Baripril 5 mg tablets

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Baripril 5 mg tablets

Enalapril Maleate

Read the entire leaflet carefully before you start taking this medicine, because 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What Baripril is and what it is used for

Baripril belongs to a group of medicines called angiotensin-converting enzyme (ACE) inhibitors.

Baripril is indicated for:

• Treating hypertension (high blood pressure)
• 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 to any of the components of Baripril.

• If you have previously been treated with a medicine from the same drug class as Baripril (ACE inhibitors) and experienced allergic reactions with swelling of the face, lips, tongue, and/or throat, accompanied by difficulty swallowing or breathing.

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

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

• If you are more than 3 months pregnant. (Baripril should also be avoided early in pregnancy. See Pregnancy section.)

Warnings and precautions

Talk to your doctor or pharmacist before starting Baripril

• If you have heart disease.

• If you have a condition affecting 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 elimination).

• If you have recently experienced excessive vomiting or diarrhea.

• If you are on a salt-free diet, take potassium supplements, potassium-sparing medicines, salt substitutes containing potassium, or medicines associated with increased blood potassium levels (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 may lead to high blood potassium levels, which can be serious.

• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, accompanied by difficulty swallowing or breathing. Note that patients of Black race are more prone to this type of reaction to ACE inhibitors.

• If you are about to undergo a treatment called LDL apheresis or desensitization therapy to reduce the effect of an allergy to bee or wasp stings.

• If you have low blood pressure (you may experience fainting or dizziness, especially with initial doses and when standing up. In such cases, lying down may help).

• If you have vascular collagen disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, or are taking allopurinol, 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), particularly 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 information under the heading “Do not take Baripril”.

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

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

Note that Baripril is less effective in lowering blood pressure in Black patients compared to non-Black patients.

Inform your doctor if you think you may be pregnant (or could be). Baripril is not recommended during early pregnancy and must not be used after 3 months of pregnancy, as it may cause serious harm to your baby if used during this period (see Pregnancy section).

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 adjust your dose and/or take other precautions, or discontinue treatment with one of the medicines.

It is especially important to 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 information under the headings “Do not take Baripril” and “Take special care with Baripril”).
• Other blood pressure-lowering medicines, such as beta-blockers or diuretics ("water pills")
• 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 drugs (NSAIDs) (medicines used to treat pain or certain inflammations, e.g.: acetylsalicylic acid)
• Sympathomimetics
• Certain medicines for pain or arthritis, including gold therapy.
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

Taking Baripril with food, drinks, and alcohol:

Food does not affect the absorption of Baripril.

Alcohol enhances the hypotensive effect (blood pressure lowering) of enalapril; therefore, inform your doctor if you are consuming alcoholic beverages while taking this medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Pregnancy

Inform your doctor if you think you are pregnant (or could be). Your doctor will usually

advise you to stop taking Baripril before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Baripril is not recommended during early pregnancy and must not be taken after 3 months of pregnancy, as it may cause serious harm to your baby if used from the third month of pregnancy onwards.

Breastfeeding

Inform your doctor if you are breastfeeding or planning to breastfeed.

Breastfeeding is not recommended in newborns (first weeks after birth) while taking Baripril, and especially in premature infants. For older infants, 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 medication may vary.

Since Baripril may cause dizziness or fatigue, avoid performing tasks that require special attention (such as driving or operating machinery) until you know how you tolerate the medicine.

Baripril contains lactose and sodium

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him 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 instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Remember to take your medicine.

Your doctor will tell you how long you should take Baripril. Do not stop treatment earlier.

Baripril may be taken with meals or between meals together with a glass of water.

Your doctor will decide the appropriate dose of Baripril for you, depending on your condition and whether you are taking other medicines.

Hypertension

For most patients, the usual recommended starting dose is 5 to 20 mg once daily. Some patients may require a lower starting dose.

The usual long-term dose is 20 mg once daily.

Heart failure

The recommended starting dose is usually 2.5 mg once daily. Your doctor will gradually increase the dose until the appropriate dose for you is reached. The usual long-term dose is 20 mg daily, taken in one or two doses.

Extra caution should be taken at the beginning of treatment due to the possibility of dizziness or vertigo.

Inform your doctor immediately if you experience these symptoms.

If you think that 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 dizziness or vertigo due to a sudden or excessive drop in blood pressure.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 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 about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Baripril can have adverse effects, although not everyone experiences them.

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

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

Please be aware that patients of black race have a higher risk of experiencing these types of reactions. If any of the above reactions occur, stop taking Baripril and speak 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 drop in your blood pressure. This will improve as you continue taking the medicine. If you are concerned, please speak to your doctor.

The adverse effects reported are listed below by frequency:

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

• feeling dizzy, weak, or nauseous
• 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 or chest pain
• headache, depression, fainting (syncope), taste disturbances
• difficulty breathing
• diarrhea, abdominal pain
• tiredness (fatigue)
• rash, allergic reactions with swelling of the face, lips, tongue, or throat causing difficulty swallowing or breathing
• elevated potassium levels in blood, elevated creatinine levels in 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 heartbeat (palpitations)
• myocardial infarction (possibly due to very low blood pressure in certain high-risk patients, including those with impaired blood flow to the heart or brain)
• stroke (possibly due to very low blood pressure in high-risk patients)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness
• itching or numbness sensation in the skin
• vertigo (dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma-related chest tightness
• slow movement of food through the intestine (ileus), inflammation of the pancreas
• 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
• elevated protein levels in urine (detected in a urine test)
• low blood sugar or sodium levels, elevated blood urea levels (all detected 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 poor blood flow
• changes in blood values such as reduced number of white or red blood cells, reduced hemoglobin, reduced platelet count
• bone marrow depression
• swollen glands in the neck, armpits, or groin
• autoimmune diseases
• sleep disturbances or sleep problems
• accumulation of fluid or other substances in the lungs (as seen on X-rays)
• inflammation of the nose
• lung inflammation causing difficulty breathing (pneumonitis)
• swelling of cheeks, gums, tongue, lips, or throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder where you have red, peeling skin, blistering ulcers or open sores), exfoliative dermatitis/erythroderma (severe skin rash with peeling or shedding of the skin), pemphigus (small fluid-filled blisters on the skin)
• liver or gallbladder problems such as reduced liver function, liver inflammation, jaundice (yellowing of the skin or eyes), elevated liver enzymes or bilirubin levels (detected in a blood 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, causing fluid retention and resulting in weakness, fatigue, or confusion
• a group of symptoms has been reported that may include one or several of the following: fever, inflammation of blood vessels (serositis, vasculitis), muscle pain (myalgia, myositis), joint pain (arthralgia/arthritis). Skin rash, photosensitivity, or other skin manifestations may also occur.

Reporting of adverse effects: If you experience any adverse effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Baripril

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard containers and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Baripril

The active substance 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).

Appearance of the product and contents of the pack

Baripril 5 mg tablets are presented as tablets. The tablets are round, white, biconvex with flat bevelled edges, with a score line on one side and the imprint "5" on the other.

Baripril 5 mg tablets are available in packs containing 10 and 60 tablets, and hospital pack containing 500 tablets.

Marketing Authorisation Holder and Manufacturer:

Marketing Authorisation 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 most recent revision of this leaflet: March 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.