Package Leaflet: Information for the User

Amlodipino/Valsartán NORMON 10 mg/160 mg Film-Coated Tablets EFG

amlodipino / valsartán

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. See section 4.

Amlodipino/Valsartán NORMON tablets contain two substances called amlodipine and valsartan. Both substances help 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 blood vessel constriction.
• Valsartan belongs to a group of substances called "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to constrict, thereby increasing blood pressure. Valsartan acts by blocking the effect of angiotensin II.

This means that both substances help prevent blood vessel constriction. As a result, blood vessels relax and blood pressure decreases.

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

Do not take Amlodipino/Valsartán NORMON

• if you are allergic to amlodipino or any other calcium channel blocker. This may include symptoms such as itching, skin redness, or difficulty breathing.
• if you are allergic to valsartán or any of the other components of this medication (including those listed in section 6). If you think you may be allergic, inform your doctor before taking Amlodipino/Valsartán NORMON.
• if you have severe liver problems or bile duct problems such as biliary cirrhosis or cholestasis.
• if you are more than 3 months pregnant (in any case, it is best to avoid taking this medication also at the beginning of your pregnancy, see Pregnancy section).
• if you have a severe decrease in blood pressure (hypotension).
• if you have a narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a situation in which your heart cannot supply enough blood to your body).
• if you have heart failure after a heart attack.
• if you have diabetes or kidney failure and are being treated with a medication that lowers blood pressure that contains aliskiren.

Do not take Amlodipino/Valsartán 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 Amlodipino/Valsartán Normon. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipino/Valsartán Normon in monotherapy.

Consult your doctor or pharmacist before starting to take Amlodipino/Valsartán NORMON:

• if you have been ill (with vomiting or diarrhea).
• if you have liver or kidney problems.
• if you have undergone a kidney transplant or if you have been told that you have a narrowing of the kidney arteries.
• 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 treatment carefully. Your doctor may also check your kidney function.
• if your doctor has told you that you have a narrowing of the heart valves (known as "aortic or mitral stenosis") or that the thickness of your heart muscle has increased abnormally (known as "hypertrophic obstructive cardiomyopathy").
• if you have experienced swelling, particularly in the face and throat, while taking other medications (including ACE inhibitors). If you have these symptoms, stop taking Amlodipino/Valsartán and contact your doctor immediately. You should never take Amlodipino/Valsartán again.
• if you are taking any of the following medications used to treat high blood pressure:
• • an ACE inhibitor (such as enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

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

See also the information under the heading “Do not take Amlodipino/Valsartán NORMON”.

Inform your doctor before taking Amlodipino/Valsartán if you are affected by any of the cases mentioned.

Children and adolescents

Amlodipino/Valsartán is not recommended for use in children or adolescents (under 18 years).

Taking Amlodipino/Valsartán NORMON with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. 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 medications. This applies especially to the medications listed below:

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

Taking Amlodipino/Valsartán NORMON with food and drinks

People taking Amlodipino/Valsartán should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in the blood levels of the active ingredient amlodipino, which may lead to an unpredictable increase in the blood pressure-lowering effect of amlodipino/valsartán.

Pregnancy, breastfeeding, and fertility

Pregnancy

You should inform your doctor if you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant.If you are pregnant, your doctor will advise you to stop taking Amlodipino/Valsartán before becoming pregnant or as soon as you become pregnant, and will recommend taking another antihypertensive medication instead. Amlodipino/Valsartán is not recommended for use during the first 3 months of pregnancy and should not be administered after the third month of pregnancy as it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Amlodipino has been shown to pass into breast milk in small amounts. Inform your doctor ifyou are planning to start or are breastfeedingas Amlodipino/Valsartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of Amlodipino/Valsartán NORMON is one tablet per day.

• It is preferable to take the medication at the same time every day.
• Swallow the tablets with a glass of water.
• You can take Amlodipino/Valsartán NORMON with or without food. Do not take Amlodipino/Valsartán NORMON with grapefruit or grapefruit juice.

Your doctor may suggest a higher or lower dose depending on your response to treatment.

Do not exceed the prescribed dose.

Amlodipino/Valsartán NORMON and Older Adults (65 years or older)

Your doctor should exercise caution when increasing the dose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

If You Take More Amlodipino/Valsartán NORMON Than You Should

If you have taken too many tablets of Amlodipino/Valsartán, or if someone else has taken your tablets, consult your doctor immediately.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If You Forget to Take Amlodipino/Valsartán NORMON

If you forget to take this medication, 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 the missed doses.

If You Interrupt Treatment with Amlodipino/Valsartán NORMON

Stopping your treatment with Amlodipino/Valsartán NORMON may cause your condition to worsen. Do not stop taking your medication unless your doctor tells you to.

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

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

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

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

Other possible side effects of Amlodipino/Valsartán:

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

Infrequent (may affect up to 1 in 100 patients):Dizziness; nausea and abdominal pain; dry mouth; drowsiness, tingling, or numbness in 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 anxious; ringing in the ears (tinnitus); fainting; increased urine output or urgent need to urinate; inability to achieve or maintain an erection; feeling of heaviness; low blood pressure with symptoms such as dizziness, fainting; excessive sweating; skin rash all over the body, itching, muscle spasms.

Notify your doctor if any of the mentioned cases severely affect you.

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

Amlodipino

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

• Sudden hissing sounds while breathing (sibilant breathing), 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 that include intense skin rash, blisters, redness of the skin all over the body, severe itching, blistering, peeling, and inflammation of the skin, inflammation of 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 great discomfort.

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

Frequent (may affect up to 1 in 10 patients):Dizziness, somnolence; palpitations (feeling the heartbeat); hot flashes, swelling of the ankles (edema); abdominal pain, feeling unwell (nausea).

Infrequent (may affect up to 1 in 100 patients):Mood changes, anxiety, depression, somnolence, tremor, altered taste, fainting, loss of pain sensation; visual disturbances, visual deterioration, ringing in the ears; decreased blood pressure; nasal congestion or secretion caused by inflammation of the nasal mucosa (rhinitis); indigestion, vomiting (discomfort); hair loss, increased sweating, itching skin, skin discoloration; urinary disorders, increased need to urinate at night, increased frequency of urination; inability to achieve an erection, discomfort or breast enlargement in men, pain, feeling unwell, muscle pain, muscle cramps; weight gain or loss.

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

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

Valsartán

Very rare:

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

Unknown frequency (frequency cannot be estimated from available data):Decreased red blood cell count, fever, sore throat or ulcers in the mouth due to infection; spontaneous skin bleeding or hematomas; increased potassium 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, red-purple spots; fever; itching; allergic reaction, blistering skin disease (sign of a disease called bullous dermatitis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

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.

No special storage conditions are required.

Do not use Amlodipino/Valsartán NORMON if you observe that the packaging is damaged or shows signs of manipulation.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Amlodipino/Valsartán NORMON

• The active principles are: amlodipine (as amlodipine besilate) and valsartan. Each tablet contains 10 mg of amlodipine and 160 mg of valsartan.
• The other components 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 contents of the packaging

Amlodipino/Valsartán NORMON 10 mg/160 mg are elongated, biconvex, light yellow tablets, marked with «AV10» on one face and blank on the other face.

Amlodipino/Valsartán NORMON is available in packaging containing 28 tablets.

Holder of the marketing authorization and responsible for manufacturing

LABORATORIOS NORMON, S.A.

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

Other presentations

Amlodipino/Valsartán NORMON 5 mg/160 mg film-coated tablets.

Last review date of this leaflet: February 2025

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Medical Deviceshttp://www.aemps.gob.es