Gopten 2.0: detailed information

Package leaflet: Information for the patient

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

Keep this leaflet for future reference.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are similar.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Gopten 2.0 is and what it is used for
Important information before taking Gopten 2.0
How to take Gopten 2.0
Possible side effects
How to store Gopten 2.0
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 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 then converted in the liver into its active metabolite, trandolaprilat, which is potent and long-acting.
Administration of trandolapril in 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 after administration and lasts for 24 hours, with maximum effect observed between 8 and 12 hours after dosing.

Gopten 2.0 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 2.0

When not to use Gopten 2.0

If the patient is allergic to trandolapril or to any of the other ingredients of this medicine (listed in section 6) or to any other angiotensin-converting enzyme (ACE) inhibitor.
If the patient has previously experienced angioedema (swelling of any part of the body, which, when affecting the throat and larynx, may impair 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.
In women after the third month of pregnancy. Use of Gopten 2.0 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), because the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g. in the throat area) is increased.

Warnings and precautions
Before starting treatment with Gopten 2.0, discuss this with your doctor, pharmacist, or nurse.

If the patient is undergoing desensitization therapy for animal venoms (including insect venoms), temporary discontinuation of the medicine should be considered.
If the patient is undergoing dialysis therapy (hemodialysis or low-density lipoprotein (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 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 impaired kidney function develops increased serum potassium levels (hyperkalemia).
If the patient has risk factors for hypotension, such as hypovolemia (reduced blood volume), sodium depletion due to prolonged use of diuretics, a low-salt diet, dialysis, or diarrhea or vomiting. In such patients, before starting Gopten 2.0, the doctor may recommend discontinuation of diuretics and/or fluid and (or) sodium repletion. 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 impaired kidney function, especially those suffering from collagenoses (e.g. systemic lupus erythematosus or systemic sclerosis), because after administration of medicines from the same class as Gopten 2.0, agranulocytosis (a decrease in granulocytes, a type of white blood cells) or bone marrow suppression may occur. Granulocyte count reduction is transient and resolves after discontinuation of the ACE inhibitor.
In patients with collagenoses, especially 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, after administration of Gopten 2.0, the patient develops an acute allergic reaction—angioedema of the face, limbs, tongue, glottis, and (or) larynx—immediate medical attention is required. The medicine must be discontinued immediately and the patient monitored until the swelling resolves. Angioedema limited to 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, after administration of Gopten 2.0, the patient develops abdominal pain (with or without nausea or vomiting), because medicines from the same class as Gopten 2.0 may cause intestinal angioedema. In such cases, immediate medical attention is required, as prompt treatment may be necessary.
In patients with renovascular hypertension.
If, after administration of the medicine, the patient develops increased serum potassium levels (hyperkalemia), 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.
If the patient is undergoing surgical procedures or anesthesia 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, because 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 blood electrolyte levels (e.g. potassium).
See also the section “When not to use Gopten 2.0”.
Important information

Gopten 2.0 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 2.0 may cause a marked drop in blood pressure.
Inform the doctor if pregnancy is suspected (or planned). 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”).
Patients taking medicines from the same class as Gopten 2.0 may develop a dry, persistent cough without expectoration. This symptom resolves after discontinuation of treatment with these medicines.
Use of Gopten 2.0 during breastfeeding is not recommended, especially in newborns or preterm infants. The doctor will recommend an alternative medicine during breastfeeding.

Children
The safety and efficacy of the medicine in children have not been established, 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 caution is required:

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 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;
anesthetics;
allopurinol (used in the treatment of gout);
procainamide (used to treat cardiac arrhythmias);
cytostatic agents (used in cancer diseases);
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. to relieve pain);
medicines reducing gastric acidity;
injectable gold preparations (used in the treatment of rheumatoid arthritis).

No clinically relevant interactions were observed in patients with left ventricular dysfunction after myocardial infarction when Gopten 2.0 was administered concomitantly with:

thrombolytic agents (used in thrombosis and embolism);
acetylsalicylic acid;
β-adrenolytic agents (used in the treatment of heart diseases and hypertension);
calcium channel blockers (used in the treatment of hypertension and heart diseases);
nitrates (used in ischemic heart disease);
anticoagulant medicines (medicines inhibiting blood coagulation);
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) other 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 is planning to have a child, 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 2.0 before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine instead of Gopten 2.0.
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.
Inform the doctor if you are breastfeeding or plan to breastfeed. Use of Gopten 2.0 is not recommended during breastfeeding, especially in the case of breastfeeding a newborn or preterm infant; the doctor may recommend an alternative medicine.

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

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

3. How to use Gopten 2.0

This medicine should always be taken as directed by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Oral administration.
Each capsule on the blister is marked with a symbol indicating the day of the week on which it
should be taken (symbol key is located at the end of the leaflet).
Labelling blisters with symbols for consecutive days of the week helps ensure regular
use of the medicine.
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 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, up to
a maximum dose of 4 mg to 8 mg daily.
The maintenance dose is typically 1 mg to 4 mg once daily. If the response to 4 mg to 8 mg of
trandolapril daily 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, starting with a single
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 drug (occurrence of symptomatic
hypotension), increasing the dose may be temporarily discontinued.
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 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 receiving concomitant diuretic therapy, those with
congestive heart failure, or those with renal or hepatic impairment. Dose adjustment should be
based on blood pressure values.
Patients using diuretics
In patients who are dehydrated or sodium-depleted, your doctor may discontinue the diuretic
2–3 days before initiating Gopten 2.0 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 strict
medical supervision.
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 recommended doses are the same as in adults, including elderly
patients.
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 effect is achieved. 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 blood pressure should be closely monitored and the dose of the drug
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 established; therefore, its use is
not recommended.
Taking more Gopten 2.0 than recommended
Overdose may result in the following symptoms: severe hypotension (low blood pressure), shock,
stupor, bradycardia (slow heart rate), electrolyte disturbances in blood, and renal failure. In case of
overdose, the patient should be closely monitored, preferably in an intensive care unit. Your doctor
should frequently monitor serum electrolytes and creatinine levels. Treatment depends on the
severity of symptoms. If the drug was taken recently, your doctor will take steps to remove it (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.
Your 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 will experience them.
During clinical studies and after the marketing of 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,
somnolence,
peripheral dizziness,
palpitations (awareness of irregular or rapid heartbeat),
sudden flushing with sensation of warmth,
upper respiratory tract inflammation, hyperaemia of upper respiratory tract,
nausea, diarrhoea, stomach and intestinal pain, constipation, gastrointestinal disorders,
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, restlessness, 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 upon changing from lying to standing position), peripheral vascular disorders, varicose veins,
dyspnoea, epistaxis, pharyngitis, pain in the throat, cough with sputum, 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,
arthralgia, 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 patient per 10,000 treated):

cholestasis (biliary 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 (reduction in red blood cells, white blood cells and platelets), agranulocytosis (severe, rapidly progressing reduction in granulocytes), thrombocytopenia, haemolytic anaemia*;
increased serum potassium concentration (hyperkalaemia);
confusion*;
transient ischaemic attack, intracranial 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*;
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 associated with angiotensin-converting enzyme inhibitors as a class of medicines
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 adverse reactions helps to provide more information on the safe use of the medicine.

5. How to store Gopten 2,0

Store below 25°C.
Keep the medicine in a place invisible and inaccessible to 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. This will help protect the environment.

6. Contents of the pack and other information

What Gopten 2.0 contains

The active substance is trandolapril. Each hard capsule contains 2 mg of trandolapril.
Other ingredients are: corn starch, lactose monohydrate, povidone K 25, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide, erythrosine, iron oxide yellow, 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.
Other pack sizes of Gopten are also available: Gopten 0.5, hard capsules, 0.5 mg and Gopten 4.0, hard capsules, 4 mg.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder 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:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw, Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing Authorisation Number in the Czech Republic, country of export: 58/067/95-B/C
Parallel Import Authorisation Number: 207/15

Translation of the symbols for days of the week printed on each tablet in the immediate packaging:
Po - Monday
Út - Tuesday
St - Wednesday
Čt - Thursday
Pá - Friday
So - Saturday
Ne - Sunday