Patient Information Leaflet

Simvastatina Benel 40 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicinebecause it contains important information for you.

- 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 only. Do not pass it on to others even if they have similar symptoms, as it may harm them.

- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet.

1. What Simvastatina is and what it is used for

2.What you need to know before taking Simvastatina Benel

3. How to take Simvastatina Benel

4. Possible side effects

5. Storage of Simvastatina Benel

6.Contents of the pack and additional information

Simvastatina Benel 40 mg belongs to a group of medicines known as HMG-CoA reductase inhibitors that act by reducing levels of lipids, cholesterol, and triglycerides in the blood.

Simvastatina Benel 40 mg is indicated for:

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

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

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

Do not take Simvastatina Benel if:

- You are allergic to simvastatina or to any of the other components of this medication (listed in section 6).

- You have active liver disease or have elevated transaminases.

- You are pregnant or breastfeeding.

- You are taking one of the following medications:

• Itraconazol or ketoconazol (medications used to treat fungal infections).

• Erythromycin, clarithromycin, or telithromycin (antibiotics).

• HIV protease inhibitors such as indinavir, nelfinavir, ritonavir, and saquinavir (medications used to treat HIV infections that cause AIDS).

• Nefazodone (medication used to treat depression).

Warnings and precautions

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

-Experience muscle pain, sensitivity to pressure, or muscle weakness.Inform your doctor immediately. In rare cases, simvastatina can cause severe muscle problems that may lead to kidney damage.

This risk is higher in patients taking high doses of Simvastatina Benel or taking it with medications that increase simvastatina levels in the blood, thereby increasing the risk of muscle alterations, such as:

• Fibrates and niacin (medications that lower cholesterol levels).

• Amiodarone, verapamil, and diltiazem (medications used to treat heart problems).

• Cyclosporine (medication used to prevent transplant rejection).

- Experience severe respiratory insufficiency

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

- If you have a history of 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.

- If you are scheduled for surgery, it is recommended that you stop taking Simvastatina Benel at least a few days before the procedure.

- This medication contains lactose. If your doctor has indicated that you have a lactose intolerance, consult with them before taking this medication.

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

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

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

Consult with your doctor or pharmacist before starting to take Simvastatina Benel 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 myasthenia gravis (a disease that causes eye muscle weakness), as statins may exacerbate the disease or cause its onset (see section 4).

Simvastatina Benel with other medications:

Inform your doctor or pharmacist that you are taking, have taken, or may need to take any other medication.

Certain medications may interact with Simvastatina Benel 20 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 to inform your doctor if you are taking or have taken recently any of the following medications:

- Fibrates and niacin (medications that lower cholesterol levels).

- Itraconazole, ketoconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone. The use of simvastatina is contraindicated with these medications (see section 2. Do not take Simvastatina Benel 20 mg).

- Cyclosporine (medication used to prevent transplant rejection).

- Verapamil, diltiazem, and amiodarone (medications used to treat heart problems).

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

- Oral anticoagulants (medications to prevent blood clots), as they potentiate the anticoagulant effect if taken with Simvastatina Benel.

Simvastatina Benel with food and beverages:

Simvastatina Benel 20 mg can be taken with or without food.

Orange juice increases simvastatina levels in the blood. Avoid consuming orange juice while taking Simvastatina Benel.

Simvastatina Benel 20 mg should be administered with caution in patients who consume alcohol. If you regularly drink alcohol, consult with your doctor.

Pregnancy and breastfeeding:

Consult with your doctor or pharmacist before taking a medication.

Simvastatina Benel 20 mg is contraindicated during pregnancy and lactation.

In the event 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 Benel 20 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 medication.

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

Your doctor will inform you of the duration of your treatment with Simvastatina Benel. Do not discontinue treatment beforehand.

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

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 previously or have certain kidney disorders.

Children and adolescents:

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

Elderly patients:

No dose adjustment is necessary.

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

If you take more Simvastatina Benel 40 mg than you should:

If you have taken more Simvastatina Benel 20 mg than you should, contact your doctor or pharmacist or the Toxicological Information Service, telephone: 91 562 04 20, indicating the medication and the amount used.

If you forgot to take Simvastatina Benel 40 mg:

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 medication, ask your doctor or pharmacist.

Like all medicines, Simvastatina Benel can cause side effects, although not everyone will experience them.

Some patients may experience these side effects during treatment or when stopping it.

If any of the following side effects are observed, which may or may not be related to simvastatina, consult a doctor or pharmacist.

Possible side effects during treatment

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.

Diabetes. It is more likely if you have high blood sugar and fat levels, overweight, and high blood pressure. Your doctor will monitor you while taking this medication.

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) and isolated cases.

The following serious rare side effects have been reported:

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

Allergic reactions that include:

Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema).

The following very rare serious side effects have been reported:

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

Blood and lymphatic system disorders:

Rare: anemia.

Digestive system disorders:

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

General and local reactions:

Rare: weakness.

Hepatobiliary disorders:

Rare: hepatitis (liver inflammation), yellowing of the skin and eyes (jaundice).

Musculoskeletal, connective tissue, and bone disorders:

Rare: myopathy, rhabdomyolysis (muscle damage), muscle pain, muscle cramps.

Very rare:muscle rupture (may affect up to 1 in 10,000 people).

Unknown frequency:constant muscle weakness.

Nervous system disorders:

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

Unknown frequency:: myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).

Eye disorders:

Rare:blurred vision and vision deterioration (may affect up to 1 in 1,000 people).

Unknown frequency:: 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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Skin and subcutaneous tissue disorders:

Rare:skin rash, itching, hair loss.

Rarely reported is a syndrome of apparent allergy that has included some of the following characteristics: hives, lupus-like syndrome, polymyalgia rheumatica, inflammation of blood vessels, thrombocytopenia, eosinophilia (decrease in certain blood cells: platelets and eosinophils), increased erythrocyte sedimentation rate, arthritis, joint pain, itching, sensitivity to light, fever, redness, difficulty breathing, and general discomfort.

Very rare:skin eruptions that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).

Reproductive and mammary system disorders:

Very rare:gynecomastia (breast enlargement in men) (may affect up to 1 in 10,000 people).

Complementary tests:

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

If any of these symptoms become bothersome or worsen, inform your doctor.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side 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:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not store at a temperature above 25 °C.

Store in the original packaging.

Do not use this medication 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 at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need.This will help protect the environment.

Content of Simvastatina Benel 40 mg

• The active ingredient is simvastatina. Each tablet contains 20 mg of simvastatina.

• The other components (excipients) are:

Lactose monohydrate (32.92 mg), pregelatinized cornstarch without gluten, microcrystalline cellulose, butylhydroxyanisole, ascorbic acid, citric acid monohydrate, magnesium stearate, hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol 400, yellow iron oxide (E172), ponceau 4R lake (E124), indigo carmine lake (E132), and sunset yellow lake (E110).

Appearance of the product and content of the packaging

Simvastatina Benel 20 mg is presented in the form of film-coated tablets with a salmon-colored coating, oblong, and scored on both sides. Each package contains 28 or 500 tablets.

Holder of the marketing authorization and manufacturer

Holder:

Laboratorio Farmalider, S.A

C/ Aragoneses, 15 - Pol. Ind. Alcobendas

28108 Madrid (Spain).

Responsible for manufacturing:

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora.

This prospectus was approved in May 2024

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