Simratio 10

Leaflet accompanying the packaging: patient information

Simratio 10, 10 mg, film-coated tablets

Simratio 20, 20 mg, film-coated tablets

Simratio 40, 40 mg, film-coated tablets

Simvastatin
This medication is absolutely contraindicated in pregnancy

Read the leaflet carefully before taking the medication, as it contains important information for the patient.

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

Table of contents of the leaflet:

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

1. What is Simratio and what is it used for

• high levels of cholesterol in the blood (primary hypercholesterolemia) or high levels of fats in the blood (mixed hyperlipidemia);
• inherited disorders (homozygous familial hypercholesterolemia) that cause high levels of cholesterol in the blood. Other treatments may also be used;
• ischemic heart disease (coronary artery disease) or a high risk of developing ischemic heart disease (due to diabetes, a history of stroke, or other vascular diseases). Simratio may prolong life by reducing the risk of heart disease, regardless of cholesterol levels in the blood.

In most people, there are no direct symptoms of high cholesterol levels. A doctor can assess cholesterol levels by ordering a simple blood test. Regular check-ups, monitoring of cholesterol levels, and discussion of treatment goals with the doctor are necessary.

2. Important information before taking Simratio

When not to take Simratio

• if the patient is allergic to simvastatin or any of the other ingredients of this medication (listed in section 6: Contents of the packaging and other information),
• if there are currently liver function disorders,
• if the patient is pregnant or breastfeeding,
• if the patient is taking any of the following medications:
• itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections)
• erythromycin, clarithromycin, or telithromycin (used to treat infections),
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors used to treat HIV infection),
• boceprevir and telaprevir (used to treat hepatitis C),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to reduce cholesterol levels),
• cyclosporine (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).
• if the patient is currently taking or has taken within the last 7 days a medication called fusidic acid (an antibiotic used to treat bacterial infections) orally or by injection. Taking fusidic acid with Simratio may lead to serious muscle problems (rhabdomyolysis). Do not take Simratio at a dose greater than 40 mg if the patient is taking lomitapide (used to treat a rare genetic cholesterol disorder).

In case of doubts about taking any of the above medications, consult a doctor.

Warnings and precautions

Before starting Simratio, inform the doctor:

• about all conditions, including allergies,
• about consuming large amounts of alcohol,
• about a history of liver disease. Taking Simratio may not be suitable,
• about planned surgery. It may be necessary to stop taking Simratio for a short time,

Consult a doctor or pharmacist before starting Simratio:

• if the patient is of Asian origin, as a different dose may be suitable for this patient.
• if the patient has or has had myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing) or ocular myasthenia (a disease that causes muscle weakness in the eyes), as statins can sometimes exacerbate symptoms or cause myasthenia (see section 4).

The doctor should perform a blood test before starting Simratio and during treatment if the patient has any liver disorders. The purpose of the test is to assess liver function.
The doctor may also perform blood tests to assess liver function after starting Simratio.
During therapy, the doctor will closely monitor the patient's health if they have diabetes or are at risk of developing diabetes. The risk of developing diabetes exists in people who have high levels of sugar and fat in the blood, are overweight, and have high blood pressure.
Inform the doctor about any serious lung diseases.

Immediately contact a doctor if the patient experiences unexplained muscle pain, tenderness, or weakness. In rare cases, muscle problems can be serious, including muscle breakdown leading to kidney damage, and in very rare cases, death.

Muscle damage is more likely to occur when taking higher doses of Simratio, particularly the 80 mg dose. The risk of muscle breakdown is also higher in some patients. Inform the doctor if:

• the patient consumes large amounts of alcohol,
• the patient has kidney problems,
• the patient has thyroid problems,
• the patient is 65 years or older,
• the patient is female,
• the patient has experienced muscle problems while taking cholesterol-lowering medications called "statins" or fibrates,
• the patient or a close relative has been diagnosed with a genetic muscle disorder.

Also, inform the doctor or pharmacist if muscle weakness persists. To diagnose and treat this condition, additional tests and medications may be necessary.

Children and adolescents

The safety and efficacy of Simratio have been studied in boys aged 10-17 and girls who have started menstruating (at least one year before). Simratio has not been studied in children under the age of 10. For more information, consult a doctor.

Simratio and other medications

Inform the doctor about all medications the patient is currently taking or has recently taken, as well as any medications they plan to take, including those containing the following active substances. Taking Simratio with any of the following medications may increase the risk of muscle problems (some of which are listed above in the "When not to take Simratio" section).

• If it is necessary to take fusidic acid orally for bacterial infection treatment, it may be necessary to temporarily stop taking Simratio.

The doctor will inform you when it is safe to restart Simratio. Taking Simratio with fusidic acid can rarely lead to muscle weakness, tenderness, or pain (rhabdomyolysis). Additional information about rhabdomyolysis can be found in section 4.

• cyclosporine (often 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),
• medications containing the following active substances: itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing the following active substances: gemfibrozil and bezafibrate (used to reduce 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 medications used to treat hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C),
• nefazodone (used to treat depression),
• medications containing the active substance cobicistat,
• amiodarone (used to treat heart rhythm disorders),
• 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 rare genetic cholesterol disorder),
• daptomycin (an antibiotic used to treat complicated skin and soft tissue infections and bacteremia). It is possible that muscle-related side effects may be more common when taking this medication with simvastatin (e.g., Simratio). The doctor may decide to stop Simratio for a while.
• colchicine (used to treat gout),
• tikagrelor (an antiplatelet medication).

Similarly, inform the doctor or pharmacist about all medications recently taken, including those available without a prescription. In particular, inform the doctor about medications containing the following active substances:

• medications that prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulant medications),
• fenofibrate (also used to reduce cholesterol levels),
• niacin (also used to reduce cholesterol levels),
• rifampicin (used to treat tuberculosis).

Also, inform any doctor prescribing a new medication about taking Simratio. Patients of Chinese origin should also inform their doctor about taking niacin (nicotinic acid) or products containing niacin.

Simratio with food and drink

Grapefruit juice contains one or more compounds that affect the action of some medications in the body, including Simratio. Avoid drinking grapefruit juice.

Pregnancy and breastfeeding

Do not take Simratio if pregnant, planning to become pregnant, or suspecting pregnancy. If pregnancy occurs while taking Simratio, stop treatment immediately and consult a doctor. Do not take Simratio during breastfeeding, as it is not known whether the medication is excreted in breast milk.
Before taking any medication, consult a doctor or pharmacist.

Driving and using machines

Simratio does not affect the ability to drive or operate machines. However, consider that some people may experience dizziness after taking Simratio.

Simratio contains lactose

Simratio tablets contain a sugar called lactose. If the patient has previously been diagnosed with intolerance to some sugars, consult a doctor before taking Simratio.

3. How to take Simratio

The doctor will determine the appropriate dose for the patient based on their current treatment and individual risk.
Always take this medication as directed by the doctor. In case of doubts, consult a doctor or pharmacist.
While taking Simratio, follow a low-cholesterol diet.
Dosage:
The recommended dose is one Simratio 10 mg, 20 mg, 40 mg, or 80 mg tablet taken orally once a day.

Adults:

The initial 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 of treatment to a maximum of 80 mg per day. Do not take more than 80 mg per day.
The doctor may recommend lower doses, especially if the patient is taking certain medications listed above or has kidney problems.
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 their target cholesterol level with a lower dose.

Use in children and adolescents:

For children (aged 10-17), the recommended initial dose is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.
Method of administration:
Take Simratio in the evening. The medication can be taken with or without food. Take Simratio continuously until the doctor advises stopping it.
If the doctor prescribes Simratio with another cholesterol-lowering medication containing a bile acid sequestrant, take Simratio at least 2 hours before or 4 hours after taking the bile acid sequestrant.

Taking a higher dose of Simratio than recommended

Consult a doctor or pharmacist.

Missing a dose of Simratio

Do not take a double dose to make up for a missed dose. Take the next dose of Simratio at the usual time the next day.

Stopping Simratio treatment

Consult a doctor or pharmacist, as cholesterol levels may rise again.
In case of further doubts about taking this medication, consult a doctor or pharmacist.

4. Possible side effects

Like all medications, Simratio can cause side effects, although not everyone will experience them.
The following terms are used to describe how often side effects have been reported:

• rare (may affect up to 1 in 100 people)
• very rare (may affect up to 1 in 10,000 people)
• frequency not known (frequency cannot be estimated from available data).

If any of the following serious side effects occur, stop taking Simratio and immediately consult a doctor or go to the emergency department of the nearest hospital.

The following serious side effects have been reported rarely:

• muscle pain, tenderness, weakness, muscle rupture, or muscle cramps. In rare cases, these conditions can be severe and associated with muscle breakdown leading to kidney damage; very rare cases of death have been reported.
• allergic reactions, including:
• swelling of the face, tongue, and throat that can cause breathing difficulties (angioedema),
• severe muscle pain, usually in the shoulder and hip areas,
• rash with muscle weakness in the arms and neck,
• rash that can occur on the skin or ulcers in the mouth (lichenoid skin changes),
• joint pain or inflammation (polymyalgia rheumatica),
• inflammation of blood vessels (vasculitis),
• unusual bruising, skin rashes, and swelling (dermatomyositis), hives, sun sensitivity, fever, and flushing.
• liver inflammation with symptoms of yellowing of the skin and eyes, itching, dark urine, or pale stools, fatigue, or weakness, loss of appetite, liver failure (very rare),
• pancreatitis, often with severe abdominal pain.

The following very rare serious side effects have been reported:

• a severe allergic reaction that causes breathing difficulties or dizziness (anaphylaxis),
• a rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid changes),
• muscle damage,
• memory loss,
• gynecomastia (breast enlargement in men),
• sleep disturbances.

The following side effects have also been reported rarely:

• reduced red blood cell count (anemia),
• numbness or weakness in the hands and feet,
• headaches, tingling, dizziness,
• blurred vision, vision disturbances,
• gastrointestinal problems (abdominal pain, constipation, bloating, indigestion, diarrhea, nausea, vomiting),
• rash, itching, hair loss,
• weakness,
• memory loss, confusion.

The following side effects have also been reported, but their frequency cannot be estimated from available data (frequency not known):

• erectile dysfunction,
• depression,
• lung inflammation that causes breathing difficulties, including persistent cough and/or shortness of breath or fever,
• tendon disorders, sometimes complicated by tendon rupture,
• persistent muscle weakness,
• myasthenia (a disease that causes general muscle weakness, including muscles involved in breathing),
• ocular myasthenia (a disease that causes muscle weakness in the eyes).

Consult a doctor if the patient experiences weakness in the hands or feet, worsening after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or shortness of breath.
Additional possible side effects reported during the use of some statins:

• sleep disturbances, including nightmares,
• sexual disorders,
• diabetes. The development of diabetes is more likely in people with high levels of sugar and fat in the blood, overweight, and high blood pressure. The doctor will monitor the patient's health during treatment with this medication.
• muscle pain, tenderness, or persistent weakness, which may not resolve after stopping Simratio (frequency not known).

Laboratory test results
Elevated muscle enzyme activity (creatine kinase) in the blood and abnormal liver function test results have been observed.

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform a doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw
Phone: +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 this medication.

5. How to store Simratio

Store the medication out of sight and reach of children. Store the medication at a temperature below 25°C.
Do not use this medication after the expiration date stated on the blister pack after "EXP" and the outer packaging after "Expiration date". The expiration date (EXP) is the last day of the specified month. The batch number on the blister pack is after the "Lot" abbreviation.
Medications should not be disposed of in wastewater or household waste. Ask a pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the packaging and other information

What Simratio contains

• The active substance is simvastatin. Simratio 10 mg film-coated tablets contain 10 mg of simvastatin. Simratio 20 mg film-coated tablets contain 20 mg of simvastatin. Simratio 40 mg film-coated tablets contain 40 mg of simvastatin.
• The medication also contains: lactose monohydrate, microcrystalline cellulose, maize starch, citric acid monohydrate, ascorbic acid, butylhydroxyanisole, magnesium stearate. The coating contains: hypromellose, lactose monohydrate, titanium dioxide, macrogol PEG 3350, triacetin, iron oxide red, and for 10 mg and 20 mg tablets: iron oxide yellow.

What Simratio looks like and contents of the packaging

28, 30 film-coated tablets
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

ratiopharm GmbH, Graf-Arco-Str 3,
89079 Ulm
Germany
Representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
Phone: +48 22 345 93 00

Manufacturer:

Merckle GmbH, Ludwig-Merckle-Str. 3,
89143 Blaubeuren
Germany
Teva Pharmaceutical Works Private Limited Company
Pallagi út 13
4042 Debrecen
Hungary
Teva Operations Poland Sp. z o.o.
Mogilska 80
31-546 Kraków