Coaramlessa

Package Leaflet: Information for the Patient

CoAramlessa, 5 mg + 1.25 mg + 5 mg, tablets

CoAramlessa, 10 mg + 2.5 mg + 5 mg, tablets

CoAramlessa, 10 mg + 2.5 mg +10 mg, tablets

Perindopril arginine + Indapamide + Amlodipine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

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

1. What is CoAramlessa and what is it used for

CoAramlessa is a combination product containing three active substances: perindopril, indapamide, and amlodipine. It is an antihypertensive medicine used to treat high blood pressure (hypertension). Adult patients already taking perindopril and indapamide in one medicine and amlodipine in another can take one CoAramlessa tablet, which contains these three active substances in the same doses. Each active substance lowers blood pressure, and together they help control blood pressure in the patient:

• Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). It works by widening the blood vessels, making it easier for the heart to pump blood.
• Indapamide is a diuretic (a medicine that increases urine production) belonging to the group of sulfonamide derivatives with an indole ring. Diuretics increase the amount of urine produced by the kidneys. However, indapamide differs from other diuretics because it only causes a slight increase in urine production.
• Amlodipine is a calcium antagonist (belonging to the group of medicines called dihydropyridines). It causes relaxation of the blood vessels, making it easier for blood to flow through them.

2. Important information before taking CoAramlessa

When not to take CoAramlessa

• if you are allergic to perindopril or other ACE inhibitors, indapamide or other sulfonamides, amlodipine or other dihydropyridines, or any of the other ingredients of this medicine (listed in section 6),
• if you have had symptoms such as wheezing, swelling of the face or tongue, intense itching, or severe rash during previous treatment with an ACE inhibitor, or if you have had such symptoms in any other circumstances (a condition called angioedema),
• if you have severe liver disease or a condition called hepatic encephalopathy (a brain disorder caused by liver disease),
• if you have suspected or untreated heart failure (severe water retention, breathing difficulties),
• if you have a narrowing of the aortic valve in the heart (aortic stenosis) or cardiogenic shock (a condition where the heart is unable to supply enough blood to the body),
• if you have heart failure after a heart attack,
• if you have very low blood pressure (hypotension),
• if you have low potassium levels in the blood,
• if you have severe kidney disease that reduces blood flow to the kidneys (renal artery stenosis),
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, CoAramlessa may not be suitable for you.
• if you have moderate kidney disease (for CoAramlessa 10 mg + 2.5 mg + 5 mg and 10 mg + 2.5 mg + 10 mg),
• after the third month of pregnancy (it is also recommended to avoid taking CoAramlessa during early pregnancy - see section on pregnancy and breastfeeding),
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren,
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat chronic heart failure, as the risk of angioedema (rapid swelling of tissues under the skin, in the area of the throat, which can cause difficulty swallowing or breathing) increases (see "Warnings and precautions" and "CoAramlessa and other medicines").

Warnings and precautions

Before taking CoAramlessa, discuss with your doctor or pharmacist:

• if you have hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying the kidney),
• if you have heart failure or any other heart disease,
• if you have a significant increase in blood pressure (hypertensive crisis),
• if you have liver disease,
• if you have collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma,
• if you have atherosclerosis (hardening of the arteries),
• if you are going to have parathyroid function tests,
• if you have gout,
• if you have diabetes,
• if you are on a low-salt diet or using salt substitutes containing potassium (it is essential to have the right potassium level in the blood),
• if you are taking lithium or potassium-sparing diuretics (spironolactone, triamterene), as you should avoid taking them with CoAramlessa (see "CoAramlessa and other medicines"),
• if you are elderly and the dose needs to be increased,
• if you have had light-sensitive reactions,
• in black patients, angioedema (swelling of the face, lips, mouth, tongue, or throat, which can cause difficulty swallowing or breathing) may occur more frequently, and the medicine may be less effective in lowering blood pressure,
• if you are undergoing dialysis using high-flux membranes,
• if you have kidney disease or are on dialysis,
• if you experience vision changes or eye pain. These may be symptoms of fluid accumulation in the vascular layer of the eye (choroidal effusion) or glaucoma - increased pressure in one or both eyes, which can occur within a few hours to a few weeks after taking CoAramlessa. If left untreated, they can lead to permanent vision loss. If you have previously been allergic to penicillin or sulfonamides, you may be at greater risk of such a reaction.

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