Gopten 2,0

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Gopten 2.0(Gopten 2 mg)

2 mg, hard capsules

Trandolapril
Gopten 2.0 and Gopten 2 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 as yours.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Gopten 2.0 and what is it used for
• 2. Important information 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 packaging and other information

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

The active substance of Gopten 2.0 hard capsules is trandolapril. The medicine belongs to the group of angiotensin-converting enzyme inhibitors (ACE inhibitors). Trandolapril is rapidly absorbed from the gastrointestinal tract and then undergoes conversion in the liver to a highly potent and long-acting active metabolite - trandolaprilat.
Taking trandolapril in therapeutic doses in 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 8th and 12th hour after administration.
Gopten 2.0 is used to treat:

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

2. Important information before taking Gopten 2.0

When not to take Gopten 2.0

• If you are allergic to trandolapril or any of the other ingredients of this medicine (listed in section 6) or to another angiotensin-converting enzyme inhibitor.
• If you have 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 2.0 belongs.
• If you have been diagnosed with hereditary or idiopathic (of unknown cause) angioedema.
• In women after the third month of pregnancy. You should also avoid taking Gopten 2.0 in early pregnancy (see "Pregnancy and breastfeeding").
• If you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine containing aliskiren.
• If you have taken or are 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, such as the throat).

Warnings and precautions

Before starting treatment with Gopten 2.0, you should discuss it with your doctor, pharmacist, or nurse.

• If you are to undergo desensitization to animal venom (including insect venom), you should consider temporary discontinuation of the medicine.
• If you are undergoing dialysis therapy (hemodialysis or low-density lipoprotein apheresis).
• If you have been diagnosed with liver failure.
• If you have been diagnosed with kidney problems, congestive heart failure, unilateral or bilateral renal artery stenosis, renal artery stenosis of a single functioning kidney, and after kidney transplantation, as there is a risk of worsening kidney function.
• If you have kidney failure and experience an increase in serum potassium levels (hyperkalemia).
• If you have 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 2.0, the doctor may recommend discontinuation of diuretics and supplementation of fluid and/or sodium deficiency. Similar precautions should be taken in patients with coronary heart disease or cerebrovascular disorders, in whom excessive blood pressure lowering may cause myocardial infarction or cerebrovascular incident.
• In patients with kidney failure, especially those with collagenosis (e.g., systemic lupus erythematosus and 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 2.0 belongs. The decrease in the number of granulocytes is a transient phenomenon after discontinuation of the angiotensin-converting enzyme inhibitor.
• In patients with collagenosis, especially those with kidney failure, and in cases of concomitant use of glucocorticoids and antimetabolites, the doctor will recommend regular monitoring of white blood cell count and urine protein levels.
• If you experience an acute allergic reaction - angioedema of the face, limbs, tongue, larynx, and/or throat after taking Gopten 2.0, you should immediately consult a doctor. You should immediately discontinue the medicine and monitor the patient's condition 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. You should be cautious in patients with hereditary or idiopathic angioedema.
• If you experience abdominal pain (with or without nausea and vomiting) after taking Gopten 2.0, as medicines from the group to which Gopten 2.0 belongs may cause angioedema of the intestines. If such symptoms occur, you should immediately consult a doctor, as prompt treatment may be necessary.
• In patients with hypertensive nephrosclerosis.
• If you experience an increase in serum potassium levels (hyperkalemia) after taking the medicine, you should have regular monitoring of this element in the serum. Risk factors for hyperkalemia include kidney failure, use of potassium-sparing diuretics, concomitant administration of drugs used to treat hypokalemia, diabetes, and/or left ventricular dysfunction after myocardial infarction.

If you are to undergo surgery or anesthesia with the use of medicines that cause hypotension.

• If you are 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 you have kidney problems related to diabetes,
• aliskiren.
• If you are taking any of the following medicines, as the risk of angioedema (sudden swelling of tissue, e.g., in the throat) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium).
See also the subsection "When not to take Gopten 2.0".

Important information

• Gopten 2.0 should not be taken by patients with aortic or mitral stenosis.
• You should inform your doctor if you are taking diuretics, especially if you have recently started taking them, as concomitant use with Gopten 2.0 may cause a significant decrease in blood pressure.
• You should inform your doctor if you suspect (or plan) pregnancy. Gopten 2.0 is not recommended during the first three months of pregnancy and should not be taken after 3 months of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
• Patients taking medicines from the group to which Gopten 2.0 belongs may experience a dry, persistent cough without expectoration. This symptom subsides after discontinuation of the medicine.
• Gopten 2.0 is not recommended during breastfeeding, especially in newborns or premature infants. The doctor will recommend other 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

You should tell your doctor or pharmacist about all the medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
You should inform your doctor if you 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);
• 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);

In patients with left ventricular dysfunction after myocardial infarction, no clinically significant interactions have been observed when Gopten 2.0 was administered in combination with:

• thrombolytic agents (used to treat thrombosis and embolism);
• acetylsalicylic acid;
• beta-adrenergic blockers (used to treat heart disease and hypertension);
• calcium channel blockers (used to treat hypertension and heart disease);
• nitrates (used to treat coronary heart disease);
• anticoagulants (medicines that inhibit blood clotting);
• digoxin (a medicine used to treat congestive heart failure);
• cimetidine (a medicine used to treat gastric and duodenal ulcers, gastroesophageal reflux disease).

Your doctor may recommend a dose change and/or other precautions:

• If you are taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also the subsections "When not to take Gopten 2.0" and "Warnings and precautions").

Gopten 2.0 with food and drink

Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
You should inform your doctor if you suspect (or plan) pregnancy. Your doctor will usually recommend discontinuation of Gopten 2.0 before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Gopten 2.0.

Gopten 2.0 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.

You should inform your doctor if you are breastfeeding or plan to breastfeed. Gopten 2.0 is not recommended during breastfeeding, especially in newborns or premature infants; your doctor may recommend another medicine.

Driving and using machines

Gopten 2.0 may affect your ability to drive and use machines, especially during the initial treatment period, after changing your current 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 2.0 contains lactose monohydrate and sodium

If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means that the medicine is considered "sodium-free".

3. How to take Gopten 2.0

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Oral administration.

Adults

Hypertension
In adult patients not taking diuretics, without congestive heart failure, and without kidney or liver problems, the recommended initial dose is 0.5 mg to 2 mg once daily. A dose of 0.5 mg is effective in only 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 to 8 mg per 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 concomitant administration of 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, reduction of the dose of concomitantly administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 2.0 can only be reduced 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 concomitantly with diuretics, with congestive heart failure, or with kidney or liver problems.
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 2.0 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 problems
In patients with a creatinine clearance (a measure of kidney function) of 30 to 70 ml/min, the recommended dose is 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 0.5 mg once daily, and the dose is then 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 adjust the initial dose.
Dialysis patients
In dialysis patients, blood pressure should be closely monitored, and the dose of the medicine should be adjusted as necessary.
Patients with liver problems
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 2.0 in children have not been studied, and therefore, its use is not recommended.

Overdose of Gopten 2.0

In case of overdose, the following symptoms may occur: severe hypotension, shock, stupor, slow heart rate, electrolyte disturbances, and kidney failure. After an overdose, the patient should be closely monitored, preferably in an intensive care unit. The doctor should frequently monitor electrolyte and creatinine levels in the serum. 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 2.0

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Gopten 2.0 can cause side effects, although not everybody gets them.
During clinical trials and after the marketing of Gopten 2.0 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,
• palpitations (feeling of irregular or rapid heartbeat),
• flushing,
• upper respiratory tract inflammation, nasal 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), hypercholesterolemia (elevated cholesterol), hyperlipidemia (elevated triglycerides and cholesterol), hyperuricemia (elevated uric acid),
• gout, anorexia, increased appetite, abnormal liver function,
• hallucinations, depression, sleep disturbances, anxiety, agitation, apathy,
• cerebrovascular incident, syncope, 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, oropharyngeal pain, cough with expectoration, respiratory disturbances,
• hematemesis, gastritis, abdominal pain, vomiting, nausea, dry mouth, flatulence,
• hepatitis,
• angioedema, psoriasis, hyperhidrosis, rash, acne, dry skin, skin disorders,
• arthralgia, bone pain, osteoarthritis,
• kidney failure, azotemia (elevated levels of nitrogen compounds in the blood), polyuria, nocturia,
• congenital vascular malformation, ichthyosis,
• edema, fatigue,
• increased bilirubin levels (jaundice),
• injury.

Very rare(in less than 1 patient out of 10,000):

• cholestasis (bile flow obstruction),
• dermatitis,
• abnormal diagnostic test results (elevated γ-glutamyltransferase, 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;
• hyperkalemia (elevated potassium levels);
• confusional state;
• transient ischemic attack, cerebrovascular hemorrhage, balance disturbances;
• blurred vision;
• atrioventricular block, arrhythmia, cardiac arrest;
• bronchospasm;
• intestinal obstruction, pancreatitis, angioedema of the intestines;
• jaundice;
• Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, urticaria, alopecia, psoriasiform dermatitis;
• myalgia;
• fever;
• abnormal diagnostic test results (abnormal liver function tests, thrombocytopenia, elevated creatinine, elevated urea, elevated lactate dehydrogenase, elevated alkaline phosphatase, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated liver enzyme levels, decreased hemoglobin, decreased hematocrit, abnormal ECG).

*Side effects related to angiotensin-converting enzyme inhibitors as a group of medicines

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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 side effects, you can help gather more information on the safety of this medicine.

5. How to store Gopten 2.0

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 stated.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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 2.0 contains

• The active substance of Gopten 2.0 is trandolapril. Each hard capsule contains 2 mg of trandolapril.
• The other ingredients are: cornstarch, lactose monohydrate, povidone K 25, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide (E 171), erythrosine, yellow iron oxide (E 172), sodium lauryl sulfate.

What Gopten 2.0 looks like and contents of the pack

Gopten 2.0 is available in the form of hard capsules. The capsule cap and body are red.
Packaging:
28 pieces.
PVC/PVDC/Al blisters in a cardboard box.
Gopten 0.5, hard capsules, 0.5 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 parallel importer.

Marketing authorization holder in Portugal, the country of export:

BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 e 7.4
1990-095 Lisbon, Portugal

Manufacturer:

Mylan Hungary Kft.
Mylan utca 1
Komárom 2900, Hungary

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Portugal, the country of export:2181485

Parallel import authorization number: 177/23

Date of leaflet approval: 30.08.2023

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