Imbarix 5 mg/1.5 mg modified-release tablets

Package leaflet: Information for the user

Introduction

Package leaflet: patient information

Imbarix 5 mg/1.5 mg modified release tablets

Imbarix 10 mg/1.5 mg modified release tablets

ramipril/indapamide

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, ask 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 these are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Imbarix is and what it is used for

Imbarix contains two active substances: ramipril and indapamide. It is an antihypertensive and is used in the treatment of high blood pressure (hypertension). Ramipril belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors). These work by relaxing and widening blood vessels, making it easier for the heart to pump blood through them. Indapamide is a diuretic. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics in that it produces only a slight increase in the amount of urine formed. Each of the active substances helps reduce blood pressure, and together they work to control blood pressure.

This medicine is used to treat hypertension (high blood pressure) in adult patients whose blood pressure is adequately controlled with ramipril and indapamide given simultaneously at the same doses as in the combination, but as separate medicines.

2. What you need to know before taking Imbarix

Do not take Imbarix:

• If you are allergic to ramipril, to indapamide (active substances), to any other ACE inhibitor medicine, to any other sulfonamide, or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include itching, skin redness, or difficulty breathing.
• If you have ever had a severe allergic reaction called “angioedema.” Symptoms include itching, hives, red marks on hands, feet, and throat, swelling of the throat and tongue, swelling around the eyes and lips, difficulty breathing and swallowing.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling beneath the skin, such as in the throat) is high.
• If you are undergoing dialysis or any other type of blood filtration. Depending on the machine used, this medicine may not be suitable for you.
• If you have severe kidney disease or kidney problems where blood supply to the kidneys is reduced (renal artery stenosis).
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding” below).
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If your blood pressure is abnormally low or unstable. Your doctor will need to assess this.
• If you have severe liver disease or suffer from a condition called hepatic encephalopathy (a degenerative brain disorder).
• If you have low levels of potassium in your blood.

Do not take this medicine if any of the above apply to you. If you are unsure, speak with your doctor before taking Imbarix.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before taking this medicine. Inform your doctor if any of the following situations apply to you:

• If you have heart, cardiac rhythm, liver, or kidney problems.
• If you have lost a significant amount of salts or fluids (due to vomiting, diarrhea, excessive sweating, a low-salt diet, long-term use of diuretics, or dialysis).
• If you are undergoing treatment to reduce your allergy to bee or wasp stings (desensitization).
• If you are to receive an anesthetic. This may be administered during surgery or dental procedures. You may need to stop taking this medicine one day beforehand; consult your doctor.
• If you have high levels of potassium in your blood (shown in blood test results).
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus.
• If you are taking medicines or have a disease that could reduce sodium levels in your blood. Your doctor may perform periodic blood tests, particularly to monitor blood sodium levels, especially if you are elderly.
• If you are taking any of the following medicines used to treat high blood pressure:
  • an angiotensin II receptor antagonist (ARA) (also known as “sartans”; e.g., valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
  • aliskiren.
• You must inform your doctor if you are pregnant (or suspect you might be). Ramipril is not recommended during the first 3 months of pregnancy and may cause serious harm to your baby after 3 months of pregnancy (see section “Pregnacy and breastfeeding”).
• If you have diabetes.
• If you have gout.
• If you experience decreased vision or eye pain. These could be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or increased eye pressure, which may occur within hours to a week after taking this medicine. This may lead to permanent vision loss if untreated. If you previously had an allergy to penicillin or sulfonamide, you may be at higher risk.
• If you have muscle disorders such as muscle pain, tenderness, weakness, or cramps.
• If you need to undergo tests to check whether your parathyroid gland is functioning properly.
• If you are taking any of the following medicines that may increase the risk of angioedema (rapid swelling under the skin in the throat area):
  • Neprilysin inhibitors (such as racecadotril), a medicine used to treat diarrhea.
  • Medicines used to prevent rejection of transplanted organs and for cancer, such as mTOR inhibitors (e.g., temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.
  • Sacubitril/valsartan (see section 2, “Do not take Imbarix”).

You should inform your doctor if you have experienced photosensitivity reactions.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., sodium, potassium, or calcium) at regular intervals. See also the information under the heading “Do not take Imbarix.”

Children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age, as data are not available for this population.

Other medicines and Imbarix

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

You must not take this medicine with lithium (used to treat depression) due to the risk of increased lithium levels in the blood.

Inform your doctor if you are taking any of the following medicines, which may make this medicine less effective:

• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines used to treat low blood pressure, shock, heart failure, asthma, or allergies, such as ephedrine, noradrenaline, or adrenaline. Your doctor will need to monitor your blood pressure.

Inform your doctor if you are taking any of the following medicines. They may increase the likelihood of adverse effects when taken with this medicine:

• Sacubitril/valsartan, used to treat a type of long-term (chronic) heart failure in adults (see section 2 "Do not take Imbarix").
• Sirolimus, everolimus (for prevention of graft rejection).
• Cyclosporine, an immunosuppressive medicine used to prevent organ rejection after transplantation.
• Medicines used to relieve pain and inflammation (e.g., non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or indomethacin, and aspirin).
• Medicines for cancer treatment (chemotherapy) such as temsirolimus.
• Diuretics (water tablets) such as furosemide.
• Medicines that may increase potassium levels in blood such as spironolactone, triamterene, amiloride, potassium salts, trimethoprim alone or in combination with sulfamethoxazole (for infections), and heparin, a medicine used to thin the blood to prevent clots.
• Allopurinol (used to lower uric acid in blood).
• Procainamide (to treat heart rhythm problems).
• Vildagliptin (used to treat type 2 diabetes).
• Racecadotril (used to treat diarrhea).
• Medicines used to treat heart rhythm disorders (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, digoxin, bretylium).
• Medicines used to treat mental disorders such as depression, anxiety, and schizophrenia (e.g., tricyclic antidepressants, antipsychotics, neuroleptics such as amisulpride, sulpiride, sultopride, tiapride, haloperidol, droperidol).
• Bepridil (used to treat angina pectoris, a condition causing chest pain).
• Cisapride, difenoxin (used to treat gastrointestinal problems).
• Antibiotics used to treat bacterial infections (e.g., sparfloxacin, moxifloxacin, injectable erythromycin).
• Intravenous vincamine (used to treat symptomatic cognitive disorders in elderly patients including memory loss).
• Halofantrine (an antiparasitic used to treat certain types of malaria).
• Pentamidine (used to treat certain types of pneumonia).
• Antihistamines used to treat allergic reactions, such as hay fever (e.g., mizolastine, astemizole, terfenadine).
• Intravenous amphotericin B (antifungal medicines).
• Oral corticosteroids used in various treatments, including inflammation, severe asthma, and rheumatoid arthritis.
• Stimulant laxatives.
• Baclofen (for treatment of muscle stiffness occurring in diseases such as multiple sclerosis).
• Digitalis (to strengthen the heart and reduce heart rate).
• Metformin (to treat diabetes).
• Iodinated contrast agents (used in X-ray tests).
• Calcium tablets or other calcium supplements.
• Tacrolimus (to prevent rejection of a transplanted organ).
• Tetracosactide (to treat Crohn's disease).
• Methadone (used to treat addiction).

Your doctor may need to adjust your dose and/or take other precautions:

If you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (also see information in sections “Do not take Imbarix” and “Warnings and precautions”).

Inform your doctor if you are taking any of the following medicines. Their effect may be affected by this medicine:

• Medicines for treating diabetes such as oral glucose-lowering agents and insulin. This medicine may reduce your blood sugar levels. Monitor your blood sugar levels closely while taking this medicine.

If any of the above conditions apply to you (or you are unsure), speak with your doctor before taking this medicine.

Taking Imbarix with food, drinks, and alcohol

Imbarix can be taken with or without food.

Drinking alcohol with Imbarix may make you feel dizzy or lightheaded. If you are concerned about how much alcohol you can drink while taking this medicine, talk to your doctor, as blood pressure-lowering medicines and alcohol may have additive effects.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before taking this medicine.

Pregnancy

Your doctor will normally advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. This medicine is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breastfeeding

This medicine is not recommended for breastfeeding mothers, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is a newborn or was born prematurely.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

This medicine may affect your ability to drive or use machines. If this medicine causes you nausea, dizziness, tiredness, or headache, do not drive or operate tools or machinery.

Imbarix contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

Imbarix contains sodium

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

3. How to take Imbarix

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

If you feel that the effect of this medicine is too strong or too weak, consult your doctor or pharmacist.

The recommended dose is one tablet daily, preferably in the morning and before a meal. The tablets must be swallowed whole with a glass of water, without chewing.

Your doctor may adjust the dose depending on its effect on you.

Use in children and adolescents

The use of this medicine is not recommended in children and adolescents under 18 years of age, as there are no data available for this population.

If you take more Imbarix than you should

Contact your doctor immediately or go to the nearest hospital emergency department.

The most likely effect in case of overdose is arterial hypotension. If marked hypotension occurs (associated with nausea, vomiting, cramps, dizziness, somnolence, mental confusion, changes in the amount of urine produced by the kidneys), it may be helpful to lie down with the legs elevated.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Imbarix

If you forget to take a dose, skip that dose completely. Take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you stop taking Imbarix

Since treatment for high blood pressure is usually lifelong, you should speak with your doctor before stopping this medicine.

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 experiences them.

Stop taking this medicine and go immediately to a doctor if you notice any of the following serious adverse effects. You may need urgent medical treatment:

• Swelling of the face, lips, or throat that may make swallowing or breathing difficult, along with itching and rash. This could be a sign of a severe allergic reaction to this medicine. (Frequency not known).
• Angioedema. Angioedema is characterized by swelling of the skin of the limbs or face, swelling of the lips or tongue, or swelling of the mucous membranes of the throat or airways causing difficulty breathing or swallowing. If this occurs, contact your doctor immediately. (Uncommon) (may affect up to 1 in 100 people).
• Severe skin reactions including intense rash, redness of the skin all over the body, severe itching, blisters, skin peeling, and swelling of the skin, inflammation of mucous membranes (Stevens-Johnson Syndrome), or other allergic reactions. (Very rare) (may affect up to 1 in 10,000 people).
• Life-threatening irregular heartbeat. (Frequency not known).
• Inflammation of the pancreas that may cause severe abdominal and back pain accompanied by intense discomfort. (Very rare) (may affect up to 1 in 10,000 people).
• Brain disease caused by liver disease (hepatic encephalopathy). (Frequency not known).
• Inflammation of the liver (hepatitis). (Frequency not known).
• Muscle weakness, cramps, tenderness, or pain, particularly if you also feel unwell or have a high fever, which may be caused by abnormal muscle breakdown. (Frequency not known).

Inform your doctor immediately if you experience:

• Faster heartbeat, irregular or strong heartbeats (palpitations), chest pain, chest tightness, or more serious problems including heart attack and stroke. The frequency of these side effects is common (chest pain, chest tightness, palpitations) or uncommon (increased heart rate, heart attack, or stroke).
• Difficulty breathing or cough. These could be symptoms of lung problems. These are common adverse effects.
• Bruising more easily, bleeding for longer than normal, any sign of bleeding (e.g., from gums), purple spots on the skin, or infections occurring more frequently than usual, sore throat and fever, feeling tired, fainting, dizziness, or pale skin. These could be symptoms of blood or bone marrow problems. Frequency is unknown.
• Severe stomach pain that may extend to the back. This could be a sign of pancreatitis (inflammation of the pancreas). These are uncommon side effects.
• Fever, chills, fatigue, loss of appetite, stomach pain, nausea (feeling sick), yellowing of the skin or eyes (jaundice). These could be symptoms of liver problems such as hepatitis (liver inflammation) or liver damage. (Frequency is very rare).

Other adverse effects include:

Inform your doctor if any of the following symptoms worsen or last more than a few days.

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

• Dizziness (especially at the beginning of treatment).
• Headache or feeling tired.
• Fainting, hypotension (abnormally low blood pressure), especially when standing up or sitting down quickly.
• Irritative dry cough, sinus inflammation (sinusitis), or bronchitis, shortness of breath.
• Stomach or abdominal pain, diarrhoea, indigestion, feeling sick or vomiting.
• Skin rash, with or without raised areas.
• Allergic reactions, mainly dermatological, in individuals with a predisposition to allergic and asthmatic reactions.
• Chest pain.
• Muscle cramps or pain.
• Blood tests showing higher than usual potassium levels in the blood.
• Low blood potassium levels.

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

• Trouble sleeping.
• Heartburn, constipation, or dry mouth.
• Urinating more than usual during the day.
• Sweating more than normal.
• Sudden redness of the face, neck, or upper chest due to increased blood flow.
• Sexual dysfunction in men (inability to get or maintain an erection), decreased sexual desire in men or women.
• Balance problems (dizziness).
• Itching and abnormal skin sensations such as numbness, tingling, pricking, burning, or pins and needles in the skin (paraesthesia).
• Blurred vision.
• Loss or changes in taste.
• Feeling sad, anxious, more nervous than usual, or restless.
• Nasal congestion, difficulty breathing, or worsening of asthma.
• Swelling in the abdomen called “intestinal angioedema” with symptoms such as abdominal pain, vomiting, and diarrhoea.
• Loss or decrease in appetite (anorexia).
• Increased or irregular heartbeats.
• Swelling of arms and legs. This may be a sign that your body is retaining more fluid than normal.
• Joint pain.
• Fever.
• Increased number of white blood cells (eosinophilia) detected in a blood test.
• Blood tests show changes in how your liver, pancreas, or kidneys are functioning.
• Vomiting.
• Red spots on the skin (purpura).
• Low blood sodium levels that may cause dehydration and low blood pressure.

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

• Feeling insecure or confused.
• Redness and swelling of the tongue.
• Severe peeling or shedding of the skin, rash, lumps, itching.
• Nail problems (e.g., nail loss or separation of the nail from its bed).
• Rash or bruising on the skin.
• Skin redness and cold extremities.
• Redness, itching, swelling, or watering of the eyes.
• Hearing disturbances and ringing in the ears.
• Feeling weak.
• Involuntary, rhythmic, trembling movements of part of the body (tremors).
• Inadequate blood flow.
• Blood tests show a decrease in red blood cells, white blood cells, or platelets (which may cause unusual bruising or easy bleeding) or in hemoglobin levels.
• Nausea.
• Low blood chloride levels.
• Low blood magnesium levels.

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

• Increased sensitivity to sunlight.
• Urticaria (hives).
• High blood calcium levels.
• Irregular heart rhythm, low blood pressure.
• Kidney disease.
• Abnormal liver function.

Frequency not known:

• Fainting.
• If you suffer from systemic lupus erythematosus (a type of collagen disease), it may worsen.
• Short-sightedness (myopia).
• Visual disability.
• Decreased vision or eye pain due to increased pressure (possible signs of fluid accumulation in the vascular layer of the eye (choroidal effusion) or acute angle-closure glaucoma).
• Changes in laboratory tests (blood tests) may be observed, so your doctor may prescribe blood tests to monitor your condition. The following changes may be observed in your laboratory tests:
  • increased uric acid, a substance that may cause or worsen gout (joint pain, especially in the feet),
  • increased blood glucose levels in diabetic patients,
  • high blood calcium levels,
  • increased levels of liver enzymes.
• Abnormal electrocardiogram.

Other reported adverse effects:

Inform your doctor if any of the following symptoms worsen or last more than a few days.

• Difficulty concentrating.
• Swelling of the mouth.
• Blood tests show lower than normal sodium levels in the blood.
• Concentrated urine (dark-colored), feeling unwell or nausea, muscle cramps, confusion, and seizures, which may be due to inappropriate ADH (antidiuretic hormone) secretion. If you experience these symptoms, contact your doctor as soon as possible.
• Fingers of the hands and feet change color when exposed to cold, and you feel tingling or pain when warming up (Raynaud's phenomenon).
• Breast enlargement in men.
• Slowness or difficulty reacting.
• Burning sensation.
• Change in the smell of things.
• Hair loss.

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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Imbarix

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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

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

6. Package contents and other information

Composition of Imbarix

• The active substances are:

Imbarix 5 mg/1.5 mg, modified-release tablets: each tablet contains 5 mg of ramipril and 1.5 mg of indapamide.

Imbarix 10 mg/1.5 mg, modified-release tablets: each tablet contains 10 mg of ramipril and 1.5 mg of indapamide.

• The other components are: monohydrate lactose, povidone K 30, hypromellose, colloidal anhydrous silica, magnesium stearate, sodium croscarmellose, poly(vinyl alcohol), sodium stearyl fumarate, partially hydrolyzed poly(vinyl alcohol), calcium carbonate, macrogol 4000, talc, yellow iron oxide (E172) (10 mg/1.5 mg and 5 mg/1.5 mg), red iron oxide (E172) (10 mg/1.5 mg).

Appearance of the product and contents of the pack

Imbarix 5 mg/1.5 mg modified-release tablets: pale yellow to yellow, round, biconvex, film-coated tablets with a diameter of 9 mm, marked with the inscription “5” on one side.

Imbarix 10 mg/1.5 mg modified-release tablets: orange to light orange, round, biconvex, film-coated tablets with a diameter of 9 mm, marked with the inscription “10” on one side.

Imbarix is available in blisters containing 30, 60 or 100 modified-release tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Madrid

Spain

Manufacturer

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

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

Date of the most recent review of this leaflet: August 2025

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/