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BROCHURE

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Endocrine - Metabolic

KORANTREC

Korantrec, 5mg, Tablets

Korantrec 10, 10mg, Tablets

Korantrec, 20mg, Tablets

 

1.      What is Korantrec and what it is used for

Korantrec contains the active substance enalapril maleate.

Enalapril belongs to the group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. These medicines are mostly prescribed to treat all grades of essential hypertension. Korantrec works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen.

Indications:

Korantrec is indicated for the treatment of hypertension (high blood pressure), the treatment of heart failure by lowering the need to go to hospital and can helping some patients live longer and for preventing the signs of heart failure. The signs include: shortness of breath, tiredness after light physical activity such as walking, or swelling of the ankles and feet.

 

2.      What you need to know before you take Korantrec     

Do not take Korantrec if:

  • You are allergic (hypersensitive) to enalapril maleate or any of the other ingredients of Korantrec.
  • You have ever had an allergic reaction to a type of medicine similar to Korantrec called an ACE inhibitor.
  • You have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited.
  • You are more than 3 months pregnant (it is also better to avoid Korantrec 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

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

Warnings and precautions

Talk to your doctor or pharmacist before taking Korantrec if:

  • You have a heart problem.
  • You have a condition involving the blood vessels in the brain.
  • You have a blood problem 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).
  • You have a liver problem.
  • You have a kidney problem (including kidney transplantation). These may lead to higher levels of potassium in your blood which can be serious. Your doctor may need to adjust your dose of Korantrec or monitor your blood level of potassium.
  • You are having dialysis.
  • You have been very sick (excessive vomiting) or had bad diarrhoea recently.
  • You are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes.
  • You are over 70 years of age.
  • You have diabetes. You should monitor your blood for low blood glucose levels, especially during the first month of treatment. The level of potassium in your blood can also be higher.
  • You have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
  • You have low blood pressure (you may notice this as faintness or dizziness, especially when standing).
  • You have collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these.
  • You think you are (or might become) pregnant. Korantrec is not recommended in 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 at that stage (see Pregnancy section).
  • You are breast-feeding or about to start breast-feeding (see Breast-feeding section).
  • 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 Korantrec’’.

You should be aware that Korantrec lowers the blood pressure in black patients less effectively than in non-black patients.

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

If you are about to have a procedure

If you are about to have any of the following, tell your doctor that you are taking Korantrec:

  • Any surgery or receive anesthetics (even at the dentist).
  • A treatment to remove cholesterol from your blood called 'LDL aphaeresis’'.
  • A desensitization treatment, to lower the effect of an allergy to bee or wasp stings.

If any of the above applies to you, talk to your doctor or dentist before the procedure.

Other medicines and Korantrec:                          

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because Korantrec can affect the way some medicines work. Also some other medicines can affect the way Korantrec works.  Tell your doctor or pharmacist if you are taking particularly any of the following medicines:

Other medicines to lower blood pressure, such as beta-blockers or water tablets (diuretics), medicines containing potassium (including dietary salt substitutes), medicines for diabetes (including oral antidiabetic medicines and insulin), lithium (a medicine used to treat a certain kind of depression), tricyclic antidepressants, antipsychotics, certain cough and cold medicines and weight reducing medicines which contain something called a ‘sympathomimetic agent', certain pain or arthritis medicines including gold therapy,  non-steroidal anti-inflammatory drugs including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain), aspirin (acetyl salicylic acid), medicines used to dissolve blood clots (thrombolytics) and alcohol.  

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

If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Korantrec” and “Warnings and precautions’’).

Korantrec with food and drink

Korantrec can be taken with or without food. Most people take Korantrec with a drink of water.

Pregnancy and breast-feeding

Pregnancy:

You must tell your doctor if you think you are (or might become) pregnant.  Your doctor will normally advice you to stop taking Korantrec before you become pregnant or as soon as you know you are pregnant and will advice you to take another medicine instead of Korantrec.

Korantrec 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.

Consult your doctor or your pharmacist before taking any medication.

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 Korantrec.

In case of an older baby your doctor should advice you on the benefits and risks of taking Korantrec whilst breast-feeding, compared with other treatments.

Driving and using machines:

When driving or operating machinery it should be taken into account that occasionally dizziness or sleepiness may occur. If this happens do not drive or use any tools or machines.

Excipient warnings:

Korantrec contain 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

Korantrec 10 and Korantrec 20 Tablets contain Ponceau 4R E124, which may cause allergic reactions.

 

3.       How to take Korantrec

Always take this medicine exactly as our doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

It is very important to continue taking Korantrec for as long as your doctor prescribes it.

Do not take more tablets than prescribed.

The tablet can be divided into equal doses.

Hypertension: The initial dose is 5 mg to 20 mg given once daily. Some patients may need a lower starting dose. The usual long term dose is 20 mg taken once a day. The maximal long term dose is 40 mg taken once a day.

Heart failure: The initial dose is 2.5 mg taken once a day. Your doctor will raise this amount step by step until the dose that is right for you, has been achieved. The usual long term dose is 20 mg taken in one or two doses. The maximal long term dose is 40 mg each day divided in two doses.

Patients with kidney problems: Your dose of medicine will be changed depending on how well your kidneys are working:

  • Moderate kidney problems – 5 mg to 10 mg each day.
  • Severe kidney problems – 2.5 mg each day.
  • If you are having dialysis – 2.5 mg each day. On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.

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

Use in children

Children: Experience in the use of Korantrec 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:

  • between 20 kg and 50 kg – 2.5 mg each day.
  • more than 50 kg – 5 mg each day.

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

  • a maximum of 20 mg daily can be used in children who are between 20 kg and 50 kg.
  • a maximum of 40 mg daily can be used in children who are more than 50kg.

Korantrec is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.   

If you take more Korantrec than you should:

In case you take a dose larger than normal, stop taking the medicine and contact your doctor or go to a hospital immediately. The following effects may happen: feeling of light-headed or dizziness. This is due to a sudden or excessive drop in blood pressure.

If you forget to take Korantrec:

If you have to take your medicine continuously and you missed a dose, skip the missed dose and go back to your regular dosing schedule. Do not double dose to make up for a forgotten dose.

 

4.      Possible side-effects

As with all medicines, Korantrec can cause undesirable effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Korantrec and talk to a doctor straight away, if you notice any of the following:

  • Swelling of your face, lips, tongue or throat which may cause difficulty in breathing or swallowing.
  • Swelling of your hands, feet or ankles.
  • If you develop a raised red skin rash (hives).

You should be aware that black patients are at increased risk of these types of reactions. If any of the above happen, stop taking Korantrec and talk to a doctor straight away.

When you start taking Korantrec you may feel faint or dizzy. If this happens, it will help to lie down. This is caused by your blood pressure lowering. It should improve as you continue to take the medicine. If you are worried, please talk to your doctor.

Other side effects include:

Very Common (affects more than 1 in 10 people)

  • Feeling dizzy, weak or sick.
  • Blurred vision.
  • Cough.

Common (affects less than 1 in 10 people)

  • Low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain.
  • Headache, fainting (syncope).
  • Change in sense of taste, shortness of breath.
  • Diarrhea or abdominal pain, rash.
  • Tiredness (fatigue), depression.
  • Allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing.
  • Increased blood potassium level, increased levels of creatinine in your blood (both are usually detected by a test).

Uncommon (affects less than 1 in 100 people)

  • Sudden fall in blood pressure.
  • 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).
  • anaemia (including aplastic and haemolytic).
  • Stroke (possibly due to very low blood pressure in high-risk patients).
  • Confusion, sleeplessness or sleepiness, nervousness.
  • Feeling your skin prickling or being numb.
  • Vertigo.
  • Ringing in your ears (tinnitus).
  • Runny nose, sore throat or hoarseness.
  • Asthma.
  • Slow movement of food through your intestine, inflammation of your pancreas.
  • Being sick (vomiting), indigestion, constipation, anorexia.
  • Irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure.
  • Increased perspiration.
  • Itching or nettle rash.
  • Loss of hair.
  • Muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence.
  • High level of proteins in your urine (measured in a test).
  • Low level of blood sugar or sodium, high level of blood urea (all measured in a blood test).

Rare (affects less than 1 in 1,000 people)

  • ‘Raynaud’s phenomenon’ where your hands and feet may become very cold and white due to low blood flow.
  • Changes in blood values such as a lower number of white and red blood cells, lower hemoglobin, lower number of blood platelets.
  • Bone marrow depression.
  • Autoimmune diseases.
  • Strange dreams or sleep problems.
  • Pulmonary infiltrates.
  • Inflammation of your nose.
  • Pneumonia.
  • Inflammation of the cheeks, gums, tongue, lips, throat.
  • Lower amount of urine produced.
  • erythema multiforme.
  • ‘Stevens-Johnson syndrome’ a serious skin condition where you have reddening and scaling of your skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers.
  • Liver problems such as lower liver function, inflammation of your liver, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin (measured in a blood test).
  • Enlargement of the mammary glands in males.

Very Rare (affects less than 1 in 10,000 people)

  • Swelling in your intestine (intestinal angioedema).

 

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

In case you have purchased or been given the product in the Republic of Cyprus you can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

Pharmaceutical Services

Ministry of Health

CY-1475

Fax: + 357 22608649

Website: www.moh.gov.cy/phs

 

5.      How to store Korantrec

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 inner and outer label.

Special precautions for storage of the product:

Keep below 250C, protected from light and moisture.

 

6.       Contents of the pack and other information

What Korantrec contains

The active ingredient of Korantrec is Enalapril Maleate.

Korantrec 5 Tablets contains 5mg of enalapril maleate.

Korantrec 10 Tablets contains 10mg of enalapril maleate.

Korantrec 20 Tablets contains 20mg of enalapril maleate.

Other ingredients are: Lactose, Maleic Acid and Zinc Stearate. Korantrec 10 and Korantrec 20 also contain Ponceau 4R E124 and Quinoline Yellow E104.

 

 

What Korantrec looks like and contents of the pack

Korantrec 5 Tablets are white, scored, NC, barrel shaped tablets with Remedica’s logo on one side. This product is available in pack-sizes of 30, 50, 100 and 1000 tablets.

Korantrec 10 Tablets are  light red, scored, NC, barrel shaped tablets with Remedica’s logo on one side. This product is available in pack-sizes of 30, 50, 100 and 1000 tablets.

Korantrec 20 Tablets are peach, scored, NC, barrel shaped tablets with Remedica’s logo on one side. This product is available in pack-sizes of 10, 30, 100 and 1000 tablets.

Not all pack-sizes may be marketed.

 

Marketing Authorization Holder and Manufacturer

Remedica Ltd.

Aharnon street, Limassol Industrial Estate, 3056, Limassol, Cyprus.

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