PATIENT INFORMATION LEAFLET

Simvastatina Tarbis 10 mgfilm-coated tablets

1. What isSimvastatina Tarbisand what is it used for

2. What you needto know before you start takingSimvastatina Tarbis

3. How to takeSimvastatina Tarbis

4. Possible side effects

5. Storage ofSimvastatina Tarbis

6. Contents of the pack and additional information

Simvastatina Tarbis10 mg belongs to a group of medicines known ashydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitorsthat act by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatina Tarbis10 mg is indicated for:

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

• The treatment of high blood cholesterol levels (familial homozygous hypercholesterolemia) in conjunction with diet and other treatments to reduce cholesterol levels.

The prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, with high or normal cholesterol levels, in conjunction with other treatments.

Do not take Simvastatina Tarbis

-If you are allergic (hypersensitive) to simvastatina 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:

• Itraconazol or ketoconazol (medicines used to treat fungal infections).
• Eritromicina, claritromicina or telitromicina (antibiotics).
• Inhibitors of HIV protease such as indinavir, nelfinavir, ritonavir and saquinavir (medicines used to treat HIV infections that cause AIDS).
• Nefazodona (medicine used to treat depression).

Be especially careful with Simvastatina Tarbis

• If you have or have had myasthenia(a disease that runs with generalized muscle weakness that, in some cases, affects the muscles used to breathe) or myasthenia ocular (a disease that causes weakness of the eye muscles), as statins sometimes can 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, simvastatina can 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.
• Be necessary to diagnose and treat this problem.

This risk is higher in patients taking high doses of Simvastatina Tarbis or taking it with another medicine that increases simvastatina levels in the blood, and therefore the risk of muscle alterations, such as:

• Fibrates and niacin (medicines that lower cholesterol levels).
• Amiodarona, verapamilo and diltiazem (medicines used to treat heart problems).
• Ciclosporina (medicine used to prevent rejection in transplants).

-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 medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Simvastatina Tarbis can cause severe muscle problems (rhabdomyolysis).

• Inform your doctor if you have kidney insufficiency, hypothyroidism, if you have a family history or have previously had muscle alterations or if you normally consume alcohol, as these factors can 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 suspend treatment.

• Si you have a scheduled surgical intervention, it is recommended that you stop taking Simvastatina Tarbis at least a few days before being operated on.

Your doctor may want to perform blood tests or liver function tests to check that your liver is functioning properly before and during your treatment with Simvastatina 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 your doctor, even if any of the circumstances mentioned above have occurred at any time.

Use of Simvastatina Tarbis with other medicines

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

Certain medicines can interact with Simvastatina Tarbis 10 mg and may increase the risk of adverse muscle reactions; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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

• Fibrates and niacin (medicines that lower cholesterol levels).
• Itraconazol, ketoconazol, eritromicina, claritromicina, telitromicina, inhibitors of HIV protease and nefazodona. The use of simvastatina is contraindicated with these medicines (see section 2. Do not take Simvastatina Tarbis).
• Ciclosporina (medicine used to prevent rejection in transplants).
• Verapamilo, diltiazem and amiodarona (medicines used to treat heart problems).

• Si you have to take fusidic acid orally to treat a bacterial infection, you will have to stop using this medicine. Your doctor will indicate when you can restart treatment with Simvastatina Tarbis. The use of Simvastatina Tarbis with fusidic acid can 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 the anticoagulant effect is potentiated if taken with Simvastatina Tarbis.

Administration of Simvastatina Tarbis with food and drinks

Simvastatina Tarbis 10 mg can be taken with or without food.

Orange juice elevates simvastatina levels in the blood. Avoid consuming orange juice while taking Simvastatina Tarbis.

Simvastatina Tarbis 10 mg should be administered with caution in patients who consume alcohol. If you normally drink alcohol, consult your doctor.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medicine.

Simvastatina Tarbis 10 mg is contraindicated during pregnancy and breastfeeding.

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

Driving and operating machinery

At normal doses, Simvastatina Tarbis 10 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 an intolerance to certain sugars, consult with him before taking this medicine.

Follow exactly the administration instructions forSimvastatina Tarbis10 mg as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Your doctor will inform you of the duration of your treatment withSimvastatina 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 is10 to40 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:

The efficacy and safety of use in children have not been established. Therefore, the use ofSimvastatina Tarbisis not recommended in children.

Elderly patients:

No dose adjustment is necessary.

If you estimate that the action ofSimvastatina Tarbis10 mg is too strong or too weak, inform your doctor or pharmacist.

If you take more Simvastatina Tarbisthan you should

If you have taken moreSimvastatina Tarbis10 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 medications,Simvastatina Tarbis10 mg may have side effects, although not everyone will experience them.

Very common (more than 1 in 10), common (less than 1 in 10 but more than 1 in 100), uncommon (less than 1 in 100 but more than 1 in 1000), Rare (less than 1 in 1000), Very rare (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: Constant 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 medication.

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, hair loss.

Rarely reportedthe rare severe adverse effectsudden onset of an 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 effects have been reported:

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

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

Reproductive and breast disorders:

Effects of frequency not known: sexual dysfunction

Complementary tests:

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

Adverse reactions with frequency not known:

• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia gravis (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 or eyelid drooping, difficulty swallowing or difficulty breathing.

Other possible adverse effects:

• Blurred vision and vision deterioration (can affect up to 1 in 1,000 people).
• eruption that can occur on the skin or ulcers in the mouth (drug-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 effects

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

KeepSimvastatina Tarbisout of the reach and sight of children.

Do not store at temperatures above30°C.

Expiration:

Do not useSimvastatina Tarbis10 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.Deposit the packaging and unusedmedicines atthe SIGREcollection pointofthepharmacy.In case of doubt, ask your pharmacisthow to dispose ofthe packaging andthe unusedmedicines. By doing so,you will help protect the environment.

Other presentations:

Simvastatina Tarbis20 mg tablets.

Simvastatina Tarbis40 mg tablets.

Composition of Simvastatina Tarbis

The active ingredient is simvastatina. Each tablet contains 10 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 10 mg is presented in the form of coated tablets, pale pink in 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 reviewed date of this prospectus: April 2023

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