AMLODIPINE/ATORVASTATIN NORMON 10 mg/10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine/Atorvastatin Normon 10 mg/10 mg film-coated tablets EFG

amlodipine / 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 and other information

1. What is Amlodipine/Atorvastatin Normon and what is it used for
2. What you need to know before you take Amlodipine/Atorvastatin Normon
3. How to take Amlodipine/Atorvastatin Normon
4. Possible side effects
5. Storing Amlodipine/Atorvastatin Normon

Contents of the pack and further information

1. What is Amlodipine/Atorvastatin Normon and what is it used for

Amlodipine/Atorvastatin Normon is used to prevent cardiovascular events (such as angina, heart attack) in patients with high blood pressure and who also have risk factors for cardiovascular disease, such as smoking, being overweight, high cholesterol levels, family history of heart disease, or diabetes. The presence of these risk factors associated with high blood pressure makes patients more likely to suffer cardiovascular events.

Amlodipine/Atorvastatin Normon is a product that contains two active substances, amlodipine (a calcium antagonist) and atorvastatin (a statin), and is used when your doctor considers it appropriate to take both medications. Amlodipine is used to treat high blood pressure (hypertension) and atorvastatin reduces cholesterol levels.

High blood pressure (hypertension) is a disease in which blood pressure is permanently elevated in an abnormal way and is one of the risk factors for cardiovascular events (angina, heart attack, stroke).

Cholesterol is a substance that is naturally found in the body and is necessary for normal growth. However, if there is too much cholesterol in the blood, it can deposit on the walls of blood vessels, increasing the risk of blood clots and cardiovascular events. This is one of the most common causes of heart disease.

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2. What you need to know before you take Amlodipine/Atorvastatin Normon

Do not take Amlodipine/Atorvastatin Normon

• If you are allergic (hypersensitive) to amlodipine, atorvastatin, or any other calcium channel blocker, or if you are allergic (hypersensitive) to any of the other ingredients of this medicine (listed in section 6).
• If you currently have a disease that affects the liver (if in the past you had a disease that affected the liver, see the section "Warnings and precautions" below).
• If you have had unexplained abnormal results in blood tests for liver function.
• If you are pregnant, trying to become pregnant, or breastfeeding.
• If you are taking any of the following medicines: ketoconazole, itraconazole (medicines used to treat fungal infections), telithromycin (an antibiotic).
• If you have low blood pressure (hypotension).
• If you have narrowing of the cardiac valve of the aorta (aortic stenosis) or cardiogenic shock (a situation where the heart is unable to provide enough blood to the body).
• If you have heart failure after a heart attack.
• If you use the combination of glecaprevir/pibrentasvir for the treatment of hepatitis C.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Amlodipine/Atorvastatin Normon:

• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have repeated or unexplained muscle pain, personal or family history of muscle problems.
• If you have had muscle problems in the past while taking other cholesterol-lowering medications (e.g., statins or fibrates).
• If you regularly drink large amounts of alcohol.
• If you have had a liver disease in the past.
• If you are over 70 years old.
• If you have had a previous stroke with bleeding in the brain or have small fluid-filled sacs in the brain due to previous strokes.
• 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 Amlodipine/Atorvastatin Normon can cause serious muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness, which in some cases affects 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).

Consult your doctor or pharmacist before taking Amlodipine/Atorvastatin Normon

• If you have severe respiratory failure.

In any of these cases, your doctor will indicate whether you should have blood tests before and possibly during treatment with Amlodipine/Atorvastatin Normon to calculate the risk of muscle side effects. It is known that the risk of muscle side effects, such as rhabdomyolysis, increases when taken with certain medications (see section 2 "Taking Amlodipine/Atorvastatin Normon with other medicines").

Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medications may be necessary to diagnose and treat this problem.

While 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 sugar and fat levels in your blood, are overweight, and have high blood pressure.

Taking Amlodipine/Atorvastatin Normon with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

There are some medicines that can interact with Amlodipine/Atorvastatin Normon. This interaction can mean that one or both medicines are less effective. It can also increase the risk or severity of side effects, including the important muscle damage known as rhabdomyolysis and myopathy (described in section 4):

• Some antibiotics, such as rifampicin, or "macrolide antibiotics", such as erythromycin, clarithromycin, telithromycin, fusidic acid; or medicines for treating fungal infections, such as ketoconazole, itraconazole.
• Medicines for controlling your lipid levels: fibrates, such as gemfibrozil or colestipol.
• Medicines for controlling your heart rate, such as amiodarone, diltiazem, and verapamil.
• Anticonvulsants, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone.
• Medicines used to modify the functioning of your immune system, such as cyclosporine, tacrolimus.
• Medicines used in the treatment of HIV infection, such as ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc., nelfinavir.
• Some medicines used in the treatment of hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Medicines used in the treatment of depression, such as nefazodone and imipramine.
• Medicines used in the treatment of mental disorders, such as neuroleptics.
• Medicines for treating heart failure, such as beta blockers.
• Medicines for treating high blood pressure, such as angiotensin II receptor antagonists, ACE inhibitors, verapamil, and diuretics.
• Alpha blockers used in the treatment of high blood pressure and prostate problems.
• Other medicines that are known to interact with Amlodipine/Atorvastatin Normon include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (an anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a pain reliever), colchicine (used in the treatment of gout), and antacids (products for indigestion that contain aluminum or magnesium).
• Amifostine (used in cancer treatment).
• Sildenafil (for erectile dysfunction).
• Dantrolene and baclofen (muscle relaxants).
• Corticosteroids.
• Cyclosporine (an immunosuppressant).
• Medicines without a prescription that contain St. John's Wort (Hypericum perforatum).

Amlodipine/Atorvastatin Normon may reduce your blood pressure even more if you are already taking other medicines to treat high blood pressure.

Tell your doctor or pharmacist if you are using, have recently used, or could use other medicines, including those bought without a prescription.

If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with Amlodipine/Atorvastatin Normon. The use of Amlodipine/Atorvastatin Normon with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Amlodipine/Atorvastatin Normon with food, drinks, and alcohol

Amlodipine/Atorvastatin Normon can be taken at any time of the day, with or without food.

Grapefruit juice

Do not drink more than one or two glasses of grapefruit juice per day, as large amounts of grapefruit juice can alter the effects of Amlodipine/Atorvastatin Normon.

Alcohol

Avoid drinking too much alcohol while taking Amlodipine/Atorvastatin Normon. See the details in the section 2 "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Do not take Amlodipine/Atorvastatin Normon if you are pregnant, breastfeeding, or trying to become pregnant. It has been shown that amlodipine passes into breast milk in small amounts. When taking Amlodipine/Atorvastatin Normon or any other medicine, women of childbearing age must take adequate contraceptive measures. Consult your doctor or pharmacist before using any medicine.

Driving and using machines

Do not drive or operate machinery if you feel dizzy after taking this medicine.

Amlodipine/Atorvastatin Normon contains sodium

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

3. How to take Amlodipine/Atorvastatin Normon

Follow exactly the administration instructions of this medicine given by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

The usual initial dose of Amlodipine/Atorvastatin Normon for adults is one 5 mg/10 mg tablet per day. If necessary, your doctor may increase the dose to one 10 mg/10 mg tablet per day.

Amlodipine/Atorvastatin Normon should be swallowed whole, with a little water. The tablets can be taken orally at any time of the day, with or without food. However, try to take your tablet at the same time every day.

Follow your doctor's dietary recommendations, especially regarding fat restriction in your diet, quitting smoking, and regular exercise.

If you think the effect of the Amlodipine/Atorvastatin Normon tablets is too strong or too weak, tell your doctor or pharmacist.

Use in children and adolescents

This medicine is not recommended for children and adolescents.

If you take more Amlodipine/Atorvastatin Normon than you should

If you accidentally take too many Amlodipine/Atorvastatin Normon tablets (more than your usual daily dose), consult your doctor or the nearest hospital or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount taken. Bring the remaining tablets, the package, and the complete box so that hospital staff can easily identify the medicine you have taken.

Excess fluid may accumulate in the lungs (pulmonary edema) causing difficulty breathing, which can develop up to 24-48 hours after ingestion.

If you forget to take Amlodipine/Atorvastatin Normon

If you forget to take a dose, take the next scheduled dose at the correct time.

Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine/Atorvastatin Normon

Do not stop taking Amlodipine/Atorvastatin Normon unless your doctor tells you to. If you have any further questions on the use of this medicine or wish to stop treatment, 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 any of the following occur, stop taking Amlodipine/Atorvastatin Normon and inform your doctor immediately:

• Swelling of the face, tongue, and airways that can cause great difficulty in breathing.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• If you have unexplained muscle weakness, muscle pain on palpation, or muscle pain and at the same time you feel unwell or have a fever (very rarely, this combination of effects can become a potentially life-threatening disease called rhabdomyolysis).

Very Common Adverse Effects (may affect more than 1 in 10 people):

• Swelling of arms, hands, legs, joints, or feet

Common Adverse Effects (may affect up to 1 in 10 people):

• Allergic reaction
• Headache (especially at the beginning of treatment), dizziness, feeling of fatigue, drowsiness
• Irregular heartbeats, flushing
• Palpitations (abnormal sensation of heartbeat), difficulty breathing
• Nasal congestion, sore throat, nosebleeds
• Feeling of discomfort, abdominal pain, indigestion, changes in bowel habits (including diarrhea, constipation, and flatulence)
• Pain in muscles and joints, muscle cramps and spasms, back pain, pain in the limbs, muscle fatigue
• Increased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), increased creatine kinase in the blood, blood test results showing that your liver function may become abnormal.
• Vision problems (including double vision), blurred vision

Uncommon Adverse Effects (may affect up to 1 in 100 people):

• Hepatitis (inflammation of the liver)
• Rhinorrhea, loss of appetite, decreased blood sugar levels (if you have diabetes, you should continue to carefully monitor your blood sugar levels), weight gain or loss
• Difficulty sleeping, with nightmares, mood changes (including anxiety), depression, tremors, nervous system disorders (decreased sensitivity) of the arms and legs, memory loss
• Ringing or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, taste disturbances, vomiting, belching
• Hair loss, bruising or small spots on the skin, skin discoloration, decreased skin sensitivity to touch or pain, numbness or tingling in the fingers and toes, skin rash, urticaria or itching
• Urinary disorders (including excessive urination at night and increased frequency of urination), impotence, abnormal development of the breasts in men
• Feeling of discomfort, muscle fatigue, pancreatitis (inflammation of the pancreas that causes stomach pain), pain, neck pain, chest pain
• Positive urine tests for white blood cells.
• Abnormal heart rhythm
• Cough

Rare Adverse Effects (may affect up to 1 in 1,000 people):

• Blurred vision
• Unexpected bleeding or bruising
• Muscle weakness, sensitivity, pain, or rupture, and especially if you also have discomfort or have a high fever, it may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle degradation does not always disappear, even after stopping atorvastatin, and can be potentially life-threatening and cause kidney problems.
• Decreased platelet count in the blood
• Liver disorders (yellowing of the skin and whites of the eyes)
• Severe allergic skin reactions, skin redness, blistering rash, peeling skin that can spread rapidly to the rest of the body and may start with symptoms such as those of the flu, accompanied by high fever
• Inflammation of the deep layers of the skin - including inflammation of the lips, eyelids, and tongue
• Inflammation or swelling of the skeletal muscle, blistering rash, sudden and severe skin inflammation in an area
• Tendon inflammation, tendon injury
• Confusion.

Very Rare Adverse Effects (may affect up to 1 in 10,000 people):

• Allergic reaction - symptoms may include sudden wheezing and chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Gynecomastia (breast enlargement in men)
• Decreased white blood cell count
• Increased muscle tension or stiffness
• Heart attack, inflammation of small blood vessels, stomach pain (gastritis)
• Gum growth
• Hearing loss, liver failure

• Photosensitivity (skin sensitivity to light)
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).

Adverse Effects of Unknown Frequency

• Constant muscle weakness
• 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.

Other Possible Adverse Effects:

• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Disorders of the combination of stiffness, tremors, and/or movement disorders
• Diabetes. It is more likely if you have high levels of sugar and fat in the blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Go to your doctor immediately if you experience any of the following adverse effects after taking this medicine:

Severe skin reactions, including intense skin rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, 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: http://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Amlodipine/Atorvastatin Normon

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

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the packaging after "CAD". The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packaging and medicines you no longer need in the SIGRE Point of 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.

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6. Package Contents and Additional Information

The active ingredients are amlodipine and atorvastatin. Each tablet contains 10 mg of amlodipine as amlodipine besylate and 10 mg of atorvastatin as atorvastatin calcium trihydrate.

The other components are: pregelatinized cornstarch, microcrystalline cellulose, sodium croscarmellose, calcium carbonate, polysorbate 80, hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate, indigo carmine lake (E-132), and opadry II white 85F18422 (which contains polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, and talc).

Product Appearance and Package Contents

Amlodipine/Atorvastatin Normon 10 mg/10 mg are film-coated tablets of blue color, round, biconvex, and marked with "10/10" on one face.

Each package contains 28 tablets

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Other Presentations

Amlodipine/Atorvastatin Normon 5 mg/10 mg film-coated tablets EFG.

Date of the Last Revision of this Prospectus: July 2024

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/