Gopten

Package leaflet: Information for the patient

GOPTEN 0.5 mg hard capsules, 2 mg hard capsules

Trandolapril
Please read this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What GOPTEN is and what it is used for
2. What you need to know before taking GOPTEN
3. How to take GOPTEN
4. Possible side effects
5. How to store GOPTEN
6. Contents of the pack and other information

1. What GOPTEN is and what it is used for

GOPTEN is a medicine that contains trandolapril, an active substance belonging to a group
of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors). These
medicines relax the blood vessels, helping the heart to pump blood effectively throughout the
body and reducing blood pressure.
GOPTEN is used:

• for the treatment of high blood pressure (arterial hypertension);
• to protect the heart after a heart attack.

2. What you need to know before taking GOPTEN

Do not take GOPTEN if:

• you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren;
• you are more than 3 months pregnant (second and third trimester). The use of GOPTEN should also preferably be avoided at the beginning of pregnancy – see “Pregnancy and breastfeeding”;
• you have previously experienced swelling of the face, eyes, lips, tongue, throat and/or breathing difficulties due to a condition called hereditary/idiopathic angioedema;
• you have a blockage slowing blood flow in the heart, such as narrowing or obstruction of heart valves (aortic stenosis or obstruction);
• you have had an allergic reaction after taking other ACE inhibitors, called allergic angioedema (Quincke's edema), characterized by skin lesions (urticaria) and swelling of the extremities, face, tongue, mouth and throat and/or breathing difficulties;
• you have taken or are currently taking sacubitril/valsartan, a medicine used to treat chronic heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin, for example in the throat); Page 1 of 8
• you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Please consult your doctor before taking GOPTEN, as you may need to undergo monitoring tests or have your treatment adjusted if:

• you are being treated with diuretics (medicines that increase urine production) or are on a low-salt diet;
• you have recently experienced severe or prolonged episodes of vomiting or diarrhoea;
• you have liver problems, for example ascitic cirrhosis or liver failure;
• you have kidney problems, for example renal failure, bilateral or unilateral renal artery stenosis, you have only one kidney, or you have had a kidney transplant;
• you are on dialysis (certain dialysis membranes should not be used in patients treated with GOPTEN);
• you have diabetes mellitus;
• you have heart problems, such as ischaemic heart disease, congestive heart failure, left ventricular dysfunction following myocardial infarction;
• you have cerebrovascular disorders (cerebrovascular problems);
• you have diseases affecting blood vessel collagen (vascular collagenopathies), such as systemic lupus erythematosus or scleroderma;
• you have high levels of potassium in the blood (hyperkalaemia);
• you are being treated for low blood potassium levels (hypokalaemia);
• you are undergoing treatment involving blood fat removal (LDL apheresis) or venom desensitisation therapy;
• you are taking immunosuppressive/anticancer medicines such as temsirolimus, sirolimus, everolimus;
• you are taking one of the following medicines for high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans – for example valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes (diabetic nephropathy);
• aliskiren. In such cases, your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals (see “Do not take GOPTEN” and “Other medicines and GOPTEN”).
• you are taking any of the following medicines, as the risk of angioedema (rapid swelling under the skin or mucosa, for example in the throat) may be increased:
• Racecadotril, a medicine used to treat diarrhoea.
• Medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus).
• Vildagliptin, a medicine used to treat diabetes.
• Neprilysin inhibitors such as sacubitril (available in fixed-dose combination with valsartan), used in patients with heart failure.
• you are scheduled for surgery or anaesthesia (see section “Other important information”).

During treatment with GOPTEN, periodic blood and urine tests are recommended, especially in patients with collagenopathies.
Children and adolescents
GOPTEN must not be administered to children and adolescents.
Other medicines and GOPTEN
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In particular, inform your doctor or pharmacist if you are taking, have recently taken or might take any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase blood potassium levels (such as trimethoprim and cotrimoxazole used to treat bacterial infections; ciclosporin, an immunosuppressive medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood and prevent clotting).

Your doctor may consider it necessary to adjust your dose and/or take additional precautions if you are taking:

• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see “Do not take GOPTEN” and “Warnings and precautions”);
• medicines for high blood pressure;
• anti-inflammatory medicines, such as non-steroidal anti-inflammatory drugs (NSAIDs), including ibuprofen or acetylsalicylic acid (known as aspirin);
• medicines used to treat depression or mood disorders (e.g. lithium, neuroleptics or imipramine-type antidepressants);
• medicines usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the mTOR inhibitor class). See section “Warnings and precautions”;
• sympathomimetics (medicines used as decongestants, or for cough, colds and asthma);
• antacids (used to treat indigestion and/or heartburn);
• medicines that reduce immune defences (immunosuppressants);
• anticancer medicines (cytostatics);
• allopurinol (used to treat gout);
• corticosteroids, medicines used for severe asthma or allergic reactions;
• medicines used for certain heart conditions (procainamide and β-blockers);
• medicines used to treat diabetes (e.g. insulin and oral hypoglycaemics);
• gold salts, used in rheumatoid arthritis.
• NEP inhibitors such as sacubitril (available in combination with valsartan) and racecadotril; the risk of angioedema (rapid swelling under the skin or mucosa, for example in the throat) is higher.

Other important information

• If you are scheduled for surgery or anaesthesia, it is important to inform your surgeon or dentist that you are taking GOPTEN, as this medicine may affect the anaesthetic or other treatments used.
• If you have had a blood or urine test, remember to inform your doctor that you are taking GOPTEN, as certain parameters may be altered.
• If you are on dialysis, it is important to inform your doctor that you are taking GOPTEN, as allergic reactions may occur.

GOPTEN and alcohol
Do not take GOPTEN with alcohol, as this may enhance the effect of the medicine, leading to a significant drop in blood pressure.
Pregnancy and breastfeeding
Pregnancy
If you suspect or are planning a pregnancy, or if you become pregnant while taking GOPTEN, contact your doctor immediately, as treatment with GOPTEN must be stopped and replaced with an appropriate alternative.
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GOPTEN is not recommended during early pregnancy, and must not be used if you are more than 3 months pregnant, as treatment with this medicine may cause serious harm to the unborn child if taken after the third month of pregnancy (see “Do not take GOPTEN”).
Breastfeeding
If you are breastfeeding, contact your doctor immediately.
GOPTEN is not recommended for breastfeeding mothers: your doctor will switch your treatment to an appropriate alternative; this is particularly important if your baby is a newborn or was born prematurely.
Driving and using machines
It is not advisable to drive or operate machinery for several hours after taking the first dose of GOPTEN or after any dose increase.
GOPTEN contains:
Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, please consult them before taking this medicine.
Sodium (as sodium stearil fumarate and sodium lauryl sulphate)
This medicine contains less than 1 mmol (23 mg) of sodium per capsule, i.e. essentially “sodium-free”.

3. How to take GOPTEN

Take this medicine exactly as your doctor has instructed. If you are unsure, consult your doctor or pharmacist.
The dose depends on the reason for which you are taking GOPTEN:

• High blood pressure: The usual starting dose is 1 capsule of 2 mg once daily. After 2 or 4 weeks of treatment, depending on your response, your doctor may decide to double this dose. If you have kidney problems or have previously been treated with diuretics, your doctor will prescribe 1 capsule of 0.5 mg once daily; if necessary, your doctor may increase this dose to 1 mg daily.
• Protecting the heart after a heart attack: Treatment is usually started 3–7 days after the heart attack; the usual dose is 1 capsule of 0.5 mg daily. Your doctor may gradually increase this dose up to a maximum of 4 mg once daily.

Method of administration
The capsule should be swallowed with a little water and can be taken with or without food.
If you take more GOPTEN than you should, you may experience severe or sudden lowering of blood pressure (hypotension, shock), slowing of the heartbeat (bradycardia), disorientation (stupor), disturbances in blood ions (electrolyte imbalances), and kidney problems (renal failure).
In case of accidental ingestion/overdose of GOPTEN, contact your doctor immediately or go to the nearest hospital.
If you forget to take GOPTEN
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Take GOPTEN as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the missed capsule.
If you stop taking GOPTEN
If you stop treatment with GOPTEN, your condition may worsen. It is important that you continue to take this medicine regularly even if you feel well; do not stop treatment without consulting your doctor.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, GOPTEN may cause side effects, although not everybody gets them.
Stop taking GOPTEN and contact a doctor immediately if you notice one or more of the
following symptoms:

• swelling of the face, eyes, extremities, lips, tongue, throat, and/or difficulty breathing (angioedema). This side effect is rare;
• severe skin rashes with redness, blistering, and skin peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this side effect is unknown.

Contact your doctor as soon as possible if you notice:

• yellowing of the eyes and/or skin (jaundice).

Contact your doctor if, during treatment with GOPTEN, you notice the following:
Common side effects (may affect up to 1 in 10 people)

• headache;
• dizziness;
• low blood pressure (hypotension);
• cough;
• weakness (asthenia).

Uncommon side effects (may affect up to 1 in 100 people)

• difficulty falling asleep (insomnia), drowsiness;
• decreased sexual desire;
• vertigo;
• sensation of heart pounding (palpitations);
• hot flushes;
• inflammation, infection, or sensation of stuffiness (congestion) in the nose and throat (upper respiratory tract);
• stomach or intestinal problems such as nausea, diarrhoea, pain, difficulty passing stools (constipation);
• skin rash, itching;
• back or chest pain, leg and/or arm pain, swelling of hands and/or feet;
• muscle spasms;
• erectile problems;
• malaise and general discomfort.

Rare side effects (may affect up to 1 in 1,000 people)

• bladder or urethra infection (urinary tract);
• throat inflammation (pharyngitis) or bronchitis;
• decrease in the number of white blood cells (leucopenia) or red blood cells (anaemia);
• abnormalities in white blood cells or platelets;
• allergic reactions (hypersensitivity);
• increased blood sugar levels (hyperglycaemia), cholesterol (hypercholesterolaemia), or fats (hyperlipidaemia) in the blood, or decreased sodium levels in the blood (hyponatraemia);
• gout or increased uric acid levels in the blood;
• increased or decreased appetite;
• changes in enzyme function;
• hallucinations, depression, sleep disorders, anxiety, agitation, lack of motivation (apathy);
• stroke (cerebrovascular accident), fainting;
• involuntary muscle contraction (myoclonus);
• altered sensation (paraesthesia);
• headache affecting one side of the head (migraine), with or without aura (e.g. sensation of a tight band around the head);
• altered taste;
• eyelid inflammation (blepharitis), conjunctival oedema;
• eye disorders or impaired vision;
• ringing in the ears (tinnitus);
• heart problems such as: heart attack, chest pain, heart failure, increased or decreased heart rate;
• increased blood pressure (hypertension), drop in blood pressure upon sudden change from sitting or lying down to standing (orthostatic hypotension);
• vascular disorders (angiopathy, peripheral vascular disorder), e.g. varicose veins;
• breathing difficulties or respiratory disorders;
• nosebleeds (epistaxis), cough with mucus production;
• mouth and throat pain (oropharyngeal), vomiting blood (haematemesis), stomach inflammation (gastritis), abdominal pain, vomiting, indigestion, dry mouth, presence of gas in the intestine (flatulence);
• liver inflammation (hepatitis), increased bilirubin in the blood;
• increased sweating;
• skin problems such as skin redness (eczema) with possible formation of silvery plaques on the skin (psoriasis), acne, dry skin;
• joint or bone pain, osteoarthritis;
• kidney function disorders (renal failure), increased nitrogen in the blood (azotaemia), increased urine output (polyuria), or frequent urination with small volumes (pollakiuria);
• arterial abnormalities;
• ichthyosis, presenting as dry, thickened, scaly skin;
• trauma;
• swelling (oedema), fatigue, injuries.

Very rare side effects (may affect up to 1 in 10,000 people)

• bile flow problems (cholestasis);
• skin inflammation (dermatitis);
• increased potassium levels in the blood, increased gamma-glutamyl transferase, lipase, and immunoglobulin levels.

Other side effects (frequency unknown)

• absence of certain white blood cells leading to infections, sore throat, or fever (agranulocytosis);
• decrease in all blood components (pancytopenia), decreased platelets, haemoglobin, or haematocrit; Page 6 of 8
• increased potassium levels (hyperkalaemia);
• minor stroke (transient ischaemic attack), rupture of a blood vessel in the brain (cerebral haemorrhage);
• balance disorders;
• disturbances in the heart's electrical signals (atrioventricular block), cardiac arrest, irregular heart rhythm, changes in electrocardiogram (ECG);
• contraction of muscles around the airways (bronchospasm);
• intestinal distension with inability to pass stools or gas (ileus);
• pancreas inflammation (pancreatitis);
• patchy hair loss (alopecia), urticaria;
• muscle pain;
• laboratory test abnormalities such as increased creatinine or urea in the blood (substances assessing kidney function), increased liver enzymes such as transaminases and alkaline phosphatase (substances assessing liver function), increased lactate dehydrogenase in the blood;
• fever.

Some side effects observed with other ACE inhibitors may also occur with
GOPTEN.
Inform your doctor if you notice:

• haemolytic anaemia (anaemia due to destruction of blood cells);
• increased number of certain white blood cells (eosinophilia), increased antinuclear antibody (ANA) titres;
• confusion;
• blurred vision;
• inflammation of the paranasal sinuses (sinusitis), runny nose (rhinitis), swelling of the tongue (glossitis);
• swelling of tissue in the intestinal tract (intestinal angioedema);
• skin lesions (erythema multiforme, psoriasiform dermatitis); The frequency of these side effects is unknown.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you help provide more information on the safety of this medicine.

5. How to store GOPTEN

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month. This date applies to the product in its original, unopened packaging, properly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
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6. Pack contents and other information

What GOPTEN contains
The active substance is: trandolapril.
One 0.5 – 2 mg capsule contains: 0.5 – 2 mg of trandolapril.
The other components are: maize starch, lactose, povidone, sodium stearil fumarate, erythrosine (E 127), gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Description of the appearance of GOPTEN and pack contents
GOPTEN 0.5 mg hard capsules are available in packs containing 28 – 56 capsules of 0.5 mg.
GOPTEN 2 mg hard capsules are available in packs containing 14 – 28 capsules of 2 mg.

Marketing Authorisation Holder
Mylan Italia S.r.l.
Via Vittor Pisani, 20
20124 Milan

Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25, 20021 Baranzate (MI)
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