Simvagen 20

Package leaflet: Information for the user

Simvagen 20, 20 mg, film-coated tablets
Simvagen 40, 40 mg, film-coated tablets
Simvastatinum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please 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 the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Simvagen is and what it is used for

Simvagen is used to lower blood levels of cholesterol and certain fats called triglycerides.
While taking this medicine, you should follow a cholesterol-lowering diet. This medicine belongs to a group of medicines known as statins.
Simvagen is used together with diet in patients:

• who have been diagnosed with high blood cholesterol (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia), when physical exercise and weight loss have not been effective.
• with an inherited condition called homozygous familial hypercholesterolemia, which causes increased blood cholesterol levels. 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 coronary heart disease is higher in patients with diabetes, a history of stroke, or other blood vessel diseases.

Most people do not experience any symptoms related to high cholesterol levels.
Your doctor or pharmacist can assess your cholesterol levels with a simple blood test. Excessively high cholesterol levels in the bloodstream may lead to coronary heart disease. It may block blood vessels, leading to hardening of the arteries (atherosclerosis). Stiffened arteries have reduced ability to deliver blood to the heart and the entire body. This may cause chest pain (angina pectoris) and may lead to heart attack.
The risk of developing coronary heart disease is greater in people with high cholesterol if any of the following additional factors are present:

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

For advice regarding the above-mentioned factors, please consult your 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 currently taking medicines for fungal infections (such as: itraconazole, ketoconazole, posaconazole or voriconazole), medicines used to treat HIV infections (such as indinavir, nelfinavir, ritonavir and saquinavir), medicines containing cobicistat (also used in the treatment of HIV infections), medicines used to treat hepatitis C virus infection (boceprevir, telaprevir), antibiotics (such as: erythromycin, clarithromycin or telithromycin), or nefazodone, a medicine used to treat depression (see section 2. "Simvagen with other medicines")
• if the patient is taking gemfibrozil (a medicine used to lower cholesterol levels)
• if the patient is taking cyclosporine (a medicine commonly used in transplant patients)
• if the patient is taking danazol (a synthetic hormone used to treat endometriosis)

Simvagen must not be used at doses higher than 40 mg if the patient is taking lomitapide
(used in the treatment of a severe and rare genetic disorder affecting cholesterol levels).
If any of the above situations apply, the medicine should not be taken. Instead, the patient should
contact their doctor again to discuss treatment options.
Warnings and precautions
Before starting Simvagen, discuss with your doctor or pharmacist 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 of the disease or lead to the development of myasthenia (see section 4)
• There are conditions such as allergies
• There has been a history of liver function disorders. In such cases, Simvagen may not be the appropriate medicine
• There is high blood pressure or elevated levels of fats and sugars in the blood, or if body mass index exceeds 30 kg/m². In such patients, there is an increased risk of developing diabetes. In this case, the doctor will closely monitor the patient's condition
• The patient regularly drinks large amounts of alcohol
• The patient is taking or has taken within the last 7 days fusidic acid (a medicine used to treat bacterial infections), orally or by injection. Concomitant use of fusidic acid and Simvagen may lead to serious muscle problems (rhabdomyolysis)

Children and adolescents
Safety and efficacy have been studied in boys aged 10–17 years and in girls who have had regular menstruation for at least one year (see "How to use Simvagen").
Studies on simvastatin have not been conducted in children under 10 years of age. For additional information, consult your 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 treatment.
After starting simvastatin, the doctor will recommend regular blood tests to monitor the effectiveness of the medicine.
During treatment
While taking simvastatin, patients with diabetes or those at risk of diabetes will be under continuous medical supervision. Increased risk of developing diabetes applies to patients with high blood sugar and fat levels, overweight patients, and those with high blood pressure.
Note – keep your doctor informed regularly
Immediately contact your doctor if unexplained muscle pain, tenderness or weakness occurs,
because in very rare cases serious muscle problems may occur, leading to kidney damage, and in very rare cases, patient deaths have been reported.
The risk of muscle tissue damage is higher in patients taking Simvagen at high doses, especially at the 80 mg dose. The risk of muscle damage is greater in certain patient groups.
Talk to your doctor if:

• the patient consumes large amounts of alcohol
• the patient has kidney disease
• the patient has thyroid disorders
• the patient is aged 65 years or older
• the patient is female
• the patient is of Asian origin, as a different dose may be required
• the patient has previously experienced muscle problems while taking cholesterol-lowering medicines such as statins or fibrates
• the patient or close family members have a history of inherited muscle disorders.

Inform your doctor or pharmacist if the patient experiences persistent muscle weakness.
Additional tests may be necessary for diagnosis and treatment.
If the patient has breathing difficulties or a chronic cough, they should contact their doctor.
If the patient is due to undergo surgery – temporary discontinuation of simvastatin may be necessary.
Simvagen with other medicines
Many medicines affect the action of simvastatin. Tell your doctor about all medicines the patient is currently taking or has recently taken, including medicines available without a prescription, herbal remedies, and vitamin or dietary supplements.

• Cyclosporine – a medicine used to prevent organ transplant rejection
• The hormone danazol, used to treat severe or painful menstruation
• Antifungal medicines such as ketoconazole, itraconazole, fluconazole, posaconazole or voriconazole
• Fibrates such as gemfibrozil, fenofibrate and bezafibrate, also used to treat high cholesterol
• Niacin or nicotinic acid or acipimox used in high doses to treat high cholesterol
• Antibiotics such as erythromycin, clarithromycin, telithromycin
• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir or saquinavir (medicines used in HIV infections) or medicines containing cobicistat (also used in HIV treatment)
• Antiviral medicines used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir
• Glecaprevir/pibrentasvir (also used in the treatment of hepatitis C)
• The antidepressant nefazodone
• Medicines such as amiodarone (used for heart rhythm disorders), verapamil, diltiazem or amlodipine (used to treat high blood pressure or heart conditions)
• Lomitapide (used in the treatment of a severe and rare genetic disorder affecting cholesterol levels)
• Daptomycin (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)
• Ticagrelor (an antiplatelet medicine)

Taking simvastatin with any of these medicines may increase the risk of muscle problems
(some of which are listed in the section "When not to use Simvagen").
If the patient needs to take fusidic acid orally for bacterial infection treatment, they should temporarily stop taking this medicine. The doctor will decide when it is safe to resume Simvagen. Concomitant use of Simvagen with fusidic acid may rarely lead to muscle weakness, tenderness or pain (rhabdomyolysis). More information on rhabdomyolysis can be found in section 4.
If the patient is taking any of the following medicines, contact the doctor before starting simvastatin:

• Rifampicin – used to treat tuberculosis
• Medicines used to treat blood clots, such as warfarin, phenprocoumon or acenocoumarol, because dose adjustments of warfarin, phenprocoumon or acenocoumarol may be necessary

Also inform your doctor if you are taking niacin (nicotinic acid) or products containing niacin, especially if you are of Chinese origin.
Simvagen with food and drink
Grapefruit juice may affect how simvastatin works in the body. Do not drink grapefruit juice while taking simvastatin.
Pregnancy and breastfeeding
DO NOT use Simvagen in women who are pregnant, planning pregnancy, or suspect they may be pregnant. If pregnancy occurs during treatment with Simvagen, STOP treatment immediately and contact your doctor.
Do not take Simvagen while breastfeeding, as it is not known whether the medicine passes into breast milk.
Before taking any medicine, consult your doctor or pharmacist.
Driving and operating machinery
Simvagen does not affect the ability to drive or operate machinery.
However, Simvagen may cause dizziness; therefore, patients should ensure this symptom does not occur before driving or operating machinery.
Simvagen contains lactose (20 mg and 40 mg doses).
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Simvagen

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
consult your doctor or pharmacist. The dose will be determined by your doctor according to the results
of blood tests.
It is important to follow a low-fat diet and maintain physical activity.

Patients with coronary heart disease
The recommended dose is 20 mg – 40 mg taken in the evening. Your doctor may increase the dose
every 4 weeks. The maximum dose is 80 mg. Your doctor will determine the appropriate dose for each
patient depending on individual condition, current treatment, and risk profile.
Do not stop taking Simvagen unless instructed by your doctor.

Patients with high cholesterol/fat levels in the blood
(hypercholesterolemia/hyperlipidemia)
The recommended starting dose is 10 mg – 20 mg taken in the evening. Your doctor may increase
the dose every 4 weeks. The maximum dose is 80 mg.

Patients with inherited high cholesterol (homozygous familial hypercholesterolemia)
The recommended starting dose is 40 mg taken in the evening.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high
risk of heart disease, in whom target cholesterol levels have not been achieved with lower doses.

Use in children and adolescents (aged 10–17 years)
The recommended starting dose for children aged 10–17 years is 10 mg, usually taken in the evening.
If necessary, the dose may be increased up to a maximum of 40 mg.
Some patients may require a lower dose, especially if they are also taking medicines such as fibrates or niacin, or if they have kidney problems.

Use of other cholesterol-lowering medicines together with Simvagen
During treatment with simvastatin, your doctor may prescribe a medicine called cholestyramine.
This medicine may affect the action of simvastatin. Simvastatin should be taken 2 hours before or
4 hours after cholestyramine.

How to take the medicine
Swallow the tablet with a large amount of water. The medicine can be taken with or without food.
The 20 mg tablet may be divided into equal doses.

Taking more Simvagen than prescribed
If you take more Simvagen than prescribed, contact your doctor or go to the nearest hospital emergency room immediately. Take the medicine packaging with you.

Missed dose of Simvagen
If you accidentally miss a dose, take it as soon as you remember, unless it is almost time for the next dose. Do not take a double dose to make up for a missed dose.

Stopping Simvagen
Your doctor will determine how long you should take the medicine. Do not stop taking Simvagen suddenly without consulting your doctor first, 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 list of possible side effects below should not cause alarm. It is possible that none of them will occur,
but it is important to know what to do if they do occur.
If any of these serious adverse reactions occur, stop taking the medicine
and contact your doctor or go to the nearest hospital immediately.

• Unexplained muscle problems such as pain, tenderness, weakness—especially persistent weakness—muscle damage, or muscle cramps. In rare cases, muscle problems may be very serious and lead to muscle breakdown (rhabdomyolysis) and kidney damage. In some cases, these problems may be life-threatening. Very rare cases of death have been reported.
• Allergic (hypersensitivity) reactions such as:
• swelling of the face, tongue, and throat causing breathing difficulties (angioedema)
• severe muscle pain, usually around the shoulder and hip joints
• rash with muscle weakness affecting limbs and neck
• rash occurring on the skin or oral mucosal ulcerations (lichenoid lesions)
• joint pain or inflammation
• inflammation of blood vessels
• unusual bruising, skin rashes, swelling, hives, photosensitivity, fever, hot flushes
• shortness of breath and malaise
• symptoms of lupus-like illness (including rash, joint problems, and blood cell abnormalities)
• severe allergic reaction causing difficulty breathing or dizziness (anaphylaxis)
• gynaecomastia (enlargement of breasts in males)
• liver inflammation with yellowing of the skin and whites of the eyes (jaundice), itching, dark-coloured urine, or pale stools, possibly leading to liver failure (very rare)
• severe abdominal pain which may be swollen and tender (pain may radiate to the back), accompanied by nausea and vomiting with fever due to pancreatitis
• lung inflammation causing breathing problems, 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 risk of developing diabetes is higher if the patient has high blood sugar and fat levels, overweight, and high blood pressure. During treatment with this medicine, the doctor should monitor the patient carefully.

Other possible adverse reactions:
Rare (may affect up to 1 in 1,000 people):

• feeling of fatigue and breathlessness with pale skin due to reduced number of red blood cells (anaemia)
• numbness or weakness in arms or legs
• headaches, tingling sensations, dizziness
• blurred vision; visual disturbances
• gastrointestinal disorders (abdominal pain, constipation, bloating, indigestion, diarrhoea, nausea, vomiting)
• rash, itching, hair loss
• weakness
• increased levels in blood of substances indicating liver or muscle status, detected in laboratory tests

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

• difficulty sleeping
• memory impairment, memory loss, confusion

Not known (frequency cannot be estimated from available data):

• erectile dysfunction
• depression
• feeling of thirst, need to urinate more frequently, feeling of fatigue due to increased blood sugar levels
• myasthenia (a disease causing general muscle weakness, including in some cases muscles involved in breathing)
• ocular myasthenia (a disease causing weakness of eye muscles)

You should speak to your doctor if you experience weakness in arms or legs worsening after periods of activity, double vision or drooping eyelids, difficulty swallowing, or shortness of breath.
In addition, adverse reactions that have occurred with other statins may also occur:

• sleep disorders, including nightmares
• sexual dysfunction

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, phone: +48 22 4921301, fax: +48 22 4921309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Simvagen

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/bottle/blister after:
EXP. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Simvagen contains
Simvagen is available as film-coated tablets in two different strengths, each containing 20 mg or 40 mg of simvastatin as the active substance.
Each film-coated tablet also contains ascorbic acid, butylated hydroxyanisole (E320), citric acid monohydrate, lactose monohydrate (see section 2 “Simvagen contains lactose”), magnesium stearate, microcrystalline cellulose, pregelatinized corn 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 contents of the pack
Simvagen 20 film-coated tablets: dark brown, oval, biconvex film-coated tablets with bevelled edges, embossed with the code "SV3" on one side and a division line on the other side. The tablet can be divided into equal doses.
Simvagen 40 film-coated tablets: pink, oval, biconvex film-coated tablets with bevelled edges, embossed with the code "SV4" on one side and the letter "M" on the other side.

Simvagen film-coated tablets are packed in plastic bottles or blister packs containing 28 or 30 tablets.
Simvagen 20 tablets are additionally packed in blister packs containing 84 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product and its names in the European Economic Area countries, please contact the local representative of the Marketing Authorisation Holder:
Viatris Healthcare Sp. z o.o.
Tel: +48 22 546 64 00