Captopril Normon 25 mg tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Captopril Normon 25 mg tablets EFG
Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.
- Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if these adverse effects are not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Captopril Normon is and what it is used for
- What you need to know before taking Captopril Normon
- How to take Captopril Normon
- Possible side effects
- How to store Captopril Normon
- Contents of the pack and other information
1. What Captopril Normon is and what it is used for
Captopril Normon is a medicine that belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors. Captopril causes relaxation of the 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 medications and beta-blockers.
- After a myocardial infarction (heart attack).
- Treatment of kidney problems in patients with type I diabetes.
2. What you need to know before taking Captopril Normon
Do not take Captopril Normon:
- If you are allergic to captopril or to any of the other components 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 medicines of the same group as captopril (ACE inhibitors).
- If you have idiopathic or hereditary angioedema.
- If you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- If you are pregnant (especially if you are in the second or third trimester of pregnancy).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before starting this medicine:
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), particularly 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”.
Take special care 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 developing these symptoms after treatment with Captopril Normon is higher in black patients.
- abdominal pain, with or without nausea and vomiting (possible symptoms of intestinal angioedema).
- any signs of infection (such as sore throat or fever) that do not respond quickly to usual treatment.
- low blood pressure (this may present as dizziness or fainting, especially when standing up).
- severe or persistent vomiting or diarrhoea.
- any heart, liver, kidney disease or diabetes.
- are undergoing, or are scheduled to undergo, desensitization procedures for allergy to bee or wasp stings.
- are undergoing haemodialysis or apheresis (a blood separation procedure), as reactions may occur related to the type of membrane used.
- any collagen disease.
- follow a low-salt diet.
- cough.
Excessive sweating and dehydration should be avoided, as they may lead to a sudden drop in blood pressure.
Inform your doctor that you are taking this medicine if you are scheduled for surgery or to receive anaesthetics.
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 conditions occurred in the past.
Other medicines and Captopril Normon
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
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 medicines may interact with Captopril Normon. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
It is important to inform your doctor if you are taking any of the following medicines:
- Diuretics.
- Medicines containing potassium.
- Medicines that lower blood pressure.
- Antidiabetic agents.
- Anti-inflammatory medicines.
- Lithium (a medicine used in some types of depression).
- Tricyclic antidepressants/antipsychotics.
- Sympathomimetics or agents affecting the activity of the sympathetic nervous system.
- Alpha-blockers.
- Allopurinol.
- Procainamide (a medicine used for cardiac rhythm disorders).
- Cytostatic or immunosuppressive agents.
- Medicines used to treat acute myocardial infarction.
Taking Captopril Normon with food and drink
This medicine may be taken with or without food.
Inform your doctor if you take potassium supplements or consume a potassium-rich diet.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before taking any medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
The use of Captopril Normon is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy. Inform your doctor immediately if you think you may be pregnant.
ACE inhibitors (the class of medicines to which captopril belongs) may cause fetal harm or death when administered during the second and third trimesters of pregnancy.
If pregnancy is detected, treatment with this medicine should be stopped as soon as possible.
The use of this medicine during breastfeeding is not recommended.
Driving and using machines
Treatment for high blood pressure may reduce your ability to drive and use machines, especially at the beginning of treatment, when the dose is changed, or when alcohol is consumed. Do not drive or operate machinery if you notice that this medicine impairs your ability to perform these tasks.
Captopril Normon contains lactose and sodium
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them 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 instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.
The dosage must be individualized, so your doctor will determine the appropriate dose for you and make any adjustments they consider necessary.
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 also recommend taking other medicines together 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 closely 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.
Kidney problems
The recommended initial dose for the treatment of kidney problems in patients with type I diabetes is 75–100 mg per day, administered in several divided doses.
The tablets should be swallowed with water and may be taken with or without food.
Remember to take your medicine.
If you think that the effect of this medicine is too strong or too weak, inform your doctor or pharmacist.
Your doctor will tell you how long to take Captopril Normon. Do not stop treatment earlier, as only your doctor knows what is best for you.
Use in children
The recommended initial dose is 0.30 mg/kg body weight. In children requiring special precautions, the starting dose should be 0.15 mg/kg body weight. The use of this medicine in children and adolescents should be initiated under close medical supervision. Your doctor will tell you how many doses per day to take.
Use in elderly patients
In elderly patients with impaired renal function and other organ impairments, doses lower than those recommended should be administered.
Renal impairment
In patients with kidney problems, doses lower 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, contact your doctor or pharmacist immediately. Symptoms of overdose include severe hypotension, shock, stupor, bradycardia (slowing of the heart rate), electrolyte disturbances, and renal failure.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to take Captopril Normon
If you forget to take your medicine, take the dose as soon as you remember on the same day. If you miss a dose 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
The following adverse effects have been observed:
Frequent (may affect up to 1 in 10 people): anorexia (loss of appetite), sleep disorders, taste disturbances, dizziness, headache and tingling sensation, cough and breathing difficulty, nausea, vomiting, gastric irritation, abdominal pain, diarrhoea, constipation, dry mouth, stomach ulcer, itching with or without skin rash (sometimes with fever, joint pain and eosinophilia), skin 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 (episodes of pallor followed by cyanosis and redness, occurring in the fingers), redness, 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 renal failure, kidney failure, and disturbances in urine elimination.
Very rare (may affect up to 1 in 10,000 people): blood cell count abnormalities, lymph node disorders, autoimmune diseases, changes in blood test results regarding potassium and glucose levels, confusion, depression, stroke, blurred vision, cardiac arrest, cardiogenic shock, respiratory disorders, tongue inflammation, pancreatitis, hepatic dysfunction and yellowing of the skin, hepatitis (liver inflammation) including necrosis, elevations in liver enzymes and bilirubin, blistering accompanied by itching, Stevens-Johnson syndrome, photosensitivity, skin redness, skin peeling, muscle pain, joint pain, nephrotic syndrome, impotence, excessive breast enlargement in men, fever, blood cell count abnormalities and changes in blood test results.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Captopril Normon Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.
Store in the original packaging. Do not store above 30 °C. Keep the container tightly closed to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of any unused medicines and their packaging. This will help protect the environment.
6. Contents of the pack and other information
Composition of Captopril Normon
- The active substance is captopril. Each tablet contains 25 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 pack
Captopril Normon is presented as white or slightly cream-colored, flat, round tablets, with a double score line on one side and the imprint "CA" on the other. The tablet can be divided into equal doses.
The tablets are supplied in blister packs, in pack sizes of 60 tablets or 500 tablets (clinical pack).
Only certain 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 50 mg tablets EFG
Date of the most recent revision of this leaflet: November 2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.es/).