Simvastatin Kern Pharma 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatina Kern Pharma 20 mg film-coated tablets EFG

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to other people, even if they have the same symptoms, as it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents:

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

1. What Simvastatina Kern Pharma is and what it is used for

Simvastatina Kern Pharma belongs to a group of medicines that work by reducing levels of fats such as cholesterol and triglycerides in the blood, when a low-fat diet and lifestyle changes alone have failed.

Simvastatina Kern Pharma is indicated for:

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

• Treatment of elevated blood cholesterol levels (homozygous familial hypercholesterolemia) together with diet and other cholesterol-lowering treatments.

Prevention of cardiovascular problems and cardiovascular death in patients with a history of blood vessel disease (arteriosclerosis) or diabetes, regardless of whether cholesterol levels are high or normal, in combination with other treatments.

2. What you need to know before taking Simvastatina Kern Pharma

Do not take Simvastatina Kern Pharma

• If you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6).

• If you have active liver disease or elevated transaminase levels.

• 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 causing AIDS)

• Nefazodone (a medicine used to treat depression).

Warnings and precautions

• If you experience muscle pain, tenderness, or weakness, inform your doctor immediately. Rarely, simvastatin may cause serious muscle problems that can lead to kidney damage.

This risk is higher in patients taking high doses of Simvastatina Kern Pharma or taking Simvastatina Kern Pharma together with a medicine that increases simvastatin blood levels, thus 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).

• Inform your doctor if you have kidney failure (renal insufficiency), hypothyroidism (low thyroid hormone levels), a personal or family history of muscle disorders, or if you regularly consume alcohol, as these factors may increase the risk of muscle problems.

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

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

Talk to your doctor or pharmacist before taking Simvastatina Kern Pharma if you:

• Have or have had myasthenia (a disease characterized by generalized muscle weakness, which 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).
• Have severe respiratory insufficiency.
• Experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.
• Are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Simvastatina Kern Pharma may cause serious muscle problems (rhabdomyolysis).

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

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

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

Interaction of Simvastatina Kern Pharma with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Certain medicines may interact with Simvastatina Kern Pharma 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 very important 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 Simvastatina Kern Pharma")
• Cyclosporine (a medicine used to prevent transplant rejection)
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems)
• Ribociclib (used to treat breast cancer)
• Palbociclib (used to treat breast cancer)

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 their anticoagulant effect may be enhanced when taken with Simvastatina Kern Pharma.

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 Kern Pharma. Using Simvastatina Kern Pharma with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Interaction of Simvastatina Kern Pharma with food, drink, and alcohol

Simvastatina Kern Pharma can be taken with or without food.

Grapefruit juice should be avoided during treatment with Simvastatina Kern Pharma, as it increases simvastatin blood concentrations.

Simvastatina Kern Pharma 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 Kern Pharma is contraindicated during pregnancy and breastfeeding.

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

Driving and using machines

At normal doses, Simvastatina Kern Pharma does not affect the ability to drive or operate machinery. However, if you experience symptoms of dizziness, do not drive or use machines until you know how you react to the medicine.

Simvastatina Kern Pharma contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking any medicine.

3. How to take Simvastatina Kern Pharma

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long to take Simvastatina Kern Pharma. Do not stop treatment prematurely.

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

Adults:

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

Your doctor may adjust your dose up to a maximum of 80 mg once 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.

Patients over 65 years of age:

Dose adjustment is not necessary.

If you think that the effect of Simvastatina Kern Pharma is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

The efficacy and safety of use in children have not been established. Therefore, the use of Simvastatina Kern Pharma is not recommended in children.

If you take more Simvastatina Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Simvastatina Kern Pharma

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

Take the next dose at your usual time.

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 Kern Pharma may cause adverse effects, although not everyone gets them.

Adverse effects have been classified according to the following frequency definitions: 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 isolated cases.

Blood and lymphatic system disorders:

Rare: Anaemia.

Gastrointestinal disorders:

Rare: Constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea, vomiting, inflammation of the pancreas.

General disorders:

Rare: Weakness.

Hepatobiliary disorders:

Rare: Hepatitis, yellowing of the skin and eyes (jaundice).

Musculoskeletal and connective tissue disorders:

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

Frequency not known: Persistent muscle weakness.

Nervous system disorders:

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

Frequency not known: Myasthenia gravis* (a disease causing generalized muscle weakness which, in some cases, affects the muscles used for breathing).

Eye disorders:

Frequency not known: Ocular myasthenia* (a disease causing weakness of the eye muscles).

• Consult your doctor if you experience arm or leg weakness that worsens after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Skin and subcutaneous tissue disorders:

Rare: Skin rash, itching, hair loss.

Rarely, an apparent allergic syndrome has been reported, including 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, difficulty breathing, and general malaise.

Immune system disorders:

Rare: Hypersensitivity (allergic) reactions including: swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema).

The following very rare serious adverse effects have been reported:

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

Other possible adverse effects:

• Sleep disorders, including insomnia and nightmares
• Memory loss
• Sexual dysfunction
• Depression
• Respiratory problems including persistent cough and/or difficulty breathing or fever.
• Diabetes. This is more likely if you have high levels of blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Blurred vision and deterioration of vision (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).

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.

Additional investigations:

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

If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Kern Pharma

Keep this medicine out of sight and reach of children.

Do not store at temperatures above 30°C.

Do not use Simvastatin Kern Pharma after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. If you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Kern Pharma 20 mg tablets:

• The active substance is simvastatin. Each tablet contains 20 mg of simvastatin.
• The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, butylated hydroxyanisole (E-320), ascorbic acid, citric acid, colloidal anhydrous silica, talc, magnesium stearate, hypromellose, red iron oxide (E-172), yellow iron oxide (E-172), triethyl citrate, titanium dioxide (E-171), and povidone.

Appearance of the product and contents of the pack

Simvastatin Kern Pharma is presented as orange, oval, biconvex film-coated tablets. Each pack contains 28 tablets (regular pack) or 500 tablets (hospital pack).

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus 72 – Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent review of this leaflet: March 2026

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