Simvahexal 10

Patient Information Leaflet

SimvaHEXAL 10, 10 mg, film-coated tablets
SimvaHEXAL 20, 20 mg, film-coated tablets
SimvaHEXAL 40, 40 mg, film-coated tablets
Simvastatin
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet Contents:

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

1. What SimvaHEXAL is and what it is used for

SimvaHEXAL contains the active substance simvastatin. SimvaHEXAL is a medicine used to lower blood levels of total cholesterol, LDL cholesterol (so-called "bad" cholesterol), and a type of blood fat called triglycerides.
Additionally, SimvaHEXAL increases HDL cholesterol levels (so-called "good" cholesterol).
SimvaHEXAL belongs to a group of medicines known as 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 plaque. The buildup of plaque 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 can result in a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of "bad" cholesterol in the arteries and protects against heart disease.
Triglycerides are another type of fat in the blood – they may increase the risk of heart disease.
A low-cholesterol diet should be followed during treatment.
SimvaHEXAL 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) causing high blood cholesterol levels. Your doctor may also prescribe other medicines.
• with coronary heart disease or at risk of developing it (due to diabetes, previous stroke, or other blood vessel disease). SimvaHEXAL may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.
  In most people, elevated cholesterol does not cause immediate symptoms. Your doctor can assess it by analyzing a blood sample. You should attend regular check-ups, have your cholesterol levels tested, and discuss treatment goals and results with your 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 any 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)
• protease inhibitors for HIV 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 patients who have had an organ transplant)
• danazol (a synthetic hormone used to treat endometriosis, in which the lining of the uterus grows outside the uterine cavity).

If the patient is taking lomitapide (a medicine used to treat a rare, severe genetic disorder affecting cholesterol), SimvaHEXAL should not be taken 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, discuss with your doctor or pharmacist if:
the patient has any diseases, including allergies;
the patient consumes large amounts of alcohol;
the patient has ever had liver disease (SimvaHEXAL may not be suitable for them);
the patient is currently taking or has taken within the last 7 days, orally or by injection, a medicine containing fusidic acid (used to treat bacterial infection). Taking fusidic acid together with SimvaHEXAL may cause severe muscle disorders (rhabdomyolysis);
the patient is due to undergo surgery (it may be necessary to temporarily stop taking this medicine);
the patient has or has had myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease causing weakness of eye muscles), because statins may sometimes worsen symptoms of the disease or lead to the development of myasthenia (see section 4);
the patient is of Asian origin (an adjusted dose may be recommended).

The doctor should order a blood test before starting SimvaHEXAL 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.

Patients with diabetes or at risk of developing diabetes will remain under close medical supervision while taking SimvaHEXAL. The risk of developing diabetes may affect individuals with high blood sugar and fat levels, overweight, and high blood pressure.
Inform the doctor if the patient has a severe lung disease.

If the patient experiences unexplained muscle pain, increased tenderness to touch (tenderness), or weakness, they should seek medical advice immediately. 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. Diagnosing it may require additional tests, and treatment may involve appropriate medications.

The risk of muscle breakdown increases with the dose of simvastatin (particularly at the 80 mg dose). The risk is also higher in certain patients. Consult the doctor if any of the following apply to the patient:

• consuming large amounts of alcohol
• kidney function disorders
• thyroid function disorders
• age 65 years or older
• female gender
• previous muscle-related problems while taking 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 boys aged 10–17 years and in girls (who have had menstruation for at least one year), see section 3 “How to take SimvaHEXAL”. Simvastatin has not been evaluated in children under 10 years of age. More information can be obtained from the doctor.

SimvaHEXAL 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 with any of the listed medicines may increase the risk of muscle-related adverse effects (some of these medicines have already been listed above in the section “When not to take SimvaHEXAL”).

fusidic acid: if the patient needs to take fusidic acid orally to treat a bacterial infection, temporary discontinuation of SimvaHEXAL will be necessary. The doctor will advise when it is safe to resume taking it.
Concurrent use of SimvaHEXAL and fusidic acid may rarely cause muscle weakness, muscle tenderness upon pressure, 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 uterine cavity)
• 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)
• protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infection)
• medicines used to treat viral 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 for 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 disorder affecting cholesterol)
• daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). Muscle-related adverse effects may be increased when this medicine is taken during simvastatin treatment. The doctor may decide to temporarily discontinue simvastatin.
• colchicine (a medicine used to treat gout)
• ticagrelor (used in patients after heart attack or with angina pectoris or chest pain that is not well controlled). If the patient is taking ticagrelor, do not take more than 40 mg of SimvaHEXAL daily.

In addition to the medicines listed above, inform the doctor or pharmacist about all medicines currently taken or recently taken, including over-the-counter medicines. Especially inform the doctor about taking medicines containing any of the following active substances:

• blood clot prevention medicines 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).

Also inform any doctor prescribing a new medicine that the patient is taking SimvaHEXAL.

SimvaHEXAL with food, drink and alcohol
Grapefruit juice contains one or more components that may alter the action of certain medicines, including SimvaHEXAL. 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 plans to have a child, she should consult a doctor or pharmacist before taking this medicine.
Do not take SimvaHEXAL if the patient is pregnant, trying to become pregnant, or suspects she may be pregnant. If pregnancy occurs during treatment with SimvaHEXAL, the patient should stop taking the medicine immediately and contact her doctor.
Do not take SimvaHEXAL if the patient is breastfeeding, as it is unknown whether the medicine passes into breast milk.

Driving and operating machinery
SimvaHEXAL 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 contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use SimvaHEXAL

The doctor determines the appropriate tablet strength depending on the patient's health condition, current treatment, and individual risk.
This medicine should always be taken as prescribed by the doctor. In case of doubt, 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, 20 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 mentioned 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 once daily 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 continued until the doctor advises stopping.
Tablets may be divided into equal doses.
If the doctor has prescribed SimvaHEXAL together with another cholesterol-lowering medicine containing a bile acid-binding substance, SimvaHEXAL should be taken at least 2 hours before or at least 4 hours after taking that medicine.
Taking more than the recommended dose of SimvaHEXAL
Seek immediate medical advice. In case of overdose, the doctor will provide symptomatic and supportive treatment.
Missing a dose of SimvaHEXAL
Do not take a double dose to make up for the missed dose; continue treatment according to the prescribed schedule.
Stopping SimvaHEXAL
Discuss this with your doctor or pharmacist, as blood cholesterol levels may rise again.
If you have any further doubts 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 experiences them.
If the patient experiences any of the following serious adverse reactions, the medicine must be discontinued immediately and the patient should contact a doctor or go to the nearest hospital emergency department.
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 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 make breathing difficult (angioedema); severe muscle pain, usually in shoulders and hips; rash with muscle weakness in limbs and neck; joint pain or inflammation; inflammation of blood vessels; unusual bruising, skin lesions and swelling, urticaria, photosensitivity, fever, sudden redness of the skin; shortness of breath and malaise; lupus-like reactions (including rash, joint disorders and effects on blood cells)

• liver inflammation with the following symptoms: yellowing of the skin and eyes (jaundice), 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 serious adverse reactions have been reported:

• severe allergic reaction causing difficulty in breathing or dizziness (anaphylaxis)
• gynaecomastia (enlargement of breasts in males)
• rash which may affect the skin or cause ulceration of the oral mucosa (lichenoid drug eruptions)
• muscle damage

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

• low number of red blood cells (anaemia)
• numbness or weakness in arms and legs
• headache, tingling sensation, dizziness
• blurred vision; visual disturbances
• gastrointestinal disturbances (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• fatigue
• increased values in certain liver function tests and increased activity of an enzyme present in muscles (creatine kinase)
• memory loss, confusion

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

• difficulty sleeping
• memory disorders

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

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

Additional possible adverse reactions reported during the use of some statins:

• sleep disorders, including nightmares
• sexual dysfunction
• diabetes. The risk of developing diabetes is higher in patients with high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your health while you are taking this medicine.

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

5. How to store SimvaHexal 10

Keep this medicine out of the 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 specified month.
Do not store above 30°C.
Store blisters in the carton to protect from light.
Tablet container
Keep tablets in the original 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 will help protect the environment.

6. Contents of the pack and other information

What SimvaHEXAL contains

• The active substance is simvastatin. Each 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 6 cps, hypromellose 3 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 6 cps, hypromellose 3 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 coated tablets are pale pink, oval, biconvex, with a score line, marked “SIM 10” on one side.
SimvaHEXAL 20 coated tablets are orange, oval, biconvex, with a division line on both sides, marked “20” on one side.
SimvaHEXAL 40 coated tablets are brownish-red, oval, biconvex, with a division line on both sides, marked “40” on one side.
Blister packs made of PVC/aluminum foil or polyethylene bottles with screw caps contain 28, 30, or 90 coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturers
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
D-39179 Barleben, Germany
LEK S.A.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
LEK S.A.
ul. Podlipie 16
95-010 Stryków, Poland
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 Târgu Mureș, Romania

For further information about this medicinal product and its trade names in other European Economic Area countries, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warszawa, Poland
Tel. +48 22 209 70 00