Gopten 0,5

Package Leaflet: Information for the Patient

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

Gopten 0.5(Gopten)

0.5 mg, hard capsules

Trandolapril
Gopten 0.5 and Gopten 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 to you specifically. 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. Contents of the pack and other information

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

The active substance of Gopten 0.5 hard capsules is trandolapril. The medicine belongs to the group of angiotensin-converting enzyme (ACE) inhibitors. Trandolapril is rapidly absorbed from the gastrointestinal tract, and then in the liver, it is converted into a strongly and long-acting active metabolite - trandolaprilat.
Administration of trandolapril in therapeutic doses to patients with arterial hypertension causes a significant decrease in arterial blood pressure measured in the patient in a lying and standing position.
The blood pressure-lowering effect becomes apparent after one hour and lasts for 24 hours, with maximum effect observed between the 8th and 12th hour after administration.
Gopten 0.5 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 0.5

When not to take Gopten 0.5

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

Warnings and precautions

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

• If the patient is to undergo desensitization to animal venom (including insect venom), it is recommended to consider temporary discontinuation of the medicine.
• If the patient is undergoing dialysis therapy (hemodialysis or low-density lipoprotein apheresis).
• 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 after 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 (reduced granulocyte count) and bone marrow suppression after taking a medicine from the group to which Gopten 0.5 belongs. The reduced granulocyte count is a transient phenomenon after discontinuation of the angiotensin-converting enzyme inhibitor.
• In patients with collagen diseases, especially those with kidney problems and concomitant use of glucocorticoids and antimetabolites, the doctor will recommend regular monitoring of white blood cell count and protein levels in the urine.
• If the patient experiences an acute allergic reaction - angioedema of the face, limbs, tongue, larynx, and/or throat - they should immediately consult a doctor. The medicine should be discontinued immediately, and the patient's condition should be monitored until the swelling subsides. Angioedema 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 intestinal angioedema. If such symptoms occur, the patient should immediately consult a doctor, as prompt treatment may be necessary.
• In patients with renovascular hypertension.
• If the patient experiences hyperkalemia (elevated potassium levels in the blood), the doctor will recommend regular monitoring of potassium levels in the blood. Risk factors for hyperkalemia include kidney problems, use of potassium-sparing diuretics, concomitant administration of potassium-sparing medicines, diabetes, and/or left ventricular dysfunction after myocardial infarction.

If the patient is to undergo surgery or anesthesia with the use of medicines that cause hypotension.

• If the patient is taking any of the following medicines used to treat high blood pressure:
• angiotensin II receptor antagonist (AIIRA), also known as a sartan - e.g., valsartan, telmisartan, irbesartan, especially if the patient has kidney problems related to diabetes,
• aliskiren.
• If the patient is taking any of the following medicines, as the risk of angioedema (sudden swelling of tissue, e.g., in the throat area) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent transplant rejection and to treat cancer (e.g., temsirolimus, sirolimus, everolimus),
• vildagliptin, a medicine used to treat diabetes.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also the subsection "When not to take Gopten 0.5".

Important information

• Gopten 0.5 should not be taken by patients with aortic stenosis or outflow tract obstruction.
• The patient should inform their doctor if they are taking diuretics, especially if they have been taking them recently, as concomitant use with Gopten 0.5 may cause a significant decrease in blood pressure.
• The patient should inform their doctor if they suspect or plan pregnancy. Gopten 0.5 is not recommended in the first three months of pregnancy and should not be taken after the 3rd month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
• Patients taking medicines 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 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 have been observed when Gopten 0.5 was administered in combination with:

• thrombolytic agents (used to treat thrombosis and embolism),
• aspirin,
• 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 gastric and duodenal ulcers, gastroesophageal reflux disease).

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

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

Gopten 0.5 with food and drink

Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding

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

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

The patient should inform their doctor about breastfeeding or intending 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 a few 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 certain 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 that 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 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 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 concomitantly administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 0.5 can be reduced only if the above measures are ineffective or cannot be taken.
Elderly patients
In elderly patients with normal kidney and liver function, there is no need to reduce the dose.
Caution should be exercised in elderly patients treated with diuretics, with congestive heart failure, or with kidney or liver 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 treatment with Gopten 0.5 to reduce the risk of symptomatic hypotension. If necessary, the diuretic can be restarted later.
Heart failure
Treatment should be started with a dose of 0.5 mg to 1 mg once daily, under close medical supervision.
Patients with kidney 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 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, bradycardia, 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:
Common(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 (reduced white blood cell count), anemia, blood platelet disorders, white blood cell disorders,
• hypersensitivity,
• abnormal laboratory test results: hyperglycemia (elevated blood sugar), hyponatremia (reduced sodium levels in the blood), hypercholesterolemia (elevated cholesterol levels in the blood), hyperlipidemia (elevated triglyceride and cholesterol levels in the blood), hyperuricemia (elevated uric acid levels in the blood),
• 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 (sudden drop in blood pressure when changing 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, myalgia, bone pain, osteoarthritis,
• kidney failure, azotemia (elevated nitrogen levels 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 laboratory test results (increased γ-glutamyltransferase levels in the blood, increased lipase levels, increased immunoglobulin levels).

Side effects with unknownfrequency (frequency cannot be estimated from available data):

• sinusitis, rhinitis, glossitis,
• pancytopenia (reduced red, white, and platelet blood cell count), agranulocytosis (significant, rapidly progressing reduction in granulocyte count), thrombocytopenia (reduced platelet count), hemolytic anemia,
• hyperkalemia (elevated potassium levels in the blood),
• confusional state,
• transient ischemic attack, cerebral hemorrhage, balance disorders,
• blurred vision,
• atrioventricular block, arrhythmia, cardiac arrest,
• bronchospasm,
• intestinal obstruction, pancreatitis, intestinal angioedema,
• jaundice (yellowing of the skin and eyes),
• Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, urticaria, alopecia, psoriasiform dermatitis, dry skin,
• myalgia,
• fever,
• abnormal laboratory test results (abnormal liver function tests, reduced platelet count, increased creatinine levels in the blood, increased urea levels in the blood, increased lactate dehydrogenase levels, increased alkaline phosphatase levels, increased aspartate aminotransferase levels, increased alanine aminotransferase levels, increased liver enzyme levels, reduced hemoglobin levels, reduced hematocrit values, abnormal ECG).

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Gopten 0.5

Do not store above 25°C.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack 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 K 25, 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 cap is yellow, and the body is red.
The pack contains 28 hard capsules.
PVC/PVDC/Al blisters in a cardboard box.
For more detailed information, please contact the marketing authorization holder or the 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
2900 Komárom
Hungary
Alloga (Nederland) B.V.
Bijusterhuizen 2204
6604 LD Wijchen, Netherlands

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
Portuguese marketing authorization number: 2181287

Parallel import authorization number: 421/22 Date of leaflet approval: 05.12.2022

[Information about the trademark]