Gopten 2.0

Package leaflet: information for the patient

Warning! Please keep the leaflet. Information on the immediate packaging is in a foreign language.
Gopten 2.0 (Gopten 2 mg)
2 mg, hard capsules
Trandolaprilum
Gopten 2.0 and Gopten 2 mg are different trade names for the same medicinal product.
Please read the following information carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• 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 the same as yours.
• 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 2.0 is and what it is used for
2. Important information before taking Gopten 2.0
3. How to take Gopten 2.0
4. Possible side effects
5. How to store Gopten 2.0
6. Contents of the pack and other information

1. What Gopten 2.0 is and what it is used for

The active substance in Gopten 2.0 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 then converted in the liver into its potent and long-acting active metabolite, trandolaprilat.
Administration of trandolapril in therapeutic doses to patients with hypertension results in a significant reduction of arterial blood pressure measured both in the supine and standing positions. The antihypertensive effect becomes apparent within one hour after administration and lasts for 24 hours, with maximum effect observed between 8 and 12 hours after dosing.

Gopten 2.0 is used for the treatment of:

• mild to moderate arterial hypertension,
• left ventricular dysfunction following myocardial infarction,
• symptomatic heart failure.

2. Important information before using Gopten 2.0

When not to use Gopten 2.0

• 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 (ACE) inhibitor.
• If the patient has previously experienced angioedema (swelling of any body area, which in the case of swelling of the throat and larynx may cause difficulty in swallowing and breathing) after taking another medicine from the same class as Gopten 2.0.
• If the patient has hereditary or idiopathic (of unknown cause) angioedema.

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• In women after the third month of pregnancy. Gopten 2.0 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) increases.

Warnings and precautions
Before starting treatment with Gopten 2.0, 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 dysfunction.
• 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 concentration (hyperkalaemia).
• If the patient has risk factors for hypotension, such as hypovolaemia (reduced blood volume), sodium deficiency due to prolonged use of diuretics, low-sodium diet, dialysis, or diarrhoea or vomiting. In such patients, before starting treatment with Gopten 2.0, the doctor may recommend discontinuation of diuretics and repletion of fluid volume and/or sodium deficiency. Similar precautions should be taken in patients with ischaemic heart disease or cerebrovascular disorders, in whom excessive reduction in blood pressure may lead to myocardial infarction or cerebrovascular incident.
• In patients with kidney impairment, especially those suffering from collagenoses (e.g. systemic lupus erythematosus and systemic sclerosis), because after administration of a medicine from the same class as Gopten 2.0, agranulocytosis (i.e. reduced number of granulocytes, a type of white blood cell) or bone marrow suppression may occur. Reduction in granulocyte count is transient and resolves after discontinuation of the ACE inhibitor.
• In patients with collagenoses, especially those complicated by kidney impairment, and in cases of concomitant use of glucocorticosteroids and antimetabolites, the doctor will recommend regular monitoring of white blood cell count and urinary protein levels.
• If the patient develops an acute allergic reaction – angioedema of the face, limbs, tongue, glottis, and/or larynx – after taking Gopten 2.0, 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 2.0, because medicines from the same class as Gopten 2.0 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 concentration (hyperkalaemia) after taking Gopten 2.0, regular monitoring of serum potassium levels is recommended. Risk factors for hyperkalaemia include: kidney impairment, use of potassium-sparing diuretics, concomitant administration of medicines used to treat hypokalaemia, diabetes and/or left ventricular dysfunction after myocardial infarction.

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• If the patient is to undergo surgical procedures or anaesthesia with medicines causing 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 – for example, valsartan, telmisartan, irbesartan, especially if the patient has kidney impairment related to diabetes;
• aliskiren.
• If the patient is taking any of the following medicines, because the risk of angioedema (rapid swelling of tissue, e.g. in the throat area) may increase:
• racecadotril, a medicine used to treat diarrhoea;
• 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 blood electrolyte levels (e.g. potassium).
See also the section “When not to use Gopten 2.0”.
Important information

• Gopten 2.0 should 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 recently initiated, because concomitant use with Gopten 2.0 may cause a marked drop in blood pressure.
• Inform the doctor about suspected (or planned) pregnancy. Use of Gopten 2.0 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 “Pregnancy and breastfeeding”).
• In patients taking medicines from the same class as Gopten 2.0, a dry, persistent cough without expectoration may occur. This symptom resolves after discontinuation of treatment with these medicines.
• Use of Gopten 2.0 is not recommended during breastfeeding, especially for newborns or preterm infants. The doctor will recommend alternative medicines during breastfeeding.

Children
The safety and efficacy of Gopten 2.0 in children have not been studied, and therefore its use is not recommended.

Gopten 2.0 and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if any of the following medicines are being used, as special precautions are necessary:

• neprilysin inhibitors, such as racecadotril, due to 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 increasing blood potassium levels (e.g. trimethoprim and co-trimoxazole, used in bacterial infections; cyclosporine, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots);
• antidiabetic medicines (insulin or oral antidiabetic medicines);
• lithium; Page 3 of 9
• anaesthetics;
• allopurinol (used in the treatment of gout);
• procainamide (used to treat cardiac arrhythmias);
• cytostatics (used in cancer diseases);
• immunosuppressive medicines (acting on the immune system);
• systemic glucocorticosteroids (anti-inflammatory medicines);
• sympathomimetic medicines (vasoconstrictors);
• antipsychotics and tricyclic antidepressants;
• non-steroidal anti-inflammatory drugs (including acetylsalicylic acid used in higher doses as an anti-inflammatory medicine, e.g. to relieve pain);
• medicines reducing gastric acidity;
• injectable gold preparations (used in the treatment of rheumatoid arthritis).

In patients with left ventricular dysfunction after myocardial infarction, no clinically significant interactions were observed when Gopten 2.0 was administered concomitantly with:

• thrombolytic medicines (used in thrombosis and arterial/venous embolism);
• acetylsalicylic acid;
• β-adrenolytic medicines (used in the treatment of heart diseases and hypertension);
• calcium channel blockers (used in the treatment of hypertension and heart diseases);
• nitrates (used in ischaemic heart disease);
• anticoagulant medicines (medicines inhibiting blood clotting);
• digoxin (a medicine used in the treatment of congestive heart failure);
• cimetidine (a medicine used in peptic ulcer disease, gastroesophageal reflux disease).

The doctor may recommend dose adjustment and/or additional precautions:

• If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections “When not to use Gopten 2.0” and “Warnings and precautions”).

Gopten 2.0 with food and drink
Alcohol increases the risk of hypotension.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Inform the doctor about suspected (or planned) pregnancy. The doctor will usually recommend discontinuation of Gopten 2.0 before planned pregnancy or immediately after confirmation of pregnancy and will recommend an alternative medicine instead of Gopten 2.0.
Gopten 2.0 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.
Inform the doctor about breastfeeding or intention to breastfeed. Use of Gopten 2.0 is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant; the doctor may recommend an alternative medicine.

Driving and operating machinery
In some individuals, the medicine may affect the ability to drive and operate machinery, particularly during the initial period of treatment, after changing the previously used medicine, or when alcohol is consumed concurrently.
It is not advisable to drive or operate machinery within several hours after taking the first dose of the medicine or after increasing the dose.

Gopten 2.0 contains lactose monohydrate and sodium
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If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Gopten 2.0

This medicine should always be taken as directed by a doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Available on the market are: Gopten 0.5 (0.5 mg), Gopten 2.0 (2 mg), Gopten 4.0 (4 mg).
Oral administration.
Adults
Hypertension
In adult patients not taking diuretics, without congestive heart failure, and without renal or hepatic
impairment, the recommended initial dose is 0.5 mg to 2 mg once daily. The 0.5 mg dose 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, depending on the patient's response to the medicine, until reaching a maximum
daily dose of 4 mg to 8 mg.
The maintenance dose is usually 1 mg to 4 mg once daily. If the patient's response to 4 mg to 8 mg of
trandolapril daily is unsatisfactory, your doctor may consider combining this medicine with diuretics
and/or calcium antagonists.
Left ventricular dysfunction after myocardial infarction
Treatment may be initiated as early as the third day after myocardial infarction, with an initial dose
of 0.5 mg to 1 mg once daily. The dose should be gradually increased up to a maximum of 4 mg once
daily. Depending on the patient's response to the medicine (occurrence of symptomatic
hypotension), increasing the dose may be temporarily suspended.
In case of hypotension, your doctor may recommend, if possible, reducing the dose of concomitantly
administered vasodilators (including nitrates) and diuretics.
The dose of Gopten 2.0 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 also being treated with diuretics, those with
congestive heart failure, or those with renal or hepatic impairment.
The dose should be adjusted according to blood pressure values.
Patients taking diuretics
In patients who are dehydrated or have sodium depletion, your doctor may discontinue the diuretic
for 2 to 3 days before starting Gopten 2.0 to reduce the risk of symptomatic hypotension. If
necessary, the diuretic may be restarted later.
Heart failure
Treatment should be initiated with trandolapril at a dose of 0.5 mg to 1 mg once daily under strict
medical supervision.
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Patients with renal impairment
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 to achieve
the desired effect. These patients should be treated under strict medical supervision.
In patients with creatinine clearance above 30 ml/min, there is no need to modify the initial dose.
Patients undergoing dialysis
In dialyzed patients, arterial pressure should be closely monitored and the dose of medicine adjusted
accordingly if necessary.
Patients with hepatic impairment
Treatment should be initiated with a dose of 0.5 mg once daily and conducted under strict medical
supervision.
Use in children
The safety and efficacy of this medicine in children have not been studied, and therefore its use is
not recommended.
Taking more Gopten 2.0 than recommended
In case of overdose, the following symptoms may occur: severe hypotension, shock, stupor,
bradycardia, electrolyte disturbances in blood, and renal failure. After an overdose, the patient should
be closely monitored, preferably in an intensive care unit. The doctor should frequently monitor serum
electrolytes and creatinine levels. Treatment depends on the severity of symptoms. If the medicine
was recently ingested, the doctor will take measures to remove the medicine (e.g., induction of
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.
If you miss a dose of Gopten 2.0
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
During clinical studies and after marketing of the medicinal product Gopten 2.0 for various indications, the following adverse reactions 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;
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• somnolence;
• peripheral dizziness;
• palpitations (sensation of irregular or rapid heartbeat);
• sudden skin flushing with sensation 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 abnormal.

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, restlessness, agitation, apathy;
• cerebrovascular incident, fainting, clonic muscle seizures, paraesthesia (numbness, tingling in one or more limbs), migraine, migraine without aura, taste disturbances;
• eyelid inflammation, 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 oral part of throat, cough with expectoration, breathing disorders;
• haematemesis, gastric mucositis, abdominal pain, vomiting, dyspepsia, dryness of oral mucosa, flatulence;
• hepatitis;
• angioedema, psoriasis, excessive sweating, exanthema, 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):

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

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

• sinusitis*, rhinitis*, glossitis*;
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• pancytopenia (reduction in red blood cells, white blood cells and platelets), agranulocytosis (significant, rapidly progressive reduction in granulocytes), thrombocytopenia, haemolytic anaemia*;
• increased potassium concentration in serum (hyperkalaemia);
• confusion*;
• transient ischaemic attack, cerebral haemorrhage, balance disorders;
• blurred vision*;
• atrioventricular block, cardiac arrhythmias, cardiac arrest;
• bronchospasm;
• intestinal obstruction, pancreatitis, angioedema of intestine*;
• yellowing of skin or eyes (jaundice);
• Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*;
• myalgia;
• 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 reactions related to angiotensin-converting enzyme inhibitors as a drug class

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the 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 reactions allows the collection of additional information on the safety of the medicine.

5. How to store Gopten 2.0

Store below 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 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 required. These measures will help protect the environment.

6. Contents of the package and other information

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What Gopten 2,0 contains

• The active substance is trandolapril. Each hard capsule contains 2 mg of trandolapril.
• 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 2,0 looks like and contents of the pack
Gopten 2,0 is available as hard capsules. The capsule cap and body are red.
Pack sizes:
28 capsules
PVC-PVDC/Al blisters in a cardboard box.

For further information, please contact the responsible party or parallel importer:
Responsible party in the Czech Republic, country of export:
Mylan IRE Healthcare Limited
Unit 35/36, Grange Parade
Baldoyle Industrial Estate
Dublin 13, 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
Permit number in the Czech Republic, country of export: 58/067/95-B/C
Parallel import licence number: 620/15
Translation of the weekday symbols printed next to each capsule in the immediate packaging:
Po – Monday
Út – Tuesday
St – Wednesday
Čt – Thursday
Pá – Friday
So – Saturday
Ne – Sunday
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