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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

amlodipine / atorvastatin

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

• Keep this leaflet, as 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 reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

Pack contents and additional information

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

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

Amlodipine/Atorvastatin Normon is a fixed combination product containing two active substances, amlodipine (a calcium antagonist) and atorvastatina (a statin), and is used when your doctor considers it appropriate to take both medicines. Amlodipine is used in the treatment of high blood pressure (hypertension), and atorvastatin lowers cholesterol levels.

High blood pressure (hypertension) is a condition in which blood pressure is abnormally and persistently elevated, and is one of the risk factors for cardiovascular events (angina, heart attack, stroke).

Cholesterol is a substance naturally present in the body and necessary for normal growth. However, if there is too much cholesterol in the blood, it may 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.

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

Do not take Amlodipine/Atorvastatin Normon

• If you are allergic (hypersensitive) to amlodipine, atorvastatin, 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 liver disease (if you have previously had a liver condition, see the section “Warnings and precautions” below).
• If you have had unexplained abnormal results in liver function blood tests.
• If you are pregnant, trying to become pregnant, or during 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 heart's aortic valve (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply sufficient blood to the body).
• If you suffer from heart failure following myocardial infarction.
• If you are using 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 an underactive thyroid gland (hypothyroidism).
• If you experience unexplained or recurrent muscle pain, or have personal or family history of inherited muscle disorders.
• If you have previously experienced muscle problems during treatment with other cholesterol-lowering (lipid-lowering) medicines (e.g., medicines containing “statins” or “fibrates”).
• If you regularly drink large amounts of alcohol.
• If you have previously had a liver disease.
• If you are over 70 years old.
• If you have had a prior stroke with bleeding in the brain, or have small fluid-filled areas in the brain due to previous strokes.
• If you are taking or have taken within the last 7 days an oral or injectable medicine containing fusidic acid (used to treat bacterial infection). The combination of fusidic acid and Amlodipine/Atorvastatin Normon may cause serious muscle problems (rhabdomyolysis).
• 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).

Consult your doctor or pharmacist before taking Amlodipine/Atorvastatin Normon

• If you have severe respiratory insufficiency.

In any of these cases, your doctor may advise you to have blood tests before and possibly during treatment with Amlodipine/Atorvastatin Normon to assess the risk of muscle-related adverse effects. It is known that the risk of experiencing muscle-related adverse effects, such as rhabdomyolysis, increases when taken concomitantly with certain medicines (see section 2 “Taking Amlodipine/Atorvastatin Normon with other medicines”).

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.

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 your blood, are overweight, or 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 need to take any other medicines.

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

• Certain antibiotics, for example rifampicin, or “macrolide antibiotics”, such as erythromycin, clarithromycin, telithromycin, fusidic acid; or medicines used to treat fungal infections, for example ketoconazole, itraconazole.
• Medicines to control your lipid levels: fibrates such as gemfibrozil or colestipol.
• Medicines to control your heart rhythm, for example amiodarone, diltiazem, and verapamil.
• Anticonvulsants, for example carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone.
• Medicines used to modify the function of your immune system, for example cyclosporine, tacrolimus.
• Medicines used in the treatment of HIV infection, for example ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc., nelfinavir.
• Certain medicines used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Medicines used to treat depression, for example nefazodone and imipramine.
• Medicines used in the treatment of mental disorders, for example neuroleptics.
• Medicines used to treat heart failure, for example beta-blockers.
• Medicines used to treat high blood pressure, for example angiotensin II receptor antagonists, ACE inhibitors, verapamil, and diuretics.
• Alpha-blockers used to treat high blood pressure and prostate problems.
• Other medicines known to interact with Amlodipine/Atorvastatin Normon include ezetimibe (cholesterol-lowering), warfarin (blood-thinning), oral contraceptives, stiripentol (an anticonvulsant for epilepsy), cimetidine (used for heartburn and peptic ulcer), phenazone (a painkiller), colchicine (used in the treatment of gout), and antacids (indigestion remedies containing aluminium or magnesium).
• Amifostine (used in cancer treatment).
• Sildenafil (for erectile dysfunction).
• Dantrolene and baclofen (muscle relaxants).
• Steroids.
• Cyclosporine (immunosuppressant).
• Over-the-counter medicines containing St. John’s wort (Hypericum perforatum).
• Daptomycin (a medicine used to treat complicated skin and skin structure infections and bloodstream infections caused by bacteria).

Amlodipine/Atorvastatin Normon may lower your blood pressure even more if you are already taking other medicines for high blood pressure.

Inform your doctor or pharmacist if you are using, have recently used, or may need to use other medicines, including those obtained without a prescription.

If you need to take oral fusidic acid to treat a bacterial infection, you must stop taking this medicine. Your doctor will advise you when you can restart treatment with Amlodipine/Atorvastatin Normon. Using Amlodipine/Atorvastatin Normon with fusidic acid may cause muscle weakness, tenderness, or pain (rhabdomyolysis). For further 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 day, with or without food.

Grapefruit juice

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

Alcohol

Avoid drinking large amounts of alcohol while taking Amlodipine/Atorvastatin Normon. See details in 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. Women of childbearing potential who take Amlodipine/Atorvastatin Normon or any other medicine should use appropriate 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; hence, it is essentially “sodium-free”.

3. How to take Amlodipine/Atorvastatin Normon

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Adults

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

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

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

If you think the effect of Amlodipine/Atorvastatin Normon tablets is too strong or too weak, inform 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), contact your doctor or the nearest hospital immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount taken. Bring any remaining tablets, the carton, and the full packaging so that hospital staff can easily identify the medicine you have taken.

Excess fluid may accumulate in the lungs (pulmonary edema), causing breathing difficulties, which may develop within 24–48 hours after ingestion.

If you forget to take Amlodipine/Atorvastatin Normon

If you forget to take a dose, take the next dose at the scheduled 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 other questions about using this medicine or wish to discontinue treatment, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If any of the following occur, stop taking Amlodipine/Atorvastatin Normon and contact your doctor immediately:

• Swelling of the face, tongue, or airways, which may cause severe breathing difficulties.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• If you experience unexplained muscle weakness, muscle tenderness or pain, and at the same time feel unwell or have a fever (very rarely, this combination of effects may progress to a serious, potentially fatal illness 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, fatigue, drowsiness
• Irregular heartbeat, flushing
• Palpitations (abnormal awareness of heartbeat), difficulty breathing
• Nasal inflammation, sore throat, nosebleeds
• Malaise, abdominal pain, indigestion, changes in bowel habits (including diarrhea, constipation, and flatulence)
• Muscle and joint pain, muscle cramps and spasms, back pain, limb pain, muscle fatigue
• Increased blood glucose levels (if you have diabetes, continue to monitor your blood glucose levels carefully), increased blood creatine kinase, blood test results indicating possible abnormal liver function
• Vision problems (including double vision), blurred vision

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

• Hepatitis (liver inflammation)
• Runny nose, loss of appetite, decreased blood sugar levels (if you have diabetes, continue to monitor your blood glucose levels carefully), weight gain or loss
• Difficulty sleeping, nightmares, mood changes (including anxiety), depression, tremor, sensory nerve disturbances (reduced sensation) in arms and legs, memory loss
• Ringing or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, taste disturbances, vomiting, burping
• Hair loss, bruising or small spots on the skin, skin discoloration, reduced skin sensitivity to touch or pain, numbness or tingling in fingers and toes, skin rash, hives, or itching
• Urinary disorders (including excessive urination at night and increased frequency of urination), impotence, abnormal breast development in men
• Malaise, muscle fatigue, pancreatitis (inflammation of the pancreas causing 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, tenderness, pain, or breakdown, especially if accompanied by feeling unwell or high fever, which may be due to abnormal muscle breakdown (rhabdomyolysis). Abnormal muscle breakdown may not always resolve even after stopping atorvastatin and can be potentially fatal, leading to kidney problems
• Decreased number of platelets in the blood
• Liver disorders (yellowing of the skin and whites of the eyes)
• Severe allergic skin reactions, skin redness, blistering rash, skin peeling that may rapidly spread to the rest of the body, possibly starting with flu-like symptoms and accompanied by high fever
• Deep swelling of the skin layers – including swelling of the lips, eyelids, and tongue
• Inflammation or swelling of skeletal muscle, blistering rash, sudden and severe skin inflammation in an area
• Tendon inflammation, tendon injury
• Confusion
• Skin rash or mouth ulcers (drug-induced lichenoid reaction)

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

• Allergic reaction – symptoms may include sudden wheezing, chest pain or tightness, swelling of the eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Gynecomastia (enlargement of breasts in men)
• Reduced levels of white blood cells in the blood
• Increased muscle tension or stiffness
• Heart attack, inflammation of small blood vessels, stomach pain (gastritis)
• Gum overgrowth
• Hearing loss, liver failure
• Photosensitivity (skin sensitivity to light)
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells)

Adverse effects with unknown frequency:

• Persistent muscle weakness
• 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 worsening weakness in the arms or legs 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 involving stiffness, tremor, and/or movement disturbances
• Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Seek immediate medical attention if you experience any of the following adverse effects after taking this medicine:

Severe skin reactions including severe rash, hives, widespread skin redness, intense itching, blistering, skin peeling and inflammation, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions.

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: http://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage 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 expiry date stated on the packaging 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 empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and other information

The active substances 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 corn starch, 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 (containing polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, and talc).

Appearance of the product and contents of the container

Amlodipine/Atorvastatin Normon 10 mg/10 mg are film-coated blue tablets, round, biconvex, marked with “10/10” on one side.

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 latest review of this leaflet: January 2026

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