BARIPRIL 20 mg TABLETS

Introduction

Prospect: information for the user

Baripril 20 mg tablets

Enalapril Maleate

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

1. What is Baripril and what is it used for

Baripril belongs to the group of medications called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Baripril is indicated for:

• Treating high blood pressure (hypertension)
• Treating symptomatic heart failure.
• Preventing symptomatic heart failure.

2. What you need to know before taking Baripril

Do not take Baripril:

• If you are allergic (hypersensitive) to enalapril or any of the components of Baripril.

• If you have been previously treated with a medication from the same group of drugs as Baripril (ACE inhibitors) and have had allergic reactions with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing.

• If you have been diagnosed with hereditary or idiopathic angioedema (which is the development of large hives on the skin surface, especially around the eyes and lips, which can also affect hands, feet, and throat and can also cause swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing).

• If you have diabetes or kidney failure and are being treated with a blood pressure medication containing aliskiren.

• If you are pregnant for more than 3 months. (It is also best to avoid Baripril at the beginning of pregnancy. See the Pregnancy section.)

Warning and precautions

Consult your doctor or pharmacist before starting to take Baripril

• If you have heart disease.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low or lack of white blood cells (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have liver problems.
• If you are undergoing dialysis.
• If you are receiving treatment with diuretics (medications that increase urine production).
• If you have recently experienced excessive vomiting or diarrhea.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medications, or salt substitutes that contain potassium or medications associated with elevated potassium levels in the blood (e.g., anticoagulants such as heparin).
• If you are over 70 years old.
• If you have diabetes mellitus or any kidney problem (including kidney transplant), as these can lead to high levels of potassium in the blood, which can be serious.
• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing. You should be aware that black patients are more sensitive to this type of reaction to ACE inhibitors.
• If you are about to undergo a treatment called LDL apheresis or desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice dizziness or fainting, especially in the initial doses and when standing. In these cases, lying down may help).
• If you have vascular collagen disease (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medications that suppress your immune system, or are taking medications such as allopurinol or procainamide or any combination of these.

• 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 "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 Baripril".

In all these cases, inform your doctor, as you may need a dose adjustment or to discontinue medication with Baripril or monitor your potassium levels in the blood. If you have diabetes and are taking oral antidiabetics or insulin, you should closely monitor your blood glucose levels, especially during the first month of treatment with Baripril.

Before undergoing surgery or anesthesia (even at the dentist's office), inform your doctor or dentist that you are taking Baripril, as there may be a sudden drop in blood pressure associated with anesthesia.

You should be aware that Baripril lowers blood pressure in black patients less effectively than in non-black patients.

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Baripril before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Baripril. Baripril is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Taking Baripril with other medications:

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

Certain medications may interact with Baripril; your doctor may need to modify your dose and/or take other precautions or discontinue treatment with one of them.

It is especially important that you inform your doctor if you are taking or have recently taken any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskiren (see also the information under the headings "Do not take Baripril" and "Be careful with Baripril".
• Other medications for reducing blood pressure, such as beta-blockers or diuretics
• Potassium-containing medications (including dietary salt substitutes)
• Medications for diabetes (including oral antibiotics and insulin)
• Lithium (a medication used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Non-steroidal anti-inflammatory drugs (NSAIDs) (medications for treating pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medications for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medications (NSAIDs), including COX-2 inhibitors (medications that reduce inflammation and can be used to help relieve pain).

Taking Baripril with food, drinks, and alcohol:

Food does not affect the absorption of Baripril.

Alcohol enhances the hypotensive effect (reduction of blood pressure) of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Pregnancy

You must inform your doctor if you think you are pregnant (or might be). Normally, your doctor will advise you to stop taking Baripril before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of Baripril. Baripril is not recommended at the beginning of pregnancy and should not be used if you are pregnant for more than 3 months, as it may cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding.

While taking Baripril, breastfeeding is not recommended in newborns (first few weeks after birth), especially in premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking Baripril compared to other treatments while breastfeeding.

Driving and using machines:

Individual responses to the medication may vary.

Since Baripril can cause dizziness or fatigue, avoid performing tasks that require special attention (driving vehicles or operating machinery) until you know how you tolerate the medication.

Baripril contains lactose and sodium

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.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Baripril

Follow the administration instructions for this medication exactly 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 your treatment with Baripril. Do not discontinue treatment before.

Baripril can be taken with or without food, along with a glass of water.

Your doctor will decide the appropriate dose of Baripril that you should take, depending on your condition and whether you are taking other medications.

Hypertension

For most patients, the recommended initial dose is usually 5 to 20 mg once a day. Some patients may need a lower initial dose.

The usual long-term dose is 20 mg once a day.

Heart failure

The recommended initial dose is usually 2.5 mg once a day. The doctor will gradually increase the dose until the appropriate dose is reached in your case. The usual long-term dose is 20 mg per day in one or two doses.

At the start of treatment, precautions should be taken due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

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

If you take more Baripril than you should

If you take more Baripril than you should, consult your doctor or pharmacist immediately.

In case of an overdose, the most likely symptom is a feeling of dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91 562-0420.

If you forget to take Baripril:

You should continue taking Baripril as prescribed. Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

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

If you experience any of the following symptoms, stop taking Baripril and talk to your doctor immediately:

• swelling of the face, lips, tongue, or throat that can cause difficulty swallowing or breathing
• swelling of your hands, feet, or ankles
• if you develop a red rash on the skin with swelling (hives).

You should be aware that black patients have a higher risk of experiencing this type of reaction. If you experience any of the above reactions, stop taking Baripril and talk to your doctor immediately.

When you start taking this medication, you may feel faint or dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue taking the medication. If you are concerned, please talk to your doctor.

The reported adverse effects are listed below by frequency:

Very common(may affect more than 1 in 10 people)

• dizziness, weakness, or vomiting
• blurred vision
• cough.

Common(may affect up to 1 in 10 people)

• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina pectoris, or chest pain
• headache, depression, fainting (syncope), taste disorder
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing
• high levels of potassium in the blood, high levels of creatinine in the blood (both usually detected in a blood test).

Uncommon(may affect up to 1 in 100 people)

• flushing
• sudden drop in blood pressure
• rapid or irregular heartbeat (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, even those with alterations in blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic anemia and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• tingling or numbness in your skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-associated chest tightness
• slow movement of food through your intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach (gastric irritation), dry mouth, ulcer
• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or hives
• hair loss
• malaise (general discomfort), elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in a test)
• low blood sugar or sodium levels, high levels of urea in the blood (all determined in a blood test).

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

• "Raynaud's phenomenon" in which your hands and feet may become very cold and white due to low blood flow
• changes in blood values such as a lower number of white or red blood cells, lower hemoglobin, or lower platelet count in the blood
• bone marrow depression
• inflamed glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• fluid or substance accumulation in the lungs (as seen on X-rays)
• nasal inflammation
• lung inflammation causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced urine production
• rash with a target-like shape (erythema multiforme)
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, blisters or open sores), exfoliative dermatitis/erythroderma (severe skin rash with scaling or peeling), pemphigus (small blisters filled with fluid on the skin)
• liver or bile duct problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzyme or bilirubin levels (determined in a test)
• breast enlargement in men (gynecomastia).

Very rare(may affect up to 1 in 10,000 people)

• swelling in your intestine (intestinal angioedema)

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

• overproduction of antidiuretic hormone, leading to fluid retention, causing weakness, fatigue, or confusion
• a set of symptoms has been reported that may include one or more of the following: fever, inflammation of the blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). A rash, photosensitivity, or other skin manifestations may occur.

Reporting adverse effects:If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Baripril

Keep out of sight and reach of children.

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

6. Package Contents and Additional Information

Composition of Baripril

The active ingredient is enalapril maleate. Each tablet contains 20 mg of enalapril maleate.

The other components are: Sodium hydrogen carbonate (E500), lactose monohydrate (lactose), corn starch, magnesium stearate (E470b), and red iron oxide (E172).

Appearance of the Product and Package Contents

BARIPRIL 20 mg tablets are presented in the form of tablets. The tablets are cylindrical, with flat faces of pink color, with a notch on one face and the inscription "20" on the other.

BARIPRIL 20 mg tablets are presented in packages containing 28 tablets and a clinical package with 500 tablets.

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 the Last Revision of this Leaflet: March 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/.