Simvastatin Tarbis 10 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatina Tarbis 10 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not give it to other people, even if they have the same symptoms, as it may harm them.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Leaflet contents

1. What Simvastatina Tarbis is and what it is used for
2. What you need to know before taking Simvastatina Tarbis
3. How to take Simvastatina Tarbis
4. Possible side effects
5. How to store Simvastatina Tarbis
6. Contents of the pack and other information

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

Simvastatina Tarbis 10 mg belongs to a group of medicines known as hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, which work by reducing blood lipid, cholesterol, and triglyceride levels.

Simvastatina Tarbis 10 mg is indicated for:

• The treatment of elevated blood cholesterol levels (primary hypercholesterolemia or mixed dyslipidemia) together with diet, when diet or exercise alone have not reduced cholesterol.

• The treatment of elevated blood cholesterol levels (homozygous familial hypercholesterolemia) together with diet and other cholesterol-lowering therapies.

• The prevention of cardiovascular problems and cardiovascular death in patients with atherosclerosis or diabetes, regardless of whether cholesterol levels are high or normal, in combination with other treatments.

2. Before taking Simvastatina Tarbis

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 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 infection that causes AIDS).

• Nefazodone (a medicine used to treat depression).

Take special care with Simvastatina Tarbis

• If you have or have had myasthenia (a disease characterized by generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).
• If you experience muscle pain, tenderness, or weakness. Inform your doctor immediately. Rarely, simvastatin may cause serious muscle problems that could lead to kidney damage.
• Also inform your doctor or pharmacist if you have persistent muscle weakness. Additional tests or treatments may be needed to diagnose and manage this condition.

This risk is higher in patients taking high doses of Simvastatina Tarbis or taking Simvastatina Tarbis together with a medicine that increases simvastatin blood levels, thereby increasing 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 Simvastatina Tarbis if you:

  • Have severe respiratory insufficiency.
  • Are taking or have taken within the last 7 days a medicine containing fusidic acid (used to treat bacterial infection) by oral or injectable route. The combination of fusidic acid and Simvastatina Tarbis may cause serious muscle problems (rhabdomyolysis).

• Inform your doctor if you have renal impairment, hypothyroidism, a personal or family history of muscle disorders, or if you regularly consume alcohol, as these factors may increase the risk of muscle-related side effects.

• If you have had liver disease. Moderate increases in transaminase levels may occur, which in most cases return to baseline without discontinuing treatment.

• If you are scheduled for surgery, it is recommended to stop taking Simvastatina Tarbis at least a few days before the procedure.

Your doctor may wish to perform blood tests or liver function tests to ensure your liver is working properly before and during treatment with Simvastatina Tarbis.

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

Consult your doctor, even if any of the above conditions occurred in the past.

Use of Simvastatina Tarbis with other medicines

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

Certain medicines may interact with Simvastatina Tarbis 10 mg and increase the risk of muscle-related adverse reactions; in such cases, it may be necessary to adjust the dose or discontinue one of the treatments.

It is important to 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 Simvastatina 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 oral fusidic acid to treat a bacterial infection, you must stop using this medicine. Your doctor will advise you when you can restart treatment with Simvastatina Tarbis. Using Simvastatina Tarbis with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

• Ribociclib (used to treat breast cancer).

• Palbociclib (used to treat breast cancer).

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

• Oral anticoagulants (medicines to prevent blood clots), as their anticoagulant effect may be enhanced when taken together with Simvastatina Tarbis.

Taking Simvastatina Tarbis with food and drinks

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

Grapefruit juice increases simvastatin blood concentrations. Consumption of grapefruit juice should be avoided during treatment with Simvastatina Tarbis.

Simvastatina Tarbis 10 mg should be used 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.

Simvastatina Tarbis 10 mg is contraindicated during pregnancy and breastfeeding.

If you become pregnant or suspect pregnancy, you must stop treatment and inform your doctor immediately.

Driving and using machines

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 react to the medicine.

Important information about some components of Simvastatina Tarbis

• This medicine contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Simvastatina Tarbis

Follow exactly the instructions given by your doctor for taking Simvastatina Tarbis 10 mg. If you have any doubts, consult your doctor or pharmacist.

Remember to take your medicine.

Your doctor will tell you how long to continue treatment with Simvastatina Tarbis. Do not stop treatment prematurely.

The tablets should be taken at night and may be taken with water, with or without food.

Simvastatina tablets are for oral use.

The usual starting dose is 10 to 40 mg once daily, administered as a single dose at night.

Your doctor may adjust your dose up to a maximum of 80 mg daily, taken as a single dose at night.

Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned 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 Simvastatina Tarbis in children is not recommended.

Elderly patients:

Dose adjustment is not necessary.

If you think that the effect of Simvastatina Tarbis 10 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 10 mg than you should, contact your doctor, pharmacist, or the nearest hospital.

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

If you forget to take Simvastatina Tarbis

Do not take a double dose to make up for missed doses. Wait until your next scheduled dose.

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

4. Possible adverse effects

Like all medicines, Simvastatin Tarbis 10 mg can cause adverse effects, although not everyone experiences them.

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

Blood and lymphatic system disorders:

Rare: anemia.

Gastrointestinal disorders:

Rare: constipation, abdominal pain, flatulence, indigestion, diarrhea, nausea, vomiting, inflammation of the pancreas.

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: persistent muscle weakness.

Endocrine disorders:

Frequency not known: diabetes. This is more likely if you have high levels of sugar and fats in the blood, overweight, and high blood pressure. Your doctor will monitor you while you are taking this medicine.

Psychiatric disorders:

Effects with frequency not known: 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.

Rare, serious adverse effects rarely reported include apparent allergic syndrome with some of the following features: angioedema, lupus-like syndrome, polymyalgia rheumatica, vasculitis, thrombocytopenia, eosinophilia, increased erythrocyte sedimentation rate, arthritis and joint pain, itching, photosensitivity, fever, redness, breathing difficulty, and general malaise.

The following very rare, serious adverse effects have been reported:

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

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

Reproductive system and breast disorders:

Effects with frequency not known: sexual dysfunction.

Investigations:

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

Adverse reactions with frequency not known:

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

Other possible adverse effects:

• Blurred vision and visual impairment (may affect up to 1 in 1,000 people).
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).
• Muscle pain, tenderness to pressure, muscle weakness, or cramps; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture.
• Gynaecomastia (enlargement of breast tissue in men) (may 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatine Tarbis

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

Do not store at temperatures above 30°C.

Expiry:

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

Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

Other presentations:

Simvastatine Tarbis 20 mg tablets.

Simvastatine Tarbis 40 mg tablets.

6. Additional Information

Composition of Simvastatin Tarbis

The active substance 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, iron oxide red (E172), iron oxide yellow (E172), triethyl citrate, titanium dioxide (E171) and povidone.

Appearance of the product and contents of the pack

Simvastatin Tarbis 10 mg is presented as pale pink, oval, biconvex coated tablets. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturer

Holder:

TARBIS FARMA, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer:

Amarox Pharma B.V.

Rouboslaan 32

2252TR Voorschoten

The Netherlands

Pharmadox Healthcare Ltd

KW20A Kordin Industrial Estate

Paola, PLA3000

Malta

Date of the most recent revision of this leaflet: April 2023

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/