Label: information for the user

Aproxxamlo 150 mg/5 mg film-coated tablets

Aproxxamlo 150 mg/10 mg film-coated tablets

Aproxxamlo 300 mg/5 mg film-coated tablets

Aproxxamlo 300 mg/10 mg film-coated tablets

irbesartán/amlodipino

Read this label carefully before starting to take this medicine, as it contains important information for you.

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

What is Aproxxamlo

Aproxxamlo contains two active principles: irbesartan and amlodipine.

For what Aproxxamlo is used

Aproxxamlo is used for the treatment ofhigh blood pressurein adult patients who already receive irbesartan and amlodipine in separate tablets.

How Aproxxamlo acts

Irbesartanbelongs to a group of medicines known as “angiotensin II receptor antagonists”. Angiotensin II is a substance produced in the body and causes a contraction of blood vessels, resulting in an increase in blood pressure. Irbesartan acts by blocking the effect of angiotensin-II, relaxing blood vessels and reducing blood pressure.

Amlodipinebelongs to a group of medicines known as “calcium antagonists”. Amlodipine prevents calcium from passing into the walls of blood vessels, causing blood vessels to relax, which in turn reduces blood pressure.

This means that both active principles contribute to preventing blood vessels from constricting. As a result, blood vessels relax and blood pressure decreases.

Do not take Aproxxamlo

• if you are allergic to irbesartan, amlodipine, any other calcium channel blocker, or any of the other ingredients of this medication (listed in section 6).
• if you have aortic stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to your body).
• if you have heart failure after a heart attack.
• if you have very low blood pressure (hypotension).
• if you aremore than 3 months pregnant (see “Pregnancy and breastfeeding” in section 2).
• if you have diabetes or kidney problems and are being treated with a blood pressure medication that contains aliskiren.

Warnings and precautions

Consult your doctor before starting to take Aproxxamlo if you have any of the following conditions:

• excessive vomiting or diarrhea – this can cause extreme loss of fluid and/or salt in your body
• severe liver dysfunction
• kidney problems
• narrowing or obstruction of blood vessels
• heart problems
• diabetic nephropathy
• if you are taking any of the following medications to treat high blood pressure (hypertension):
• 1. a converting enzyme inhibitor (ACE inhibitor) - for example, enalapril, lisinopril, ramipril - particularly if you have kidney problems related to diabetes
  2. aliskiren

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

• severe increase in blood pressure (hypertensive crisis)
• if you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, tremors, headache, flushing or pallor, numbness, rapid and strong heartbeats), especially if you are being treated for diabetes.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Aproxxamlo. Your doctor will decide whether to continue treatment. Do not stop taking Aproxxamlo in monotherapy.

If you are pregnant or think you may be, inform your doctor. Aproxxamlo is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause serious harm to your baby (see “Pregnancy and breastfeeding” in section 2).

See also the information in “Do not take Aproxxamlo” in section 2.

Children and adolescents

This medication should not be used in children and adolescents under 18 years of age, as its safety and efficacy have not been fully established.

Other medications and Aproxxamlo

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

Aproxxamlomay affect or be affected by other medications, such as:

• converting enzyme inhibitors (ACE inhibitors) or aliskiren(see also “Do not take Aproxxamlo” and “Warnings and precautions”)
• diuretics - this includes potassium-sparing diuretics (also known as “water pills” that increase urine production), or have a restricted salt intake that leads to extreme loss of fluids and salt in your body
• potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels
• lithium - a medication used to treat certain types of depression
• some types of analgesics or anti-inflammatory medications known as “nonsteroidal anti-inflammatory drugs” (NSAIDs) or “selective cyclooxygenase-2 inhibitors” (COX-2 inhibitors) - as this may cause progressive worsening of kidney function
• anticonvulsant agents (medications used to treat epilepsy) - such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• St. John's Wort- also known as “Hypericum perforatum”. It is a medicinal herb used to treat depression
• nitroglycerin and other nitrates, or other medications called “vasodilators” (medications that promote the dilation of blood vessels)
• medications used to treat HIV/AIDS - such as ritonavir, indinavir, nelfinavir
• medications used to treat fungal infections - such as ketoconazole, itraconazole
• medications used to treat bacterial infections - such as rifampicin, erythromycin, clarithromycin
• medications for the heart - such as verapamil, diltiazem
• medication used to control high cholesterol levels(simvastatin)
• dantrolene in infusion - a medication used to treat rare reactions to anesthesia in which the body temperature increases extremely quickly(malignant hyperthermia)
• medications used to prevent rejection after a transplant (ciclosporin)
• medications used to modify the functioning of the immune system - such as tacrolimus, sirolimus, temsirolimus, and everolimus.
• repaglinide (a medication used to reduce blood sugar levels).

Taking Aproxxamlo with food anddrinks

Aproxxamlo can be taken with or without food.

People taking Aproxxamlo should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may cause an increase in blood levels of the active ingredient amlodipine, which may cause unpredictable lowering of blood pressure.

Pregnancy and breastfeeding

Pregnancy

Do not take Aproxxamlo if you are pregnant.

Inform your doctor if you think you may be pregnant, or are planning to become pregnant. Your doctor will usually advise you to stop taking Aproxxamlo and recommend an alternative antihypertensive medication.Aproxxamlo is not recommended for use at the beginning 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.

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Breastfeeding

Inform your doctor if you are planning to start or are breastfeeding, as Aproxxamlo is not recommended for use during this period.Your doctor will usually advise you to stop taking Aproxxamlo before and during breastfeeding and recommend an alternative antihypertensive medication, especially if your baby is newborn or premature.

Driving and operating machinery

Aproxxamlo may affect your ability to drive or operate machinery. If the tablets make you feel sick, dizzy, tired, or give you a headache, do not drive or operate machinery and consult your doctor immediately.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this 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.

Your doctor will decide on the appropriate dose of Aproxxamlo based on your condition and if you are taking other medications.

It is essential to continue taking Aproxxamlo for the time your doctor prescribes it to maintain precise control of your blood pressure.

Administration Method

Aproxxamlo is administered orally.

The recommended dose is one tablet once a day.You should try to take your daily dose at the same time every day.

Tablets should be swallowed with a sufficient amount of liquid, such as a glass of water. Do not take Aproxxamlo with grapefruit or grapefruit juice.

Aproxxamlo can be taken with or without food.

Use in Children and Adolescents

Aproxxamlo should not be administered to children and adolescents under 18 years of age.

If You Take More Aproxxamlo Than You Should

If you accidentally take too many tablets, contact your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. The symptoms of overdose are low blood pressure, increased heart rate, and possible decreased heart rate.

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

If You Forget to TakeAproxxamlo

If you accidentally forget to take a dose, simply take your regular dose when it is next due.Do not take a double dose to compensate for missed doses.

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

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

Severe side effects

Stop taking Aproxxamlo and contact your doctor immediately or go to the nearest hospital's Emergency Department if you experience any of the following severe side effects:

• Severe allergic reactions - with symptoms such as skin rash, itching, swelling of the face, lips, mouth, or throat that may cause difficulty swallowing or breathing, anaphylactic shock(unknown frequency)
• Severe skin reactions - including intense skin rash, blisters, skin redness all over the body, severe itching, blistering, peeling, and skin inflammation, mucous membrane inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis)(unknown frequency)
• Heart attack(may affect up to 1 in 10,000 people)
• Pancreatitis - which may cause severe abdominal pain and back pain accompanied by a great sense of discomfort(may affect up to 1 in 10,000 people)

Other side effects

The following side effects have been reported with irbesartan and/or amlodipine:

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

• If you have high blood pressure and type 2 diabetes with kidney disease, blood tests may show an increase in potassium levels
• Edema (fluid retention)

Common(may affect up to 1 in 10 people)

• Dizziness, dizziness when standing up, headache, fatigue, weakness, drowsiness
• Visual disturbances (including double vision)
• Blood tests may show elevated levels of an enzyme that measures muscle damage (creatine phosphokinase)
• Fast or irregular heartbeats
• Redness and warmth in the face and/or neck
• Shortness of breath or difficulty breathing
• Abdominal pain, feeling of discomfort or nausea
• Alteration of bowel habits, diarrhea, constipation, indigestion
• Muscle cramps.

Uncommon(may affect up to 1 in 100 people)

• Changes in mood, depression, anxiety, insomnia
• Tremor, taste disturbances, fainting
• Numbness or tingling in the hands or feet, loss of pain sensation
• Tinnitus
• Decreased blood pressure
• Runny nose or nasal secretion caused by inflammation of the nasal mucosa (rhinitis)
• Cough
• Dry mouth
• Hair loss, increased sweating
• Itching, red patches on the skin, skin discoloration, skin rash
• Muscle or joint pain, back pain
• Urinary disorders, increased need to urinate at night, increased frequency of urination
• Yellowing of the skin (jaundice)
• Impotence, discomfort or breast tenderness in men, sexual dysfunction
• Pain, chest pain, feeling of discomfort
• Weight gain or loss.

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

• Confusion.
• Intestinal angioedema: swelling in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• Decreased white blood cell count, decreased platelet count that may cause easy bleeding or unusual bruising
• Hyperglycemia (high blood sugar)
• Gingivitis (inflammation of the gums)
• Abdominal distension (gastritis)
• Abnormal liver function, hepatitis (inflammation of the liver), elevated liver enzymes that may affect some medical tests
• Unusual muscle stiffness
• Numbness or weakness of arms and legs
• Inflammation of blood vessels, often with skin eruptions
• Light sensitivity.

Unknown(frequency cannot be estimated from available data)

• Renal function alteration
• Severe skin reactions that start with red, painful areas, then with large blisters, and end with peeling of the skin's layers. This is accompanied by fever and chills, muscle pain, and general discomfort
• Decreased red blood cell count (anemia - symptoms may include fatigue, headaches, difficulty breathing when exercising, dizziness, and paleness)
• Low blood sugar levels.
• Tremor, rigid posture, mask-like face, slow movements, and walking with feet dragging and unbalanced.

If any of the aforementioned side effects severely affect you, inform your doctor.

Reporting 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://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 and blister, after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Medications should not be disposed of through drains or trash. Dispose of 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 packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Aproxxamlo

The active principles are irbesartan and amlodipine.

• Each film-coated tablet of Aproxxamlo 150 mg/5 mg contains 150 mg of irbesartan and 5 mg of amlodipine (as amlodipine besilate).
• Each film-coated tablet of Aproxxamlo 300 mg/10 mg contains 300 mg of irbesartan and 10 mg of amlodipine (as amlodipine besilate).
• The other components are:
• Core:sodium croscarmellose, hypromellose, magnesium stearate, microcrystalline cellulose, and anhydrous colloidal silica.
• Coating:hypromellose, macrogol, and titanium dioxide (E171).
• Each film-coated tablet of Aproxxamlo 150 mg/10 mg contains 150 mg of irbesartan and 10 mg of amlodipine (as amlodipine besilate).
• The other components are:
• Core:sodium croscarmellose, hypromellose, magnesium stearate, microcrystalline cellulose, and anhydrous colloidal silica.
• Coating:hypromellose, macrogol, titanium dioxide (E171), and iron oxide red (E172).

• Each film-coated tablet of Aproxxamlo 300 mg/5 mg contains 300 mg of irbesartan and 5 mg of amlodipine (as amlodipine besilate).
• The other components are:
• Core:sodium croscarmellose, hypromellose, magnesium stearate, microcrystalline cellulose, and anhydrous colloidal silica.
• Coating:hypromellose, macrogol, titanium dioxide (E171), and iron oxide yellow (E172).

Appearance of the product and contents of the package

The film-coated tablets of Aproxxamlo 150 mg/5 mg are white, oval-shaped, and marked with “150/5” on one face.

The film-coated tablets of Aproxxamlo 150 mg/10 mg are pink, oval-shaped, and marked with “150/10” on one face.

The film-coated tablets of Aproxxamlo 300 mg/5 mg are yellow, oval-shaped, and marked with “300/5” on one face.

The film-coated tablets of Aproxxamlo 300 mg/10 mg are white, oval-shaped, and scored on one face.

The Aproxxamlo tablets are presented in blister packs of 15, 28, 30, 90, and 98 film-coated tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Responsible for manufacturing

S.C. Zentiva, S.A.

B-dul Theodor Pallady nr. 50, sector 3

032266 Bucharest

Romania

or

Sanofi Winthrop Industrie

30-36 Avenue Gustave Eiffel

37100 Tours

France

This medicinal product is authorized in the Member States of the European Economic Area with the following names

Spain: APROXXAMLO 150 mg/5 mg film-coated tablets; APROXXAMLO 150 mg/ 10 mg film-coated tablets; APROXXAMLO 300 mg/5 mg film-coated tablets; APROXXAMLO 300 mg/10 mg film-coated tablets

Greece, Italy, Portugal: APROXXAMLO

Belgium, Luxembourg: Aprexevo 150 mg/5 mg filmomhulde tabletten – comprimés pelliculés – Filmtabletten; Aprexevo 150 mg/10 mg filmomhulde tabletten – comprimés pelliculés – Filmtabletten; Aprexevo 300 mg/5 mg filmomhulde tabletten – comprimés pelliculés – Filmtabletten; Aprexevo 300 mg/10 mg filmomhulde tabletten – comprimés pelliculés – Filmtabletten

France, Romania: APREXEVO

Last review date of this leaflet: December 2024

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