Gopten 2.0

Package leaflet: Information for the patient

Warning! Keep this leaflet! The 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 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, 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 someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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 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 is 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 in 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 part of the body, which, if 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 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), as this increases the risk of angioedema (rapid swelling of the subcutaneous tissue, e.g., in the throat area).

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 therapy (hemodialysis or LDL apheresis).

• If the patient has liver impairment.

• If the patient has kidney function impairment, congestive heart failure, unilateral or bilateral renal artery stenosis, stenosis of the artery of a single functioning kidney, or has undergone kidney transplantation, as there is a risk of worsening kidney function.

• If the patient with kidney impairment develops increased serum potassium levels (hyperkalemia).

• If the patient has risk factors for hypotension, such as hypovolemia (reduced blood volume), sodium deficiency due to prolonged use of diuretics, low-sodium 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 replacement. Similar precautions should be taken in patients with ischemic heart disease or cerebrovascular disorders, in whom excessive reduction in blood pressure may lead to myocardial infarction or cerebrovascular events.

• In patients with kidney impairment, especially those suffering from collagenoses (e.g., systemic lupus erythematosus and systemic sclerosis), as treatment with medicines from the same class as Gopten 2.0 may lead to 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, especially those complicated by kidney impairment, and in cases of concomitant use of glucocorticosteroids and antimetabolites, the doctor may recommend regular monitoring of white blood cell count and urinary protein levels.

• If, after taking 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 should 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 taking 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 intervention may be necessary.

• In patients with renovascular hypertension.

• If, after taking Gopten 2.0, 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 drugs used to treat hypokalemia, diabetes, and (or) left ventricular dysfunction after myocardial infarction.

• If the patient is to undergo surgery or anesthesia with drugs 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 they may increase the risk of angioedema (rapid swelling of tissue, e.g., in the throat area):

• racecadotril, a medicine used to treat diarrhea,

• medicines used to prevent organ transplant rejection and to treat cancer (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 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 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").
• A 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 during breastfeeding, especially of a newborn or preterm infant, is not recommended. The doctor will advise on alternative medicines 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
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines planned for future use.
Inform your doctor if you are taking any of the following medicines, as special precautions may be 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);
• cytostatics (used in cancer treatment);
• immunosuppressive medicines (affecting 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, e.g., for pain relief);
• medicines that reduce gastric acidity;
• injectable gold preparations (used in the treatment of rheumatoid arthritis).

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

• thrombolytic agents (used in thrombosis and arterial/venous embolism);
• acetylsalicylic acid;
• β-adrenolytic agents (used in heart disease and hypertension);
• calcium channel blockers (used in hypertension and heart disease);
• nitrates (used in ischemic heart disease);
• anticoagulants (medicines that inhibit blood clotting);
• digoxin (used in congestive heart failure);
• cimetidine (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 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 advise using 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 intend to breastfeed. Use of Gopten 2.0 during breastfeeding is not recommended, especially when breastfeeding a newborn or preterm infant; the doctor may recommend using another medicine.

Driving and operating machinery
In some individuals, this medicine may affect the ability to drive and operate machinery, particularly during the initial phase of treatment, after changing 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 2.0 contains monohydrate 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 the medicine is considered "sodium-free".

3. How to use Gopten 2.0

This medicine should always be taken according to the instructions given by your doctor or pharmacist. If in
doubt, consult your doctor or pharmacist.
Oral administration.
Adults
Hypertension
In adult patients not taking diuretics, without congestive heart failure, or renal or hepatic impairment, the recommended initial dose is 0.5 mg to 2 mg once daily. The 0.5 mg dose is effective in only a small number of patients. In 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 doses of 4 mg to 8 mg per day is inadequate, your doctor may consider combining the drug with diuretics and/or calcium antagonists.
Left ventricular dysfunction after myocardial infarction
Treatment with this medicine 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 (e.g. 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 vasodilating drugs (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, or those with congestive heart failure, or renal or hepatic impairment. The dose should be adjusted according to blood pressure response.
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, 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) 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 to achieve the desired effect. 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.
Dialysis patients
In dialysis patients, blood pressure should be closely monitored and the drug dose adjusted accordingly if necessary.
Patients with hepatic impairment
Treatment should be initiated at a dose of 0.5 mg once daily and conducted under close medical supervision.
Use in children
The safety and efficacy of this medicine in children have not been studied, and therefore its use is not recommended.
Taking more Gopten 2.0 than prescribed
Overdose may lead to 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. Your doctor should frequently monitor serum electrolyte and creatinine levels. Treatment depends on the severity of symptoms. If the drug was taken recently, your doctor will take measures to remove the drug (e.g. induced vomiting, gastric lavage, administration of adsorbents and sodium sulfate).
In case of symptomatic hypotension, the patient should be placed immediately in a shock position. 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 experiences them.
During clinical trials and after the marketing of Gopten 2.0 for various indications, the following adverse reactions have been observed:

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

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

Uncommon (in 1 to 1,000 patients out of 100 patients):

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

Rare (in 1 to 10,000 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 triglycerides and cholesterol (hyperlipidaemia), increased blood uric acid concentration (hyperuricaemia),
• gout, loss of appetite, increased appetite, abnormal enzyme activity,
• hallucinations, depression, sleep disorders, anxiety, agitation, apathy,
• cerebrovascular incident, fainting, clonic muscle seizures, paraesthesia (numbness, tingling in one or more limbs), migraine, migraine without aura, taste disturbances,
• blepharitis, conjunctival oedema, visual disturbances, eye disorders,
• tinnitus,
• myocardial infarction, myocardial ischaemia, angina pectoris, heart failure, ventricular tachycardia, tachycardia, bradycardia,
• hypertension, cerebral vascular abnormalities (angiopathy), orthostatic hypotension (sudden drop in blood pressure upon changing position from lying to standing), peripheral vascular disorders, varicose veins,
• dyspnoea, epistaxis, pharyngitis, pain in the oral part of the throat, productive cough, breathing disorders,
• haematemesis, gastric mucositis, abdominal pain, vomiting, dyspepsia, dryness of the 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 patient per 10,000 treated patients):

• 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 determined from available data):

• sinusitis*, rhinitis*, glossitis*;
• pancytopenia (reduced number of 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 the intestine*;
• yellowing of the skin or eyes (jaundice);
• Stevens-Johnson syndrome, erythema multiforme*, toxic epidermal necrolysis*, urticaria, alopecia, psoriasiform dermatitis*;
• muscle pain;
• fever;
• abnormal diagnostic test results (abnormal liver function tests, thrombocytopenia, increased blood creatinine concentration, increased blood urea concentration, increased lactate dehydrogenase activity, increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity, increased liver enzyme activity, decreased haemoglobin concentration, decreased haematocrit value, abnormal ECG recording).

*Adverse reactions associated with angiotensin-converting enzyme inhibitors as a class of medicines

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, patients should inform their doctor or pharmacist. 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, tel.: + 48 22 49 21 301, fax: + 48 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 the medicine in a place out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer 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, lactose monohydrate, povidone K 25, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide (E 171), erythrosine, iron oxide yellow (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 sizes:
28 capsules
PVC/PVDC/Al blisters in a cardboard box.
Other strengths 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 responsible party or the parallel importer.
Responsible party in Portugal, country of export:
BGP Products, Unipessoal Lda.
Av. D. João II, Edifício Atlantis, N.º 44C - 7.3 and 7.4
1990-095 Lisbon, Portugal
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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw, Poland
Marketing authorization number in Portugal, country of export: 2181485
Parallel import authorization number: 177/23