Package Insert: Information for the User

Captopril Aristo 50 mg Tablets EFG

Read this package insert carefully before you start taking this medicine, because 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 for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Captopril Aristo 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.

Captopril Aristo is 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.
• Treatment of kidney problems in patients with type 1 diabetes (type 1 diabetic nephropathy).

Do not take Captopril Aristo

• If you are allergic to captopril or any of the other ingredients in 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.
• During the last 6 months of pregnancy (see section “Pregnancy and breastfeeding”).
• If you are breastfeeding (see section “Pregnancy and breastfeeding”).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Captopril Aristo:

• 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 Aristo”.

• If you experience swelling of the arms, legs, face, lips, tongue, and/or throat with difficulty swallowing or breathing (angioedema).
• When you experience any sign of infection (such as sore throat or fever) that does not respond quickly to usual treatment.
• If you experience 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 undergo desensitization treatment for allergy to 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 coughing occurs during treatment.
• Avoid excessive sweating and dehydration, which may cause a sudden drop in blood pressure.
• Inform your doctor that you are taking Captopril Aristo if you are to undergo surgery or receive anesthetics.
• If you are of black race, as this medication may be less effective in black patients, similar to other medications used to lower blood pressure.
• If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Captopril is not recommended for use in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy because it may cause serious harm to your baby (see section “Pregnancy and breastfeeding”).

Avoid exposure to the sun (even on cloudy days) and ultraviolet A (UVA) lamps while taking this medication.

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

Use of Captopril Aristo with other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

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 Aristo” and “Warnings and precautions”).

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

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

• diuretics
• potassium-containing medications
• blood pressure-lowering medications
• antidiabetic medications
• anti-inflammatory medications
• lithium (medication used for certain types of depression)
• tricyclic antidepressants/antipsychotics
• succinylcholine
• allopurinol (medication used to treat gout attacks)
• procainamide (medication used to treat arrhythmias)
• cytostatic or immunosuppressive agents
• medications for acute myocardial infarction

Taking Captopril Aristo with food and drinks

Captopril Aristo can be taken with or without food.

Inform your doctor if you take potassium supplements or consume a diet rich in potassium.

Use in elderly patients

Captopril Aristo can be used in elderly patients, but as with other antihypertensive agents, in elderly patients, treatment should be initiated with lower doses (see section “How to take Captopril Aristo”).

Use in children and adolescents

The efficacy and safety of captopril have not been fully established. The use of captopril in children and adolescents should be initiated under close medical supervision.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant.

Generally, your doctor will advise you to take another medication instead of captopril, as captopril is not recommended for use in the first trimester of pregnancy and is contraindicated in the second and third trimesters of pregnancy because it may cause serious harm to your baby.

Normally, before becoming pregnant, your doctor will substitute captopril with another suitable antihypertensive medication. In any case, captopril should not be taken during the second or third trimester of pregnancy or during breastfeeding.

Generally, your doctor will advise you to discontinue treatment with Captopril Aristo as soon as you know you are pregnant. If you become pregnant while taking captopril, inform and visit your doctor immediately.

Captopril Aristo should not be administered during breastfeeding.

Driving and operating machinery

Observe your response to the medication, as it may reduce your ability to drive and operate machinery, 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 Aristo contains lactose

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

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

Remember to take your medication.

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

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

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

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 100-125 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 125 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 125 mg per day.

Type 1 diabetic nephropathy

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

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.

Older adults: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 of Captopril Aristo is too strong or too weak, inform your doctor or pharmacist.

If you take more Captopril Aristo than you should

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, contact your doctor or pharmacist or call the Toxicological Information Service, phone 915 620 420, indicating the medication and the amount taken.

If you forget to take Captopril Aristo

In case of forgotten dose, take the medication as soon as possible, continuing as prescribed, however if the next dose is near, it is better not to take the forgotten dose and wait for the next one. Do not take a double dose to compensate for the forgotten doses.

If you interrupt treatment with Captopril Aristo

Do not discontinue treatment beforehand, as it may worsen your condition.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Captopril Aristo can cause side effects, although not everyone will experience them.

Side effects are classified as: Very common (affects more than 1 in 10 patients), Common (affects between 1 and 10 in 100 patients), Uncommon (affects between 1 and 10 in 1,000 patients), Rare (affects between 1 and 10 in 10,000 patients), Very rare (affects less than 1 in 10,000 patients) and Unknown frequency (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

Uncommon:feeling of sleepiness, headache and sensation of tingling

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 presents 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.

Uncommon: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 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, light sensitivity, skin redness, skin peeling.

Musculoskeletal and connective tissue disorders:

Very rare:muscle pain, joint pain.

Renal and urinary disorders:

Uncommon: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.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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 notification system included in the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use.Website:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

The tablets should be stored in their original packaging. This medication does not require special storage conditions.

Do not use Captopril Aristo after the expiration date indicated 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. Dispose of the packaging and unused medicines at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Captopril Aristo

• The active ingredient is captopril. Each tablet contains 50 mg of captopril.
• The other components (excipients) are: anhydrous lactose, microcrystalline cellulose, cornstarch, palmatic acid, anhydrous colloidal silica, and talc.

Appearance of the product and contents of the packaging

Captopril Aristo 50 mg are round, flat tablets with beveled edges, unnotched, and white to grayish in color.

Packaging with 30 tablets and clinical packaging with 500 tablets.

Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Responsible for Manufacturing:

LABORATORIOS ALCALÁ FARMA, S.L.

Ctra. M-300, km. 29,920

28802 ALCALÁ DE HENARES (MADRID)

Or

LABORATORIOS MEDICAMENTOS INTERNACIONALES S.A.(MEDINSA)

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

This leaflet has been approved in:April 2017

The 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.gob.es/