APROXXAMLO 300 MG/5 MG FILM-COATED TABLETS

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Aproxxamlo and what is it used for
2. What you need to know before you take Aproxxamlo
3. How to take Aproxxamlo
4. Possible side effects
5. Storage of Aproxxamlo
6. Contents of the pack and other information

1. What is Aproxxamlo and what is it used for

What is Aproxxamlo

Aproxxamlo contains two active substances: irbesartan and amlodipine.

What is Aproxxamlo 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

Irbesartanbelongs 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, leading to an increase in blood pressure. Irbesartan works by blocking the action of angiotensin-II, relaxing blood vessels and lowering blood pressure.

Amlodipinebelongs to a group of medicines known as “calcium channel blockers”. Amlodipine prevents calcium from entering the blood vessel walls, which makes the blood vessels relax and lowers 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 you take Aproxxamlo

Do not take Aproxxamlo

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

Warnings and precautions

Tell your doctor before starting to take Aproxxamlo if you have any of the following diseases:

• excessive vomiting or diarrhea - this can lead to extreme loss of fluid and/or salt in your body
• severe liver dysfunction
• 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:
• 1. an angiotensin-converting enzyme inhibitor (ACE inhibitor) - for example, enalapril, lisinopril, ramipril - especially if you have kidney problems related to diabetes
  2. aliskiren

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

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

Tell 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 on your own.

If you are pregnant or think you might be pregnant, tell your doctor. Aproxxamlo is not recommended during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby (see “Pregnancy and breast-feeding” in section 2).

See also the information in “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 the safety and efficacy have not been fully established.

Other medicines and Aproxxamlo

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 - this includes potassium-sparing diuretics (also called “water pills” that increase urine production), or you have a restricted salt intake that leads to extreme loss of fluid and salt in your body
• potassium supplements, salt substitutes that contain potassium, and other substances that may increase potassium levels
• lithium - a medicine used to treat some types of depression
• certain types of painkillers or medicines that reduce inflammation known as “non-steroidal anti-inflammatory drugs” (NSAIDs) or “cyclooxygenase-2 inhibitors” (COX-2 inhibitors) - as this 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 known as “Hypericum perforatum”. It is a herbal remedy used for depression
• nitroglycerin and other nitrates, or other medicines called “vasodilators” (medicines that promote the dilation of blood vessels)
• 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
• medicines for the heart - such as verapamil, diltiazem
• medicine used to control high cholesterol levels (simvastatin)
• dantrolene in infusion - a medicine used to treat rare reactions to anesthesia in which body temperature rises extremely rapidly (malignant hyperthermia)
• medicines to protect against transplant rejection (cyclosporin)
• medicines used to modify the functioning 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 should not consume grapefruit or grapefruit juice. This is because grapefruit and grapefruit juice can lead to an increase in blood levels of the active ingredient amlodipine, which can cause an unpredictable decrease in blood pressure.

Pregnancy and breast-feeding

Pregnancy

Do not take Aproxxamlo if you are pregnant.

You should tell your doctor if you think you might be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Aproxxamlo and will recommend an alternative medicine to take instead. Aproxxamlo should not be used during pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this time.

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

Breast-feeding

Tell your doctor if you are about to start or are already breast-feeding, as Aproxxamlo is not recommended for use during breast-feeding. Your doctor will normally advise you to stop taking Aproxxamlo and will recommend an alternative medicine to take instead, especially if your baby is newborn or premature.

Driving and using machines

Aproxxamlo may affect your ability to drive or use machines. If the tablets make you feel sick, dizzy, tired, or give you a headache, do not drive or use machines and contact 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

Always take this medicine exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Your doctor will decide 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 prescribes it to maintain precise control of your blood pressure.

Method of administration

Aproxxamlo is taken 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 should 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, stating the medicine and the amount taken. 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 can develop up to 24-48 hours after ingestion.

If you forget to take Aproxxamlo

If you accidentally miss a dose, simply take your normal dose when it is due. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects

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

• severe allergic reactions - with symptoms such as skin rash, itching, swelling of the face, lips, mouth, or throat that can cause difficulty swallowing or breathing, anaphylactic shock (frequency not known)
• severe 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 the 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 can cause severe abdominal pain and back pain accompanied by a feeling of being very unwell (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, somnolence
• 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 feeling of warmth in the face and/or neck
• shortness of breath or difficulty breathing
• abdominal pain, feeling unwell, or vomiting
• change in bowel habit, diarrhea, 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 in hands or feet, loss of pain sensation
• ringing in the ears
• low blood pressure
• runny nose or nasal congestion caused by inflammation of the nasal mucosa (rhinitis)
• cough
• dry mouth
• hair loss, increased sweating
• itching, red spots on the skin, skin discoloration, skin rash
• muscle or joint pain, back pain
• urination 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 that presents with symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

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

• decrease in the number of white blood cells, decrease in blood platelets that can cause easy bruising or bleeding
• high blood sugar levels (hyperglycemia)
• gum inflammation
• abdominal swelling (gastritis)
• abnormal liver function, liver inflammation (hepatitis), 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 rashes
• sensitivity to light.

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

• kidney function disorders
• severe skin reactions that start with red, painful areas, then with large blisters, and end with peeling of skin layers. This is accompanied by fever and chills, painful muscles, and general feeling of being unwell
• decrease in the number of red blood cells (anemia - symptoms can include tiredness, headaches, difficulty breathing when exercising, dizziness, and paleness)
• low blood sugar levels.
• tremor, rigid posture, mask-like face, slow movements, and unsteady, shuffling gait.

If any of the above side effects affect you severely, tell your doctor.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side 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 which is stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated.

Do not store above 30°C.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Packaging Content and Additional Information

Aproxxamlo Composition

The active ingredients are irbesartan and amlodipine.

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

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

Product Appearance and Packaging Content

The film-coated Aproxxamlo 150 mg/5 mg tablets are white, oval-shaped, and marked with "150/5" on one side.

The film-coated Aproxxamlo 150 mg/10 mg tablets are pink, oval-shaped, and marked with "150/10" on one side.

The film-coated Aproxxamlo 300 mg/5 mg tablets are yellow, oval-shaped, and marked with "300/5" on one side.

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

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

Only some 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 film-coated tablets - pellicule-coated tablets - Filmtabletten; Aprexevo 150 mg/10 mg film-coated tablets - pellicule-coated tablets - Filmtabletten; Aprexevo 300 mg/5 mg film-coated tablets - pellicule-coated tablets - Filmtabletten; Aprexevo 300 mg/10 mg film-coated tablets - pellicule-coated tablets - Filmtabletten

France, Romania: APREXEVO

Date of the last revision of this prospectus: December 2024

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