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PATIENT INFORMATION LEAFLET

Simvastatina Kern Pharma 10 mg Film-Coated Tablets

Read this leaflet carefully before you start taking this medicine because 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. Do not give it to others, even if they have the same symptoms of the disease, as it may harm them.

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

Simvastatina Kern Pharma belongs to a group of medicines that act by reducing the 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:

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

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

The prevention of cardiovascular problems and cardiovascular death in patients with a history of vascular diseases (arteriosclerosis) or diabetes, with high or normal cholesterol levels, along with other treatments.

Do not take Simvastatina Kern Pharma

• If you are allergic to simvastatina or any of the other components of this medication (listed in section 6).
• If you have active liver disease or have elevated transaminases.
• If you are pregnant or breastfeeding.
• If you are taking one of the following medications:

• Itraconazol or ketoconazol (medications used to treat fungal infections)
• Eritromicina, claritromicina or telitromicina (antibiotics)
• Protease inhibitors for HIV such as indinavir, nelfinavir, ritonavir and saquinavir (medications used to treat HIV infections that cause AIDS)
• Nefazodona (medication used to treat depression).

Warnings and precautions

• If you experience pain, sensitivity to pressure, or muscle weakness.Inform your doctor immediately. In rare cases, simvastatina may cause severe muscle problems that can cause kidney damage.

This risk is higher in patients taking high doses of Simvastatina Kern Pharma or taking it with other medications that increase simvastatina levels in the blood, and therefore the risk of developing muscle disorders, such as:

• Fibrates and niacin (medications that lower cholesterol levels)
• Amiodarona, verapamilo and diltiazem (medications used to treat heart problems)
• Ciclosporina (medication used to prevent transplant rejection).

• Inform your doctor if you have kidney failure, hypothyroidism (insufficient thyroid hormones), if you have a family history or have previously experienced muscle disorders, or if you consume alcohol regularly, as these factors may increase the risk of muscle disorders.

• If you have a history of 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 Simvastatina Kern Pharma at least a few days before the procedure.

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

• Take or have taken 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 myasthenia (see section 4).
• Have severe respiratory failure
• Have persistent muscle weakness. Additional tests and medications may be necessary to diagnose and treat this condition.
• Are taking or have taken within the last 7 days a medication containing fusidic acid (used to treat bacterial infections) by mouth or injection. The combination of fusidic acid and Simvastatina Kern Pharma may cause severe muscle problems (rhabdomyolysis).

While 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, obesity, and high blood pressure.

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 Kern Pharma.

Consult your doctor, even if any of the circumstances mentioned above have occurred at any time.

Interaction of Simvastatina Kern Pharma with other medications

Inform your doctor or pharmacist that you are using, or have used recently, or may need to use any other medication.

Certain medications may interact with Simvastatina Kern Pharma and may 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 very important 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)
• Itraconazol, ketoconazol, and ritromicina, claritromicina, telitromicina, and protease inhibitors for HIV, and nefazodona. The use of simvastatina is contraindicated with these medications (see section 2. "Do not take Simvastatina Kern Pharma")
• Ciclosporina (medication used to prevent transplant rejection)
• Verapamilo, diltiazem and amiodarona (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 the anticoagulant effect is potentiated if taken with Simvastatina Kern Pharma.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication. Your doctor will indicate when you can resume treatment with Simvastatina Kern Pharma. The use of Simvastatina Kern Pharma with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more 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.

It is recommended to avoid consuming grapefruit juice while taking Simvastatina Kern Pharma, as this juice increases simvastatina levels in the blood.

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

Pregnancy and lactation

Consult your doctor or pharmacist before taking a medication.

Simvastatina Kern Pharma 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 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 tolerate the medication.

Simvastatina Kern Pharma contains lactose

If your doctor has told you that you have a lactose intolerance, consult with them before taking any 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.

Remember to take your medication.

Your doctor will indicate the duration of your treatment with Simvastatina Kern Pharma. Do not discontinue treatment before.

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

Adults:

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 earlier or have certain kidney disorders.

Patients over 65 years old:

No dose adjustment is necessary.

If you estimate that the action of Simvastatina Kern Pharma is too strong or too weak, inform 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, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Simvastatina Kern Pharma

Do not take a double dose to compensate for the missed doses, wait for the next scheduled dose.

Take the next dose at your usual time.

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

Like all medicines, Simvastatina Kern Pharma may cause side effects, although not everyone will experience them.

Side effects have been classified according to the following definitions of frequencies: 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.

Blood and lymphatic system disorders:

Rare: anemia.

Digestive system disorders:

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

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.

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:

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.

In rare cases, an apparent allergic syndrome 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, joint pain, itching, photosensitivity, fever, redness, difficulty breathing, and general malaise.

Immune system disorders:

Rare:hypersensitivity reactions (allergic) that include: swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema).

The following serious adverse reactions have been reported very rarely:

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

Other possible side effects:

• 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, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.
• Blurred vision and vision deterioration (may affect up to 1 in 1,000 people).
• Rashes that can occur on the skin or ulcers in the mouth (medication-induced lichenoid eruptions) (may affect up to 1 in 10,000 people).
• Muscle pain, sensitivity to pressure, weakness, or muscle cramps; 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).

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

Complementary examinations:

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

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines 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 sight and reach.

Do not store at temperatures above30°C.

Do not use Simvastatina Kern Pharmaafter the expiration date indicated 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 packaging and medicines you no longer need at the SIGRE collection pointat the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Simvastatina Kern Pharma 10 mg tablets:

• The active ingredient is simvastatina. Each tablet contains 10 mg of simvastatina.
• The other components (excipients) are: Lactose monohydrate, microcrystalline cellulose, pregelatinized cornstarch, 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 packaging

Simvastatina Kern Pharma 10 mg is presented in the form of film-coated tablets, pale pink, oval, and biconvex. Each package contains 28 tablets (standard package) or 500 tablets (clinical package).

Holder of the marketing authorization and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Last review date of this leaflet: May 2023.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)www.aemps.gob.es