SIMVASTATIN TARBIS 10 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin Tarbis 10 mgfilm-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, 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, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any of the side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Contents of the pack

1. What Simvastatin Tarbis is and what it is used for
2. Before you take Simvastatin Tarbis
3. How to take Simvastatin Tarbis
4. Possible side effects
5. Storage of Simvastatin Tarbis
6. Contents of the pack and other information

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

Simvastatin Tarbis 10 mg belongs to a group of medicines known as HMG-CoA reductase inhibitors, which act by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatin Tarbis 10 mg is indicated in:

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

• Treatment of high blood cholesterol levels (homozygous familial hypercholesterolemia) in addition to diet and other cholesterol-reducing treatments.

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

2. Before taking Simvastatin Tarbis

Do not take Simvastatin Tarbis

• If you are allergic (hypersensitive) to simvastatin or any of the other components of Simvastatin Tarbis.
• If you have active liver disease or elevated transaminases.
• If you are pregnant or breastfeeding. If you are taking any of the following medicines:

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

Be careful with Simvastatin 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 ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• If you experience pain, tenderness, or muscle weakness.Inform your doctor immediately. Rarely, simvastatin can cause serious muscle problems that can lead to kidney damage.
• Tell your doctor or pharmacist if you experience constant muscle weakness. Further tests and medication may be necessary to diagnose and treat this problem.

This risk is higher in patients who take high doses of Simvastatin Tarbis or take Simvastatin Tarbis with other medicines that increase simvastatin blood levels, and therefore the risk of muscle disorders, such as:

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

• Consult your doctor or pharmacist before taking Simvastatin Tarbis if you:
• Have severe respiratory failure
• Are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simvastatin Tarbis can cause serious muscle problems (rhabdomyolysis).

• Tell your doctor if you have kidney failure, hypothyroidism, a family history of, or have previously had muscle disorders, or if you normally consume alcohol, as these factors can increase the risk of muscle disorders.

• If you have had liver disease. Moderate increases in transaminase levels may occur, which in most cases return to normal without the need to discontinue treatment.

• If you are scheduled for surgery, it is recommended that you stop taking Simvastatin Tarbis at least a few days before the operation.

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

While you are taking this medicine, your doctor will monitor you for diabetes or the risk of developing diabetes. This risk of diabetes is higher if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Using Simvastatin Tarbis with other medicines

Tell your doctor or pharmacist if you are using, or have recently used, any other medicines, including those obtained without a prescription.

Certain medicines can interact with Simvastatin Tarbis 10 mg and 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 that you inform your doctor if you are taking or have recently taken any of the following medicines:

• 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 medicines (see section 2. Do not take Simvastatin Tarbis 10 mg).
• Cyclosporine (a medicine used to prevent transplant rejection).
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems).

• If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Tarbis. The use of Simvastatin Tarbis with fusidic acid can cause serious muscle problems (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

It is also very important that you inform your doctor if you are taking or have recently taken:

• Oral anticoagulants (medicines to prevent blood clots), as the anticoagulant effect is enhanced if taken with Simvastatin Tarbis.

Taking Simvastatin Tarbis with food and drinks

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

Grapefruit juice increases simvastatin concentrations in the blood. You should avoid consuming grapefruit juice while taking Simvastatin Tarbis.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking any medicine.

Simvastatin Tarbis 10 mg is contraindicated during pregnancy and breastfeeding.

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

Driving and using machines

At normal doses, Simvastatin Tarbis 10 mg does not affect the ability to drive or use machines. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you tolerate the medicine.

Important information about some components of Simvastatin Tarbis

• This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Simvastatin Tarbis

Follow the administration instructions of Simvastatin Tarbis 10 mg indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Remember to take your medicine.

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

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

Simvastatin tablets are for oral administration.

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

Your doctor may adjust the 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 medicines indicated above or have certain kidney disorders.

Children and adolescents:

The efficacy and safety of use in children have not been established. Therefore, the use of Simvastatin Tarbis is not recommended in children.

Elderly patients:

No dose adjustment is necessary.

If you think the effect of Simvastatin Tarbis 10 mg is too strong or too weak, tell your doctor or pharmacist.

If you take more Simvastatin Tarbis than you should

If you have taken more Simvastatin Tarbis 10 mg than you should, contact your doctor or pharmacist or the nearest hospital.

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

If you forget to take Simvastatin Tarbis

Do not take a double dose to make up for forgotten doses, wait for the next dose.

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

4. Possible side effects

Like all medicines, Simvastatin Tarbis 10 mg can have side effects, although not everyone gets them.

Very common (more than 1 person in 10), common (less than 1 person in 10 but more than 1 person in 100), uncommon (less than 1 person in 100 but more than 1 person in 1000), rare (less than 1 person in 1000), very rare (less than 1 person in 10,000), and frequency 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, yellowing of the skin and eyes (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. This is more likely if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Psychiatric disorders:

Effects of unknown frequency: sleep disorders, including insomnia, nightmares, and memory loss.

Nervous system disorders:

Rare: headache, tingling sensation, dizziness, peripheral neuropathy.

Skin and subcutaneous tissue disorders:

Rare: skin rash, itching, hair loss.

Rarely, a serious allergic reaction has been reported, which has included some of the following characteristics: angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis, and joint pain, itching, photosensitivity, fever, redness, difficulty breathing, and general malaise.

The following very rare but serious side effects have been reported:

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

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

Reproductive system and breast disorders:

Effects of unknown frequency: sexual dysfunction

Investigations:

Rare: increased blood transaminase, alkaline phosphatase, and creatine kinase (CK) levels.

Adverse reactions with unknown frequency:

• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).
• Tell your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• Blurred vision and vision impairment (may affect up to 1 in 1,000 people).
• A skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).
• Muscle pain, tenderness, or weakness; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture.
• Gynecomastia (breast enlargement in men) (may affect up to 1 in 10,000 people).

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Tarbis

Keep Simvastatin Tarbis out of the reach and sight of children.

Do not store above 30°C.

Expiration date:

Do not use Simvastatin Tarbis 10 mg after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

Other presentations:

Simvastatin Tarbis 20 mg tablets.

Simvastatin Tarbis 40 mg tablets.

6. Additional information

Composition of Simvastatin Tarbis

The active ingredient is simvastatin. Each tablet contains 10 mg of simvastatin.

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 packaging contents

Simvastatin Tarbis 10 mg is presented in the form of film-coated tablets, pale pink in color, oval, and biconvex. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

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

Date of last revision of this leaflet: April 2023

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/