Ezetimibe/atorvastatin Normon 10 mg/20 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

Ezetimibe/Atorvastatin Normon 10 mg/10 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/20 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/40 mg tablets

Ezetimibe/Atorvastatin Normon 10 mg/80 mg 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 symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Ezetimiba/Atorvastatina Normon is and what it is used for

Ezetimiba/Atorvastatina Normon is a medicine that lowers high cholesterol levels. Ezetimiba/Atorvastatina Normon contains ezetimibe and atorvastatin.

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

Ezetimiba/Atorvastatina works by reducing cholesterol in two ways: it reduces the cholesterol absorbed in the gastrointestinal tract, as well as the cholesterol produced by the body itself.

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 may slow down or block blood flow to vital organs such as the heart and brain. This interruption in blood flow may lead to 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 present in your blood that may increase the risk of heart disease.

Ezetimiba/Atorvastatina is used in patients who cannot control their cholesterol levels with diet alone. While taking this medicine, you must continue to follow a cholesterol-lowering diet.

Your doctor may prescribe Ezetimiba/Atorvastatina if you are already taking both ezetimibe and atorvastatin at the same dose levels.

Ezetimiba/Atorvastatina does not help you lose weight.

2. What you need to know before taking Ezetimiba/Atorvastatina Normon

Do not take Ezetimiba/Atorvastatina Normon

• if you are allergic to ezetimibe, atorvastatin, 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 blood tests assessing liver function,
• 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,
• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop using this medicine. Your doctor will advise you when it is safe to restart treatment with ezetimiba/atorvastatina. The use of ezetimiba/atorvastatina together with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezetimiba/Atorvastatina

• if you have previously had a stroke with intracranial haemorrhage, or have small accumulations of fluid in the brain due to previous strokes,
• if you have kidney problems,
• if your thyroid gland is underactive (hypothyroidism),
• if you have had recurrent or unexplained muscle pain or discomfort, or have a personal or family history of muscle disorders,
• if you have previously experienced muscle problems while being treated with other lipid-lowering medicines (e.g., other medicines containing "statins" or "fibrates"),
• 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 are taking or have taken, within the last 7 days, a medicine containing fusidic acid (used to treat bacterial infection) by mouth or by injection. The combination of fusidic acid and ezetimiba/atorvastatina may cause serious muscle problems (rhabdomyolysis),
• 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 weakness while taking Ezetimiba/Atorvastatina. This is because, although rarely, muscle problems can be serious, including muscle breakdown leading to kidney damage.

Talk to your doctor or pharmacist before taking Ezetimiba/Atorvastatina

• if you suffer from severe respiratory insufficiency.

If you are in any of the above situations (or are unsure), consult your doctor before starting ezetimiba/atorvastatina, as your doctor may need to perform a blood test before starting and possibly during treatment with ezetimiba/atorvastatina to assess your risk of experiencing 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 “Taking Ezetimiba/Atorvastatina Normon with other medicines”).

While taking this medicine, your doctor will monitor whether you have diabetes or are at risk of developing diabetes. This risk increases 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

Ezetimiba/Atorvastatina is not recommended for use in children and adolescents.

Taking Ezetimiba/Atorvastatina Normon with other medicines

Tell 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 used to lower cholesterol) should be avoided while taking Ezetimiba/Atorvastatina.

Some medicines may alter the effect of Ezetimiba/Atorvastatina or their effects may be affected by Ezetimiba/Atorvastatina (see section 3). This type of interaction could reduce the effectiveness of one or both medicines. It could also increase the risk or severity of adverse effects, including a serious condition involving muscle breakdown known as “rhabdomyolysis”, described in section 4:

• ciclosporin (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, 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),

• 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 combination of elbasvir/grazoprevir,

• if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will advise you when it is safe to restart treatment with Ezetimiba/Atorvastatina. Taking Ezetimiba/Atorvastatina with fusidic acid may rarely cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further information on rhabdomyolysis, see section 4.

• Other medicines known to interact with Ezetimiba/Atorvastatina:

• oral contraceptives (medicines that prevent pregnancy),

• stiripentol (an anticonvulsant used to treat epilepsy),

• cimetidine (a medicine used for stomach acidity and peptic ulcers),

• phenazone (an analgesic),

• antacids (products for treating 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 Ezetimiba/Atorvastatina Normon with food and alcohol

See section 3 for instructions on how to take Ezetimiba/Atorvastatina. 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 Ezetimiba/Atorvastatina.

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 Ezetimiba/Atorvastatina if you are pregnant, trying to become pregnant, or think you might be pregnant.

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

Do not take Ezetimiba/Atorvastatina while breastfeeding.

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

Driving and using machines

Ezetimiba/Atorvastatina is not expected to affect your ability to drive or operate machinery. However, some people may experience dizziness after taking Ezetimiba/Atorvastatina. If you feel dizzy after taking this medicine, do not drive or use machinery.

Ezetimiba/Atorvastatina Normon contains lactose

Ezetimiba/Atorvastatina Normon tablets contain a sugar called lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

Ezetimiba/Atorvastatina Normon contains sodium

Ezetimiba/Atorvastatina Normon contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Ezetimibe/Atorvastatin Normon

Follow exactly the instructions for use of this medicine as indicated 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 Ezetimibe/Atorvastatin, you must already be following a cholesterol-lowering diet.
• You must continue this cholesterol-lowering diet while taking Ezetimibe/Atorvastatin.

How much to take

The recommended dose is one tablet of Ezetimibe/Atorvastatin once daily by oral administration, always at the same time.

The tablets should be swallowed with a sufficient amount of liquid (for example, a glass of water).

Method of administration

Take Ezetimibe/Atorvastatin at any time of day. You may take it with or without food.

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

If you take more Ezetimibe/Atorvastatin Normon than you should

Consult your doctor or pharmacist.

In case of overdose, consult your doctor or pharmacist or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Ezetimibe/Atorvastatin Normon

Do not take a double dose to make up for missed doses. Take your usual dose of Ezetimibe/Atorvastatin at the regular 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 can cause adverse effects, although not everyone will experience them.

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

• Severe allergic reactions causing swelling of the face, tongue, and throat, which may lead to severe breathing difficulties.
• A serious illness characterized by severe skin peeling and inflammation, blistering of 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 may progress to blisters.
• Muscle weakness, tenderness, pain, or brownish-red discoloration of the urine, particularly if accompanied by feeling unwell or having a high temperature, possibly due to abnormal muscle breakdown that can be life-threatening and cause kidney problems.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

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

Other possible adverse effects with Ezetimibe/Atorvastatin:

Frequent adverse effects (may affect up to 1 in 10 people):

• Nasal inflammation, sore throat, nosebleeds.
• Allergic reactions.
• Increased blood glucose levels; diabetic patients should monitor their blood glucose levels.
• Headache.
• Nausea, constipation, flatulence, diarrhea, indigestion, abdominal pain.
• Pain in the pharynx and/or larynx.
• Joint and/or hand and foot pain, back pain, muscle pain (myalgia), muscle spasms, joint swelling.
• Increased blood creatine kinase levels.
• Increased liver enzymes ALT and/or AST.
• Feeling of fatigue.
• Abnormal liver function tests.

Uncommon adverse effects (may affect up to 1 in 100 people):

• Swelling due to an allergic reaction.
• Reduced blood glucose levels; diabetic patients should monitor their blood glucose levels.
• Loss of appetite, weight gain.
• Cough.
• Muscle weakness, neck pain, chest pain.
• High blood pressure, hot flushes.
• Vomiting, belching, inflammation of the pancreas and liver, stomach acid reflux, inflammation of the stomach lining, dry mouth.
• Skin redness, hives, skin rash, itching, hair loss.
• Nightmares, sleep problems.
• Dizziness, numbness, altered sense of taste, amnesia, localized abnormal sensations.
• Blurred vision.
• Ringing in the ears.
• General malaise, restlessness, or discomfort.
• Weakness.
• Increased liver enzyme gamma-glutamyl transferase.
• Positive urine test for white blood cells.

Rare adverse effects (may affect up to 1 in 1,000 people):

• Decrease in blood platelets.
• Swelling of the deeper layers of skin tissue in the face, tongue, throat, abdomen, arms, or legs (angioedema).
• Widespread skin rash forming red spots or defined rashes with blisters and skin peeling, particularly around the mouth, nose, eyes, and genitals due to an allergic reaction.
• Inflammation of skeletal muscle, tendon inflammation, sometimes complicated by rupture, muscle weakness due to skeletal muscle fibers.
• Visual disorders.
• Yellowing of the skin and whites of the eyes.

Very rare adverse effects (may affect up to 1 in 10,000 people):

• Anaphylactic shock due to allergic reaction.
• Hearing loss.
• Liver failure.
• Enlargement of the breasts in men.

Adverse effects with frequency not known: (frequency cannot be estimated from available data):

• Allergic reaction including redness and swelling of the lower layers of the skin.
• Shortness of breath, inflammation of the gallbladder, gallstones.
• Physical weakness and loss of strength, loss of muscle tissue due to autoimmune antibodies.
• Depression.
• Myasthenia gravis (a disease causing generalized muscle weakness that, 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 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 during post-marketing surveillance for some statins (medicines used to lower cholesterol):

• Respiratory problems, including persistent cough and/or choking episodes or fever.
• Diabetes: frequency depends on the presence or absence of risk factors (fasting blood glucose ≥ 5.6 mmol/L, BMI > 20 kg/m², elevated triglycerides, high blood pressure).
• Depression.
• Sexual dysfunction.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, 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 Ezetimibe/Atorvastatin Normon

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Store in the original packaging to protect from light.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. 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 Ezetimiba/Atorvastatina Normon

• The active substances are ezetimibe and atorvastatine. Each tablet contains 10 mg of ezetimibe and 10 mg, 20 mg, 40 mg or 80 mg of atorvastatine (as calcium atorvastatine).

• The other components are: monohydrate lactose, calcium carbonate, microcrystalline cellulose, sodium lauryl sulfate (E487), sodium croscarmellose, povidone K30, hydroxypropylcellulose, magnesium stearate and polysorbate 80.

Appearance of the product and contents of the pack

Ezetimiba/Atorvastatina Normon 10 mg/10 mg tablets: white to off-white capsule-shaped tablets (12.7 mm x 5.1 mm), marked with “1” on one side.

Ezetimiba/Atorvastatina Normon 10 mg/20 mg tablets: white to off-white capsule-shaped tablets (14.5 mm x 6.8 mm), marked with “2” on one side.

Ezetimiba/Atorvastatina Normon 10 mg/40 mg tablets: white to off-white capsule-shaped tablets (16.4 mm x 6.3 mm), marked with “3” on one side.

Ezetimiba/Atorvastatina Normon 10 mg/80 mg tablets: white to off-white capsule-shaped tablets (17.0 mm x 8.0 mm), marked with “4” on one side.

Ezetimiba/Atorvastatina Normon is available in PVC/Aluminum/OPA blisters. Pack sizes of 10, 30, 90 and 100 tablets are available.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Hennig Arzneimittel Gmbh & Co. KG

Liebigstraße. 1-2

D-65439 Flörsheim

Germany

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

Netherlands: Ezetimibe/Atorvastatine Normon 10 mg/10 mg, 20 mg, 40 mg, 80 mg, tabletten

Spain: Ezetimiba/Atorvastatina Normon 10 mg/10 mg, 20 mg, 40 mg, 80 mg comprimidos

Date of the most recent review of this leaflet: March 2023

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