Aramlessa

Leaflet attached to the packaging: patient information

Aramlessa, 5 mg + 5 mg, tablets

Aramlessa, 5 mg + 10 mg, tablets

Aramlessa, 10 mg + 5 mg, tablets

Aramlessa, 10 mg + 10 mg, tablets

Perindopril arginine + Amlodipine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Aramlessa and what is it used for

Aramlessa is used to treat high blood pressure (hypertension) and (or) stable coronary artery disease (a condition in which blood flow to the heart is reduced or blocked). Patients already taking perindopril and amlodipine in separate tablets may use one Aramlessa tablet instead, which contains both active substances. Aramlessa is a combination medicine that contains two active substances: perindopril and amlodipine. Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (which belongs to a group of medicines called dihydropyridines). Together, these medicines work by widening and relaxing blood vessels, making it easier for blood to flow through them and for the heart to maintain a normal blood flow.

2. Important information before taking Aramlessa

When not to take Aramlessa

• if the patient is allergic to perindopril or any other ACE inhibitor, to amlodipine or other calcium antagonists, or to any of the other ingredients of Aramlessa;
• if the patient is pregnant for more than 3 months (it is also recommended to avoid taking Aramlessa in early pregnancy - see section Pregnancy);
• if the patient has previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rash when taking an ACE inhibitor;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has a narrowing of the aortic valve (aortic stenosis) or is in cardiogenic shock (a condition in which the heart is unable to supply enough blood to the body);
• if the patient has very low blood pressure (hypotension);
• if the patient has heart failure after a heart attack;
• if the patient is undergoing dialysis or blood filtration by another method. Depending on the device used, Aramlessa may not be suitable for the patient.
• if the patient has kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan, used to treat heart failure (see "Warnings and precautions" and "Aramlessa and other medicines").

Warnings and precautions

Before starting to take Aramlessa, the patient should discuss with their doctor if they have any of the following conditions:

• hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the blood vessel that supplies blood to the kidney);
• heart failure;
• severe high blood pressure (hypertensive crisis);
• any other heart disease;
• liver disease;
• kidney disease or dialysis;
• the patient has an abnormally high level of a hormone called aldosterone in their blood (primary aldosteronism);
• collagen vascular disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• diabetes;
• use of a low-sodium diet or salt substitutes containing potassium (it is necessary to monitor potassium levels in the blood);
• need to increase the dose in elderly patients;
• if the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan - for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (such as potassium) in the blood. See also the subsection "When not to take Aramlessa".
• if the patient is taking any of the following medicines, as the risk of angioedema may increase:
• racecadotril (used to treat diarrhea);
• sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors (used to prevent rejection of a transplanted organ);
• sacubitril (available in a combination medicine containing sacubitril and valsartan), used to treat chronic heart failure;
• linagliptin, saxagliptin, sitagliptin, vildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);
• if the patient is black - in this case, there may be a greater risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races.

Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Aramlessa. This reaction may occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Aramlessa and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Aramlessa in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby (see section Pregnancy).
When taking Aramlessa, the patient should also inform their doctor or medical staff if:

• they are to be given general anesthesia and (or) undergo surgery;
• they have recently had diarrhea or vomiting;
• they are to undergo LDL apheresis (removal of cholesterol from the blood using a special device);
• they are to undergo desensitization treatment to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Aramlessa should not be used in children and adolescents.

Aramlessa and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
The patient should avoid taking Aramlessa with:

• lithium (used to treat mania or depression);
• estradiol (used to treat cancer);
• potassium-sparing medicines (triamterene, amiloride), potassium supplements, or salt substitutes containing potassium, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent blood clots; trimethoprim and cotrimoxazole, also known as a combination medicine containing trimethoprim and sulfamethoxazole, used to treat bacterial infections);
• potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone in a dose of 12.5 mg to 50 mg per day.

Taking other medicines may affect the treatment with Aramlessa. The doctor may recommend changing the dose and (or) taking other precautions. The patient should tell their doctor if they are taking any of the following medicines, as this may require special precautions:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also subsections "When not to take Aramlessa" and "Warnings and precautions") or diuretics (medicines that increase the amount of urine produced by the kidneys);
• medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, and other medicines belonging to the group of medicines called mTOR inhibitors). See section "Warnings and precautions".
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Aramlessa" and "Warnings and precautions".
• non-steroidal anti-inflammatory medicines (e.g., ibuprofen) used to relieve pain or high doses of acetylsalicylic acid, a substance found in many medicines, used as a pain reliever and antipyretic, as well as to prevent blood clots;
• medicines used to treat diabetes (such as insulin);
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics);
• immunosuppressive medicines (which weaken the body's defense mechanisms), used to treat autoimmune diseases or after organ transplantation (e.g., cyclosporine, tacrolimus);
• trimethoprim and cotrimoxazole (used to treat bacterial infections);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• ephedrine, norepinephrine, or epinephrine (medicines used to treat low blood pressure, shock, or asthma);
• baclofen or dantrolene (used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia that occurs during anesthesia);
• certain antibiotics, such as rifampicin, erythromycin, clarithromycin (used to treat bacterial infections);
• Hypericum perforatum(St. John's Wort, used to treat depression);
• simvastatin (a medicine that lowers cholesterol levels in the blood);
• antiepileptic medicines, such as carbamazepine, phenobarbital, phenytoin, fosphenytoin, primidone;
• itraconazole, ketoconazole (medicines used to treat fungal infections);
• alpha-adrenergic receptor antagonists - medicines used to treat prostate enlargement (prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce the side effects of other medicines or radiation therapy for cancer);
• corticosteroids (used to treat various diseases, including severe asthma and rheumatoid arthritis);
• gold salts, especially when given by injection (used to treat symptoms of rheumatoid arthritis);
• ritonavir, indinavir, nelfinavir (so-called protease inhibitors used to treat HIV infection).

Aramlessa with food and drink

Aramlessa should be taken before a meal.
While taking Aramlessa, the patient should not drink grapefruit juice or eat grapefruits, as grapefruits and grapefruit juice may increase the levels of the active substance amlodipine, which may result in unpredictable intensification of the blood pressure-lowering effect of Aramlessa.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should tell their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Usually, the doctor will recommend stopping Aramlessa before becoming pregnant or as soon as the patient finds out they are pregnant, and will recommend taking another medicine instead of Aramlessa. It is not recommended to take Aramlessa in early pregnancy and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the baby.
Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. The patient should tell their doctor if they are breastfeeding or start breastfeeding. It is not recommended to take Aramlessa while breastfeeding. The doctor may recommend taking another medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Aramlessa may affect the patient's ability to drive or use machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the medicine, they should not drive or use machines and should contact their doctor immediately.

Aramlessa contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means that it is considered "sodium-free".

3. How to take Aramlessa

This medicine should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The tablet should be swallowed with a glass of water, preferably at the same time every day, in the morning, before a meal. The doctor will determine the appropriate dose for the patient. The recommended dose is usually one tablet per day.
Aramlessa is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Aramlessa should not be used in children and adolescents.

Taking a higher dose of Aramlessa than recommended

In case of taking too many tablets, the patient should immediately go to the emergency department of the nearest hospital or contact their doctor. The most common symptom of overdose is low blood pressure, which can cause dizziness or fainting. In such a situation, lying down with elevated legs may help.
Up to 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulating in the lungs (pulmonary edema) may occur.

Missing a dose of Aramlessa

It is important to take the medicine every day, as regular treatment is most effective.
If a dose of Aramlessa is missed, the next dose should be taken at the usual time. A double dose should not be taken to make up for the missed dose.

Stopping Aramlessa treatment

Treatment with Aramlessa is usually long-term, so before stopping the tablets, the patient should contact their doctor.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aramlessa can cause side effects, although not everybody gets them.
If any of the following side effects occur, the patient should stop taking the medicine and contact their doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat, which can cause severe difficulty breathing;
• severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis) or other allergic reactions;
• severe dizziness or fainting;
• heart attack, too fast or irregular heartbeat, or chest pain;
• pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition.

The following very common and common side effects have been reported. If any of these side effects are troublesome for the patient, or if they last for more than a week, the patient should contact their doctor.

• Very common side effects (may affect more than 1 in 10 people): swelling (fluid retention).
• Common side effects (may affect up to 1 in 10 people): headache, dizziness of central origin, drowsiness (especially at the start of treatment), dizziness of labyrinthine origin, feeling of numbness or tingling in the limbs, visual disturbances (including double vision), tinnitus (feeling of hearing sounds), palpitations (feeling of heartbeat), sudden flushing of the face, feeling of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, indigestion or digestive disorders, changes in bowel movements, diarrhea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral edema).

Other side effects that have been reported are listed below. If any of these side effects worsen or if the patient experiences any side effects not listed in the leaflet, they should tell their doctor or pharmacist.

• Uncommon side effects (may affect up to 1 in 100 people): mood changes, anxiety, depression, insomnia, sleep disturbances, tremors, fainting, loss of pain sensation, irregular heartbeat, inflammation of the nasal mucosa (nasal congestion or runny nose), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia, increased urination, pain, poor general condition, bronchospasm (feeling of chest tightness, wheezing, and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, facial or tongue swelling), blistering of the skin, kidney disorders, impotence, increased sweating, increased eosinophil count (a type of white blood cell), breast tenderness or enlargement in men, weight gain or loss, tachycardia (fast heartbeat), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased skin sensitivity to sunlight), fever, falls, changes in laboratory test results: high potassium levels in the blood, transient after stopping treatment, low sodium levels, hypoglycemia (very low blood sugar) in patients with diabetes, increased urea levels in the blood, increased creatinine levels in the blood.
• Rare side effects (may affect up to 1 in 1,000 people): acute kidney failure, symptoms of a condition called SIADH (inappropriate antidiuretic hormone secretion): dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures, reduced or absent urination, worsening of psoriasis, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in serum.
• Very rare side effects (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, heart attack, and stroke), eosinophilic pneumonia (a rare type of pneumonia), swelling of the eyelids, face, or lips, swelling of the tongue and throat, which can cause severe difficulty breathing, severe skin reactions, including severe rash, hives, redness of the skin all over the body, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), erythema multiforme (a skin rash that often starts with the appearance of red, itchy spots on the face, arms, or legs), photosensitivity reactions, changes in blood parameters, such as decreased white blood cell count and red blood cell count, decreased hemoglobin levels, decreased platelet count, blood disorders, pancreatitis, which can cause severe abdominal pain, radiating to the back, and very poor general condition, liver function disorders, liver inflammation, jaundice, increased liver enzyme activity, which may affect some laboratory test results, abdominal bloating (gastritis), nerve disorders, which can cause weakness, numbness, or tingling, increased muscle tone, gum hypertrophy, increased blood sugar levels (hyperglycemia).

Frequency not known (cannot be estimated from the available data): tremors, stiffness, mask-like face, slow movements and shuffling gait, discoloration, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Aramlessa

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging (box and blister) after the abbreviation EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
There are no special storage temperature requirements for the medicine.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Aramlessa contains

• The active substances of Aramlessa are perindopril arginine and amlodipine. Aramlessa, 5 mg + 5 mg, tablets Each tablet contains 5 mg of perindopril arginine (which corresponds to 3.395 mg of perindopril) and 5 mg of amlodipine (in the form of amlodipine besylate). Aramlessa, 5 mg + 10 mg, tablets Each tablet contains 5 mg of perindopril arginine (which corresponds to 3.395 mg of perindopril) and 10 mg of amlodipine (in the form of amlodipine besylate). Aramlessa, 10 mg + 5 mg, tablets Each tablet contains 10 mg of perindopril arginine (which corresponds to 6.79 mg of perindopril) and 5 mg of amlodipine (in the form of amlodipine besylate).

Aramlessa, 10 mg + 10 mg, tablets
Each tablet contains 10 mg of perindopril arginine (which corresponds to 6.79 mg of perindopril) and 10 mg of amlodipine (in the form of amlodipine besylate).

• Other ingredients (excipients) are: calcium chloride hexahydrate, microcrystalline cellulose, sodium carboxymethylcellulose (Type A), sodium hydrogen carbonate, colloidal hydrated silica, iron oxide, yellow (E172) [only for 5 mg + 5 mg and 10 mg + 10 mg], magnesium stearate. See section 2 "Aramlessa contains sodium".

What Aramlessa looks like and contents of the pack

Aramlessa, 5 mg + 5 mg, tablets
Light brown-yellow, round, biconvex tablets, with possible single dark spots, with the marking S1 on one side of the tablet. Tablet dimensions: diameter approximately 7 mm.
Aramlessa, 5 mg + 10 mg, tablets
White or almost white, oval, biconvex tablets, with the marking S2 on one side of the tablet. Tablet dimensions: approximately 13 mm x 6 mm.
Aramlessa, 10 mg + 5 mg, tablets
White or almost white, round, biconvex tablets, with the marking S3 on one side of the tablet. Tablet dimensions: diameter approximately 9 mm.
Aramlessa, 10 mg + 10 mg, tablets
Light brown-yellow, oval, biconvex tablets, with possible single dark spots, with a score line on one side of the tablet. On one side of the score line, the marking S, and on the other side, the marking 4. Tablet dimensions: approximately 12 mm x 7 mm. The score line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.
Tablets are available in a cardboard box containing:

• 30, 60, or 90 tablets in blisters. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

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

In order to obtain more detailed information on this medicine, the patient should contact their local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warszawa

tel. +48 22 57 37 500
Date of last revision of the leaflet:01.03.2024