Aproxxamlo 150 mg/10 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 the entire 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 could 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.

Contents of the leaflet

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 for the treatment of high blood pressure in adult patients who are already being treated with irbesartan and amlodipine in 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 constrict, 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 antagonists”. 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 is reduced.

2. What you need to know before taking Aproxxamlo

Do not take Aproxxamlo

• if you are allergic to irbesartan, amlodipine, any other calcium channel blocker, or any of the other ingredients 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 suffer from 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

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

• excessive vomiting or diarrhoea – this may cause severe loss of fluid and/or salt from 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 for 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.

Consult 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 as monotherapy.

If you are pregnant or think you might be pregnant, you must inform your doctor. The use of Aproxxamlo 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 (see “Pregnacy and breastfeeding” in section 2).

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

Children and adolescents

This medicine should 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 using, have recently used, or might need to use any other medicines.

Aproxxamlo may affect or may 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 known as “water pills” that increase urine production), or if you have a restricted salt intake leading to severe 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 medicines (used for epilepsy) – such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone
• St John’s wort – also known as “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 the function of the immune system – such as tacrolimus, sirolimus, temsirolimus, and everolimus
• repaglinide (a medicine used to reduce blood sugar levels).

Taking Aproxxamlo with food and drinks

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 unpredictable lowering of blood pressure.

Pregnancy and breastfeeding

Pregnancy

Do not take Aproxxamlo if you are pregnant.

You must 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 medicine. Aproxxamlo is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

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

Breastfeeding

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

Driving and using machines

Aproxxamlo may affect your ability to drive or use machines. If the tablets make you feel unwell, dizzy, tired, or cause 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; that is, essentially “sodium-free”.

3. How to take Aproxxamlo

Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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

It is important to continue 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, telephone: 91 562 04 20, indicating 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 dose at the usual time. Do not take a double dose to make up for forgotten doses.

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.

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)
• severe skin reactions – including severe 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 upon standing, headache, fatigue, weakness, drowsiness
• visual disturbances (including double vision)
• blood tests may show elevated levels of an enzyme that indicates muscle damage (creatine phosphokinase)
• rapid or irregular heartbeat
• flushing and sensation of warmth in the face and/or neck
• shortness of breath or difficulty breathing
• abdominal pain, nausea 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 the hands or feet, loss of pain sensation
• ringing in the ears
• low blood pressure
• sneezing or nasal discharge due to inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth
• hair loss, increased sweating
• skin itching, red spots on the skin, skin discoloration, 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 achieve or maintain an erection, discomfort or enlargement of the breasts in men, sexual dysfunction
• pain, chest pain, feeling of discomfort
• 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), increased 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
• photosensitivity (sensitivity to light)

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

• impaired kidney function
• severe skin reactions starting with painful red areas, followed by large blisters and ending 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 fatigue, headaches, shortness of breath during exercise, dizziness and paleness)
• low blood sugar levels
• tremor, rigid posture, mask-like facial expression, slow movements, shuffling gait and unsteadiness

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

Reporting of adverse effects

If you experience any type of adverse effect, consult 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 Aproxxamlo

Keep this medicine out of 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 is the last day of the month indicated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines 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).

• The other components 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).

• The other components 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).

• The other components 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 with “150/5” on one side.

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

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

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

Aproxxamlo tablets are available 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 most recent review of this leaflet: December 2024

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