Simvastatin aurovitas: detailed information

Patient Information Leaflet

Simvastatin Aurovitas, 20 mg, film-coated tablets
Simvastatin Aurovitas, 40 mg, film-coated tablets
(Simvastatinum)
Please read this leaflet carefully before taking this medicine because it contains important
information for you.
Keep this leaflet as you may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others. This medicine may harm
other people even if their symptoms are the same as yours.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or
pharmacist. See section 4.
Leaflet contents:

What Simvastatin Aurovitas is and what it is used for
What you need to know before taking Simvastatin Aurovitas
How to take Simvastatin Aurovitas
Possible side effects
How to store Simvastatin Aurovitas
Contents of the pack and other information

1. What Simvastatin Aurovitas is and what it is used for

Simvastatin Aurovitas is a medicine used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and to reduce levels of fatty substances called triglycerides in the blood. In addition, this medicine increases the level of "good" cholesterol (HDL cholesterol). Simvastatin Aurovitas belongs to a group of medicines called statins.
Cholesterol is one of several fatty substances present in the bloodstream. Total cholesterol mainly consists 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 can narrow the arteries, slowing down or blocking blood flow to vital organs such as the heart and brain. Such blockage of blood flow may lead to a heart attack or stroke.
HDL cholesterol is often called "good" cholesterol because it helps prevent the buildup of bad cholesterol in the artery walls and protects against heart disease.
Triglycerides are another type of fat in the blood that may increase the risk of heart disease.
While taking this medicine, you should continue a low-cholesterol diet.
This medicine is used together with a low-cholesterol diet in the following conditions:
elevated cholesterol levels in the blood (primary hypercholesterolemia) or elevated fat levels in the blood (mixed hyperlipidemia);
a hereditary condition (homozygous familial hypercholesterolemia) which causes high cholesterol levels in the blood. Other treatment methods may also be used.
ischaemic heart disease (IHD) or high risk of IHD (due to diabetes, previous stroke, or other vascular diseases). Simvastatin Aurovitas may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.
Most people do not experience direct symptoms of high cholesterol levels. Your doctor can determine your cholesterol levels with a simple blood test. You should regularly attend check-up visits with your doctor, monitor your cholesterol levels, and discuss with your doctor the goals you wish to achieve.

2. Important information before using Simvastatin Aurovitas

When not to use Simvastatin Aurovitas
if the patient is allergic (hypersensitive) to simvastatin or any of the other
ingredients of Simvastatin Aurovitas (listed in section 6).
if there are current liver problems
during pregnancy or breastfeeding
if the patient is concurrently taking one or more medicinal products containing
the following active substances:

itraconazole, ketoconazole, posaconazole or voriconazole (antifungal medicines)
erythromycin, clarithromycin or telithromycin (used to treat infections)
HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used in HIV infections)
boceprevir or telaprevir (used in the treatment of hepatitis C virus infection)
nefazodone (used to treat depression)
cobicistat
gemfibrozil (used to lower cholesterol levels)
cyclosporine (used in organ transplant patients)
danazol (a human hormone used to treat endometriosis – a condition in which the lining of the uterus grows outside the uterus)
if the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (a medicine used to treat bacterial infections) orally or by injection. Taking fusidic acid in combination with simvastatin may lead to serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of simvastatin if the patient is taking lomitapide (used to treat a serious and rare genetic condition of very high cholesterol).

If in doubt whether a medicine taken by the patient is listed above, consult a
doctor.
Warnings and precautions
Before starting Simvastatin Aurovitas, discuss this with your doctor or
pharmacist.
Inform your doctor about all current medical conditions, including allergies.
Inform your doctor if the patient consumes significant amounts of alcohol.
Inform your doctor if the patient has ever had liver disease. Simvastatin Aurovitas may not be suitable.
Inform your doctor if the patient is scheduled for surgery. Temporary discontinuation of this medicine may be required.
If the patient is of Asian descent, as a different dosage may be needed.
Before starting treatment, the doctor should order a blood test. This test checks liver function. After starting treatment with Simvastatin Aurovitas, the doctor may also consider it necessary to perform blood tests to check liver function.
Even after starting this medicine, the doctor may recommend a blood test to confirm that the liver is functioning properly.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high blood sugar and fat levels, overweight, and high blood pressure may be at risk of developing diabetes.
Inform your doctor if the patient has a severe lung disease.
Contact your doctor immediately if the patient experiences unexplained muscle pain, tenderness, or
weakness. In rare cases, serious muscle disorders may occur, including muscle breakdown leading to
kidney damage; very rare fatal cases have also been reported.
The risk of muscle problems is higher when taking higher doses of Simvastatin Aurovitas, particularly the 80 mg dose. The risk of muscle problems is also increased in certain patients. Inform your doctor if the patient:
consumes significant amounts of alcohol
has kidney problems
has thyroid problems
is 65 years of age or older
is female
has previously experienced muscle disorders while taking cholesterol-lowering medicines called statins or fibrates
has a personal or family history of inherited muscle diseases.
Also inform your doctor or pharmacist if the patient has persistent muscle weakness. The doctor may order additional tests and prescribe treatments to diagnose the condition and initiate appropriate therapy.
If 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 or trigger myasthenia (see section 4).
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 prior (see section 3: How to use Simvastatin Aurovitas). Studies on the effect of simvastatin in children under 10 years of age have not been conducted. For additional information, consult a doctor.
Simvastatin Aurovitas and other medicines
Tell your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to take. Concurrent use of simvastatin with the medicines listed below increases the risk of muscle-related problems (some of which were mentioned in the previous section "When not to use Simvastatin Aurovitas"):

If the patient needs to take fusidic acid orally to treat a bacterial infection, treatment with Simvastatin Aurovitas should be temporarily discontinued. The doctor will inform the patient when it is safe to resume taking Simvastatin Aurovitas. Concurrent use of Simvastatin Aurovitas with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
Cyclosporine (a medicine commonly used in organ transplant patients).
Danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus)
Medicines such as itraconazole, ketoconazole, posaconazole or voriconazole (antifungal medicines)
Fibrates containing active substances such as gemfibrozil and bezafibrate (used to lower cholesterol levels).
Erythromycin, clarithromycin, telithromycin (used to treat bacterial infections)
HIV protease inhibitors, for example indinavir, nelfinavir, ritonavir and saquinavir (used in the treatment of AIDS)
Antiviral medicines for hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir
Boceprevir or telaprevir (used in the treatment of hepatitis C virus infection)
Nefazodone (used to treat depression)
Medicines containing the active substance cobicistat
Amiodarone (used for arrhythmia)
Verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain related to heart disease or other heart conditions)
Lomitapide (used to treat a serious and rare genetic condition of very high cholesterol)
Daptomycin (a medicine used to treat complicated skin and soft tissue infections and bacteremia). The risk of muscle-related adverse effects may be increased when this medicine is taken during simvastatin treatment. The doctor may decide to temporarily discontinue simvastatin.
Colchicine (used to treat gout)

Similarly to the medicines listed above, inform your doctor or
pharmacist about all medicines currently used or recently used, including over-the-counter medicines. In particular, inform your doctor if the patient is taking:

anticoagulants such as warfarin, phenprocoumon, acenocoumarol (anticoagulants)
fenofibrate (another cholesterol-lowering medicine)
niacin (another cholesterol-lowering medicine)
rifampicin (used to treat tuberculosis)
ticagrelor (a medicine that reduces platelet aggregation).

Also inform your doctor if the patient is taking niacin (nicotinic acid) or a niacin-containing product and if the patient is Chinese.
Taking Simvastatin Aurovitas with food and drink
Grapefruit juice contains one or more components that affect how the human body absorbs certain medicines, including Simvastatin Aurovitas. Grapefruit juice should be avoided during treatment.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine. Do not take Simvastatin Aurovitas if the patient is pregnant, planning a pregnancy, or suspects she is pregnant. If pregnancy occurs while taking this medicine, stop taking it immediately and contact a doctor.
Breastfeeding must not be undertaken while taking Simvastatin Aurovitas, as it is not known whether the medicine is excreted in human milk.
Driving and using machines
This medicine does not affect the ability to drive or operate machinery.
However, caution should be exercised, as it may cause dizziness in some patients.
Simvastatin Aurovitas contains lactose
Simvastatin Aurovitas contains a sugar called 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 Simvastatin Aurovitas.

The appropriate tablet strength will be determined by the doctor, depending on the patient's health status, current treatment, and personal risk level.
This medicine should always be taken as directed by the doctor. If in doubt, consult the doctor or pharmacist.
While being treated with Simvastatin Aurovitas, a cholesterol-lowering diet should be followed.

Dosage
The usual recommended dose is one tablet of 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of Simvastatin Aurovitas taken orally once daily.

Adults:
The usual starting dose is 10 mg, 20 mg, or, in some cases, 40 mg per day. The doctor may adjust the dose after at least 4 weeks to a maximum of 80 mg per day. Do not take more than 80 mg per day.
The doctor may recommend lower doses, especially when taking certain other medicines listed above or in case of kidney impairment.
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 the desired cholesterol levels with lower doses.

Use in children and adolescents
For children (10–17 years of age), the recommended starting dose is 10 mg taken in the evening.
The maximum recommended dose is 40 mg per day.

Method and timing of administration
Simvastatin Aurovitas should be taken in the evening. It may be taken with or without food. Do not stop treatment without consulting the doctor.
If the doctor has prescribed Simvastatin Aurovitas together with another cholesterol-lowering medicine containing a bile acid-binding ingredient, Simvastatin Aurovitas should be taken at least two hours before or at least four hours after taking the bile acid-binding medicine.

Taking more Simvastatin Aurovitas than prescribed
Contact the doctor or pharmacist immediately.

Missing a dose of Simvastatin Aurovitas
Do not take a double dose to make up for the missed dose; take the next dose at the usual time the following day. Do not take a double dose to make up for a missed tablet.

Stopping Simvastatin Aurovitas
Contact the doctor or pharmacist, as 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.
The following terms have been used to describe the frequency of occurrence of adverse reactions:
Rare (may affect up to 1 in 1,000 patients)
Very rare (may affect up to 1 in 10,000 patients)
Not known (frequency cannot be estimated from the available data)

The following serious adverse reactions, which occur rarely, have been observed.
If any of the following serious adverse reactions occur, treatment must be discontinued and
immediate medical advice must be sought from a doctor or by going to the nearest hospital
emergency department:
Muscle pain, tenderness, weakness, muscle breakdown or muscle cramps. In rare cases, muscle problems may have serious consequences, including breakdown of muscle tissue leading to kidney damage; in very rare cases, death has occurred.

Hypersensitivity (allergic) reactions including:
swelling of the face, tongue and throat, which may cause difficulty in breathing (angioedema),
severe muscle pain, usually in shoulders and hips,
rash with muscle weakness in limbs and neck,
rash which may appear on the skin or sores in the mouth (lichenoid eruption),
joint pain or inflammation (polymyalgia rheumatica),
inflammation of blood vessels,
abnormal bruising, skin rash and swelling (dermatomyositis),
urticaria, photosensitivity, fever, redness, difficulty in breathing (shortness of breath) or malaise,
symptoms of a lupus-like syndrome (including rash, joint disorders and blood cell abnormalities).

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, liver failure (very rare).

Inflammation of the pancreas, often with severe abdominal pain.

The following adverse reactions have also been observed rarely:
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,
weakness.
Sleep disturbances (very rare),
poor memory (very rare), memory loss, disorientation.

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).

The following adverse reactions have also been reported, but frequency cannot be estimated from the available data (frequency not known):

erectile dysfunction,
depression,
lung inflammation causing breathing problems, including persistent cough or shortness of breath or fever,
- tendon problems, sometimes complicated by tendon rupture,
- myasthenia (a disease causing generalised muscle weakness, including in some cases muscles involved in breathing),
- ocular myasthenia (a disease causing weakness of eye muscles). Patients should consult their doctor if they experience weakness in arms or legs that worsens with activity, double vision or drooping eyelids, difficulty swallowing or shortness of breath.

Additional adverse reactions reported with the use of some statins:
sleep disorders, including nightmares,
sexual dysfunction,
diabetes. The risk of developing diabetes is higher in people who have high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor your condition during treatment with this medicine.

Laboratory test results
Elevated results in certain blood tests assessing liver function and increased activity of muscle enzymes (creatine kinase) have been observed.

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 Reactions to Medicinal Products 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 may also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Simvastatin Aurovitas

Keep this medicine out of the sight and reach of children.
There are no special requirements for storage of this medicine.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the stated month.
Medicines should 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 Simvastatin Aurovitas contains
The active substance is simvastatin.
Simvastatin Aurovitas 20 mg: Each coated tablet contains 20 mg of simvastatin.
Simvastatin Aurovitas 40 mg: Each coated tablet contains 40 mg of simvastatin.

The other ingredients are:
Tablet core: Butylated hydroxyanisole (E 320), Ascorbic acid, Monohydrate citric acid, Microcrystalline cellulose, Pregelatinized corn starch, Lactose monohydrate, Magnesium stearate.
Coating of 20 mg tablet (Opadry Pink 20A54239): Hypromellose 6cP, Hydroxypropylcellulose, Titanium dioxide (E 171), Talc, Yellow iron oxide (E 172), Red iron oxide (E 172).
Coating of 40 mg tablet (Opadry Pink 20A54211): Hypromellose 6cP, Hydroxypropylcellulose, Titanium dioxide (E 171), Talc, Red iron oxide (E 172).

What Simvastatin Aurovitas looks like and contents of the pack
Simvastatin Aurovitas 20 mg, coated tablets
Light pink, round, biconvex, film-coated tablets (8.1 mm in diameter), engraved with "SI" on one side and "20" on the other.
Simvastatin Aurovitas 40 mg, coated tablets
Pink, round, biconvex, film-coated tablets (10.1 mm in diameter), engraved with "SI" on one side and "40" on the other.

Simvastatin Aurovitas 20 mg and 40 mg coated tablets: blister (PVC/PE/PVDC/Aluminium). Packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 or 100 tablets.
Simvastatin Aurovitas 10, 20 and 40 mg coated tablets are also packed in white, opaque, round HDPE containers with white opaque polypropylene caps, containing 30, 50, 56, 60, 90, 98, 100 and 1000 tablets (the latter exclusively for hospital use or dose dispensing).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warszawa
Poland

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far,
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica S.A.
Rua João de Deus, no 19, Venda Nova
2700-487 Amadora
Portugal

This medicinal product is authorised in the European Economic Area countries under the following names:
France: SIMVASTATINE ARROW LAB 10 /20 /40 mg, comprimés pelliculés
Germany: Simvastatin PUREN 10 /20 /40 /80 mg Filmtabletten
Italy: Simvastatina Aurobindo 10 /20 /40 mg compresse rivestite con film
Poland: Simvastatin Aurovitas
Portugal: Simvastatina Aurobindo
Spain: Simvastatina Aurovitas 10 /20 /40 mg comprimidos recubiertos con película
Netherlands: Simvastatine Aurobindo 5/10/20 /40 /80 mg filmomhulde tabletten

Date of latest revision of the leaflet: 03/2023