Amlodipine/valsartan/hydrochlorothiazide Normon 10 mg/160 mg/12.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Amlodipine/Valsartan/Hydrochlorothiazide NORMON 10 mg/160 mg/12.5 mg film-coated tablets EFG

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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

Amlodipine/Valsartan/Hydrochlorothiazide NORMON tablets contain three substances called amlodipine, valsartan, and hydrochlorothiazide. All of these substances help control high blood pressure.

• Amlodipine belongs to a group of substances known as "calcium channel blockers". Amlodipine prevents calcium from entering the blood vessel wall, thereby preventing blood vessels from narrowing.
• Valsartan belongs to a group of substances known as "angiotensin II receptor antagonists". Angiotensin II is produced by the body and causes blood vessels to narrow, thereby increasing blood pressure. Valsartan works by blocking the effect of angiotensin II.
• Hydrochlorothiazide belongs to a group of substances known as "thiazide diuretics". Hydrochlorothiazide increases urine production, which also lowers blood pressure.

As a result of these three mechanisms, blood vessels relax and blood pressure decreases.

Amlodipine/Valsartan/Hydrochlorothiazide NORMON is used to treat high blood pressure in adult patients whose blood pressure is already controlled while taking amlodipine, valsartan, and hydrochlorothiazide, and who may benefit from taking a single tablet containing the three substances.

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

Do not take Amlodipine/Valsartan/Hydrochlorothiazide NORMON

• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON also during early pregnancy – see Pregnancy section).
• if you are allergic to amlodipine or any other calcium channel blocker, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary tract infections), or to any of the other ingredients of this medicine (listed in section 6).

If you think you may be allergic, do not take Amlodipine/Valsartan/Hydrochlorothiazide NORMON and inform your doctor.

• if you have liver disease, destruction of the small bile ducts within the liver (primary biliary cirrhosis) leading to bile accumulation in the liver (cholestasis).
• if you have severe kidney problems or are undergoing dialysis.
• if you are unable to urinate (anuria).
• if your blood potassium or sodium levels are too low despite treatment to increase potassium or sodium levels in the blood.
• if your blood calcium levels are too high despite treatment to reduce blood calcium levels.
• if you have gout (uric acid crystals in the joints).
• if you have severe low blood pressure (hypotension).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart cannot supply enough blood to the body).
• if you have heart failure following a heart attack.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

Do not take Amlodipine/Valsartan/Hydrochlorothiazide NORMON and inform your doctor if any of the above conditions apply to you.

Warnings and precautions

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON without medical advice.

Talk to your doctor or pharmacist before taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON

• if you have low levels of potassium or magnesium in your blood (with or without symptoms such as muscle weakness, muscle cramps, irregular heartbeat).
• if you have low levels of sodium in your blood (with or without symptoms such as fatigue, confusion, muscle twitching, seizures).
• if you have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle twitching, and muscle weakness).
• if you have kidney problems, have had a kidney transplant, or have been told you have narrowing of the kidney arteries.
• if you have liver problems.
• if you have or have had heart failure or coronary artery disease, especially if you have been prescribed the maximum dose of this medicine (10 mg/320 mg/25 mg).
• if you have had a heart attack. Follow your doctor’s instructions for carefully initiating dosing. Your doctor may also monitor your kidney function.
• if your doctor has informed you that you have narrowing of the heart valves (called “aortic or mitral stenosis”) or abnormal thickening of your heart muscle (called “obstructive hypertrophic cardiomyopathy”).
• if you have aldosteronism. A condition in which the adrenal glands produce too much aldosterone hormone. In this case, use of Amlodipine/Valsartan/Hydrochlorothiazide NORMON is not recommended.
• if you have a disease called systemic lupus erythematosus (also known as “lupus” or “SLE”).
• if you have diabetes (high blood sugar).
• if you have high cholesterol or triglyceride levels in your blood.
• if you experience skin reactions such as rash after sun exposure.
• if you have had an allergic reaction to other high blood pressure medicines or diuretics, especially if you have asthma and allergies.
• if you have been ill (with vomiting or diarrhea).
• if you experience swelling, particularly in the face and throat, while taking other medicines (including angiotensin-converting enzyme inhibitors). If you have these symptoms, stop taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON and contact your doctor immediately. You must never take this medicine again.
• if you experience dizziness and/or fainting during treatment with Amlodipine/Valsartan/Hydrochlorothiazide, inform your doctor as soon as possible.
• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased intraocular pressure, which can occur within hours to a week after taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON. If untreated, this may lead to permanent vision loss.
• if you are taking any of the following medicines for high blood pressure:
  • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• if you have had skin cancer or develop an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially long-term use at high doses, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. Protect your skin from sun and UV exposure while taking this medicine.
• if you have had respiratory or lung problems (such as inflammation or fluid in the lungs) after taking hydrochlorothiazide in the past. If you develop shortness of breath or severe difficulty breathing after taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON, seek medical help immediately.

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

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

Inform your doctor if any of the above conditions apply to you.

Children and adolescents

The use of Amlodipine/Valsartan/Hydrochlorothiazide NORMON is not recommended in children and adolescents under 18 years of age.

Elderly people (65 years and older)

Amlodipine/Valsartan/Hydrochlorothiazide NORMON can be used in people aged 65 years and older at the same dose as in other adults and in the same way as they have previously taken the three active substances amlodipine, valsartan, and hydrochlorothiazide. Blood pressure should be monitored periodically in elderly patients, especially those taking the maximum dose (10 mg/320 mg/25 mg).

Other medicines and Amlodipine/Valsartan/Hydrochlorothiazide NORMON

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important if you are taking any of the following:

Do not take together with:

• lithium (a medicine used to treat certain types of depression);
• medicines or substances that may increase blood potassium levels. These include potassium supplements or potassium-containing salt substitutes, potassium-sparing medicines, and heparin;
• an ACE inhibitor or aliskiren (see also information under the headings “Do not take Amlodipine/Valsartan/Hydrochlorothiazide NORMON” and “Warnings and precautions”).

Should be used with caution with:

• alcohol, sleeping pills, and anesthetics (medicines for patients undergoing surgery or other procedures);
• amantadine (used to treat Parkinson’s disease, also used to treat or prevent certain viral illnesses);
• anticholinergic medicines (used to treat various disorders such as gastrointestinal cramps, urinary bladder spasms, asthma, motion sickness, muscle spasms, Parkinson’s disease, and as an aid in anesthesia);
• anticonvulsants and mood stabilizers used to treat epilepsy and bipolar disorder (e.g., carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone);
• cholestyramine, colestipol, or other resins (substances mainly used to treat high blood lipid levels);
• simvastatin (a medicine used to control high cholesterol);
• cyclosporine (a medicine used in organ transplantation to prevent organ rejection or for other conditions, e.g., rheumatoid arthritis or atopic dermatitis);
• cytotoxic medicines (used to treat cancer), such as methotrexate or cyclophosphamide;
• digoxin or other digitalis glycosides (medicines used to treat heart problems);
• verapamil, diltiazem (heart medicines);
• iodinated contrast agents (used in imaging procedures);
• medicines for diabetes (oral medicines such as metformin or insulin);
• medicines to treat gout, such as allopurinol;
• medicines that may increase blood sugar levels (beta-blockers, diazoxide);
• medicines that may cause «torsades de pointes» (irregular heartbeat), such as antiarrhythmics (medicines used to treat heart problems) and some antipsychotics;
• medicines that may reduce blood sodium levels, such as antidepressants, antipsychotics, antiepileptics;
• medicines that may reduce blood potassium levels, such as diuretics (medicines to increase urination), corticosteroids, laxatives, amphotericin, or penicillin G;
• medicines to increase blood pressure, such as adrenaline or noradrenaline;
• medicines used for HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir);
• medicines used to treat fungal infections (e.g., ketoconazole, itraconazole);
• medicines used for esophageal inflammation and ulceration (carbenoxolone);
• medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors;
• muscle relaxants (medicines used to relax muscles during surgery);
• nitroglycerin and other nitrates, or other substances called “vasodilators”;
• other medicines used to treat high blood pressure, including methyldopa;
• rifampicin (used, for example, to treat tuberculosis), erythromycin, clarithromycin (antibiotics);
• St. John’s wort;
• dantrolene (intravenous for severe body temperature abnormalities);
• vitamin D and calcium salts.

Taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON with food, drinks, and alcohol

People prescribed Amlodipine/Valsartan/Hydrochlorothiazide NORMON should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can increase blood levels of the active substance amlodipine, which may cause an unpredictable increase in the blood pressure-lowering effects of this medicine. Consult your doctor before drinking alcohol. Alcohol may greatly lower your blood pressure and/or increase the risk of dizziness or fainting.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. This medicine is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Amlodipine has been shown to pass into breast milk in small amounts. Amlodipine/Valsartan/Hydrochlorothiazide NORMON is not recommended for use in women during this period. Your doctor may decide to prescribe a treatment more suitable for breastfeeding, especially for newborns or premature infants.

Consult your doctor or pharmacist before using any medicine.

Driving and using machines

As with other medicines used to treat high blood pressure, this medicine may make you feel dizzy, drowsy, nauseous, or cause headache. If you experience these symptoms, do not drive or operate tools or machinery.

3. How to take Amlodipine/Valsartan/Hydrochlorothiazide NORMON

Follow exactly the instructions for administration of this medicine given by your doctor. If in doubt, consult your doctor again. This will help you achieve the best results and reduce the risk of adverse effects.

The usual dose of Amlodipine/Valsartan/Hydrochlorothiazide NORMON is one tablet daily.

• It is best to take the tablet at the same time each day. The best time is in the morning.
• Swallow the tablet whole with a glass of water.
• You may take Amlodipine/Valsartan/Hydrochlorothiazide NORMON with or without food. Do not take this medicine with grapefruit or grapefruit juice.

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

Do not exceed the prescribed dose.

If you take more Amlodipine/Valsartan/Hydrochlorothiazide NORMON than you should

If you have accidentally taken too many tablets of Amlodipine/Valsartan/Hydrochlorothiazide NORMON, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone: 91 562 04 20, indicating the medicine and the amount ingested. You may require medical attention.

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

If you forget to take Amlodipine/Valsartan/Hydrochlorothiazide NORMON

If you forget to take a dose of this medicine, take it as soon as you remember, and then take the next dose at the usual time. If it is almost time for the next dose, you should only take the next tablet at the usual time. Do not take a double dose (two tablets at the same time) to make up for a missed dose.

If you stop taking Amlodipine/Valsartan/Hydrochlorothiazide NORMON

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

Always take this medicine, even if you feel well

People with high blood pressure often do not notice any symptoms of their condition. Many feel perfectly well. It is very important that you take this medicine exactly as prescribed by your doctor to achieve the best results and reduce the risk of adverse effects. Keep your appointments with your doctor even if you feel well.

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

4. Possible adverse effects

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

As with any combination containing three active substances, adverse effects associated with each individual component cannot be excluded. The adverse effects observed with Amlodipine/Valsartan/Hydrochlorothiazide or with any of its three active ingredients (amlodipine, valsartan, and hydrochlorothiazide) are listed below and may occur with the use of Amlodipine/Valsartan/Hydrochlorothiazide NORMON.

Some adverse effects may be serious and require immediate medical attention. Contact your doctor immediately if you experience any of the following serious adverse effects after taking this medicine:

Common (may affect up to 1 in 10 patients):

• dizziness
• low blood pressure (feeling faint, dizziness, sudden loss of consciousness)

Uncommon (may affect up to 1 in 100 patients):

• decreased urine production (reduced kidney function)

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

• spontaneous bleeding
• irregular heartbeat
• liver disorder

Very rare (may affect up to 1 in 10,000 patients):

• sudden wheezing (sudden whistling sound when breathing), chest pain, shortness of breath or difficulty breathing
• swelling of the eyelids, face, or lips
• swelling of the tongue and throat causing severe difficulty breathing
• severe skin reactions including severe rash, hives, redness of the skin all over the body, intense itching, blistering, peeling, and skin inflammation, inflammation of mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions
• heart attack
• inflammation of the pancreas which may cause severe abdominal pain and back pain accompanied by a strong feeling of illness
• weakness, bruising, fever, and frequent infections
• stiffness
• acute breathing difficulty (symptoms include severe shortness of breath, fever, weakness, and confusion)

Other adverse effects may include:

Very common (may affect more than 1 in 10 patients)

• low potassium levels in the blood
• increased blood lipids

Common (may affect up to 1 in 10 patients)

• drowsiness
• palpitations (awareness of heartbeat)
• hot flushes
• swelling of the ankles (edema)
• abdominal pain
• stomach discomfort after eating
• fatigue
• headache
• frequent urination
• high uric acid levels in the blood
• low magnesium levels in the blood
• low sodium levels in the blood
• dizziness, dizziness upon standing
• decreased appetite
• nausea and vomiting
• itchy rash and other types of rashes
• inability to achieve or maintain an erection

Uncommon (may affect up to 1 in 100 patients)

• rapid heartbeat
• sensation of everything spinning (vertigo)
• vision disorders
• stomach discomfort
• chest pain
• increased blood urea, creatinine, and uric acid
• high levels of calcium, lipids, or sodium in the blood
• decreased potassium in the blood
• bad breath
• diarrhea
• dry mouth
• weight gain
• loss of appetite
• altered sense of taste
• back pain
• joint swelling
• muscle cramps/weakness/muscle pain
• limb pain
• inability to stand or walk normally
• weakness
• abnormal coordination
• dizziness upon standing or after exercise
• lack of energy
• sleep disturbances
• tingling or numbness
• neuropathy
• sudden transient loss of consciousness
• low blood pressure upon standing
• cough
• shortness of breath
• throat irritation
• excessive sweating
• itching
• swelling, redness, and pain along a vein
• skin redness
• tremor
• mood changes
• anxiety
• depression
• drowsiness
• taste disturbances
• fainting
• loss of pain sensation
• visual disturbances
• visual deterioration
• ringing in the ears
• sneezing/nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• changes in bowel habits
• indigestion
• hair loss
• skin itching
• skin discoloration
• urinary disorders
• increased need to urinate at night
• increased frequency of urination
• discomfort or enlargement of the breasts in men
• pain
• feeling unwell
• weight loss

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

• low platelet count in the blood (sometimes with bleeding or bruising under the skin)
• glucose in the urine
• high blood sugar levels
• worsening of diabetic metabolic state
• abdominal discomfort
• constipation
• liver disorders, which may present with yellowing of the skin and eyes or dark-colored urine (hemolytic anemia)
• increased sensitivity of the skin to sunlight
• purplish spots on the skin
• kidney disorders
• confusion

Very rare (may affect up to 1 in 10,000 patients)

• decreased number of white blood cells
• decreased blood platelets, which may cause unusual bruising or easy bleeding (damage to red blood cells)
• gum inflammation
• abdominal swelling (gastritis)
• liver inflammation (hepatitis)
• yellowing of the skin (jaundice)
• increased liver enzymes, which may affect certain medical tests
• increased muscle tension
• inflammation of blood vessels, often with skin rashes
• light sensitivity
• disorders combining stiffness, tremor, and/or movement disorders
• fever, sore throat, or mouth ulcers, increased frequency of infections (low or very low white blood cell count)
• pale skin, fatigue, shortness of breath, dark urine (hemolytic anemia, abnormal decrease due to rupture of red blood cells in blood vessels and other body parts)
• confusion, fatigue, muscle cramps and spasms, rapid breathing (hypochloremic alkalosis)
• severe upper abdominal pain (pancreatitis)
• difficulty breathing with fever, cough, wheezing, shortness of breath (respiratory distress, pulmonary edema, pneumonitis)
• facial rash, joint pain, muscle disorders, fever (lupus erythematosus)
• inflammation of blood vessels with symptoms such as rash, red-purple spots, fever (vasculitis)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (toxic epidermal necrolysis)
• Intestinal angioedema: swelling in the intestine presenting with symptoms such as abdominal pain, nausea, vomiting, and diarrhea

Frequency not known (frequency cannot be estimated from available data)

• changes in blood test results for kidney function, increased potassium in the blood, low number of red blood cells
• abnormal red blood cell count
• low levels of certain types of white blood cells and platelets in the blood
• increased creatinine in the blood
• abnormal liver function test
• significant decrease in urine production
• inflammation of blood vessels
• weakness, bruising, and frequent infections (aplastic anemia)
• decreased vision or eye pain due to high intraocular pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma)
• shortness of breath
• severe decrease in urine production (possible signs of kidney dysfunction or kidney failure)
• severe skin disease causing rash, red skin, blisters on lips, eyes or mouth, skin peeling, fever (erythema multiforme)
• muscle spasms
• fever (pyrexia)
• blistering skin disease (sign of a condition called bullous dermatitis)
• skin and lip cancer (non-melanoma skin cancer)

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, 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: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Amlodipine/Valsartan/Hydrochlorothiazide 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 and blister (after CAD/EXP). The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Package contents

Composition of Amlodipine/Valsartan/Hydrochlorothiazide NORMON

Amlodipine/Valsartan/Hydrochlorothiazide NORMON 10 mg/160 mg/12.5 mg film-coated tablets

The active substances in Amlodipine/Valsartan/Hydrochlorothiazide NORMON are amlodipine (as amlodipine besylate), valsartan, and hydrochlorothiazide. Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.

The other components are microcrystalline cellulose; crospovidone; anhydrous colloidal silica; magnesium stearate; Opadry II White 85F18422 (containing: polyvinyl alcohol, titanium dioxide (E-171), macrogol 4000, and talc); talc; yellow iron oxide (E-172); and red iron oxide (E-172).

Appearance of the product and pack contents

Amlodipine/Valsartan/Hydrochlorothiazide NORMON 10 mg/160 mg/12.5 mg film-coated tablets are biconvex, oval-shaped, light orange tablets with bevelled edges, marked with "AV10" on one side and "H12.5" on the other.

Amlodipine/Valsartan/Hydrochlorothiazide NORMON is available in packaging containing 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent revision of this leaflet: February 2025.

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