2.5 mg, 5 mg, 10 mg and 20 mg tablets
of enalapril maleate
What Renitec is and what it is used for
Renitec contains an active substance called enalapril maleate. Renitec belongs to a group of medicines called ACE inhibitors ( angiotensin-converting enzymes).
Renitec is used:
- to treat high blood pressure ( hypertension )
- to treat heart failure (impaired heart function). Renitec may reduce the need for hospitalization and may, for some, lead to prolonged survival
- to reduce the symptoms of heart failure. Symptoms include shortness of breath, and 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 Renitec 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 Renitec
Do not take Renitec:
- if you are allergic to enalapril 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 this medicine, 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 diabetes or renal impairment and are being treated with a blood pressure-lowering medicine containing aliskiren
- during the last 6 months of pregnancy. (Even earlier in pregnancy, it is good to avoid Renitec, see Pregnancy and breast-feeding)
- if you have taken or are currently taking sacubitril/valsartan, a medicine used to treat a type of chronic ( chronic ) heart failure in adults, 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
Talk to your doctor or pharmacist before taking Renitec:
- 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 blood cell count or lack of white blood cells (neutropenia/agranulocytosis), low platelet count ( thrombocytopenia ), or decreased red blood cell count ( anemia )
- if you have liver problems
- if you have any kidney disease (including kidney transplantation), are on a low-salt diet, are being treated with potassium supplements, potassium-sparing agents, potassium-containing salt substitutes, or other medicines that may increase the level of potassium in your blood (eg heparin [a medicine used to prevent blood clots], medicines containing trimethoprim such as the combination trimethoprim/sulfamethoxazole [medicines used to treat infections ]). This can lead to elevated levels of potassium in the blood which can be serious. Your doctor may need to adjust your dose of Renitec or check your blood potassium levels. See also information under the heading “Other medicines and Renitec”
- if you are undergoing dialysis
- if you have recently had severe vomiting or diarrhea
- if you have diabetes. You should monitor your blood sugar levels, especially during the first month of treatment. Potassium levels in the blood can 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 low blood pressure (you may experience weakness or dizziness, especially when standing up)
- if you have a collagenous vascular disease (lupus erythematosus, rheumatoid arthritis, or scleroderma), are on immunosuppressive therapy, treated with allopurinol or procainamide, or a combination of these
- if you are taking any of the following medicines, the risk of angioedema may be increased:
- racecadotril, a medicine used to treat diarrhea
- drugs used to prevent rejection of transplanted organs and against cancer (eg temsirolimus, sirolimus, everolimus)
- 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.
See also the information under the heading “Do not take Renitec”.
Contact your doctor if you think you are (or might become) pregnant. This medicine is not recommended during early pregnancy and should not be used during the last 6 months of pregnancy as it may cause fetal harm (see Pregnancy).
You should be aware that this medicine 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 this medicine.
If you are going to undergo a treatment
Tell them you are taking Renitec if you are going to undergo 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 -apheresis
- 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 Renitec.
Other medicines and Renitec
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also applies to (traditional) herbal medicines and herbal medicines. Renitec can affect the way other medicines work in the body and some other medicines can also affect the way Renitec works in the body. Your doctor may need to change your dose and/or take other precautions.
It is especially important to tell your doctor if you are taking any of the following medicines:
- an angiotensin II receptor blocker (ARB) or aliskiren (see also the information under the headings “Do not take Renitec” and “Warnings and precautions”)
- other antihypertensive drugs such as beta-blockers or diuretics ( diuretics )
- potassium supplements (including salt substitutes), potassium-sparing diuretics, and other drugs that can increase the amount of potassium in your blood (eg trimethoprim and the combination trimethoprim/sulfamethoxazole for infection caused by bacteria; ciclosporin, an immune-boosting drug used to prevent rejection of transplanted organs, and heparin, a blood-thinning drug used to prevent blood clots). See also information under the heading “Warnings and precautions”.
- antidiabetic drugs (including oral antidiabetic drugs and insulin )
- lithium (a medicine used to treat a certain type of depression)
- antidepressants so-called tricyclic antidepressants
- medicines for mental disorders 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
- an inhibitor of mTOR (eg temsirolimus, sirolimus, everolimus – medicines used to treat certain types of cancer or to prevent the body’s immune system from rejecting a transplanted organ). See also information under the heading “Warnings and precautions”
- a drug containing a neprilysin inhibitor such as sacubitril (available as a combination with valsartan), racecadotril, or vildagliptin. The risk of angioedema (swelling of the face, lips, tongue, or throat with difficulty swallowing or breathing) may increase. See also the information under the headings “Do not take Renitec” and “Warnings and precautions”.
- 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 )
- alcohol.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Renitec.
Renitec with food and drink
Renitec can be taken with or without food. Most people take Renitec with a glass of water.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine. Usually, your doctor will suggest that you stop taking Renitec before pregnancy or as soon as you know you are pregnant and instead recommend another medicine for you. This medicine 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 breastfeeding or planning to start breastfeeding. This medicine is not recommended for breastfeeding, especially if your baby is a 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 this medicine while breastfeeding compared to other treatments.
Driving and using machines
You may experience dizziness or drowsiness while taking this medicine. If you experience this, do 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 sharpened 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.
Renitec contains lactose and sodium
Renitec contains lactose
Renitec contains lactose, which is a sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Renitec contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to take Renitec
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 have been prescribed
- the notch is only for you to be able to divide the tablet if you have difficulty swallowing it whole.
High blood pressure
- The usual starting dose varies from 5 mg to 20 mg once daily.
- Some patients may need a lower starting dose.
- The usual maintenance dose is 20 mg once daily.
- 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 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 it is based on how well your kidneys are working.
Use for children
Experience with the use of Renitec 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:
- 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.
This medicine is not recommended for newborns (the first weeks after birth) or children with kidney problems.
If you take more Renitec than you should
If you take more Renitec than you should, talk to your doctor or see 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, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you forget to take Renitec
- 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 Renitec
Do not stop taking Renitec unless your doctor tells you to.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
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 Renitec 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 Renitec 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)
- dizziness, weakness, or malaise
- dimsyn
- cough.
Common (may affect up to 1 in 10 people)
- dizziness due to low blood pressure, changes in heart rate, palpitations, angina or chest pain
- headache, depression, fainting ( syncope ), taste changes
- respiratory distress
- diarrhea, abdominal pain,
- fatigue
- skin rash, allergic reactions with swelling of the face, lips, tongue, or throat with difficulty swallowing and/or breathing
- high levels of potassium in the blood, and 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 in the heart or brain)
- stroke (possibly due to low 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 tightness in the chest
- 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, and 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 of the nose
- inflammation of the lungs that causes difficulty breathing ( pneumonia ), inflammation of the cheeks, gums, tongue, lips, throat
- reduced urine output
- circular rash (erythema multiforme)
- “Stevens-Johnson syndrome” and “toxic epidermal necrolysis” (severe skin conditions with redness and scaling of the skin, blisters, or sores) exfoliative dermatitis/erythroderma (severe rash with flaking or flaking of the skin), pemphigus (small fluid-filled bumps on the skin)
- liver problems or problems with the gallbladder such as hepatic impairment, inflammation of the liver, jaundice (yellowing of the skin and eyes), high levels of liver enzymes and bilirubin (measured in a blood test)
- breast augmentation in men ( gynecomastia ).
Very rare (may affect up to 1 in 10,000 people)
- swelling of the intestine (intestinal angioedema ).
No known frequency (can not be calculated from the available data)
- 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.
How to store Renitec
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 the carton after “EXP” and “EXP”. The expiration date is the last day of the specified month.
Do not store above 25 ° 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.
Contents of the pack and other information
Content declaration
- The active substance is enalapril maleate (2.5 mg, 5 mg, 10 mg, and 20 mg respectively).
- The other ingredients are lactose monohydrate, sodium bicarbonate, corn starch, pregelatinized starch, and magnesium stearate. The 10 mg tablet also contains red iron oxide (E172) and the 20 mg tablet also contains red iron oxide (E172) and yellow iron oxide (E172).
What the medicine looks like and the contents of the pack
Renitec 2.5 mg: white, round, with one side marked MSD 14 and the other side smooth.
Renitec 5 mg: white, rounded triangular, with one side, notched and the other side marked MSD 712.
Renitec 10 mg: rust red, rounded triangular, with one side-notched and the other side marked MSD 713.
Renitec 20 mg: peach-colored, rounded triangular, with one side, notched and the other side marked MSD 714.
The breaker is not for dividing the tablet into equal doses, but only for easier swallowing.
Renitec is available in the following pack sizes:
Renitec 2.5 mg: Aluminum / aluminum blister pack containing 2, 11, 20, 28, 30, 40, 49×1, 50 or 100 tablets.
Renitec 5 mg: Aluminum / aluminum blister pack containing 2, 14, 20, 28, 28×1, 30, 49×1, 50, 56, 98 or 100 tablets.
Renitec 10 mg: Aluminum / aluminum blister pack containing 28, 49×1, 30, 50, 98 or 100 tablets.
Renitec 20 mg: Aluminum / aluminum blister pack containing 10, 14, 20, 28, 28×1, 30, 49×1, 50, 56, 60, 84, 90, 98, 100 or 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
| Marketing Authorization Holder: NV OrganonKloosterstraat 65349 AB OssNetherlands | |
| ManufacturerMerck Sharp & Dohme BVPO Box 5812003 PC Haarlem Netherlands | |
| Schering-Plow Labo NVIndustrial Park 30Heist-op-den-Berg, 2220Belgium | |
| Local representative:Organon Sweden ABTel: +46 8 502 597 00 dpoc.sweden@organon.com |
This medicine is authorized in the European Economic Area
and in the United Kingdom (Northern Ireland) under the names:
Austria, Belgium, Finland, France, Greece, Luxembourg, Netherlands, Portugal, Spain, Sweden: UNITEC
Germany: XANEF
Italy: ENAPREN
United Kingdom (Northern Ireland), Ireland: INNOVATE