Enalapril 20 mg. 30 tablets

1. What Enalapril is and what it is used for

Enalapril contains an active substance called enalapril maleate. It belongs to a group of medicines called ACE inhibitors (angiotensin-converting enzyme inhibitors), which widen blood vessels, making it easier for the heart to pump blood to all parts of the body. This leads to lowering of high blood pressure. In patients with heart failure, Enalapril-Chaikapharma helps the heart to function better.

Enalapril is used for:

Treatment of high blood pressure (hypertension);

Treatment of symptomatic (overt) heart failure;

Prevention of symptomatic heart failure in asymptomatic patients with impaired left ventricular function (ejection fraction < 35%)

2. What you should know before taking Enalapril-Chaikapharma

Do not use Enalapril-Chaikapharma:

If you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6).

If during previous treatment with drugs similar to Enalapril-Chaikapharma (ACE inhibitors) you have experienced allergic reactions such as swelling of the face, lips, tongue and / or throat, with difficulty in breathing and swallowing. You should not take Enalapril-Chaikapharma if you have had similar reactions for no known reason or if you have been diagnosed with congenital or idiopathic angioedema.

If you are more than 3 months pregnant (It is recommended to avoid the use of Enalapril-Chaikafarma in earlier pregnancy - see section Pregnancy, breastfeeding and fertility).

If you have diabetes or impaired kidney function and are being treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor or pharmacist before taking Enalapril-Chaikapharma.

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

an angiotensin II receptor blocker (ARB) (also known as sartans - eg valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes;

aliskiren.

Your doctor may periodically check your kidney function, blood pressure and the amount of electrolytes (eg potassium) in your blood.

See also the information entitled "Do not take Enalapril-Chaikapharma".

Before you start taking Enalapril-Chaikafarma, tell the doctor about all your medical problems, as well as about any allergies.

Inform the doctor if you have heart disease, if you are on dialysis or are being treated with diuretics (medicines that increase the excretion of water from the body), if you have recently had severe and prolonged vomiting or indigestion. You should also report if you are on a salt-restricted diet, take potassium supplements, potassium-sparing medicines or potassium-containing table salt substitutes, if you have diabetes or kidney problems (including a kidney transplant), as these may lead to to a significant increase in potassium in the blood, which can cause serious disturbances in the work of the heart. In these cases, it may be necessary to adjust the dose of Enalapril-Chaikapharma or monitor the level of potassium in the blood.

Tell your doctor if you notice symptoms such as feeling sick or dizzy, especially when standing up, which may indicate low blood pressure (orthostatic hypotension).

If you have diabetes and if you take oral antidiabetic medicines or insulin, you should monitor your blood glucose level regularly, especially during the first month of treatment with Enalapril-Chaikapharma.

If you have blood disorders such as low or no white blood cells (neutropenia/agranulocytosis), low platelets (thrombocytopenia) or low red blood cells (anaemia).

If you have liver problems, you are undergoing desensitizing treatment (reduces the effects of allergies, e.g. from bee and wasp stings), undergoing hemodialysis or treatment to remove cholesterol from your body using a machine (LDL apheresis).

Tell your doctor if you have ever had an allergic reaction with swelling of the face, lips, tongue and/or throat with difficulty in swallowing and breathing.

Before surgery or anesthesia (even during dental manipulation), inform the surgeon or dentist that you are taking Enalapril-Chaikapharma. This is necessary because a sudden drop in blood pressure can occur during anesthesia

Cough may occur during treatment with ACE inhibitors, including Enalapril-Chaikapharma. It is dry, long-lasting and resolves after stopping the treatment.

Application in elderly patients

Data from clinical studies on efficacy and tolerability when administered to an elderly patient and younger patients do not show differences.

Ethnic differences

Like other ACE inhibitors, enalapril is less effective in lowering blood pressure in blacks

patients compared to non-blacks.

Pregnancy

It is necessary to inform your doctor if you think you are pregnant or are planning to become pregnant. It is not recommended to use Enalapril-Chaikapharma at the beginning of pregnancy. It should 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 (see section Pregnancy, breast-feeding and fertility)

Breastfeeding

Inform the doctor if you are breast-feeding or about to breast-feed (see section Breast-feeding).

Other medicines and Enalapril-Chaikapharma

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Some medicinal products can affect the action of others.

Talk to your doctor if you are taking any of the following medicines:

Diuretics (medicines that increase the excretion of fluids from the body, including potassium-sparing diuretics).

Potassium tablets or potassium-containing salt substitutes.

Other medicines for high blood pressure (antihypertensive medicines).

Medicines for mental disorders, such as lithium, antipsychotics or tricyclic antidepressants.

Nonsteroidal anti-inflammatory drugs (NSAIDs), which are used to treat arthritis or muscle pain.

Gold-containing agents (for the treatment of arthritis).

Medicines for insomnia and anxiety (hypnotics and sedatives).

Medicines to treat diabetes, such as insulin or medicines taken by mouth.

Medicines that stimulate the central nervous system (sympathomimetics). This also includes some medicines to treat coughs, colds and weight loss.

Alcohol.

Your doctor may need to change your dose and/or take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also the information entitled "Do not take Enalapril-Chaikapharma" and "Warnings and precautions ").

Enalapril-Chaikapharma with food, drink and alcohol

There is no indication of the need for a special diet or restrictions on certain types of food and drink during treatment with this product. Enalapril-Chaikafarma can be taken before, during or after a meal.

Pregnancy, lactation and fertility

Pregnancy

It is necessary to inform your doctor if you think you are pregnant or may become pregnant. Your doctor will usually advise you to stop taking Enalapril-Chaikapharma before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril-Chaikapharma. Enalapril-Chaikapharma is not recommended in the early months of pregnancy and should not be taken after the third month, as it may cause serious harm to your baby if used during this period.

Breastfeeding

Inform your doctor if you are breast-feeding or about to breast-feed. It is not recommended to use Enalapril-Chaikapharma when breastfeeding newborns (during the first few weeks after birth) and especially prematurely born children.

For older infants, your doctor will explain to you the benefits and risks for you and your baby of taking Enalapril-Chaikapharma while breastfeeding compared to other medicines.

Driving and using machines

At the beginning of treatment with Enalapril-Chaikapharma, temporary fatigue and dizziness may be observed, which could affect driving and operating machinery.

Enalapril-Chaikapharma contains lactose monohydrate

If you have been warned by your doctor that you have an intolerance to some sugars, contact him before you start taking this medicinal product.

3. How to take Enalapril-Chaikafarma

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

The dosage and duration of treatment are determined by the attending physician, being individual depending on the effect, tolerance and intake of other drugs. It is taken before, during or after a meal, orally with a sufficient amount of liquid.

Treatment with Enalapril-Chaikapharma is usually long-term, and the duration is determined by your doctor. Do not take more tablets than prescribed.

High blood pressure:

The usual starting dose is in the range of 5 to 20 mg once daily.

Some patients may need a lower starting dose.

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

The maximum maintenance dose during a long course of treatment is 40 mg once a day.

Heart failure:

The usual recommended starting dose is 2.5 mg once daily.

Your doctor will increase this amount step by step until the right dose for you is reached.

The usual maintenance dose for a long course of treatment is 20 mg every day, taken as a single or in two doses.

The maximum maintenance dose during a long course of treatment is 40 mg per day, divided into two doses.

Be especially careful when you take your first dose or if your dose has been increased. If you experience symptoms such as dizziness or lightheadedness, tell your doctor immediately.

Patients with kidney problems

Your doctor will change the dose you take depending on how well your kidneys are working.

Moderately impaired renal function - 5 mg to 10 mg daily.

Severely impaired renal function - 2.5 mg per day.

If you are on dialysis - 2.5 mg on dialysis days. The dose on non-hemodialysis days may be adjusted depending on changes in blood pressure.

Elderly patients

Your dose will be decided by your doctor and will be based on how well your kidneys are working.

Children

There is limited experience with the use of enalapril in children with high blood pressure. For children who can swallow tablets, the dose is determined individually according to the child's weight and blood pressure. Usual starting doses are:

Between 20 kg and 50 kg - 2.5 mg daily.

Over 50 kg - 5 mg daily.

The dose can be changed depending on the child's needs:

A maximum of 20 mg per day can be used in children who weigh between 20 and 50 kg.

A maximum of 40 mg per day can be used in children weighing more than 50 kg.

Enalapril-Chaikapharma is not recommended for newborns and children with impaired kidney function.

If you have taken more than the required dose of Enalapril-Chaikapharma

If you have taken more than the required dose of Enalapril-Chaikapharma, contact your doctor.

The most common symptoms of overdose are dizziness, vertigo (as a result of a sudden or severe drop in blood pressure), confusion and decreased urine output.

In case of overdose, it is necessary to stop taking the product, perform a gastric lavage and appoint activated charcoal and symptomatic agents. Follow-up of the patient by a doctor is necessary until all symptoms subside.

If you forget to take Enalapril-Chaikapharma

If you have missed a tablet

a, skip the missed dose. Continue with your normal schedule.

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

If you have stopped taking Enalapril-Chaikapharma

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

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

4. Possible side effects

Like all medicines, Enalapril-Chaikapharma can cause side effects, although not everyone gets them.

Stop taking Enalapril-Chaikapharma and contact a doctor immediately if you notice any of the following serious side effects, which may be life-threatening:

Allergic reactions - swelling of the face, eyes, lips or throat, which may cause difficulty in breathing or swallowing.

Swelling of the hands, feet or ankles.

If a skin rash and itching occurs.

Stop taking Enalapril-Chaikapharma and contact your doctor if you notice any of the following side effects:

Pronounced dizziness and malaise, especially at the beginning of treatment or when increasing the dose, as well as when standing up; severe reddening of the skin, blistering, severe peeling of the skin.

Other side effects include:

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

Feeling dizzy, tired, sick;

Blurred vision;

A cough.

Common (may affect up to 1 in 10 people)

Headache, depression;

Low blood pressure, syncope (fainting), chest pain, heart rhythm disorders, angina pectoris, rapid pulse;

Shortness of breath;

Diarrhea, abdominal pain, taste changes;

Rash, hypersensitivity/angioedema (severe life-threatening allergic reaction): angioedema (swelling) of the face, limbs, lips, tongue, throat, causing difficulty swallowing and shortness of breath;

Fatigue;

Increase in blood potassium content, increase in blood creatinine.

Uncommon (may affect up to 1 in 100 people)

Anemia, hypoglycemia (low blood sugar);

Confusion, drowsiness, sleep disturbance, nervousness, numbness and tingling, vertigo;

Low blood pressure (which can cause dizziness when standing up), heart palpitations, heart or stroke (in high-risk patients);

Runny nose, sore throat and hoarse voice, difficulty breathing or asthma;

Impaired intestinal permeability (ileus), pancreatitis, vomiting, indigestion, constipation, loss of appetite, stomach irritation, dry mouth, peptic ulcer;

Excessive sweating, itching, urticaria, hair loss;

Impaired kidney function, kidney failure, protein in the urine (detected with an appropriate test);

Impotence;

Muscle cramps, skin flushing, tinnitus, malaise, high fever;

Increase in urea and decrease in sodium in the blood (found with the help of tests).

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

Changes in the number of different blood cells (decrease in white and red blood cells and platelets), enlarged lymph nodes, suppression of bone marrow function, autoimmune diseases;

Unusual dreams, sleep problems;

Decreased blood supply to the fingers and toes, leading to redness and pain (Raynaud's syndrome);

Inflammatory changes in the lung, nasal discharge, eosinophilic pneumonia (expressed in cough, high fever and difficulty breathing);

Pain, swelling or ulceration of the oral mucosa and tongue;

Impaired liver function or hepatitis, which can cause yellowing of the skin (jaundice);

Excessive redness of the skin, blisters, severe peeling of the skin, as a manifestation of severe skin disorders (erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma);

Decreased amount of urine output;

Breast enlargement in men;

Elevation of liver enzymes or bilirubin (blood indicators of liver damage).

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

intestinal angioedema (swelling of the bowel) - symptoms may include stomach pain, general malaise and vomiting.

Not known (frequency cannot be estimated from the available data)

syndrome of inadequate antidiuretic hormone secretion

Others

A complex of side effects has also been reported, which may include some or all of the following complaints:

Fever, inflammation of the vessels, pain and inflammation of muscles or joints.

Blood disorders (detected by blood tests).

Rash, photosensitivity and other skin manifestations.

5. How to store Enalapril-Chaikafarma

To be stored below 25°C. Keep away from light and moisture.

Keep out of the reach of children!

Do not use this medicine after the expiry date which is stated on the pack. The expiration date corresponds to the last day of the specified month.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information

What Enalapril-Chaikapharma contains

The active ingredient is enalapril maleate.

The other ingredients are: lactose monohydrate, sodium hydrogen carbonate, corn starch, croscarmellose sodium, pregelatinized starch, magnesium stearate, iron oxide red E172, iron oxide black E172.

What Enalapril-Chaikapharma looks like and what the package contains

Enalapril-Chaikapharma is available in cardboard boxes containing 3 blister strips of 10 tablets, a total of 30 tablets in a box or 2 blister strips of 10 tablets, a total of 20 tablets in a box.