Package Leaflet: Information for the User

Enalapril Davur 2.5 mg Tablets

Enalapril maleate

Enalapril Davurcontains an active ingredient called enalapril maleate.It belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors).

Enalapril Davur is used for:

• Treating high blood pressure (hypertension).
• Treating symptomatic heart failure (weakening of the heart's function). It may reduce the need for hospital visits and may help some patients live longer.

• Preventing symptoms of symptomatic heart failure.The symptoms include: difficulty breathing, fatigue after light physical activity such as walking or swelling of the ankles and feet.

This medicine works by widening your blood vessels. This lowers your blood pressure. Normally, the medicine starts to work within an hour and the effect lasts for at least 24 hours. Some people may need several weeks of treatment before they notice the greatest effect on their blood pressure.

Do not take Enalapril Davur

• If you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• If you have ever been treated for an allergic reaction to a similar medication to this one, called an ACE inhibitor.
• If you have ever hadswelling of the face, lips, mouth, tongue, or throat that caused difficulty swallowing or breathing(angioedema) when the cause was unknown or hereditary.
• If you have diabetes or kidney failure and are being treated with a medication to lower blood pressure that contains aliskirén.
• If you are more than 3 months pregnant. (It is also best to avoid this medication at the beginning of pregnancy - see Pregnancy section).
• If you have taken or are currently taking sacubiril/valsartán, a medication used to treat a type of chronic heart failure in adults, as the risk of angioedema (rapid swelling under the skin in an area such as the throat) is high.
• Do not take this medication if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Enalapril Davur

• If you have a heart problem.
• If you have a disease that affects the blood vessels in the brain.
• If you have blood disorders such as low white blood cell count (neutropenia/agranulocytosis), low platelet count (thrombocytopenia), or low red blood cell count (anemia).
• If you have a liver problem.
• If you have a kidney problem (including kidney transplant), follow a low-sodium diet, take potassium supplements, potassium-sparing medications, or salt substitutes that contain potassium, or other medications that may increase potassium levels in the blood, such as heparin (a medication used to prevent blood clots), trimethoprim, or cotrimoxazole (a medication used to treat infections). This may cause high levels of potassium in the blood that can be serious. Your doctor may need to adjust your enalapril dose or monitor your potassium levels in the blood. See also the information under the heading “Taking Enalapril Davur with other medications”.
• Recently.
• If you are undergoing dialysis.
• If you have had many vomiting episodes (excessive vomiting) orhave had intense diarrhea recently.

• If you have diabetes.You should monitor your blood for low blood glucose levels, especially during the first month of treatment. Your potassium levels in the blood may also be higher.

• 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 patients of black racehave a higher risk of sufferingthese types of reactions to ACE inhibitors.
• If you have low blood pressure (you may notice it as dizziness or lightheadedness, especially in the initial doses and when standing up).

• If you have vascular collagen disease (e.g. lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with immunosuppressive medications, are taking alopurinol or procainamide, or any combination of these.

• If you are taking any of the following medications, the risk of angioedema may increase:

• racecadotril, a medication used to treat diarrhea.
• Medications used to prevent organ transplant rejection and for cancer (e.g.,sirolimus, everolimus, temsirolimus)
• vildagliptin, a medication used to treat diabetes.

• 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 kidney problems related to diabetes.

- aliskirén

Your doctor may need to monitor your renal function, blood pressure, and electrolyte levels in the blood (e.g., potassium) at regular intervals.

See also the information under the heading “Do not take Enalapril Davur”

You should inform your doctor if you think you may be pregnant (or could be). Enalapril Davur is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage (see Pregnancy section).

You should be aware that enalapril reduces blood pressure in black patients less effectively than in patients who are not black.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medication.

If you are about to undergo a procedure

If you are about to undergo any of the following procedures, inform your doctor that you are taking enalapril:

• any surgery or if you are to receive anesthetics(even at the dentist's office),
• a treatment to remove cholesterol from your blood called “apheresis of LDL”,
• a desensitization treatment to reduce the effect of an allergy to a bee or wasp sting.

If any of the above situations apply to you, consult your doctor or dentist before starting the procedure.

Taking Enalapril Davur with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

This includes herbal treatments. This is because enalapril may affect how other medications work andcertain medications may also affect how enalapril works. Your doctor may need to modify your dose and/or take other precautions.

Especially, inform your doctor or pharmacist if you are taking or have taken recently any of the following medications:

• An angiotensin II receptor antagonist (ARA) or aliskirén (see also the information under the headings “Do not take Enalapril Davur” and “Warnings and precautions”)

• Other medications to reduce elevated blood pressuresuch as blockers or diuretics.
• Potassium supplements (including salt substitutes), diuretics that spare potassium, and other medications that may increase potassium levels in the blood (e.g., heparin, trimethoprim, and cotrimoxazole , also known as trimethoprim/sulfamethoxazole for bacterial infections; ciclosporin, an immunosuppressive medication used to prevent organ transplant rejection; and heparin, a medication used to prevent blood clots).See also the information in the section “Warnings and precautions”.

• Medications for diabetes (including oral antidiabetic medications and insulin)
• Lithium (a medication used to treat certain types of depression)
• Medications for depression called “tricyclic antidepressants”.
• Medications for mental problems called “antipsychotics”.
• Certain medications for cough and cold and weight loss medications that contain a substance called “sympathomimetic”.
• Certain medications for pain or arthritis, including gold treatment.
• An mTOR inhibitor (e.g. sirolimus, everolimus, temsirolimus; medications used to treat certain types ofcancer or to prevent the immune system from rejecting an organ transplant). See section “Warnings and precautions”.
• A medication containing sacubitril/valsartán, racecadotril, or vildagliptin. This may increase the risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing). See also “Do not take Enalapril Davur” and “Warnings and precautions”.
• Nonsteroidal anti-inflammatory drugs, including COX-2 inhibitors (medications that reduce inflammation and may be used to help you relieve pain).
• Aspirin (acetylsalicylic acid)
• Medications used to dissolve blood clots (thrombolytics)
• Alcohol

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take this medication.

Taking Enalapril Davur with food, drinks, and alcohol

Enalapril can be taken with or without food. Most people take enalapril with a little water.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant (or could be, inform your doctor or pharmacist before using this medication. Your doctor will usually advise you to stop taking this medication before becoming pregnant or as soon as you know you are pregnant and will advise you to take a different medication instead of enalapril. This medication is not recommended at the beginning of pregnancy and should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used in this stage (see Pregnancy section).

Breastfeeding

Inform your doctor if you are breastfeeding or are about to start breastfeeding. While taking this medication, it is not recommended to breastfeed newborns (first weeks after birth), and especially premature babies. In the case of an older baby, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments while breastfeeding.

Driving and operating machines

You may feel dizzy or drowsy while taking this medication. If this happens, do not drive or use tools or machines.

Enalapril Davur contains lactose and sodium

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 1 mmol of sodium (23 mg) per tablet; this is, essentially “sodium-free”.

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

It is very important that you continue taking this medication for the time your doctor prescribes.

Do not take more tablets than those prescribed to you.

Hypertension

The usual recommended dose varies between5 to20 mg administered once a day. Some patients may need a lower initial dose.

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

The maximum long-term dose is 40 mg administered once a day.

Heart failure

The usual initial dose is 2.5 mg, administered once a day. Your doctor will gradually increase the dose until you reach the appropriate dose for you.

The usual long-term dose is 20 mg per day in one or two doses.

The maximum long-term dose is 40 mg per day, divided into two doses.

Patients with kidney problems

Your medication dose will change depending on how well your kidneys are functioning:

• Moderate kidney problems - 5 mg to 10 mg per day
• Severe kidney problems - 2.5 mg per day
• On dialysis - 2.5 mg per day. On non-dialysis days, your dose may change depending on your low blood pressure.

Older patients

Your doctor will decide the dose and will base it on your kidney function.

Use in children

The experience with the use of enalapril in children with high blood pressure is limited. If the child can swallow tablets, the dose will be calculated based on the child's weight and blood pressure. The usual initial doses are:

- between 20 kg and 50 kg - 2.5 mg per day

- over 50 kg - 5 mg per day.

The dose may be adjusted as needed:

- a maximum of 20 mg per day may be used in children weighing between 20 kg and 50 kg

- a maximum of 40 mg per day may be used in children weighing over 50 kg.

This medication is not recommended for newborns (first weeks after birth) or children with kidney problems.

If you take more Enalapril Davur than you should

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

Bring the medication packaging with you.

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, consult the Toxicological Information Service. Phone: 91 562 04 20,indicating the medication and the amount taken.

If you forget to take Enalapril Davur

If you forget to take a tablet, do not take the missed dose.

Take the next dose as usual..

Do not take a double dose to make up for the missed doses.

If you interrupt treatment with Enalapril Davur

Do not stop taking your medication unless your doctor tells you to.

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

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

Stop taking Enalapril Davur and consult your doctor immediately in any of the following cases:

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

You should be aware that patients of black race have a higher risk of experiencing this type of reaction. If any of the above reactions occur, stop taking it and speak with your doctor immediately.

When you start taking this medicine, you may feel a loss of consciousness or feel dizzy. If this happens, lying down may help. This is due to a decrease in your blood pressure. This will improve as you continue to take the medicine. If you are concerned, please speak with your doctor.

Other side effects include:

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

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

Common(may affect up to 1 in 10 people):

• headache, depression,syncope (fainting), alteration of taste
• low blood pressure dizziness, changes in heart rhythm, rapid heart rate,chest pain or chest discomfort
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (tiredness)
• eruption, hypersensitivity, or allergic reactions with swelling of the face, extremities, lips, tongue,or throat with difficulty swallowing or breathing
• high levels of potassium in the blood,high levels of creatinine in your blood(usually both are detected in a blood test).

Uncommon(may affect up to 1 in 100 people):

• rubefaction
• sudden drop in blood pressure
• rapid and arrhythmic heartbeats (palpitations)
• myocardial infarction or stroke possibly due to very low blood pressure in high-risk patients (patients with alterations in blood flow to the heart and/or brain)
• anemia (including aplastic and hemolytic anemia)
• confusion, drowsiness, or inability to sleep, nervousness,
• sensation of itching or numbness in your skin
• dizziness(dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma associated with chest tightness
• slow movement of food through your intestine (ileus), pancreatitis
• vomiting, indigestion, constipation, anorexia
• irritated stomach(gastritis), dry mouth, ulcers

• muscle cramps
• reduced kidney function, kidney failure
• increased sweating
• itching or urticaria
• hair loss
• general feeling of being unwell, elevated temperature (fever)
• impotence
• high levels of protein in your urine (determined in a blood test)
• low levels of sugar or sodium in the blood, 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 levels, 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 accumulation or other substances in the lungs (as seen in X-rays)
• inflammation of the nose
• inflammation of the lungs, causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduced urine production
• eruption in the shape of a target (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a severe skin disorder in which you have red skin, peeling skin, ulcers with vesicles, or open ulcers), dermatitis exfoliativa/erythroderma (severe skin eruption with peeling or shedding of the skin,pellagra (small blisters filled with liquid on the skin)
• liver or bile duct problems such as reduced liver function, inflammation of the liver, jaundice (yellow color of the skin or eyes), elevated levels of liver enzymes or bilirubin (determined in a blood test).
• enlargement of the breasts in men (gynecomastia)

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

• swelling in the intestine (Angioedema intestinal)

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

• excessive production of the antidiuretic hormone, causing fluid retention, leading to weakness, fatigue, or confusion

a complex symptom syndrome that may includeany or some of the following symptoms: fever, inflammation of blood vessels(serositis, vasculitis), muscle pain (mialgia, miositis), joint pain (arthritis/arthritis). It may cause a rash, photosensitivity, or other skin manifestations.

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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.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.

Do not store at a temperature above 30°C.

Store in the original packaging.

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

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition ofEnalapril Davur 2,5mg tablets

The active ingredient of this medication is enalapril maleate 2.5 mg. Each tablet contains 2.5mg of enalapril maleate as the active ingredient.

The other components (excipients) are: sodium croscarmellose, lactose monohydrate, magnesium stearate, pregelatinized cornstarch (cornstarch), sodium bicarbonate, and cornstarch.

Appearance of the product and content of the packaging

Enalapril Davur 2.5 mgare circular, flat, white tablets.

It is presented in packaging of 10 or 60 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

Teva Pharma, S.L.U.

C/Anabel Segura 11, Albatros B Building, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Responsible for manufacturing:

Teva Pharma, S.L.U.

Malpica Industrial Estate c/C nº4

50016 Zaragoza. Spain.

Date of the last review of this leaflet: September 2024

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