Gopten 0,5

Leaflet accompanying the packaging: patient information

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

Gopten 0.5 (Gopten 0.5 mg capsule)

0.5 mg, hard capsules

Trandolapril
Gopten 0.5 and Gopten 0.5 mg capsule are different trade names for the same drug.

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 or pharmacist. 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. Package contents 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 drug belongs to the group of angiotensin-converting enzyme (ACE) inhibitors. Trandolapril is rapidly absorbed from the gastrointestinal tract and then undergoes conversion in the liver to a 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 maximum effect observed between 8 and 12 hours 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 drug from the group to which Gopten 0.5 belongs.
• If the patient has been diagnosed with hereditary or idiopathic (of unknown cause) angioedema.
• In women after the third month of pregnancy. It is also recommended to avoid taking Gopten 0.5 in early pregnancy (see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney problems 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, 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 treatment with animal venom (including insect venom), it is recommended to temporarily discontinue the medicine.
• If the patient is undergoing dialysis therapy (hemodialysis or low-density lipoprotein apheresis - LDL).
• If the patient has been diagnosed with liver failure.
• If the patient has been diagnosed with kidney problems, congestive heart failure, unilateral or bilateral renal artery stenosis, renal artery stenosis of a single functioning kidney, and in patients who have undergone kidney transplantation, as there is a risk of worsening kidney function.
• If the patient has hyperkalemia (elevated potassium levels in the blood).
• 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, and diarrhea or vomiting. In these patients, before starting treatment with Gopten 0.5, 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 problems, especially those with collagen diseases (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 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 problems and those taking 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 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 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 angioedema of the intestines. 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 hyperkalemia (elevated potassium levels in the blood) after taking the medicine, regular monitoring of potassium levels in the blood is recommended. Risk factors for hyperkalemia include kidney problems, use of potassium-sparing diuretics, concurrent administration of drugs used to treat hypokalemia, diabetes, and/or left ventricular dysfunction after myocardial infarction.
• If the patient is to undergo surgical procedures or anesthesia using drugs that cause hypotension.
• If the patient is taking any of the following drugs 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 problems related to diabetes,
• aliskiren.
• If the patient is taking any of the following drugs, as the risk of angioedema (sudden swelling of tissue, e.g., in the throat) may increase:
• racecadotril, a drug used to treat diarrhea,
• drugs used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• wildagliptin, a drug 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 or outlet stenosis.
• The patient should inform their doctor if they are taking diuretics, especially if they have recently started taking them, as concurrent use with Gopten 0.5 may cause a significant decrease in blood pressure.
• The patient should inform their doctor if they suspect or plan to become pregnant. Gopten 0.5 is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
• Patients taking drugs from the group to which Gopten 0.5 belongs may experience a dry, persistent cough without expectoration. This symptom subsides after discontinuation of the medicine.
• Gopten 0.5 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 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 precautions are necessary:

• neprilysin inhibitors, such as racecadotril, due to the increased risk of angioedema (sudden swelling of tissue, e.g., in the throat)
• 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 drug used to prevent transplant rejection, and heparin, a drug used to thin the blood to prevent clots)
• antidiabetic drugs (insulin or oral antidiabetic drugs)
• lithium
• anesthetics
• allopurinol (used to treat gout)
• procainamide (used to treat arrhythmias)
• cytostatics (used to treat cancer)
• immunosuppressive drugs (affecting the immune system)
• systemic glucocorticoids (anti-inflammatory drugs)
• sympathomimetic drugs (vasoconstrictors)
• antipsychotic and tricyclic antidepressant drugs
• nonsteroidal anti-inflammatory drugs (including aspirin used in higher doses as an anti-inflammatory, e.g., to relieve pain)
• drugs that reduce stomach acid
• gold preparations for injection (used to treat rheumatoid arthritis) In patients with left ventricular dysfunction after myocardial infarction, no clinically significant interactions have been observed when Gopten 0.5 was administered in combination with:
• thrombolytic drugs (used to treat thrombosis and embolism)
• aspirin
• beta-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)
• anticoagulant drugs (drugs that prevent blood clotting)
• digoxin (a drug used to treat congestive heart failure)
• cimetidine (a drug used to treat gastric and duodenal ulcers, gastroesophageal reflux disease)

The doctor may recommend changing the dose and/or taking 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 to become pregnant. The doctor will usually recommend stopping 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 the third month of pregnancy, as it may seriously harm the fetus.

The patient should inform their doctor if they are breastfeeding or plan to breastfeed. Gopten 0.5 is not recommended during breastfeeding, especially in newborns or premature infants. The doctor may recommend taking 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 several hours after taking the first dose of the medicine or after increasing the dose.

Gopten 0.5 contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to some sugars, they should contact 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 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 increased, every one to four weeks, taking into account the patient's response to the medicine, until the 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 may consider administering the medicine in combination with 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 concurrently administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 0.5 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 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 dehydrated patients and those with sodium deficiency, the doctor may discontinue the diuretic 2-3 days before starting 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 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 reduced (i.e., an initial dose of 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 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 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, 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 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
• palpitations (feeling of irregular or rapid heartbeat)
• flushing
• pharyngitis, rhinitis
• nausea, diarrhea, abdominal pain, constipation, gastrointestinal disorders
• 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 disorders
• hypersensitivity
• abnormal laboratory test results: hyperglycemia (elevated blood sugar), hyponatremia (low sodium levels), hypercholesterolemia (elevated cholesterol), hyperlipidemia (elevated lipid levels), hyperuricemia (elevated uric acid)
• gout, anorexia, increased appetite, abnormal liver function
• hallucinations, depression, sleep disorders, anxiety, agitation, apathy
• cerebrovascular incident, syncope, clonic muscle spasms, paresthesia (numbness, tingling of one or more limbs), migraine, migraine without aura, taste disorders
• conjunctivitis, eye irritation, vision disorders, eye disorders
• tinnitus
• myocardial infarction, myocardial ischemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia
• hypertension, cerebrovascular disorders, orthostatic hypotension (sudden drop in blood pressure when changing position from lying to standing), peripheral vascular disorders, varicose veins
• dyspnea, epistaxis, pharyngitis, cough with expectoration, respiratory disorders
• hematemesis, gastritis, abdominal pain, vomiting, dyspepsia, dry mouth, flatulence
• hepatitis
• angioedema, psoriasis, hyperhidrosis, rash, acne, dry skin, skin disorders
• back pain, muscle pain, arthralgia, osteoarthritis
• kidney failure, azotemia (elevated nitrogen compounds in the blood), polyuria, frequent urination
• congenital vascular malformation, ichthyosis
• edema, fatigue
• increased bilirubin levels
• injury

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

• cholestasis (bile flow obstruction)
• dermatitis
• abnormal laboratory test results (increased gamma-glutamyltransferase, increased lipase, increased immunoglobulin levels) Side effects with unknownfrequency:
• sinusitis*, rhinitis*, glossitis* (inflammation of the tongue)

Unknown frequency: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 in the blood)
confusional state*
transient ischemic attack, cerebral hemorrhage, balance disorders,
blurred vision*
atrioventricular block, arrhythmias, cardiac arrest

• bronchospasm
• intestinal obstruction, pancreatitis, abdominal pain, vomiting, dyspepsia, dry mouth, gastrointestinal disorders*
• jaundice (yellowing of the skin and eyes)
• Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*
• muscle pain
• fever
• abnormal laboratory test results (abnormal liver function tests, decreased platelet count, increased creatinine, increased urea, increased lactate dehydrogenase, increased alkaline phosphatase, increased aspartate aminotransferase, increased alanine aminotransferase, increased liver enzyme activity, decreased hemoglobin, decreased hematocrit, abnormal ECG)

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gopten 0.5

Store in a temperature below 25°C, in the original packaging.
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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents 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.
• The other ingredients are: cornstarch, lactose monohydrate, povidone, sodium stearyl fumarate, and the capsule shell: gelatin, titanium dioxide (E 171), yellow iron oxide (E 172), sodium lauryl sulfate, and the capsule body: gelatin, titanium dioxide (E 171), erythrosine (E 127), yellow iron oxide (E 172), 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 shell is yellow, and the capsule body is red.
Packaging: 30 capsules.
Blisters PVC-PVDC/Al 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 Romania, the country of export:

MYLAN HEALTHCARE GmbH
Lütticher Straße 5, 53842 Troisdorf, Germany

Manufacturer:

MYLAN HUNGARY Kft./ MYLAN HUNGARY Ltd.
Mylan utca 1., Komárom, 2900, Hungary

Parallel importer:

Aga Kommerz spol. s r.o.
Frydecka 2006
737 01 Czeski Cieszyn
Czech Republic

Repackaged by:

Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Wytwórnia Euceryny Laboratorium Farmaceutyczne COEL S.J. E.Z.M. KONSTANTY
ul. Wł. Żeleńskiego 45
31-353 Kraków
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Romania, the country of export:11131/2018/01

Parallel import authorization number: 238/22 Date of leaflet approval: 01.06.2022

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