PLAXOS 10 mg/20 mg FILM-COATED TABLETS

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 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 pack

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

1. What is Plaxos and what is it used for

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

This medicine is used in adults to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and a type of fat called triglycerides in the blood. It also raises the levels of "good" cholesterol (HDL cholesterol).

This medicine works by reducing cholesterol in two ways. It reduces the amount of cholesterol absorbed in the gut and the amount of cholesterol produced by the body.

Cholesterol is one of the fatty substances that can be 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 can lead to a narrowing of the arteries. This narrowing can reduce or block the flow of blood to vital organs such as the heart and brain. This blockage can 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 found in the blood that can increase the risk of heart disease.

Your doctor may prescribe this medicine for you if you are already taking atorvastatin and ezetimibe at the same dose level, but as separate products, in addition to your cholesterol-lowering diet, if you have:

• high levels of cholesterol in the blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) or high levels of fats in the blood (mixed hyperlipidaemia):
• heart disease. This medicine reduces the risk of heart attack, stroke, surgery to increase blood flow to the heart, or hospitalization for chest pain.

This medicine does not help you lose weight.

2. What you need to know before you take 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 any unexplained abnormal blood test results indicating liver disease,
• if you are a woman who can become pregnant and are not using reliable contraceptive methods,
• if you are pregnant, trying to become pregnant or are breast-feeding,
• if you are taking the combination of glecaprevir/pibrentasvir in the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before taking this medicine:

• if you have had a previous stroke with bleeding in the brain, or have small amounts of fluid in the brain caused by previous strokes,
• if you have kidney problems,
• if your thyroid gland does not produce enough hormones (hypothyroidism),
• if you have had recurring or unexplained muscle pains or a family history of muscle problems,
• if you have had muscle problems while taking other lipid-lowering medicines (e.g. other medicines containing "statins" or "fibrates"),
• if you are taking or have taken in the last 7 days a medicine called fusidic acid (an antibiotic), by mouth or by injection. The combination of fusidic acid and medicines containing Ezetimibe/Atorvastatin can cause muscle problems (rhabdomyolysis),
• if you regularly drink 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 muscular dystrophy (a disease characterized by progressive muscle weakness) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or trigger the onset of myasthenia (see section 4).

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

Also, inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medicines may be needed to diagnose and treat this condition.

Consult your doctor or pharmacist before taking 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 taking this medicine, as your doctor will need to perform a blood test before starting treatment with this medicine, and possibly during treatment, to assess your risk of muscle side effects. The risk of muscle side effects, e.g. rhabdomyolysis (breakdown of damaged skeletal muscle), increases when certain medicines are taken at the same time (see section 2 "Other medicines and Plaxos").

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. You are more likely to develop diabetes if you have high levels of sugar and fat in your blood, are overweight, and have high blood pressure.

Tell your doctor about all your medical problems, including allergies.

Children

This medicine is not recommended for children and adolescents.

Other medicines and Plaxos

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription.

Fibrates (cholesterol-lowering medicines) should be avoided while taking this medicine.

There are some medicines that can affect the way this medicine works or that can increase the risk of side effects. This type of interaction can reduce the effectiveness of one or both medicines. On the other hand, it can also increase the risk or severity of side effects, including a serious disorder in which muscle tissue breaks down, known as "rhabdomyolysis", which is described in section 4:

• cyclosporin (a medicine 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, derivatives, colestipol, colestyramine (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 that helps prevent illness from cytomegalovirus),
• medicines used to treat HIV, e.g. ritonavir, lopinavir, atazanavir, indinavir, darunavir, the combination of tipranavir/ritonavir, etc. (used to treat AIDS),
• certain medicines used to treat hepatitis C, e.g. telaprevir, boceprevir and the combination of 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 stop using this medicine temporarily. Your doctor will tell you when it is safe to restart treatment with this medicine. The use of this medicine with fusidic acid can rarely cause muscle weakness, tenderness or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Other medicines that are known to interact with this medicine

• oral contraceptives (medicines that prevent pregnancy),
• stiripentol (an anticonvulsant medicine used to treat epilepsy),
• cimetidine (a medicine used for stomach acid and peptic ulcers),
• phenazone (a pain reliever),
• antacids (products for the treatment of indigestion that contain aluminium or magnesium),
• warfarin, phenprocoumon, acenocoumarol or fluindione (medicines that prevent blood clotting),
• colchicine (used to treat gout),
• St. John's Wort (a medicine 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 amounts of grapefruit juice can affect the way this medicine works.

Alcohol

Avoid excessive alcohol consumption while taking this medicine. For more details, see section 2 "Warnings and precautions".

Pregnancy, breast-feeding 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 can become pregnant, unless you use 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 breast-feeding.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines. However, it should be taken into account that some people experience dizziness after taking this medicine. If you feel dizzy after taking this medicine, do not drive or use machinery.

Plaxos contains lactose

Plaxos 10 mg/20 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Plaxos 10 mg/40 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Plaxos 10 mg/80 mg film-coated tablets contain lactose. If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

Plaxos contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Plaxos

Follow the instructions for administration of this medicine exactly as prescribed by your doctor. Your doctor will determine the appropriate dose of this medicine for you, depending on your current treatment and personal risk situation. If in doubt, consult your doctor or pharmacist again.

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

How much to take

The recommended dose is one tablet of this medicine once a day, preferably at the same time every day. The tablet should be swallowed with a sufficient amount of liquid (e.g. a glass of water).

Method of administration

Take this medicine at any time of day. You can take it with or without food.

If your doctor has prescribed this medicine for you to take with colestyramine or any other bile acid sequestrant (medicines that lower cholesterol), you should 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Plaxos

Do not take a double dose to make up for forgotten doses. The next day, take your normal dose of this medicine at the usual time.

If you have any further questions on the use of this medicine, 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.

If you experience any of the following serious adverse effects or symptoms, stop taking your tablets and immediately inform your doctor, or go to the emergency department of the nearest hospital and bring the tablets.

• severe allergic reactions that cause swelling of the face, tongue, and throat and can cause great difficulty breathing
• severe disease whose symptoms are intense exfoliation and skin inflammation, blister formation on the skin, mouth, eyes, genitals, and fever; skin rash with pink or red spots, especially on the palms of the hands or soles of the feet, which can lead to blisters
• weakness, sensitivity, pain, or muscle rupture or change in urine color to reddish-brown and especially, if it occurs at the same time, a feeling of discomfort or high temperature that may be caused by abnormal muscle destruction that can be potentially fatal and trigger 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 the unexpected or unusual appearance of bleeding or bruising, as this fact may be indicative of a liver condition.

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 disorders; sleep disturbances,
• dizziness; headache; tingling sensation,
• slow heartbeat,
• hot flashes,
• shortness of breath,
• abdominal pain; abdominal swelling; constipation; indigestion; flatulence; frequent bowel movements; stomach inflammation; nausea; stomach discomfort; stomach upset,
• acne; hives,
• joint pain; back pain; muscle cramps in the legs; muscle fatigue, spasms, or muscle weakness; pain in the arms and legs,
• unusual weakness; feeling of fatigue or discomfort; swelling, especially in the ankles (edema),
• increase or decrease in some liver or muscle function tests (CK) in laboratory blood tests,
• weight gain.

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

• rash that can occur on the skin or sores in the mouth (lichenoid drug reaction)
• purple-colored skin lesions (signs of inflammation of the blood vessels, vasculitis)

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

• 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 the arms or legs that worsens 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 in tablets (medicines used to reduce cholesterol):

• allergic reactions that include inflammation of the face, lips, tongue, and/or throat that can cause difficulty breathing or swallowing (which require immediate medical treatment),
• red, sometimes target-shaped, skin rash,
• liver problems,
• cough,
• heartburn,
• decreased appetite; loss of appetite,
• high blood pressure,
• skin rash and itching; allergic reactions that include the appearance of skin rash and hives,
• tendon injury,
• gallstones or gallbladder inflammation (which can cause abdominal pain, nausea, or vomiting),
• pancreatitis, often accompanied by severe abdominal pain,
• decrease in blood cell count, which can cause bruising/bleeding (thrombocytopenia),
• inflammation of the nasal passages; nosebleeds,
• neck pain; chest pain; throat pain,
• increase or decrease in blood sugar levels (if you have diabetes, you should closely monitor your blood glucose levels),
• nightmares,
• numbness or tingling in the 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 shortness of breath or fever,
• diabetes. This is more likely if you have high levels of sugars and fats in the 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, and especially if it occurs at the same time, a feeling of discomfort or high temperature that may not disappear after stopping treatment with this medicine (frequency not known).

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing 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 expiration date that appears on the box and on the blister pack after "EXP". The expiration date is the last day of the month indicated.

This medicine does not require any special storage temperature.

Keep it in the original packaging to protect it from light.

Medicines should not be thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Plaxos

The active ingredients 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:

Core of the tablet

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).

Appearance of the Product and Package Contents

Plaxos 10 mg/20 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink in color, marked with "20" on one side and smooth on the other, with an approximate size of 15 mm (length) x 6 mm (width).

Plaxos 10 mg/40 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink in color, marked with "40" on one side and smooth on the other, with an approximate size of 17 mm (length) x 6 mm (width).

Plaxos 10 mg/80 mg: Film-coated tablets, biconvex, oval-shaped, white and light pink in color, marked with "80" on one side and smooth on the other, with an approximate size of 18 mm (length) x 8 mm (width).

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

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

Only some package 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 medicine is authorized in the Member States of the European Economic Area 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 last revision of this prospectus: May 2025

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