Package Insert: Information for the User

Gopten 2 mg Hard Capsules

trandolapril

Read this package insert carefully before starting to take this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

This medication contains trandolapril, which belongs to a group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors).

It is indicated for the treatment of high blood pressure and myocardial infarction with left ventricular dysfunction (with or without heart failure).

Do not take Gopten:

• If you are allergic (hypersensitive) to trandolapril or any of the other components of this medication (listed in section 6).
• If you have a history of angioneurotic edema (Quincke's edema, characterized by swelling of the face, lips, tongue, larynx, extremities) related to the use of ACE inhibitors or hereditary or idiopathic angioedema (a disorder that is characterized by inflammation of the face and respiratory tracts and abdominal cramps).
• If you are more than 3 months pregnant [it is also recommended to avoid Gopten at the beginning of pregnancy (see section "Pregnancy, breastfeeding and fertility")].
• If you have diabetes or renal insufficiency and are being treated with a medication to treat high blood pressure that contains aliskirén.
• If you have taken or are currently taking sacubitril/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Gopten:

• If you are on a very strict low-sodium diet, have diarrhea or vomiting.
• If you are undergoing dialysis.
• If you have heart, kidney or liver problems. Your doctor may need to monitor and change your dose.
• If you have kidney disease caused by a narrowing (stenosis) of the renal artery.
• If you are being treated with diuretics (medications that increase urine production).
• If you have a narrowing of one of the heart valves (mitral valve stenosis) or other obstruction in the left ventricle of the heart.
• If you experience abdominal pain (with or without nausea or vomiting), as you may be at risk of developing intestinal angioedema (intestinal swelling).
• If you notice an allergic reaction with swelling (edema) in the face, extremities, lips, tongue, glottis or larynx. If so, seek medical attention immediately. You may be more prone to it if you are black.
• If you are undergoing plasma exchange/apheresis (a treatment for familial hypercholesterolemia, a hereditary disorder characterized by high levels of "bad" cholesterol in the blood).
• If you are undergoing desensitization treatment, for example, for wasp or bee venom, as some allergic reactions have been reported.
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus (a disorder in which the immune system attacks parts of the body instead of protecting it and in this case attacks the collagen fibers of the tissues) and/or kidney disease, inform your doctor, as you may require regular blood tests.
• If you have a cough.
• If you are undergoing major surgery or receiving anesthesia.
• If you are diabetic, as your doctor will need to closely monitor your blood sugar levels during the first month of treatment.
• If you are taking any of the following medications used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartanes" - for example, valsartán, telmisartán, irbesartán), particularly if you have kidney problems related to diabetes.
  • Aliskirén.

Your doctor may need to monitor your renal function, blood pressure and electrolyte levels in the blood (such as potassium) at regular intervals.

See also the information under the heading "Do not take Gopten".

• If you are (or think you may be) pregnant. Gopten is not recommended in the first months of pregnancy and is contraindicated after the third month of pregnancy, as it may cause serious harm to the baby (see section Pregnancy).
• If you are taking any of the following medications, as the risk of angioedema may increase:
• • Racecadotril, a medication used to treat diarrhea.
  • Medications used to prevent organ transplant rejection and for cancer (such as temsirolimus, sirolimus, everolimus).
  • Vildagliptina, a medication used to treat diabetes.

Taking Gopten with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication, including those purchased without a prescription.

Inform your doctor or pharmacist if you are being treated with any of the following medications, as they may interact with Gopten:

• Lithium: for bipolar disorder and depression. It is not recommended to take this medication and lithium at the same time.
• Diuretics: medications that increase urine production. Normally used to treat hypertension and heart failure.
• Potassium supplements (including salt substitutes), diuretics that save potassium and other medications that may increase potassium levels in the blood (such as trimetoprima and cotrimoxazol, for bacterial infections; ciclosporina, an immunosuppressant, used to prevent organ transplant rejection; and heparin, a medication used to dilute the blood to prevent clots).
• Neuroleptics (for psychosis), tricyclic antidepressants (for depression).
• Anesthetics.
• Medications used to treat diabetes (insulin or oral hypoglycemic medications).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Alopurinol, for the treatment of gout or after receiving chemotherapy for cancer.
• Cancer chemotherapy.
• Immunosuppressants, after a transplant or for the treatment of some autoimmune diseases.
• Systemic corticosteroids, for example, for inflammatory diseases, autoimmune diseases, after a transplant.
• Procainamida, to correct irregular heartbeats.
• Your doctor may need to modify your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings "Do not take Gopten" and "Warnings and precautions").
• Other medications used to treat high blood pressure.
• Medications used to treat low blood pressure and colds (such as, for example, efedrina and pseudoefedrina).

• Medications used more frequently to prevent organ transplant rejection (sirolimús, everolimús and other medications of the class of mTOR inhibitors). See section "Warnings and precautions".
• Inhibitors of the NEP, such as sacubitril (available in fixed-dose combination with valsartán) and racecadotrilo:The risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase.

Taking Gopten with food and drinks

This medication can be taken before, during or after meals.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

Pregnancy

Consult your doctor if you are (or think you may be) pregnant. Your doctor will usually advise you to stop taking Gopten before becoming pregnant or as soon as you know you are pregnant and will advise you to change to another medication.

This medication is not recommended in the first months of pregnancy and is contraindicated after the third month of pregnancy, as it may cause serious harm to the baby.

Breastfeeding

Inform your doctor or pharmacist if you are breastfeeding or plan to start breastfeeding.

This medication is not recommended for breastfeeding mothers and your doctor may prescribe another treatment if you wish to breastfeed your baby, especially if your baby is a newborn or premature.

Consult your doctor or pharmacist before using any medication.

Driving and operating machinery

No specific effects can be anticipated. However, in some individuals, ACE inhibitors may affect the ability to drive or operate machinery, particularly at the beginning of treatment, when changing the medication to trandolapril or with alcohol consumption. Therefore, after the first dose or subsequent adjustments, it is not recommended to drive or operate machinery for several hours.

Gopten contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Gopten contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablets; that is, it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Remember to take your medication. Take the capsules at the same time every day. This medication is administered orally.

Your doctor will inform you of the duration of your treatment. Do not discontinue treatment beforehand, as although you may be feeling better, your condition could worsen or recur.

In hypertensionin adults who are not taking diuretics, do not have heart disease, or kidney or liver disease,the recommended initial dose is 0.5 mg to 1 mg of trandolapril once a day (1 to2 capsules of 0.5 mg) or 2 mg once a day (1 capsule of 2 mg). If you are black, your recommended initial dose is 2 mg per day (see section 4.4). If necessary, the dose of this medication can be doubled after1 to4 weeks of treatment, up to a maximum of 4 mg to 8 mg of trandolapril per day (2 to4 capsules of 2 mg).

If you are hypertensive and also have heart disease, associated or not with kidney disease, the initial dose is 0.5 mg to 1 mg of trandolapril once a day (1 to2 capsules of 0.5 mg), and under close monitoring by your doctor.

In myocardial infarction with left ventricular dysfunction, the initial dose is 0.5 mg to 1 mg of trandolapril (1 to2 capsules of 0.5 mg) once a day from the third day after the infarction, and should be increased progressively to a maximum of 4 mg (2 capsules of 2 mg) as a single daily dose. If hypotension (a drop in blood pressure that can cause dizziness, vertigo, blurred vision, or paleness) appears, treatment will be carefully reviewed by your doctor.

Inform your doctor if you are taking diuretics, as in the case of previous treatment with diuretics, the initial dose of trandolapril will be 1 capsule of 0.5 mg per day, and diuretic administration should be interrupted for at least two or three days before starting treatment with this medication.

In the case of kidney failure (a kidney disease that prevents it from performing its filtration function correctly), your doctor will decide what the most suitable initial dose will be for you.

In severe liver failure (a liver disease by which it is unable to carry out its synthetic and metabolic functions), treatment will begin with a dose of 0.5 mg per day (1 capsule of 0.5 mg), under close monitoring by your doctor.

If you are an elderly patient, the recommended dose is the same as for adults.

If you feel that the effect of this medication is too strong or too weak for the treatment of your disease, consult your doctor or pharmacist.

Use in children

This medication has not been studied in this age group, so it is not recommended for administration in children.

If you take more Gopten than you should

If you have taken more trandolapril than you should, acute intoxication is unlikely to occur. However, you should inform your doctor because the recommended treatment in these cases is the intravenous administration of normal saline solution (0.9%). If you experience hypotension (a drop in blood pressure), you should lie down, face up, with your legs about30 cmabove the floor (higher than the level of the heart), and will be continuously monitored by your doctor.

The symptoms of an overdose with this medication are severe hypotension, shock (a sudden and intense drop in blood pressure that, if not treated, can cause death), stupor (a decrease in cerebral function), bradycardia (a decrease in heart rate), electrolyte imbalance (alteration of electrolytes in the blood), and kidney failure.

In case of overdose or accidental ingestion, consult the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount ingested.

If you forgot to take Gopten

Do not take a double dose to compensate for the missed doses.

If you have any other doubts about the use of this medication, ask your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following have been reported:

Frequent(can affect up to 1 in 10 people):

• In the treatment of hypertension: dizziness, headache, cough, and asthenia (weakness and lack of vitality).
• In the treatment after acute myocardial infarction: dizziness, hypotension, cough.

Infrequent(can affect up to 1 in 100 people):

• In the treatment of hypertension: hypotension, palpitations, nausea, pruritus, discomfort.
• In both treatments: upper respiratory tract infection (nose, mouth, pharynx, and larynx), insomnia, decreased libido, somnolence, vertigo, hot flashes, inflammation of the upper respiratory tract, congestion of the upper respiratory tract, diarrhea, gastrointestinal pain, constipation, gastrointestinal disorder, skin rash, back pain, muscle spasms, pain in arms and legs, impotence, chest pain, swelling of ankles, feet, and legs due to fluid accumulation, abnormal sensitivity.

Rare(can affect up to 1 in 1,000 people):

• In both treatments: urinary tract infection (kidneys, bladder, and urethra), bronchitis, pharyngitis, decreased white blood cells, decreased red blood cells, platelet disorder, white blood cell disorder, allergy, excessive glucose in the blood, low sodium concentration in plasma, elevated cholesterol in the blood, excessive fats in the blood, elevated uric acid, gout, loss of appetite, increased appetite, enzymatic anomaly, hallucinations, depression, sleep disorder, anxiety, agitation (restlessness, excitement, and/or repetitive behavior), apathy, stroke (interruption of blood supply to any part of the brain), sudden and usually brief and reversible loss of consciousness, sudden or spasmodic contraction of muscles, abnormal sensation of tingling, numbness, or burning, usually in the extremities, migraine (chronic and recurrent headache with other symptoms such as vomiting, nausea, or sensitivity to light), migraine without aura (migraine without visual alterations), alteration of the taste of food and drinks, inflammation of the eyelid, conjunctival edema of the eye, decreased vision, eye disorder, tinnitus, myocardial infarction (death of heart muscle cells or part of them due to lack of blood supply), myocardial ischemia (insufficient blood supply that if prolonged can cause death of heart cells and thus myocardial infarction), angina pectoris (chest pain usually of oppressive nature due to myocardial ischemia), heart failure (when the heart can no longer pump enough blood to the rest of the body), rapid heart palpitations that start in the ventricles, increased heart rate, decreased heart rate, hypertension, vascular disease, dizziness when standing up, decreased blood flow to the legs and feet, varicose veins (enlarged and painful veins), feeling of lack of air, nasal bleeding, inflammation of the pharynx, pain in the mouth and pharynx, cough accompanied by phlegm, respiratory disorder, vomiting of fresh blood, inflammation of the inner walls of the stomach, abdominal pain, vomiting, indigestion, dry mouth, excessive gas in the intestine, hepatitis, elevated bilirubin levels, angioedema (swelling under the skin), psoriasis, excessive sweating, eczema, acne, dry skin, skin disorder, pain in one or more joints, pain in bones, wear and tear between the joints of the bones that produces pain and stiffness, kidneys stop functioning correctly, elevated levels in the blood of waste products of cellular metabolism, excessive urine production, increased frequency of urination, congenital arterial malformation (birth defect in the arteries), ichthyosis (skin disease of genetic origin in which it becomes dry and scaly), edema (excessive accumulation of fluid in tissues), fatigue, injury.

Cases of angioedema (swelling) affecting the face, extremities, lips, tongue, glottis, and/or larynx have been reported.

A complex of symptoms that may include fever, inflammation of blood vessels, muscle pain, joint pain, a test for antinuclear antibodies to diagnose a disease called lupus positive, elevated erythrocyte sedimentation rate, increased eosinophils, a type of white blood cell, and increased white blood cells in peripheral blood. It may also appear skin rash, photosensitivity (abnormal sensitivity to light that produces rashes on the skin) or other skin manifestations.

After the commercialization of the medicine, the following additional side effects have been reported, of unknown frequency:

Decreased number of a type of white blood cell in the blood, decreased number of all blood cells, elevated potassium levels in the blood, temporary cerebral dysfunction caused by lack of blood and oxygen, cerebral hemorrhage, balance disorders, alteration of electrical conduction in the heart, cardiac arrest, irregular heartbeats, bronchial constriction, with less air entering and causing cough and rapid breathing, intestinal obstruction, pancreatitis, yellowish color of the skin and white of the eyes, hair loss, urticaria (skin lesions with liquid inside, usually accompanied by itching), Stevens-Johnson syndrome (skin disorder derived from an allergic reaction with more severe generalized symptoms), toxic epidermal necrolysis (another type of severe skin disorder with blisters), muscle pain, high fever, elevated creatinine levels, elevated urea nitrogen levels, elevated alkaline phosphatase levels, elevated lactate dehydrogenase levels, abnormal electrocardiogram, abnormal laboratory tests, abnormal liver function tests, decreased platelet count, elevated transaminases, decreased hemoglobin and hematocrit.

In the group of ACE inhibitors, to which this medicine belongs, the following additional side effects have been reported:

Confusion, blurred vision, sinusitis, rhinitis (inflammation of the nasal passages), glossitis (inflammation of the tongue), intestinal angioedema, erythema multiforme (skin disorder derived from an allergic reaction), psoriasis-like skin eruptions, hemolytic anemia (anemia caused by destruction of red blood cells).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children

Do not store at a temperature above25°C.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Gopten 2 mg hard capsules

The active ingredient is trandolapril. Each hard capsule contains 2 mg of trandolapril.

The other components are: lactose monohydrate, cornstarch, povidone, stearate of stearic acid and sodium, gelatin, titanium dioxide (E-171), erythrosine (E-127), yellow iron oxide (E-172), and sodium lauryl sulfate.

Appearance of the product and contents of the packaging

Hard capsules with a red body and red cap. Each package contains 28 hard capsules.

Holder of the marketing authorization and responsible manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last review of this leaflet:March 2021

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”