Gopten 0.5

Package leaflet: Information for the patient

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Gopten 0.5 (Gopten 0.5 mg)
0.5 mg, hard capsules
Trandolaprilum
Gopten 0.5 and Gopten 0.5 mg are different trade names for the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are identical.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

The active substance in Gopten 0.5 hard capsules is trandolapril. This medicine belongs to a group of drugs known as angiotensin-converting enzyme (ACE) inhibitors. Trandolapril is rapidly absorbed from the gastrointestinal tract and subsequently converted in the liver into its potent, long-acting active metabolite, trandolaprilat.

Administration of trandolapril at therapeutic doses to patients with arterial hypertension leads to a significant reduction in arterial blood pressure measured both in the supine and standing positions. The blood pressure-lowering effect becomes apparent within one hour after administration, lasts for 24 hours, and reaches its maximum between the 8th and 12th hour after dosing.

Gopten 0.5 is used in the treatment of:

• Mild to moderate arterial hypertension,
• Left ventricular dysfunction following myocardial infarction,
• Symptomatic heart failure.

2. Important information before using Gopten 0.5

When not to use Gopten 0.5

• If the patient is allergic to trandolapril or to any of the other ingredients of this medicine (listed in section 6) or to another angiotensin-converting enzyme (ACE) inhibitor.
• If the patient has previously experienced angioedema (swelling of any body area, which, in case of swelling of the throat and larynx, may impair swallowing and breathing) after taking another medicine belonging to the same group as Gopten 0.5.
• If the patient has hereditary or idiopathic (of unknown cause) angioedema.

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• In women during the third trimester of pregnancy. Gopten 0.5 should also be avoided in early pregnancy (see section "Pregnancy and breastfeeding").
• If the patient has diabetes or kidney function impairment 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 in the treatment of certain types of chronic (long-term) heart failure in adults), because the risk of angioedema (rapid swelling of subcutaneous tissue, e.g. in the throat area) is increased.

Warnings and precautions
Before starting treatment with Gopten 0.5, discuss this with your doctor, pharmacist, or nurse.

• If the patient is to undergo desensitization therapy for animal venoms (including insects), temporary discontinuation of the medicine should be considered.
• If the patient is undergoing dialysis (hemodialysis or low-density lipoprotein (LDL) apheresis).
• If the patient has liver impairment.
• If the patient has kidney function impairment, congestive heart failure, unilateral or bilateral renal artery stenosis, stenosis of the renal artery of a single functioning kidney, or has undergone kidney transplantation, as there is a risk of worsening kidney function.
• If the patient with kidney impairment develops increased serum potassium levels (hyperkalemia).
• If the patient has risk factors for hypotension, such as hypovolemia (reduced blood volume), sodium deficiency due to prolonged use of diuretics, a low-sodium diet, dialysis, or diarrhea or vomiting. In such patients, the doctor may recommend discontinuation of diuretics and repletion of fluid volume and/or sodium deficiency before starting Gopten 0.5. Similar precautions should be taken in patients with ischemic heart disease or cerebrovascular disorders, in whom excessive reduction in blood pressure may lead to myocardial infarction or cerebrovascular events.
• In patients with kidney impairment, especially those suffering from collagenoses (e.g. systemic lupus erythematosus and systemic sclerosis), as after administration of medicines from the same group as Gopten 0.5, agranulocytosis (a decrease in granulocytes, a type of white blood cells) or bone marrow suppression may occur. Granulocyte reduction is transient and resolves after discontinuation of the ACE inhibitor.
• In patients with collagenoses, especially those complicated by kidney impairment, and when glucocorticosteroids and antimetabolites are used concomitantly, the doctor may recommend regular monitoring of white blood cell count and urinary protein levels.
• If the patient develops acute allergic reaction—angioedema of the face, limbs, tongue, glottis, and/or larynx—after taking Gopten 0.5, immediate medical attention is required. The medicine should be discontinued immediately and the patient's condition monitored until the swelling resolves. Angioedema limited to the face usually resolves spontaneously. Angioedema of the face and glottis may be life-threatening due to the risk of airway obstruction. Caution is advised in patients with hereditary or idiopathic angioedema.
• If the patient develops abdominal pain (with or without nausea or vomiting) after taking Gopten 0.5, as medicines from the same group as Gopten 0.5 may cause intestinal angioedema. In case of such symptoms, immediate medical attention is required, as prompt treatment may be necessary.
• In patients with renovascular hypertension.
• If the patient develops increased serum potassium levels (hyperkalemia) after taking Gopten 0.5, regular monitoring of serum potassium levels is recommended. Risk factors for hyperkalemia include: kidney impairment, use of potassium-sparing diuretics, concomitant administration of medicines used to treat hypokalemia, diabetes, and/or left ventricular dysfunction after myocardial infarction.

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• If the patient is to undergo surgery or anesthesia with medicines that cause hypotension.
• If the patient is taking any of the following medicines used to treat high blood pressure:
• an angiotensin II receptor antagonist (AIIRA), also known as a sartan—e.g. valsartan, telmisartan, irbesartan, especially if the patient has kidney impairment related to diabetes;
• aliskiren.
• If the patient is taking any of the following medicines, as the risk of angioedema (rapid swelling of tissue, e.g. in the throat area) may increase:
• racecadotril, a medicine used to treat diarrhea,
• medicines used to prevent organ transplant rejection and in cancer treatment (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 blood.
See also the section "When not to use Gopten 0.5".
Important information

• Gopten 0.5 must not be used in patients with stenosis of the main artery or outflow tract obstruction.
• Inform the doctor if the patient is taking diuretics, especially if they have recently started taking them, as concomitant use with Gopten 0.5 may cause a marked decrease in blood pressure.
• Inform the doctor about suspected (or planned) pregnancy. Use of Gopten 0.5 is not recommended during the first three months of pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregn游戏副本

3. How to use Gopten 0.5

This medicine should always be taken as directed by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Oral administration.
Adults
Hypertension
In adult patients not taking diuretics, without congestive heart failure, or renal or hepatic impairment, the recommended initial dose is 0.5 mg to 2 mg once daily. The 0.5 mg dose is effective in only 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, depending on the patient's response to the drug, until reaching a maximum dose of 4 mg to 8 mg per day.
The maintenance dose is usually 1 mg to 4 mg once daily. If the response to trandolapril at doses of 4 mg to 8 mg per day is inadequate, your doctor may consider combining the drug with diuretics and/or calcium antagonists.
Left ventricular dysfunction following myocardial infarction
Treatment may be initiated as early as the third day after myocardial infarction, starting with a single daily dose of 0.5 mg to 1 mg. The dose should be gradually increased up to a maximum of 4 mg once daily. Depending on the patient's response to the drug (occurrence of symptomatic hypotension), increasing the dose may be temporarily withheld.
In case of hypotension, your doctor will recommend, if possible, reducing the dose of concomitantly administered vasodilators (including nitrates) and diuretics. The dose of Gopten 0.5 may be reduced only if the above measures prove ineffective or cannot be applied.
Elderly patients
In elderly patients with normal renal and hepatic function, there is no need to reduce the dose.
Caution should be exercised in elderly patients who are concurrently taking diuretics, or who have congestive heart failure, or renal or hepatic impairment. The dose should be adjusted according to blood pressure values.
Patients taking diuretics
In patients who are dehydrated or sodium-depleted, your doctor may discontinue the diuretic 2 to 3 days before initiating Gopten 0.5 to reduce the risk of symptomatic hypotension. If necessary, diuretic therapy may be resumed later.
Heart failure
Treatment should be initiated with trandolapril at a dose of 0.5 mg to 1 mg once daily, under close medical supervision.
Patients with renal impairment
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In patients with creatinine clearance (a laboratory marker of kidney function measured in blood) between 30 and 70 ml/min, the same dosing as in adults, including elderly patients, is recommended.
In patients with creatinine clearance below 30 ml/min, a reduced initial dose of trandolapril is recommended (i.e., initial dose of 0.5 mg once daily), followed by gradual dose escalation until the desired therapeutic effect is achieved. Treatment in these patients should be closely supervised by a physician.
In patients with creatinine clearance above 30 ml/min, no change in the initial dose is required.
Patients undergoing dialysis
In dialyzed patients, blood pressure should be closely monitored and the drug dose adjusted accordingly if necessary.
Patients with hepatic impairment
Treatment should be initiated at a dose of 0.5 mg once daily and conducted under close medical supervision.
Use in children
The safety and efficacy of this medicine in children have not been established; therefore, its use is not recommended.
Use of a higher than recommended dose of Gopten 0.5
Overdose may result in the following symptoms: severe hypotension, shock, stupor, bradycardia, electrolyte disturbances in blood, and renal failure. In case of overdose, the patient should be closely monitored, preferably in an intensive care unit. The doctor should frequently monitor serum electrolyte and creatinine levels. Treatment depends on the severity of symptoms. If the drug has been recently ingested, the doctor will take measures to remove the drug (e.g., induced vomiting, gastric lavage, administration of adsorbents and sodium sulfate).
In case of symptomatic hypotension, the patient should be placed immediately in a shock position. The doctor should initiate appropriate treatment as quickly as possible.
Missed dose of Gopten 0.5
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
During clinical studies and after the marketing of Gopten 0.5 for various indications, the following adverse effects have been observed:

Common (in 1 to 10 patients out of 100 patients):

• headache, central dizziness;
• hypotension;
• cough;
• fatigue.

Uncommon (in 1 to 10 patients out of 1,000 patients):

• upper respiratory tract infection;
• insomnia, decreased libido;
• somnolence;
• peripheral dizziness;
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• palpitations (sensation of irregular or rapid heartbeat);
• sudden flushing with a feeling of warmth;
• inflammation of upper respiratory tract, congestion of upper respiratory tract;
• nausea, diarrhoea, stomach and intestinal pain, constipation, gastrointestinal disturbances;
• rash, pruritus;
• back pain, muscle cramps, limb pain;
• erectile dysfunction;
• malaise, chest pain, peripheral oedema, feeling unwell.

Rare (in 1 to 10 patients out of 10,000 patients):

• urinary tract infection, bronchitis, pharyngitis;
• leucopenia (reduced number of white blood cells in blood), anaemia, platelet disorders, white blood cell disorders;
• hypersensitivity;
• abnormal laboratory test results: increased blood glucose concentration (hyperglycaemia), decreased blood sodium concentration (hyponatraemia), increased blood cholesterol concentration (hypercholesterolaemia), increased blood triglyceride and cholesterol concentration (hyperlipidaemia), increased blood uric acid concentration (hyperuricaemia);
• gout, loss of appetite, increased appetite, abnormal enzyme activity;
• hallucinations, depression, sleep disorders, anxiety, agitation, apathy;
• cerebrovascular incident, fainting, clonic muscle seizures, paraesthesia (numbness, tingling in one or more limbs), migraine, migraine without aura, taste disturbances;
• blepharitis, conjunctival oedema, visual disturbances, eye disorders;
• tinnitus;
• myocardial infarction, myocardial ischaemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia;
• hypertension, pathological changes in cerebral vessels (angiopathy), orthostatic hypotension (sudden drop in blood pressure caused by changing position from lying to standing), peripheral vascular disorders, varicose veins;
• dyspnoea, epistaxis, pharyngitis, pain in throat, cough with expectoration, breathing disorders;
• haematemesis, gastritis, abdominal pain, vomiting, dyspepsia, dryness of oral mucosa, flatulence with gas release;
• hepatitis;
• angioedema, psoriasis, excessive sweating, rash, acne, dry skin, skin disorders;
• joint pain, bone pain, osteoarthritis;
• renal failure, azotaemia (increased concentration of nitrogen compounds in blood), polyuria, pollakiuria;
• congenital vascular malformation, ichthyosis;
• oedema, feeling of fatigue;
• increased bilirubin concentration (bile pigment);
• injury.

Very rare (in less than 1 patient per 10,000 treated):

• cholestasis;
• dermatitis;
• abnormal diagnostic test results (increased γ-glutamyltransferase activity in blood, increased lipase activity, increased immunoglobulin concentration).

Adverse effects occurring with unknown frequency (frequency cannot be estimated from available data):

• sinusitis*, rhinitis*, glossitis*;
• pancytopenia (reduction in red blood cells, white blood cells and platelets), agranulocytosis (significant, rapidly progressive reduction in granulocytes), thrombocytopenia, haemolytic anaemia*;
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• increased serum potassium concentration (hyperkalaemia);
• confusion*;
• transient ischaemic attack, cerebral haemorrhage, balance disorders;
• blurred vision*;
• atrioventricular block, cardiac arrhythmias, cardiac arrest;
• bronchospasm;
• intestinal obstruction, pancreatitis, angioedema of the intestine*;
• yellowing of the skin or eyes (jaundice);
• Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*;
• muscle pain;
• fever;
• abnormal diagnostic test results (abnormal liver function tests, thrombocytopenia, increased blood creatinine concentration, increased blood urea concentration, increased lactate dehydrogenase activity, increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased liver enzyme activity, decreased haemoglobin concentration, decreased haematocrit value, abnormal ECG recording).

*Adverse effects related to angiotensin-converting enzyme inhibitors as a class of medicines

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 49 21 301
Fax: +48 (22) 49 21 309
Website: https://smz.ezdrowie.gov.pl

Reporting adverse effects allows the collection of further information on the safety of the medicine.

5. How to store Gopten 0.5

Do not store above 25°C.
Keep the medicine 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Gopten 0.5 contains

• The active substance is trandolapril. Each hard capsule contains 0.5 mg of trandolapril.

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• Other ingredients are: maize starch, monohydrate lactose, povidone K 25, sodium stearyl fumarate, and capsule shell: gelatin, titanium dioxide, erythrosine, yellow iron oxide, sodium lauryl sulfate.

What Gopten 0.5 looks like and contents of the pack
Gopten 0.5 is available as hard capsules. The capsule cap is yellow and the body is red.
Packaging:
28 pieces
PVC-PVDC-Aluminium blisters in a cardboard box.
Also marketed are Gopten 2.0, hard capsules, 2 mg and Gopten 4.0, hard capsules, 4 mg.
For more detailed information, please contact the Marketing Authorisation Holder or Parallel Importer.
Marketing Authorisation Holder in Spain, country of export:
Viatris Healthcare Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Dublin, Ireland
Manufacturer:
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 in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing Authorisation number in Spain, country of export: 709220.9
Parallel Import Licence number: 25/25
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