2.5 mg tablet of
enalapril maleate
1. What Enalapril Krka is and what it is used for
Enalapril Krka contains an active substance called enalapril maleate. This belongs to a group of medicines called ACE inhibitors ( angiotensin-converting enzyme ).
Enalapril Krka is used:
- to treat high blood pressure ( hypertension )
- to treat heart failure (impaired heart function). It can reduce the need for hospital care and can for some lead to prolonged survival
- 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.
This medicine works by dilating your blood vessels and this lowers your blood pressure. The drug usually has an effect 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 Krka 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 use Enalapril Krka
Do not use Enalapril Krka
- if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6).
- if you have ever had an allergic reaction with swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing ( angioedema ) in connection with previous treatment with ACE inhibitors, or if you or someone in your family has had a similar reaction without a known cause.
- during the last 6 months of pregnancy (even earlier in pregnancy it is good to avoid Enalapril Krka, see Pregnancy and breast-feeding).
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
- 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 this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Warnings and cautions
- if you have heart problems
- if you suffer from any disease that affects the blood vessels in the brain
- if you have a blood disorder such as low white blood cell count (neutropenia/agranulocytosis), low platelet count ( thrombocytopenia ), or decreased red blood cell count ( anemia )
- if you have any kidney disease or have had a kidney transplant. 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 Krka or check your blood potassium levels
- if you are receiving dialysis treatment
- if 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. You should be aware that black patients are at increased risk for these types of reactions with ACE inhibitors
- if you have liver problems
- if you have low blood pressure (you may experience weakness or dizziness, especially when standing up)
- if 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
- If you think you may be pregnant or become pregnant during treatment, consult your doctor. Enalapril Krka is not recommended during pregnancy and should not be used during the last 6 months of pregnancy as it may cause birth defects, see Pregnancy and breast-feeding.
- 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:
- racecadotril, a medicine used to treat diarrhea
- temsirolimus sirolimus, everolimus, and other medicines belonging to the group mTOR inhibitors (used to prevent rejection of transplanted organs and against cancer)
- vildagliptin, a medicine used to treat diabetes
- 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 – 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.
You should be aware that this medicine does not lower blood pressure as effectively in black patients.
See also the information under the heading “Do not take Enalapril Krka”.
It is important to exercise caution at the beginning of treatment to avoid a sharp drop in blood pressure. This is especially true if you are over 70 years old, treated with diuretic or potassium-sparing drugs, on a strictly low-salt diet, have severe vomiting or diarrhea, or if you have heart disease or have had a stroke.
If you are going to undergo a treatment
Tell her you are taking Enalapril Krka if you are going to take any of the following:
- 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 feraferes
- 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 taking Enalapril Krka.
Children and young people
Enalapril Krka should not be given to children.
Other medicines and Enalapril Krka
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect or be affected by concomitant treatment with EnalaprilKrka. It is especially important to tell your doctor or pharmacist if you are taking any of the following medicines. Your doctor may need to change your dose and/or take other precautions:
- an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Enalapril Krka” and “Warnings and precautions”)
- other antihypertensive drugs such as beta-blockers or diuretics ( diuretics )
- potassium supplements (including salt substitutes), potassium-sparing diuretic agent (diuretic), and other drugs that may increase the amount of potassium in your blood (such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) against infection s caused by bacteria, cyclosporine, an immunosuppressive drug which prevents the rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots).
- lithium (a medicine used to treat a certain type of depression)
- non-steroidal anti-inflammatory drugs, including COX 2 inhibitors (drugs that reduce inflammation and can be used to relieve pain)
- aspirin ( acetylsalicylic acid )
- drugs used to dissolve blood clots ( thrombolytics )
- antidepressants, antipsychotics, narcotics
- anesthetics (anesthetics)
- certain medicines for coughs and colds and for weight loss which contain something called sympathomimetic
- drugs for diabetes (such as sulphonylureas and biguanide) or insulin
- gold injections for the treatment of arthritis (sodium aurothiomalate)
- drugs most commonly used to prevent rejection of transplanted organs and against cancer (temsirolimus, sirolimus, everolimus, and other drugs belonging to the group mTOR inhibitors). See section “Warnings and Precautions”.
- sacubitril/valsartan (used to treat long-term heart failure )
- a drug used to treat diarrhea (racecadotril). See section “Warnings and Precautions”.
- a drug used to treat diabetes (vildagliptin). See section “Warnings and Precautions”.
Enalapril Krka with food, drink, and alcohol
Enalapril Krka can be taken independently of meals but should be taken with enough fluid (approx. 1½ dl).
Alcohol potentiates the antihypertensive effect of Enalapril Krka.
Pregnancy, breastfeeding, and fertility
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
If you think you may be pregnant or become pregnant during treatment, consult your doctor. Usually, your doctor suggests that you stop taking Enalapril Krka before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Enalapril Krka 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. Breast-feeding of a newborn (the first weeks after birth), especially of premature babies, is not recommended when using Enalapril Krka.
When breast-feeding an elderly infant, you should consult your doctor about the benefits and risks of using Enalapril Krka compared to other medicines.
Driving and using machines
During treatment with Enalapril Krka, dizziness and fatigue may occur. This should be kept in mind at times when sharper attention is required, e.g. when driving or using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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 Krka contains lactose and sodium
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 dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Enalapril Krka
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 this medicine as prescribed by your doctor
- Do not take more tablets than you were prescribed
The usual dose is:
High blood pressure
The usual starting dose is 5 mg to 20 mg once a day. 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. The doctor will increase the dose gradually until the correct dose is reached. The usual maintenance dose is 20 mg daily (as a single dose or divided into 2 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
- severely impaired renal function – 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 dosage will be determined by a doctor and will be based on how well your kidneys are working.
Use for children
Experience with use in children with high blood pressure is limited. If the child can swallow tablets, the dose will be based on the child’s weight and blood pressure.
The usual starting dose is:
- between 20 kg and 50 kg: 2.5 mg daily.
- 50 kg or more: 5 mg daily.
Dose one can be changed depending on the needs of the child:
- a maximum dose of 20 mg daily can be used for children between 20 kg and 50 kg.
- a maximum dose of 40 mg daily can be used for children weighing 50 kg or more.
Enalapril Krka is not recommended for newborns (the first weeks after birth) and children with kidney problems.
If you use more Enalapril Krka then you should
If you take more Enalapril Krka than you should, talk to your doctor or go to a hospital immediately. 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 have ingested too much medicine or if e.g. a child ingested the medicine accidentally contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Enalapril Krka
If you forget to take a tablet, skip the missed dose.
Do not take a double dose to make up for a forgotten tablet.
If you stop using Enalapril Krka
Do not stop taking Enalapril Krka 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.
Enalapril Krka can cause severe allergic reactions. Stop taking Enalapril Krka and contact a doctor immediately if you get any of the following symptoms ( angioedema):
- swelling of the face, lips, tongue, or throat, which may cause difficulty breathing
- difficulty swallowing
- swelling of hands, feet, or ankles
- if you develop raised red skin rashes ( hives ).
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 Krka and contact your doctor immediately.
When you start taking this medicine, 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 if 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)
- dimsyn
- dizziness, weakness, or malaise
- cough.
Common (may affect up to 1 in 10 people)
- headache, depression
- low blood pressure (can be experienced as a feeling of fainting when you get up quickly), fainting, chest pain, angina ( angina pectoris ), disturbed heart rhythm, high heart rate
- breathing difficulties
- diarrhea, abdominal pain
- skin rash, hypersensitivity reactions such as swelling of the face, arms, and legs, lips, tongue, vocal cords, and/or larynx
- fatigue
- 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 to 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 (fraud)
- ringing in the ears ( tinnitus )
- runny nose, sore throat, or hoarseness
- asthma-associated chest tightness
- delayed intestinal passage (intestinal knot), inflammation of the pancreas
- nausea (vomiting), indigestion, constipation, anorexia
- 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 I näsan
- inflammation i lungorna som orsakar andningssvårigheter (lunginflammation)
- inflammation i kinderna, tandkött, tunga, läppar, svalg
- minskad urinmängd
- cirkelformade hudutslag (erythema multiforme)
- “Stevens-Johnson syndrom” och ”toxisk epidermal nekrolys” (allvarliga hudsjukdomar med rodnad och fjällning av huden, blåsor eller sår) exfoliativ dermatit/erytrodermi (svåra hudutslag med fjällning eller flagning av huden), pemfigus (små vätskefyllda bulor på huden)
- leverproblem eller problem med gallblåsan såsom nedsatt leverfunktion, inflammation i levern, gulsot (gulfärgning av hud och ögon), höga nivåer av leverenzymer och bilirubin (mäts i ett blodprov)
- förstoring av brösten (gynekomasti).
Mycket sällsynta (kan förekomma hos upp till 1 av 10 000 användare)
- svullnad i tarmen (intestinalt angioödem).
Ingen känd frekvens (kan inte beräknas från tillgängliga data)
- överproduktion av antidiuretiskt hormon, vilket orsakar vätskeretention och leder till svaghet, trötthet eller förvirring
- 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.
5. How to store Enalapril Krka
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.
Do not store above 30 ° 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 tablet contains 2.5 mg of enalapril maleate.
- The other ingredients are sodium bicarbonate, lactose monohydrate, corn starch, talc, hydroxypropylcellulose, and magnesium stearate. See section 2 “Enalapril Krka contains lactose and sodium”.
What the medicine looks like and the contents of the pack
Tablet Appearance:
Round, white tablet with beveled edges and a diameter of 6 mm.
Pack sizes:
Blister (Polyamide / Al / PVC / Al): 28, 30, 50, 60, 98, 100 and 100×1 tablets.
Not all pack sizes may be marketed.
Manufacturer:
KRKA, dd, Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia