe genetic disorder affecting cholesterol)
• colchicine (a medicine used to treat gout)
• ticagrelor (used in patients after heart attack or with angina, or chest pain not well controlled). If the patient is taking ticagrelor, do not take more than 40 mg of SimvaHEXAL 20 per day.

In addition to the medicines listed above, inform the doctor or pharmacist about all medicines currently or recently taken, including those available without a prescription. Especially inform the doctor about using medicines containing any of the following active substances:

• blood clot prevention medicines such as warfarin, phenprocoumon or acenocoumarol (anticoagulants)
• fenofibrate (also used to reduce cholesterol levels)
• niacin (also used to reduce cholesterol levels)
• rifampicin (a medicine used to treat tuberculosis).

Also inform any doctor prescribing a new medicine that the patient is taking SimvaHEXAL 20.
SimvaHEXAL 20 with food, drink and alcohol
Grapefruit juice contains one or more components that may alter the effect of certain medicines, including SimvaHEXAL 20. Avoid drinking grapefruit juice during treatment.
Inform the doctor about consuming large amounts of alcohol.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
Do not use SimvaHEXAL 20 if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If the patient becomes pregnant while taking SimvaHEXAL 20, she should stop taking the medicine immediately and contact her doctor.
Do not use SimvaHEXAL 20 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 impair the ability to drive or operate machinery. However, consider the possibility of dizziness occurring in some individuals after taking the medicine.
SimvaHEXAL 20 contains lactose monohydrate
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use SimvaHEXAL 20

The appropriate tablet strength is determined by the physician based on the patient's health condition, current treatment, and individual risk factors.
SimvaHEXAL 10 (10 mg), SimvaHEXAL 20 (20 mg), and SimvaHEXAL 40 (40 mg) are available on the market.
This medicine should always be used according to the doctor's instructions. In case of doubts, consult a doctor or pharmacist.
While taking this medicine, a low-cholesterol diet should be followed.
The recommended dose is one tablet taken orally once daily.
Adults
The usual starting dose is 10 mg, 20 mg, or sometimes 40 mg once daily. The doctor may adjust the dose after at least 4 weeks, up to a maximum dose of 80 mg once daily. 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 specific kidney disease.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of heart disease who have not achieved target cholesterol levels with lower doses.
Use in children and adolescents
In children and adolescents (aged 10–17 years), the usual recommended starting dose is 10 mg taken in the evening. The maximum recommended dose is 40 mg per day.
Method and duration of administration
The medicine should be taken in the evening, regardless of meals. The medicine should be continued until the doctor advises stopping.
Tablets may be divided into equal doses.
If the doctor has prescribed SimvaHEXAL 20 together 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 more SimvaHEXAL than recommended
Seek immediate medical advice. In case of overdose, the doctor will provide symptomatic and supportive treatment.
Missing a dose of SimvaHEXAL 20
Do not take a double dose to make up for a missed dose. Continue treatment according to the prescribed dosing schedule.
Stopping SimvaHEXAL 20
Discuss this with your doctor or pharmacist, as blood cholesterol levels may rise again.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following serious adverse reactions, treatment must be discontinued and the patient should immediately consult a doctor or go to the emergency department of the nearest hospital.
The following rare but serious adverse reactions have been reported:

• muscle pain, tenderness, weakness, or cramps. In rare cases, these symptoms may be severe, including rhabdomyolysis (muscle breakdown) leading to kidney damage, and very rarely resulting in death.
• hypersensitivity (allergic) reactions, including:
• swelling of the face, tongue, and throat, which may cause difficulty in breathing (angioedema)
• severe muscle pain, usually in the shoulders and hips
• rash with limb and neck muscle weakness
• joint pain or arthritis
• vasculitis (inflammation of blood vessels)
• unusual bruising, skin lesions, swelling, urticaria (hives), photosensitivity, fever, sudden redness of the skin
• shortness of breath and malaise
• lupus-like symptoms (including rash, joint disorders, and effects on blood cells)
• hepatitis (liver inflammation), with the following symptoms: yellowing of the skin and eyes (jaundice), itching, dark urine, pale stools, feeling tired or weak, loss of appetite, and very rarely liver failure
• pancreatitis, often with severe abdominal pain

The following very rare serious adverse reactions have been reported:

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis)
• gynaecomastia (enlargement of breasts in men)
• skin rash or oral mucosal ulceration (lichenoid eruptions)
• muscle damage

The following adverse reactions have also been reported:
Rare (may affect fewer than 1 in 1,000 people):

• low red blood cell count (anaemia)
• numbness or weakness in arms and legs
• headache, tingling sensation, dizziness
• blurred vision; visual disturbances
• gastrointestinal disturbances (abdominal pain, constipation, flatulence, dyspepsia, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• fatigue
• increased levels in certain liver function tests and increased activity of an enzyme present in muscle tissue (creatine kinase)
• memory loss, confusion

Very rare (may affect fewer than 1 in 10,000 people):

• difficulty in falling asleep
• memory disorders

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

• erectile dysfunction
• depression
• lung inflammation causing breathing difficulties, including persistent cough and/or dyspnoea or fever
• tendon disorders, sometimes complicated by tendon rupture
• persistent muscle weakness

Additional possible adverse reactions reported during treatment with certain statins:

• sleep disorders, including nightmares
• sexual dysfunction
• diabetes. The risk of developing diabetes is higher in patients with elevated blood sugar and lipid levels, overweight, and high blood pressure. Your doctor will monitor your health during treatment with this medicine.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store SimvaHEXAL 20

Keep this medicine out of the 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 stated month.
Translation of some information on the immediate packaging:
Ch.-B./verwendbar bis: siehe Prägung – batch number/expiry date: see imprint
Do not store above 30°C. Keep blisters in the outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What SimvaHEXAL 20 contains

• The active substance is simvastatin. Each coated tablet contains 20 mg of simvastatin.
• Other ingredients are: butylated hydroxyanisole (E 320), microcrystalline cellulose, citric acid monohydrate, lactose monohydrate, magnesium stearate, pregelatinized corn starch.
  Coating: hypromellose, talc, titanium dioxide (E 171), red iron oxide (E 172), yellow iron oxide (E 172).

What SimvaHEXAL 20 looks like and contents of the pack
SimvaHEXAL 20 coated tablets are orange, oval-shaped, biconvex, with a score line on both sides, marked "20" on one side.
PVC/Aluminium blisters contain 30 or 90 coated tablets.
For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Germany, the country of export:
1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany

Manufacturers:
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
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

German Marketing Authorisation Number (country of export): 52556.02.00
Parallel Import Authorisation Number: 109/22