GOPTEN 0.5 mg HARD CAPSULES

Introduction

Package Leaflet: Information for the User

Gopten 0.5 mg Hard Capsules

Trandolapril

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Gopten and what is it used for
2. What you need to know before you take Gopten
3. How to take Gopten
4. Possible side effects
5. Storage of Gopten

1. Contents of the pack and other information

1. What is Gopten and what is it used for

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

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

2. What you need to know before you take Gopten

Do not take Gopten:

• If you are allergic (hypersensitive) to trandolapril or any of the other ingredients of this medicine (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 causes inflammation of the face and respiratory tract and abdominal colic).
• If you are pregnant for more than 3 months [it is also recommended to avoid Gopten at the beginning of pregnancy (see section "Pregnancy, breastfeeding and fertility")].
• If you have diabetes or kidney failure and are being treated with a blood pressure medication that contains aliskiren.
• If you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as the risk of angioedema (rapid swelling under the skin in areas 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-salt diet, have diarrhea or vomiting.
• If you are undergoing dialysis.
• If you have heart, kidney or liver problems. Your doctor may need to monitor you and change your dose.
• If you have a kidney disease caused by a narrowing (stenosis) of the renal artery.
• If you are being treated with diuretics (medicines that increase urine production).
• If you have a narrowing of one of the heart valves (mitral valve stenosis) or another obstruction in the flow of the left ventricle of the heart.
• If you experience abdominal pain (with or without nausea or vomiting), as you may suffer from intestinal angioedema (swelling of the intestine).
• If you notice an allergic reaction with edema (swelling) in the face, extremities, lips, tongue, glottis or larynx. If so, go to your doctor immediately. You may be more prone to it if you are of black race.
• If you are undergoing blood/plasma exchange treatment (apheresis of low-density lipoproteins) for familial hypercholesterolemia (a hereditary disease in which there are high levels of "bad" cholesterol in the blood).
• If you are undergoing desensitization treatment, for example, to wasp, bee, etc. venom, as some allergic reactions have been found.
• If you have a collagen vascular disease such as scleroderma or systemic lupus erythematosus (a reaction 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 associated kidney disease, inform your doctor, as you may need regular blood tests.
• If you have a cough.
• If you are going to undergo major surgery or receive anesthesia.
• If you are diabetic, as your blood sugar levels will need to be closely monitored during the first month of treatment.
• If you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • An angiotensin II receptor antagonist (ARA) (also known as "sartans" - for example, valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
  • Aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (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 medicines, as the risk of angioedema may increase:
• • Racecadotril, a medicine used to treat diarrhea.
  • Medicines used to prevent organ transplant rejection and cancer (such as temsirolimus, sirolimus, everolimus).
  • Vildagliptin, a medicine used to treat diabetes.

Taking Gopten with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.

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

• Lithium: for bipolar disorder and depression. It is not recommended to take this medicine and lithium at the same time.
• Diuretics: medicines that increase urine production. Normally used to treat hypertension and heart failure.
• 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 bacterial infections; cyclosporin, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots).
• Neuroleptics (for psychosis), tricyclic antidepressants (for depression).
• Anesthetics.
• Medicines for treating diabetes (insulin or oral hypoglycemic agents).
• Non-steroidal anti-inflammatory drugs (NSAIDs).
• Allopurinol, for the treatment of gout or after receiving chemotherapy for cancer.
• Cancer chemotherapy.
• Immunosuppressants, after a transplant or for the treatment of certain autoimmune diseases.
• Systemic corticosteroids, for example, for inflammatory diseases, autoimmune diseases, after a transplant.
• Procainamide, to correct irregular heartbeats.
• Your doctor may need to adjust your dose and/or take other precautions: if you are taking an angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Gopten" and "Warnings and precautions").
• Other medicines for treating high blood pressure.
• Medicines used to treat low blood pressure and colds (such as ephedrine and pseudoephedrine).

• Medicines used more frequently to prevent organ transplant rejection (sirolimus, everolimus, and other mTOR inhibitor class medicines). See section "Warnings and precautions".
• NEP inhibitors, such as sacubitril (available in fixed-dose combination with valsartan) and racecadotril:the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase.

Taking Gopten with food and drinks

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Ask your doctor if you are (or think you may be) pregnant. Your doctor will normally advise you to stop taking Gopten before you become pregnant or as soon as you find out you are pregnant and will advise you to switch to another medicine.

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

Breastfeeding

Tell your doctor or pharmacist if you are breastfeeding or plan to breastfeed your baby.

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

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

No particular effect is expected. However, in some individuals, ACE inhibitors may affect the ability to drive or operate machinery, especially at the beginning of treatment, when changing 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.

Goptencontains lactose

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

Gopten contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Gopten

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.

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

Your doctor will decide the duration of your treatment. Do not stop treatment before, as your illness may worsen or reappear.

In arterial hypertension in adults who do not take diuretics, do not have heart disease, kidney disease, or liver disease, the recommended initial dose is 0.5 mg to 1 mg of trandolapril once a day (1 to 2 capsules of 0.5 mg) or 2 mg once a day (1 capsule of 2 mg), but in this case, it is recommended to take 1 capsule of Gopten 2 mg hard capsules per day. If you are of black race, your recommended initial dose is 2 mg per day (see section 4.4). If necessary, the dose of this medicine may be doubled after 1 to 4 weeks of treatment, up to a maximum of 4 mg to 8 mg of trandolapril per day (2 to 4 capsules of 2 mg).

If you are hypertensive and also have heart disease, with or without kidney disease, the initial dose is 0.5 mg to 1 mg of trandolapril once a day (1 to 2 capsules of 0.5 mg), and under close medical supervision.

In myocardial infarction with left ventricular dysfunction, the initial dose is 0.5 mg to 1 mg of trandolapril (1 to 2 capsules of 0.5 mg) once a day, starting from the third day after the infarction, and should be progressively increased up to a maximum of 4 mg (2 capsules of 2 mg) as a single daily dose. If hypotension (low blood pressure) occurs, the treatment will be carefully reviewed by your doctor.

Tell 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 will be discontinued at least 2 or 3 days before starting treatment with this medicine.

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

In severe liver failure (a liver disease that prevents the liver from performing its synthetic and metabolic functions), treatment will be started with a dose of 0.5 mg per day (1 capsule of 0.5 mg), under close medical supervision.

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

If you think the effect of this medicine is too strong or too weak for the treatment of your illness, consult your doctor or pharmacist.

Use in children

The use of this medicine has not been studied in this group, so its administration is not recommended in children.

If you take more Gopten than you should

If you have taken more trandolapril than you should, it is unlikely that acute intoxication will occur. However, you should inform your doctor, as the recommended treatment in these cases is the intravenous administration of normal saline solution (0.9%). If you experience hypotension (low blood pressure), you should be placed in a supine position, with your legs elevated about 30 cm above the level of your heart, and will be continuously monitored by your doctor.

The symptoms of an overdose with this medicine are severe hypotension (low blood pressure), shock (a condition that causes a sudden and intense drop in blood pressure, which can be life-threatening if not treated), stupor (decreased brain function), bradycardia (slow heart rate), electrolyte imbalance (alteration of electrolytes in the blood), and kidney failure.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, telephone 91.562.04.20, indicating the medicine and the amount ingested.

If you forget to take Gopten

Do not take a double dose to make up for forgotten doses.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

The following have been reported:

Frequent (may 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.

Uncommon (may affect up to 1 in 100 people):

• In the treatment of hypertension: hypotension, palpitations, nausea, itching, discomfort.
• In both treatments: upper respiratory tract infection (nose, mouth, pharynx, and larynx), insomnia, decreased sexual appetite, somnolence, vertigo, hot flashes, upper respiratory tract inflammation, upper respiratory tract congestion, 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 (may affect up to 1 in 1,000 people):

• In both treatments: urinary tract infection (kidneys, bladder, and urethra), bronchitis, pharyngitis, decreased white blood cell count, decreased red blood cell count, platelet disorder, white blood cell disorder, allergy, high blood glucose, low sodium concentration in plasma, high blood cholesterol, high blood fat, high 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 contraction or muscle spasms, abnormal sensation of tingling, numbness, or burning, usually in the limbs, migraine (chronic and recurrent headache with other symptoms such as vomiting, nausea, or sensitivity to light), migraine without aura (migraine without visual disturbances), alteration of taste of food and drinks, eyelid inflammation, conjunctival edema, decreased vision, eye disorder, tinnitus, myocardial infarction (death of heart muscle cells or part of it due to lack of blood flow), myocardial ischemia (insufficient blood flow, which if prolonged can cause death of heart cells and therefore infarction), angina pectoris (chest pain, usually oppressive, resulting from myocardial ischemia), heart failure (when the heart can no longer pump enough blood to the rest of the body), rapid ventricular heartbeat, increased heart rate, decreased heart rate, hypertension, blood vessel disease, dizziness when standing up, decreased blood flow to the legs and feet, varicose veins (enlarged and painful veins), shortness of breath, nasal bleeding, pharyngeal inflammation, mouth and pharyngeal pain, cough with phlegm, respiratory disorder, vomiting blood, stomach inflammation, abdominal pain, vomiting, indigestion, dry mouth, excess gas in the intestine, hepatitis, high bilirubin levels, angioedema (swelling under the skin), psoriasis, excessive sweating, eczema, acne, dry skin, skin disorder, pain in one or more joints, bone pain, wear and tear between the joints of the bones that produces pain and stiffness, kidneys stop functioning properly, high level of cellular metabolism waste products in the blood, excessive urine production, increased frequency of urination, congenital arterial malformation (birth defect in the arteries), ichthyosis (genetic skin disease in which the skin becomes dry and scaly), edema (excessive accumulation of fluid in tissues), fatigue, injury.

There have been reports of angioedema (swelling) affecting the face, limbs, lips, tongue, glottis, and/or larynx.

A complex of symptoms has been reported, which may include fever, blood vessel inflammation, muscle pain, joint pain, a positive antinuclear antibody test to diagnose a disease called lupus, elevated erythrocyte sedimentation rate, increased eosinophils, a type of white blood cell, and increased white blood cells in peripheral blood. Skin rash, photosensitivity (abnormal sensitivity to light, which produces skin rashes), or other skin manifestations may also appear.

After the marketing of the medicine, the following additional adverse effects have been reported, with an unknown frequency:

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

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

State of confusion, blurred vision, sinusitis, rhinitis (inflammation of the nasal passages), glossitis (inflammation of the tongue), intestinal angioedema, erythema multiforme (skin disorder resulting from an allergic reaction), psoriasis-like skin rashes, hemolytic anemia (anemia produced by the destruction of red blood cells).

Reporting of Adverse Effects

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

5. Conservation of Gopten

Keep this medicine out of sight and reach of children.

Do not store above 25°C.

Do not use this medicine 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 thrown down the drain or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Gopten 0.5 mg hard capsules

The active ingredient is trandolapril. Each hard capsule contains 0.5 mg of trandolapril.

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

Appearance of the Product and Package Contents

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

Marketing Authorization Holder and Manufacturer:

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer:

Mylan Hungary Kft.

Mylan utca 1

Komárom, 2900

Hungary

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this prospectus:March 2021

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