Package Insert: Information for the Patient

Pantok 10 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 10 mg Film-Coated Tablets are and for what they are used

2.- What you need to know before starting to take Pantok 10 mg Film-Coated Tablets

3.- How to take Pantok 10 mg Film-Coated Tablets

4.- Possible adverse effects

5.- Storage of Pantok 10 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 the 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 to prevent the accumulation of bad cholesterol 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 10 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 components of this medication (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 medications 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 with organ transplants),

• danazol (a synthetic hormone used to treat endometriosis, a condition 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) by mouth or 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 unsure if your medication is on the above list.

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 scheduled for surgery. You may need to stop taking Pantok for a short period of time,
• if you are of Asian descent, as you may need a different dose,
• if you have or have had myasthenia (a condition that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a condition that causes weakness of the eye muscles), as statins may sometimes worsen the condition or cause myasthenia (see section 4).

Your doctor will perform 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 perform blood tests to check how well your liver is working after you start taking Pantok.

While you are taking this medication, your doctor will monitor 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, obesity, and high blood pressure.

Inform your doctor if you have a severe lung disease.

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

The risk of muscle failure is higher with high doses of Pantok, especially with the 80 mg dose. The risk of muscle failure 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 female,
• you have ever had muscle problems during treatment with cholesterol-lowering medications called "statins" or fibrates,
• you or a close relative have a hereditary muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and medications may be necessary to diagnose and treat this condition.

Children and adolescents

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

Other medications and Pantok

Inform your doctor if you are taking, have taken recently, or may need to take any other medication with any of the following active ingredients. Taking Pantok with any of the following medications may increase the risk of muscle problems (some of which are already included in the previous section "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 medication. Your doctor will indicate when you can resume 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 inner lining of the uterus grows outside the uterus),
• medications 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),
• medications 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 diseases),
• lomitapide (used to treat rare and severe genetic cholesterol disorders),
• daptomycin (a medication used to treat skin and skin structure infections and bacteremia). It is possible that the muscle-related side effects may be greater when this medication is taken during treatment with simvastatin (for example, Pantok). Your doctor may decide that you should stop taking Pantok for a time.
• colchicine (used to treat gout).

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

• medications 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 should also inform any doctor who prescribes a new medication that you are taking Pantok.

Taking Pantok with food and drinks

The juice of grapefruit contains one or more components that alter how the body uses some medications, including Pantok. You should avoid consuming grapefruit 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, as it is unknown whether this medication passes into breast milk.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

Pantok is not expected to interfere with your ability to drive or operate machinery. However, some people may experience dizziness after taking Pantok.

Pantok 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.

Your doctor will determine the appropriate dose for you, depending on your condition, current treatment, and 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.

Posology:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once a day byoral 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 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 that contains 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 10 mg

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

If you interrupt treatment with Pantok

Speak 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, sensitivity to pressure, weakness or muscle cramps. In rare cases, these muscle problems can be severe, including muscle failure which 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,
  • Pain or inflammation of the joints (polymyalgia rheumatica),
  • Inflammation of the blood vessels (vasculitis),
  • Atypical hematomas, skin rash, and swelling (dermatomyositis), urticaria, skin sensitivity to sunlight, fever, hot flashes,
  • Difficulty breathing (dyspnea) and general discomfort,
  • Pseudo-lupus 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 information (frequency not known):

• Erectile dysfunction,
• Depression,
• Pneumonitis, which 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, which 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, which 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 Pharmacovigilance of Medicines 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 30°C. Store in the original packaging.

Do not use this medication after the expiration date shown on the carton 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 10 mg

The active ingredient is simvastatina. Each coated tablet contains 10 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 contents of the packaging

Pantok 10 mg is presented in the form of coated tablets with a film coating, of peach color, round, biconvex, scored on one side and with a “P” on the other 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