GOPTEN 2 мг Капсулы твердые

Содержание инструкции

1. GOPTEN 0.5 mg hard capsules, 2 mg hard capsules
   1. What is GOPTEN and what is it used for
   2. What you need to know before taking GOPTEN
2. GOPTEN is not recommended for breastfeeding mothers: the doctor will modify the treatment
   1. How to take GOPTEN
   2. Possible side effects
   3. How to store GOPTEN
   4. Contents of the pack and other information

GOPTEN 0.5 mg hard capsules, 2 mg hard capsules

Trandolapril

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is GOPTEN and what is it used for

GOPTEN is a medicine that contains trandolapril, an active ingredient belonging to the group
of drugs called angiotensin converting enzyme inhibitors (ACE inhibitors). These
drugs, by relaxing blood vessels, help the heart to pump blood effectively throughout the
body and reduce 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 suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren;
• you are pregnant for more than 3 months (second and third trimester). It is preferable to avoid the use of GOPTEN even at the beginning of pregnancy - see “Pregnancy and breastfeeding”;
• you have experienced swelling of the face, eyes, lips, tongue, throat and/or difficulty breathing, caused by a condition called hereditary/idiopathic angioedema;
• you have an obstruction that slows the flow of blood to the heart, such as a narrowing or blockage of the heart valves (aortic stenosis or obstruction);
• you have had an allergic reaction after taking other ACE inhibitor drugs, called allergic angioedema (Quincke's edema) which manifests with skin lesions (urticaria) and swelling of the extremities, face, tongue, mouth and throat and/or difficulty breathing;
• you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat); Page 1of 8
• you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking GOPTEN, as it may be necessary to perform
check-ups or modify therapy, if:

• you are being treated with diuretics (drugs that increase urine production) or are following a low-salt diet;
• you have recently experienced severe or prolonged vomiting or diarrhea;
• you have liver problems such as cirrhosis with ascites, hepatic insufficiency;
• you have kidney problems, for example, you suffer from renal insufficiency, have bilateral or unilateral renal artery stenosis, have a single kidney or have undergone a kidney transplant;
• you are undergoing dialysis (some membranes used in dialysis should not be used in patients treated with GOPTEN);
• you have diabetes mellitus;
• you suffer from heart problems, such as ischemic heart disease, congestive heart failure, left ventricular dysfunction following myocardial infarction;
• you suffer from disorders of the cerebral blood vessels (cerebrovascular problems);
• you have diseases that affect the collagen of the blood vessels (vascular collagenopathies) such as lupus erythematosus and scleroderma;
• you have a high level of potassium in the blood (hyperkalaemia);
• you are being treated to cure potassium deficiency in the blood (hypokalaemia);
• you are undergoing blood purification therapy from fats (LDL apheresis) or desensitization to animal venoms;
• you are taking immunosuppressant/anticancer drugs such as tensirolimus, sirolimus, everolimus.
• you are taking any of the following medicines used to treat high blood pressure:
• an “angiotensin II receptor antagonist” (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you suffer from kidney problems related to diabetes (diabetic nephropathy);
• aliskiren. In such cases, the doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals (see “Do not take GOPTEN” and “Other medicines and GOPTEN”).
• you are taking any of the following drugs, the risk of angioedema (rapid swelling under the skin or submucosa in areas such as the throat) may be increased
• Racecadotril, a medicine used to treat diarrhea.
• 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 to undergo surgery or take anesthetics (see section “Other important information”).

During treatment with GOPTEN, periodic blood and
urine tests are recommended, especially in subjects affected by collagenopathies.

Children and adolescents
GOPTEN should not be given to children and adolescents.

Other medicines and GOPTEN
Page 2of 8
In particular, tell your doctor or pharmacist if you are taking, have recently taken or
may take any of the following medicines:

• potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that may increase the amount of potassium in the blood (such as trimethoprim and cotrimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots).

The doctor may need to adjust the dose and/or take other precautions if you are
taking:

• an angiotensin II receptor antagonist (AIIRA) or aliskiren (see “Do not take GOPTEN” and “Warnings and precautions”);
• drugs used for high blood pressure;
• drugs against inflammation, for example non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or acetylsalicylic acid (known as aspirin);
• drugs used to treat depression or mood swings (e.g. lithium, neuroleptics or imipramine antidepressants);
• drugs usually used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the class of mTOR inhibitors). See section “Warnings and precautions”;
• sympathomimetics (drugs used as decongestants, or for cough, cold and asthma);
• antacids (used to treat indigestion and/or heartburn);
• drugs that reduce immune defenses (immunosuppressants);
• anti-cancer drugs (cytostatics);
• allopurinol (used against gout);
• corticosteroids, drugs used for severe asthma or allergic reactions;
• drugs used for some heart disorders (procainamide and beta-blockers);
• drugs used against diabetes (e.g. insulin and oral hypoglycemic agents);
• 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 submucosa in areas such as the throat) is greater.

Other important information

• If you are to undergo surgery or take anesthetics, it is important to tell the surgeon or dentist that you are taking GOPTEN, as this medicine may affect the anesthetic or other treatments used.
• If you have had a blood or urine test, remember to tell your doctor that you are taking GOPTEN, as some parameters may be altered.
• If you are undergoing 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 increase the effect of this medicine,
resulting in a significant drop in blood pressure.

Pregnancy and breastfeeding

Pregnancy
If you suspect or are planning a pregnancy, if you confirm a pregnancy during treatment
with GOPTEN, contact your doctor immediately as you need to stop therapy
with GOPTEN and change treatment with an appropriate alternative.
Page 3of 8
GOPTEN is not recommended at the beginning of pregnancy, and should not be used if you are
pregnant for more than 3 months, as therapy with this medicine can cause serious harm
to the baby 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: the doctor will modify the treatment

with GOPTEN with an appropriate alternative; this is particularly important if the child is
newborn or was born prematurely.

Driving and operating machinery
It is not advisable to drive or use machinery for several hours after taking the first dose
of treatment or after an increase in the dose of GOPTEN.

GOPTEN contains:
Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before
taking this medicine.

Sodium (as sodium stearyl fumarate and sodium lauryl sulfate)
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 following exactly the instructions of your doctor. If you have doubts
consult your doctor or pharmacist.
The dose depends on the reason why you are taking GOPTEN:

• High blood pressureThe usual starting dose is 1 capsule of 2 mg once a day. After 2 or 4 weeks of therapy, based on your response, your doctor may decide to double this dose. In case of kidney problems or previous therapy with diuretics, your doctor will prescribe 1 capsule of 0.5 mg once a day; if necessary, your doctor may increase this dose to 1 mg per day.
• Protecting the heart after a heart attackTreatment will usually be started after 3-7 days from the heart attack; the usual dose is 1 capsule of 0.5 mg per day. Your doctor may gradually increase this dose, up to a maximum of 4 mg once a day.

Method of administration
The capsule must be swallowed with a little water and can be taken with or without food.

If you take more GOPTEN than you should, you may notice severe or sudden lowering of
blood pressure (hypotension, shock), slowing of the heartbeat (bradycardia),
detachment from reality (stupor), alteration of ions in the blood (electrolyte disturbances) and problems
with the kidneys (renal failure).
In case of accidental ingestion/intake of an excessive dose of GOPTEN contact
your doctor immediately or go to the nearest hospital.

If you forget to take GOPTEN
Page 4of 8
Take GOPTEN as soon as you remember, unless it is almost time to take the next
dose. Do not take a double dose to compensate for forgetting a single 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
interrupt treatment without consulting your doctor.
If you have any doubts about the use of this medicine, consult your doctor.

4. Possible side effects

Like all medicines, GOPTEN can cause side effects, although not everybody gets them.
manifest.

Stop taking GOPTEN and contact your doctor immediatelyif 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 peeling (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis). The frequency of this side effect is not known.

Contact your doctor as soon as possibleif you notice:

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

Contact your doctor if you notice during therapy with GOPTEN:

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;
• feeling of heart racing (palpitations);
• hot flushes;
• inflammation, infection or feeling of congestion of the nose and throat (upper respiratory tract);
• stomach or intestinal disorders such as nausea, diarrhea, pain, difficulty evacuating (constipation);
• skin rash, itching;
• back or chest pain, leg and/or arm pain, swelling of hands and/or feet;
• muscle spasms;
• erection problems;
• general feeling of discomfort and bodily distress.

Rare side effects(may affect up to 1 in 1000 people)

• infection of the bladder or urethra (urinary tract);
• inflammation of the throat (pharyngitis) or bronchi (bronchitis); Page 5of 8
• decreased number of white blood cells (leukopenia) or red blood cells (anemia);
• alteration of white blood cells or platelets;
• allergic reactions (hypersensitivity);
• increased levels of sugars (hyperglycemia) or cholesterol (hypercholesterolemia) or fats (hyperlipidemia) in the blood or decreased sodium in the blood (hyponatremia);
• gout or increased uric acid levels in the blood;
• increase or decrease in appetite;
• alteration of enzyme function;
• hallucinations, depression, sleep disorders, anxiety, agitation, lack of motivation (apathy);
• stroke (cerebrovascular accident), fainting;
• involuntary muscle contraction (myoclonus);
• altered sensation (paresthesia);
• headache affecting one side of the head (migraine) with or without aura;
• altered taste;
• inflammation of the eyelid (blepharitis), edema of the conjunctiva;
• eye disorders or impaired vision;
• ringing in the ears (tinnitus);
• heart problems such as: heart attack, chest pain, heart failure, acceleration or slowing of the heartbeat;
• increased blood pressure (hypertension), lowering of blood pressure when suddenly moving from a sitting or lying position to an upright position (orthostatic hypotension);
• vascular disorders (angiopathy, peripheral vascular disorder), e.g. varicose veins;
• difficulty or respiratory disorders;
• nosebleeds (epistaxis), cough with mucus secretion;
• pain in the mouth and throat (oropharyngeal), vomiting with blood (hematemesis), inflammation of the stomach (gastritis), abdominal pain, vomiting, indigestion, dry mouth, presence of gas in the intestine (flatulence);
• inflammation of the liver (hepatitis), increased bilirubin in the blood;
• increased sweating;
• skin problems such as skin redness (eczema) with possible formation of silver-colored patches on the skin (psoriasis), acne, dry skin;
• joint or bone pain, osteoarthritis;
• renal dysfunction (renal insufficiency), increased nitrogen in the blood (azotemia), increased urine output (polyuria) or frequent urination of small amounts (pollachiuria);
• arterial alterations;
• ichthyosis manifesting with dry, thickened and scaly skin;
• trauma;
• swelling (edema), fatigue, injuries.

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

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

Other side effects(the frequency of these side effects is not known)

• lack of certain white blood cells that can lead to infections, sore throat or fever (agranulocytosis);
• decrease of all blood components (pancytopenia), decrease of platelets or hemoglobin or hematocrit; Page 6of 8
• increased potassium levels (hyperkalemia);
• minor stroke (transient ischemic attack), bleeding in the brain (cerebral hemorrhage);
• balance disorders;
• alteration of the electrical signals of the heart (atrioventricular block), heart arrest, alteration of the heart rhythm, alteration of the electrocardiogram (ECG);
• contraction of the muscles around the airways (bronchospasm);
• distension of the intestine with inability to evacuate or pass gas (ileus);
• inflammation of the pancreas (pancreatitis);
• patchy hair loss (alopecia), urticaria;
• muscle pain;
• alterations of laboratory tests such as increased creatinine or urea in the blood (substances that assess kidney function), increased liver enzymes such as transaminases and alkaline phosphatase (substances that assess liver function), increased lactate dehydrogenase in the blood;
• fever.

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

• hemolytic anemia (anemia due to the breakdown of blood cells);
• increased number of specific white blood cells (eosinophilia), increases in antinuclear antibody (ANA) titers;
• confusion;
• blurred vision;
• inflammation of the sinuses (sinusitis), runny nose (rhinitis), swelling of the tongue (glossitis);
• swelling of the tissue in the intestinal tract (intestinal angioedema);
• skin lesions (erythema multiforme, psoriasiform dermatitis); The frequency of these side effects is not known.

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

5. How to store GOPTEN

Keep this medicine out of sight and reach of children.
Store at a temperature not exceeding 25  C.
Do not use this medicine after the expiry date which is reported on the pack. The expiry
date refers to the last day of that month. This date applies to the product in its
intact packaging, correctly stored.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.
Page 7of 8

6. Contents of the pack and other information

What GOPTEN contains
The active ingredient is: trandolapril.
Each 0.5 – 2 mg capsule contains: 0.5 – 2 mg of trandolapril.
The other ingredients are: corn starch, lactose,povidone, sodium stearyl fumarate, erythrosine
(E 127), gelatin, yellow iron oxide (E 172), titanium dioxide (E 171), sodium lauryl sulfate.

Description of the appearance of GOPTEN and contents of the pack
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 Milano

Manufacturer
Famar Italia S.p.A. - Via Zambeletti 25, 20021 Baranzate (MI)
Page 8of 8