Package Insert: Information for the Patient

Pantok 20 mg Film-Coated Tablets

Simvastatina

Read this package insert carefully before starting to take this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

1.- What Pantok 20 mg Film-Coated Tablets are and for what they are used

2.- What you need to know before starting to take Pantok 20 mg Film-Coated Tablets

3.- How to take Pantok 20 mg Film-Coated Tablets

4.- Possible adverse effects

5.- Storage of Pantok 20 mg Film-Coated Tablets

6.- Contents of the package and additional information

Pantok contains the active ingredient simvastatina. Pantok is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (low-density lipoprotein, LDL) and certain fatty substances called triglycerides in the blood. Additionally, Pantok increases the levels of "good" cholesterol (high-density lipoprotein, HDL). Pantok is a member of a class of medicines called statins.

Cholesterol is one of the fatty substances found in the bloodstream. Its total cholesterol is mainly composed of LDL and HDL.

LDL cholesterol is often referred to as "bad" cholesterol because it can accumulate in the walls of your arteries, forming plaques. Over time, this accumulation of plaque can cause a narrowing of the arteries. This narrowing can make blood flow to vital organs such as the heart and brain slower or interrupted. This interruption of blood flow can cause a myocardial infarction or a stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent bad cholesterol from accumulating in the arteries and protects them from cardiovascular diseases.

Triglycerides are another type of fat in your blood that can increase the risk of cardiovascular disease.

While taking this medicine, you must follow a cholesterol-lowering diet.

Pantok is used, along with a cholesterol-lowering diet, if you have:

? elevated levels of cholesterol in the blood (primary hypercholesterolemia) or elevated levels of fatty substances in the blood (mixed hyperlipidemia).

? a hereditary disease (familial hypercholesterolemia homozygote), which increases the level of cholesterol in the blood. You may also receive other treatments.

? coronary heart disease (CHD) or if you have a high risk of coronary heart disease (because you have diabetes, a history of stroke or other vascular disease). Pantok 20 mg can prolong your life by reducing the risk of cardiovascular problems, regardless of the amount of cholesterol in your blood.

Most people do not have immediate symptoms of high cholesterol. Your doctor may measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

Do not take Pantok

? If you are allergic to simvastatin or any of the other ingredients in this medicine (listed in section 6. Contents of the pack and additional information).

? If you currently have liver problems.

? If you are pregnant or breastfeeding.

? If you are taking medicines with one or more of the following active ingredients:

• 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 infection),

• nefazodone (used to treat depression),

• cobicistat,

• gemfibrozil (used to reduce cholesterol),

• cyclosporin (used in patients who have had an organ transplant),

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

• If you are taking or have taken, in the last 7 days, a medicine that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Pantok may cause severe muscle problems (rhabdomyolysis).

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

Consult your doctor if you are not sure if your medicine is on the list above.

Warnings and precautions

Inform your doctor:

• of all your medical problems, including allergies,
• if you consume large amounts of alcohol,
• if you have ever had liver disease. Pantok may not be suitable for you,
• if you are due to have an operation. You may need to stop taking the Pantok tablets for a short time,
• if you are of Asian origin, as you may need a different dose,
• if you have or have had myasthenia (a condition that causes generalised muscle weakness, which in some cases affects the muscles used for breathing) or myasthenia gravis (a condition that causes weakness of the eye muscles), as statins sometimes make the condition worse or cause it to develop (see section 4).

Your doctor will do a blood test before you start taking Pantok and also if you have any symptoms of liver problems while taking Pantok. This is to check how well your liver is working.

Your doctor may also want to do blood tests to check how well your liver is working after you start taking Pantok.

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 your blood, are overweight and have high blood pressure.

Inform your doctor if you have a severe lung disease.

Consult your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because in rare cases, muscle problems can be severe, including kidney damage; and very rarely, deaths have occurred.

The risk of muscle damage is higher with high doses of Pantok, especially with the 80 mg dose. The risk of muscle damage is also higher in certain patients. Talk to 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 a woman,
• you have ever had muscle problems during treatment with cholesterol-lowering medicines called statins or fibrates,
• you or a close relative have a hereditary muscle disorder.

Inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this problem.

Children and adolescents

The effectiveness and safety of Pantok 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. How to take Pantok). Pantok has not been studied in children under 10 years old. For more information, consult your doctor.

Other medicines and Pantok

Inform your doctor if you are taking, have taken recently or may need to take any other medicine with any of the following active ingredients. Taking Pantok with any of the following medicines may increase the risk of muscle problems (some of these are already included in the section above “Do not take Pantok”).

• if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop taking this medicine. Your doctor will tell you when you can restart the treatment with Pantok. The use of Pantok with fusidic acid rarely may cause muscle weakness, sensitivity or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporin (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus),
• medicines with an active ingredient such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections),
• fibrates with an active ingredient 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 HIV infections),
• antivirals for hepatitis C, such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C infection),
• nefazodone (used to treat depression),
• medicines with the active ingredient 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 conditions),
• lomitapide (used to treat rare and severe genetic cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medicine is taken during treatment with simvastatin (for example Pantok). Your doctor may decide that you should stop taking Pantokfor a time,
• colchicine (used to treat gout).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have taken recently other medicines, including those bought without a prescription. In particular, inform your doctor if you are taking medicines with any of the following active ingredients:

• medicines with an active ingredient 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 must also inform any doctor who prescribes a new medicine that you are taking Pantok.

Taking Pantok with food and drink

Orange juice contains one or more components that affect how the body uses some medicines, including Pantok. You should avoid consuming orange juice.

Pregnancy, breastfeeding and fertility

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

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Pantok is unlikely to affect your ability to drive or use machines. However, some people may experience dizziness after taking Pantok.

Pantok contains lactose

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

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

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

Before starting to take Pantok, you must be following a diet to reduce cholesterol.

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once a day by oral route.

? Adults:

The usual starting dose is 10, 20, or in some cases, 40 mg per day. After at least 4 weeks, your doctor may adjust your dose, 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 indicated earlier or have certain kidney disorders.

The 80 mg dose is only recommended for adult patients with very high cholesterol levels and a high risk of heart disease problems who have not achieved 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 for treatment is 10 mg, at night. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Pantok at night. You can take it with or without food. Continue taking Pantok until your doctor tells you to stop.

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

If you take more Pantok than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 915 62 04 20.

If you forget to take Pantok 20 mg

Do not take a double dose to make up for the missed dose, wait for the next scheduled dose.

If you interrupt treatment with Pantok

Discuss with your doctor or pharmacist because your cholesterol may rise again.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following terms are used to describe how often side effects 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 available data).

The following serious rare side effects have been reported.

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

• Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure that causes kidney damage; and very rarely, deaths have occurred.
• Allergic reactions that include:
• • Swelling of the face, tongue, and throat, which can cause difficulty breathing (angioedema),
  • Intense muscle pain, usually in the shoulders and hips,
  • Skin rash with weakness of the muscles of the limbs and neck,
  • Joint pain or inflammation (polymyalgia rheumatica),
  • Inflammation of blood vessels (vasculitis),
  • Atypical hematomas, skin rashes, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes,
  • Difficulty breathing (dyspnea) and general discomfort,
  • 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 urine or pale stools, feeling tired or weak, loss of appetite; liver insufficiency (very rare).
• Pancreatitis, often with intense abdominal pain.

The following serious very rare side effects have been reported:

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

Rarely, the following side effects have also been reported:

• Anemia (low red blood cell count),
• Numbness or weakness of the arms and legs,
• Headache, tingling sensation, dizziness,
• Digestive problems (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,
• Blurred vision and vision deterioration (rare).

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

• Erectile dysfunction,
• Depression,
• Lung inflammation that causes breathing problems, including persistent cough and/or difficulty breathing or fever,
• Tendon problems, sometimes complicated by tendon rupture.
• Myasthenia gravis (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing).
• Myasthenia ocular (a disease that causes weakness of the eye muscles).
• Consult your doctor if you experience weakness in the arms or legs that worsens after periods of activity, double vision, or eyelid drooping, difficulty swallowing, or difficulty breathing.

Additional side effects reported with some statins:

• Sleep disorders, including nightmares,
• Sexual dysfunction,
• 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 medicine,
• Constant muscle pain, sensitivity, or weakness that may not disappear after stopping treatment with Pantok (frequency not known).

Complementary tests

In some blood tests, elevations in liver function (transaminases) and a muscle enzyme (creatine kinase) were observed.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use. Website: www.notificaram.es

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not store above 30º C. Store in the original packaging.

Do not use this medication 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 disposed of through the drains or in the trash. Dispose of the packaging and medicines you no longer need at theSIGREcollection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Pantok 20 mg

The active ingredient is simvastatina. Each coated tablet contains 20 mg of simvastatina.

The other components (excipients) are: Butylhydroxyanisole (E320), ascorbic acid (E300), citric acid monohydrate (E330), microcrystalline cellulose, pregelatinized cornstarch, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropylcellulose, titanium dioxide (E171), talc, iron oxide red (E172), and iron oxide yellow (E172).

Appearance of the product and content of the packaging

Pantok 20 mg is presented in the form of coated tablets with a film, round, biconvex, brownish in color, and with a “P” on one side. Each package contains 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Last review date of this leaflet: April 2023

Detailed and updated information about this medication is available on the website of

the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/