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• Enalapril Krka 2,5 mg tablet PL
• Enalapril Krka tablet ENG PL

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Package leaflet: Information for the patient

<Invented name> 2.5 mg tablets

Enalapril maleate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to others. It may harm them, even if their signs of illness are the same as 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.

What is in this leaflet

1. What <Invented name> is and what it is used for

2. What you need to know before you take <Invented name>

3. How to take <Invented name>

4. Possible side effects

5. How to store <Invented name>

6. Contents of the pack and other information

1. What <Invented name> is and what it is used for

<Invented name> belongs to the group of medicines called ACE inhibitors. Enalapril reduces formation of substances that increase the blood pressure by constricting blood vessels. Treatment with enalapril dilates blood vessels resulting in lowering of the blood pressure. In patients with heart failure provides the vasodilatory effect which reduces the workload on the heart.

<Invented name> is used for the treatment of high blood pressure and heart failure.

2. What you need to know before you take <Invented name>

Do not take<Invented name>

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

• if you have a history of an allergic reaction with swelling of the face, lips, tongue and/or pharynx associated with swallowing or breathing difficulties in connection with previous treatment with ACE inhibitors or if you or someone in your family has had a similar reaction with no known reason.

• if you are more than 3 months pregnant (it is also better to avoid <Invented name> in early pregnancy – see Pregnancy section).

• if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren

Warnings and precautions

Talk to your doctor or pharmacist before taking <Invented name>:

• if you have a blood disorder such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anaemia)

• if you have kidney problem or you have undergone a kidney transplantation

• if you are currently on dialysis therapy

• if you suffer from Conn’s syndrome (an adrenocortical disease that leads to excessive production of aldosterone hormone)

• if you are diabetic

• if you have proteins in your urine (proteinuria)

• if you are undergoing LDL apheresis (a procedure to remove cholesterol from the blood)

• if you receive desensitisation therapy with hymenoptera (e.g. bee or wasp) venom

• if you have a liver problem

• if you have low blood pressure

• you must tell your doctor if you think that you are (or might become) pregnant. <Invented name> is not recommended in early pregnancy, and must not be taken if you are more than 3months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

• if you are breast-feeding or about to start breast-feeding (see Breast-feeding section).

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

• an angiotensin II receptor blocker (ARBs) (also known as sartans - for example valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney problems,

• aliskiren.
  
  

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading “Do not take <Invented name>”.

Caution should be followed in the beginning of the therapy to prevent severe reduction in blood pressure. This is particularly important in patients over 65 years of age, in patients receiving treatment with diuretics or with potassium-sparing drugs, in patients on a strict low-salt diet, in patients with severe vomiting or diarrhoea or in case of a cardiac disease or a history of stroke.

If you are scheduled for a surgery under anaesthesia, you should inform the doctor/dentist that you are using <Invented name>, because certain anaesthetics may cause severe reduction in blood pressure.

Children and adolescents

<Invented name> should not be used in children.

Other medicines and <Invented name>

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

Certain medicines may alter the effects from <Invented name> or it may alter the effects from other drugs. It is particularly important to tell your doctor if you are currently using any of the following:

• antihypertensive drugs

• drugs dilating the blood vessels (nitroglycerin and other nitrates)

• potassium-sparing diuretics (spironolactone, triamterene, amiloride)

• other diuretics (thiazides or loop diuretics)

• drugs containing potassium

• certain pain killers and anti-inflammatory drugs, so-called NSAIDs (e.g. indometacin and sulindac)

• drugs for bipolar affective syndrome (lithium)

• antidepressants, antipsychotics, hypnotics, narcotics

• anaesthetics

• certain cardiostimulants

• antidiabetic drugs (e.g. sulfonylureas and biguanides) or insulin

• gold by injection for treatment of arthritis (sodium aurothiomalate).

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

<Invented name> with food, drink and alcohol

<Invented name> can be taken independently of meals, but should be taken with an adequate amount of water (approx. 1½ dl).

Alcohol enhances the blood pressure lowering effects of <Invented name>.

Pregnancy and breast-feeding

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

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking <Invented name> before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of <Invented name>. <Invented name> is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding newborn babies (first few weeks after birth), and especially premature babies, is not recommended whilst taking <Invented name>. In the case of an older baby your doctor should advise you on the benefits and risks of taking <Invented name> whilst breast-feeding, compared to other treatments.

Driving and using machines

Treatment with <Invented name> may cause dizziness or weariness.This should be considered in situations such as driving and using machines.

<Invented name> contains lactose

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

3. How to take <Invented name>

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is:

High blood pressure

The usual starting dose is 5 to 20 mg once daily.

Some patients may need a lower starting dose.

The usual maintenance dose is 20 mg daily.

The maximum maintenance dose is 40 mg daily.

Heart failure/prevention of heart function deterioration

The usual starting dose is 2.5 mg once daily.

The doctor gradually increases the dose until the correct dosage is achieved.

The normal maintenance dose is 20 mg daily (as a single dose or divided into 2 sub-doses). The maximum dose is 40 mg daily given in two divided doses.

Dosage for patients with impaired kidney function

Dosage is determined by the doctor according to kidney impairment:

Elderly patients (over 65 years of age)

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

Use in children

Experience in the use of <Invented name>in children with high blood pressure is limited. If the child can swallow tablets, the dose will be worked out using the child’s weight and blood pressure. The usual starting doses are:

The dose can be changed according to the needs of the child:

<Invented name>is not recommended in newborn babies (the first weeks after birth) and in children with kidney problems.

If you take more <Invented name> than you should

If you take more <Invented name> than you should, talk to your doctor or go to a hospital straight away.

If you forget to take <Invented name>

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

If you have forgotten to take a dose, continue by taking your normal dose as usual.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

<Invented name> may cause severe allergic reactions. Discontinue <Invented name> medication and contact your doctor immediately, if any of the following symptoms (angioedema) appear:

• swelling of the face, tongue or throat

• swallowing difficulties

• urticaria and breathing difficulties.

In rare cases, <Invented name> may affect the white blood cells thus impairing the immune defence system. If you experience symptoms of an infection, such as fever with severe impairment of your general condition or fever with local symptoms of an infection, e.g. sore throat/pharynx/mouth or urinary problems, you should see a doctor as soon as possible to exclude white blood cell deficiency (agranulocytosis) with blood tests. It is important in such a case that you tell the doctor about your medication.

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

• Blurring of the vision.

• Feeling dizzy, weak or sick.

• Cough.

Common(may affect up to 1 in 10 people)

• Headache, depression.

• Low blood pressure (standing abruptly up may cause feeling of dizziness), fainting, chest pain, constriction of blood vessels (angina pectoris), disturbed heart rhythm, rapid pulse.

• Difficulties breathing.

• Diarrhoea, stomach pain, taste disturbances.

• Rash, hypersensitivity reactions, such as swelling of the face, arms, legs, lips, tongue, vocal cords and/or larynx.

• Tiredness.

• High blood potassium concentrations, increased levels of creatinine in your blood.

Uncommon(may affect up to 1 in 100 people)

• Sudden fall in blood pressure.

• Anaemia.

• Low blood sugar levels.

• Confusion, somnolence, sleeping difficulties, nervousness, needles and pins, vertigo.

• Ringing in your ears (tinnitus).

• Fast or uneven heart beats (palpitations).

• Heart attack (possibly due to very low blood pressure in certain high-risk patients, including those with blood flow problems of the heart or brain).

• Stroke (possibly due to very low blood pressure in high-risk patients).

• Rhinitis, sore throat, hoarseness, cramps in the airways, asthma.

• Blockage of the gut (ileus), inflammation of the pancreas, vomiting, dyspepsia, constipation, loss of apetite, dry mouth, irritated stomach, gastric ulcer.

• Excessive sweating, itching, nettle rash, hair loss.

• Reduced kidney function, kidney failure, presence of protein in the urine.

• Impotence.

• Muscle cramps, flushing, tinnitus, feeling unwell, fever.

• Low blood sodium concentration, high level of blood urea.

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

• Changes in the blood count, e.g. reduction in the red and white blood cell count, reduction in the platelet count.

• Effects on the immune system and lungs,

• Pulmonary infiltrates (shown on X-ray), pneumonia.

• Abnormal dreams.

• Cold hand and feet (Raynaud’s syndrome).

• Inflammation of the cheeks, gums, tongue, lips, throat.

• Reduced liver function, hepatitis, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin.

• Severe skin reactions, such as blistering and peeling of the skin.

• Reduced urination.

• Enlargening of the breasts.

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

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store <Invented name>

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 package after “EXP:”. The expiry date refers to the last day of that month.

Store below 30°C. Store in the original package in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.These measures will help protect the environment.

6. Contents of the pack and other information

What <Invented name> contains

• The active substance is enalapril maleate. Each tablet contains 2.5 mg enalapril maleate.

• The other ingredients are sodium hydrogen carbonate, lactose monohydrate, maize starch, talc, hydroxipropylcellulose and magnesium stearate.

What <Invented name> looks like and contents of the pack

Tablet appearance:

Round, white, tablet with bevelled edges and a diameter of 6 mm.

Pack sizes:

Blister (Polyamide/Alu/PVC/Alu):28, 30, 50, 60, 98, 100 or 100x1 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in: 5 December 2014