AMLODIPINE/VALSARTAN NORMON 5 mg/160 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Amlodipine/Valsartan NORMON 5 mg/160 mg film-coated tablets EFG

amlodipine / valsartan

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

1. What Amlodipine/Valsartan NORMON is and what it is used for

Amlodipine/Valsartan NORMON tablets contain two active substances called amlodipine and valsartan. Both substances help to control high blood pressure.

• Amlodipine belongs to a group of substances called «calcium channel blockers». Amlodipine prevents calcium from entering the blood vessel wall, which prevents the blood vessels from narrowing.
• Valsartan belongs to a group of substances called «angiotensin II receptor antagonists». Angiotensin II is produced by the body and makes the blood vessels narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.

This means that both substances help to prevent the blood vessels from narrowing. As a result, the blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan NORMON is used to treat high blood pressure in adults whose blood pressure is not adequately controlled with amlodipine or valsartan alone.

2. What you need to know before you take Amlodipine/Valsartan NORMON

Do not take Amlodipine/Valsartan NORMON

• if you are allergic to amlodipine or any other calcium channel blocker. This may include itching, redness of the skin, or difficulty breathing.
• if you are allergic to valsartan or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipine/Valsartan NORMON.
• if you have severe liver problems or biliary problems such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant (in any case, it is better to avoid taking this medicine also at the start of your pregnancy, see section Pregnancy).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation where your heart is unable to supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

Do not take Amlodipine/Valsartan and inform your doctor if you are affected by any of the above cases.

Warnings and precautions

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Amlodipine/Valsartan Normon. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipine/Valsartán Normon on your own.

Consult your doctor or pharmacist before starting to take Amlodipine/Valsartan NORMON:

• if you have been ill (with vomiting or diarrhea).
• if you have liver or kidney problems.
• if you have had a kidney transplant or if you have been told that you have narrowing of the arteries to the kidneys.
• if you have a disease that affects the adrenal glands called «primary hyperaldosteronism».
• If you have had heart failure or have had a heart attack. Follow your doctor's instructions to start the dosage carefully. Your doctor may also check your kidney function.
• if your doctor has informed you that you have narrowing of the heart valves (this is called «aortic or mitral stenosis») or that the thickness of your heart muscle has increased abnormally (this is called «hypertrophic cardiomyopathy»).
• if you have experienced swelling, particularly in the face and throat, while taking other medicines (including ACE inhibitors). If you have these symptoms, stop taking Amlodipine/Valsartan and contact your doctor immediately. You should never take Amlodipine/Valsartán again.
• if you are taking any of the following medicines used to treat high blood pressure:
• • an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may check your kidney function, blood pressure, and electrolyte levels (e.g. potassium) in your blood at regular intervals.

See also the information under the heading “Do not take Amlodipine/Valsartan NORMON”.

Tell your doctor before taking Amlodipine/Valsartan if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipine/Valsartan is not recommended for use in children and adolescents (under 18 years).

Taking Amlodipine/Valsartan NORMON with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to change the dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the medicines listed below:

• an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Amlodipine/Valsartan” and “Warnings and precautions”).
• diuretics (a type of medicine that increases the amount of urine);
• lithium (a medicine used to treat certain types of depression);
• potassium-sparing diuretics, potassium supplements, salt substitutes that contain potassium, and other substances that may increase potassium levels;
• a certain type of pain medication called non-steroidal anti-inflammatory drugs (NSAIDs) or selective cyclooxygenase-2 (COX-2) inhibitors. Your doctor may also check your kidney function;
• antiepileptic agents (e.g. carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• St. John's Wort;
• nitroglycerin and other nitrates, or other substances called «vasodilators»;
• medicines used to treat HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g. ketoconazole, itraconazole);
• medicines used to treat bacterial infections (such as rifampicin, erythromycin, clarithromycin, telithromycin);
• verapamil, diltiazem (heart medicines);
• simvastatin (a medicine used to control high cholesterol levels);
• dantrolene (in infusion for severe body temperature abnormalities);
• medicines used to protect against rejection in a transplant (cyclosporine).

Taking Amlodipine/Valsartan NORMON with food and drinks

People taking Amlodipine/Valsartan should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in the levels of the active substance amlodipine in the blood, which can cause an unpredictable increase in the blood pressure-lowering effect of amlodipine/valsartan.

Pregnancy, breast-feeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant.Your doctor will normally advise you to stop taking Amlodipine/Valsartan before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to treat your high blood pressure. Amlodipine/Valsartan is not recommended during the first 3 months of pregnancy and should not be used after the third month of pregnancy as it may cause serious harm to your baby when used after this point.

Breast-feeding

Amlodipine has been shown to pass into breast milk in small amounts. If you are about to start or are already breast-feeding, inform your doctor as Amlodipine/Valsartan is not recommended for use during breast-feeding. Your doctor may decide to prescribe a different treatment, especially if you are breast-feeding a newborn or premature baby.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine may make you feel dizzy, which may affect your ability to concentrate. Therefore, if you are unsure how this medicine will affect you, do not drive, use machines, or perform other activities that require concentration.

3. How to take Amlodipine/Valsartan NORMON

Follow the instructions for administration of this medicine exactly as told by your doctor. If you are unsure, consult your doctor or pharmacist again. This will help you get the best results and reduce the risk of side effects.

The normal dose of Amlodipine/Valsartan NORMON is one tablet per day.

• It is preferable to take the medicine at the same time each day.
• Swallow the tablets with a glass of water.
• You can take Amlodipine/Valsartan NORMON with or without food. Do not take Amlodipine/Valsartan NORMON with grapefruit or grapefruit juice.

Depending on your response to the treatment, your doctor may suggest a higher or lower dose.

Do not exceed the prescribed dose.

Amlodipine/Valsartan NORMON and elderly patients (65 years or older)

Your doctor should exercise caution when increasing the dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

If you take more Amlodipine/Valsartan NORMON than you should

If you have taken too many tablets of Amlodipine/Valsartan, or if someone else has taken your tablets, contact a doctor immediately.

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

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 Amlodipine/Valsartan NORMON

If you forget to take this medicine, take it as soon as you remember. Then take the next dose at the usual time. However, if it is almost time for the next dose, do not take the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking Amlodipine/Valsartan NORMON

Stopping your treatment with Amlodipine/Valsartan NORMON may cause your illness to worsen. Do not stop taking your medicine unless your doctor tells you to.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention:

A few patients have experienced these serious side effects (may affect up to 1 in 1,000 patients).If you notice any of the following, tell your doctor immediately:

Allergic reaction with symptoms such as skin rash, itching, swelling of the face, lips, or tongue, difficulty breathing, low blood pressure (feeling of fainting, dizziness).

Other possible side effects of Amlodipine/Valsartan:

Common (may affect up to 1 in 10 patients):Flu; stuffy nose, sore throat, and discomfort when swallowing; headache; swelling in the arms, hands, legs, ankles, or feet; fatigue; asthenia (weakness); flushing and warming of the face and/or neck.

Uncommon (may affect up to 1 in 100 patients):Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling, or numbness of the hands or feet; vertigo, rapid heartbeat including palpitations; dizziness when standing up; cough; diarrhea; constipation; skin rash, redness of the skin; joint inflammation, back pain; joint pain.

Rare (may affect up to 1 in 1,000 patients):Feeling of anxiety; ringing in the ears (tinnitus); fainting; increased urine production or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, lightheadedness; excessive sweating; skin rash all over the body, itching, muscle spasms.

Tell your doctor if you are severely affected by any of the cases mentioned.

Side effects reported with amlodipine or valsartan alone and not observed with Amlodipine/Valsartan or observed with a higher frequency than with Amlodipine/Valsartan:

Amlodipine

Consult your doctor immediately if you experience any of the following serious side effects, which are very rare after taking this medicine:

• Sudden wheezing, chest pain, shortness of breath, or difficulty breathing.
• Swelling of the eyelids, face, or lips.
• Swelling of the tongue and throat that causes great difficulty breathing.
• Severe skin reactions including intense skin rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions.

• Heart attack, abnormal heartbeat.
• Pancreatitis that can cause severe abdominal pain and back pain accompanied by a feeling of being very unwell.

The following side effects have been reported. If any of these cause problems or last more than a week, consult your doctor.

Common (may affect up to 1 in 10 patients):Dizziness, drowsiness; palpitations (feeling the heartbeat); flushing, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Uncommon (may affect up to 1 in 100 patients):Changes in mood, anxiety, depression, drowsiness, tremor, changes in taste, fainting, loss of pain sensation; visual disturbances, impaired vision, ringing in the ears; low blood pressure; runny nose/nasal secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (nausea); hair loss, increased sweating, itching of the skin, change in skin color; urinary disorders, increased need to urinate at night, increased number of times urinating; inability to achieve an erection, discomfort or enlargement of the breasts in men, pain, feeling unwell, muscle pain, muscle cramps; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 patients):Decreased number of white blood cells, decreased platelet count that can cause easy bruising or unusual bleeding (damage to red blood cells); high blood sugar (hyperglycemia); gum inflammation, abdominal swelling (gastritis); abnormal liver function, liver inflammation (hepatitis), yellowing of the skin (jaundice), increased liver enzymes that can affect some medical tests; increased muscle tension; inflammation of blood vessels often with skin rash, sensitivity to light; disorders combining stiffness, tremor, and/or movement disorders.

Valsartan

Very rare:

Intestinal angioedema: swelling in the intestine that presents symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (frequency cannot be estimated from the available data):Decreased number of red blood cells, fever, sore throat, or mouth ulcers due to infection; spontaneous bleeding or bruising; high potassium levels in the blood; abnormal liver function test results; decreased kidney function and severely decreased kidney function; swelling, mainly of the face and throat; muscle pain; skin rash, purplish red spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan NORMON

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

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

No special storage conditions are required.

Do not use Amlodipine/Valsartan NORMON if you notice that the packaging is damaged or shows signs of tampering.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medicines at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Amlodipine/Valsartan NORMON

• The active ingredients are: amlodipine (as amlodipine besylate) and valsartan. Each tablet contains 5 mg of amlodipine and 160 mg of valsartan.
• The other ingredients are: microcrystalline cellulose, crospovidone; anhydrous colloidal silica; magnesium stearate; opadry II white 85F18422 (contains: poly(vinyl alcohol), titanium dioxide (E-171), macrogol 4000, and talc), yellow iron oxide (E-172), and red iron oxide (E-172).

Appearance of the Product and Package Contents

Amlodipine/Valsartan NORMON 5 mg/160 mg are prolonged, biconvex tablets, dark yellow in color, marked with "AV5" on one face and anonymous on the other face.

Amlodipine/Valsartan NORMON is available in packages containing 28 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other Presentations

Amlodipine/Valsartan NORMON 10 mg/160 mg film-coated tablets EFG.Date of the last revision of this leaflet: February 2025

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