Gopten 2.0

Package leaflet: Information for the patient

Warning! Keep the package leaflet. Information on the immediate packaging is in a foreign language.
Gopten 2.0 (Gopten 2 mg)
2 mg, hard capsules
Trandolaprilum
Gopten 2.0 and Gopten 2 mg are different trade names for the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm others, 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.

Table of contents

1. What Gopten 2.0 is and what it is used for
2. What you need to know before taking Gopten 2.0
3. How to take Gopten 2.0
4. Possible side effects
5. How to store Gopten 2.0
6. Contents of the pack and other information

1. What Gopten 2.0 is and what it is used for

The active substance in Gopten 2.0 hard capsules is trandolapril. This medicine belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors. Trandolapril is rapidly absorbed from the gastrointestinal tract and is then converted in the liver into its potent and long-acting active metabolite – trandolaprilat.

When administered in therapeutic doses to patients with hypertension, trandolapril causes a significant reduction in arterial blood pressure measured both in the supine and standing positions. The blood pressure-lowering effect becomes apparent within one hour after administration and lasts for 24 hours, with maximum effect observed between 8 and 12 hours after dosing.

Gopten 2.0 is used for the treatment of:

• Mild to moderate arterial hypertension,
• Left ventricular dysfunction following myocardial infarction,
• Symptomatic heart failure.

2. Important information before using Gopten 2.0

When not to use Gopten 2.0

• 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 (ACE) inhibitor.
• If the patient has previously experienced angioedema (swelling of any body area, which, in case of swelling of the throat and larynx, may impair swallowing and breathing) after taking another medicine belonging to the same class as Gopten 2.0.
• If the patient has been diagnosed with hereditary or idiopathic (of unknown cause) angioedema.
• In women during the third trimester of pregnancy. Use of Gopten 2.0 should also be avoided 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 medicine containing sacubitril and valsartan (used in the treatment of certain types of chronic (long-term) heart failure in adults), because the risk of angioedema (rapid swelling of subcutaneous tissue, e.g. in the throat area) increases.

Warnings and precautions
Before starting treatment with Gopten 2.0, discuss this with your doctor, pharmacist, or nurse.

• If the patient is to undergo venom immunotherapy (e.g. for insect stings), temporary discontinuation of the medicine should be considered.
• If the patient is undergoing dialysis therapy (hemodialysis or LDL apheresis).
• If the patient has been diagnosed with liver impairment.
• If the patient has been diagnosed with kidney dysfunction, congestive heart failure, unilateral or bilateral renal artery stenosis, stenosis of the renal artery of a single functioning kidney, or if the patient has undergone kidney transplantation, because there is a risk of worsening kidney function.
• If the patient with kidney dysfunction develops increased serum potassium concentration (hyperkalemia).
• If the patient has risk factors for hypotension, such as hypovolemia (reduced blood volume), sodium deficiency due to prolonged use of diuretics, low-sodium diet, dialysis, or diarrhea or vomiting. In such patients, before starting Gopten 2.0, the doctor may recommend discontinuation of diuretics and/or fluid and (or) sodium supplementation. Similar precautions should be taken in patients with ischemic heart disease or cerebrovascular disorders, in whom excessive reduction in blood pressure may lead to myocardial infarction or cerebrovascular event.
• In patients with kidney dysfunction, especially those suffering from collagenoses (e.g. systemic lupus erythematosus or systemic sclerosis), because after administration of medicines from the same class as Gopten 2.0, agranulocytosis (reduction in granulocyte count – a type of white blood cell) and bone marrow suppression may occur. Granulocyte reduction is transient and resolves after discontinuation of the ACE inhibitor.
• In patients with collagenoses, especially those complicated by kidney dysfunction and in cases of concomitant use of glucocorticosteroids and antimetabolites, the doctor may recommend regular monitoring of white blood cell count and urinary protein levels.
• If the patient develops acute allergic reaction – angioedema of the face, limbs, tongue, glottis, and (or) larynx – after taking Gopten 2.0, immediate medical attention is required. The medicine should be discontinued immediately and the patient’s condition monitored until the swelling resolves. Isolated facial angioedema usually resolves spontaneously. Angioedema involving the face and glottis may be life-threatening due to risk of airway obstruction. Caution is advised in patients with hereditary or idiopathic angioedema.
• If the patient develops abdominal pain (with or without nausea or vomiting) after taking Gopten 2.0, because medicines from the same class as Gopten 2.0 may cause intestinal angioedema. In such cases, immediate medical attention is required, as prompt treatment may be necessary.
• In patients with renovascular hypertension.
• If the patient develops increased serum potassium concentration (hyperkalemia) after taking Gopten 2.0, regular monitoring of serum potassium levels is recommended. Risk factors for hyperkalemia include: kidney dysfunction, use of potassium-sparing diuretics, concomitant administration of drugs used to treat hypokalemia, diabetes, and (or) left ventricular dysfunction after myocardial infarction.
• If the patient is to undergo surgery or anesthesia with drugs causing hypotension.
• 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 – 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, because the risk of angioedema (rapid swelling of tissue, e.g. in the throat area) may increase:
• racecadotril, a medicine used to treat diarrhea;
• medicines used to prevent organ transplant rejection and in cancer treatment (e.g. temsirolimus, sirolimus, everolimus);
• vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section “When not to use Gopten 2.0”.
Important information

• Gopten 2.0 should not be used in patients with aortic stenosis or outflow tract obstruction.
• Inform the doctor if the patient is taking diuretics, especially if recently initiated, because concomitant use with Gopten 2.0 may cause a marked drop in blood pressure.
• Inform the doctor about suspected (or planned) pregnancy. Use of Gopten 2.0 is not recommended during the first three months of pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).
• In patients taking medicines from the same class as Gopten 2.0, a dry, persistent cough without sputum production may occur. This symptom resolves after discontinuation of treatment with these medicines.
• Use of Gopten 2.0 during breastfeeding is not recommended, especially in newborns or preterm infants. The doctor may recommend alternative medicines during breastfeeding.

Children
The safety and efficacy of Gopten 2.0 in children have not been studied, and therefore its use is not recommended.

Gopten 2.0 and 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.
Inform the doctor if any of the following medicines are being used, because special caution is required:

• neprilysin inhibitors, such as racecadotril, due to 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 increasing blood potassium levels (e.g. trimethoprim and cotrimoxazole, used for bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• antidiabetic medicines (insulin or oral antidiabetic agents);
• lithium;
• anesthetics;
• allopurinol (used in the treatment of gout);
• procainamide (used to treat cardiac arrhythmias);
• cytostatics (used in cancer treatment);
• immunosuppressive medicines (affecting the immune system);
• systemic glucocorticosteroids (anti-inflammatory medicines);
• sympathomimetic medicines (vasoconstrictors);
• antipsychotics and tricyclic antidepressants;
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid used in higher doses as an anti-inflammatory, e.g. to relieve pain);
• medicines reducing gastric acidity;
• gold preparations administered by injection (used in the treatment of rheumatoid arthritis).

In patients with left ventricular dysfunction after myocardial infarction, no clinically significant interactions were observed when Gopten 2.0 was administered concomitantly with:

• thrombolytic agents (used in thrombosis and arterial/venous embolism);
• acetylsalicylic acid;
• β-adrenolytic agents (used in heart disease and hypertension);
• calcium channel blockers (used in hypertension and heart disease);
• nitrates (used in ischemic heart disease);
• anticoagulants (medicines inhibiting blood coagulation);
• digoxin (a medicine used in congestive heart failure);
• cimetidine (a medicine used in peptic ulcer disease, duodenal ulcer, and reflux esophagitis).

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

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “When not to use Gopten 2.0” and “Warnings and precautions”).

Gopten 2.0 with food and drink
Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor about suspected (or planned) pregnancy. The doctor will usually recommend discontinuing Gopten 2.0 before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
Gopten 2.0 is not recommended during the first three months of pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
Inform the doctor about breastfeeding or plans to breastfeed. Use of Gopten 2.0 is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant; the doctor may recommend an alternative medicine.

Driving and using machines
In some individuals, this medicine may affect the ability to drive and operate machinery, especially during the initial period of treatment, after changing from a previously used medicine, or when alcohol is consumed concurrently.
It is not advisable to drive or operate machinery for several hours after taking the first dose of the medicine or after increasing the dose.

Gopten 2.0 contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to take Gopten 2.0

This medicine should always be taken as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Oral administration.
Adults
Hypertension
In adult patients not taking diuretics, without congestive heart failure, or renal or hepatic impairment, the recommended initial dose is 0.5 mg to 2 mg once daily. The 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, depending on the patient's response to the drug, until the 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 response to trandolapril 4–8 mg daily is inadequate, your doctor may consider combining the drug with diuretics and/or calcium antagonists.
Left ventricular dysfunction following myocardial infarction
Treatment may be initiated as early as the third day after myocardial infarction, starting with a single dose of 0.5 mg to 1 mg once daily. The dose should be gradually increased up to a maximum of 4 mg once daily. Depending on the patient's response (e.g. occurrence of symptomatic hypotension), dose escalation may be temporarily discontinued.
In case of hypotension, your doctor may recommend, if possible, reducing the dose of concomitantly administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 2.0 may be reduced only if the above measures are ineffective or cannot be applied.
Elderly patients
In elderly patients with normal renal and hepatic function, there is no need to reduce the dose.
Caution is advised in elderly patients receiving concomitant diuretic therapy, those with congestive heart failure, or those with renal or hepatic impairment.
Dose selection should be based on blood pressure values.
Patients taking diuretics
In patients who are dehydrated or sodium-depleted, your doctor may discontinue the diuretic 2–3 days before starting Gopten 2.0 to reduce the risk of symptomatic hypotension. Diuretic therapy may be resumed later if necessary.
Heart failure
Treatment should be initiated with trandolapril 0.5 mg to 1 mg once daily under close medical supervision.
Patients with renal impairment
In patients with creatinine clearance (a laboratory marker of kidney function measured in blood tests) between 30 and 70 ml/min, the same dosing as in adults, including elderly patients, is recommended.
In patients with creatinine clearance below 30 ml/min, a reduced initial dose of trandolapril is recommended (i.e. initial dose of 0.5 mg once daily), followed by gradual dose escalation to achieve the desired therapeutic effect. Treatment in these patients should be closely monitored by a physician.
In patients with creatinine clearance above 30 ml/min, no adjustment of the initial dose is required.
Patients undergoing dialysis
In dialyzed patients, blood pressure should be closely monitored and the dose of the drug adjusted accordingly if necessary.
Patients with hepatic impairment
Treatment should be initiated with a dose of 0.5 mg once daily and conducted under close medical supervision.
Use in children
The safety and efficacy of this medicine in children have not been studied and therefore its use is not recommended.
Taking more Gopten 2.0 than recommended
In case of overdose, the following symptoms may occur: severe hypotension, shock, stupor, bradycardia (slow heart rate), disturbances in blood electrolyte concentrations, and renal failure.
After an overdose, the patient should be closely monitored, preferably in an intensive care unit. The doctor should frequently monitor serum electrolyte and creatinine levels. Treatment depends on the severity of symptoms. If the drug was recently ingested, the doctor may initiate procedures to remove the drug (e.g. induced vomiting, gastric lavage, administration of adsorbent agents and sodium sulfate).
In case of symptomatic hypotension, the patient should be placed immediately in a shock position. The doctor should initiate appropriate treatment as quickly as possible.
Missed dose of Gopten 2.0
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
During clinical trials and after marketing of Gopten 2.0 for various indications, the following adverse effects have been observed:
Common (in 1 to 100 patients out of 100 patients):
˗ headache, central dizziness;
˗ hypotension;
˗ cough;
˗ fatigue.
Uncommon (in 1 to 1000 patients out of 1000 patients):
˗ upper respiratory tract infection;
˗ insomnia, decreased libido;
˗ drowsiness;
˗ peripheral dizziness;
˗ palpitations (sensation of irregular or rapid heartbeat);
˗ sudden flushing with sensation of warmth;
˗ upper respiratory tract inflammation, congestion of upper respiratory tract;
˗ nausea, diarrhoea, stomach and intestinal pain, constipation, gastrointestinal disturbances;
˗ rash, itching;
˗ back pain, muscle cramps, limb pain;
˗ erectile dysfunction;
˗ malaise, chest pain, peripheral oedema, feeling unwell.
Rare (in 1 to 10,000 patients out of 10,000 patients):
˗ urinary tract infection, bronchitis, pharyngitis;
˗ leukopenia (reduced number of white blood cells in blood), anaemia, platelet disorders, white blood cell disorders;
˗ hypersensitivity;
- abnormal laboratory test results: increased blood glucose concentration (hyperglycaemia), decreased blood sodium concentration (hyponatraemia), increased blood cholesterol concentration (hypercholesterolaemia), increased blood triglyceride and cholesterol concentration (hyperlipidaemia), increased blood uric acid concentration (hyperuricaemia);
˗ gout, loss of appetite, increased appetite, abnormal enzyme activity;
˗ hallucinations, depression, sleep disorders, restlessness, agitation, apathy;
˗ cerebrovascular incident, fainting, clonic muscle seizures, paraesthesia (numbness, tingling in one or more limbs), migraine, migraine without aura, taste disturbances;
˗ eyelid inflammation, conjunctival oedema, visual disturbances, eye disorders;
˗ tinnitus;
˗ myocardial infarction, myocardial ischaemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia;
˗ hypertension, pathological changes in cerebral vessels (angiopathy), orthostatic hypotension (sudden drop in blood pressure caused by changing position from lying to standing), peripheral vascular disorders, varicose veins;
- shortness of breath, nosebleed, sore throat, pain in oral part of throat, cough with expectoration, breathing disorders;
- haematemesis, gastric mucosal inflammation, abdominal pain, vomiting, dyspepsia, dryness of oral mucosa, flatulence;
- hepatitis;
- angioedema, psoriasis, excessive sweating, rash, acne, dry skin, skin disorders;
- joint pain, bone pain, osteoarthritis;
- renal failure, azotaemia (increased concentration of nitrogen compounds in blood), polyuria, frequent urination;
- congenital arterial malformation, ichthyosis;
- oedema, feeling of fatigue;
- increased bilirubin concentration (bile pigment);
- injury.
Very rare (in less than 1 patient out of 10,000 treated):
- cholestasis (biliary stasis);
- dermatitis;
- abnormal diagnostic test results (increased blood γ-glutamyltransferase activity, increased lipase activity, increased immunoglobulin concentration).
Adverse effects occurring at unknown frequency (frequency cannot be determined from available data):
- sinusitis*, rhinitis*, glossitis*;
- pancytopenia (reduction in red blood cells, white blood cells and platelets), agranulocytosis (significant, rapidly progressing reduction in granulocytes), thrombocytopenia, haemolytic anaemia*;
- increased serum potassium concentration (hyperkalaemia);
- confusion*;
- transient ischaemic attack, cerebral haemorrhage, balance disorders;
- blurred vision*;
- atrioventricular block, cardiac arrhythmias, cardiac arrest;
- bronchospasm;
- intestinal obstruction, pancreatitis, angioedema of intestine*;
- yellowing of skin or eyes (jaundice);
- Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*;
- muscle pain;
- fever;
- abnormal diagnostic test results (abnormal liver function tests, thrombocytopenia, increased blood creatinine concentration, increased blood urea concentration, increased lactate dehydrogenase activity, increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased liver enzyme activity, decreased haemoglobin concentration, decreased haematocrit value, abnormal ECG recording).
*Adverse effects related to angiotensin-converting enzyme inhibitors as a class of medicines
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store Gopten 2.0

Do not store above 25°C. Keep in the original packaging to protect from light.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Gopten 2.0 contains

• The active substance is trandolapril. Each hard capsule contains 2 mg of trandolapril.
• The other ingredients are: maize starch, lactose monohydrate, povidone K 25, sodium stearyl fumarate, and the capsule coating: gelatin, titanium dioxide (E171), erythrosine (E127), yellow iron oxide (E172), sodium lauryl sulfate.

What Gopten 2.0 looks like and contents of the pack
Gopten 2.0 is available as hard capsules. The cap and body of the capsule are red.
Pack size:
28 capsules
PVC/PVDC/Al blisters in a cardboard box.
Other strengths available on the market are Gopten 0.5, hard capsules, 0.5 mg and Gopten 4.0, hard capsules, 4 mg.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing Authorisation Holder in Lithuania, country of export:
Viatris SIA
Mūkusalas 101, Riga LV 1004, Latvia
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, Poland
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation Number in Lithuania, country of export: LT/1/94/0356/002
Parallel Import Authorisation Number: 113/24
Translation of the weekday symbols printed next to each capsule in the immediate packaging:
Pirm./Pirmd./E - Monday
Antr./Otrd./T - Tuesday
Treč./Trešd./K - Wednesday
Ketv./Ceturtd./N - Thursday
Penk./Piektd./R - Friday
Šešt./Sestd./L - Saturday
Sekm./Svētd./P - Sunday