PATIENT INFORMATION LEAFLET

Simvastatina Tarbis 40 mg Film-Coated Tablets

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

2. What you need to know before starting to take Simvastatina Tarbis

3. How to take Simvastatina Tarbis

4. Possible side effects

5. Storage of Simvastatina Tarbis

6. Contents of the pack and additional information

Simvastatina Tarbis40 mgbelongs to a group of medicines known ashydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitorsthat act by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatina Tarbis40 mgis indicated for:

• Treatment of high blood cholesterol levels (primary hypercholesterolemia or mixed dyslipidemia) in combination with diet, when diet or exercise have not reduced cholesterol levels.

• Treatment of high blood cholesterol levels (familial homozygous hypercholesterolemia) in combination with diet and other cholesterol-lowering treatments.

• Prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, with high or normal cholesterol levels, in combination with other treatments.

Do not take Simvastatina Tarbis

-If you are allergic (hypersensitive) to simvastatin or to any of the other components of Simvastatina Tarbis.

• If you have active liver disease or have elevated transaminases.
• If you are pregnant or breastfeeding.
• If you are taking one of the following medications:

• Itraconazole or ketoconazole (medicines used to treat fungal infections).
• Erythromycin, clarithromycin, or telithromycin (antibiotics).
• Inhibitors of HIV protease such as indinavir, nelfinavir, ritonavir, and saquinavir (medicines used to treat HIV infections that cause AIDS).
• Nefazodone (medicine used to treat depression).

Be especially careful with Simvastatina Tarbis

• If you have or have had myasthenia(a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or myasthenia gravis (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).
• If you experience pain, sensitivity to pressure, or muscle weakness.Inform your doctor immediately. In rare cases, simvastatin may cause severe muscle problems that can cause kidney damage.

• Also inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

This risk is higher in patients taking high doses ofSimvastatina Tarbisor taking it with another medication that increases simvastatin levels in the blood, and therefore the risk of muscle alterations, such as:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Amiodarone, verapamil, and diltiazem (medicines used to treat heart problems).
• Ciclosporin (medicine used to prevent transplant rejection).

-Consult with your doctor or pharmacist before taking Simvastatina Tarbis if you:

• Present severe respiratory insufficiency
• Si you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Simvastatina Tarbis may cause severe muscle problems (rhabdomyolysis).

• Inform your doctor if you have kidney insufficiency, hypothyroidism, if you have a family history or have previously experienced muscle alterations or if you normally consume alcohol, as these factors may increase the risk of muscle alterations.

• Si you have had any liver disease. It is possible that moderate increases in transaminase levels may occur, which in most cases return to normal without the need to discontinue treatment.

• Si you are scheduled for surgery, it is recommended that you stop takingSimvastatina Tarbisat least a few days before the operation.

Your doctor may want to perform blood tests or liver function tests to check that your liver is functioning properly before and during treatment withSimvastatina Tarbis.

While you are taking this medicine, your doctor will monitor if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and fat levels, obesity, and high blood pressure.

Consult with your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of Simvastatina Tarbis with other medications

Inform your doctor or pharmacist if you are using, or have used recently, any other medication, including those purchased without a prescription.

Certain medications may interact withSimvastatina Tarbis40 mg and may increase the risk of adverse muscle reactions; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone. The use of simvastatin is contraindicated with these medications (see section 2. Do not take Simvastatina Tarbis 40 mg).
• Ciclosporin (medicine used to prevent transplant rejection).
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems).
• Si you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medication. Your doctor will indicate when you can resume treatment with Simvastatina Tarbis. The use of Simvastatina Tarbis with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Also, it is very important to inform your doctor if you are taking or have taken recently:

• Anticoagulants (medicines to prevent blood clots), as they potentiate the anticoagulant effect if taken withSimvastatina Tarbis.

Administration of Simvastatina Tarbis with food and beverages

Simvastatina Tarbis40 mg can be taken with or without food.

Orange juice elevates simvastatin levels in the blood. Avoid consuming orange juice while takingSimvastatina Tarbis.

Simvastatina Tarbis40 mg should be administered with caution in patients who consume alcohol. If you normally drink alcohol, consult with your doctor.

Pregnancy and breastfeeding

Consult with your doctor or pharmacist before taking a medicine.

Simvastatina Tarbis40 mg is contraindicated during pregnancy and lactation.

In case of pregnancy or suspected pregnancy, you should discontinue treatment and inform your doctor as soon as possible.

Driving and operating machinery

At normal doses,Simvastatina Tarbis40 mg does not affect the ability to drive or operate machinery. However, if you experience dizziness, do not drive or operate machinery until you know how you tolerate the medicine.

Important information about some components of Simvastatina Tarbis

This medicine contains lactose. If your doctor has told you that you have intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions for Simvastatina Tarbis 40 mg prescribed by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

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

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

Simvastatina tablets are for oral administration.

The usual starting dose is 10 to 40 mg per day, administered in a single dose at night.

Your doctor may adjust your dose up to a maximum of 80 mg per day, administered in a single dose at night.

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

Children and Adolescents:

No efficacy and safety have been established for use in children. Therefore, the use of Simvastatina Tarbis is not recommended in children.

Elderly Patients:

No dose adjustment is necessary.

If you estimate that the action of Simvastatina Tarbis 40 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Simvastatina Tarbis than you should

If you have taken more Simvastatina Tarbis 40 mg than you should, contact your doctor or pharmacist or the nearest hospital.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone: 91 562 0420.

If you forgot to take Simvastatina Tarbis

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

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

Like all medicines, Simvastatina Tarbis 40 mg can have side effects, although not everyone will experience them.

Very common (affecting more than 1 in 10 people), common (affecting less than 1 in 10 but more than 1 in 100), uncommon (affecting less than 1 in 100 but more than 1 in 1000), rare (affecting less than 1 in 1000), very rare (affecting less than 1 in 10,000) andfrequency not known (cannot be estimated from available data).

Blood and lymphatic system disorders:

Rare: anemia.

Digestive disorders:

Rare: constipation, abdominal pain, gas, indigestion, diarrhea, nausea, vomiting, pancreatitis.

General disorders and administration site conditions:

Rare: weakness.

Hepatobiliary disorders:

Rare: hepatitis, jaundice.

Musculoskeletal, connective tissue and bone disorders:

Rare: myopathy, rhabdomyolysis, muscle pain, muscle cramps.

Frequency not known: persistent muscle weakness

Endocrine disorders:

Frequency not known:diabetes. It is more likely if you have high blood sugar and fat levels, being overweight and high blood pressure. Your doctor will monitor you while taking this medicine.

Psychiatric disorders:

Effects of frequency not known:sleep disorders, including insomnia, nightmares and memory loss.

Nervous system disorders:

Rare: headache, paresthesia, dizziness, peripheral neuropathy.

Skin and subcutaneous tissue disorders:

Rare:skin rash, pruritus, alopecia.

Rarely reported severe adverse reactions include apparent allergic syndrome that has included some of the following characteristics: angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis and joint pain, pruritus, photosensitivity, fever, erythema, dyspnea and general malaise.

The following severe adverse reactions have been reported:

A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).

If any of these severe adverse reactions occur, stop taking the medicine and inform your doctor immediately or go to the nearest hospital emergency department.

Reproductive and breast disorders:

Effects of frequency not known: sexual dysfunction.

Haematological laboratory tests:

Rare:increased levels in blood of transaminases, alkaline phosphatase and creatine kinase (CK).

Adverse reactions of unknown frequency:

• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenic eye disease (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision or eyelid drooping, difficulty swallowing or difficulty breathing.

Other possible adverse reactions:

• Blurred vision and deterioration of vision (can affect up to 1 in 1,000 people).
• Skin rash that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions) (can affect up to 1 in 10,000 people).
• Muscle pain, sensitivity to pressure, weakness or muscle cramps; muscle failure; muscle rupture (can affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture.
• Gynecomastia (breast enlargement in men) (can affect up to 1 in 10,000 people).

Reporting of adverse reactions

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

KeepSimvastatina Tarbisout of the reach and sight of children.

Do not store at temperatures above30°C.

Expiration:

Do not useSimvastatina Tarbis40 mgafter 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 packaging and medicines that you no longer need at the SIGRE collection pointofthepharmacy.In case of doubt, please ask your pharmacist how to dispose of packaging and medicines that you no longer need. This will help protect the environment.

Other presentations:

Simvastatina Tarbis10 mg tablets.

Simvastatina Tarbis20 mg tablets.

Composition of Simvastatina Tarbis

The active ingredient is simvastatina. Each tablet contains 40 mg of simvastatina.

The other components (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, butylhydroxyanisole (E320), ascorbic acid, citric acid, anhydrous colloidal silica, talc, magnesium stearate, hypromellose, red iron oxide (E172), yellow iron oxide (E172), triethyl citrate, titanium dioxide (E171) and povidone.

Appearance of the product and contents of the package

Simvastatina Tarbis 40 mg is presented in the form of coated tablets, of intense pink color, oval and biconvex. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible for manufacturing:

FERRER INTERNACIONAL, S.A.

Joan Buscallà, 1-9

08173 – Sant Cugat del Vallès (Barcelona)

Spain

or

TEVA PHARMA, S.L.U.

Polígono Industrial Malpica calle C.4

50016-Zaragoza

Spain

Last review date of this prospectus: April 2023

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