PANTOK 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Pantok 20 mg Film-Coated Tablets

Simvastatin

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Pantok 20 mg film-coated tablets are and what they are used for

2. What you need to know before you take Pantok 20 mg film-coated tablets

3. How to take Pantok 20 mg film-coated tablets

4. Possible side effects

5. Storage of Pantok 20 mg film-coated tablets

6. Contents of the pack and further information

1. What Pantok 20 mg film-coated tablets are and what they are used for

Pantok contains the active substance simvastatin. Pantok is a medicine used to reduce the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol). Pantok belongs to a group of medicines called statins.

Cholesterol is one of the fatty substances that can be found in the bloodstream. Your total cholesterol level is made up mainly of LDL and HDL cholesterol.

LDL cholesterol is often referred to as "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this can lead to a narrowing of the arteries, which can reduce or block blood flow to vital organs such as the heart and brain. This blockage can cause a heart attack or stroke.

HDL cholesterol is often referred to as "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another type of fat found in the blood that can increase the risk of heart disease.

While taking this medicine, you should also follow a low-cholesterol diet.

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

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

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

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

In most people, there are no immediate symptoms of high cholesterol. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, monitor your cholesterol, and discuss your goals with your doctor.

2. What you need to know before you take Pantok 20 mg film-coated tablets

Do not take Pantok

? if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6. Contents of the pack and further 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 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 organ transplant patients),
• 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 medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and Pantok can cause serious muscle problems (rhabdomyolysis).

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

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

Warnings and precautions

Tell your doctor:

• about all your medical problems, including allergies,
• if you drink 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 tablets for a short time,
• 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 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).

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 treatment with 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 the blood, are overweight, and have high blood pressure.

Tell your doctor if you have severe lung disease.

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

The risk of muscle failure is greater with higher doses of Pantok, especially with the 80 mg dose. The risk of muscle failure is also greater in certain patients. Talk to your doctor if any of the following situations apply to you:

• you drink 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 medicines called "statins" or fibrates,
• you or a close relative have a hereditary muscle problem.

Also, tell your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

Children and adolescents

The efficacy and safety of treatment with Pantok have been studied in boys aged 10 to 17 years and in girls who had their first menstrual period at least one year before (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 medicines and Pantok

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. In particular, tell your doctor if you are taking medicines with any of the following active substances:

• ? if you need to take fusidic acid orally to treat a bacterial infection, you will temporarily need to stop using this medicine. Your doctor will tell you when you can restart treatment with Pantok. Taking Pantok with fusidic acid can rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.
• cyclosporine (often used in transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a disease in which the inner lining of the uterus grows outside the uterus),
• medicines 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),
• medicines with the active substance cobicistat,
• amiodarone (used to treat irregular heartbeat),
• 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 serious genetic cholesterol disorders),
• daptomycin (a medicine used to treat skin and skin structure infections with complications and bacteremia). The adverse effects that affect the muscles may be greater when this medicine is taken during treatment with simvastatin (e.g., Pantok). Your doctor may decide that you should stop taking Pantok for a while.
• colchicine (used to treat gout).

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

• medicines with an active substance to prevent blood clots, 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 tell any doctor who prescribes you a new medicine that you are taking Pantok.

Taking Pantok with food and drinks

Grapefruit juice contains one or more components that alter how the body uses some medicines, including Pantok. You should avoid consuming grapefruit juice.

Pregnancy, breastfeeding, and fertility

Do not take Pantok if you are pregnant, if you are trying to become pregnant, or if you 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 not expected to interfere with your ability to drive or use machines. However, you should be aware that some people experience dizziness after taking Pantok.

Pantok contains lactose

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

3. How to take Pantok 20 mg film-coated tablets

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

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

Before starting to take Pantok, you should be following a low-cholesterol diet.

Dosage:

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

? 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 medicines indicated above 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 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, taken in the evening. The maximum recommended daily dose is 40 mg.

Method of administration:

Take Pantok in the evening. 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 medicine that contains a bile acid sequestrant, you should 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 Toxicology Information Service, telephone 915 62 04 20.

If you forget to take Pantok 20 mg

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

If you stop taking Pantok

Talk to your doctor or pharmacist because your cholesterol levels may rise again.

If you have any further questions on the use of this product, 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 how frequently adverse 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 the available data).

The following serious rare adverse effects have been reported.

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

• Muscle pain, pressure sensitivity, weakness, or muscle cramps. In rare cases, these muscle problems can be serious, including muscle failure leading to 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 of the limb 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 urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).
• Pancreas inflammation, often with severe abdominal pain.

The following serious very rare adverse effects have been reported:

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

Rarely, the following adverse effects have also been reported:

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

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

• Erectile dysfunction,
• Depression,
• Lung inflammation causing breathing problems, including 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. This is more likely if you have high levels of sugar and fat in your 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 Pantok (frequency not known).

Complementary tests

In some blood tests, elevations of liver function (transaminases) and a muscle enzyme (creatine kinase) have been observed.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines. Website: www.notificaram.es

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

5. Storage of Pantok 20 mg film-coated tablets

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

Do not store above 30°C. Store in the original package.

Do not use this medicine after the expiration date stated on the carton after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

Pantok 20 mg composition

The active ingredient is simvastatin. Each film-coated tablet contains 20 mg of simvastatin.

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

Product appearance and package contents

Pantok 20 mg is presented as film-coated tablets, round, biconvex, brown in color, and with a "P" on one face. Each package contains 28 tablets.

Marketing authorization holder and manufacturer

LACER, S.A. - Boters, 5

08290 Cerdanyola del Vallès

Barcelona – Spain

Date of the last revision of this leaflet: April 2023

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