Gopten 4,0

Patient Information Leaflet: Information for the Patient

Gopten 4.0, 4 mg, hard capsules
Trandolapril

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Gopten 4.0 and what is it used for
• 2. Important information before taking Gopten 4.0
• 3. How to take Gopten 4.0
• 4. Possible side effects
• 5. How to store Gopten 4.0
• 6. Contents of the pack and other information

1. What is Gopten 4.0 and what is it used for

The active substance of Gopten 4.0 hard capsules is trandolapril. The medicine belongs to a group of angiotensin-converting enzyme inhibitors (ACE inhibitors). Trandolapril is rapidly absorbed from the gastrointestinal tract, and then in the liver, it is converted to a highly potent 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 appears after one hour and lasts for 24 hours, with maximum effect observed between the 8th and 12th hour after administration.
Gopten 4.0 is used in the treatment of:

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

2. Important information before taking Gopten 4.0

When not to take Gopten 4.0

• If you are allergic to trandolapril or any of the other ingredients of this medicine (listed in section 6) or to any other ACE 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 same group as Gopten 4.0.
• If you have hereditary or idiopathic (of unknown cause) angioedema.
• In women after the third month of pregnancy. It is also recommended to avoid taking Gopten 4.0 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, in areas such as the throat).

Warnings and precautions

Before starting treatment with Gopten 4.0, discuss it with your doctor, pharmacist, or nurse.

• If you are to undergo desensitization to animal venom (including insect venom), consider temporary discontinuation of the medicine.
• If you are undergoing dialysis therapy (hemodialysis or low-density lipoprotein apheresis - LDL).
• If you have liver failure.
• If you have kidney problems, congestive heart failure, unilateral or bilateral renal artery stenosis, stenosis of the artery of a single functioning kidney, and after kidney transplantation, as there is a risk of worsening kidney function.
• If you have kidney failure and 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 4.0, the doctor may recommend discontinuing diuretics and supplementing 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 failure, especially those with collagen diseases (e.g., systemic lupus erythematosus and systemic sclerosis), 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 an ACE inhibitor. The decrease in granulocyte count is a transient phenomenon after discontinuation of the ACE inhibitor.
• In patients with collagen diseases, especially those with kidney failure and 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 4.0, seek medical attention immediately. The medicine should be discontinued immediately, and the patient's condition should be monitored until the swelling subsides. Angioedema of 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 you experience abdominal pain (with or without nausea and vomiting) after taking Gopten 4.0, as ACE inhibitors may cause angioedema of the intestines. If such symptoms occur, seek medical attention immediately, as prompt treatment may be necessary.
• In patients with hypertensive nephrosclerosis.
• If you experience an increase in serum potassium levels (hyperkalemia) after taking Gopten 4.0, regular monitoring of potassium levels in the blood is recommended. 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 using drugs 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 diabetic kidney disease,
• aliskiren.
• If you are 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),
• vildagliptin, a medicine used to treat diabetes.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the section "When not to take Gopten 4.0".

Important information

• Gopten 4.0 should not be taken by patients with aortic stenosis or outflow tract obstruction.
• Tell your doctor if you are taking diuretics, especially if you have recently started taking them, as concomitant use with Gopten 4.0 may cause a significant decrease in blood pressure.
• Tell your doctor if you suspect or plan to become pregnant. Gopten 4.0 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 (see "Pregnancy and breastfeeding").
• Patients taking ACE inhibitors, such as Gopten 4.0, may experience a dry, persistent cough without expectoration. This symptom disappears after discontinuation of the medicine.
• Gopten 4.0 should not be taken during breastfeeding, especially in newborns or premature infants. The doctor will recommend other medicines during breastfeeding.

Children

The safety and efficacy of Gopten 4.0 in children have not been studied, and therefore, its use is not recommended.

Gopten 4.0 and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Tell your doctor if you are taking any of the following medicines, as special caution is required:

• neprilysin inhibitors, such as racecadotril, due to increased risk of angioedema (sudden swelling of tissue, e.g., in the throat area)
• diuretics
• potassium-sparing diuretics, such as spironolactone, canrenone, amiloride, triamterene, and 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 prevent blood clotting)

In patients with left ventricular dysfunction after myocardial infarction, no clinically significant interactions were observed when Gopten 4.0 was administered concomitantly with:

• thrombolytic agents (used to treat blood clots and embolisms)
• acetylsalicylic acid
• beta-blockers (used to treat heart diseases and hypertension)
• calcium channel blockers (used to treat hypertension and heart diseases)
• nitrates (used to treat coronary heart disease)
• anticoagulants (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)

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 sections "When not to take Gopten 4.0" and "Warnings and precautions").

Gopten 4.0 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 baby, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you suspect or plan to become pregnant. Your doctor will usually recommend stopping Gopten 4.0 before planned pregnancy or as soon as possible after confirmation of pregnancy and will recommend taking another medicine instead of Gopten 4.0.

Gopten 4.0 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.
Tell your doctor if you are breastfeeding or plan to breastfeed. Gopten 4.0 should not be taken during breastfeeding, especially in newborns or premature infants. The doctor may recommend taking another medicine.

Driving and using machines

Gopten 4.0 may affect your ability to drive and use machines, especially during the initial treatment period, after changing your previous medicine, and when consuming alcohol.
It is not recommended to drive or operate machinery for a few hours after taking the first dose or after increasing the dose of the medicine.

Gopten 4.0 contains lactose monohydrate and sodium

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

3. How to take Gopten 4.0

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Oral administration

Adults

Hypertension
In adult patients not taking diuretics, without congestive heart failure, and without kidney or liver disease, 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 increased, every one to four weeks, depending on the patient's response to the medicine, 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 patient's response to a dose of 4 mg to 8 mg of trandolapril per day is not satisfactory, the doctor will consider concomitant administration of diuretics and/or calcium channel blockers.
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 4.0 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 disease. The dose is adjusted according to blood pressure values.
Patients taking diuretics
In dehydrated patients and those with sodium deficiency, the doctor may discontinue the diuretic 2-3 days before starting Gopten 4.0 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 30-70 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 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 carefully monitored, and the dose of Gopten 4.0 should be adjusted as needed.
Patients with liver problems
Treatment should be started with a dose of 0.5 mg once daily, under close medical supervision.

Use in children

The safety and efficacy of Gopten 4.0 in children have not been studied, and therefore, its use is not recommended.

Overdose of Gopten 4.0

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 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 4.0

Do not take a double dose to make up for a forgotten dose.

4. Possible side effects

Like all medicines, Gopten 4.0 can cause side effects, although not everybody gets them.
During clinical trials and after the marketing of Gopten 4.0, the following side effects have been observed:
Common(in 1 to 10 patients out of 100):
˗
headache, dizziness of central origin
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hypotension
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cough
˗
weakness
Uncommon(in 1 to 10 patients out of 1,000):
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upper respiratory tract infection
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insomnia, decreased libido
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drowsiness
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dizziness of peripheral origin
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palpitations (feeling of irregular or rapid heartbeat)
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flushing
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upper respiratory tract inflammation, nasal congestion
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nausea, diarrhea, abdominal pain, constipation, gastrointestinal disturbances
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rash, itching
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back pain, muscle cramps, limb pain
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erectile dysfunction
˗
malaise, chest pain, peripheral edema, feeling abnormal
Rare(in 1 to 10 patients out of 10,000):
˗
urinary tract infection, bronchitis, pharyngitis
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leukopenia (decrease in white blood cell count), anemia, blood platelet disorders, white blood cell disorders
˗
hypersensitivity
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abnormal laboratory test results: hyperglycemia (elevated blood sugar), hyponatremia (low sodium levels), hypercholesterolemia (elevated cholesterol), hyperlipidemia (elevated triglycerides and cholesterol), hyperuricemia (elevated uric acid)
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gout, anorexia, increased appetite, abnormal liver function tests
˗
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
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blepharitis, conjunctivitis, visual disturbances, eye disorders
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tinnitus
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myocardial infarction, myocardial ischemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia
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hypertension, cerebrovascular disorders (angiopathy), orthostatic hypotension (sudden drop in blood pressure when changing position from lying to standing), peripheral vascular disorders, varicose veins
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dyspnea, epistaxis, pharyngitis, oropharyngeal pain, cough with expectoration, respiratory disorders
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hematemesis, gastritis, abdominal pain, vomiting, nausea, dry mouth, flatulence
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hepatitis
˗
angioedema, psoriasis, hyperhidrosis, urticaria, skin disorders
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arthralgia, myalgia, osteoarthritis
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kidney failure, azotemia (elevated nitrogen compounds in the blood), polyuria, frequent urination
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congenital vascular malformation, fish-scale skin
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edema, fatigue
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increased bilirubin levels (jaundice)
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injury
Very rare(in less than 1 patient out of 10,000):
˗
cholestasis (bile flow obstruction)
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skin inflammation
˗
abnormal laboratory test results (elevated γ-glutamyltransferase, elevated lipase, elevated immunoglobulins)
Side effects with unknownfrequency (frequency cannot be estimated from available data):
˗
sinusitis, rhinitis, glossitis
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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
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hyperkalemia (elevated potassium levels)
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confusional state
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transient ischemic attack, cerebral hemorrhage, cerebrovascular disorders
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blurred vision
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atrioventricular block, arrhythmias, cardiac arrest
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bronchospasm
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intestinal obstruction, pancreatitis, angioedema of the intestines
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jaundice (yellowing of the skin and eyes)
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Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, urticaria, alopecia, psoriatic-like skin inflammation
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myalgia (muscle pain)
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fever
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abnormal laboratory test results (abnormal liver function tests, decreased platelet count, elevated creatinine, elevated urea, elevated lactate dehydrogenase, elevated alkaline phosphatase, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated liver enzymes, decreased hemoglobin, decreased hematocrit, abnormal ECG)
*Side effects related to ACE inhibitors as a class of medicines
Reporting side effects
If you experience any side effects, including those not listed in this leaflet, please inform 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gopten 4.0

Do not store above 25°C.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Gopten 4.0 contains

• The active substance of Gopten 4.0 is trandolapril. Each hard capsule contains 4 mg of trandolapril.
• The other ingredients are: cornstarch, lactose monohydrate, povidone (K25), sodium stearyl fumarate, and the ingredients of the capsule shell: gelatin, titanium dioxide (E171), erythrosine (E127), iron oxide black (E172), iron oxide yellow (E172), sodium lauryl sulfate.

What Gopten 4.0 looks like and contents of the pack

Gopten 4.0 is available in the form of hard capsules. The capsule cap is burgundy, and the body is red.
Packaging:
28 capsules.
PVC/PVDC/Aluminum blisters in a cardboard box.
Gopten 0.5, hard capsules, 0.5 mg, and Gopten 2.0, hard capsules, 2 mg, are also available on the market.

Marketing authorization holder

Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw

Importer

Mylan Hungary Kft.
Mylan utca 1.
Komárom, 2900
Hungary
To obtain more detailed information, please contact the marketing authorization holder:
Viatris Healthcare Sp. z o.o.
ul. Postępu 21B
02-676 Warsaw
tel.: (22) 546 64 00
Date of last revision of the leaflet:02/2024