ENALAPRIL DAVUR 10 mg TABLETS

Introduction

Package Leaflet: Information for the User

Enalapril Davur 10 mg Tablets

Enalapril Maleate

Contents of the Package Leaflet

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

1. What is Enalapril Davur and what is it used for

Enalapril Davur contains the active substance enalapril maleate, it belongs to a group of medicines called angiotensin-converting enzyme inhibitors (ACE inhibitors)

Enalapril Davur is used to:

• Treat high blood pressure (hypertension)
• Treat symptomatic heart failure (weakening of the heart's function), it may reduce the need to go to the hospital and may help some patients live longer

• Prevent signs of symptomatic heart failure, the signs include: difficulty breathing, tiredness after light physical activity such as walking, or swelling of the ankles and feet

This medicine works by widening your blood vessels, this reduces your blood pressure, normally the medicine starts working within an hour and the effect lasts at least 24 hours, some people may need several weeks of treatment before the full effect on blood pressure is seen

2. What you need to know before taking Enalapril Davur

Do not take Enalapril Davur

• If you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)
• If you have ever been treated for an allergic reaction to a medicine similar to this one, called an ACE inhibitor
• If you have ever had swelling of the face, lips, tongue, or throat that caused difficulty swallowing or breathing (angioedema) when the cause was unknown or hereditary
• If you have diabetes or kidney problems and are being treated with a blood pressure medicine that contains aliskiren
• If you are more than 3 months pregnant, (it is also better to avoid this medicine at the start of pregnancy, see section Pregnancy)
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (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 medicine if any of the above applies to you, if you are not sure, consult your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor or pharmacist before taking 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 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 have kidney problems (including kidney transplant), follow a low-salt diet, take potassium supplements, potassium-sparing diuretics, or salt substitutes that contain potassium, or other medicines that may increase potassium levels in the blood, such as heparin (a medicine used to prevent blood clots), trimethoprim, or cotrimoxazole, also known as trimethoprim/sulfamethoxazole (medicines used to treat bacterial infections), this may cause high levels of potassium in the blood which can be serious, your doctor may need to adjust your dose of enalapril or monitor your potassium levels in the blood, see also the information under the heading “Taking Enalapril Davur with other medicines”
• If you are on dialysis
• If you have recently had severe vomiting or diarrhea

• If you have diabetes, you should monitor your blood for low blood sugar 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 black patients have a higher risk of these reactions to ACE inhibitors
• If you have low blood pressure (you may notice this as fainting or dizziness, especially with the initial doses and when standing up)

• If you have a disease of the collagen vascular system (e.g., lupus erythematosus, rheumatoid arthritis, or scleroderma), are being treated with medicines that suppress your immune system, are taking the medicines allopurinol or procainamide, or any combination of these

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

• Racecadotril, a medicine used to treat diarrhea
• Medicines used to prevent organ transplant rejection and for cancer (e.g., sirolimus, everolimus, temsirolimus)
• Vildagliptin, a medicine used to treat diabetes

• If you are taking any of the following medicines used to treat high blood pressure (hypertension):

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

• Other medicines to reduce high blood pressure, such as beta blockers or diuretics

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 Enalapril Davur”

You should inform your doctor if you think you are pregnant (or might be), do not take Enalapril Davur if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy

You should be aware that Enalapril Davur reduces blood pressure in black patients less effectively than in non-black patients

If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine

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 going to receive anesthetics (even at the dentist)
• a treatment to remove cholesterol from your blood called “LDL apheresis”
• a desensitization treatment to reduce the effect of an allergy to bee or wasp stings

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

Taking Enalapril Davur with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, this includes herbal treatments, this is because enalapril may affect the way other medicines work and some medicines may affect the way enalapril works, your doctor may need to change your dose and/or take other precautions

In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

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

• Other medicines to reduce high blood pressure, such as beta blockers or diuretics

• Potassium supplements (including salt substitutes), potassium-sparing diuretics, and other medicines that may increase potassium levels in the blood (e.g., heparin, trimethoprim, and cotrimoxazole, also known as trimethoprim/sulfamethoxazole for bacterial infections; cyclosporin, an immunosuppressant medicine used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots), see also the information in the section “Warnings and precautions”
• Medicines for diabetes (including oral antidiabetics and insulin)
• Lithium (a medicine used to treat certain types of depression)
• Medicines for depression called “tricyclic antidepressants”
• Medicines for mental problems called “antipsychotics”
• Certain cough and cold medicines and weight loss medicines that contain a substance called “sympathomimetic medicines”
• Certain medicines for pain or arthritis, including gold treatment
• An mTOR inhibitor (e.g., sirolimus, everolimus, temsirolimus; medicines used to treat certain types of cancer or to prevent the immune system from rejecting a transplanted organ), see section “Warnings and precautions”
• A medicine that contains sacubitril/valsartan, racecadotril, or vildagliptin, it 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”
• Non-steroidal anti-inflammatory medicines, including COX-2 inhibitors (medicines that reduce inflammation and may be used to help relieve pain)
• Aspirin (acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Alcohol
• If you are not sure if any of the above applies to you, consult your doctor or pharmacist before taking this medicine

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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine, your doctor will normally advise you to stop taking this medicine before you become pregnant or as soon as you know you are pregnant and will advise you to take a different medicine instead of enalapril, this medicine is not recommended during the first trimester of pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding, while taking this medicine, 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 enalapril, compared to other treatments, while breastfeeding

Driving and using machines

You may feel dizzy or drowsy while taking this medicine, 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 some sugars, consult them before taking this medicine

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, it is essentially “sodium-free”

3. How to take Enalapril Davur

Take this medicine exactly as your doctor has told you, if you are not sure, consult your doctor or pharmacist

It is very important that you continue taking this medicine for as long as your doctor prescribes it

Do not take more tablets than your doctor has told you to

Hypertension

The usual starting dose is between 5 to 20 mg taken once a day, some patients may need a lower starting dose

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

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

Heart failure

The usual starting dose is 2.5 mg taken once a day, your doctor will gradually increase the dose until the suitable dose for you is reached

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

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

Patients with kidney problems

Your dose of medicine will change depending on how well your kidneys are working:

• moderate kidney problems - 5 mg to 10 mg per day
• severe kidney problems - 2.5 mg per day
• if you are on dialysis - 2.5 mg per day, on the days you are not on dialysis, your dose may change depending on how low your blood pressure is

Elderly patients

Your doctor will decide the dose based on how well your kidneys are working

Use in children

Experience with 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 starting doses are:

• between 20 kg and 50 kg - 2.5 mg per day
• over 50 kg - 5 mg per day

The dose may be changed according to the child's needs:

• a maximum of 20 mg per day can be used in children who weigh between 20 kg and 50 kg
• a maximum of 40 mg per day can be used in children who weigh over 50 kg

This medicine is not recommended in newborns (first few weeks after birth) or in 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

Take the medicine pack with you

In case of an overdose, the most likely symptom is a feeling of dizziness or lightheadedness 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 04 20, stating the medicine 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 forgotten doses

If you stop taking Enalapril Davur

Do not stop taking your medicine unless your doctor tells you to

If you have any further questions on the use of this medicine, ask your doctor or pharmacist

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

If you experience any of the following symptoms, stop taking this medicine and consult your doctor immediately:

• swelling of the face, lips, tongue, or throat that can cause difficulty breathing or swallowing,
• 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 it and talk to your doctor immediately.

When you start taking this medicine, you may feel loss of consciousness or dizziness. If this occurs, 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.

Other adverse effects include:

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

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

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

• headache, depression, fainting (syncope), alteration of taste
• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeats, angina pectoris, or chest pain
• difficulty breathing
• diarrhea, abdominal pain
• fatigue (fatigue)
• rash, 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 the blood (both are usually detected in a blood test).

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

• flushing
• 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
• feeling of itching or numbness in the skin
• vertigo (feeling of dizziness)
• ringing in the ears (tinnitus)
• runny nose, sore throat, or hoarseness
• asthma associated with 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 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 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 amount of hemoglobin, lower number of platelets 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)
• inflammation of the nose
• inflammation of the lungs, causing difficulty breathing (pneumonia)
• inflammation of the cheeks, gums, tongue, lips, throat
• reduction in the amount of urine produced
• target-shaped rash (erythema multiforme)
• "Stevens-Johnson syndrome" and "toxic epidermal necrolysis" (a severe skin disorder in which you have red and scaly skin, ulcers with blisters or open ulcers), 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 decreased liver function, liver inflammation, jaundice (yellowish color of the skin or eyes), elevated levels of liver enzymes or bilirubin (determined in a test).
• breast enlargement in men (gynecomastia)

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

• swelling in the intestine (intestinal angioedema)

Frequency Not Known(frequency cannot be estimated from available data)

• overproduction of antidiuretic hormone, which causes fluid retention, leading to weakness, fatigue, or confusion

a symptomatic complex has been observed that may include all or some of the following symptoms: 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 of Adverse Effects:

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

5. Conservation of Enalapril Davur

Keep this medicine out of sight and reach of children.

Do not store at a temperature above 30 °C.

Keep in the original package.

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

Medicines should not be thrown away through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofEnalapril Davur 10mg tablets

The active ingredient of this medicine is enalapril maleate 10 mg. Each tablet contains 10 mg of enalapril maleate as the active ingredient.

The other components (excipients) are: sodium croscarmellose, lactose monohydrate, magnesium stearate, pregelatinized corn starch (corn starch), sodium bicarbonate, red iron oxide (E-172), yellow iron oxide (E-172), and corn starch.

Appearance of the Product and Package Contents

Enalapril Davur 10 mg are circular, flat, scored tablets, peach-colored.

The score line is only for fracturing and facilitating swallowing, but not for dividing into equal doses.

It is presented in a package of 28 or 56 tablets.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

Anabel Segura 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108 Madrid (Spain)

Manufacturer:

Teva Pharma, S.L.U.

Polígono Malpica c/C nº4

50016 Zaragoza, Spain.

Date of the Last Revision of this Prospectus: September 2024

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/