Gopten 0,5

Leaflet accompanying the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gopten 0.5 (Gopten 0.5 mg)

0.5 mg, hard capsules
Trandolaprilum
Gopten 0.5 and Gopten 0.5 mg are different trade names for the same medicine.

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 that 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Gopten 0.5 and what is it used for
• 2. Important information before taking Gopten 0.5
• 3. How to take Gopten 0.5
• 4. Possible side effects
• 5. How to store Gopten 0.5
• 6. Contents of the packaging and other information

1. What is Gopten 0.5 and what is it used for

The active substance of Gopten 0.5, hard capsules, is trandolapril. The medicine belongs to the group
of angiotensin-converting enzyme inhibitors (ACE). Trandolapril is absorbed quickly from the gastrointestinal tract, and then in the liver, it is converted into a strongly and long-acting active metabolite - trandolaprilat.
Administration of trandolapril in therapeutic doses to patients with arterial hypertension causes
a significant decrease in arterial blood pressure measured in the patient in a lying and standing position.
The blood pressure-lowering effect becomes apparent after one hour and lasts for 24 hours, with the maximum effect observed between the eighth and twelfth hour after administration.
Gopten 0.5 is used to treat:

• mild or moderate arterial hypertension,
• left ventricular dysfunction after myocardial infarction,
• symptomatic heart failure.

2. Important information before taking Gopten 0.5

When not to take Gopten 0.5

• If the patient is allergic to trandolapril or any of the other ingredients of this medicine (listed in section 6) or to another angiotensin-converting enzyme inhibitor.
• If the patient has experienced angioedema (swelling of any part of the body, which in the case of swelling of the throat and larynx can make swallowing and breathing difficult) after taking another medicine from the group to which Gopten 0.5 belongs.
• If the patient has been diagnosed with hereditary or idiopathic (of unknown cause) angioedema.

Page 1 9

• In women after the third month of pregnancy. It is also recommended to avoid taking Gopten 0.5 in early pregnancy (see section "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently taking a combination medicine containing sacubitril and valsartan (used to treat a certain type of chronic heart failure in adults), as this increases the risk of angioedema (rapid swelling of the subcutaneous tissue, in areas such as the throat).

Warnings and precautions

Before starting treatment with Gopten 0.5, you should discuss it with your doctor, pharmacist, or
nurse.

• If the patient is to undergo desensitization to animal venom (including insect venom), it is recommended to consider temporary discontinuation of the medicine.
• If the patient is undergoing dialysis therapy (hemodialysis or low-density lipoprotein apheresis - LDL).
• If the patient has been diagnosed with liver dysfunction.
• If the patient has been diagnosed with kidney dysfunction, congestive heart failure, unilateral or bilateral renal artery stenosis, renal artery stenosis of a single functioning kidney, and in patients after kidney transplantation, as there is a risk of worsening kidney function.
• If the patient with kidney dysfunction experiences an increase in potassium levels in the blood (hyperkalemia).
• If the patient has risk factors for hypotension, such as hypovolemia (decreased blood volume), sodium deficiency due to prolonged use of diuretics, low-sodium diet, dialysis, and diarrhea or vomiting. In these patients, before starting treatment with Gopten 0.5, the doctor may recommend discontinuing diuretics and replenishing fluid and (or) sodium deficiency. Similar precautions should be taken in patients with coronary heart disease or cerebrovascular disorders, in whom excessive blood pressure reduction may cause myocardial infarction or cerebrovascular incident.
• In patients with kidney dysfunction, especially those with collagen diseases (e.g., systemic lupus erythematosus and systemic scleroderma), as these patients may experience agranulocytosis (a decrease in the number of granulocytes, a type of white blood cell) and bone marrow suppression after taking a medicine from the group to which Gopten 0.5 belongs. The decrease in the number of granulocytes is a transient phenomenon after discontinuation of the angiotensin-converting enzyme inhibitor.
• In patients with collagen diseases, especially those with kidney dysfunction and concomitant use of glucocorticoids and antimetabolites, the doctor will recommend regular monitoring of white blood cell count and protein levels in the urine.
• If the patient experiences an acute allergic reaction - angioedema of the face, limbs, tongue, larynx, and (or) throat after taking Gopten 0.5, they should immediately consult a doctor. The medicine should be discontinued immediately, and the patient's condition should be monitored until the swelling subsides. Angioedema limited to the face usually subsides on its own. Angioedema of the face and larynx can be life-threatening due to the risk of airway obstruction. Caution should be exercised in patients with hereditary or idiopathic angioedema.
• If the patient experiences abdominal pain (with or without nausea and vomiting) after taking Gopten 0.5, as medicines from the group to which Gopten 0.5 belongs may cause intestinal angioedema. If such symptoms occur, the patient should immediately consult a doctor, as prompt treatment may be necessary.
• In patients with renovascular hypertension.
• If the patient experiences an increase in potassium levels in the blood (hyperkalemia) after taking the medicine, regular monitoring of potassium levels in the blood is recommended. Risk factors for hyperkalemia include kidney dysfunction, use of potassium-sparing diuretics, concomitant administration of medicines used to treat hypokalemia, diabetes, and (or) left ventricular dysfunction after myocardial infarction.

Page 2 9

• If the patient is to undergo surgical procedures or anesthesia using medicines that cause hypotension.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney dysfunction associated with diabetes;
• aliskiren.
• If the patient is taking any of the following medicines, as the risk of angioedema (sudden swelling of tissue, e.g., in the throat area) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• wildagliptin, a medicine used to treat diabetes.

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 Gopten 0.5".

Important information

• Gopten 0.5 should not be taken by patients with aortic stenosis or outflow tract obstruction.
• The patient should inform their doctor if they are taking diuretics, especially if they have recently started taking them, as concomitant use with Gopten 0.5 may cause a significant decrease in blood pressure.
• The patient should inform their doctor if they suspect (or plan) pregnancy. It is not recommended to take Gopten 0.5 during the first three months of pregnancy, and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see section "Pregnancy and breastfeeding").
• In patients taking medicines from the group to which Gopten 0.5 belongs, a dry, persistent cough without expectoration may occur. This symptom subsides after discontinuation of the medicine.
• It is not recommended to take Gopten 0.5 during breastfeeding, especially in newborns or premature infants. The doctor will recommend other medicines during breastfeeding.

Children

The safety and efficacy of Gopten 0.5 in children have not been studied, and therefore, its use is not recommended.

Gopten 0.5 and 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 inform their doctor if they are taking any of the following medicines, as special caution is then required:

• neprilysin inhibitors, such as racecadotril, due to the increased risk of angioedema (sudden swelling of the skin, e.g., in the throat area);
• diuretics;
• potassium-sparing diuretics, such as spironolactone, canrenone, amiloride, triamterene, eplerenone;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that increase potassium levels in the blood (e.g., trimethoprim and cotrimoxazole, used to treat bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent transplant rejection, and heparin, a medicine used to thin the blood to prevent clots);
• antidiabetic medicines (insulin or oral antidiabetic medicines);
• lithium;

Page 3 9

• anesthetics;
• allopurinol (used to treat gout);
• procainamide (used to treat arrhythmias);
• cytostatics (used to treat cancer);
• immunosuppressive medicines (affecting the immune system);
• systemic glucocorticoids (medicines with anti-inflammatory effects);
• sympathomimetic medicines (medicines that constrict blood vessels);
• antipsychotic and tricyclic antidepressant medicines;
• nonsteroidal anti-inflammatory medicines (including acetylsalicylic acid used in higher doses as an anti-inflammatory medicine, e.g., to relieve pain);
• medicines that reduce stomach acid;
• gold injections (used to treat rheumatoid arthritis).

In patients with left ventricular dysfunction after myocardial infarction, no clinical interactions have been observed when Gopten 0.5 was administered in combination with:

• thrombolytic medicines (used to treat thrombosis and embolism),
• acetylsalicylic acid,
• beta-blockers (used to treat heart diseases and arterial hypertension),
• calcium channel blockers (used to treat arterial hypertension and heart diseases),
• nitrates (used to treat coronary heart disease),
• anticoagulant medicines (medicines that prevent blood clotting),
• digoxin (a medicine used to treat congestive heart failure),
• cimetidine (a medicine used to treat stomach ulcers and gastroesophageal reflux disease).

The doctor may recommend a dose change and (or) other precautions:

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also subsections "When not to take Gopten 0.5" and "Warnings and precautions").

Gopten 0.5 with food and drink

Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The patient should inform their doctor if they suspect (or plan) pregnancy. The doctor will usually recommend discontinuing Gopten 0.5 before planned pregnancy or as soon as pregnancy is confirmed and recommend taking another medicine instead of Gopten 0.5.

Gopten 0.5 should not be taken during the first three months of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It is not recommended to take Gopten 0.5 during breastfeeding, especially in newborns or premature infants; the doctor may recommend another medicine.

Driving and using machines

The medicine may affect the ability to drive and use machines, especially during the initial treatment period, after changing the previously used medicine, and when consuming alcohol.
It is not recommended to drive or operate machines for a few hours after taking the first dose of the medicine or after increasing the dose of the medicine.

Gopten 0.5 contains lactose monohydrate and sodium

Page 4 9
If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Gopten 0.5

This medicine should always be taken as directed by the doctor or pharmacist. If you have any doubts, you should consult a doctor or pharmacist.
Oral administration.

Adults

Hypertension
In adult patients not taking diuretics, without congestive heart failure, and without kidney or liver dysfunction, the recommended initial dose is 0.5 mg to 2 mg once daily. A dose of 0.5 mg is effective only in a small number of patients.
In black patients, the initial dose is usually 2 mg. The dose should be gradually doubled every one to four weeks, taking into account the patient's response to the medicine, until a maximum dose of 4 mg/day to 8 mg/day is reached.
The maintenance dose is usually 1 mg to 4 mg once daily. If the patient's response to a dose of 4 mg to 8 mg of trandolapril per day is unsatisfactory, the doctor will consider administering the medicine in combination with diuretics and (or) calcium antagonists.
Left ventricular dysfunction after myocardial infarction
Treatment can be started as early as the third day after myocardial infarction, with an initial dose of 0.5 mg to 1 mg once daily. The dose is gradually increased to a maximum of 4 mg once daily. Depending on the patient's response to the medicine (occurrence of symptomatic hypotension), the dose increase can be temporarily discontinued.
In case of hypotension, the doctor will recommend, if possible, reducing the dose of concomitantly administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 0.5 can be reduced only if the above measures are ineffective or cannot be taken.
Elderly patients
In elderly patients with normal kidney and liver function, there is no need to reduce the dose.
Caution should be exercised in elderly patients treated with diuretics, with congestive heart failure, or with kidney or liver dysfunction.
The dose is adjusted according to blood pressure values.
Patients taking diuretics
In patients who are dehydrated and have a sodium deficiency, the doctor may discontinue the diuretic 2-3 days before starting treatment with Gopten 0.5 to reduce the risk of symptomatic hypotension. If necessary, the diuretic can be restarted later.
Heart failure
Treatment should be started with a dose of 0.5 mg to 1 mg once daily, under close medical supervision.
Patients with kidney dysfunction
Page 5 9
In patients with a creatinine clearance (a measure of kidney function determined by laboratory tests in blood) of 30 to 70 ml/min, the recommended doses are the same as for adults, including the elderly.
In patients with a creatinine clearance below 30 ml/min, the recommended initial dose of trandolapril is reduced (i.e., the initial dose is 0.5 mg once daily), and the dose is gradually increased to achieve the desired effect. In these patients, treatment should be carried out under close medical supervision.
In patients with a creatinine clearance above 30 ml/min, there is no need to change the initial dose.
Dialysis patients
In dialysis patients, blood pressure should be carefully monitored, and the dose of the medicine should be adjusted as needed.
Patients with liver dysfunction
Treatment should be started with a dose of 0.5 mg once daily and carried out under close medical supervision.

Use in children

The safety and efficacy of Gopten 0.5 in children have not been studied, and therefore, its use is not recommended.

Overdose of Gopten 0.5

In case of overdose, the following symptoms may occur: severe hypotension, shock, stupor, slow heart rate, disturbances in electrolyte levels in the blood, and kidney failure. After an overdose, the patient should be closely monitored, preferably in an intensive care unit. The doctor should frequently monitor electrolyte levels and creatinine in the blood. Treatment depends on the severity of symptoms. If the medicine was taken recently, the doctor will take measures to remove the medicine (e.g., induce vomiting, gastric lavage, administer absorbents, and sodium sulfate).
In case of symptomatic hypotension, the patient should be placed in a shock position as soon as possible. The doctor will administer appropriate treatment as soon as possible.

Missed dose of Gopten 0.5

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Gopten 0.5 can cause side effects, although not everybody gets them.
During clinical trials and after the marketing of Gopten 0.5 for various indications, the following side effects have been observed:
Frequent(in 1 to 10 patients out of 100):
˗
headache, dizziness of central origin;
˗
hypotension;
˗
cough;
˗
weakness.
Uncommon(in 1 to 10 patients out of 1000):
˗
upper respiratory tract infection;
˗
insomnia, decreased libido;
˗
drowsiness;
˗
dizziness of peripheral origin;
Page 6 9
˗
palpitations (feeling of irregular or rapid heartbeat);
˗
sudden flushing of the skin with a feeling of heat;
˗
upper respiratory tract inflammation, upper respiratory tract congestion;
˗
nausea, diarrhea, abdominal pain, constipation, gastrointestinal disturbances;
˗
rash, itching;
˗
back pain, muscle cramps, limb pain;
˗
erectile dysfunction;
˗
malaise, chest pain, peripheral edema, feeling abnormal.
Rare(in 1 to 10 patients out of 10,000):
˗
urinary tract infection, bronchitis, pharyngitis;
˗
leukopenia (decrease in white blood cell count), anemia, blood platelet disorders, white blood cell disorders;
˗
hypersensitivity;
˗
abnormal laboratory test results: hyperglycemia (elevated blood sugar), hyponatremia (low sodium levels in the blood), hypercholesterolemia (elevated cholesterol in the blood), hyperlipidemia (elevated triglycerides and cholesterol in the blood), hyperuricemia (elevated uric acid in the blood);
˗
gout, loss of appetite, increased appetite, abnormal liver function;
˗
hallucinations, depression, sleep disturbances, anxiety, agitation, apathy;
˗
cerebrovascular incident, fainting, clonic muscle spasms, paresthesia (numbness, tingling of one or more limbs), migraine, migraine without aura, taste disturbances;
˗
blepharitis, conjunctival edema, vision disturbances, eye disorders;
˗
tinnitus;
˗
myocardial infarction, myocardial ischemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia;
˗
hypertension, cerebrovascular disorders (angiopathy), orthostatic hypotension (a sudden drop in blood pressure caused by a change in position from lying to standing), peripheral vascular disorders, varicose veins;
˗
dyspnea, epistaxis, pharyngitis, cough with expectoration, respiratory disorders;
˗
hematemesis, gastritis, abdominal pain, vomiting, nausea, dry mouth, flatulence;
˗
hepatitis;
˗
angioedema, psoriasis, hyperhidrosis, rash, acne, dry skin, skin disorders;
˗
arthralgia, bone pain, arthritis;
˗
renal failure, azotemia (elevated levels of nitrogen compounds in the blood), polyuria, nocturia;
˗
fish-scale disease, fatigue, edema;
˗
increased bilirubin levels (jaundice);
˗
injury.
Very rare(in less than 1 patient out of 10,000):
˗
bile duct obstruction (cholestasis);
˗
skin inflammation;
˗
abnormal laboratory test results (elevated gamma-glutamyltransferase in the blood, elevated lipase, elevated immunoglobulin levels).
Side effects with unknownfrequency (frequency cannot be determined from available data):
˗
sinusitis*, rhinitis*, glossitis*;
˗
pancytopenia (decrease in red, white, and platelet blood cell count), agranulocytosis (significant, rapidly progressing decrease in granulocyte count), thrombocytopenia (decrease in platelet count), hemolytic anemia*;
Page 7 9
˗
hyperkalemia (elevated potassium levels in the blood);
˗
confusional state*;
˗
transient ischemic attack, cerebral hemorrhage, balance disorders;
˗
blurred vision*;
˗
atrioventricular block, arrhythmias, cardiac arrest;
˗
bronchospasm;
˗
intestinal obstruction, pancreatitis, angioedema of the intestine*;
˗
jaundice;
˗
Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*;
˗
myalgia;
˗
fever;
˗
abnormal laboratory test results (abnormal liver function tests, decreased platelet count, elevated creatinine levels in the blood, elevated urea levels in the blood, elevated dehydrogenase levels, elevated alkaline phosphatase levels, elevated aspartate aminotransferase levels, elevated alanine aminotransferase levels, elevated liver enzyme levels, decreased hemoglobin levels, decreased hematocrit values, abnormal ECG recordings).

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor, pharmacist, or nurse. 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
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gopten 0.5

Do not store above 25°C.
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. The expiry date refers to the last day of the month.
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 packaging and other information

What Gopten 0.5 contains

• The active substance of Gopten 0.5 is trandolapril. Each hard capsule contains 0.5 mg of trandolapril.

Page 8 9

• The other ingredients are: cornstarch, lactose monohydrate, povidone K 25, sodium stearyl fumarate, and the capsule shell: gelatin, titanium dioxide, erythrosine, yellow iron oxide, sodium lauryl sulfate.

What Gopten 0.5 looks like and contents of the pack

Gopten 0.5 is available in the form of hard capsules. The capsule cap is yellow, and the body is red.
Packaging:
28 pieces.
PVC-PVDC-Aluminum blisters in a cardboard box.
Gopten 2.0, hard capsules, 2 mg, and Gopten 4.0, hard capsules, 4 mg, are also available on the market.
For more detailed information, please contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Spain, the country of export:

Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland

Manufacturer:

Mylan Hungary Kft., Mylan utca 1, Komárom, 2900, Hungary

Parallel importer:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Spanish marketing authorization number, country of export: 709220.9

Parallel import authorization number: 25/25

Date of leaflet approval: 22.01.2025

[Information about the trademark]
Page 9 9