BARIPRIL 5 mg TABLETS

Introduction

Package Leaflet: Information for the User

Baripril 5 mg Tablets

Enalapril Maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Baripril and what is it used for
2. What you need to know before you take Baripril
3. How to take Baripril
4. Possible side effects
5. Storing Baripril
6. Contents of the pack and other information

1. What is Baripril and what is it used for

Baripril belongs to a group of medicines 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 other ingredients of Baripril.

• If you have previously been treated with a medicine from the same group of medicines 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 (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 problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

Warnings 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 absent 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 (medicines that increase urine production).
• If you have recently had excessive vomiting or diarrhea.
• If you follow a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes that contain potassium or medicines 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 problems (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 a desensitization treatment to reduce the effect of an allergy to bee or wasp stings.
• If you have low blood pressure (you may notice this as fainting or dizziness, especially in the initial doses and when standing up. 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 medicines that suppress your immune system, or are taking the medicines allopurinol or procainamide or any combination of these.

• 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" - 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 stop taking 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), 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 you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Baripril. Baripril is not recommended at the start of pregnancy and should not be used if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

Taking Baripril with other medicines:

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Certain medicines may interact with Baripril; your doctor may need to change your dose and/or take other precautions or stop 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 medicines:

• 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 medicines for lowering blood pressure, such as beta-blockers or water pills (diuretics)
• Potassium-containing medicines (including dietary salt substitutes)
• Medicines for diabetes (including oral antibiotics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Tricyclic antidepressants
• Antipsychotics
• Anesthetics
• Non-steroidal anti-inflammatory medicines (NSAIDs) (medicines for treating pain or certain inflammations, e.g., acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold treatment.
• Non-steroidal anti-inflammatory medicines (NSAIDs), including COX-2 inhibitors (medicines 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 blood pressure-lowering effect of enalapril, so inform your doctor if you are taking alcoholic beverages while being treated with this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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 you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of Baripril. Baripril is not recommended at the start of pregnancy and should not be used if you are more than 3 months pregnant, as it can cause serious harm to your baby if used from the third month of pregnancy.

Breastfeeding

Tell 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), and 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 medicine 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 medicine.

Baripril contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some 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 Baripril

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

Remember to take your medicine.

Your doctor will indicate the duration of your treatment with Baripril. Do not stop treatment before.

Baripril can be taken with or without food, 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 medicines.

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 medicine is too strong or too weak, tell 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 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Baripril can cause side effects, although not everybody gets 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 suffering from 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 medicine, 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 medicine. If you are concerned, please talk to your doctor.

The side effects reported are listed below by frequency:

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

• feeling of 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 heartbeats, angina pectoris, or chest pain
• headache, depression, fainting (syncope), taste disturbance
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (tiredness)
• 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 and irregular heartbeats (palpitations)
• heart attack (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 sensation on the 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 the 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 the 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” where your hands and feet can 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, 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 other 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 amount of urine produced
• 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 of the skin), 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 the available data)

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

Reporting of side effects:If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Baripril

Keep out of sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicines to the pharmacy. Ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Packaging Content and Additional Information

Baripril Composition

The active ingredient is enalapril maleate. Each tablet contains 5 mg of enalapril maleate.

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

Product Appearance and Packaging Content

Baripril 5 mg tablets are presented in tablet form. The tablets are round, flat-faced with beveled edges, white in color, with a notch on one side and the inscription "5" on the other.

Baripril 5 mg tablets are available in packages containing 10, 60 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/.