SIMVASTATINA 10 mg Film-Coated Tablets

2. What you need to know before taking Simvastatin Cinfamed

Do not take Simvastatin Cinfamed

• if you are allergic to simvastatin or any of the other components of this medication (listed in section 6).
• if you currently have liver problems.
• if you are pregnant or breastfeeding.
• if you are taking medications with one or more of the following active substances:

? itraconazole, ketoconazole, posaconazole, or voriconazole (used to treat fungal infections).

? erythromycin, clarithromycin, or telithromycin (used to treat infections).

? HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (HIV protease inhibitors are used to treat HIV infections).

? boceprevir or telaprevir (used to treat hepatitis C virus infection).

? nefazodone (used to treat depression).

? cobicistat.

? gemfibrozil (used to reduce cholesterol).

? cyclosporine (used in patients with organ transplants).

? danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).

• if you are taking or have taken, in the last 7 days, a medication that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and simvastatin can cause serious muscle problems (rhabdomyolysis).

Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat rare and severe genetic cholesterol disorders).

Consult your doctor if you are unsure whether your medication is included in the above list.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Simvastatin Cinfamed.

Inform your doctor:

• of all your medical problems, including allergies.
• if you consume large amounts of alcohol.
• if you have ever had liver disease. Simvastatin may not be suitable for you.
• if you are scheduled for surgery. You may need to stop taking simvastatin tablets for a short period.
• if you are Asian, as you may need a different dose.
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects 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).

Your doctor should perform a blood test before starting to take simvastatin and also if you have any symptoms of liver problems while taking simvastatin. This is done to check how your liver is functioning.

Your doctor may also perform blood tests to monitor how your liver is functioning after starting to take simvastatin.

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 levels of sugar and fat in the blood, are overweight, and have high blood pressure.

Inform your doctor if you have severe lung disease.

Contact your doctor immediately if you experience pain, tenderness, or unexplained muscle weakness.

This is because, in rare cases, muscle problems can be serious, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.

The risk of muscle failure is greater with high doses of simvastatin, especially with doses of 80 mg, and in certain patients. Inform your doctor if any of the following situations apply to you:

• you consume large amounts of alcohol
• you have kidney problems
• you have thyroid problems
• you are 65 years or older
• you are female
• you have ever had muscle problems during treatment with cholesterol-reducing medications called "statins" or fibrates
• you or a close relative have a hereditary muscle problem

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

Children and Adolescents

The efficacy and safety of simvastatin treatment were studied in boys aged 10 to 17 years and in girls who had their first menstrual period (menstruation) at least one year before (see section 3). Simvastatin has not been studied in children under 10 years of age. For more information, consult your doctor.

Other Medications and Simvastatin Cinfamed

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

Taking simvastatin with any of these medications can increase the risk of muscle problems (some of which are already listed in the "Do not take Simvastatin Cinfamed" section):

• if you need to take oral fusidic acid to treat a bacterial infection, you will temporarily need to stop using this medication. Your doctor will tell you when you can restart simvastatin treatment. The use of simvastatin with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in patients with organ transplants).
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus).
• medications with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections).
• fibrates with an active substance such as gemfibrozil and bezafibrate (used to reduce cholesterol).
• erythromycin, clarithromycin, or telithromycin (used to treat bacterial infections).
• HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir (used to treat AIDS).
• antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir, or grazoprevir (used to treat hepatitis C virus infection).
• nefazodone (used to treat depression).
• medications with the active substance cobicistat.
• amiodarone (used to treat irregular heart rhythm).
• verapamil, diltiazem, or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart diseases).
• lomitapide (used to treat rare and severe genetic cholesterol disorders).
• daptomycin (a medication used to treat skin and skin structure infections with complications and bacteremia). The adverse effects that affect the muscles may be greater when this medication is taken during simvastatin treatment. Your doctor may decide that you should stop taking simvastatin for a while.
• colchicine (used to treat gout).
• Ticagrelor (antiplatelet medication).

As with the medications mentioned above, inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication, including those purchased without a prescription. In particular, inform your doctor if you are taking medications with any of the following active substances:

• medications with an active substance to prevent blood clot formation, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants).
• fenofibrate (also used to reduce cholesterol).
• niacin (also used to reduce cholesterol).
• rifampicin (used to treat tuberculosis).

You should also inform any doctor who prescribes you a new medication that you are taking simvastatin.

Taking Simvastatin Cinfamed with Food and Drinks

Grapefruit juice contains one or more components that alter the way the body uses some medications, including simvastatin. Grapefruit juice should be avoided.

Pregnancy and Breastfeeding

Do not take this medication if you are pregnant, trying to become pregnant, or think you may be pregnant. If you become pregnant while taking this medication, stop taking it immediately and inform your doctor. Do not take this medication if you are breastfeeding, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and Using Machines

Simvastatin is not expected to interfere with your ability to drive or use machines. However, it should be noted that some people experience dizziness after taking simvastatin.

Simvastatin Cinfamed Contains Lactose

This medication contains a sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to Take Simvastatin Cinfamed

Your doctor will determine the appropriate dose of simvastatin for you, depending on your condition, current treatment, and personal risk situation.

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

You should follow a cholesterol-reducing diet while taking this medication.

Dosage:

The recommended dose is 10 mg, 20 mg, 40 mg, or 80 mg of simvastatin orally once a day.

Adults:

The usual initial dose is 10, 20, or, in some cases, 40 mg per day. Your doctor may adjust your dose after at least 4 weeks, up to a maximum of 80 mg per day. Do not take more than 80 mg per day.

Your doctor may prescribe lower doses, especially if you are taking certain medications mentioned earlier or if you have certain kidney disorders.

The dose of 80 mg is only recommended for adult patients with very high cholesterol levels and a high risk of heart problems who have not reached their cholesterol goal with lower doses.

Use in Children and Adolescents

In children and adolescents aged 10 to 17 years, the recommended daily starting dose is 10 mg per day, taken in the evening. The maximum recommended dose is 40 mg per day.

Method of Administration

Take simvastatin in the evening. You can take it with or without food. Continue taking simvastatin until your doctor tells you to stop.

The score line on the 10 mg tablet is only for breaking the tablet if you find it difficult to swallow it whole.

If your doctor has prescribed simvastatin along with another cholesterol-reducing medication that contains a bile acid sequestrant, take simvastatin at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If You Take More Simvastatin Cinfamed 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 medication and the amount ingested.

If You Forget to Take Simvastatin Cinfamed

Do not take a double dose to make up for forgotten doses. The next day, take your normal amount of simvastatin at the usual time.

If You Interrupt Treatment with Simvastatin Cinfamed

Talk to your doctor or pharmacist because your cholesterol level may increase again.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following terms are used to describe the frequency of adverse effects that have been reported:

• Rare (may affect up to 1 in 1,000 people).
• Very rare (may affect up to 1 in 10,000 people).
• Frequency not known (cannot be estimated from the available data).

The following serious adverse effects have been reported rarely.

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

• Muscle pain, sensitivity to pressure, weakness, or muscle cramps. In rare cases, muscle problems can be serious, including muscle rupture resulting in kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity reactions (allergic) including:
• Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema).
• Severe muscle pain, usually in the shoulders and hips.
• Skin rash with weakness in the limbs and neck muscles.
• Pain or inflammation of the joints (polymyalgia rheumatica).
• Inflammation of the blood vessels (vasculitis).
• Atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes.
• Difficulty breathing (dyspnea) and general malaise.
• Pseudolupus syndrome (including skin rash, joint disorders, and effects on blood cells).
• Liver inflammation with the following symptoms: yellowing of the skin and eyes, itching, dark-colored urine or pale-colored stools, feeling of fatigue and weakness, loss of appetite, liver failure (very rare).
• Pancreatitis, often with severe abdominal pain.

The following very rare serious adverse effects have been reported:

• A severe allergic reaction that causes difficulty breathing or dizziness (anaphylactic reaction).
• Rash that may occur on the skin or ulcers in the mouth (drug-induced lichenoid eruptions).
• Muscle rupture.
• Gynecomastia (enlargement of the breast in men).

The following adverse effects have also been reported rarely:

• Low red blood cell count (anemia).
• Numbness or weakness of the arms and legs.
• Headache, tingling sensation, dizziness.
• Blurred vision, vision impairment.
• Digestive disorders (abdominal pain, constipation, gas, indigestion, diarrhea, nausea, vomiting).
• Skin rash, itching, hair loss.
• Weakness.
• Sleep problems (very rare).
• Poor memory (very rare), memory loss, confusion.

The following adverse effects have also been reported, but the frequency cannot be estimated from the available information (frequency not known):

• Erectile dysfunction.
• Depression.
• Lung inflammation that causes respiratory problems such as persistent cough and/or difficulty breathing or fever.
• Tendon problems, sometimes complicated by tendon rupture.
• Severe myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Ocular myasthenia (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 or drooping eyelids, difficulty swallowing or difficulty breathing.

Additional possible adverse effects reported with some statins:

• Sleep disorders, including nightmares.
• Sexual dysfunction.
• Diabetes. It is more likely if you have high levels of sugars and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with simvastatin (frequency not known).

Laboratory Values

Elevations in some blood tests of liver function and a muscle enzyme (creatinine kinase) have been observed.

Reporting of Adverse Effects:

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Simvastatina cinfamed

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

Do not store above 30°C. Store in the original packaging to protect it from light and moisture.

Do not use this medicine after the expiration date that appears on the box after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the containers and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Simvastatina cinfamed

• The active ingredient is simvastatin. Each film-coated tablet contains 10 mg of simvastatin.
• The other components are:

Core of the tablet:Lactose monohydrate, microcrystalline cellulose (E460), pregelatinized corn starch, butylhydroxyanisole (E320), butylhydroxytoluene (E321), ascorbic acid (E300), citric acid (E330), colloidal anhydrous silica (E551), talc (E553b), magnesium stearate (E470b).

Coating:Hypromellose (E464), red iron oxide (E172), yellow iron oxide (E172), triethyl citrate (E1505), titanium dioxide (E171), talc (E553b), and povidone.

Appearance of the Product and Package Contents

Simvastatina cinfamed 10 mg is presented in the form of film-coated tablets, biconvex, oval, peach-colored, and with a score line on one side.

The tablets are packaged in blisters inside a carton, containing 10, 20, 28, 30, 98, and 100 tablets. Only some pack sizes may be marketed.

Simvastatina cinfamed is also available in 20 mg and 40 mg tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Manufacturer

Pharmaceutical Works Polpharma S.A.

19 Pelplinska street

83-200 Starogard Gdanski

Poland

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) – Spain

Date of the Last Revision of this Prospectus: May 2023

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).

You can access detailed and updated information about this medicine by scanning the QR code included in the prospectus and packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/70230/P_70230.html

QR code to: https://cima.aemps.es/cima/dochtml/p/70230/P_70230.html