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

Read all of this leaflet carefully before you start taking 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 includes any possible side effects not listed in this leaflet. See section 4.

This leaflet contains information about: 
1. What Enalapril Orion is and what it is used for 
2. What you need to know before you take Enalapril Orion 
3. How to take Enalapril Orion 
4. Possible side effects 
5. How to store Enalapril Orion 
6. Contents of the packaging and other information 

What Enalapril Orion is and what it is used for

Enalapril Orion contains an active substance called enalapril maleate, which belongs to a group of medicines called ACE inhibitors.

This medicine is used to:

  • treat high blood pressure
  • treat heart failure (impaired heart function). It can reduce the need for hospital care and can for some lead to prolonged survival.
  • 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.

The drug works by dilating your blood vessels and this causes the blood pressure to drop. The effect usually starts within an 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 maleate contained in Enalapril Orion may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before you take Enalapril Orion

Do not take Enalapril Orion if:

  • you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
  • you have previously had an allergic reaction to a medicine belonging to the same group of medicines as this medicine ( ACE inhibitor )
  • you have previously experienced swelling of the face, lips, mouth, tongue, or throat which caused swallowing and/or breathing difficulties ( angioedema ) of unknown cause or in hereditary angioedema
  • you have passed the first 3 months of pregnancy (even earlier in pregnancy it is good to avoid Enalapril Orion, see section Pregnancy).
  • you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
  • you have been taking or have been taking a neprilysin inhibitor (eg medicines containing sacubitril) for the last 36 hours.

Warnings and cautions

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

  • you have disturbances in the blood circulation in the brain
  • you have a blood disease such as low number or lack of white blood cells, low platelet count, or decreased red blood cell count ( anemia )
  • you have a liver disease
  • you have 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 or check your blood potassium levels.
  • you get dialysis
  • you have recently had vomiting or diarrhea
  • you are on a low-salt diet, treated with potassium supplements, potassium-sparing drugs, or potassium-containing salt substitutes
  • you have diabetes. as in that case you should monitor your blood sugar levels closely, especially during the first month of treatment. The levels of potassium in the blood may also increase.
  • you have previously had an allergic reaction with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing. Black patients are at increased risk for these types of reactions with ACE inhibitors.
  • 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, treated with allopurinol or procainamide, or a combination of these
  • you receive a treatment to remove cholesterol in the blood (so-called LDL -pheresis)
  • you are going to have a surgical procedure or if you are going to undergo anesthesia (also at the dentist)
  • you receive a hyposensitization treatment to reduce hypersensitivity to bee or wasp stings.
  • 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.
  • if you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is higher:
    • sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs)
    • neprilysin inhibitors, e.g. sacubitril-containing drugs for the treatment of heart failure.

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 Orion”.

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

Tell your doctor if you think you may be pregnant or if you may become pregnant. The use of Enalapril Orion is not recommended in early pregnancy and should not be used after the first three months of pregnancy as it may cause serious harm to the baby (see section Pregnancy).

The drug usually does not lower blood pressure as effectively in black patients.

Children

Experience with use in children with high blood pressure is limited. This medicine is not recommended for newborns (during the first weeks after birth) or children with kidney disease.

Other medicines and Enalapril Orion

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This applies to prescription drugs as well as over-the-counter drugs, (traditional) herbal medicines, and herbal medicines.

If Enalapril Orion is taken with certain other medicines, the effect of these medicines or the effect of Enalapril Orion may change or you may experience side effects. These medicines include:

  • other antihypertensive drugs such as beta-blockers or diuretics ( diuretics )
  • potassium supplements or salt substitutes containing potassium, diuretics ( diuretics, especially so-called potassium-sparing diuretics ), other medicines that can increase potassium levels in the body (eg heparin and the combination trimethoprim/sulfamethoxazole)
  • drugs for diabetes (both medicines taken by mouth and insulin )
  • lithium (a medicine used to treat certain types of depression)
  • medicines for depression called tricyclic antidepressants drugs
  • 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 preparations
  • acetylsalicylic acid
  • drugs used to dissolve blood clots ( thrombolytics )
  • drugs most commonly used to prevent rejection of transplanted organs (sirolimus, everolimus, and other drugs belonging to the mTOR inhibitor group). See section “Warnings and Precautions”.

Your doctor may need to change your dose and/or take other precautions:

if you are taking an angiotensin II receptor blocker (ARB), aliskiren, or a neprilysin inhibitor (see also the information under the headings “Do not take Enalapril Orion” and “Warnings and precautions”).

Enalapril Orion with food, drink, and alcohol

Alcohol

Avoid the use of alcohol, as alcohol may potentiate the antihypertensive effect of Enalapril Orion too much.

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 or pharmacist for advice before taking this medicine.

Pregnancy

Tell your doctor if you think you may be pregnant or if you may become pregnant. Usually, your doctor will suggest that you stop taking Enalapril Orion before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Enalapril Orion is not recommended in early pregnancy and should not be used after the first three months of pregnancy as it may cause serious harm to the baby.

Breast-feeding

Tell your doctor if you are breast-feeding or planning to start breast-feeding. Enalapril Orion is not recommended for breast-feeding to newborns (the first weeks after birth) and especially not too premature babies. In the case of an older child, your doctor will advise you on the benefits and risks of taking Enalapril Orion while breastfeeding compared to other treatments.

Driving and using machines

This medicine may cause dizziness or drowsiness and may impair the ability to drive and use machines. Driving and using machines should be avoided at the beginning of drug treatment until you know how this medicine affects you.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased 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 Orion contains lactose

This medicine contains 64 mg of lactose (5 mg tablet), 59 mg (10 mg tablet) or 118 mg (20 mg tablet). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Other ingredients

This medicine contains less than 1 mmol (23 mg) sodium per daily dose, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to take Enalapril Orion

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

Taking the medicine

The tablets can be taken with or without food. Drink a glass of water or other beverage while taking the tablet.

Dosage of the drug

With high blood pressure,

  • the usual starting dose is 5-20 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 daily.
  • your doctor may gradually increase the dose until the appropriate dose 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 your kidney function:

  • 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 prescribe a dose based on your kidney function. Age in itself does not affect the dose of one of the drugs.

Use for children

Experience with use 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:

  • for patients weighing 20-50 kg: 2.5 mg daily
  • for patients weighing more than 50 kg: 5 mg daily

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

  • the maximum dose is 20 mg daily in children weighing 20-50 kg
  • the maximum dose is 40 mg daily in children weighing over 50 kg.

This medicine is not recommended for newborns (during the first weeks after birth) or children with kidney disease.

If you take more Enalapril Orion then you should

If you have ingested too much medicine or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you if you see a doctor or hospital.

Symptoms of overdose are a feeling of fainting or dizziness, which is due to a sudden or sharp drop in blood pressure.

If you forget to take Enalapril Orion

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 Orion

Do not change the dosage or stop the drug treatment without first talking to your doctor.

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.

Stop taking the tablets and contact a doctor immediately, if you experience:

  • swelling of the face, lips, tongue, or throat, which may cause breathing and/or swallowing difficulties
  • swelling of hands, feet, or ankles
  • if you develop raised red skin rashes ( hives ).

Black patients are at increased risk for these types of reactions.

Contact your doctor if necessary:

At the beginning of the treatment, you may experience a feeling of fainting or dizziness, which is caused by a drop in blood pressure. If this happens, it helps to lie down. It usually improves if you continue to take the medicine. If you are worried, talk to a doctor.

A very common side effect is (can occur in more than 1 in 10):

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

Common side effects are (may affect up to 1 in 10):

  • low blood pressure, changes in heart rate, palpitations, angina or chest pain
  • headache
  • taste changes, shortness of breath
  • diarrhea or abdominal pain, rash
  • fatigue, depression
  • allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing
  • increased levels of potassium and/or creatinine in the blood (both detected by a blood test).

Less common side effects are (may affect up to 1 in 100):

  • a sudden drop in blood pressure
  • fast or uneven heartbeat (palpitations)
  • myocardial infarction (possibly due to hypotension in some high-risk patients including patients with angina pectoris )
  • anemia
  • stroke (possibly due to excessive blood pressure in high-risk patients)
  • confusion, insomnia or drowsiness, nervousness, hallucination, dizziness
  • stinging or numb feeling in the skin
  • ringing in the ears ( tinnitus )
  • runny nose, sore throat or hoarseness, asthma
  • inflammation of the pancreas
  • nausea (vomiting), indigestion, constipation, loss of appetite
  • irritated stomach (irritation of the stomach), dry mouth, stomach ulcers, impaired kidney function, kidney failure
  • increased sweating, itching or hives, hair loss
  • muscle cramps, redness  general malaise, fever, impotence
  • high level of protein in the urine (detected in urine test)
  • low blood sugar or low level of sodium in the blood, high level of urea in the blood (detected by a blood test).

Rare side effects are (may affect up to 1 in 1000 people):

  • “Raynaud’s phenomenon” where hands and feet can become very cold and white due to low blood flow
  • changes in blood counts such as low white and red blood cell counts, low hemoglobin levels, low platelet count
  • decreased bone marrow function
  • autoimmune diseases
  • strange dreams or difficulty sleeping
  • changes in the lung tissue, inflammation of the nose, pneumonia
  • inflammation of the cheeks, gums, tongue, lips, throat
  • reduced urine output
  • erythema multiforme or Stevens-Johnson syndrome, ie a serious skin condition with redness and scaling of the skin, blisters or sores, or skin loosening
  • liver problems such as hepatic impairment, inflammation of the liver, jaundice (yellowing of the skin and eyes), higher levels of liver enzymes, and bilirubin(detected in blood tests)
  • enlargement of the mammary glands in men.

Very rare side effects are (may affect up to 1 in 10 000 users):

  • swelling of the intestine (intestinal angioedema ).

No known frequency (occurs in an unknown number of users) :

  • overproduction of the antidiuretic hormone, which causes fluid retention and leads to weakness, fatigue, or confusion
  • a symptom complex has 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 changes may occur.

Reporting of side effects ar

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly (see details below). By reporting side effects, you can help increase the safety of medicines.

The Medical Products Agency

Box 26

751 03 Uppsala

www.lakemedelsverket.se

5. How to store Enalapril Orion

Do not store above 30 ° C.

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 carton (after EXP). The expiration date is the last day of the specified month.

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 tablet contains 5 mg, 10 mg, or 20 mg of enalapril maleate.
  • The other ingredients are maleic acid, lactose monohydrate, hypromellose, croscarmellose sodium, and sodium stearyl fumarate.

What the medicine looks like and the contents of the pack

5 mg: White or almost white, round, flat, oblique tablet with one side-notched and the other side marked “5”. The tablet can be divided into two equal doses 

10 mg: White or almost white, round, flat, oblique tablet with one side-notched and the other side marked “10”. The tablet can be divided into two equal doses.

20 mg: White or almost white, round, flat, oblique tablet with one side-notched and the other side marked “20”. The tablet can be divided into two equal doses.

Pack sizes:

Blister pack: 30 tablets (3×10)

Plastic jar: 100 and 250 tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Sale

Orion Corporation

Orionintie 1

02200 Espoo

Finland

Manufacturer

Orion Corporation Orion Pharma

Orionintie 1

02200 Espoo

Finland

For further information on this medicine, please contact your local representative:

Orion Pharma AB, Danderyd

medinfo@orionpharma.com

Muhammad Nadeem

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