Gopten 4.0

Package leaflet: Information for the patient

Warning! Keep this leaflet! Information on the immediate packaging is 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 for the same medicine.
Please read the following information 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. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Gopten 4.0 is and what it is used for
2. Important information before taking Gopten 4.0
3. How to take Gopten 4.0
4. Possible side effects
5. How to store Gopten 4.0
6. 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 hard capsules is trandolapril. This medicine belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Trandolapril is rapidly absorbed from the gastrointestinal tract and is then converted in the liver into its active metabolite, trandolaprilat, which is a potent and long-acting substance.
Administration of therapeutic doses of trandolapril to patients with hypertension leads to a significant reduction in arterial blood pressure measured both in 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 8 and 12 hours after dosing.
Gopten 4.0 is used in the treatment of:

• Mild to moderate essential 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 components 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 or 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. Use of 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 an antihypertensive 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 4.0, discuss this with your doctor, pharmacist, or nurse.

• If the patient is to undergo desensitization therapy for animal venoms (including insects), temporary discontinuation of Gopten 4.0 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 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, a low-sodium diet, dialysis, or diarrhea 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 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 with collagen diseases (e.g. systemic lupus erythematosus or systemic sclerosis), because after administration of a medicine from the same class as Gopten 4.0, agranulocytosis (a decrease in granulocytes, a type of white blood cell) or bone marrow suppression may occur. A reduction in granulocyte count is usually transient and resolves after discontinuation of the ACE inhibitor.

• In patients with collagen diseases, especially those complicated by kidney impairment, and when corticosteroids and antimetabolites are used concomitantly, the doctor may recommend regular monitoring of white blood cell count and urinary protein levels.

• If the patient develops an acute allergic reaction—angioedema of the face, extremities, tongue, glottis, and/or larynx—after taking Gopten 4.0, 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 the patient develops abdominal pain (with or without nausea or vomiting) after taking Gopten 4.0, because medicines from the same class as Gopten 4.0 may cause intestinal angioedema. If such symptoms occur, immediate medical attention is required, as prompt treatment may be necessary.

• In patients with renovascular hypertension.

• If the patient develops increased serum potassium levels (hyperkalemia) after taking Gopten 4.0, 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 scheduled for 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, because the risk of angioedema (rapid swelling of tissue, e.g. in the throat) may increase:

• 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 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").
• In patients taking medicines from the same class as Gopten 4.0, a dry, persistent, non-productive cough may occur. This symptom resolves after discontinuation of treatment with these medicines.
• Use of Gopten 4.0 during breastfeeding, especially in newborns or preterm infants, is not recommended. The doctor will advise on alternative medicines 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
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if any of the following medicines are being used, as special precautions 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 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 in the treatment of cardiac arrhythmias);
• Cytostatic agents (used in cancer treatment);
• Immunosuppressive medicines (affecting the immune system);
• Systemic-acting glucocorticoids (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 significant interactions have been observed in patients with left ventricular dysfunction after myocardial infarction when Gopten 4.0 was administered concomitantly with:

• Thrombolytic agents (used in thrombosis and arterial/venous embolism);
• Acetylsalicylic acid;
• β-adrenergic blocking 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 ischemic heart disease);
• Anticoagulant medicines (drugs that inhibit blood clotting);
• Digoxin (used in the treatment of congestive heart failure);
• Cimetidine (used in peptic ulcer disease, duodenal ulcer, and reflux esophagitis).

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 a pregnancy, 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 4.0 before a planned pregnancy or immediately after pregnancy is confirmed, and will advise on 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 the patient is breastfeeding or intends to breastfeed. Use of Gopten 4.0 is not recommended during breastfeeding, especially when breastfeeding a newborn or preterm infant; 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 period of treatment, after changing the 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 of the medicine 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, 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 4.0

This medicine should always be taken as directed by a doctor or pharmacist. If in
doubt, consult a doctor or pharmacist.
Oral administration.
Each capsule on the blister is marked with a symbol indicating the day of the week it should be taken
(symbol explanations are located at the end of this leaflet).
Labelling of blisters with symbols for consecutive days of the week facilitates control over 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. A dose of 0.5 mg 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, according to the patient's response to the medicine, until the
maximum dose of 4 mg/day to 8 mg/day is reached.
The maintenance dose is usually 1 mg to 4 mg once daily. If the patient's response to 4 mg to 8 mg of
trandolapril per day is unsatisfactory, the doctor may consider combining the medicine with diuretics
and (or) calcium antagonists.
Left ventricular dysfunction after myocardial infarction
Treatment may be initiated as early as the third day after myocardial infarction, with a single initial dose
of 0.5 mg to 1 mg once daily. The dose should be gradually increased up to a maximum of 4 mg once
daily. Depending on the patient's response to the medicine (occurrence of symptomatic hypotension),
the dose increase may be temporarily suspended.
In case of hypotension, the doctor may recommend, if possible, reducing the dose of concomitantly
administered vasodilating drugs (including nitrates) and diuretics. The dose of Gopten 4.0 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. The dose should be adjusted
according to blood pressure values.
Patients using diuretics
In patients who are dehydrated or have sodium depletion, the doctor may discontinue the diuretic
2–3 days before initiating treatment with Gopten 4.0 to reduce the risk of symptomatic hypotension.
Diuretic therapy may be resumed later if necessary.
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 same dosing as in adults, including elderly patients, is recommended.
In patients with creatinine clearance below 30 ml/min, a reduced initial dose of trandolapril is
recommended (i.e. initial dose of 0.5 mg once daily), followed by gradual dose escalation to achieve the
desired effect. Treatment in these patients should be conducted under strict medical supervision.
In patients with creat游戏副本

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 Gopten 4.0 for various indications, the following adverse reactions have been observed:

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

• headache, centrally-mediated dizziness,
• hypotension,
• cough,
• fatigue.

Uncommon (in 1 to 1000 patients out of 1000 patients):

• upper respiratory tract infection,
• insomnia, decreased libido,
• somnolence,
• peripherally-mediated dizziness,
• palpitations (awareness of irregular or rapid heartbeat),
• sudden flushing with sensation of warmth,
• upper respiratory tract inflammation, hyperaemia of the upper respiratory tract,
• nausea, diarrhoea, stomach and intestinal pain, constipation, gastrointestinal disturbances,
• rash, itching,
• 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 the 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,
• 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 upon changing from lying to standing position), peripheral vascular disorders, varicose veins,
• dyspnoea, epistaxis, pharyngitis, pain in the throat, productive cough, breathing disorders,
• haematemesis, gastric mucosal inflammation, 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, frequent urination,
• congenital arterial 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 stagnation (cholestasis),
• dermatitis,
• abnormal diagnostic test results (increased blood γ-glutamyltransferase activity, 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 progressing reduction in granulocytes), thrombocytopenia, haemolytic anaemia*;
• increased serum potassium concentration (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 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 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 4921301, fax: +48 22 4921309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Gopten 4.0

Store below 25°C.
Keep the medicine 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. Such measures help protect the environment.

6. Contents of the packaging 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, lactose monohydrate, povidone K 25, sodium stearyl fumarate; capsule shell: gelatin, titanium dioxide, erythrosine, yellow iron oxide, black iron oxide, 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.
Also marketed are Gopten 0.5, hard capsules, 0.5 mg and Gopten 2.0, hard capsules, 2 mg.
For more detailed information, please contact the Marketing Authorisation Holder 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 in:
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: 58/001/05-C
Parallel import authorisation number: 119/17

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