Aramlessa

Leaflet accompanying 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 you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms 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 ingredients. 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

Warnings and precautions

Before starting Aramlessa, the patient should discuss the following conditions with their doctor:

• hypertrophic cardiomyopathy (heart muscle disease) 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 conditions;
• 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 condition that affects connective tissue), such as systemic lupus erythematosus or scleroderma;
• diabetes;
• the patient is on a low-sodium diet or uses salt substitutes that contain potassium (it is necessary to monitor potassium levels in the blood);
• the need to increase the dose in elderly patients;
• if the patient is taking any of the following medicines for high blood pressure:
• 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".
• 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, wildagliptin, and other medicines belonging to the group of medicines called gliptins (used to treat diabetes);

Angioedema
Patients treated with ACE inhibitors, including Aramlessa, have reported angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty swallowing or breathing). This reaction can 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. Aramlessa should not be taken during pregnancy and 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 undergo general anesthesia and (or) surgery;
• they have recently experienced 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 with 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 that contain potassium, and 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 Aramlessa treatment. 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 they 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 urine production in 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);
• vasodilators, including nitrates;
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma);
• baclofen or dantrolene (used to treat muscle stiffness in conditions 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 conditions, including severe asthma and rheumatoid arthritis);
• gold salts, especially those 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 Aramlessa's blood pressure-lowering effect.

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. Aramlessa should not be taken during pregnancy and 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 about to start breastfeeding. Aramlessa should not be taken during 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 operate machines. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the medicine, they should not drive or operate 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 it is considered "sodium-free".

3. How to take Aramlessa

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they 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 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

If the patient has taken too many tablets, they 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.
Even 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 the patient misses a dose of Aramlessa, they should take the next dose at the usual time. They should not take a double dose 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.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Aramlessa can cause side effects, although not everybody gets them.
If the patient experiences any of the following side effects, they 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, rapid 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, they 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, drowsiness (especially at the start of treatment), vertigo, numbness or tingling of the limbs, vision disturbances (including double vision), tinnitus (ringing in the ears), 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 rashes, 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 (need to urinate at night), increased urination, pain, poor general condition, bronchospasm (feeling of constriction in the chest, 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 eosinophils (a type of white blood cell), breast tenderness or enlargement in men, weight gain or loss, rapid heartbeat (tachycardia), vasculitis (inflammation of blood vessels), sensitivity to light, changes in blood test results, such as high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar levels) 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 blood test results, such as increased liver enzyme activity, high bilirubin levels in the blood.
• 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), sensitivity to light, changes in blood test results, 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 disorders, liver inflammation, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect some 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 or toes (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.
Do not use this medicine after the expiry date stated on the packaging (carton and blister) after the term EXP. The expiry date refers to the last day of the month stated.
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 they no longer use. 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 silica hydrated, 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. The tablet dimensions are: 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. The tablet dimensions are: 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. The tablet dimensions are: diameter approximately 9 mm.
Aramlessa, 10 mg + 10 mg, tablets
Light brown-yellow, oval, biconvex tablets, with possible single dark spots, with a break line on one side of the tablet. On one side of the break line is the marking S, and on the other side is the marking 4. The tablet dimensions are: approximately 12 mm x 7 mm. The break line on the tablet is only to facilitate breaking the tablet and not to divide it into equal doses.
Tablets are available in a carton 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 the 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