Enalapril Davur 2.5 mg tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Enalapril Davur 2.5 mg tablets

Enalapril maleate

Package leaflet

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

Enalapril Davur contains an active substance called enalapril maleate. It belongs to a group of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

Enalapril Davur is used to:

• Treat hypertension (high blood pressure).

• Treat symptomatic heart failure (weakening of heart function). It may reduce the need for hospitalization and may help some patients live longer.

• Prevent the signs of symptomatic heart failure. These signs include: shortness of breath, fatigue after mild physical activity such as walking, and swelling of the ankles and feet.

This medicine works by widening your blood vessels, thereby lowering your blood pressure. The medicine usually starts to work within one hour, and the effect lasts for at least 24 hours. Some people may require several weeks of treatment before the full effect on blood pressure is observed.

2. What you need to know before taking Enalapril Davur

Do not take Enalapril Davur

• If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• If you have previously been treated for an allergic reaction to a similar medicine, known as an ACE inhibitor.
• If you have ever had swelling of the face, lips, mouth, tongue, or throat causing 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 blood pressure-lowering medicine containing aliskiren.
• If you are more than 3 months pregnant. (It is also advisable to avoid this medicine early in pregnancy—see Pregnancy section.)
• If you have taken or are currently 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, such as in the throat) is high.
• Do not take this medicine if any of the above situations apply to you. If you are unsure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril Davur

• If you have a heart condition.

• If you have a disease 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 a liver problem.

• If you have a kidney condition (including after kidney transplant), follow a salt-free diet, take potassium supplements, potassium-sparing medicines, or salt substitutes containing 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 infections). This may lead to high potassium levels in the blood, which can be serious. Your doctor may need to adjust your enalapril dose or monitor your blood potassium levels. See also information under the heading “Taking Enalapril Davur with other medicines”.

• If you have recently undergone dialysis.

• If you have had excessive vomiting or severe diarrhea recently.

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

• If you have ever had an allergic reaction with swelling of the face, lips, tongue, or throat, causing difficulty swallowing or breathing. Please note that black patients have a higher risk of such reactions to ACE inhibitors.

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

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

• If you are taking any of the following medicines, your risk of developing 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) (also known as “sartans”—for example, 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 Enalapril Davur”.

You should inform your doctor if you think you are pregnant (or could be). Enalapril Davur is not recommended during early 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 during this stage (see Pregnancy section).

Please note that enalapril is less effective in lowering blood pressure in black patients than in non-black patients.

If you are unsure whether any of the above situations apply to you, consult your doctor or pharmacist before starting to take 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 to receive anesthetics (including 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 apply 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 need to take any other medicines. This includes herbal treatments. This is because enalapril may affect how other medicines work, and certain medicines may also affect how enalapril works. Your doctor may need to adjust your dose and/or take other precautions.

In particular, inform your doctor or pharmacist 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 Enalapril Davur” and “Warnings and precautions”).

• Other medicines to lower high blood pressure, such as blockers or water tablets (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; cyclosporine, an immunosuppressant used to prevent organ transplant rejection; and heparin, a medicine used to thin the blood to prevent clots). See also 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 health conditions called “antipsychotics”.

• Certain cough and cold medicines and weight-reducing medicines containing a substance called “sympathomimetic medicine”.

• Certain medicines for pain or arthritis, including gold therapy.

• 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 containing sacubitril/valsartan, racecadotril, or vildagliptin. These 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 drugs, including COX-2 inhibitors (medicines that reduce inflammation and may help relieve pain).

• Aspirin (acetylsalicylic acid).

• Medicines 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 medicine.

Taking Enalapril Davur with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Your doctor will usually advise you to stop taking this medicine before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative to enalapril. This medicine is not recommended during early 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 from the third month of pregnancy onward.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Breastfeeding is not recommended in newborns (first weeks after birth) while taking this medicine, especially in premature infants. For older infants, your doctor should advise you on the benefits and risks of taking enalapril compared to other treatments during breastfeeding.

Driving and using machines

You may feel dizzy or drowsy while taking this medicine. If this occurs, do not drive or operate tools or machinery.

Enalapril Davur contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

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

3. How to take Enalapril Davur

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

Do not take more tablets than prescribed.

Hypertension

The usual recommended dose ranges from 5 to 20 mg taken once daily. Some patients may require a lower initial dose.

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

The maximum long-term dose is 40 mg taken once daily.

Heart failure

The usual initial dose is 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, given in one or two doses.

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

Patients with kidney problems

Your dose will depend on how well your kidneys are functioning:

• moderate kidney problems - 5 to 10 mg daily
• severe kidney problems - 2.5 mg daily
• if undergoing dialysis - 2.5 mg daily. On days when you are not undergoing dialysis, your dose may be adjusted depending on how low your blood pressure is.

Elderly patients

Your doctor will decide the dose based on kidney function.

Use in children

Experience with enalapril use 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. Usual initial doses are:

• between 20 kg and 50 kg - 2.5 mg daily
• over 50 kg - 5 mg daily.

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

• a maximum of 20 mg daily may be used in children weighing between 20 kg and 50 kg
• a maximum of 40 mg daily may be used in children weighing over 50 kg.

This medicine is not recommended in newborn infants (first weeks after birth) or in children with kidney problems.

If you take more Enalapril Davur than you should

If you take more enalapril than prescribed, contact your doctor or pharmacist immediately.

Take the medicine pack 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, 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 at the usual time.

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

If you stop taking Enalapril Davur

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

If you have any further questions about 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 everyone will experience them.

Stop taking Enalapril Davur and consult your doctor immediately if any of the following occur:

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

Please note that patients of black race have a higher risk of experiencing these types of reactions. If you experience any of the above reactions, stop taking the medicine 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.

Other adverse 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, fainting (syncope), altered taste
• dizziness due to low blood pressure, changes in heart rhythm, rapid heartbeat, angina or chest pain
• difficulty breathing
• diarrhoea, abdominal pain
• tiredness (fatigue)
• rash, hypersensitivity or allergic reactions with swelling of the face, limbs, lips, tongue, or throat with 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 or stroke possibly due to very low blood pressure in high-risk patients (patients with impaired blood flow to the heart and/or brain)

• anaemia (including aplastic and haemolytic anaemia)

• confusion, drowsiness or inability to sleep, nervousness

• sensation of itching or numbness in the skin

• vertigo (sensation 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), 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 urticaria

• hair loss

• malaise (general discomfort), high temperature (fever)

• impotence

• elevated protein levels in urine (detected in a test)

• low blood sugar or sodium levels, elevated blood urea levels (all determined by blood tests).

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 reduced blood flow
• changes in blood values such as reduced number of white or red blood cells, reduced haemoglobin, reduced number of platelets in blood
• 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
• inflammation of the lungs causing difficulty breathing (pneumonitis)
• inflammation of cheeks, gums, tongue, lips, throat
• reduced amount of urine produced
• target-shaped rash (erythema multiforme)
• “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (a serious skin disorder in which you have red, peeling skin, blistering sores or open ulcers), 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 (gynaecomastia)

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):

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

A symptomatic complex has been observed which may include all or some of the following symptoms: 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 effect, consult your doctor or pharmacist, even if it is a possible adverse effect 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 Enalapril Davur

Keep this medicine out of the sight and reach of children.

Do not store above 30°C.

Store in the original packaging.

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

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and additional information

Composition of Enalapril Davur 2.5 mg tablets

The active substance in this medicine is enalapril maleate 2.5 mg. Each tablet contains 2.5 mg of enalapril maleate as the active substance.

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

Appearance of the product and contents of the container

Enalapril Davur 2.5 mg are white, circular, flat tablets.

They are available in packs of 10 or 60 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder:

Teva Pharma, S.L.U.

C/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 most recent review of this leaflet: September 2024

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