Aproxxamlo 300 mg/5 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: 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

irbesartan/amlodipine

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, 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 Aproxxamlo is and what it is used for
2. What you need to know before taking Aproxxamlo
3. How to take Aproxxamlo
4. Possible side effects
5. How to store Aproxxamlo
6. Contents of the pack and other information

1. What Aproxxamlo is and what it is used for

What Aproxxamlo is

Aproxxamlo contains two active substances: irbesartan and amlodipine.

What Aproxxamlo is used for

Aproxxamlo is used to treat high blood pressure in adult patients who are already taking irbesartan and amlodipine as separate tablets.

How Aproxxamlo works

Irbesartan belongs to a group of medicines known as “angiotensin-II receptor antagonists”. Angiotensin-II is a substance produced in the body that causes blood vessels to narrow, resulting in increased blood pressure. Irbesartan works by blocking the effect of angiotensin-II, relaxing blood vessels and thereby lowering blood pressure.

Amlodipine belongs to a group of medicines known as “calcium channel blockers”. Amlodipine prevents calcium from entering the walls of blood vessels, causing the blood vessels to relax, which in turn reduces blood pressure.

This means that both active substances help prevent blood vessels from constricting. As a result, blood vessels relax and blood pressure decreases.

2. What you need to know before taking Aproxxamlo

Do not take Aproxxamlo

• if you are allergic to irbesartan, amlodipine, any other calcium antagonist, or any of the other components of this medicine (listed in section 6).
• if you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart is unable to pump enough blood to the body).
• if you have heart failure following a heart attack.
• if you have very low blood pressure (hypotension).
• if you are more 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-lowering medicine containing aliskiren.

Warnings and precautions

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

• severe vomiting or diarrhoea – this may cause a significant loss of fluid and/or salt in your body
• severe impairment of liver function
• kidney problems
• narrowing or blockage of blood vessels
• heart problems
• diabetic kidney disease
• if you are taking any of the following medicines to treat high blood pressure (hypertension):
  1. an angiotensin-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 blood electrolyte levels (e.g. potassium) at regular intervals.

• signs of severe high blood pressure (hypertensive crisis)
• if you experience low blood sugar levels (symptoms may include sweating, weakness, hunger, dizziness, trembling, headache, flushing or paleness, numbness, rapid and strong heartbeat), especially if you are being treated for diabetes.

Talk to your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Aproxxamlo. Your doctor will decide whether to continue treatment. Do not stop taking Aproxxamlo used as monotherapy.

If you are pregnant or think you might be pregnant, you must inform your doctor. Use of Aproxxamlo is not recommended during early pregnancy and must not be used 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 under “Do not take Aproxxamlo” in section 2.

Children and adolescents

This medicine must not be used in children and adolescents under 18 years of age, as safety and efficacy have not yet been fully established.

Other medicines and Aproxxamlo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Aproxxamlo may affect, or be affected by, other medicines, such as:

• angiotensin-converting enzyme inhibitors (ACE inhibitors) or aliskiren (see also “Do not take Aproxxamlo” and “Warnings and precautions”)
• diuretics – including potassium-sparing diuretics (also called “water tablets” that increase urine production), or if you have restricted salt intake leading to significant loss of fluid and salt from your body
• potassium supplements, salt substitutes containing potassium, and other substances that may increase potassium levels
• lithium – a medicine used to treat certain types of depression
• certain types of painkillers or medicines that reduce inflammation known as “non-steroidal anti-inflammatory drugs” (NSAIDs) or “selective cyclooxygenase-2 inhibitors” (COX-2 inhibitors) – as these may cause progressive worsening of kidney function
• anticonvulsant agents (medicines used for epilepsy) – such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• St John’s wort – also called “Hypericum perforatum”. It is a herbal remedy used for depression
• nitroglycerin and other nitrates, or other medicines called “vasodilators” (medicines that promote blood vessel dilation)
• medicines used for HIV/AIDS – such as ritonavir, indinavir, nelfinavir
• medicines used to treat fungal infections – such as ketoconazole, itraconazole
• medicines used to treat bacterial infections – such as rifampicin, erythromycin, clarithromycin
• heart medicines – such as verapamil, diltiazem
• medicine used to control high cholesterol (simvastatin)
• intravenous dantrolene – a medicine used to treat rare reactions to anaesthesia in which body temperature rises extremely rapidly (malignant hyperthermia)
• medicines used to prevent transplant rejection (cyclosporine)
• medicines used to modify immune system function – such as tacrolimus, sirolimus, temsirolimus, and everolimus
• repaglinide (a medicine used to reduce blood sugar levels)

Taking Aproxxamlo with food and drink

Aproxxamlo can be taken with or without food.

People taking Aproxxamlo must not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could cause an unpredictable reduction in 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 another antihypertensive medicine instead. Aproxxamlo is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when used from that time onward.

If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as Aproxxamlo is not recommended for women during this period. Your doctor will usually advise you to stop taking Aproxxamlo before and during breastfeeding and recommend another antihypertensive medicine instead, especially if your baby is a newborn or premature.

Driving and use of machines

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

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

3. How to take Aproxxamlo

Follow exactly the instructions for using this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Your doctor will decide the appropriate dose of Aproxxamlo depending on your condition and whether you are taking other medicines.

It is important to keep taking Aproxxamlo for as long as your doctor has prescribed it, in order to maintain accurate control of your blood pressure.

Method of administration

Aproxxamlo is administered orally.

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

The 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 must not be given 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 Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested. Symptoms of overdose include low blood pressure, increased heart rate, and possibly decreased heart rate.

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 Aproxxamlo

If you accidentally miss a dose, simply take your next scheduled dose at the usual time. Do not take a double dose to make up for the missed dose.

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 everybody gets them.

Serious adverse effects

Stop taking Aproxxamlo and contact your doctor immediately or go to the nearest hospital emergency department if you experience any of the following serious adverse effects:

• severe allergic reactions – symptoms such as skin rash, itching, swelling of the face, lips, mouth or throat which may cause difficulty swallowing or breathing, anaphylactic shock (frequency not known)
• serious skin reactions – including severe skin rash, hives, 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) (frequency not known)
• heart attack (may affect up to 1 in 10,000 people)
• inflammation of the pancreas – which may cause severe abdominal pain and back pain accompanied by a general feeling of being unwell (may affect up to 1 in 10,000 people)

Other adverse effects

The following adverse 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 increased levels of potassium
• oedema (fluid retention)

Common (may affect up to 1 in 10 people)

• dizziness, dizziness when standing up, headache, tiredness, weakness, sleepiness
• visual disturbances (including double vision)
• blood tests may show elevated levels of an enzyme that measures muscle damage (creatine phosphokinase)
• rapid or irregular heartbeats
• flushing and sensation of warmth in the face and/or neck
• shortness of breath or difficulty breathing
• abdominal pain, feeling unwell or vomiting
• changes in bowel habits, diarrhoea, constipation, indigestion
• muscle cramps

Uncommon (may affect up to 1 in 100 people)

• mood changes, depression, anxiety, insomnia
• tremor, taste disturbances, fainting
• numbness or tingling sensation in hands or feet, loss of sensation to pain
• ringing in the ears
• decrease in blood pressure
• sneezing or runny nose caused by inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth
• hair loss, increased sweating
• itching of the skin, red spots 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)
• inability to obtain or maintain an erection, discomfort or enlargement of the breasts in men, sexual dysfunction
• pain, chest pain, feeling unwell
• weight gain or weight 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 diarrhoea

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

• decrease in the number of white blood cells, decrease in blood platelets which may cause easy bleeding or unusual bruising
• high blood sugar (hyperglycaemia)
• inflammation of the gums
• abdominal swelling (gastritis)
• abnormal liver function, inflammation of the liver (hepatitis), increase in liver enzymes which may affect certain medical tests
• unusual muscle stiffness
• numbness or weakness of arms and legs
• inflammation of blood vessels, often with skin rashes
• sensitivity to light

Not known (frequency cannot be estimated from the available data)

• impaired kidney function
• serious skin reactions which start with painful red areas, followed by large blisters and end with peeling of skin layers. This is accompanied by fever and chills, muscle aches, and general malaise
• decrease in the number of red blood cells (anaemia – symptoms may include tiredness, headaches, difficulty breathing during exercise, dizziness and paleness)
• low blood sugar levels
• tremor, rigid posture, mask-like face, slow movements and shuffling gait with imbalance

If any of the adverse effects listed above affect you severely, inform your doctor.

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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Aproxxamlo

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

Do not use this medicine after the expiry date stated on the packaging and blister, after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Aproxxamlo

The active substances 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).

• Other ingredients are:

  • Core: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous 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).

• Other ingredients are:

  • Core: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica.
  • Coating: hypromellose, macrogol, titanium dioxide (E171), and red iron oxide (E172).

• Each film-coated tablet of Aproxxamlo 300 mg/5 mg contains 300 mg of irbesartan and 5 mg of amlodipine (as amlodipine besilate).

• Other ingredients are:

  • Core: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, and colloidal anhydrous silica.
  • Coating: hypromellose, macrogol, titanium dioxide (E171), and yellow iron oxide (E172).

Appearance of the product and contents of the pack

Film-coated tablets of Aproxxamlo 150 mg/5 mg are white, oval-shaped, marked “150/5” on one side.

Film-coated tablets of Aproxxamlo 150 mg/10 mg are pink, oval-shaped, marked “150/10” on one side.

Film-coated tablets of Aproxxamlo 300 mg/5 mg are yellow, oval-shaped, marked “300/5” on one side.

Film-coated tablets of Aproxxamlo 300 mg/10 mg are white, oval-shaped, with a score on one side.

Aproxxamlo tablets are supplied in blister packs containing 15, 28, 30, 90, and 98 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

sanofi-aventis, S.A.
C/ Rosselló i Porcel, 21
08016 Barcelona
Spain

Manufacturer

S.C. Zentiva, S.A.
B-dul Theodor Pallady nr. 50, sector 3
Cod 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 under 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

Date of the last revision of this leaflet: December 2024

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