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
Perindoprilum argininum + Amlodipinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.
Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm
another person, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor,
pharmacist, or nurse. See section 4.
Contents of the leaflet:
What Aldan Combo is and what it is 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 Aldan Combo is and what it is used for
Aldan Combo is used to treat high blood pressure (hypertension) and/or stable angina (a condition
in which blood flow to the heart is reduced or blocked).
Patients already taking perindopril and amlodipine in separate tablets may instead use one tablet of
Aldan Combo, 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
(which belongs to a group of medicines called dihydropyridines). Together, these medicines work by
dilating and relaxing blood vessels, making it easier for blood to flow through them and helping the
heart pump blood effectively.
Important information before taking Aldan Combo
When not to take Aldan Combo:
if you are allergic to perindopril or any other ACE inhibitor, to amlodipine or any other calcium
antagonist, or to any of the other ingredients of this medicine (listed in section 6);
if you are pregnant beyond the 3rd month (it is also advisable to avoid using Aldan Combo in early
pregnancy – see section “Pregnancy”);
if you previously experienced symptoms such as wheezing, facial or tongue swelling, intense
itching, or severe skin rashes while taking an ACE inhibitor, or if you or a family member have
ever experienced such symptoms under any circumstances (a condition known as angioedema);
if you have diabetes or kidney problems and are being treated with a blood pressure-lowering
medicine containing aliskiren;
if you have aortic valve stenosis (narrowing of the aortic valve) or cardiogenic shock (a condition
in which the heart cannot supply sufficient blood to the body);
if you have very low blood pressure (hypotension);
if you have heart failure following a heart attack;
if you are undergoing dialysis or another form of blood filtration. Depending on the device used,
Aldan Combo may not be suitable for you;
if you have kidney disorders that reduce blood supply to the kidneys (renal artery stenosis);
if you have taken or are currently taking a combination medicine containing sacubitril and
valsartan, used to treat heart failure, as this increases the risk of angioedema (rapid swelling of
tissues under the skin in the throat area) (see “Warnings and precautions” and “Aldan Combo with
other medicines”).
Warnings and precautions
Before starting Aldan Combo, discuss with your doctor, pharmacist, or nurse if you have any of the
following conditions:
hypertrophic cardiomyopathy (a heart muscle disease) or renal artery stenosis (narrowing of the
blood vessel supplying blood to the kidney);
heart failure;
severe high blood pressure (hypertensive crisis);
any other heart conditions;
liver disease;
kidney disease or undergoing dialysis;
abnormally high levels of a hormone called aldosterone in your blood (primary hyperaldosteronism);
vascular collagen diseases (connective tissue disorders), such as systemic lupus erythematosus or
scleroderma;
diabetes;
a low-sodium diet or use of salt substitutes containing potassium (your blood potassium levels
should be monitored);
need for dose adjustment in elderly patients;
if you are 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 you have kidney problems related to diabetes,
aliskiren.
Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels
of electrolytes (e.g. potassium).
See also the section “When not to take Aldan Combo”.
if you are 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 and in cancer treatment);
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
drugs called gliptins (used to treat diabetes);
if you are 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
Angioedema (a severe allergic reaction with swelling of the face, lips, tongue, or throat, and difficulty
swallowing or breathing) has been reported in patients treated with ACE inhibitors, including Aldan
Combo. This reaction may occur at any time during treatment. If you experience such symptoms, stop
taking Aldan Combo immediately and contact your doctor without delay. See also section 4.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy.
Aldan Combo is not recommended during early pregnancy and must not be used after the 3rd month
of pregnancy, as it may cause serious harm to the unborn baby if used during this period (see section
“Pregnancy”).
When taking Aldan Combo, also inform your doctor or medical staff if:
you are scheduled for general anaesthesia and/or surgery;
you have recently experienced diarrhoea or vomiting;
you are scheduled for LDL apheresis (removal of cholesterol from the blood using a special
device);
you are undergoing desensitisation treatment to reduce allergic reactions to bee or wasp stings.
Children and adolescents
Aldan Combo is not recommended for use in children and adolescents.
Aldan Combo with other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or
plan to take.
Avoid using Aldan Combo:
with lithium (used to treat mania or depression);
with estramustine (used to treat cancer);
with potassium-sparing medicines (triamterene, amiloride), potassium supplements, or salt
substitutes containing potassium, or 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);
with potassium-sparing medicines used to treat heart failure: eplerenone and spironolactone at
a dose of 12.5 mg to 50 mg per day.
Other medicines may affect treatment with Aldan Combo. Your doctor may recommend a dose
adjustment and/or additional precautions. Inform your doctor if you 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
(AIIRAs), aliskiren (see also sections “When not to take Aldan Combo” and “Warnings and
precautions”) or diuretics (medicines that increase urine volume 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 Aldan Combo” 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 medicines used for pain relief, fever reduction, and
prevention of 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 defences), 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 to treat bacterial
infections);
Hypericum perforatum (St. John’s wort, used to treat depression);
simvastatin (a medicine that lowers blood cholesterol levels);
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
(prostate enlargement), such as: prazosin, alfuzosin, doxazosin, tamsulosin, terazosin;
amifostine (used to prevent or reduce adverse 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).
Aldan Combo with food and drink
Aldan Combo should be taken before a meal.
While taking Aldan Combo, do not drink grapefruit juice or eat grapefruits, as grapefruit and
grapefruit juice may increase the concentration of the active substance amlodipine, which could lead
to unpredictable intensification of the blood pressure-lowering effect of Aldan Combo.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, suspect you may be pregnant, or are planning to have a child,
consult your doctor or pharmacist before using this medicine.
Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy.
Usually, your doctor will recommend stopping Aldan Combo before becoming pregnant or as soon as
you find out you are pregnant, and will advise taking another medicine instead. Aldan Combo is not
recommended during early pregnancy and must not be taken after the 3rd month of pregnancy, as it
may cause serious harm to the unborn baby if used during this period.
Breastfeeding
Small amounts of amlodipine have been shown to pass into human milk. Inform your doctor if you are
breastfeeding or plan to breastfeed. Aldan Combo is not recommended during breastfeeding. Your
doctor may recommend another medicine if you wish to breastfeed, especially if the baby is a newborn
or premature infant.
Driving and using machines
Aldan Combo may affect your ability to drive or operate machinery. If you experience nausea, dizziness,
weakness, fatigue, or headache after taking the medicine, do not drive or operate machinery and contact
your doctor immediately.
Aldan Combo contains lactose
Each tablet of Aldan Combo, 5 mg + 5 mg, contains 58.0 mg of lactose.
Each tablet of Aldan Combo, 10 mg + 5 mg, contains 122.7 mg of lactose.
Each tablet of Aldan Combo, 10 mg + 10 mg, contains 116.1 mg of lactose.
If you have been diagnosed with an intolerance to certain sugars, consult your doctor before taking
this medicine.
How to take Aldan Combo
Always take this medicine exactly as prescribed by your doctor or pharmacist. If you are unsure, consult
your doctor or pharmacist.
Swallow the tablet with a glass of water, preferably at the same time each day, in the morning, before a
meal. Your doctor will determine the appropriate dose for you. The usual recommended dose is one
tablet per day.
Aldan Combo is usually prescribed for patients already taking perindopril and amlodipine in separate
tablets.
Use in children and adolescents
Not recommended for use in children and adolescents.
Taking more Aldan Combo than recommended
If you take too many tablets, go immediately to the nearest hospital emergency department or contact
your doctor. The most common 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 oedema) may occur up to 24–48
hours after taking the medicine.
Missing a dose of Aldan Combo
It is important to take the medicine daily, as regular use is most effective. However, if you miss a dose,
take the next dose at the usual time. Do not take a double dose to make up for a missed dose.
Stopping Aldan Combo
Treatment with Aldan Combo is usually long-term, so consult your doctor before stopping the tablets.
If you have any further questions about using this medicine, consult your doctor, pharmacist, or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience any of the following side effects, stop taking the medicine immediately and contact
your doctor without delay:
sudden wheezing, chest pain, breathlessness, or difficulty breathing;
swelling of the eyelids, face, or lips;
swelling of the tongue or throat, causing severe breathing difficulties;
severe skin reactions, including severe rash, urticaria, redness of the entire skin, 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 severe
malaise.
The following very common and common side effects have been reported. If any of these side effects
are troublesome or persist for more than a week, contact your doctor.
Very common side effects (may occur in at least 1 in 10 patients): oedema (fluid retention).
Common side effects (may occur in less than 1 in 10 patients): headache, central dizziness, drowsiness
(especially at the beginning of treatment), labyrinthine dizziness, tingling or numbness in the limbs,
vision disturbances (including double vision), tinnitus (perception of ringing sounds), palpitations
(sensation of heartbeats), sudden flushing of the face and neck, feeling of “emptiness” in the head due
to low blood pressure, cough, breathlessness, nausea, vomiting, abdominal pain, taste disturbances,
dyspepsia or digestive disturbances, changes in bowel habits, diarrhoea, constipation, allergic reactions
(such as skin rashes, itching), muscle cramps, fatigue, weakness, swelling of the ankles (peripheral
oedema).
Other reported side effects are listed below. If any side effects worsen or if you experience any side
effects not listed in this leaflet, inform your doctor or pharmacist.
Uncommon side effects (may occur in less than 1 in 100 patients): mood swings, anxiety, depression,
insomnia, sleep disturbances, tremor, fainting, loss of pain sensation, heart rhythm disturbances,
nasal mucosa inflammation (nasal congestion or rhinitis), hair loss, red skin spots, skin depigmentation,
back pain, joint pain, muscle pain, chest pain, urinary disorders, nocturia (urinary urgency at night),
increased frequency of urination, pain, malaise, bronchospasm (feeling of chest tightness, wheezing and
breathlessness), dryness of the oral mucosa, angioedema (symptoms such as wheezing, facial or tongue
swelling), blister formation 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 loss, tachycardia (rapid 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 usually resolve after stopping treatment), low blood sodium levels, hypoglycaemia
(very low blood sugar levels) in diabetic patients, increased blood urea levels, increased blood creatinine
levels.
Rare side effects (may occur in less than 1 in 1,000 patients): acute kidney failure; symptoms of a
condition called SIADH (syndrome of inappropriate antidiuretic hormone secretion): dark urine, nausea
or vomiting, muscle cramps, confusion, and seizures; reduced or absent urine output; worsening of
psoriasis; changes in laboratory test results: increased liver enzyme activity, high serum bilirubin levels.
Very rare side effects (may occur in less than 1 in 10,000 patients): 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 severe breathing
difficulties, severe skin reactions including severe skin rash, urticaria, redness of the entire skin, intense
itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome),
erythema multiforme (a skin rash, often starting with red, itchy spots on the face, arms, or legs),
photosensitivity, changes in blood parameters such as reduced white and red blood cell counts, reduced
haemoglobin levels, reduced platelet count, blood disorders, pancreatitis (which may cause severe upper
abdominal pain radiating to the back and severe malaise), liver function disorders, hepatitis, jaundice,
increased liver enzyme activity (which may affect some test results), abdominal distension (gastritis),
nerve disorders causing weakness, tingling, or numbness, increased muscle tone, gum swelling,
increased blood glucose levels (hyperglycaemia).
Frequency not known (cannot be estimated from available data): tremor, muscle rigidity, facial masking,
slowed movements and dragging gait, unsteady gait, cyanosis, numbness and pain in fingers or toes
(Raynaud’s phenomenon).
If you experience any of these symptoms, contact your doctor as soon as possible.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, inform your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-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 responsible entity.
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Aldan Combo

Keep the medicine out of 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 of the immediate packaging: 30 days.
Do not use this medicine after the expiry date stated on the pack after “EXP”.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

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

What Aldan Combo looks like and contents of the pack
Aldan Combo 5 mg + 5 mg are white to off-white, round tablets, 7 mm nominal diameter, biconvex on both sides.
Aldan Combo 10 mg + 5 mg are white to off-white, round tablets, 9 mm nominal diameter, biconvex on both sides, with a score line on one side.
The score line on the tablet is not intended for splitting the tablet.
Aldan Combo 10 mg + 10 mg are white to off-white, elongated tablets, 12.0 mm x 5.4 mm, biconvex on both sides, with a score line on one side.
The score line on the tablet is not intended for splitting the tablet.
Aldan Combo is packaged in blisters made of OPA/Aluminium/PVC/Aluminium or in HDPE bottles with a PP cap, containing a moisture-absorbing capsule made of LDPE. The bottle or blisters are placed in a cardboard box with an instruction leaflet.
The pack contains 30 tablets.

Marketing Authorisation Holder and Manufacturer
Polfarmex S.A.
ul. Józefów 9
99-300 Kutno
Poland
Tel.: +48 24 357 44 44
Fax: +48 24 357 45 45
e-mail: [email protected]

This medicinal product is authorised 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