Amlessa

Leaflet accompanying the packaging: patient information

Amlessa, 4 mg + 5 mg, tablets

Amlessa, 4 mg + 10 mg, tablets

Amlessa, 8 mg + 5 mg, tablets

Amlessa, 8 mg + 10 mg, tablets

tert-butylamine perindopril + amlodipine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. 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, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Amlessa and what is it used for

Amlessa is used to treat high blood pressure (hypertension) and/or stable coronary heart disease (a condition in which the blood flow to the heart is reduced or blocked).
Patient already taking perindopril and amlodipine in separate tablets may take one Amlessa tablet containing both active substances instead.
Amlessa is a combination of two active substances: perindopril and amlodipine. Perindopril belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). Amlodipine is a calcium antagonist (belonging to a class of medicines called dihydropyridines). Both active substances work by widening and relaxing blood vessels, which lowers blood pressure. Blood can flow more easily through the body, and the heart is less strained.

2. Important information before taking Amlessa

When not to take Amlessa:

• if you are allergic to perindopril with tert-butylamine or any other ACE inhibitor, amlodipine besylate or any other dihydropyridine, or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (you should also avoid taking Amlessa in early pregnancy - see section "Pregnancy and breastfeeding");
• if you have ever had symptoms such as wheezing, swelling of the face or tongue, intense itching or severe skin rash when taking ACE inhibitors; or if you or a family member have had such symptoms in any other circumstances (a condition called angioedema);
• in cardiogenic shock (a condition where the heart cannot supply enough blood to the body), aortic stenosis (narrowing of the main blood vessel leaving the heart), or unstable angina (chest pain that may occur at rest);
• in patients with very low blood pressure (severe hypotension);
• in patients with heart failure (the heart is not able to pump blood sufficiently, leading to shortness of breath or swelling of the legs, ankles, or feet) after a recent heart attack;
• if you have diabetes or kidney problems and are taking a blood pressure-lowering medicine containing aliskiren;
• if you are undergoing dialysis or blood filtration by other methods. Depending on the device used, Amlessa may not be suitable for you.
• if you have kidney problems that reduce blood flow to the kidneys (renal artery stenosis);
• if you have taken or are currently taking a combination medicine containing sacubitril and valsartan, used to treat a certain type of chronic (long-term) heart failure in adults, as the risk of angioedema (rapid swelling of tissues under the skin, such as the throat) increases.

Warnings and precautions

Before starting Amlessa, discuss with your doctor or pharmacist:

• if you have hypertrophic cardiomyopathy (a disease of the heart muscle) or renal artery stenosis (narrowing of the artery supplying blood to the kidney);
• if you have other heart diseases;
• if you have liver function disorders;
• if you have kidney disease or are undergoing dialysis;
• if you have a condition called primary aldosteronism (a condition where the body produces too much of a hormone called aldosterone);
• if you have a collagen disease (a disease of the connective tissue), such as systemic lupus erythematosus or scleroderma;
• if you have diabetes;
• if you are on a low-salt diet or taking potassium-sparing diuretics (you may need to adjust your potassium levels);
• if you are elderly and need to adjust your dose;
• if you are taking any of the following medicines for high blood pressure:
• angiotensin receptor blockers (ARBs) (also known as sartans - e.g., valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes,
• aliskiren.
• if you are taking any of the following medicines, which may increase the risk of angioedema:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ rejection and to treat cancer (e.g., sirolimus, everolimus, temsirolimus, and other mTOR inhibitors),
• wildagliptin, a medicine used to treat diabetes.
• if you are black - in this case, there may be a higher risk of angioedema, and the medicine may be less effective in lowering blood pressure than in patients of other races.

Your doctor may monitor your kidney function, blood pressure, and electrolyte levels (e.g., potassium) in your blood at regular intervals.
See also the information under the heading "When not to take Amlessa".
Angioedema
Patients treated with ACE inhibitors, including perindopril, have reported angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). This reaction can occur at any time during treatment. If you experience such symptoms, stop taking Amlessa and contact your doctor immediately. See also section 4.
You must inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Amlessa is not recommended during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding").
You must inform your doctor or healthcare professional if you are taking Amlessa and:

• are scheduled for general anesthesia and/or surgery,
• have recently had diarrhea or vomiting,
• are scheduled for LDL apheresis (removal of cholesterol from the blood using a special device),
• are undergoing desensitization treatment to reduce allergic reactions to bee or wasp stings.

Children and adolescents

Amlessa is not recommended for children and adolescents.

Amlessa and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take.
Do not take Amlessa with:

• lithium (used to treat mania or depression),
• estramustine (used to treat cancer),
• potassium supplements (including salt substitutes), potassium-sparing diuretics (spironolactone, triamterene), and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressant used to prevent organ rejection and to treat certain diseases),
• potassium-sparing diuretics used to treat heart failure: eplerenone and spironolactone at a dose of 12.5 mg to 50 mg per day.

Other medicines may affect the action of Amlessa. Inform your doctor if you are taking any of the following medicines, as special care may be needed:

• other blood pressure-lowering medicines, including angiotensin receptor blockers (ARBs), aliskiren (see also sections "When not to take Amlessa" and "Warnings and precautions"), or diuretics (which increase the amount of urine excreted by the kidneys),
• a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See sections "When not to take Amlessa" and "Warnings and precautions".
• non-steroidal anti-inflammatory drugs (e.g., ibuprofen), given to relieve pain or high doses of acetylsalicylic acid,
• antidiabetic medicines (e.g., insulin or wildagliptin),
• medicines used to treat mental disorders, such as depression, anxiety, schizophrenia, etc. (e.g., tricyclic antidepressants, antipsychotics, imipramine-type antidepressants, neuroleptics),
• immunosuppressants (which weaken the immune system), used to treat autoimmune disorders 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 (used to treat low blood pressure, shock, or asthma),
• baclofen or dantrolene (given by infusion), used to treat muscle stiffness in diseases such as multiple sclerosis; dantrolene is also used to treat malignant hyperthermia (a condition characterized by very high fever and muscle stiffness) during anesthesia,

Amlessa may lower blood pressure more, if you are taking other blood pressure-lowering medicines.

Amlessa with food and drink

Take Amlessa before a meal.
Patient taking Amlessa should not consume grapefruit juice or grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which may lead to an unexpected increase in the effect of Amlessa, lowering blood pressure.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will normally advise you to stop taking Amlessa before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine instead. Do not take Amlessa during the first trimester of pregnancy and do not take it after the third month of pregnancy, as it may seriously harm the baby if taken during this period (see section "Pregnancy and breastfeeding").
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. Amlessa is not recommended during breastfeeding. Your doctor may choose another medicine if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.
It has been shown that small amounts of amlodipine pass into human milk.

Driving and using machines

Amlessa does not affect the ability to concentrate, but dizziness or weakness due to low blood pressure may occur, which may affect the ability to drive and use machines. Do not drive or use machines until you know how Amlessa affects you.

Amlessa contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Amlessa

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably in the morning before breakfast. Your doctor will decide the dose that is right for you. The usual dose is one tablet per day.
Amlessa is usually recommended for patients who are already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Amlessa is not recommended for children and adolescents.

Overdose

If you have taken more tablets than you should, contact your doctor or go to the emergency department of your nearest hospital immediately. The most likely symptoms of overdose are low blood pressure, which can cause dizziness or fainting. If you experience these symptoms, lie down and raise your legs.

Missed dose

It is important to take your medicine every day, as regular treatment is most effective. If you miss a dose, take the next dose at the usual time.
Do not take a double dose to make up for a forgotten dose.

Stopping Amlessa

Since treatment with Amlessa usually lasts for life, consult your doctor before stopping the medicine.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Amlessa can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, stop taking Amlessa and contact your doctor immediately:

• sudden wheezing, chest pain, shortness of breath, or difficulty breathing;
• swelling of the eyelids, face, or lips;
• swelling of the tongue and throat, causing 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 severe illness.

The following side effects have been reported. If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

• 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, feeling of numbness or tingling in the limbs, vision disturbances (including double vision), ringing in the ears (feeling of hearing sounds), palpitations (feeling of heartbeat), flushing, 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 get serious, or if you notice any side effects not listed in this leaflet, please tell your 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 sensation, irregular heartbeat, nasal congestion (blocked nose or sinusitis), hair loss, red spots on the skin, skin discoloration, back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia (waking up to urinate at night), increased frequency of urination, pain, malaise, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dry mouth, angioedema (symptoms such as wheezing, swelling of the face or tongue), blistering of the skin, kidney disorders, impotence, increased sweating, increased eosinophils (a type of white blood cell), gynecomastia (breast enlargement in men), weight gain or weight loss, tachycardia (rapid heartbeat), vasculitis (inflammation of blood vessels), photosensitivity reactions (increased sensitivity of the skin to sunlight), fever, falls, changes in laboratory test results: 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): confusion, exacerbation of psoriasis, changes in laboratory test results: increased liver enzyme activity, high bilirubin levels in the blood, dark urine, nausea or vomiting, muscle cramps, disorientation, and seizures. These may be symptoms of a condition called SIADH (inappropriate secretion of antidiuretic hormone), decreased or absent urine production, acute kidney failure.
• 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, causing 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, often starting with the appearance of red, itchy patches 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 severe illness, liver function disorders, hepatitis, 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 and/or bleeding, increased blood sugar levels (hyperglycemia).
• Frequency not known (cannot be estimated from the available data): tremors, rigidity, mask-like face, slow movements and dragging of the feet, unsteady gait, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. You can also report side effects 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
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
You can also report side effects to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Amlessa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "EXP". The expiry date refers to the last day of that month.
The batch number is stated on the packaging after "Lot".
Store in the original package to protect from light and moisture.
There are no special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Amlessa contains

• The active substances of Amlessa are perindopril with tert-butylamine and amlodipine. Amlessa, 4 mg + 5 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine (equivalent to 3.34 mg of perindopril) and 5 mg of amlodipine (as besylate). Amlessa, 4 mg + 10 mg, tablets Each tablet contains 4 mg of perindopril with tert-butylamine (equivalent to 3.34 mg of perindopril) and 10 mg of amlodipine (as besylate). Amlessa, 8 mg + 5 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine (equivalent to 6.68 mg of perindopril) and 5 mg of amlodipine (as besylate). Amlessa, 8 mg + 10 mg, tablets Each tablet contains 8 mg of perindopril with tert-butylamine (equivalent to 6.68 mg of perindopril) and 10 mg of amlodipine (as besylate).
• The other ingredients are: sodium hydrogen carbonate, microcrystalline cellulose, maize starch, sodium carboxymethylcellulose (Type A), colloidal anhydrous silica, and magnesium stearate (E470b). See section 2 "Amlessa contains sodium".

What Amlessa looks like and contents of the pack

Amlessa, 4 mg + 5 mg, tablets: white to almost white, round, slightly convex tablets with beveled edges, with the inscription "U 1" on one side of the tablet. Diameter: approximately 7 mm.
Amlessa, 4 mg + 10 mg, tablets: white to almost white, biconvex tablets in the shape of a capsule, with a score line on one side. The tablets have the inscription "U" on one side and "2" on the other side of the score line. Dimensions: approximately 12.5 mm x 5.5 mm. The score line on the tablet is only to facilitate breaking and not to divide into equal doses.
Amlessa, 8 mg + 5 mg, tablets: white to almost white, round, slightly convex tablets with beveled edges, with the inscription "U 3" on one side of the tablet. Diameter: approximately 9 mm.
Amlessa, 8 mg + 10 mg, tablets: white to almost white, round, biconvex tablets with beveled edges and a score line on one side. The tablets have the inscription "U" on one side and "4" on the other side of the score line. Diameter: approximately 9 mm. The tablet can be divided into equal doses.
Packaging:10, 20, 30, 60, or 90 tablets in blisters in a cardboard box
Not all pack sizes may be marketed.

Marketing authorization holder

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

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Lek Pharmaceuticals, d.d., Verovškova 57, 1526 Ljubljana, Slovenia
To obtain more detailed information on the names of the medicines in other EU member states, please contact the local representative of the marketing authorization holder:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Phone: 22 57 37 500
Date of last revision of the leaflet:02.12.2021