Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Gopten 4.0 (Gopten 4 mg)
4 mg, hard capsules
Trandolapril
Gopten 4.0 and Gopten 4 mg are different trade names of the same medicinal product.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

Keep this leaflet so that you can read it again if necessary.
If you have any doubts, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

What Gopten 4.0 is and what it is used for
Important information before taking Gopten 4.0
How to take Gopten 4.0
Possible side effects
How to store Gopten 4.0
Contents of the pack and other information

1. What Gopten 4.0 is and what it is used for

The active substance in Gopten 4.0 is trandolapril. The 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 active metabolite, trandolaprilat, which is a potent and long-acting compound.
Administration of trandolapril at therapeutic doses to patients with hypertension results in a significant reduction of arterial blood pressure measured in both supine and standing positions. The blood pressure-lowering effect becomes apparent within one hour and lasts for 24 hours, with maximum effect observed between the 8th and 12th hour after administration.

Gopten 4.0 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 4.0

When not to use 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 (ACE) inhibitor.
If the patient has previously experienced angioedema (swelling of any body area, which, if affecting the throat and larynx, may impair swallowing and breathing) after taking another medicine belonging to the same class as Gopten 4.0.
If the patient has hereditary or idiopathic (of unknown cause) angioedema.
In women during the third trimester of pregnancy. Gopten 4.0 should also be avoided in early pregnancy (see section "Pregnancy and breastfeeding").
If the patient has diabetes or impaired kidney function 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), as this increases the risk of angioedema (rapid swelling of subcutaneous tissue, e.g. in the throat area).

Warnings and precautions
Before starting treatment with Gopten 4.0, discuss this with your doctor, pharmacist, or nurse.

If the patient is undergoing desensitisation treatment for animal venoms (including insects), temporary discontinuation of the medicine should be considered.
If the patient is undergoing dialysis therapy (hemodialysis or LDL apheresis).
If the patient has liver impairment.
If the patient has impaired kidney function, congestive heart failure, unilateral or bilateral renal artery stenosis, stenosis of the artery of a single functioning kidney, or has undergone kidney transplantation, as there is a risk of worsening kidney function.
If the patient with impaired kidney function develops increased serum potassium levels (hyperkalaemia).
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, or diarrhoea or vomiting. In such patients, the doctor may recommend discontinuation of diuretics and/or repletion of fluid volume and (or) sodium deficiency before starting Gopten 4.0. 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 events.
In patients with impaired kidney function, especially those with collagenoses (e.g. systemic lupus erythematosus and systemic sclerosis), as treatment with medicines belonging to the same class as Gopten 4.0 may cause agranulocytosis (reduction in granulocyte count – a type of white blood cell) and bone marrow suppression. Granulocyte reduction is transient and resolves after discontinuation of the ACE inhibitor.
In patients with collagenoses, particularly those complicated by kidney impairment and those receiving concomitant glucocorticosteroids and antimetabolites, 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, extremities, tongue, glottis, and (or) larynx – after taking Gopten 4.0, seek immediate medical attention. The medicine should be discontinued immediately and the patient monitored until symptoms resolve. Angioedema affecting only the face usually resolves spontaneously. Angioedema involving 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 4.0, as medicines belonging to the same class may cause intestinal angioedema. In such cases, immediate medical attention is required, as prompt intervention may be necessary.
In patients with renovascular hypertension.
If the patient develops increased serum potassium levels (hyperkalaemia) after taking Gopten 4.0, regular monitoring of serum potassium levels is recommended. Risk factors for hyperkalaemia include: kidney impairment, use of potassium-sparing diuretics, concomitant administration of drugs used to treat hypokalaemia, diabetes, and (or) impaired left ventricular function after myocardial infarction.
If the patient is undergoing surgery or anaesthesia with medicines that may 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 this may increase the risk of angioedema (rapid swelling of tissue, e.g. in the throat area):
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 4.0".
Important information

Gopten 4.0 must not be used in patients with aortic stenosis or outflow tract obstruction.
Inform the doctor if the patient is taking diuretics, especially if recently initiated, as concomitant use with Gopten 4.0 may cause a marked drop in blood pressure.
Inform the doctor if pregnancy is suspected (or planned). Use of Gopten 4.0 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").
A dry, persistent, non-productive cough may occur in patients taking medicines belonging to the same class as Gopten 4.0. This symptom resolves after discontinuation of treatment.
Use of Gopten 4.0 during breastfeeding, especially in newborns or preterm infants, is not recommended. The doctor may recommend an alternative medicine during breastfeeding.

Children
The safety and efficacy of Gopten 4.0 in children have not been established, and therefore its use is not recommended.

Gopten 4.0 and other medicines
Inform your doctor or pharmacist about all medicines currently taken, recently taken, or planned to be taken.

Inform your doctor if you are taking any of the following medicines, as special precautions may be 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 that increase potassium levels in blood (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;
anaesthetics;
allopurinol (used in the treatment of gout);
procainamide (used to treat cardiac arrhythmias);
cytostatic agents (used in cancer treatment);
immunosuppressive medicines (affecting the immune system);
systemic glucocorticosteroids (anti-inflammatory medicines);
sympathomimetic agents (vasoconstrictors);
antipsychotics and tricyclic antidepressants;
non-steroidal anti-inflammatory drugs (including acetylsalicylic acid used in higher doses as an anti-inflammatory, e.g. for pain relief);
medicines that reduce gastric acidity;
injectable gold preparations (used in the treatment of rheumatoid arthritis).

No clinically relevant interactions were observed in patients with impaired left ventricular function after myocardial infarction when Gopten 4.0 was administered concomitantly with:

thrombolytic agents (used in thrombosis and arterial/venous embolism);
acetylsalicylic acid;
β-adrenolytic agents (used in the treatment of heart disease and hypertension);
calcium channel blockers (used in the treatment of hypertension and heart disease);
nitrates (used in ischaemic heart disease);
anticoagulant medicines (blood thinners);
digoxin (used in the treatment of congestive heart failure);
cimetidine (used in peptic ulcer disease and reflux oesophagitis).

The doctor may recommend dose adjustment and (or) other precautions:

If the patient is taking an angiotensin II receptor antagonist (AIIRA) or aliskiren (see also sections "When not to use 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Inform the doctor if pregnancy is suspected (or planned). The doctor will usually recommend discontinuing Gopten 4.0 before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
Gopten 4.0 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 if you are breastfeeding or plan to breastfeed. Use of Gopten 4.0 during breastfeeding, especially when breastfeeding a newborn or preterm infant, is not recommended; the doctor may recommend an alternative medicine.

Driving and using machines
In some individuals, this medicine may affect the ability to drive and operate machinery, particularly during the initial phase of treatment, after switching from a previously used medicine, or when alcohol is consumed concurrently.
It is not advisable to drive or operate machinery for several hours after taking the first dose 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 this medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning it is considered "sodium-free".

3. How to use Gopten 4.0

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
The following products are available on the market: 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 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 black patients, 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 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 response to trandolapril at a dose 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 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 (e.g. occurrence of symptomatic hypotension), dose escalation may be temporarily withheld.
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 4.0 may be reduced only if the above measures are 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 receiving concomitant diuretic therapy, 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 4.0 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
In patients with creatinine clearance (a laboratory marker of kidney function measured in blood tests) 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 therapeutic effect. Treatment in these patients should be closely monitored by a physician.
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 the drug 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 studied and therefore its use is not recommended.
Use of a higher than recommended dose of Gopten 4.0
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 drug was 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 supine position, as in shock. The doctor should initiate appropriate treatment as quickly as possible.
Missed dose of Gopten 4.0
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 will experience them.
During clinical trials and after marketing of the medicine Gopten 4.0 for various indications, the following adverse reactions have been observed:
Common (in 1 to 10 out of 100 patients):
˗ headache, central dizziness;
˗ hypotension;
˗ cough;
˗ fatigue.
Uncommon (in 1 to 10 out of 1,000 patients):
˗ upper respiratory tract infection;
˗ insomnia, decreased libido;
˗ 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 disorders;
˗ rash, itching;
˗ back pain, muscle cramps, limb pain;
˗ erectile dysfunction;
˗ malaise, chest pain, peripheral oedema, feeling unwell.
Rare (in 1 to 10 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, restlessness, 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, sore throat, productive cough, breathing disorders;
˗ haematemesis, gastric mucosal inflammation, abdominal pain, vomiting, dyspepsia, dryness of oral mucosa, flatulence;
˗ 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, frequency of urination;
˗ congenital arterial malformation, ichthyosis;
˗ oedema, feeling of fatigue;
˗ increased bilirubin concentration (bile pigment);
˗ injury.
Very rare (in less than 1 out of 10,000 treated patients):
˗ cholestasis (bile stasis);
˗ 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*;
˗ pancytopenia (reduced number of red blood cells, white blood cells and platelets), agranulocytosis (significant, rapidly progressing reduction in granulocyte count), 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, intestinal angioedema*;
˗ 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 group of medicines
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 Drug Reactions, 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 adverse reactions allows further information on the safety of the medicine to be collected.

5. How to store Gopten 4.0

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 pack and other information

What Gopten 4.0 contains

The active substance is trandolapril. Each hard capsule contains 4 mg of trandolapril.
Other ingredients: maize starch, monohydrate lactose, povidone K 25, sodium stearyl fumarate.

Capsule shell: gelatin, titanium dioxide (E 171), erythrosine (E 127), black iron oxide (E 172),
yellow iron oxide (E 172), sodium lauryl sulfate.

What Gopten 4.0 looks like and contents of the pack
Gopten 4.0 is available as hard capsules. The capsule cap is burgundy, the body red.

Pack sizes:
28 capsules

PVC-PVDC/Al blisters in a cardboard box.

For further information, please contact the responsible party or parallel importer:

Marketing Authorisation Holder in the Czech Republic, 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, Poland

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

Marketing Authorisation number in the Czech Republic, country of export: 58/001/05-C
Parallel import authorisation number: 621/15

Translation of the weekday symbols printed next to each capsule on the immediate packaging:
Po – Monday
Út – Tuesday
St – Wednesday
Čt – Thursday
Pá – Friday
So – Saturday
Ne – Sunday