Simvastatin Kern Pharma 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Simvastatin Kern Pharma 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• 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 and you should not give it to other people, even if they have the same symptoms, as it may be harmful to them.
• If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet.

Leaflet contents:

1. What Simvastatin Kern Pharma is and what it is used for
2. What you need to know before taking Simvastatin Kern Pharma
3. How to take Simvastatin Kern Pharma
4. Possible side effects
5. How to store Simvastatin 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 blood fat levels such as cholesterol and triglycerides, when a low-fat diet and lifestyle changes alone have failed.

Simvastatina Kern Pharma 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 a history of blood vessel disease (arteriosclerosis) or diabetes, with high or normal cholesterol levels, 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 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).

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 it together with medicines that increase simvastatin blood levels, thereby increasing the risk of muscle problems, 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 (kidney impairment), 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 without discontinuing treatment.

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

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

• Have or have had myasthenia (a disease causing 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 taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk is higher 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 conditions occurred in the past.

Interaction of Simvastatina Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some 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 pregnancy, 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 dizziness, do not drive or operate machinery until you know how you react to the medicine.

Simvastatina Kern Pharma contains lactose

If your doctor has informed you that you have 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 in children is not recommended.

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: 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 your 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 everybody experiences 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 people), uncommon (less than 1 in 100 but more than 1 in 1,000 people), rare (less than 1 in 1,000 people), very rare (less than 1 in 10,000 people), and isolated cases.

Blood and lymphatic system disorders:

Rare: Anaemia.

Gastrointestinal disorders:

Rare: Constipation, abdominal pain, flatulence, indigestion, diarrhoea, nausea, vomiting, pancreatitis.

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 worsening weakness in arms or legs 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, pruritus, photosensitivity, fever, flushing, difficulty breathing, and 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, weakness, or cramps; muscle breakdown; 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 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 not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: 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 is 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 collection point at your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Kern Pharma 10 mg tablets:

• The active substance is simvastatin. Each tablet contains 10 mg of simvastatin.
• The other components (excipients) are: monohydrate lactose, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (E-320), ascorbic acid, citric acid, anhydrous colloidal 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 10 mg is presented as pinkish, oval-shaped, biconvex, film-coated tablets. Each pack contains 28 tablets (standard 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 revision of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) www.aemps.gob.es