Simvastatin Aurovitas

Leaflet attached to the packaging: information for the user

Simvastatin Aurovitas, 20 mg, coated tablets

Simvastatin Aurovitas, 40 mg, coated tablets

(Simvastatinum)

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

You should keep this leaflet, so you can read it again if you need to.
In case of any doubts, you should consult a doctor or pharmacist.
This medicine has been prescribed to you specifically. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist.
See section 4.

Table of contents of the leaflet:

• 1. What is Simvastatin Aurovitas and what is it used for
• 2. Important information before using Simvastatin Aurovitas
• 3. How to use Simvastatin Aurovitas
• 4. Possible side effects
• 5. How to store Simvastatin Aurovitas
• 6. Contents of the packaging and other information

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

Simvastatin Aurovitas is a medicine used to lower the level of total cholesterol, "bad" cholesterol (LDL cholesterol) and triglycerides in the blood. Additionally, the 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 found in the bloodstream. Total cholesterol is mainly made up of LDL and HDL cholesterol.
LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of arteries, forming plaques. The buildup of such plaques can cause the arteries to narrow, slowing or blocking the flow of blood to vital organs such as the heart and brain. Such blockage of blood flow can 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 walls of arteries and protects against heart disease.
Triglycerides are another type of fat in the blood that can increase the risk of heart disease.
While taking this medicine, the patient should remain on a low-cholesterol diet.
This medicine is used in conjunction with a low-cholesterol diet in the following cases:
high blood cholesterol (primary hypercholesterolemia) or high blood fat (mixed hyperlipidemia);
a hereditary disease (homozygous familial hypercholesterolemia) that causes high blood cholesterol. Other treatments may also be used.
ischemic heart disease (IHD) or a high risk of IHD (due to diabetes, a history of stroke, or other vascular diseases). Simvastatin Aurovitas may prolong life by reducing the risk of heart disease, regardless of blood cholesterol levels.
In most people, there are no direct symptoms of high cholesterol. A doctor can determine cholesterol levels with a simple blood test. The patient should regularly visit their doctor, monitor their cholesterol levels, and discuss their goals with their doctor.

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 the patient currently has liver problems
during pregnancy or breastfeeding
if the patient is taking one or more medicines containing the following active substances:

• itraconazole, ketoconazole, posaconazole, or voriconazole (antifungal medicines)
• erythromycin, clarithromycin, or telithromycin (used to combat 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 viral hepatitis C)
• nefazodone (used in the treatment of depression)
• cobicistat
• gemfibrozil (used to lower cholesterol levels)
• cyclosporine (used in patients after organ transplantation)
• danazol (a human hormone used to treat endometriosis - a condition in which the lining of the uterus develops outside the uterus)
• if the patient is currently taking or has taken within the last 7 days a medicine called fusidic acid (an antibiotic 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 severe and rare, genetically very high cholesterol levels).

In case of doubt about whether a medicine taken by the patient is listed above, the patient should consult their doctor.

Warnings and precautions

Before starting Simvastatin Aurovitas, the patient should discuss it with their doctor or pharmacist.

The patient should inform their doctor about all current illnesses, including allergies.
The patient should inform their doctor if they consume large amounts of alcohol.
The patient should inform their doctor if they have ever had liver disease. Simvastatin Aurovitas may not be suitable.
The patient should inform their doctor if they are scheduled for surgery. It may be necessary to stop taking the medicine for a short period.
If the patient is Asian, as a different dose may be used.
Before starting treatment, the doctor should order a blood test. The 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.
Also, after starting treatment with this medicine, the doctor may recommend a blood test to check if the liver is working properly.
Patients with diabetes or those at risk of developing diabetes will be under close medical supervision while taking this medicine. Patients with high sugar and fat levels in the blood, being overweight, and having high blood pressure may be at risk of developing diabetes.
The patient should inform their doctor if they have severe lung disease.

The patient should immediately inform their doctor if they experience unexplained muscle pain, tenderness, or weakness. In rare cases, serious muscle disorders can occur, including muscle breakdown causing kidney damage; very rare cases of

death have also occurred.
The risk of muscle weakness is higher when taking higher doses of Simvastatin Aurovitas, especially the 80 mg dose. The risk of muscle weakness is also higher in certain patients. The patient should tell their doctor if they:
consume large amounts of alcohol
have kidney problems
have thyroid problems
are 65 years old or older
are female
have ever had muscle disorders while taking cholesterol-lowering medicines called statins or fibrates
have a family history of muscle disorders.
The patient should also inform their doctor or pharmacist if they experience persistent muscle weakness. The doctor may order additional tests and medicines to diagnose and treat the condition.
If the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or myasthenic syndrome (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms of the disease or lead to myasthenia (see section 4).

Children and adolescents

The safety and efficacy of simvastatin have been studied in boys aged 10-17 and girls who have started menstruation (menstruation) at least one year earlier (see section 3: How to use Simvastatin Aurovitas). No studies have been conducted on the effects of simvastatin on children under the age of 10. For more information, the patient should consult their doctor.

Simvastatin Aurovitas 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 simvastatin with the following medicines increases the risk of muscle problems (some of which are mentioned in the previous section "When not to use Simvastatin Aurovitas"):

• If the patient needs to take fusidic acid orally for the treatment of bacterial infections, they should stop taking Simvastatin Aurovitas. The doctor will inform the patient when they can safely resume taking Simvastatin Aurovitas. Taking Simvastatin Aurovitas with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• Cyclosporine (a medicine used in patients after organ transplantation)
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus develops 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, or telithromycin (used to treat bacterial infections)
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS)
• Antiviral medicines for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir
• Boceprevir or telaprevir (used in the treatment of viral hepatitis C)
• Neafazodone (used in the treatment of depression)
• Medicines containing the active substance cobicistat
• Amiodarone (used in arrhythmia)
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases)
• Lomitapide (used to treat severe and rare, genetically very high cholesterol levels)
• 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 simvastatin for a while.
• Colchicine (used to treat gout)

Similarly, 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. In particular, the patient should inform their doctor if they are taking:

• anticoagulant medicines such as warfarin, phenprocoumon, or acenocoumarol
• fenofibrate (another cholesterol-lowering medicine)
• niacin (another cholesterol-lowering medicine)
• rifampicin (used to treat tuberculosis)
• tikagrelor (a medicine that reduces platelet aggregation)

The patient should also tell their doctor if they are taking niacin (nicotinic acid) or a product containing niacin and if they are Chinese.

Using Simvastatin Aurovitas with food and drink

Grapefruit juice contains one or more ingredients that affect how the body absorbs certain medicines, including Simvastatin Aurovitas. During treatment, the patient should avoid drinking grapefruit juice.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before using this medicine. The patient should not take Simvastatin Aurovitas if they are pregnant, plan to become pregnant, or suspect they are pregnant. If the patient becomes pregnant while taking this medicine, they should stop taking it and contact their doctor.
The patient should not breastfeed while taking Simvastatin Aurovitas, as it is not known whether the medicine is excreted in breast milk.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.
However, the patient should be cautious, as it can cause dizziness in some patients.

Simvastatin Aurovitas contains lactose

Simvastatin Aurovitas contains a sugar called lactose. If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to use Simvastatin Aurovitas.

The doctor will determine the appropriate tablet strength for the patient, depending on the patient's health, current treatment, and personal risk factors.
This medicine should always be taken as directed by the doctor. In case of doubt, the patient should consult their doctor or pharmacist.
During treatment with Simvastatin Aurovitas, the patient should follow a low-cholesterol diet.
Dosage
The recommended dose is usually one 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg Simvastatin Aurovitas tablet taken orally once a day.
Adults:
The usual initial dose is 10, 20, 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. The patient should not take more than 80 mg per day.
The doctor may recommend lower doses, especially when taking certain medicines listed above or in cases of kidney disorders.
A dose of 80 mg 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 level with lower doses.

Use in children and adolescents

For children (10-17 years old), the recommended initial dose is 10 mg per day, taken in the evening.
The maximum recommended dose is 40 mg per day.
Method and time of administration
Simvastatin Aurovitas should be taken in the evening. The medicine can be taken with or without food. The patient should not stop treatment without consulting their doctor.
If the doctor has prescribed taking Simvastatin Aurovitas with another cholesterol-lowering medicine containing a bile acid sequestrant, Simvastatin Aurovitas should be taken 2 hours before taking the bile acid sequestrant or at least 4 hours after taking it.

Using a higher than recommended dose of Simvastatin Aurovitas

The patient should contact their doctor or pharmacist

Missing a dose of Simvastatin Aurovitas

The patient should not take a double dose to make up for a missed dose; they should take their normal dose of Simvastatin Aurovitas at the usual time the next day. The patient should not take a double dose to make up for a missed tablet.

Stopping Simvastatin Aurovitas

The patient should contact their doctor or pharmacist, as it is possible that cholesterol levels may rise again.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Simvastatin Aurovitas can cause side effects, although not everybody gets them.
The following terms have been used to describe the frequency of side effects:
Rare (may affect up to 1 in 100 people)
Very rare (may affect up to 1 in 10,000 people)
Unknown (frequency cannot be estimated from the available data)
The following serious side effects have been observed, occurring rarely:

In case of the following serious side effects, the patient should stop taking the medicine and consult their doctor or go to the emergency department of the nearest hospital:

Muscle pain, tenderness, weakness, muscle rupture, or muscle cramps. In rare cases, muscle problems can have serious consequences, including muscle breakdown leading to kidney damage; in very rare cases, death has occurred.
Allergic reactions, including:
swelling of the face, tongue, and throat, which can cause breathing difficulties (angioedema),
severe muscle pain, usually in the shoulders and hips,
rash with muscle weakness in the limbs and neck,
rash that can occur on the skin or mouth sores (lichen planus),
joint pain or inflammation (polymyalgia rheumatica),
vasculitis,
abnormal bruising, skin rash, and swelling (dermatomyositis),
hives, skin hypersensitivity to light, fever, redness,
breathing difficulties (dyspnea) or malaise,
symptoms of lupus-like syndrome (including rash, joint disorders, and blood disorders).
Hepatitis with the following symptoms: yellowing of the skin and eyes, itching, dark urine, or light-colored stools, feeling tired or weak, loss of appetite,
liver failure (very rare).
Pancreatitis, often with severe abdominal pain.
Rarely, the following side effects have also been observed:
low red blood cell count (anemia),
numbness or weakness in the arms and legs,
headache, tingling sensation, dizziness,
blurred vision, vision disturbances,
gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
rash, itching, hair loss,
weakness.
sleep disorders (very rare)
poor memory (very rare), memory loss, disorientation.
The following very rare but serious side effects have been reported:

• severe allergic reaction, which can cause breathing difficulties or dizziness (anaphylaxis),
• gynecomastia (breast enlargement in men).

The following side effects have also been reported, but their frequency cannot be determined from the available data (frequency unknown):

• erectile dysfunction,
• depression,
• pneumonia, which can cause breathing difficulties, including persistent cough or shortness of breath or fever,
• tendon problems, sometimes complicated by tendon rupture,
• myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing),
• myasthenic syndrome (a disease that causes muscle weakness in the eyes). The patient should talk to their doctor if they experience weakness in their arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.

Additional side effects reported in connection with the use of some statins:
sleep disorders, including nightmares,
sexual disorders,
diabetes. The risk of developing diabetes is higher in people with high sugar and fat levels in the blood, being overweight, and having high blood pressure. The doctor will monitor the patient's condition while taking this medicine.
Laboratory test results
Increased results of some blood tests that assess liver function and increased muscle enzyme activity (creatine kinase) have been observed.

Reporting side effects

If the patient experiences any side effects, including those not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 can help gather more information on the safety of the medicine.

5. How to store Simvastatin Aurovitas

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the 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 month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What Simvastatin Aurovitas contains

The active substance of the medicine 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 of the medicine are:
Tablet core: Butylhydroxyanisole (E 320), Ascorbic acid, Citric acid monohydrate, Microcrystalline cellulose, Maize starch, Lactose monohydrate, Magnesium stearate
Coating 20 mg (Opadry Pink 20A54239): Hypromellose 6cP, Hydroxypropylcellulose, Titanium dioxide (E 171), Talc, Iron oxide yellow (E 172), Iron oxide red (E 172).
Coating 40 mg (Opadry Pink 20A54211): Hypromellose 6cP, Hydroxypropylcellulose, Titanium dioxide (E 171), Talc, Iron oxide red (E 172).

What Simvastatin Aurovitas looks like and contents of the pack

Simvastatin Aurovitas, 20 mg, coated tablets
The tablets are pink, round [8.1 mm in diameter], biconvex, with the letter SI engraved on one side and the number 20 on the other.
Simvastatin Aurovitas, 40 mg, coated tablets
The tablets are pink, round [10.1 mm in diameter], biconvex, with the letter SI engraved on one side and the number 40 on the other.
Simvastatin Aurovitas 20 mg and 40 mg coated tablets: blister packs (blisters)
PVC/PE/PVDC/Aluminum. The packs contain 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, or 100 tablets.
Simvastatin Aurovitas 10, 20, and 40 mg coated tablets are packaged in white, opaque, round HDPE containers with a white, opaque polypropylene cap, containing 30, 50, 56, 60, 90, 98, 100, or 1000 (exclusively for hospital use or dose dispensing) coated tablets.
Not all pack sizes may be marketed.

Marketing authorization holder

Aurovitas Pharma Polska Sp. z o.o.
ul. Sokratesa 13D lokal 27
01-909 Warsaw

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 authorized in the Member States of the European Economic Area 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 last revision of the leaflet: 03/2023