Package Insert: Information for the User

Captopril Normon 50 mg Tablets EFG

Read this package insert carefully before starting to take this medicine, as 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 the package insert. See section 4.

Captopril Normon is a medication that belongs to the group of substances known as angiotensin-converting enzyme (ACE) inhibitors. Captopril causes relaxation of blood vessels and reduces blood pressure.

This medication is indicated for:

• Treatment of high blood pressure (hypertension).
• Treatment of chronic heart failure (when the heart does not pump blood properly), in combination with diuretics and when appropriate with digitalis medications and beta-blockers.
• After a myocardial infarction (heart attack).
• Treatment of kidney problems in patients with type I diabetes.

Do not take Captopril Normon:

• If you are allergic to captopril or any of the other components of this medication (listed in section 6).
• If you have a history of angioedema (swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing) associated with previous treatment with medications in the same group as captopril (ACE inhibitors).
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or kidney insufficiency and are being treated with a medication to lower blood pressure that contains aliskiren.
• If you are pregnant (especially in the second or third trimester of pregnancy).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication:

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, valsartan, telmisartan, irbesartan), particularly if you have kidney problems related to diabetes.
• Aliskiren

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

See Also the information under the heading “Do not take Captopril Normon”.

Be especially careful with this medication if you have:

• Swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema) or have a history of angioedema. The risk of experiencing these symptoms after treatment with Captopril Normon is higher in black patients,
• Abdominal pain, with or without nausea and vomiting (potential symptoms of intestinal angioedema),
• Any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment,
• Low blood pressure (this may manifest as dizziness or fainting, especially when standing up),
• Intense or persistent vomiting or diarrhea,
• Any heart, liver, kidney, or diabetes disease,
• You are undergoing, or will be undergoing, allergy desensitization treatment for bee or wasp stings,
• You are undergoing hemodialysis or apheresis (blood separation procedure) as you may experience reactions to the type of membrane used,
• Any collagen disease,
• You are following a low-sodium diet,
• Cough.

Avoid excessive sweating and dehydration, which can cause a sudden drop in blood pressure.

Inform your doctor that you are taking this medication if you are to undergo surgery or receive anesthetics.

Like other medications used to lower blood pressure, this medication may be less effective in black patients.

Consult your doctor, even if any of the above circumstances have occurred at any time.

Other medications and Captopril Normon

Inform your doctor or pharmacist if you are taking or have taken recently or may need to take any other medication.

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 Captopril Normon” and “Warnings and precautions”).

Certain medications may interact with Captopril Normon. In these cases, you may need to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking any of the following medications:

• Diuretics.
• Medications containing potassium.
• Medications that lower blood pressure.
• Antidiabetic medications.
• Anti-inflammatory medications.
• Lithium (medication used for certain types of depression).
• Tricyclic antidepressants/antipsychotics.
• Sympathomimetics or agents affecting the activity of the sympathetic nervous system.
• Alpha-blockers.
• Alopurinol.
• Procainamide (medication used for heart rhythm disorders).
• Cytostatic or immunosuppressive agents.
• Medications for acute myocardial infarction treatment.

Taking Captopril Normon with food and drinks

This medication can be taken with or without food.

Inform your doctor if you are taking potassium supplements or consuming a diet rich in potassium.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medication.

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

This medication is not recommended in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy. Inform your doctor immediately if you think you may be pregnant.

This medication is not recommended during breastfeeding.

Driving and operating machinery

During high blood pressure treatment, your ability to drive and operate machinery may be reduced, especially at the beginning of treatment, when the dose is changed, or when alcohol is consumed. Do not drive or operate machinery if you experience any impairment of these functions.

Captopril Normon contains lactose and sodium

This medication contains lactose. If your doctor has told you that you have a certain sugar intolerance, consult with them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The dosage must be individualized, so your doctor will establish the appropriate dose for you and make any necessary adjustments.

Hypertension

The recommended initial dose for the treatment of high blood pressure is 25-50 mg per day, administered in two daily doses. Your doctor may gradually increase the dose up to 100-150 mg per day. Your doctor may recommend the concomitant administration of other medications that lower blood pressure.

Chronic heart failure

The recommended initial dose for chronic heart failure (to help the heart pump blood properly) is 6.25-12.5 mg two or three times a day. Your doctor may gradually increase the dose up to a maximum of 150 mg per day, and will monitor you during the first weeks of treatment or when changing your dose.

Myocardial infarction

The usual dose is a test dose of 6.25 mg. Your doctor may gradually increase the dose up to a maximum of 150 mg per day.

Renal problems

The recommended initial dose for the treatment of renal problems in patients with type 1 diabetes is 75-100 mg per day, administered in several daily doses.

The tablets should be swallowed with water and can be taken with or without food.

Remember to take your medication.

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Captopril Normon. Do not discontinue treatment before, as only your doctor knows what is best for you.

Use in children

The recommended initial dose is 0.30 mg/kg of body weight. In children who require special precautions, the initial dose should be 0.15 mg/kg of body weight. The use of this medication in children and adolescents should be initiated under close medical supervision. Your doctor will indicate the number of daily doses.

Use in elderly patients

In elderly patients with renal function impairment and other organic alterations, lower doses than recommended should be administered.

Renal insufficiency

In patients with renal impairment, lower doses than recommended should be administered.

If you take more Captopril Normon than you should

If you have taken more Captopril Normon than you should, consult your doctor or pharmacist immediately. Symptoms of overdose include severe hypotension, shock, stupor, bradycardia (slowing of heart rate), electrolyte imbalances, and renal failure.

In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to take Captopril Normon

If you forgot to take the medication, take the dose as soon as you remember on the same day. If you miss a dose, take your normal dose the next day. 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 or pharmacist.

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

The following side effects have been observed:

Frequent(may affect up to 1 in 10 people): loss of appetite, sleep disorders, alteration of taste, dizziness, headaches, and a tingling sensation, cough and difficulty breathing, nausea, vomiting, stomach irritation, abdominal pain, diarrhea, constipation, dry mouth, stomach ulcers, itching with or without skin rash (sometimes with fever, joint pain, and eosinophilia), skin rash, and hair loss.

Infrequent(may affect up to 1 in 100 people): tachycardia or arrhythmia (increased heart rate), chest pain, palpitations, hypotension, Raynaud's syndrome (crises of pallor followed by cyanosis and rubor, which occurs in the fingers of the hand), redness, pallor,swelling of the arms, legs, face, lips, tongue, and/or throat,chest pain, fatigue, discomfort.

Rare(may affect up to 1 in 1,000 people): feeling sleepy, mouth lesions, intestinal angioedema, renal function disorders including renal failure, renal insufficiency, and alterations in urine elimination.

Very rare(may affect up to 1 in 10,000 people): alterations in blood cell count, lymph node disorders, autoimmune diseases, changes in blood test results related to potassium and glucose levels, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disorders, inflammation of the tongue, pancreatitis, liver damage, and yellow skin discoloration, hepatitis (inflammation of the liver) including necrosis, elevated liver enzymes and bilirubin, appearance of blisters accompanied by itching, Stevens-Johnson syndrome, light sensitivity, skin redness, skin peeling, muscle pain, joint pain, nephrotic syndrome, impotence, excessive breast volume in men, fever, alterations in blood cell count, and changes in blood test results.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, 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 of 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 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.

Store in the original packaging. Do not store at a temperature above 30 °C. Store the container perfectly closed to protect it from moisture.

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

Captopril Normon Composition

• The active ingredient is captopril. Each tablet contains 50 mg of captopril.
• The other excipients are: microcrystalline cellulose (E 460i), lactose monohydrate, sodium carboxymethyl starch (potato starch) and stearic acid.

Appearance of the product and contents of the packaging

Captopril Normon is presented in the form of white or slightly cream-colored, round, biconvex tablets with a breaking bar and C/A printing on one face. The tablet can be divided into equal doses.

The tablets are presented in blister packaging, in containers of 30 tablets or 500 tablets (clinical packaging).

Only some sizes of containers may be commercially marketed.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Normon, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)

Other presentations

Captopril Normon 25 mg tablets EFG

Last review date of this leaflet: November2017

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