CAPTOPRIL NORMON 50 mg TABLETS

Introduction

Package Leaflet: Information for the User

Captopril Normon 50 mg Tablets EFG

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:

1. What is Captopril Normon and what is it used for
2. What you need to know before you take Captopril Normon
3. How to take Captopril Normon
4. Possible side effects
5. Storage of Captopril Normon
6. Contents of the pack and further information

1. What is Captopril Normon and what is it used for

Captopril Normon is a medicine that belongs to the group of so-called angiotensin-converting enzyme inhibitors (ACE inhibitors). Captopril produces a relaxation of blood vessels and reduces blood pressure.

This medicine 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 and beta-blockers.
• After a heart attack (myocardial infarction).
• Treatment of kidney problems in patients with type 1 diabetes.

2. What you need to know before taking Captopril Normon

Do not take Captopril Normon:

• If you are allergic to captopril or any of the other ingredients of this medicine (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 drugs of the same group as captopril (ACE inhibitors).
• If you have idiopathic or hereditary angioedema.
• If you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.
• If you are pregnant (especially if you are in the second or third trimester of pregnancy).

Warnings and precautions

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

If you are taking any of the following medicines used to treat high blood pressure:

• An angiotensin II receptor antagonist (ARA) (also known as "sartans" - e.g., 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 (e.g., potassium) at regular intervals.

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

Be particularly careful with this medicine 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 presenting 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 can manifest as dizziness or fainting, especially when standing up).
• Severe or persistent vomiting or diarrhea.
• Any heart, liver, kidney, or diabetes disease.
• You are undergoing desensitization procedures for bee or wasp stings.
• You are undergoing hemodialysis or apheresis (blood separation procedure), as reactions to the type of membrane used may occur.
• Any collagen disease.
• You follow a low-salt diet.
• Cough.

Excessive sweating and dehydration that can lead to a sudden drop in blood pressure should be avoided.

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

As with other medicines used to lower blood pressure, this medicine may be less effective in black patients.

Consult your doctor, even if any of the above circumstances have occurred to you in the past.

Other medicines and Captopril Normon

Tell your doctor or pharmacist if you are taking or have recently taken or may take any other medicines.

Your doctor may need to change 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 medicines may interact with Captopril Normon. In these cases, it may be necessary to change the dose or interrupt treatment with one of them.

It is important that you inform your doctor if you take any of the following drugs:

• Diuretics.
• Medicines that contain potassium.
• Medicines that lower blood pressure.
• Antidiabetics.
• Anti-inflammatory drugs.
• Lithium (a medicine used in some types of depression).
• Tricyclic antidepressants/antipsychotics.
• Sympathomimetics or agents that affect the activity of the sympathetic nervous system.
• Alpha-blockers.
• Allopurinol.
• Procainamide (a medicine used for heart rhythm disorders).
• Cytostatic agents or immunosuppressants.
• Medicines for the treatment of acute myocardial infarction.

Taking Captopril Normon with food and drinks

This medicine can be taken with or without food.

Tell your doctor if you take potassium supplements or eat a potassium-rich diet.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before taking a medicine.

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

The use of Captopril Normon 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.

If administered during the second and third trimesters of pregnancy, angiotensin-converting enzyme inhibitors (the group to which captopril belongs) can cause fetal harm and death.

If pregnancy is detected, administration of this medicine should be discontinued as soon as possible.

The use of this medicine is not recommended during breastfeeding.

Driving and using machines

During treatment for high blood pressure, your ability to drive and use machines may be reduced, especially at the beginning of treatment, when the dose is changed, or when alcohol is consumed. Do not drive or use machinery if you observe that this medicine causes you any inability to perform these functions.

Captopril Normon contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine.

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

3. How to take Captopril Normon

Follow exactly the administration instructions of this medicine 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 suitable dose for you and make the necessary adjustments.

High blood pressure

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 medicines that lower blood pressure.

Chronic heart failure

The recommended initial dose for chronic heart failure (helping 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 the dose.

Heart attack

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.

Kidney problems

The recommended initial dose for the treatment of kidney 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 medicine.

If you think the action of this medicine is too strong or too weak, tell your doctor or pharmacist.

Your doctor will indicate the duration of treatment with Captopril Normon. Do not stop 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 starting dose should be 0.15 mg/kg of body weight. The use of this medicine 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 impaired renal function and other organic disorders, lower doses than those recommended should be administered.

Kidney failure

In patients with impaired renal function, lower doses than those 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. The symptoms of overdose include severe hypotension, shock, stupor, bradycardia (slow heart rate), electrolyte disturbances, and kidney failure.

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

If you forget to take Captopril Normon

If you forgot to take the medicine, you should take the dose as soon as you remember it on the same day. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following side effects have been observed:

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

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

Rare(may affect up to 1 in 1,000 people): drowsiness, mouth lesions, intestinal angioedema, renal function disorders including kidney failure, and changes in urine elimination.

Very rare(may affect up to 1 in 10,000 people): changes in blood cell count, lymph node disorders, autoimmune diseases, changes in blood tests related to potassium and glucose, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disorders, tongue inflammation, pancreatitis, liver disorders, and yellowing of the skin, hepatitis (liver inflammation) including necrosis, elevations of liver enzymes and bilirubin, blistering with itching, Stevens-Johnson syndrome, photosensitivity, skin redness, skin peeling, muscle pain, joint pain, nephrotic syndrome, impotence, excessive breast volume in men, fever, changes in blood cell count, and changes in blood tests.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects that are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Captopril Normon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month indicated.

Store in the original package. Do not store above 30°C. Keep the container tightly closed to protect from moisture.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Captopril Normon

• 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 pack contents

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

The tablets are presented in blisters, in packs of 30 tablets or 500 tablets (clinical pack).

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

LABORATORIOS NORMON, S.A.

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

Other presentations

Captopril Normon 25 mg tablets EFG

Date of last revision of this leaflet: N

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