Gopten 2.0: detailed information

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language!
Gopten 2.0 (Gopten)
2 mg, hard capsules
Trandolaprilum
Gopten 2.0 and Gopten are different trade names of 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, so that you may read it again if necessary.
If you have any questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

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 potent, long-acting active metabolite – trandolaprilat.

Administration of trandolapril at therapeutic doses to patients with hypertension results in a significant reduction of arterial blood pressure measured in both the 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 the 8th and 12th hour 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 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, 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 (cause unknown) 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 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 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 2.0, discuss this with your doctor, pharmacist, or nurse.

If the patient is to undergo desensitisation treatment 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 kidney dysfunction, 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 kidney dysfunction 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, a low-sodium diet, dialysis, or diarrhoea or vomiting. In such patients, before starting Gopten 2.0, the doctor may recommend discontinuing diuretics and/or replenishing 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 dysfunction, especially those with collagen vascular diseases (e.g. systemic lupus erythematosus and systemic sclerosis), because after administration of medicines from the same class as Gopten 2.0, agranulocytosis (a decrease in granulocyte count – a type of white blood cell) and bone marrow suppression may occur. Decreased granulocyte count is transient and resolves after discontinuation of the ACE inhibitor.
In patients with collagen vascular diseases, especially those complicated by kidney dysfunction, 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 acute allergic reaction – angioedema of the face, limbs, tongue, glottis, and (or) larynx – after taking Gopten 2.0, seek medical attention immediately. 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 levels (hyperkalaemia) after taking Gopten 2.0, regular monitoring of serum potassium levels is recommended. Risk factors for hyperkalaemia include: kidney dysfunction, use of potassium-sparing diuretics, concomitant administration of medicines used to treat hypokalaemia, diabetes, and (or) left ventricular dysfunction 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 dysfunction related to diabetes, or 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) 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); or 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 main artery stenosis or outflow tract stenosis.
Inform the doctor if the patient is taking diuretics, especially if recently initiated, as concomitant use with Gopten 2.0 may cause a marked decrease 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”).
Dry, persistent, non-productive cough may occur in patients taking medicines from the same class as Gopten 2.0. This symptom resolves after discontinuation of treatment with these medicines.
Use of Gopten 2.0 is not recommended during breastfeeding, especially when nursing a newborn or premature infant. The doctor may recommend an alternative medicine during breastfeeding.

Children
The safety and efficacy of Gopten 2.0 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 for 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 to treat gout)
Procainamide (used to treat cardiac arrhythmias)
Cytostatics (used in cancer treatment)
Immunosuppressive medicines (affecting the immune system)
Systemic-acting 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, e.g. to relieve pain)
Medicines reducing gastric acidity
Injectable gold preparations (used to treat rheumatoid arthritis)

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

Thrombolytic medicines (used in thrombosis and arterial/venous embolism)
Acetylsalicylic acid
β-adrenolytic medicines (used in heart disease and hypertension)
Calcium channel blockers (used in hypertension and heart disease)
Nitrates (used in ischaemic heart disease)
Anticoagulant medicines (medicines inhibiting blood clotting)
Digoxin (used in 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 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 if pregnancy is suspected (or planned). The doctor will usually recommend discontinuing Gopten 2.0 before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine.
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 breastfeeding or planning to breastfeed. Use of Gopten 2.0 is not recommended during breastfeeding, especially when nursing a newborn or premature infant; the doctor may recommend an alternative medicine.

Driving and operating machinery
This medicine may affect the ability to drive and operate machinery in some individuals, especially during the initial phase of treatment, after switching from another medicine, or when alcohol is consumed concurrently.
Driving or operating machinery should be avoided for several hours after taking the first dose or after increasing the dose.

Gopten 2.0 contains lactose and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a 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 2.0

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If you are unsure, consult your doctor or pharmacist.
Oral administration
Adults
Hypertension
In adult patients not taking diuretics, without congestive heart failure, renal or hepatic impairment,
the recommended initial dose is 0.5 mg to 2 mg once daily. The dose of 0.5 mg 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 4 mg to 8 mg of
trandolapril per day is inadequate, your doctor may consider combining the drug with diuretics
and/or calcium antagonists.
Left ventricular dysfunction after myocardial infarction
Treatment with this medicine 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), the dose escalation 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 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 who are also 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 have sodium depletion, your doctor may discontinue the diuretic
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 close
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 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 effect is achieved. These patients should be treated under close medical supervision.
In patients with creatinine clearance above 30 ml/min, there is no need to modify the initial dose.
Patients undergoing dialysis
In patients undergoing dialysis, 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 close medical
supervision.
Use in children
The safety and efficacy of this medicine in children have not been established, and therefore its use
is not recommended.
Taking more Gopten 2.0 than recommended
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 was
recently ingested, the doctor will take measures to remove the drug (e.g. induction of emesis, 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 forget to take 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 marketing of Gopten 2.0 for various indications, the following adverse reactions have been observed:

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

headache, central dizziness
hypotension
cough
fatigue

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

upper respiratory tract infection
insomnia, decreased libido
somnolence
peripheral dizziness
palpitations (awareness 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, pruritus
back pain, muscle cramps, limb pain
erectile dysfunction
malaise, chest pain, peripheral oedema, feeling unwell

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

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
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 sputum, breathing disorders
haematemesis, gastric mucositis, abdominal pain, vomiting, dyspepsia, dryness of oral mucosa, flatulence
hepatitis
angioedema, psoriasis, excessive sweating, eruption, 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 vascular malformation, ichthyosis
oedema, feeling of fatigue
increased bilirubin concentration (bile pigment)
injury

Very rare (in less than 1 patient out of 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*
pancytopenia (decreased number of red blood cells, white blood cells and platelets), agranulocytosis (significant, rapidly progressing decrease 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, 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 serum 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 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.: 22 49 21 301, fax: 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Gopten 2,0

Do not store above 25°C.
Keep in the original packaging to protect from light.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. 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.
The other ingredients are: maize starch, monohydrate lactose, povidone K 25, sodium stearyl fumarate, and capsule shell components: gelatin, titanium dioxide (E 171), erythrosine (E 127), yellow iron oxide (E 172), 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 size: 28 capsules.
PVC/PVDC/Al blisters, in a cardboard box.
Also available on the market are Gopten 0.5, hard capsules, 0.5 mg and Gopten 4.0, hard capsules, 4 mg.
For more detailed information, please contact the marketing authorization holder or the parallel importer.
Marketing authorization holder in Lithuania, country of export:
Viatris SIA
Mūkusalas 101
Riga LV 1004
Latvia
Manufacturer:
Mylan Hungary Kft.
Mylan utca 1
Komárom, 2900
Hungary
Parallel importer:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Repackaged in:
Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Marketing authorization number in Lithuania, country of export: LT/1/94/0356/002
Parallel import authorization number: 255/24
Translation of the weekday symbols printed next to each capsule in the immediate packaging:
Pirm./Pirmd./E - Monday
Antr./Otrd./T - Tuesday
Treč./Trešd./K - Wednesday
Ketv./Ceturtd./N - Thursday
Penk./Piektd./R - Friday
Šešt./Sestd./L - Saturday
Sekm./Svētd./P - Sunday