Patient Information

Captopril Qualigen 25 mg Tablets

Read this entire leaflet carefully before you start taking this medicine, as 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. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

2. What you need to know before taking Captopril Qualigen

3. How to take Captopril Qualigen

4. Possible side effects

5. Storage of Captopril Qualigen

6. Contents of the pack and additional informationl

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

Captopril Qualigenis indicated for the treatment of:

• Hypertension (high blood pressure).
• Chronic heart failure, in combination with diuretics and when appropriate with digitalis medications and beta-blockers.
• Myocardial infarction.
• Renal problems in patients with type 1 diabetes (type 1 diabetic nephropathy).

Do not take Captopril Qualigen

• 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 (angiotensin-converting enzyme 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 aliskirén.
• If you are pregnant (especially in the second or third trimester of pregnancy) (see "Pregnancy and breastfeeding" section).
• If you are breastfeeding (see "Pregnancy and breastfeeding" section).

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 may manifest as dizziness or fainting, especially when standing up),
• If you experience intense or persistent vomiting or diarrhea,
• If you have any heart, liver, kidney, or diabetes disease,
• If you are undergoing or will be undergoing allergy desensitization procedures for bee or wasp stings,
• If you are undergoing hemodialysis or apheresis, as reactions may occur with the type of membrane used,
• If you have any collagen disease,
• If you are following a low-sodium diet,
• If you experience coughing.

Excessive sweating and dehydration should be avoided, as they may lead to a sudden drop in blood pressure.

Other medications and Captopril Qualigen

Inform your doctor or pharmacist if you are taking, have taken recently, 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 (hypertension):

• An angiotensin II receptor antagonist (ARA) (Also known as "sartanes" – for example, valsartán, telmisartán, irbesartán), particularly if you have renal problems related to diabetes.
• Aliskirén

Your doctor may monitor your renal function, blood pressure, and electrolyte levels in the blood (such as 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 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 circumstances mentioned above have occurred at any time.

Your doctor may need to modify your dose and/or take other precautions:

• If you are taking an angiotensin II receptor antagonist (ARA) or aliskirén (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 to inform your doctor if you are taking any of the following medications:

• Diuretics,
• Medications containing potassium,
• Medications that lower blood pressure,
• Antidiabetics,
• Anti-inflammatory medications,
• Lithium (medication used for certain types of depression),
• Tricyclic antidepressants/antipsychotics,
• Sympathomimetics,
• Allopurinol (medication used to treat gout attacks),
• Procainamide (medication used to treat arrhythmias),
• Cytostatic or immunosuppressive agents,
• Medications for the treatment of acute myocardial infarction.

Taking Captopril Qualigen with food

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

Pregnancy and breastfeeding

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

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

Captopril Qualigen should not be administered during breastfeeding.

Driving and operating machinery

During treatment for high blood pressure, 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 observe that this medication causes any inability to perform these functions.

Captopril Qualigen contains lactose

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

Follow exactly the administration instructions for Captopril Qualigen as indicated by your doctor. In case of 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 beforehand, as it may worsen your condition

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

Adults

Hypertension

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 to three times a day. Your doctor may gradually increase the dose up to a maximum of 150 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.

Type 1 diabetic nephropathy

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.

Geriatric patients

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

Patients with renal insufficiency

Lower doses than those recommended should be administered.

If you estimate that the action ofCaptopril Qualigenis too strong or too weak, inform your doctor or pharmacist.

If you take moreCaptopril Qualigenthan you should

If you have taken moreCaptopril Qualigenthan you should, consult your doctor or pharmacist immediately.

The most frequent symptoms in case 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 915 620 420.

If you forgot to takeCaptopril Qualigen

Take the dose as soon as you remember on the same day. Do not take a double dose to compensate for the missed doses.

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

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

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

Common(may affect fewer than 1 in 10 people)

Uncommon(may affect fewer than 1 in 100 people)

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

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

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

The following side effects have been observed:

Blood and lymphatic system disorders

Very rare:abnormal blood cell counts, 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.

Mental and behavioural disorders

Common:sleep disorders.

Very rare:confusion, depression.

Nervous system disorders

Common:alteration of taste, dizziness.

Rare:feeling of sleepiness, headache, and tingling sensation.

Very rare:syncope, fainting.

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 (crisis of pallor followed by cyanosis and erythema, 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:oral lesions.

Very rare:inflammation of the tongue, gastric ulcer, pancreatitis.

Hepatobiliary disorders

Very rare:hepatic disorder and yellow skin discoloration, hepatitis (inflammation of the liver) including necrosis, elevated liver enzymes and bilirubin.

Skin and subcutaneous tissue disorders

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

Uncommon:swelling of the arms, legs, face, lips, tongueand/orthroat.

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:renal function disorders including renal failure and alterations in urine elimination.

Reproductive 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:abnormal blood cell counts in blood tests.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.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.

Store in the original packaging and maintain the packaging perfectly closed to protect it from moisture.

Do not store at a temperature above 30°C.

Do not use Captopril Qualigen 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 disposed of through drains or in the trash. Deposit the packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Captopril Qualigen Composition

• The active ingredient is captopril. Each tablet contains 25 mg of captopril.
• The other components are: lactose monohydrate, microcrystalline cellulose (E-460), cornstarch, pregelatinized cornstarch, hydrated colloidal silica (E-551), and stearic acid.

Appearance of the product and contents of the packaging

Captopril Qualigenis presented in the form of tablets. Each package contains 60 or 500 tablets.

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Last review date of this leaflet: September 2021

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