Simvagen 20

Leaflet accompanying the packaging: information for the user

Simvagen 20,20 mg, coated tablets
Simvagen 40,40 mg, coated tablets
Simvastatin

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 that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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 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 Simvagen and what is it used for
• 2. Important information before using Simvagen
• 3. How to use Simvagen
• 4. Possible side effects
• 5. How to store Simvagen
• 6. Contents of the packaging and other information

1. What is Simvagen and what is it used for

Simvagen is used to lower the level of cholesterol and fats called triglycerides in the blood.
During treatment, you should follow a low-cholesterol diet. This medicine belongs to a group of medicines called statins.
Simvagen is used in combination with a diet in people:

• who have been found to have high cholesterol levels in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia), when physical exercise and weight loss have been ineffective.
• with a hereditary disease called homozygous familial hypercholesterolemia, which causes high cholesterol levels in the blood. Other medicines may also be used in these patients.
• with coronary heart disease or who are at high risk of developing coronary heart disease. The likelihood of developing coronary heart disease is higher in people with diabetes, after a stroke, or with other blood vessel diseases.

In most people, there are no symptoms associated with high cholesterol levels.
The doctor or pharmacist can assess cholesterol levels with a simple blood test. High cholesterol levels in the blood can lead to coronary heart disease. It can clog blood vessels, leading to hardening of the arteries (atherosclerosis). Stiffened arteries have a reduced ability to supply blood to the heart and the entire body. This can cause chest pain (angina pectoris) and lead to a heart attack.
In people with high cholesterol levels, the likelihood of developing coronary heart disease is higher if they also have:

• high blood pressure (hypertension)
• diabetes (high blood sugar levels)
• low physical activity
• smoking
• overweight or a diet high in fat

To get advice on the above factors, you should consult a doctor or pharmacist.

2. Important information before using Simvagen

When not to use Simvagen:

• if the patient is allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6)
• if there are liver function disorders
• if the patient is pregnant or breastfeeding
• if the patient is taking medicines for fungal infections (such as itraconazole, ketoconazole, posaconazole, or voriconazole), medicines used to treat HIV (such as indinavir, nelfinavir, ritonavir, and saquinavir), medicines containing cobicistat (also used to treat HIV), medicines used to treat hepatitis C (boceprevir, telaprevir), antibiotics (such as erythromycin, clarithromycin, or telithromycin), or nefazodone, a medicine used to treat depression (see section 2 "Simvagen and other medicines")
• if the patient is taking gemfibrozil (a medicine used to lower cholesterol levels)
• if the patient is taking cyclosporine (a medicine often used in transplant patients)
• if the patient is taking danazol (a synthetic hormone used to treat endometriosis)

Simvagen should not be used in a dose greater than 40 mg if the patient is taking lomitapide (used to treat severe and rare genetic cholesterol disorders)
If any of the above situations occur, the medicine should not be taken, but the doctor should be consulted again to discuss treatment.

Warnings and precautions

Before starting Simvagen, you should discuss it with your doctor or pharmacist if:

• The patient has or has had myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing) or ocular myasthenia (a disease that causes eye muscle weakness), as statins can sometimes exacerbate symptoms or lead to myasthenia (see section 4)
• There are conditions such as allergies
• There have been previous liver function disorders. In such cases, Simvagen may not be the appropriate medicine
• There is high blood pressure or high levels of fats and sugars in the blood, or if the body mass index exceeds 30 kg/m. In such patients, there is an increased risk of developing diabetes. In this situation, the doctor will closely monitor the patient's condition
• The patient regularly consumes large amounts of alcohol
• The patient is taking or has taken fusidic acid (an antibiotic) orally or by injection in the last 7 days. Concurrent use of fusidic acid and Simvagen can lead to serious muscle problems (rhabdomyolysis)

Children and adolescents

The safety and efficacy of Simvagen have been studied in boys aged 10-17 and girls who have started menstruating at least one year earlier (see "How to use Simvagen").
No studies have been conducted on simvastatin in children under the age of 10. To obtain additional information, you should consult a doctor

Blood tests

Before starting simvastatin, the doctor will perform blood tests to check liver function.
The doctor may order blood tests to assess liver function after starting simvastatin.
After starting simvastatin, the doctor will order regular blood tests to check the effectiveness of the medicine.

During treatment

During simvastatin treatment, patients with diabetes or patients at risk of diabetes will be under constant observation by the doctor. The increased risk of developing diabetes applies to patients with high levels of sugars and fats in the blood, overweight patients, and patients with high blood pressure.

Warning - you should keep your doctor informed

You should immediately consult a doctor if you experience unexplained muscle pain, tenderness, or weakness, as very rare cases of serious muscle problems can occur, leading to kidney damage, and in very rare cases, death.

In rare cases, deaths have been reported.
The risk of muscle damage is higher in patients taking Simvagen in high doses, especially at a dose of 80 mg. The risk of muscle damage is higher in a certain group of patients.
You should discuss with your doctor:

• consuming large amounts of alcohol
• having kidney disease
• having thyroid disease
• being over 65 years old
• being female
• being of Asian origin, as a different dose may be necessary
• having previously experienced muscle problems while taking cholesterol-lowering medicines, such as statins or fibrates
• having a family history of muscle problems

You should inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests may be necessary to diagnose and treat the condition.
If you have breathing difficulties or a persistent cough, you should consult a doctor.
If you are to undergo surgery, it may be necessary to stop taking simvastatin for a short time.

Simvagen and other medicines

Many medicines affect the action of simvastatin. You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription, herbal preparations, and dietary supplements.

• Cyclosporine- a medicine used to prevent transplant rejection in patients after transplantation
• A hormone called danazol, which is used to treat severe or painful menstruation
• Antifungal medicines such as ketoconazole, itraconazole, fluconazole, posaconazole, or voriconazole
• Fibrates, such as gemfibrozil, fenofibrate, bezafibrate, also used to treat high cholesterol levels
• Niacinor nicotinic acidor acipimox used in high doses to treat high cholesterol levels
• Antibiotics such as erythromycin, clarithromycin, or telithromycin
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonaviror saquinavir(medicines used to treat HIV) or medicines containing cobicistat (also used to treat HIV)
• Antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir
• Glecaprevir/pibrentasvir(also used to treat hepatitis C)
• An antidepressant called nefazodone
• Medicines such as amiodarone(a medicine used to treat heart rhythm disorders), verapamil, diltiazemor amlodipine(medicines used to treat high blood pressure or heart disease)
• Lomitapide(used to treat severe and rare genetic cholesterol disorders)
• 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(a medicine used to treat gout)
• Ticagrelor(an antiplatelet medicine)

Taking simvastatin with any of these medicines can increase the risk of muscle problems (some of which are listed in the "When not to use Simvagen" section).
If you need to take fusidic acid orally for bacterial infections, you should temporarily stop taking this medicine. The doctor will decide when it is safe to return to taking Simvagen. Concurrent use of Simvagen with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.

If you are taking any of the following medicines, you should consult your doctor before taking simvastatin:

• Rifampicin- used to treat tuberculosis
• Medicines used to treat blood clots, such as warfarin, phenprocoumon, or acenocoumarol, as it may be necessary to change the dose of warfarin, phenprocoumon, or acenocoumarol

You should also tell your doctor if you are taking niacin (nicotinic acid) or products containing niacin, if you are from China.

Simvagen with food and drink

Grapefruit juice can affect the action of simvastatin in the body. You should not drink grapefruit juice while taking simvastatin.

Pregnancy and breastfeeding

DO NOTuse Simvagen in pregnant women, women planning to become pregnant, and women who suspect they may be pregnant. If you become pregnant while taking Simvagen, you should STOPtreatment and immediately consult your doctor.
You should not take Simvagen while breastfeeding, as it is not known whether the medicine passes into breast milk.
Before taking any medicine, you should consult a doctor or pharmacist.

Driving and using machines

Simvagen does not affect the ability to drive or use machines.
Simvagen can cause dizziness, and before driving or using machines, you should make sure that such symptoms do not occur.

Simvagen contains lactose (20 mg and 40 mg doses).

If you have previously been diagnosed with intolerance to some sugars, you should consult your doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is "sodium-free".

3. How to use Simvagen

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist. The dose of the medicine will be determined by your doctor based on the results of blood tests.
You should remember to follow a low-fat diet and maintain physical activity.

Patients with coronary heart disease

The recommended dose is 20 mg to 40 mg and should be taken in the evening. The doctor may increase the dose used every 4 weeks. The maximum dose is 80 mg. The doctor will determine the appropriate dose for each patient based on their condition, current treatment, and individual risk profile.
You should not stop taking Simvagen unless your doctor advises you to do so.

Patients with high cholesterol levels/fats in the blood (hypercholesterolemia/hyperlipidemia)

The recommended initial dose is 10 mg to 20 mg and is taken in the evening. The doctor may increase the dose used every 4 weeks. The maximum dose is 80 mg.

Patients with hereditary high cholesterol levels (homozygous familial hypercholesterolemia)

The recommended initial dose is 40 mg and is taken in the evening.
A dose of 80 mg is recommended only for adult patients with very high cholesterol levels in the blood and a high risk of developing heart disease, who have not achieved the target cholesterol level with lower doses.

Use in children and adolescents (10-17 years old)

The recommended initial dose for children aged 10-17 is 10 mg. This dose is usually taken in the evening. If necessary, the dose can be increased, up to a maximum of 40 mg.
Some patients may need a lower dose, especially if they are also taking medicines such as fibrates or niacin and have kidney problems.

Using other cholesterol-lowering medicines with Simvagen

During simvastatin treatment, the doctor may recommend taking a medicine called cholestyramine. This medicine may affect the action of simvastatin. Simvastatin should be taken 2 hours before or 4 hours after taking cholestyramine.

Using the medicine

The medicine should be swallowed with a large amount of water. The medicine can be taken with or without food.
The 20 mg tablet can be divided into equal doses.

Taking a higher dose of Simvagen than recommended

If you have taken a higher dose of Simvagen than recommended, you should immediately consult a doctor or go to the emergency room of the nearest hospital. You should take the packaging of the medicine with you.

Missing a dose of Simvagen

If you have missed a dose of the medicine, you should take it as soon as you remember, unless it is almost time for the next dose. You should not take a double dose to make up for the missed dose.

Stopping Simvagen treatment

The doctor will determine how long you should take the medicine. DO NOTsuddenly stop taking the medicine without consulting your doctor first, as cholesterol levels may rise again.
If you have any further doubts about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The list of side effects should not cause concern. It is possible that none of them will occur, but it is essential to know what to do if they do.

If you experience any of these severe side effects, you should stop taking the medicine and immediately consult a doctor or go to the emergency room of the nearest hospital.

• Unexplained muscle problems, such as pain, tenderness, weakness, especially persistent weakness, muscle damage, or cramps. In rare cases, muscle problems can be very severe and lead to muscle breakdown and kidney damage. In some cases, these problems can be life-threatening. Very rare cases of death have been reported.
• Allergic reactions, including:
• swelling of the face, tongue, and throat, which can cause breathing difficulties (angioedema)
• severe muscle pain, usually in the shoulder and hip area
• rash with muscle weakness and neck stiffness
• rash that can occur on the skin or mouth ulcers (drug-induced lupus-like reactions)
• joint pain or inflammation
• blood vessel inflammation
• unusual bruising, skin rashes, and swelling, hives, increased sensitivity to sunlight, fever, flushing
• breathlessness and malaise
• symptoms of lupus-like disease (including rash, joint symptoms, and blood cell changes)
• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis)
• gynecomastia (breast enlargement in men)
• liver inflammation with yellowing of the skin and eyes, itching, dark urine, or pale stools, which can lead to liver failure (very rare)
• severe abdominal pain, which can be swollen and tender, and nausea and vomiting accompanied by fever, caused by pancreatitis
• lung inflammation causing breathing difficulties, including persistent cough and (or) shortness of breath or fever
• Severe joint pain with weakness and inability to move arms and legs due to tendon problems.
• Diabetes. The likelihood of developing diabetes is higher if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. During simvastatin treatment, your doctor should closely monitor your condition.

Other possible side effects:
Rare (may affect up to 1 in 100 people):

• feeling tired and breathless with pale skin due to a decrease in the number of red blood cells (anemia)
• numbness or weakness in the arms or legs
• headaches, feeling of tingling, dizziness
• blurred vision; vision disturbances
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• elevated levels of substances in the blood that indicate liver and muscle function

Very rare (may affect up to 1 in 10,000 people)

• sleep disturbances
• memory impairment, memory loss, confusion.

Unknown (frequency cannot be estimated from available data):

• erectile dysfunction
• depression
• feeling thirsty, needing to urinate more often, feeling tired due to high blood sugar levels
• myasthenia (a disease that causes general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease that causes eye muscle weakness).

You should discuss with your doctor if you experience weakness in your arms or legs, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or breathlessness.
Additionally, side effects that have occurred with the use of some statins may include:

• sleep disturbances, including nightmares
• sexual disorders

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your 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 will help gather more information on the safety of the medicine.

5. How to store Simvagen

The medicine should be stored out of sight and reach of children.
There are no special storage instructions for the medicine.
Do not use this medicine after the expiry date stated on the packaging/bottle/blister after: EXP. The expiry date refers to the last day of the month.
Medicines should not be disposed of in wastewater or household waste. You should ask your 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 Simvagen contains

Simvagen is available in the form of coated tablets in two different doses containing 20 mg or 40 mg of simvastatin as the active substance.
Each coated tablet also contains ascorbic acid, butylhydroxyanisole (E320), citric acid monohydrate, lactose monohydrate (see section 2 "Simvagen contains lactose"), magnesium stearate, microcrystalline cellulose, maize starch, sodium lauryl sulfate, hypromellose, talc, hydroxypropylcellulose, titanium dioxide (E171), macrogol, iron oxide red (E172), and iron oxide yellow (E172).

What Simvagen looks like and what the packaging contains

Simvagen 20 mg coated tablets: dark brown, oval, biconvex coated tablets with beveled edges, with the inscription "SV3" on one side and a dividing line on the other side. The tablet can be divided into equal doses.
Simvagen 40 mg coated tablets: pink, oval, biconvex coated tablets with beveled edges, with the inscription "SV4" on one side and the inscription "M" on the other side.
Simvagen coated tablets are packaged in plastic bottles or blister packs containing 28 or 30 tablets.
Simvagen 20 mg tablets are also packaged in blister packs containing 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder:

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer:

McDermott Laboratories Ltd. trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road Dublin 13, Ireland
Mylan Hungary Kft., H-2900, Komárom, Mylan utca 1, Hungary
Mylan Germany GmbH, Zweigniederlassung Bad Homburg v. d. Hoehe, Benzstrasse 1, Bad Homburg

• v. d. Hoehe, Hessen, 61352, Germany

To obtain more detailed information about the medicine and its names in the Member States of the European Economic Area, you should contact the local representative of the marketing authorization holder:

Viatris Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: