Pantok Forte 40 mg film-coated tablets

Patient Information Leaflet

Introduction

Package Leaflet: Information for the patient

Pantok Forte 40 mg Film-coated Tablets

Simvastatin

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet Contents

1.- What Pantok Forte 40 mg Film-coated Tablets are and what they are used for

2.- What you need to know before taking Pantok Forte 40 mg Film-coated Tablets

3.- How to take Pantok Forte 40 mg Film-coated Tablets

4.- Possible adverse effects

5.- Storage of Pantok Forte 40 mg Film-coated Tablets

6.- Contents of the pack and other information

1. What is Pantok Forte 40 mg film-coated tablets and what is it used for?

Pantok contains the active substance simvastatin. Pantok is a medicine used to reduce blood levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides. Additionally, Pantok increases levels of "good" cholesterol (HDL cholesterol). Pantok belongs to a class of medicines known as statins.

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

LDL cholesterol is often called "bad" cholesterol because it can build up in the walls of your arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may cause a heart attack or stroke.

HDL cholesterol is often called "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 in your blood that may increase the risk of heart disease.

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

Pantok is used, together 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).

? an inherited condition (homozygous familial hypercholesterolemia), which increases cholesterol levels in the blood. You may also receive other treatments.

? coronary heart disease (CHD) or are at high risk of coronary heart disease (because you have diabetes, a history of stroke, or other blood vessel disease). Pantok Forte 40 mg may prolong your life by reducing the risk of heart-related problems, regardless of your blood cholesterol levels.

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

2. What you need to know before taking Pantok Forte 40 mg film-coated tablets

Do not take Pantok

? If you are allergic to simvastatin or any of the other components of this medicine (listed in section 6. Package contents and other information).

? If you currently have liver problems.

? If you are pregnant or breastfeeding.

? If you are taking medicines containing 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 infection),
• boceprevir or telaprevir (used to treat hepatitis C virus infection),
• nefazodone (used to treat depression),
• cobicistat,
• gemfibrozil (used to lower cholesterol),
• cyclosporine (used in organ transplant patients),
• danazol (a synthetic hormone used to treat endometriosis, a condition in which the tissue lining the uterus grows outside the uterus).
  • If you are taking or have taken, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by mouth or injection. The combination of fusidic acid and Pantok may cause serious muscle problems (rhabdomyolysis).

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

Consult your doctor if you are unsure whether your medicine is on the list above.

Warnings and precautions

Tell your doctor:

• about all your medical conditions, 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 tablets for a short period,
• if you are of Asian descent, as you may require a different dose,
• if you have or have had myasthenia (a disease characterized by generalized muscle weakness, which in some cases affects the muscles used for breathing) or ocular myasthenia (a disease causing weakness of the eye muscles), as statins may sometimes worsen the condition or trigger the onset of myasthenia (see section 4).

Your doctor will perform a blood test before you start taking Pantok and may repeat it if you develop symptoms of liver problems while on treatment. This is to monitor how well your liver is functioning.

Your doctor may also want to perform blood tests to monitor liver function after you start treatment with Pantok.

While taking this medicine, your doctor will monitor you for diabetes or risk factors for developing diabetes. This risk is higher if you have high levels of sugar and fats in the blood, are overweight, or have high blood pressure.

Inform your doctor if you have a severe lung disease.

Contact your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness. This is because, although rarely, muscle problems can be serious, including muscle breakdown (rhabdomyolysis) leading to kidney damage; and very rarely, deaths have occurred.

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

• you consume large amounts of alcohol,
• you have kidney problems,
• you have thyroid problems,
• you are 65 years of age or older,
• you are female,
• you have previously experienced muscle problems while taking cholesterol-lowering medicines known as “statins” or fibrates,
• you or a close family member have an inherited muscle disorder.

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Additional tests and treatments may be needed to diagnose and manage this condition.

Children and adolescents

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

Other medicines and Pantok

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

• if you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop taking this medicine. Your doctor will advise you when you can restart Pantok treatment. Using Pantok with fusidic acid may 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 condition in which the tissue lining the uterus grows outside the uterus),
• medicines containing active substances such as itraconazole, ketoconazole, fluconazole, posaconazole, or voriconazole (used to treat fungal infections),
• fibrates containing active substances such as gemfibrozil or bezafibrate (used to lower 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 containing 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 conditions),
• lomitapide (used to treat rare, serious genetic cholesterol disorders),
• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). The risk of adverse effects affecting muscles may be increased when this medicine is taken during treatment with simvastatin (e.g., Pantok). Your doctor may decide that you should temporarily stop taking Pantok,
• colchicine (used to treat gout).

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

• medicines containing active substances used to prevent blood clots, such as warfarin, phenprocoumon, or acenocoumarol (anticoagulants),
• fenofibrate (also used to lower cholesterol),
• niacin (also used to lower cholesterol),
• rifampicin (used to treat tuberculosis),
• ribociclib (used to treat breast cancer),
• palbociclib (used to treat breast cancer).

You should also inform any doctor prescribing you a new medicine that you are taking Pantok.

Taking Pantok with food and drink

Grapefruit juice contains one or more components that interfere with how the body processes certain medicines, including Pantok. Consumption of grapefruit juice should be avoided.

Pregnancy, breastfeeding, and fertility

Do not take Pantok if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking Pantok, stop taking it immediately and inform your doctor. Do not take Pantok while breastfeeding, as 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 affect your ability to drive or operate machinery. However, it should be noted that some people may experience dizziness after taking Pantok.

Pantok contains lactose

This medicine contains a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Pantok Forte 40 mg film-coated tablets

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

Always follow your doctor's instructions for taking this medicine exactly. If in doubt, consult your doctor or pharmacist again.

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

Dosage:

The recommended dose is 10 mg, 20 mg, or 40 mg of simvastatin once daily, taken orally.

? Adults:

The usual starting dose is 10 mg, 20 mg, 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 mentioned 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 disease complications who have not reached their cholesterol target with lower doses.

Use in children and adolescents

In children and adolescents aged between 10 and 17 years, the recommended starting daily dose is 10 mg, taken at night. The maximum recommended daily dose is 40 mg.

Method of administration:

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

If your doctor has prescribed Pantok together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must 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, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 915 62 04 20.

If you forget to take Pantok Forte 40 mg

Do not take a double dose to make up for missed doses. Wait until your next scheduled dose.

If you stop taking Pantok

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

If you have any further questions about 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 everyone will experience 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 immediately and contact your doctor or go to the nearest hospital emergency department.

• Muscle pain, tenderness, weakness, or cramps. In rare cases, these muscle problems can be severe, including muscle breakdown leading to kidney damage; and very rarely, deaths have occurred.
• Hypersensitivity (allergic) reactions including:
  • swelling of the face, tongue, and throat, which may cause difficulty breathing (angioedema),
  • severe muscle pain, usually in the shoulders and hips,
  • skin rash with weakness of the limb and neck muscles,
  • joint pain or inflammation (polymyalgia rheumatica),
  • inflammation of blood vessels (vasculitis),
  • atypical bruising, skin rashes, and swelling (dermatomyositis), urticaria, photosensitivity, fever, hot flushes,
  • 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 (jaundice), itching, dark-colored urine or pale stools, feeling tired or weak, loss of appetite; liver failure (very rare).
• Inflammation of the pancreas, often with severe abdominal pain.

The following serious very rare adverse effects have been reported:

• A severe allergic reaction causing difficulty breathing or dizziness (anaphylactic reaction),
• Skin rash or mouth ulcers (drug-induced lichenoid eruptions),
• Muscle rupture,
• Gynaecomastia (enlargement of the breast in men).

Rarely, the following adverse effects have also been reported:

• Low red blood cell count (anaemia),
• Numbness or weakness in arms and legs,
• Headache, tingling sensation, dizziness,
• Gastrointestinal disorders (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting),
• Skin rash, itching, hair loss,
• Weakness,
• Sleep disorders (very rare),
• Poor memory (very rare), memory loss, confusion,
• Blurred vision and visual impairment (rare).

The following adverse effects have also been reported, but based on the available information, their frequency cannot be estimated (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.
• Myasthenia gravis (a disease causing generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Ocular myasthenia (a disease causing 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 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 blood sugar and fats, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• Pain, tenderness, or persistent muscle weakness, which may not resolve after stopping treatment with Pantok (frequency not known).

Additional tests

In some blood tests, elevations in liver function (transaminases) and in 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 they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. Website: www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Pantok Forte 40 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 packaging.

Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point in your pharmacy. If you are in doubt, ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Pantok Forte 40 mg

The active substance is simvastatin. Each coated tablet contains 40 mg of simvastatin.

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

Appearance of the product and contents of the pack

Pantok Forte 40 mg is presented as film-coated, round, biconvex, brick-red tablets with a "P" on one side. Each pack contains 28 tablets.

Marketing Authorization Holder and Manufacturing Responsible Party

LACER, S.A. - Boters, 5
08290 Cerdanyola del Vallès
Barcelona – Spain

Date of the most recent review of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/