CAPTOPRIL QUALIGEN 50 mg TABLETS

Introduction

Prospect: Information for the user

Captopril Qualigen 50 mg tablets

Read the entire prospectus carefully before starting to take this medication, as it contains important information for you.

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

Contents of the prospectus

1. What Captopril Qualigen is and what it is used for
2. What you need to know before taking Captopril Qualigen
3. How to take Captopril Qualigen
4. Possible adverse effects
5. Storage of Captopril Qualigen
6. Package contents and additional information

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

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

Captopril Qualigen is indicated for the treatment of:

• High blood pressure (arterial hypertension).
• Chronic heart failure, in combination with diuretics and, when appropriate, with digitalis and beta-blockers.
• Myocardial infarction.
• Kidney problems in patients with type 1 diabetes (diabetic nephropathy type 1).

2. What you need to know before taking Captopril Qualigen

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• 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 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 medication that contains aliskiren
• if you are pregnant (especially if you are in the second or third trimester of pregnancy) (see "Pregnancy and breastfeeding").
• if you are breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions

Consult your doctor or pharmacist before starting to take Captopril Qualigen:

• if you experience swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema),
• if you experience any signs of infection (such as sore throat or fever) that do not respond quickly to usual treatment,
• if you have low blood pressure (this can manifest as dizziness or fainting, especially when standing),
• if you experience severe or persistent vomiting or diarrhea,
• if you have any heart, liver, kidney, or diabetes disease,
• if you are undergoing, or will undergo, desensitization procedures for bee or wasp stings,
• if you are undergoing hemodialysis or apheresis, as reactions to the type of membrane used may occur,
• if you have any collagen disease,
• if you follow a low-salt diet,
• if you experience cough.

You should avoid excessive sweating and dehydration, which can lead to a sudden drop in blood pressure.

Other medications and Captopril Qualigen

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

Inform your doctor or pharmacist if you are taking any of the following medications 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 Qualigen".

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

As with 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 to you in the past.

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 Qualigen" and "Consult your doctor or pharmacist before starting to take Captopril Qualigen")

Certain medications may interact with Captopril Qualigen. In these cases, it may be necessary to change the dose or discontinue treatment with one of them.

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

• diuretics,
• medications that contain potassium,
• medications that lower blood pressure,
• antidiabetics,
• anti-inflammatory medications,
• lithium (a medication used in some types of depression),
• tricyclic antidepressants/antipsychotics,
• sympathomimetics,
• allopurinol (a medication used to treat gout attacks),
• procainamide (a medication used to treat heart rhythm disorders),
• cytostatic agents or immunosuppressants,
• medications for the treatment of acute myocardial infarction.

Taking Captopril Qualigen with food

The tablets should be swallowed with water and can be taken with or without food. Inform your doctor if you take potassium supplements or follow a diet rich in potassium.

Pregnancy and breastfeeding

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

Captopril Qualigen is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters of pregnancy.

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

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

Captopril Qualigen should not be administered 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 you consume alcohol. Do not drive or use machinery if you observe that this medication causes you any disability to perform these functions.

Captopril Qualigen contains lactose

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

3. How to take Captopril Qualigen

Follow your doctor's instructions for taking Captopril Qualigen exactly. If in doubt, consult your doctor again.

Remember to take your medication.

Your doctor will indicate the duration of treatment with Captopril Qualigen. Do not discontinue treatment before, as it may worsen your condition.

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

Adults

High blood pressure

The recommended initial dose 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 concurrent administration of other medications that lower blood pressure.

Chronic heart failure

The recommended initial dose is 6.25-12.5 mg two or three times a day. Your doctor may gradually increase the dose up to a maximum of 50 mg per day.

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.

Diabetic nephropathy type 1

The recommended initial dose is 75-100 mg per day, administered in several daily doses.

Use in children and adolescents

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.

Elderly patients

In elderly patients with impaired renal function and other organic disorders, lower doses than those recommended should be administered.

Patients with renal impairment

Lower doses than those recommended should be administered.

If you think the effect of Captopril Qualigen is too strong or too weak, inform your doctor or pharmacist.

If you take more Captopril Qualigen than you should

If you have taken more Captopril Qualigen than you should, consult your doctor or pharmacist immediately.

The most frequent symptoms in case 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. Phone 915 620 420.

If you forget to take Captopril Qualigen

Take the dose as soon as you remember on the same day. Do not take a double dose to make up for forgotten doses.

4. Possible adverse effects

Like all medications, this medication can have adverse effects, although not everyone will experience them.

The classification of adverse effects is based on the following frequencies:

Very common (may affect up to 1 in 10 people)

Common (may affect less than 1 in 10 people)

Uncommon (may affect less than 1 in 100 people)

Rare (may affect up to 1 in 1,000 people)

Very rare (may affect less than 1 in 10,000 people)

Frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Blood and lymphatic system disorders

Very rare:alterations in blood cell count, lymph node disorders, autoimmune diseases.

Metabolism and nutrition disorders

Rare:anorexia (loss of appetite).

Very rare:changes in blood tests related to potassium and glucose levels.

Psychiatric disorders

Common:sleep disorders.

Very rare:confusion, depression.

Nervous system disorders

Common:taste disturbance, dizziness.

Rare:drowsiness, headache, and tingling sensation

Very rare:fainting, fainting spells.

Eye disorders

Very rare:blurred vision.

Cardiac disorders

Uncommon:tachycardia, angina pectoris, palpitations.

Very rare:cardiac arrest, cardiogenic shock.

Vascular disorders

Uncommon:hypotension, Raynaud's syndrome (crises of paleness followed by cyanosis and rubor, which occurs in the fingers of the hand), flushing, pallor.

Respiratory, thoracic, and mediastinal disorders

Common:cough and difficulty breathing.

Very rare:respiratory disorders.

Gastrointestinal disorders

Common:nausea, vomiting, gastric irritation, abdominal pain, diarrhea, constipation, dry mouth.

Rare:mouth lesions.

Very rare:tongue inflammation, stomach ulcer, pancreatitis.

Hepatobiliary disorders

Very rare:liver disorders and yellowing of the skin, hepatitis (inflammation of the liver) including necrosis, elevations of liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders

Common:itching with or without skin rash, skin rash, and hair loss.

Uncommon:swelling of the arms, legs, face, lips, tongue, and/or throat.

Very rare:appearance of blisters accompanied by itching, Stevens-Johnson syndrome, sensitivity to light, skin redness, skin peeling.

Musculoskeletal and connective tissue disorders

Very rare:muscle pain, joint pain.

Renal and urinary disorders

Rare:kidney function disorders, including kidney failure and changes in urine elimination.

Reproductive system and breast disorders

Very rare:impotence, abnormal breast development in men.

General disorders and administration site conditions

Uncommon:chest pain, fatigue, malaise.

Very rare:fever.

Investigations

Very rare:changes in blood cell count in blood tests.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Captopril Qualigen

Keep this medication out of sight and reach of children.

Store in the original package and keep the package perfectly closed to protect it from moisture.

Do not store above 30°C.

Do not use Captopril Qualigen after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Captopril Qualigen

• The active ingredient is captopril. Each tablet contains 50 mg of captopril.
• The other ingredients are: lactose monohydrate, microcrystalline cellulose (E-460), cornstarch, pregelatinized cornstarch, colloidal silica (E-551), and stearic acid.

Appearance and package contents

Captopril Qualigen is presented in tablet form. Each package contains 30 or 500 tablets.

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of last revision of this prospectus: September 2021

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