SIMVASTATIN KERN PHARMA 10 mg FILM-COATED TABLETS

2. What you need to know before you take Simvastatin Kern Pharma

Do not take Simvastatin 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 one 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 infections that cause 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 can cause serious muscle problems that can lead to kidney damage.

This risk is higher in patients who take high doses of Simvastatin Kern Pharma or who take Simvastatin Kern Pharma with certain medicines that increase simvastatin levels in the blood, and therefore 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).

• Tell your doctor if you have kidney failure, hypothyroidism, or a history of muscle disorders, or if you regularly consume alcohol, as these factors can increase the risk of muscle disorders.

• If you have had liver disease, it is possible that moderate increases in transaminase levels may occur, which in most cases return to normal without the need to stop treatment.

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

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

• Have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).
• Have severe respiratory failure
• Have constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.
• Are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Simvastatin Kern Pharma can cause serious muscle problems (rhabdomyolysis).

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

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

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

Interaction of Simvastatin Kern Pharma with other medicines

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

Certain medicines can interact with Simvastatin Kern Pharma and may increase the risk of muscle side effects; in these cases, it may be necessary to change the dose or interrupt treatment with one of them.

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 Simvastatin Kern Pharma")
• Cyclosporine (a medicine used to prevent transplant rejection)
• Verapamil, diltiazem, and amiodarone (medicines used to treat heart problems).

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 the anticoagulant effect is enhanced if taken with Simvastatin Kern Pharma.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Simvastatin Kern Pharma. The use of Simvastatin Kern Pharma with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

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

Simvastatin Kern Pharma can be taken with or without food.

Grapefruit juice should be avoided while taking Simvastatin Kern Pharma, as it increases simvastatin levels in the blood.

Simvastatin Kern Pharma should be administered 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.

Simvastatin Kern Pharma is contraindicated during pregnancy and breastfeeding.

In case of pregnancy or suspected pregnancy, treatment should be discontinued and your doctor informed as soon as possible.

Driving and using machines

At normal doses, Simvastatin Kern Pharma does not affect the ability to drive or use machines. However, if you notice symptoms of dizziness, do not drive or use machines until you know how you tolerate the medicine.

Simvastatin Kern Pharma contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking any medicine.

3. How to take Simvastatin Kern Pharma

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

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Simvastatin Kern Pharma. Do not stop 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 medicines indicated above or have certain kidney disorders.

Patient over 65 years:

No dose adjustment is necessary.

If you think that the action of Simvastatin Kern Pharma is too strong or too weak, talk to 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 Simvastatin Kern Pharma is not recommended in children.

If you take more Simvastatin Kern Pharma than you should

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

If you forget to take Simvastatin Kern Pharma

Do not take a double dose to make up for forgotten doses, wait for the next dose.

Take the next dose at your usual time.

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

4. Possible side effects

Like all medicines, Simvastatin Kern Pharma can cause side effects, although not everybody gets them.

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

Gastrointestinal disorders:

Rare: constipation, abdominal pain, gas, indigestion, diarrhea, 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: Constant muscle weakness.

Nervous system disorders:

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

Frequency not known: Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).

Eye disorders:

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

• Tell your doctor if you experience weakness in the arms or legs 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.

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, and joint pain, itching, photosensitivity, fever, flushing, difficulty breathing, and general malaise.

Immune system disorders:

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

The following serious side effects 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. This is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Blurred vision and vision impairment (can affect up to 1 in 1,000 people).
• A skin rash that can occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions) (can affect up to 1 in 10,000 people).
• Muscle pain, sensitivity to pressure, weakness, or muscle cramps; muscle failure; muscle rupture (can affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture.
• Gynecomastia (breast enlargement in men) (can affect up to 1 in 10,000 people).

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

Investigations:

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

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Simvastatin Kern Pharma

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

Do not store 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 should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Simvastatin Kern Pharma 10 mg tablets:

• The active ingredient is simvastatin. Each tablet contains 10 mg of simvastatin.
• The other ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinized corn starch, butylhydroxyanisole (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 packaging contents

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

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa (Barcelona)

Spain

Date of last revision of this leaflet: May 2023.

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) www.aemps.gob.es