Aramlessa

Patient Information Leaflet

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
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

1. What Aramlessa is and what it is 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 as separate tablets may switch to a single Aramlessa tablet containing both active substances.
Aramlessa is a combination medicine containing two active ingredients: perindopril and amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging to a class of medicines called dihydropyridines). Together, these medicines work by relaxing and widening blood vessels, making it easier for blood to flow through them and helping the heart to pump blood more effectively.

2. Important information before taking Aramlessa

When not to take Aramlessa

• if the patient is allergic to perindopril or another ACE inhibitor, to amlodipine or other calcium antagonists, or to any of the other components of Aramlessa;
• if the patient is more than 3 months pregnant (it is also preferable to avoid using Aramlessa in early pregnancy – see Pregnancy section);
• if the patient previously experienced symptoms such as wheezing, facial or tongue swelling, intense itching, or severe rashes while taking an ACE inhibitor, or if such symptoms occurred in a blood relative under any circumstances (a condition known as angioedema);
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren;
• if the patient has aortic valve stenosis (narrowing of the aortic valve) or is in cardiogenic shock (a condition in which the heart is unable to deliver sufficient blood to the body);
• if the patient has very low blood pressure (hypotension);
• if the patient has heart failure following a heart attack;
• if the patient is undergoing dialysis or another form of blood filtration. Depending on the equipment used, Aramlessa may not be suitable for the patient;
• if the patient has kidney disorders that reduce blood supply 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 with other medicines").

Warnings and precautions
Before starting Aramlessa, discuss with your doctor if the patient has any of the following conditions:

• hypertrophic cardiomyopathy (a heart muscle disorder) or renal artery stenosis (narrowing of the blood vessel supplying blood to the kidney);
• heart failure;
• severe increase in blood pressure (hypertensive crisis);
• any other heart diseases;
• liver diseases;
• kidney diseases or undergoing dialysis;
• abnormally high levels of the hormone aldosterone in the blood (primary hyperaldosteronism);
• vascular collagenoses (connective tissue disorders), such as systemic lupus erythematosus or scleroderma;
• diabetes;
• following a low-sodium diet or using salt substitutes containing potassium (blood potassium levels should be monitored);
• need for dose adjustment 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 blood electrolyte levels (e.g. potassium). See also section "When not to take Aramlessa".
• if the patient is taking any of the following medicines, as they may increase the risk of angioedema:
  • racecadotril (used to treat diarrhoea);
  • sirolimus, everolimus, temsirolimus, and other medicines belonging to the group known as mTOR inhibitors (used to prevent organ transplant rejection);
  • 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 known as gliptins (used to treat diabetes);
• if the patient is of Black race – in such cases, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure compared to patients of other races.

Angioedema
In patients treated with ACE inhibitors, including Aramlessa, cases of angioedema (a serious allergic reaction with swelling of the face, lips, tongue or throat, and difficulty swallowing or breathing) have been reported. This reaction may occur at any time during treatment. If such symptoms occur, the patient should stop taking Aramlessa immediately and contact a doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Aramlessa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period (see Pregnancy section).
When taking Aramlessa, also inform your doctor or healthcare provider if:

• the patient is to undergo general anaesthesia and/or surgery;
• the patient has recently experienced diarrhoea or vomiting;
• an LDL apheresis procedure (removal of cholesterol from the blood using a special device) is planned;
• desensitization treatment is planned to reduce allergic reactions to bee or wasp stings.

Children and adolescents
Aramlessa is not recommended for use in children and adolescents.

Aramlessa with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The use of Aramlessa should be avoided with:

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

Other medicines may affect treatment with Aramlessa. Your doctor may recommend dose adjustments and/or additional precautions. Inform your doctor if the patient is taking any of the following medicines, as special care may be required:

• other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRAs), aliskiren (see also sections "When not to take Aramlessa" and "Warnings and precautions"), or diuretics (medicines that increase the volume of urine produced by the kidneys);
• medicines most commonly used to treat diarrhoea (racecadotril) or to prevent organ transplant rejection (sirolimus, everolimus, temsirolimus, and other so-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 drugs (e.g. ibuprofen) used to relieve pain, or high doses of acetylsalicylic acid, a substance found in many pain-relieving and antipyretic medicines, also used 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 (weakening the body's immune defenses), used to treat autoimmune diseases or after organ transplantation (e.g. cyclosporine, tacrolimus);
• trimethoprim and co-trimoxazole (used to treat infections);
• allopurinol (used to treat gout);
• procainamide (used to treat heart rhythm disorders);
• vasodilating medicines, including nitrates;
• ephedrine, noradrenaline, or adrenaline (medicines used to treat low blood pressure, shock, or asthma);
• baclofen or dantrolene (by infusion), used to treat muscle stiffness in conditions such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia occurring during anaesthesia (symptoms include very high fever and muscle rigidity);
• certain antibiotics such as rifampicin, erythromycin, clarithromycin (used for bacterial infections);
• Hypericum perforatum (St. John's wort, used to treat depression);
• simvastatin (a medicine that lowers blood cholesterol);
• 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 benign prostatic hyperplasia (enlarged prostate), such as prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
• amifostine (used to prevent or reduce side effects associated with other cancer treatments or radiotherapy);
• corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
• gold salts, especially when administered 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 meals.
While taking Aramlessa, do not drink grapefruit juice or eat grapefruits, as grapefruit and grapefruit juice may increase the concentration of the active substance amlodipine, potentially leading to unpredictable intensification of the blood pressure-lowering effect of Aramlessa.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually advise stopping Aramlessa before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Aramlessa is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to the unborn child if used during this period.

Breastfeeding
It has been shown that small amounts of amlodipine pass into human milk. Inform your doctor if you are breastfeeding or plan to breastfeed. Aramlessa is not recommended during breastfeeding. Your doctor may recommend an alternative medicine if you wish to breastfeed, especially if the infant is a newborn or premature.

Driving and operating machinery
Aramlessa may affect the ability to drive or operate machinery. If the patient experiences nausea, dizziness, weakness, fatigue, or headache after taking the medicine, driving and operating machinery should be avoided, and the patient should contact a doctor immediately.

Aramlessa contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning it is considered "sodium-free".

3. How to take Aramlessa

This medicine should always be taken exactly as directed by the doctor. In case of doubts, consult
your 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 usual recommended dose is one tablet daily.
Aramlessa is generally recommended for patients already being treated with perindopril and amlodipine in separate tablets.
Use in children and adolescents
Use in children and adolescents is not recommended.
If you take more Aramlessa than you should
If you accidentally take too many tablets, seek immediate medical attention at the nearest hospital emergency department or contact your doctor. The most commonly occurring symptom of overdose is low blood pressure, which may cause dizziness or fainting.
In such a case, lying down with elevated legs may help.
Breathlessness due to excess fluid accumulating in the lungs (pulmonary edema) may occur within 24 to 48 hours after taking the medicine.
If you forget to take Aramlessa
It is important to take the medicine every day, as regular use ensures the best effect.
However, if you miss a dose of Aramlessa, take the next dose at the usual time. Do not take a double dose to make up for the missed dose.
Stopping Aramlessa
Treatment with Aramlessa is usually long-term; therefore, you should consult your doctor before stopping the tablets.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.
If any of the following adverse symptoms occur, stop taking the medicine immediately and contact your doctor without delay:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue or throat, causing significant difficulty in breathing;
• severe skin reactions, including severe rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), or other allergic reactions;
• severe dizziness or fainting;
• heart attack, abnormally fast or irregular heartbeat, or chest pain;
• pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise.

The following very common and common adverse reactions have been reported. If any of these adverse reactions are troublesome to the patient or persist for more than one week, contact your doctor.

• Very common adverse reactions (may affect more than 1 in 10 people): oedema (fluid retention).
• Common adverse reactions (may affect up to 1 in 10 people): headache, central dizziness, drowsiness (especially at the beginning of treatment), labyrinthine dizziness, sensation of numbness or tingling in the limbs, visual disturbances (including double vision), tinnitus (perception of ringing or other sounds), palpitations (awareness of heartbeat), sudden facial flushing, sensation of "emptiness" in the head due to low blood pressure, cough, shortness of breath, nausea, vomiting, abdominal pain, taste disturbances, dyspepsia or digestive disturbances, changes in bowel rhythm, diarrhoea, constipation, allergic reactions (such as skin rash, itching), muscle cramps, fatigue, weakness, swelling around the ankles (peripheral oedema).

Other reported adverse reactions are listed below. If any of these adverse symptoms worsen or if any adverse symptoms not listed in this leaflet occur, inform your doctor or pharmacist.

• Uncommon adverse reactions (may affect up to 1 in 100 people): mood swings, anxiety, depression, insomnia, sleep disturbances, tremor, fainting, insensitivity to pain, cardiac arrhythmias, nasal mucosal inflammation (nasal congestion or rhinitis), hair loss, red spots on the skin, skin depigmentation, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia (urge to urinate at night), increased frequency of urination, pain, malaise, bronchospasm (feeling of tightness in the chest, wheezing and shortness of breath), dryness of the oral mucosa, angioedema (symptoms such as wheezing, swelling of the face or tongue), formation of blister clusters on the skin, kidney disorders, impotence, excessive sweating, increased eosinophil count (a type of white blood cell), discomfort or enlargement of the breasts in men, weight gain or weight loss, tachycardia (fast heartbeat), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased skin sensitivity to sunlight), fever, falls, changes in laboratory test results: high blood potassium levels, which resolve after discontinuation of treatment, low sodium levels, hypoglycaemia (very low blood sugar levels) in patients with diabetes, increased blood urea levels, increased blood creatinine levels.

• Rare adverse reactions (may affect up to 1 in 1,000 people): acute kidney failure, symptoms of a condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion): dark-coloured urine, nausea or vomiting, muscle cramps, disorientation and seizures, reduced or absent urine output, exacerbation of psoriasis, changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels.

• Very rare adverse reactions (may affect up to 1 in 10,000 people): cardiovascular disorders (angina pectoris, myocardial infarction and stroke), eosinophilic pneumonia (a rare type of lung inflammation), swelling of the eyelids, face or lips, swelling of the tongue and throat, causing significant difficulty in breathing, severe skin reactions, including severe skin rash, urticaria, redness of the entire skin surface, intense itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome), erythema multiforme (skin rash, often beginning with the appearance of red, itchy spots on the face, arms or legs), photosensitivity, changes in blood parameters such as decreased white and red blood cell counts, decreased haemoglobin concentration, decreased platelet count, blood disorders, pancreatitis, which may cause severe upper abdominal pain radiating to the back and general malaise, liver function disorders, hepatitis, jaundice (yellowing of the skin), increased liver enzyme activity, which may affect certain laboratory test results, abdominal distension (gastric discomfort), nerve disorders, which may cause weakness, tingling or numbness, increased muscle tension, gum swelling, increased blood glucose (hyperglycaemia).

• Frequency not known (cannot be estimated from the available data): tremor, postural rigidity, facial masking, bradykinesia and dragging gait, unsteady gait, discolouration, numbness and pain in the fingers or toes (Raynaud's phenomenon).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Aramlessa

Keep this medicine 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 abbreviation EXP. The expiry date refers to the last day of the specified month.
Store in the original packaging to protect from light.
No special temperature storage conditions are required for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. Proper disposal helps protect
the environment.

6. Contents of the pack and other information

What Aramlessa contains

• The active substances are perindopril with arginine and amlodipine.
  Aramlessa 5 mg + 5 mg, tablets
  Each tablet contains 5 mg of perindopril with arginine (equivalent to 3.395 mg of perindopril) and 5 mg of amlodipine (as amlodipine besylate).
  Aramlessa 5 mg + 10 mg, tablets
  Each tablet contains 5 mg of perindopril with arginine (equivalent to 3.395 mg of perindopril) and 10 mg of amlodipine (as amlodipine besylate).
  Aramlessa 10 mg + 5 mg, tablets
  Each tablet contains 10 mg of perindopril with arginine (equivalent to 6.79 mg of perindopril) and 5 mg of amlodipine (as amlodipine besylate).

Aramlessa 10 mg + 10 mg, tablets
Each tablet contains 10 mg of perindopril with arginine (equivalent to 6.79 mg of perindopril)
and 10 mg of amlodipine (as amlodipine besylate).

• Other components (excipients) are: calcium chloride dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (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 brownish-yellow, round, biconvex tablets, possibly with single dark specks, marked with "S1" on one side. Tablet dimensions: diameter approximately 7 mm.

Aramlessa 5 mg + 10 mg, tablets
White or almost white, oval, biconvex tablets, marked with "S2" on one side. Tablet dimensions: approximately 13 mm x 6 mm.

Aramlessa 10 mg + 5 mg, tablets
White or almost white, round, biconvex tablets, marked with "S3" on one side. Tablet dimensions: diameter approximately 9 mm.

Aramlessa 10 mg + 10 mg, tablets
Light brownish-yellow, oval, biconvex tablets, possibly with single dark specks, with a score line on one side. On one side of the score line is the mark "S", and on the other side "4". Tablet dimensions: approximately 12 mm x 7 mm. The score line on the tablet is intended only to facilitate breaking for easier swallowing and does not guarantee equal dose division.

Tablets are available in cardboard boxes containing:

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

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

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

For more detailed information about this medicinal product, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
Równoległa 5 Street
02-235 Warsaw
Phone: +48 22 57 37 500