Gopten 4,0

Package Leaflet: Information for the Patient

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Gopten 4.0 (Gopten 4 mg)

4 mg, hard capsules, Trandolaprilum
Gopten 4.0 and Gopten 4 mg are different trade names for the same drug.

The leaflet should be read carefully before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept so that it can be re-read if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. 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 drug belongs to the group of angiotensin-converting enzyme inhibitors (ACE). Trandolapril is rapidly absorbed from the gastrointestinal tract and then undergoes transformation in the liver to 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 the maximum effect observed between the 8th and 12th hour after administration.
Gopten 4.0 is used to treat:

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

2. Important information before taking Gopten 4.0

When not to take Gopten 4.0

• If the patient is allergic to trandolapril or any of the other ingredients of this medicine (listed in section 6) or to another angiotensin-converting enzyme 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 4.0 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 4.0 in early pregnancy (see "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.
• If the patient has taken or is currently taking a 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, the doctor, pharmacist, or nurse should be consulted.

• 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).
• If the patient has been diagnosed with liver dysfunction.
• If the patient has been diagnosed with kidney dysfunction, 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 (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 replenishing 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 renal impairment, especially those with collagen diseases (e.g., systemic lupus erythematosus and scleroderma), as these patients may experience agranulocytosis (decreased granulocyte count) and bone marrow suppression after taking a drug from the group to which Gopten 4.0 belongs. The decrease in granulocyte count is a transient phenomenon after discontinuation of the angiotensin-converting enzyme inhibitor.
• In patients with collagen diseases, especially those with renal impairment 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 4.0, as drugs from the group to which Gopten 4.0 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), regular monitoring of potassium levels in the blood is recommended. Risk factors for hyperkalemia include renal impairment, use of potassium-sparing diuretics, concomitant administration of drugs used to treat hypokalemia, diabetes, and (or) left ventricular dysfunction after myocardial infarction.
• If the patient is to undergo 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 diabetic nephropathy;
• 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 area) may increase:
• racecadotril, a drug used to treat diarrhea,
• drugs used to prevent transplant rejection and 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).
See also the subsection "When not to take Gopten 4.0".

Important information

• Gopten 4.0 should not be used in patients with aortic stenosis or outflow tract obstruction.
• The doctor should be informed if the patient is taking diuretics, especially if they have been taken recently, as concomitant use with Gopten 4.0 may cause a significant decrease in blood pressure.
• The doctor should be informed of suspected or planned pregnancy. Gopten 4.0 is not recommended during the first three months of pregnancy and should not be used after 3 months of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
• Patients taking drugs from the group to which Gopten 4.0 belongs may experience a dry, persistent cough without expectoration. This symptom subsides after discontinuation of the medicine.
• Gopten 4.0 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 4.0 in children have not been studied, and therefore, its use is not recommended.

Gopten 4.0 and other medicines

The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
The doctor should be informed if the patient is taking any of the following medicines, as special caution is required:

• neprilysin inhibitors, such as racecadotril, due to the increased risk of angioedema (sudden swelling of the skin, e.g., in the throat area);
• diuretics;
• potassium-sparing diuretics, such as spironolactone, canrenone, amiloride, triamterene, eplerenone;
• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines 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 prevent blood clotting);
• 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 acetylsalicylic acid used in higher doses as an anti-inflammatory drug, e.g., to relieve pain);
• drugs that reduce stomach acidity;
• gold preparations for injection (used to treat rheumatoid arthritis).

In patients with left ventricular dysfunction after myocardial infarction, no clinical interactions have been observed when Gopten 4.0 was administered in combination with:

• thrombolytic drugs (used to treat thrombosis and embolism),
• 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),
• anticoagulant drugs (drugs that prevent blood clotting),
• digoxin (a drug used to treat congestive heart failure),
• cimetidine (a drug used to treat stomach ulcers and 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 4.0" and "Warnings and precautions").

Gopten 4.0 with food and drink

Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
The doctor should be informed of suspected or planned pregnancy. The doctor will usually recommend discontinuing Gopten 4.0 before planned pregnancy or immediately after confirmation of pregnancy and recommend taking another medicine instead of Gopten 4.0.

Gopten 4.0 should not be used during the first three months of pregnancy and should not be used after 3 months of pregnancy, as it may seriously harm the fetus.

The doctor should be informed of breastfeeding or intention to breastfeed. Gopten 4.0 is not recommended during breastfeeding, especially in newborns or premature infants. The doctor may recommend another medicine during breastfeeding.

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 in case of concomitant alcohol consumption.
Driving or operating machines is not recommended for several hours after taking the first dose of the medicine or after increasing the dose.

Gopten 4.0 contains lactose monohydrate and sodium

If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the doctor or pharmacist should be consulted.
Oral administration.

Adults

Hypertension
In adult patients not taking diuretics, without congestive heart failure, and without kidney or liver dysfunction, the recommended initial dose is 0.5 mg to 2 mg once daily. A dose of 0.5 mg is effective only in a small number of patients. In patients of black race, 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, reducing the dose of concomitantly administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 4.0 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 concomitantly with diuretics, with congestive heart failure, or with kidney or liver dysfunction.
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 renal impairment
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., the initial dose 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 change the initial dose.
Dialysis patients
In dialysis patients, blood pressure should be closely monitored, and the dose of Gopten 4.0 should be adjusted as needed.
Patients with liver dysfunction
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 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, 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 adsorbents, 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

A double dose should not be taken to make up for a missed 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;
˗
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 (decreased 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, conjunctivitis, visual disturbances, 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 disturbances;
˗
hematemesis, gastritis, abdominal pain, vomiting, nausea, dry mouth, flatulence;
˗
hepatitis;
˗
angioedema, psoriasis, hyperhidrosis, rash, acne, dry skin, skin disorders;
˗
arthralgia, bone pain, arthritis;
˗
renal failure, azotemia (elevated nitrogen compounds in the blood), polyuria, nocturia;
˗
congenital vascular anomaly, 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 (elevated gamma-glutamyltransferase, elevated lipase, elevated potassium levels, elevated urea levels, elevated alkaline phosphatase, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated liver enzyme activity, decreased hemoglobin levels, decreased hematocrit values, abnormal ECG).
Side effects with unknownfrequency:
˗
sinusitis*, rhinitis*, glossitis*;
˗
pancytopenia (decreased red, white, and platelet blood cell count), agranulocytosis (significant, rapidly progressing decrease in granulocyte count), thrombocytopenia (decreased platelet count), hemolytic anemia*;
˗
hyperkalemia (elevated potassium levels);
˗
confusional state*;
˗
transient ischemic attack, cerebral hemorrhage, balance disorders;
˗
blurred vision*;
˗
atrioventricular block, arrhythmia, cardiac arrest;
˗
bronchospasm;
˗
intestinal obstruction, pancreatitis, angioedema of the intestine*;
˗
jaundice (yellowing of the skin and eyes);
˗
Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasis-like skin inflammation*;
˗
muscle pain;
˗
fever;
˗
abnormal laboratory test results (abnormal liver function tests, decreased platelet count, elevated creatinine levels, elevated urea levels, elevated lactate dehydrogenase, elevated alkaline phosphatase, elevated aspartate aminotransferase, elevated alanine aminotransferase, elevated liver enzyme activity, decreased hemoglobin levels, decreased hematocrit values).

Reporting side effects

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

5. How to store Gopten 4.0

Store at a temperature below 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.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicines. This 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 25, sodium stearyl fumarate, and the capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), iron oxide black (E 172), iron oxide yellow (E 172), 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 pieces.
PVC-PVDC/Al 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.
For more detailed information, please contact the marketing authorization holder or parallel importer:

Marketing authorization holder in the Czech Republic, the country of export:

Mylan IRE Healthcare Limited
Unit 35/36, Grange Parade
Baldoyle Industrial Estate
Dublin 13, Ireland

Manufacturer:

Famar Italia S.p.A.
Via Zambeletti 25
20021 Baranzate (Milan)
Italy
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary

Parallel importer:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in the Czech Republic, the country of export: 58/001/05-C

Parallel import authorization number: 621/15

Translation of day-of-the-week symbols on the packaging:

Po

• Monday Út
• Tuesday St
• Wednesday Čt
• Thursday Pá
• Friday So
• Saturday Ne
• Sunday

Date of leaflet approval: 08.04.2022
[Information about the trademark]