Package Leaflet: Information for the User

Simvastatina STADA 10 mg Film-Coated Tablets

Simvastatina STADA 20 mg Film-Coated Tablets

Simvastatina STADA 40 mg Film-Coated Tablets

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

-Keep this package leaflet, as you may need to read it again.

-If you have any further questions, ask your doctor or pharmacist.

-This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours. It may harm them.

-If you experience any side effects, talk to your doctor or pharmacist. See section 4.

1.What Simvastatina Stada is and what it is used for

2.What you need to know before you take Simvastatina Stada

3.How to take Simvastatina Stada

4.Possible side effects

5.Storage of Simvastatina Stada

6.Contents of the pack and other information

Simvastatina Stada contains the active ingredient simvastatina. Simvastatina is used to reduce the levels of total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and fatty substances called triglycerides that circulate in the blood. Additionally, simvastatina increases the levels of "good" cholesterol (high-density lipoprotein, HDL). Simvastatina is a member of a class of medications called statins.

Cholesterol is one of the fatty substances that are found in the bloodstream. Its total cholesterol is composed mainly of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make the blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps to prevent "bad" cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of cardiovascular disease.

While taking this medication, you must follow a cholesterol-lowering diet.

Simvastatina is used, along with a cholesterol-lowering diet, if you have:

• elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia).
• a hereditary disease (familial hypercholesterolemia), which increases the level of cholesterol in the blood. You may also receive other treatments.
• coronary heart disease (CHD) or if you have a high risk of coronary heart disease (because you have diabetes, a history of stroke or other vascular disease). Simvastatina may prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood.

Most people do not have immediate symptoms of high cholesterol. Your doctor may measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

Do not take simvastatin:

• If you are allergic to simvastatin or any of the other ingredients in this medicine (listed in section 6).
• If you currently have liver problems.
• If you are pregnant or breastfeeding.
• If you are taking medicines with one or more of the following active ingredients:

• Itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).
• Erythromycin, clarithromycin, or telithromycin (antibiotics).
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infections that cause AIDS).
• Boceprevir or telaprevir (used to treat hepatitis C virus infection).
• Nefazodone (used to treat depression).
• Cobicistat
• Gemfibrozil (used to reduce cholesterol).
• Ciclosporin (used in patients who have had an organ transplant).
• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus).

• If you are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and simvastatin can cause severe muscle problems (rhabdomyolysis).

Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat rare and severe genetic cholesterol disorders).

Consult your doctor if you are unsure if your medicine is on the above list.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Simvastatin Stada.

Inform your doctor:

• About all your medical problems, including allergies.
• If you have or have had myasthenia (a disease that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you consume large amounts of alcohol.
• If you have ever had liver disease. Simvastatin may not be suitable for you.
• If you are due to have an operation. You may need to stop taking the simvastatin tablets for a short time.
• If you are of Asian origin, as you may need a different dose.

Your doctor will do a blood test before you start taking simvastatin and also if you have any symptoms of liver problems while taking simvastatin. This is to check how well your liver is working.

Your doctor may also want to do blood tests to check how well your liver is working after you start taking simvastatin.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be severe, including muscle failure which can cause kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is higher with high doses of simvastatin, especially with the 80 mg dose. The risk of muscle failure is also higher in certain patients. Talk to your doctor if any of the following situations apply to you:

• You consume large amounts of alcohol
• You have kidney problems
• You have thyroid problems
• You are 65 years or older
• You are a woman
• You have ever had muscle problems during treatment with cholesterol-lowering medicines called "statins" or fibrates
• • You or a close relative have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

Children and adolescents

The effectiveness and safety of simvastatin treatment were studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year before (see section 3). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other medicines and Simvastatin Stada

Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medicine.

Taking simvastatin with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above "Do not take simvastatin").

• If you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop using this medicine. Your doctor will tell you when you can start taking simvastatin again. The use of simvastatin with fusidic acid rarely may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information about rhabdomyolysis, see section 4
• Ciclosporin (often used in transplant patients)

• Danazol (a synthetic hormone used to treat endometriosis, a condition in which the inner lining of the uterus grows outside the uterus)
• Medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections)
• Fibrates with an active ingredient such as gemfibrozil and bezafibrate (used to reduce cholesterol)
• Erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections)
• Protease inhibitors for HIV, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat HIV infections that cause AIDS)
• Antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection)
• Nefazodone (used to treat depression)
• Medicines with an active ingredient such as cobicistat
• Amiodarone (used to treat irregular heart rhythm)
• Verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases)
• Lomitapide (used to treat rare and severe genetic cholesterol disorders)
• Daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). The muscle problems caused by this medicine may be more severe when taken during simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a time
• Colchicine (used to treat gout)
• Ticagrelor (antiplatelet medicine)

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, even those bought without a prescription. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

• Medicines with an active ingredient to prevent blood clotting, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants)
• Fenofibrate (also used to reduce cholesterol)
• Niacin (also used to reduce cholesterol)
• Rifampicin (used to treat tuberculosis).

You must also inform any doctor who prescribes a new medicine that you are taking simvastatin

Simvastatin Stada with food, drinks, and alcohol

Simvastatin can be taken with or without food.

It is recommended to avoid consuming grapefruit juice while taking simvastatin, as this juice increases the levels of simvastatin in the blood.

Simvastatin should be taken with caution in patients who consume alcohol. If you drink alcohol regularly, consult your doctor.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Simvastatin is contraindicated during pregnancy.

If you become pregnant or suspect you may be pregnant, you should stop taking the medicine and inform your doctor as soon as possible.

Do not take simvastatin if you are breastfeeding, as it is not known whether this medicine passes into breast milk.

Driving and using machines

At normal doses, simvastatin does not affect your ability to drive or use machines. However, if you experience dizziness, do not drive or use machines until you know how you tolerate the medicine.

Simvastatin Stada contains lactose

This medicine contains lactose. If your doctor has told you that you are intolerant to certain sugars, consult with them before taking this medicine.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with simvastatin. Do not discontinue treatment before.

Before starting to take simvastatina, you must be following a diet to reduce cholesterol.

Dosage

The recommended dose is one tablet once a day by oral route.

Adults

The recommended starting dose is10 to40 mg per day, administered in a single dose at night.

After at least 4 weeks, your doctor may adjust your dose up to a maximum of 80 mg per day, administered in a single dose at night.Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medications indicated earlier or have certain kidney disorders.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease problems who have not achieved their cholesterol goal with lower doses.

Use in children and adolescents

In children and adolescents aged 10 to 17 years, the recommended daily dose for starting treatment is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Older patients

No dose adjustment is necessary.

Administration form

The tablets should be taken at night and can be administered with water and with or without food.

If your doctor has prescribed simvastatina along with another cholesterol-lowering medication containing a bile acid sequestrant, you should take simvastatina at least 2 hours before or 4 hours after taking the bile acid sequestrant.

The groove is only for breaking the tablet if it is difficult to swallow whole.

If you take more Simvastatina Stada than you should

If you have taken moresimvastatinathan you should, consult your doctor or pharmacist immediately and/or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Simvastatina Stada

Do not take a double dose to compensate for the missed doses.

Take the next dose at your usual time.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine may 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 1,000 people).

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

??Frequency not known (cannot be estimated from available data).

If any of the serious side effects mentioned below occur, stop taking the medicine and inform your doctor immediately or go to the nearest hospital emergency department.

The following serious side effects have been reported:Rare:

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure leading to kidney damage; and very rarely, deaths have occurred.
• Allergic reactions (hypersensitivity) including:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema)
  • Intense muscle pain, usually in the shoulders and hips
  • Skin rash with weakness of the muscles of the limbs and neck
  • Pain or inflammation of the joints (polymyalgia rheumatica)
  • Inflammation of the blood vessels (vasculitis)
  • Atypical hematomas, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes
  • Difficulty breathing (dyspnea) and general discomfort
  • Pseudo-lupus syndrome (including skin rash, joint disorders, and effects on blood cells)
• 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 insufficiency (very rare)
• Pancreatitis, often with intense abdominal pain.

The following serious side effects have been reported:Very rare:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction)
• Rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions)
• Muscle rupture
• Gynecomastia (breast enlargement in men)

Rarely, the following side effects have also been reported:

• Anemia (low red blood cell count)
• Numbness or weakness of the arms and legs
• Headache, tingling sensation, dizziness
• Blurred vision and vision deterioration
• Digestive problems (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting)
• Skin rash, itching, hair loss
• Weakness
• Sleep problems (very rare)
• Poor memory (very rare), memory loss, confusion.

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

• Impotence
• Depression
• Lung inflammation, which can cause breathing problems, including persistent cough and/or difficulty breathing or fever
• Tendon problems, sometimes complicated by tendon rupture
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing)
• Myasthenia ocular (a disease that causes weakness of the eye muscles)

Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, eyelid drooping, difficulty swallowing, or difficulty breathing.

Possible additional side effects reported with some statins:

• Sleep disorders, including nightmares
• Sexual dysfunction
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medicine
• Constant muscle pain, sensitivity, or weakness, which may not disappear after stopping simvastatin treatment (frequency not known).

Additional tests

In some blood tests, elevations in liver function (transaminases) and a muscle enzyme (creatine kinase) were observed.

Reporting side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear inthis leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store in the original packaging.

Do not use Simvastatina Stada after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need atPunto SIGREof the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. In this way, you will help protect the environment.

Composition of Simvastatina Stada

The active ingredient is simvastatina.

Simvastatina 10 mg: Each tablet contains 10 mg of simvastatina.

Simvastatina 20 mg: Each tablet contains 20 mg of simvastatina.

Simvastatina 40 mg: Each tablet contains 40 mg of simvastatina.

The other components (excipients) are lactic acid, microcrystalline cellulose, pregelatinized cornstarch, butylhydroxyanisole (E320), magnesium stearate, talc, hypromellose, hydroxypropylcellulose, and titanium dioxide (E171).

Appearance of the product and contents of the package

Simvastatina Stada 10 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a notch on one face. The tablets are marked with “SVT” on the unnotched face and with “10” on the notched face. Each package contains 28 or 500 (clinical package) tablets.

Simvastatina Stada 20 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a notch on one face. The tablets are marked with “SVT” on the unnotched face and with “20” on the notched face. Each package contains 28 or 500 (clinical package) tablets.

Simvastatina Stada 40 mg is presented in the form of film-coated tablets, white, oblong, biconvex, with a notch on one face. The tablets are marked with “SVT” on the unnotched face and with “40” on the notched face. Each package contains 28 or 500 (clinical package) tablets.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing.

Holder of the marketing authorization

STADA Laboratorios, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona) Spain

[email protected]

Responsible for manufacturing

Synthon Hispania S.L

Castelló 1, Polígono Las Salinas

08830 Sant Boi de Llobregat (Barcelona)

Spain

or

STADA Arzneimittel AG

Stadastraße 2 – 18

D-61118 Bad Vilbel

Germany

or

STADA M&D SRL

Str. Trascaului nr. 10,

Municipiul Turda,

Judet Cluj 401135,

Romania

Last review date of this leaflet:October 2023

Further information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/