Package Leaflet: Information for the User

Amlodipino/Atorvastatina Normon 10 mg/10 mg Film-Coated Tablets

amlodipino / atorvastatina

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and additional information

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

Amlodipino/Atorvastatina Normon is a product that contains two active ingredients, amlodipino (calcium antagonist) and atorvastatina (statin), and is used when your doctor considers it appropriate to take both medications. Amlodipino is used to treat high blood pressure (hypertension) and atorvastatina reduces cholesterol levels.

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

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

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Do not take Amlodipino/Atorvastatina 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 components of this medication (including those listed in section 6).
• If you currently have a liver disease (if in the past you had a liver disease, see the section “Warnings and precautions” below).
• If you have had 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 medications: ketoconazole, itraconazole (medications used to treat fungal infections or mycosis), telithromycin (an antibiotic).
• If you have low blood pressure (hypotension).
• If you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition where the heart is unable to provide enough blood to the body).
• If you suffer from heart failure after a myocardial infarction.
• 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 Amlodipino/Atorvastatina Normon:

• If you have kidney problems.
• If you have a thyroid gland with low activity (hypothyroidism).
• If you have repeated or unjustified muscle pain, personal or family history of hereditary muscle problems.
• If you have had muscle problems in the past during treatment with other medications to reduce cholesterol (lipids) (for example, medications with “statins” or “fibrates”).
• If you regularly drink large amounts of alcohol.
• If in the past you had a liver disease.
• If you are over 70 years old.
• If you have had a previous stroke with bleeding in the brain, or have small fluid embolisms in the brain due to previous strokes.
• If you are taking or have taken in the last 7 days a medication that contains fusidic acid, (used to treat bacterial infections) by mouth or by injection. The combination of fusidic acid and Amlodipino/Atorvastatina Normon may cause severe muscle problems (rhabdomyolysis).
• If you have or have had myasthenia (a disease that causes generalized muscle weakness that, in some cases, affects the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins may sometimes worsen the disease or cause myasthenia (see section 4).

Consult your doctor or pharmacist before taking Amlodipino/Atorvastatina Normon

• If you have severe respiratory failure.

In any of these cases, your doctor will instruct you to have blood tests before and possibly during treatment with Amlodipino/Atorvastatina Normon, to calculate the risk of muscle side effects. It is known that the risk of muscle side effects, for example rhabdomyolysis, increases when taken at the same time as certain medications (see section 2 “Taking Amlodipino/Atorvastatina Normon with other medications”).

Also inform your doctor or pharmacist if you experience persistent muscle weakness. Further tests and additional medications may be necessary to diagnose and treat this problem.

While taking this medication, your doctor will monitor if you have diabetes or a risk of developing diabetes. This risk of diabetes increases if you have high blood sugar and lipid levels, overweight, and high blood pressure.

Use of Amlodipino/Atorvastatina Normon with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

There are some medications that may interact with Amlodipino/Atorvastatina Normon. This interaction may involve that one or both medications are less effective. It may also increase the risk or severity of side effects, including the important muscle deterioration known as rhabdomyolysis and myopathy (described in section 4):

• Some antibiotics, for example rifampicin, or “macrolide” antibiotics, for example erythromycin, clarithromycin, telithromycin, fusidic acid; or medications to treat fungal infections, for example, ketoconazole, itraconazole.
• Medications to control your lipid levels: fibrates, for example gemfibrozil or cholestyramine.
• Medications to control your heart rate, for example amiodarone, diltiazem, and verapamil.
• Anticonvulsants, for example carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone.
• Medications used to modify the functioning of your immune system, for example cyclosporine, tacrolimus.
• Medications used in the treatment of HIV infection, for example, ritonavir, lopinavir, atazanavir, indinavir, darunavir, tipranavir combined with ritonavir, etc, nelfinavir.
• Some medications used to treat hepatitis C, such as telaprevir, boceprevir, and the combination of elbasvir/grazoprevir.
• Medications used to treat depression, for example nefazodone and imipramine.
• Medications used in the treatment of mental disorders, for example neuroleptics.
• Medications to treat heart failure, for example beta blockers.
• Medications 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 medications that are known to interact with Amlodipino/Atorvastatina Normon include ezetimibe (which reduces cholesterol), warfarin (which reduces blood clotting), oral contraceptives, stiripentol (anticonvulsant for treating epilepsy), cimetidine (used for heartburn and peptic ulcers), phenazone (a pain reliever), colchicine (used in the treatment of gout) and antacids (products for indigestion that contain aluminum or magnesium.
• Amifostine (used to treat cancer).
• Sildenafil (for erectile dysfunction).
• Dantrolene and baclofen (muscle relaxants).
• Estrogens.
• Cyclosporine (immunosuppressant).
• Medications without a prescription that contain St. John's Wort (Hipericum perforatum).

Amlodipino/Atorvastatina Normon may lower your blood pressure even more if you are already taking other medications to treat high blood pressure.

Inform your doctor or pharmacist if you are using, have used recently or may need to use other medications, even those purchased without a prescription.

If you need to take fusidic acid orally to treat a bacterial infection, you will need to stop taking this medication. Your doctor will instruct you when you can restart treatment with Amlodipino/Atorvastatina Normon. The use of Amlodipino/Atorvastatina Normon with fusidic acid may cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

Taking Amlodipino/Atorvastatina Normon with food, drinks, and alcohol

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

Orange juice

Do not drink more than one or two glasses of orange juice per day, as large amounts of orange juice may alter the effects of Amlodipino/Atorvastatina Normon.

Alcohol

Avoid drinking large amounts of alcohol while taking Amlodipino/Atorvastatina Normon. See details in section 2 “Warnings and precautions”.

Pregnancy, breastfeeding, and fertility

Do not takeAmlodipino/Atorvastatina Normonif you are pregnant, breastfeeding, or trying to become pregnant.Amlodipine passes into breast milk in small amounts.When takingAmlodipino/Atorvastatina Normonor any other medication, women of childbearing age should take appropriate contraceptive measures. Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Amlodipino/Atorvastatina Normon contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Adults

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

Amlodipino/Atorvastatina 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 dietary fat restriction, quitting smoking, and regular exercise.

If you estimate that the effect of Amlodipino/Atorvastatina Normon tablets is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medication is not recommended for children and adolescents.

If you take more Amlodipino/Atorvastatina Normon than you should

If you accidentally take too many Amlodipino/Atorvastatina Normon tablets (more than your usual daily dose), consult your doctor immediately or go to the nearest hospital or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested..Bring the remaining tablets, the packaging, and the complete box so that hospital staff can easily identify the medication you have taken.

Excess fluid may accumulate in the lungs (pulmonary edema) causing breathing difficulties that may develop up to 24-48 hours after ingestion.

If you forget to take Amlodipino/Atorvastatina Normon

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

Do not take a double dose to compensate for missed doses.

If you interrupt treatment with Amlodipino/Atorvastatina Normon

Do not stop taking Amlodipino/Atorvastatina Normon unless your doctor tells you to. If you have any other doubts about the use of this medication or want to interrupt treatment, ask your doctor or pharmacist.

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

If any of the following occur, stop taking Amlodipino/Atorvastatina Normon and inform your doctor immediately:

• Swelling of the face, tongue, and airways that may cause severe difficulty breathing.
• Lupus-like syndrome (including skin rash, joint disorders, and effects on blood cells).
• If you experience 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 be a potentially life-threatening disease called rhabdomyolysis).

Very common side effects (may affect more than 1 in 10 people):

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

Common side effects (may affect up to 1 in 10 people):

• Allergic reaction
• Headache (especially at the beginning of treatment), dizziness, feeling of fatigue, drowsiness
• Irregular heartbeat, flushing
• Palpitations (abnormal sensation of heartbeats), difficulty breathing
• Runny nose, sore throat, nasal bleeding
• Feeling unwell, abdominal pain, indigestion, change in bowel habits (including diarrhea, constipation, and flatulence)
• Muscle and joint pain, cramps, and spasms, back pain, limb pain, muscle fatigue
• Increased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), increased creatine kinase in blood, abnormal liver function test results
• Visual disturbances (including double vision), blurred vision

Rare side effects (may affect up to 1 in 100 people):

• Heptatitis (liver inflammation)
• Sneezing, loss of appetite, decreased blood sugar levels (if you have diabetes, continue to monitor your blood sugar levels carefully), weight gain or loss
• Difficulty sleeping, nightmares, mood changes (including anxiety), depression, tremors, sensory nerve damage (decreased sensitivity) of arms and legs, memory loss
• Tinnitus or buzzing in the ears, weakness, increased sweating, low blood pressure
• Dry mouth, altered taste, vomiting, belching
• Hair loss, bruises or small spots on the skin, skin discoloration, decreased skin sensitivity to touch or pain, numbness or tingling in fingers and toes, skin rash, urticaria or itching
• Urinary disorders (including nocturia and increased urination frequency), impotence, abnormal breast development in men
• Feeling unwell, muscle fatigue, pancreatitis (inflammation of the pancreas that causes abdominal pain), pain, neck pain, chest pain
• Positive urine tests for white blood cells in the blood.
• Abnormal heart rhythm
• Cough

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

• Allergic reaction - symptoms may include sudden wheezing, chest pain or tightness, swelling of eyelids, face, lips, mouth, tongue, or throat, difficulty breathing, collapse
• Gynecomastia (breast enlargement in men)
• Reduced white blood cell count in blood
• Muscle stiffness or rigidity
• Heart attack, inflammation of small blood vessels, stomach pain (gastritis)
• Encystment of the gums
• Loss of hearing, liver insufficiency

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

Side effects of unknown frequency:

• Constant muscle weakness
• Myasthenia gravis (a disease that causes generalized muscle weakness, which in some cases affects the muscles used for breathing).
• Myasthenia ocular (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, eyelid drooping, difficulty swallowing, or difficulty breathing.

Other possible side effects:

• Sexual dysfunction
• Depression
• Respiratory problems, including persistent cough and/or difficulty breathing or fever
• Movement disorders, including rigidity, tremors, and/or movement disorders
• Diabetes. It is more likely if you have high blood sugar and fat levels, obesity, and high blood pressure. Your doctor will monitor you while taking this medication.

Seek medical attention immediately if you experience any of the following side effects after taking this medication:

Severe skin reactions that include intense skin rash, blisters, widespread skin redness, intense itching, blistering, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:http://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Do not use this medication 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 disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

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The active principles 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, polisorbate 80, hydroxypropyl cellulose, anhydrous colloidal silica, magnesium stearate, indigotin lacquer (E-132), and opadry II white 85F18422 (which contains polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, and talc).

Appearance of the product and contents of the packaging

Amlodipine/Atorvastatina Normon 10 mg/10 mg are blue-coated tablets, round, biconvex, and marked with “10/10” on one face.

Each package contains 28 tablets

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

C/ Ronda de Valdecarrizo, 6

28760 Tres Cantos, Madrid

Spain

Other presentations

Amlodipine/Atorvastatina Normon 5 mg/10 mg film-coated tablets.

Last review date of this leaflet: July 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/