Plaxos 10 mg/40 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Plaxos 10 mg/20 mg film-coated tablets

Plaxos 10 mg/40 mg film-coated tablets

Plaxos 10 mg/80 mg film-coated tablets

ezetimibe / atorvastatin

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Plaxos is and what it is used for
2. What you need to know before taking Plaxos
3. How to take Plaxos
4. Possible side effects
5. How to store Plaxos
6. Contents of the pack and other information

1. What Plaxos is and what it is used for

Plaxos is a medicine that lowers high levels of cholesterol. Plaxos contains ezetimibe and atorvastatin.

This medicine is used in adults to lower total cholesterol levels, "bad" cholesterol (LDL cholesterol), and certain fatty substances called triglycerides circulating in the blood. In addition, this medicine increases levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways: it reduces cholesterol absorbed in the digestive tract, as well as cholesterol produced by your body.

Cholesterol is one of the fatty substances found in the bloodstream. Your total cholesterol is mainly composed 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 cause 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 can trigger a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from accumulating in the arteries and protects against heart disease.

Triglycerides are another type of fat present in your blood that may increase the risk of heart disease.

Your doctor may prescribe this medicine if you are already taking atorvastatin and ezetimibe at the same dose level, but as separate products, along with a cholesterol-lowering diet, if you have:

• high blood levels of cholesterol (primary hypercholesterolemia [heterozygous familial and non-familial]) or high blood levels of fatty substances (mixed hyperlipidemia);
• heart disease. This medicine reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization due to chest pain.

This medicine does not help you lose weight.

2. What you need to know before taking Plaxos

Do not take Plaxos

• if you are allergic to atorvastatin, ezetimibe, or any of the other ingredients of this medicine (listed in section 6),
• if you have or have ever had a liver disease,
• if you have had unexplained abnormal results in liver function blood tests,
• if you are a woman who could become pregnant and are not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant, or breastfeeding,
• if you are taking the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine:

• if you have previously had a stroke with intracranial bleeding, or have small accumulations of fluid in the brain due to prior strokes,
• if you have kidney problems,
• if you have low thyroid activity (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or have personal or family history of muscle disorders,
• if you have previously experienced muscle problems during treatment with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• if you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine for bacterial infection). The combination of fusidic acid and medicines containing ezetimibe/atorvastatin may cause serious muscle problems (rhabdomyolysis),
• if you regularly consume large amounts of alcohol,
• if you have a history of liver disease,
• if you are over 70 years old,
• if you have or have had myasthenia (a disease causing 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).

Contact your doctor as soon as possible if you experience unexplained muscle pain, tenderness, or muscle weakness while taking this medicine. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage. Atorvastatin is known to cause muscle problems, and muscle problems have also been reported with ezetimibe.

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.

Consult your doctor or pharmacist before starting to take this medicine:

• if you have severe respiratory failure.

If you are in any of the above situations (or are unsure), consult your doctor or pharmacist before starting this medicine, as your doctor may need to perform a blood test before starting and possibly during treatment to assess your risk of developing muscle-related adverse effects. It is known that the risk of muscle-related adverse effects, e.g., rhabdomyolysis (breakdown of damaged skeletal muscle), increases when certain medicines are taken simultaneously (see section 2 “Other medicines and Plaxos”).

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

Inform your doctor about all your medical conditions, including allergies.

Children

This medicine is not recommended for children and adolescents.

Other medicines and Plaxos

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including over-the-counter medicines.

Fibrates (medicines to lower cholesterol) should be avoided while taking this medicine.

Some medicines may alter the effect of this medicine or their effects may be altered by this medicine (see section 3). Such interactions could reduce the effectiveness of one or both medicines. They could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as "rhabdomyolysis", described in section 4:

• cyclosporine (a medicine often used in transplant patients),

• erythromycin, clarithromycin, telithromycin, fusidic acid, rifampicin (medicines used to treat bacterial infections),

• ketoconazole, itraconazole, voriconazole, fluconazole, posaconazole (medicines used to treat fungal infections),

• gemfibrozil, other fibrates, nicotinic acid and its derivatives, colestipol, cholestyramine (medicines used to regulate lipid levels),

• certain calcium channel blockers used to treat angina or high blood pressure, e.g., amlodipine, diltiazem,

• digoxin, verapamil, amiodarone (medicines that regulate heart rhythm),

• letermovir (a medicine used to prevent cytomegalovirus infection),

• medicines used in the treatment of HIV, e.g., ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),

• some medicines used in the treatment of hepatitis C, e.g., telaprevir, boceprevir, and the combinations elbasvir/grazoprevir, ledipasvir/sofosbuvir,

• daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia).

• If you need to take oral fusidic acid to treat a bacterial infection, you will need to temporarily stop using this medicine. Your doctor will advise you when it is safe to restart treatment. Rarely, using this medicine with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Other medicines known to interact with this medicine:

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant used to treat epilepsy),
• cimetidine (a medicine used for stomach acid and peptic ulcers),
• phenazone (a painkiller),
• antacids (products for indigestion containing aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol, or fluindione (medicines that prevent blood clots),
• colchicine (used to treat gout),
• St. John’s wort (a herbal remedy used to treat depression).

Taking Plaxos with food, drink, and alcohol

See section 3 for instructions on how to take this medicine.

Please note the following:

Grapefruit juice

Do not drink more than one or two small glasses of grapefruit juice per day, as large quantities of grapefruit juice may alter the effects of this medicine.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For further details, see section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

Do not take this medicine if you are pregnant, trying to become pregnant, or think you may be pregnant.

Do not take this medicine if you could become pregnant unless you are using reliable contraceptive methods. If you become pregnant while taking this medicine, stop taking it immediately and inform your doctor.

Do not take this medicine if you are breastfeeding.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines. However, bear in mind that some people may experience dizziness after taking this medicine. If you feel dizzy after taking this medicine, do not drive or operate machinery.

Plaxos contains lactose

Plaxos 10 mg/20 mg film-coated tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Plaxos 10 mg/40 mg film-coated tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Plaxos 10 mg/80 mg film-coated tablets contain lactose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

Plaxos contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; hence, it is essentially “sodium-free”.

3. How to take Plaxos

Follow exactly the administration instructions for this medicine given by your doctor. Your doctor will determine the appropriate tablet dosage for you, depending on your current treatment and your individual risk situation. If in doubt, consult your doctor or pharmacist again.

• • Before starting to take this medicine, you must already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking ezetimibe/atorvastatin.

What amount to take

The recommended dose is one tablet of this medicine once daily, preferably always at the same time. The tablet should be swallowed with a sufficient amount of liquid (for example, a glass of water).

Method of administration

Take this medicine at any time of day. It can be taken with or without food.

If your doctor has prescribed this medicine together with colestyramine or any other bile acid sequestrant (medicines that reduce cholesterol levels), you must take this medicine at least 2 hours before or 4 hours after taking the bile acid sequestrant.

If you take more Plaxos than you should

Consult your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

If you forget to take Plaxos

Do not take a double dose to make up for missed doses. The following day, take your usual dose of this medicine at your usual time. If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets immediately and contact your doctor right away, or go to the nearest hospital emergency department, and take the tablets with you.

• severe allergic reactions causing swelling of the face, tongue, and throat, which may cause severe difficulty breathing
• a serious illness characterized by extensive skin peeling and inflammation, blistering of the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, particularly on the palms of the hands or soles of the feet, which may progress to blistering
• muscle weakness, tenderness, pain or rupture, or change in urine color to red-brown, and especially if occurring together with a feeling of malaise or high temperature, which may be due to abnormal muscle breakdown that could be potentially life-threatening and lead to kidney problems
• lupus-like syndrome (including rash, joint disorders, and effects on blood cells)

Consult your doctor as soon as possible if you experience problems associated with unexpected or unusual bleeding or bruising, as this may indicate liver disease.

Other possible adverse effects with this medicine:

Frequent (may affect up to 1 in 10 patients):

• diarrhea,
• muscle pain.

Uncommon (may affect up to 1 in 100 patients):

• flu,
• depression; sleep problems; sleep disorders,
• dizziness; headache; tingling sensation,
• slow heart rate,
• hot flushes,
• choking sensations,
• abdominal pain; bloating; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; gastrointestinal discomfort,
• acne; hives,
• joint pain; back pain; leg muscle cramps; muscle fatigue, spasms or weakness; pain in arms and legs,
• unusual weakness; feeling of tiredness or malaise; swelling, especially in the ankles (edema),
• increase in certain liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

Rare (may affect up to 1 in 1,000 patients):

• rash which may appear on the skin or sores in the mouth (lichenoid drug reaction)
• purple-colored skin lesions (signs of blood vessel inflammation, vasculitis)

Frequency not known (cannot be estimated from available data):

• myasthenia gravis (a disease causing generalized muscle weakness which, in some cases, affects muscles used for breathing),
• ocular myasthenia (a disease causing weakness of the eye muscles).

Consult your doctor if you experience worsening weakness in the arms or legs after periods of activity, double vision or drooping eyelids, difficulty swallowing, or difficulty breathing.

Additionally, the following adverse effects have been reported in people taking statins with ezetimibe, ezetimibe, or atorvastatin tablets (medicines used to lower cholesterol):

• allergic reactions including swelling of the face, lips, tongue, and/or throat, which may cause difficulty breathing or swallowing (requiring immediate medical treatment),
• red skin rash, sometimes target-shaped,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions including rash and hives,
• tendon injury,
• gallstones or inflammation of the gallbladder (which may cause abdominal pain, nausea, or vomiting),
• inflammation of the pancreas, often accompanied by severe abdominal pain,
• decreased blood cell count, which may lead to bruising/bleeding (thrombocytopenia),
• nasal inflammation; nosebleeds,
• neck pain; chest pain; sore throat,
• increased or decreased blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in fingers and toes,
• decreased sensitivity to pain or touch,
• altered sense of taste; dry mouth,
• memory loss,
  • ringing in the ears and/or head; hearing loss,
  • vomiting,
  • belching,
  • hair loss,
  • high temperature,
  • presence of white blood cells in urine tests,
  • blurred vision; visual disturbances,
  • gynecomastia (breast enlargement in men).

Possible adverse effects reported with some statins:

• sexual dysfunction,
• depression,
• respiratory problems, including persistent cough and/or choking sensations or fever,
• diabetes. This is more likely if you have high levels of sugar and fats in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine,
• persistent muscle pain, tenderness or weakness, and especially if occurring together with malaise or high temperature, which may not resolve after stopping treatment with this medicine (frequency not known).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Plaxos

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

Do not use this medicine after the expiry date stated on the carton and blister pack following “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store in the original packaging to protect from light.

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

6. Contents of the pack and other information

Composition of Plaxos

The active substances are ezetimibe and atorvastatin.

Plaxos 10 mg/20 mg: Each tablet contains 10 mg of ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate).

Plaxos 10 mg/40 mg: Each tablet contains 10 mg of ezetimibe and 40 mg of atorvastatin (as atorvastatin calcium trihydrate).

Plaxos 10 mg/80 mg: Each tablet contains 10 mg of ezetimibe and 80 mg of atorvastatin (as atorvastatin calcium trihydrate).

The other components (excipients) are:

Tablet core

Plaxos 10 mg/20 mg: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, red iron oxide (E-172), sodium lauryl sulfate, povidone K30, magnesium stearate, calcium carbonate and polysorbate 80.

Plaxos 10 mg/40 mg: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, red iron oxide (E-172), sodium lauryl sulfate, povidone K30, magnesium stearate, calcium carbonate and polysorbate 80.

Plaxos 10 mg/80 mg: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, red iron oxide (E-172), sodium lauryl sulfate, povidone K30, magnesium stearate, calcium carbonate and polysorbate 80.

Coating material

Plaxos 10 mg/20 mg: Opadry white contains: hypromellose 2910 (E-464), titanium dioxide (E-171), talc (E-553b) and propylene glycol (E-1520).

Plaxos 10 mg/40 mg: Opadry white contains: hypromellose 2910 (E-464), titanium dioxide (E-171), talc (E-553b) and propylene glycol (E-1520).

Plaxos 10 mg/80 mg: Opadry white contains: hypromellose 2910 (E-464), titanium dioxide (E-171), talc (E-553b) and propylene glycol (E-1520).

Nature of the product and contents of the pack

Plaxos 10 mg/20 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink, marked with “20” on one side and smooth on the other, approximately 15 mm (length) x 6 mm (width).

Plaxos 10 mg/40 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink, marked with “40” on one side and smooth on the other, approximately 17 mm (length) x 6 mm (width).

Plaxos 10 mg/80 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink, marked with “80” on one side and smooth on the other, approximately 18 mm (length) x 8 mm (width).

Packs containing 30 film-coated tablets in cold-formed blisters (OPA/Al/PVC-Al).

Packs containing 60 film-coated tablets in cold-formed blisters (OPA/Al/PVC-Al).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

LABORATORIOS MENARINI, S.A.

Alfonso XII, 587

08918-Badalona (Barcelona)

Spain

Manufacturer:

FACTORY BENNETT PHARMACEUTICALS S.A.

Aigaiou 26, Thesi Karela

Koropi Attiki, 19441, Greece

or

Rontis Hellas Medical and Pharmaceutical Products S.A.,

Larissa Industrial Area, P.O. BOX 3012

Larissa, 41500, Greece

This medicinal product is authorized in the European Economic Area member states under the following names:

Czech Republic: Ezetimibe/Atorvastatin Pharmaplot MFN 10 mg/20 mg film coated tablets

Ezetimibe/Atorvastatin Pharmaplot MFN 10 mg/40 mg film coated tablets

Ezetimibe/Atorvastatin Pharmaplot MFN 10 mg/80 mg film coated tablets

Spain: Plaxos 10 mg/20 mg film-coated tablets

Plaxos 10 mg/40 mg film-coated tablets

Plaxos 10 mg/80 mg film-coated tablets

Date of the most recent revision of this leaflet: May 2025

Detailed 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