2.5 mg, 5 mg, 10 mg and 20 mg enalapril maleate tablets 
respectively

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Enalapril Teva is and what it is used for 
2. What you need to know before you take Enalapril Teva 
3. How to take Enalapril Teva 
4. Possible side effects 
5. How to store Enalapril Teva 
6. Package contents and other information 

What Enalapril Teva is and what it is used for

Enalapril Teva contains an active substance called enalapril maleate. It belongs to a group of medicines called ACE inhibitors (inhibitors of enzyme and angiotensin convertase).

Enalapril Teva is used:

  • to treat high blood pressure ( hypertension )
  • to treat heart failure (impaired heart function). Enalapril Teva may reduce the need for hospitalization and may lead to prolonged life expectancy for some
  • to reduce the symptoms of heart failure. Symptoms include shortness of breath, fatigue after light physical activity such as walking, or swelling of the ankles and feet.

Enalapril Teva works by dilating your blood vessels and lowering your blood pressure. Enalapril Teva usually has an effect within one hour and the effect lasts for at least 24 hours. Some individuals may need several weeks of treatment before the optimal effect on blood pressure is achieved.

Enalapril contained in Enalapril Teva may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Enalapril Teva

Do not take Enalapril Teva:

  • if you are allergic to enalapril or any of the other ingredients of this medicine (listed in section 6)
  • if you have previously experienced an allergic reaction to any other ACE inhibitor
  • if you have previously experienced swelling of the face, lips, mouth, tongue, or throat which caused difficulty swallowing and/or breathing ( angioedema ) of unknown cause or in hereditary angioedema
  • if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren
  • if you are pregnant and your pregnancy has lasted for more than 3 months (treatment with Enalapril Teva should preferably also be avoided earlier in the pregnancy, see section “Pregnancy, breast-feeding and fertility”).
  • 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 it increases the risk of angioedema (rapid swelling under the skin in an area such as the throat).

Do not take Enalapril Teva if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril Teva.

Warnings and cautions

Talk to your doctor or pharmacist before taking Enalapril Teva if:

  • you have heart problems
  • you suffer from a disease that affects the blood vessels in the brain
  • you have a blood disease such as low white blood cell count (neutropenia/agranulocytosis), low platelet count ( thrombocytopenia ), or red blood cell count ( anemia )
  • you have liver problems
  • you have any kidney disease (including kidney transplantation). This can lead to elevated levels of potassium in the blood which can be serious. Your doctor may need to adjust your dose of Enalapril Teva or check your blood potassium levels.
  • you undergo dialysis
  • you have been very ill (severe vomiting) or recently had severe diarrhea
  • you are on a low-salt diet, treated with potassium supplements, potassium-sparing agents or potassium-containing salt substitutes begin
  • you are over 70 years old
  • you have diabetes. You should monitor your blood sugar levels, especially during the first month of treatment. The levels of potassium in the blood may also increase.
  • If you have previously had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing ( angioedema ), see also information under the heading “Do not take Enalapril Teva”. You should be aware that black patients are at increased risk for these types of reactions with ACE inhibitors.
  • you are taking an inhibitor of mTOR (eg temsirolimus, sirolimus, everolimus: medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ), racecadotril (a medicine used to treat diarrhea), or vildagliptin (a medicine used to treat diabetes ). Concomitant use may increase the risk of an allergic reaction called angioedema (for symptoms, see point above).
  • you have low blood pressure (you may experience weakness or dizziness, especially when standing up)
  • you have a collagen vascular disease (lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, are being treated with allopurinol or procainamide, or any combination of these.
  • you are taking any of the following medicines used to treat high blood pressure:
    • an angiotensin II receptor blocker (ARB) (also known as sartans – for example, valsartan, telmisartan, irbesartan), especially if you have diabetes-related kidney problems.
    • aliskiren

Your doctor may need to check your kidney function, blood pressure, and the number of electrolytes (eg potassium ) in your blood at regular intervals.

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

You must tell your doctor if you think you are (or might become) pregnant. EnalaprilTeva is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects (see Pregnancy, breast-feeding, and fertility ).

You should be aware that Enalapril Teva does not lower blood pressure as effectively in black patients.

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril Teva.

If you are going to undergo a treatment

If you are going to undergo any of the following, tell your doctor that you are taking Enalapril Teva:

  • a surgical procedure or if you are going to undergo anesthesia (even at the dentist)
  • a treatment to remove cholesterol in the blood called LDL apheresis
  • a hyposensitization, to reduce hypersensitivity to bee or wasp stings.

If any of the above apply to you, talk to your doctor or dentist before treatment.

Other medicines and Enalapril Teva

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Enalapril Teva can affect the way other medicines work in the body and some other medicines can also affect the way Enalapril Teva works in the body. Your doctor may need to change your dose and/or take other precautions.

It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines:

  • an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Enalapril Teva” and “Warnings and precautions”)
  • other antihypertensive drugs such as beta-blockers or diuretics (diuretics: eg potassium-sparing diuretics such as spironolactone, triamterene, and amiloride))
  • Potassium- containing medicinal products (including potassium-containing salt substitutes)
  • drugs that can increase potassium levels in the body such as heparin (blood thinner), cyclosporine (an immunosuppressive drug that prevents rejection of transplanted organs), and the combination trimethoprim/sulfamethoxazole (against infection caused by bacteria)
  • drugs against diabetes (including diabetes agents taken orally and insulin )
  • lithium (a medicine used to treat a certain type of depression)
  • antidepressants called the tricyclic antidepressant agent
  • medicines for mental disorders, so-called antipsychotics
  • certain medicines for coughs and colds and for weight loss which contain something called sympathomimetic
  • certain medicines for pain or rheumatism including gold therapy
  • racecadotril (a medicine used to treat diarrhea)
  • an inhibitor of mTOR (eg temsirolimus, sirolimus, everolimus: medicines used to treat certain cancers or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”
  • non-steroidal anti-inflammatory drugs, including COX-2 inhibitors (drugs that reduce inflammation and can be used for pain relief).
  • acetylsalicylic acid
  • drugs used to dissolve blood clots ( thrombolytics )

If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril Teva.

Enalapril Teva with food, drink, and alcohol

Enalapril Teva can be taken with or without food. Most people take Enalapril Teva with a glass of water. You should keep your alcohol intake to a minimum while using this medicine. Alcohol potentiates the blood pressure-lowering effect of EnalaprilTeva.

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

Pregnancy

Your doctor will usually suggest that you stop taking Enalapril Teva before you become pregnant or as soon as you know you are pregnant and instead recommend another medicine for you. Enalapril Teva should not be used in early pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Enalapril Teva is not recommended for breastfeeding, especially if your baby is newborn (the first few weeks after birth) or is born prematurely. In the case of an older child, your doctor may advise you on the benefits and risks of taking EnalaprilTeva while breastfeeding compared to other treatments.

Driving and using machines

You may experience dizziness or drowsiness while taking Enalapril Teva. If you experience this, you should not drive or use any tools or machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Enalapril Teva contains lactose and sodium

Enalapril Teva contains lactose, which is sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

How to take Enalapril Teva

Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

  • You must continue to take Enalapril Teva according to your doctor’s prescription 
  • Do not take more tablets than you have been prescribed.

Enalapril Teva 5 mg tablets, Enalapril Teva 10 mg tablets, Enalapril Teva 20 mg tablets:

The tablet can be divided into two equal doses.

If your treatment with Enalapril Teva makes it necessary to share a tablet, this is the best way to do it. Place the tablet with the notch facing upwards on a hard, smooth surface (for example, a tabletop or a plate). Place your index fingers (or thumbs) on each side of the notch and press quickly and hard with both fingers at the same time.

The picture shows how to divide a tablet into two equal doses.

This is a schematic image of a tablet and the shape may therefore look slightly different compared to your tablet.

High blood pressure

  • The usual starting dose varies from 5 mg to 20 mg once daily.
  • Some patients may need a lower starting dose.
  • The usual maintenance dose is 20 mg once a day.
  • The maximum maintenance dose is 40 mg once daily.

Heart failure

  • The usual starting dose is 2.5 mg once a day.
  • Your doctor will gradually increase the dose until a dose that is right for you is reached.
  • The usual maintenance dose is 20 mg daily, taken in one or two doses.
  • The maximum maintenance dose is 40 mg daily divided into two doses.

Impaired renal function

Your dose will need to be adjusted depending on how well your kidneys are working:

  • moderate renal impairment: 5 mg to 10 mg daily
  • severe renal impairment: 2.5 mg daily
  • if you are on dialysis: 2.5 mg daily. On days when you do not undergo dialysis, your dose may need to be adjusted depending on how low your blood pressure is.

Older

Your doctor will decide which dose to take based on how well your kidneys are working.

Use for children and adolescents

Experience with the use of Enalapril Teva in children with high blood pressure is limited. If the child can swallow tablets, the dose is calculated based on weight and blood pressure. The usual starting dose is:

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

Dose one can be adjusted depending on the child’s needs:

  • maximum dose of 20 mg daily in children weighing between 20 kg and 50 kg
  • maximum dose of 40 mg daily in children weighing more than 50 kg daily.

Enalapril Teva is not recommended for newborns (the first weeks after birth) or children with kidney problems.

If you take more Enalapril Teva then you should

If you have ingested too much medicine or if, for example, a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.

Take the medicine pack with you. The most likely symptoms are fainting or dizziness. This is due to a sudden or severe drop in blood pressure.

If you forget to take Enalapril Teva

  • If you forget to take a tablet, skip the missed dose.
  • Take the next dose as usual.
  • Do not take a double dose to make up for a forgotten dose.

If you stop taking Enalapril Teva

Do not stop taking Enalapril Teva unless your doctor tells you to stop.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects have been reported:

If any of these side effects occur, stop taking Enalapril Teva and contact your doctor immediately:

  • swelling of the face, lips, tongue, or throat, which may cause breathing and/or swallowing difficulties; swelling of hands, feet, or ankles; hives. These are symptoms of a severe allergic reaction called angioedema (may affect up to 1 in 10 people)
  • You should be aware that black patients are at increased risk for these types of reactions. If any of the above occur, stop taking Enalapril Teva and contact your doctor immediately.
  • severe skin reactions with redness and scaling of the skin, blisters or sores ( Stevens-Johnson syndrome and toxic epidermal necrolysis ), a severe rash with flaking or flaking of the skin (exfoliative dermatitis/erythroderma), small fluid-filled blisters on the skin ( pemphigus ), circular skin rash erythema multiforme) (may affect up to 1 in 1000 people)
  • fever, chills, loss of appetite, abdominal pain, nausea, yellowing of the skin or eyes (jaundice), dark urine. This can be a sign of liver problems such as hepatitis ( inflammation of the liver) or liver damage (may affect up to 1 in 1,000 people).

Enalapril Teva may in rare cases affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/throat/mouth or difficulty urinating, you should see a doctor as soon as possible so that blood tests can rule out a lack of white blood cells ( agranulocytosis, may occur in up to 1 in 1,000 users). It is important that you then information about your medication.

When you start taking Enalapril Teva, you may experience fainting or dizziness. If this happens, it helps to lie down. This is caused by a drop in blood pressure. It improves as you continue to take the medicine. If you have any concerns, talk to your doctor.

Other side effects include:

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

  • dizziness, weakness, or malaise
  • dimsyn
  • cough.

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

  • dizziness due to low blood pressure, changes in heart rate, palpitations, angina or chest pain
  • headache, depression, fainting ( syncope ), taste changes
  • respiratory distress
  • diarrhea or abdominal pain
  • fatigue
  • rash
  • high levels of potassium in the blood, increased levels of creatinine in the blood (both are usually detected by a blood test).

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

  • redness
  • a sudden drop in blood pressure
  • fast or uneven heartbeat (palpitations)
  • myocardial infarction (possibly due to low blood pressure in some high-risk patients including patients with blood flow disorders in the heart or brain)
  • stroke (possibly due to excessive blood pressure in high-risk patients)
  • anemia (including aplastic and hemolytic)
  • confusion, insomnia or drowsiness, nervousness
  • stinging or numb feeling in the skin
  • dizziness (feeling dizzy)
  • ringing in the ears ( tinnitus )
  • runny nose, sore throat, or hoarseness
  • asthma-associated tightness in the chest
  • delayed intestinal passage (intestinal knot), inflammation of the pancreas
  • nausea (vomiting), indigestion, constipation, loss of appetite
  • irritated stomach (irritation of the stomach), dry mouth, stomach ulcers
  • muscle cramps
  • renal impairment, renal failure
  • increased sweating
  • itching or hives
  • hair loss
  • general malaise, fever
  • impotence
  • high level of protein in the urine (measured in a test)
  • low blood sugar or low level of sodium in the blood, high level of urea in the blood (all measured by a blood test).

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

  • “Raynaud’s phenomenon” where your hands and feet can become very cold and white due to low blood flow
  • changes in blood values ​​such as low white and red blood cell count, low hemoglobin value, lower platelet count
  • bone marrow depression
  • swollen glands in the neck, armpits, or groin
  • autoimmune diseases
  • strange dreams or difficulty sleeping
  • accumulation of fluid or other substances in the lungs (which can be seen on X-ray)
  • inflammation of the nose
  • inflammation of the lungs that causes difficulty breathing ( pneumonia )
  • inflammation of the cheeks, gums, tongue, lips, throat
  • reduced urine output
  • high levels of liver enzymes and bilirubin (measured in a blood test)
  • breast augmentation in men ( gynecomastia ).

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

  • swelling of the intestine (intestinal angioedema ).

Has been reported (occurs in an unknown number of users):

  • overproduction of the antidiuretic hormone, which causes fluid retention and leads to weakness, fatigue, or confusion
  • a combination of several symptoms have been reported, which may include some or all of the following: fever, inflammation of the blood vessels (serositis/vasculitis), muscle pain (myalgia/myositis), joint pain (arthralgia/arthritis). Rash, photosensitivity, or other skin rashes may occur.

5. How to store Enalapril Teva

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

Do not use this medicine after the expiry date which is stated on the blister after EXP and after EXP. dat. on the carton. The expiration date is the last day of the specified month.

Do not store above 25 ° C. Store in the original package. Moisture sensitive.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is enalapril maleate. Each 2.5 mg tablet contains 2.5 mg of enalapril maleate.
  • The active substance is enalapril maleate. Each 5 mg tablet contains 5 mg of enalapril maleate.
  • The active substance is enalapril maleate. Each 10 mg tablet contains 10 mg of enalapril maleate.
  • The active substance is enalapril maleate. Each 20 mg tablet contains 20 mg enalapril maleate.
  • The other ingredients are sodium bicarbonate, lactose monohydrate, corn starch, hydroxypropylcellulose, talc, and magnesium stearate.
  • The 10 mg tablet also contains red iron oxide (E172) and the 20 mg tablet also contains red iron oxide (E172) and yellow iron oxide (E172).

What the medicine looks like and the contents of the pack

Enalapril Teva 2.5 mg tablets are white, round, biconvex tablets with a beveled edge.

The tablets are packaged in blister packs of 20, 28, 30, 50, 56, 100, and 250 tablets.

Enalapril Teva 5 mg tablets are white, round, biconvex tablets with a beveled edge and a score line on one side.

The tablets can be divided into two equal doses.

The tablets are packaged in blister packs of 20, 28, 30, 50, 50 x 1, 60, 100, 250 and 500 tablets.

Enalapril Teva 10 mg tablets are reddish-brown with occasional spots, round, biconvex tablets with a beveled edge and a score line on one side.

The tablets can be divided into two equal doses.

The tablets are packaged in blister packs of 20, 28, 30, 50, 50 x 1, 100, and 250 tablets.

Enalapril Teva 20 mg tablets are light orange with single spots, round, biconvex tablets with a beveled edge and a score line on one side.

The tablets can be divided into two equal doses.

The tablets are packaged in blister packs of 14, 20, 28, 30, 50, 50 x 1, 100 and 250 tablets.

Manufacturer

Merckle GmbH, Ludwig-Merckle-Straße 3, 89143 Blaubeuren, Germany

Teva Operations Poland Sp. z oo, ul. Mogilska 80. 31-546, Krakow, Poland

Muhammad Nadeem

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