5 mg, 10 mg, and 20 mg tablets
enalapril maleate
What Enalapril Stada is and what it is used for
Enalapril Stada contains an active substance called enalapril maleate. Enalapril Stada belongs to a group of medicines called ACE inhibitors ( angiotensin-converting enzyme inhibitors).
Enalapril Stada is used:
- to treat high blood pressure ( hypertension )
- to treat heart failure (impaired heart function). Enalapril Stada may reduce the need for hospitalization and may in some cases 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.
Enalapril Stada works by dilating your blood vessels and lowering your blood pressure. Enalapril Stada 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 maleate contained in Enalapril Stada 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 Stada
Do not use Enalapril Stada
- if you are allergic to enalapril maleate or any of the other ingredients of this medicine (listed in section 6)
- if you have previously had an allergic reaction to a medicine belonging to the same group as Enalapril Stada, a so-called 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 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)
- during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Enalapril Stada, see Pregnancy and breast-feeding)
- if you have diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.
Do not take Enalapril Stada if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Enalapril Stada.
Warnings and cautions
Talk to your doctor or pharmacist before taking Enalapril Stada 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 blood cell count or lack of white blood cells(neutropenia/agranulocytosis), low platelet count ( thrombocytopenia ), or decreased 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 Stada 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
- 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
- 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
- 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 are breast-feeding or planning to start breastfeeding (see Pregnancy and breast-feeding).
- 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.
See also the information under the heading “Do not take Enalapril Stada”
- If you take any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) may increase:
- racecadotril, a medicine used to treat diarrhea
- medicines used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- vildagliptin, a medicine used to treat diabetes.
You must tell your doctor if you think you are (or might become) pregnant. EnalaprilStada 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 and breast-feeding).
You should be aware that Enalapril Stada 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 Stada.
If you are going to undergo a treatment
Tell me if you are taking Enalapril Stada 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 EnalaprilStada.
Other medicines and Enalapril Stada
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Enalapril Stada can affect the way other medicines work in the body and some other medicines can also affect the way Enalapril Stada works in the body.
You must tell your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:
- other antihypertensive drugs such as beta-blockers
- 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 that prevents rejection of transplanted organs; and heparin, a drug used to thin the blood to prevent blood clots)
- drugs for diabetes (including oral hypoglycemics 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
- aspirin ( acetylsalicylic acid )
- drugs used to dissolve blood clots ( thrombolytics )
- alcohol
- 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) or aliskiren (see also the information under the headings “Do not take Enalapril Stada” and “Warnings and precautions”).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Enalapril Stada.
Enalapril Stada with food, drink, and alcohol
Enalapril Stada can be taken with or without food. Most people take Enalapril Stada with a glass of water.
Pregnancy, breastfeeding,g, 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
Your doctor will usually suggest that you stop taking Enalapril Stada before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. Enalapril Stada 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
Enalapril Stada is not recommended for breastfeeding, especially if your baby is newborn (the first few weeks after birth) or was born prematurely. In the case of an older child, your doctor may advise you on the benefits and risks of taking EnalaprilStada while breastfeeding compared to other treatments.
Driving and using machines
You may experience dizziness or drowsiness while taking Enalapril Stada. 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 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 Stada 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 sodium (23 mg) per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Enalapril Stada
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- you must continue to take Enalapril Stada as prescribed by your doctor
- Do not take more tablets than you were prescribed.
Enalapril STADA 5 mg tablet
The tablet can be divided into two equal doses.
If only half a dose is needed, the “snap tab” tablet can be divided by placing it on a hard surface with the center notch facing up. Press lightly from above with your thumb, and the tablet will break into two equal parts.
Enalapril STADA 10 mg tablet
The tablet can be divided into two equal doses.
If only half a dose is needed, the “snap tab” tablet can be divided by placing it on a hard surface with the center notch facing up. Press lightly from above with your thumb, and the tablet will break into two equal parts.
Enalapril STADA 20 mg tablet
The tablet can be divided into two equal doses.
If only half a dose is needed, the “snap tab” tablet can be divided by placing it on a hard surface with the center notch facing up. Press lightly from above with your thumb, and the tablet will break into two equal parts.
High blood pressure
- The recommended starting dose varies from 5 mg to 20 mg once daily.
- Some patients may need a lower starting dose.
- The recommended maintenance dose is 20 mg once daily.
- The maximum maintenance dose is 40 mg once daily.
Heart failure
- The recommended starting dose is 2.5 mg once daily.
- Your doctor may gradually increase the dose until the appropriate dose for you is reached.
- The recommended 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
- 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 doctor will decide which dose to take and based on how well your kidneys are working.
Use for children and adolescents
Experience with the use of Enalapril Stada 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 recommended starting dose is:
- between 20 kg and 50 kg – 2.5 mg daily
- more than 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.
Enalapril Stada is not recommended for newborns (the first weeks after birth) or children with kidney problems.
If you use more Enalapril Stada then you should
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.
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 use Enalapril Stada
- 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 using Enalapril Stada
Do not stop taking Enalapril Stada 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 Stada 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
- 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 Stada and contact your doctor immediately.
When you start taking Enalapril Stada, 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)
- low blood pressure, changes in heart rate, palpitations, angina or chest pain
- headache, fainting ( syncope )
- 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 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)
- 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)
- anemia (including aplastic and hemolytic)
- stroke (possibly due to excessive blood pressure in high-risk patients)
- confusion, insomnia or drowsiness, nervousness
- stinging or numb feeling in the skin
- dizziness
- ringing in the ears ( tinnitus )
- runny nose, sore throat or hoarseness
- asthma
- delayed bowel passage, 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 (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
- autoimmune diseases
- strange dreams or difficulty sleeping
- lung infiltrate
- inflammation of the nose
- pneumonia
- inflammation of the cheeks, gums, tongue, lips, throat
- reduced urine output
- erythema multiforme
- “Stevens-Johnson syndrome” 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(measured in a blood test)
- enlargement of the mammary gland in men.
Very rare (may affect up to 1 in 10,000 people)
- swelling of the intestine (intestinal angioedema ).
5. How to store Enalapril Stada
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 card or carton. The expiration date is the last day of the specified month.
Do not store above 30 ° C. Store in the original package in order to protect from moisture.
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.
Other ingredients are:
Enalapril Stada 5 mg tablets: sodium bicarbonate, lactose monohydrate, corn starch, hydroxypropylcellulose, talc, magnesium stearate
Enalapril Stada 10 mg tablets sodium bicarbonate, lactose monohydrate, corn starch, talc, magnesium stearate, red iron oxide (E172)
Enalapril Stada 20 mg tablets: sodium bicarbonate, lactose monohydrate, corn starch, talc, magnesium stearate, red and yellow iron oxide (E172)
What the medicine looks like and the contents of the pack
5 mg : Round, biconvex, white snap tab tablets with a scoreline on one side. The tablet can be divided into two equal doses .
10 mg : Round, biconvex “snap tab” tablets with a scoreline on one side. The tablets are reddish-brown with individual white spots. The tablet can be divided into two equal doses .
20 mg : Round, biconvex “snap tab” tablets with a scoreline on one side. The tablets are light orange with individual white spots. The tablet can be divided into two equal doses .
The tablets are packaged in blister packs (aluminum / OPA-A1-PVC blisters) in the following pack sizes:
Enalapril Stada 5 mg tablets : 10, 20, 28, 30, 50, 56, 60, 98, 100, 105, 120, 150, 200, 250, 300, 400, 500, 1000 tablets.
Enalapril Stada 10 mg tablets : 10, 20, 28, 30, 50, 56, 60, 98, 100, 105, 120, 150, 200, 250, 300, 400, 500, 1000 tablets.
Enalapril Stada 20 mg tablets : 10, 14, 20, 28, 30, 50, 56, 60, 98, 100, 105, 120, 150, 200, 250, 300, 400, 500, 1000 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
KRKA dd
Šmarješka Cesta 6
8501 Novo Mesto
Slovenia
Sanico NV
Veedijk 59, Industrial Zone IV
2300 Turnhout
Belgium
STADA Arzneimittel GmbH
Muthgasse 36
1190 Vienna
Austria
Centrafarm Services BV
New Donk 9,
Etten-Leur
Netherlands
Coripharma
Reykjavikurvegur 78
220 Hafnarfjordur
Iceland
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark