Aldan Combo

Package Leaflet: Information for the Patient

Aldan Combo, 5 mg + 5 mg, Tablets

Aldan Combo, 10 mg + 5 mg, Tablets

Aldan Combo, 10 mg + 10 mg, Tablets

Perindopril arginine + Amlodipine

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

Keep this leaflet, as you may need to read it again.
In case of any doubts, consult a doctor, pharmacist, or nurse.
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 as yours.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet:

What is Aldan Combo and what is it used for
Important information before taking Aldan Combo
How to take Aldan Combo
Possible side effects
How to store Aldan Combo
Contents of the pack and other information

What is Aldan Combo and what is it used for

Aldan Combo is used to treat high blood pressure (hypertension) and/or stable coronary artery disease (a condition where the blood flow to the heart is reduced or blocked).
Patients already taking perindopril and amlodipine in separate tablets may use one Aldan Combo tablet instead, which contains both active substances.
Aldan Combo is a combination medicine containing two active substances: perindopril and amlodipine.
Perindopril is an angiotensin-converting enzyme (ACE) inhibitor. Amlodipine is a calcium antagonist (belonging 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.

Important information before taking Aldan Combo

When not to take Aldan Combo:

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 this medicine (listed in section 6);
if the patient is pregnant over 3 months (it is also recommended to avoid taking Aldan Combo in early pregnancy - see "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; or if the patient or a family member has experienced such symptoms in any other circumstances (a condition called angioedema);
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren;
if the patient has aortic stenosis (narrowing of the aortic valve) or is in cardiogenic shock (a condition where 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 using a method other than hemodialysis. Depending on the device used, Aldan Combo 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 is taking a combination medicine containing sacubitril and valsartan, used to treat heart failure, as the risk of angioedema (rapid swelling of tissues under the skin in the throat area) increases (see "Warnings and precautions" and "Aldan Combo with other medicines").

Warnings and precautions

Before starting Aldan Combo, the patient should discuss the following with their doctor, pharmacist, or nurse:
hypertrophic cardiomyopathy (heart muscle disease) or renal artery stenosis (narrowing of the blood vessel supplying the kidney);
heart failure;
significant increase in blood pressure (hypertensive crisis);
any other heart disease;
liver disease;
kidney disease or dialysis;
the patient has abnormally high levels of a hormone called aldosterone in their blood (primary aldosteronism);
collagen vascular disease (connective tissue disease), 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 for high blood pressure:
angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., 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 (e.g., potassium) in the blood.
See also the subsection "When not to take Aldan Combo".
if the patient is taking any of the following medicines, as the risk of angioedema increases:
racecadotril (used to treat diarrhea);
sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors (used to prevent rejection of a transplanted organ and to treat cancer);
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 a group of medicines called gliptins (used to treat diabetes);
if the patient is 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.
Angioedema
Angioedema has been reported in patients treated with ACE inhibitors, including Aldan Combo. This is a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty breathing or swallowing. This reaction can occur at any time during treatment. If the patient experiences such symptoms, they should stop taking Aldan Combo and contact their doctor immediately. See also section 4.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planning to become pregnant. It is not recommended to take Aldan Combo during early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus (see "Pregnancy").
When taking Aldan Combo, the patient should also inform their doctor or medical staff if:
they are to undergo general anesthesia and/or 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 stings or wasp stings.

Children and adolescents

Aldan Combo is not recommended for children and adolescents.

Aldan Combo with other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take.
Aldan Combo 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, other medicines that may increase potassium levels in the body (such as heparin, a medicine used to thin the blood to prevent clotting; 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 at a dose of 12.5 mg to 50 mg per day.
Taking other medicines may affect treatment with Aldan Combo. 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 special caution may be required:
other medicines used to treat high blood pressure, including angiotensin II receptor antagonists (AIIRA), aliskiren (see also subsections "When not to take Aldan Combo" and "Warnings and precautions"), or diuretics (medicines that increase urine production);
medicines commonly used to treat diarrhea (racecadotril) or to prevent rejection of a transplanted organ (sirolimus, everolimus, temsirolimus, and other medicines belonging to a group of medicines called mTOR inhibitors). See "Warnings and precautions".
a combination medicine containing sacubitril and valsartan (used to treat chronic heart failure). See subsections "When not to take Aldan Combo" 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 anti-inflammatory, 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);
immunosuppressants (medicines that 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 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);
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 in cancer treatment);
corticosteroids (used to treat various conditions, including severe asthma and rheumatoid arthritis);
gold salts, especially when given by injection (used to treat symptoms of rheumatoid arthritis);
ritonavir, indinavir, nelfinavir (protease inhibitors used to treat HIV infection).

Aldan Combo with food and drink

Aldan Combo should be taken before a meal.
While taking Aldan Combo, 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 Aldan Combo.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or is planning 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 planning to become pregnant. The doctor will usually recommend stopping Aldan Combo before becoming pregnant or as soon as the patient knows they are pregnant, and will recommend taking a different medicine instead of Aldan Combo. It is not recommended to take Aldan Combo during early pregnancy, and it should not be taken after 3 months of pregnancy, as it may cause serious harm to the fetus.
Breastfeeding
It has been shown that small amounts of amlodipine pass into breast milk. The patient should tell their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Aldan Combo while breastfeeding. The doctor may recommend a different medicine if the patient wants to breastfeed, especially if the baby is a newborn or premature.

Driving and using machines

Aldan Combo 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.

Aldan Combo contains lactose

Each Aldan Combo 5 mg + 5 mg tablet contains 58.0 mg of lactose.
Each Aldan Combo 10 mg + 5 mg tablet contains 122.7 mg of lactose.
Each Aldan Combo 10 mg + 10 mg tablet contains 116.1 mg of lactose.
If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine.

How to take Aldan Combo

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. 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.
Aldan Combo is usually recommended for patients already taking perindopril and amlodipine in separate tablets.

Use in children and adolescents

Aldan Combo is not recommended for children and adolescents.

Overdose of Aldan Combo

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.

Missed dose of Aldan Combo

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

Stopping Aldan Combo treatment

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

Possible side effects

Like all medicines, Aldan Combo 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, causing severe difficulty breathing;
severe skin reactions, including intense rash, hives, redness of the skin, 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 severe illness.
The following side effects have been reported. If any of these side effects bother the patient or last more than a week, they should consult 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 beginning 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), sudden flushing of the face and neck, 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 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, numbness, irregular heartbeat, nasal congestion (nasal stuffiness), 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 frequency of urination, pain, malaise, bronchospasm (feeling of constriction in the chest, wheezing, and shortness of breath), dryness of the mucous membranes of the 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), discomfort or enlargement of the breasts in men, weight gain or loss, tachycardia (rapid heartbeat), vasculitis (inflammation of blood vessels), hypersensitivity to light (increased skin sensitivity to sunlight), fever, falls, changes in laboratory test results: high potassium levels in the blood, low sodium levels, hypoglycemia (very low blood sugar) in patients with diabetes, increased urea 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; decreased or absent urine production; worsening of psoriasis; changes in laboratory test results: 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, causing severe difficulty breathing, severe skin reactions, including intense rash, hives, redness of the skin, severe itching, blistering, peeling, and swelling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome), erythema multiforme (skin rash, often starting with the appearance of red, itchy spots on the face, arms, or legs), hypersensitivity to light, 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 severe illness, liver disorders, liver inflammation, jaundice (yellowing of the skin), 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 tension, gum swelling, 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, cyanosis, numbness, and pain in the fingers of the hands or feet (Raynaud's phenomenon).
If the patient experiences any of these symptoms, they should contact their doctor as soon as possible.

Reporting side effects

If the patient experiences any side effects, including any not listed in the 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
PL-02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Aldan Combo

Keep the medicine out of the sight and reach of children.
Do not store above 25°C.
Store in the original packaging to protect from light.
Shelf life after first opening the immediate packaging: 30 days.
Do not use this medicine after the expiry date stated on the packaging after "EXP".
The expiry date refers to the last day of the month stated.
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 pack and other information

What Aldan Combo contains

The active substances of Aldan Combo are: perindopril and amlodipine besylate.
Aldan Combo 5 mg + 5 mg: one tablet contains 5 mg of perindopril arginine and 5 mg of amlodipine (in the form of 6.94 mg of amlodipine besylate).
Aldan Combo 10 mg + 5 mg: one tablet contains 10 mg of perindopril arginine and 5 mg of amlodipine (in the form of 6.94 mg of amlodipine besylate).
Aldan Combo 10 mg + 10 mg: one tablet contains 10 mg of perindopril arginine and 10 mg of amlodipine (in the form of 13.87 mg of amlodipine besylate).
Other ingredients of the tablet are: lactose monohydrate, microcrystalline cellulose type 102, anhydrous colloidal silica, magnesium stearate.

What Aldan Combo looks like and contents of the pack

Aldan Combo 5 mg + 5 mg are white to light yellowish tablets, round, with a nominal diameter of 7 mm, convex on both sides.
Aldan Combo 10 mg + 5 mg are white to light yellowish tablets, round, with a nominal diameter of 9 mm, convex on both sides, with a score line on one side.
The score line on the tablet is not intended for breaking the tablet.
Aldan Combo 10 mg + 10 mg are white to light yellowish, oval, with dimensions of 12.0 mm x 5.4 mm, convex on both sides, with a score line on one side.
The score line on the tablet is not intended for breaking the tablet.
Aldan Combo is packaged in blisters of OPA/Aluminum/PVC/Aluminum foil or HDPE containers with PP caps, with a desiccant in an LDPE capsule. The container or blisters are packaged in a cardboard box with a patient information leaflet.
The pack contains 30 tablets.

Marketing authorization holder and manufacturer

Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Phone: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: polfarmex@polfarmex.pl

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

Poland
Aldan Combo, 5 mg + 5 mg, tablets
Aldan Combo, 10 mg + 5 mg, tablets
Aldan Combo, 10 mg + 10 mg, tablets
Czech Republic
Perindopril arginine/Amlodipine Polfarmex 5 mg/5 mg tablets
Perindopril arginine/Amlodipine Polfarmex 10 mg/5 mg tablets
Perindopril arginine/Amlodipine Polfarmex 10 mg/10 mg tablets

Date of last revision of the leaflet: