SIMVASTATIN KERN PHARMA 20 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.Tell your doctor immediately. Rarely, simvastatin can cause serious muscle problems that can lead to kidney damage.

This risk is higher in patients taking high doses of Simvastatin Kern Pharma or taking Simvastatin Kern Pharma with certain medicines that increase simvastatin blood levels, 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)
• cyclosporin (a medicine used to prevent transplant rejection).

• Tell your doctor if you have kidney failure, hypothyroidism, 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 surgery.

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

• Have or have had myasthenia (a disease that causes generalised 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 containing 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 is increased if you have high sugar and fat levels 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 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")
• cyclosporin (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 fusidic acid orally 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 serious muscle problems (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 blood levels.

Simvastatin 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.

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 the medicine affects you.

Simvastatin Kern Pharma contains lactose

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

3. How to take Simvastatin Kern Pharma

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you the duration of your treatment with Simvastatin Kern Pharma. Do not stop treatment before.

The tablets should be taken in the evening 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 in the evening.

Your doctor may adjust the dose up to a maximum of 80 mg per day, administered in a single dose in the evening.

Your doctor may prescribe lower doses, especially if you are taking certain medicines mentioned 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, 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 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, telephone: 91 562 04 20, indicating the medicine and the amount taken.

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 the 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: anaemia.

Gastrointestinal disorders:

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

Nervous system disorders:

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

Frequency not known: Severe myasthenia (a disease that causes generalised 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 reactions) 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 sugar and fat levels 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 loss (may 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) (may affect up to 1 in 10,000 people).
• Muscle pain, tenderness or weakness; muscle failure; muscle rupture (may affect up to 1 in 10,000 people); tendon problems, sometimes complicated by tendon rupture.
• Gynaecomastia (breast enlargement in men) (may 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 they are not listed in this leaflet.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are 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 pack after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to a pharmacy for disposal. Ask your pharmacist how to dispose of medicines no longer required. 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 ingredients (excipients) are: lactose monohydrate, microcrystalline cellulose, pregelatinised maize 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 and packaging of the product

Simvastatin Kern Pharma is presented as film-coated tablets, orange in colour, oval and biconvex. Each pack contains 28 tablets (normal pack) or 500 tablets (clinical pack).

Marketing authorisation 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 Medicines and Healthcare Products Agency (AEMPS) www.aemps.gob.es