Enalapril Maleate 2.5mg Tablets
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Enalapril maleate 2.5mg Tablets Enalapril maleate 5mg Tablets Enalapril maleate 10mg Tablets Enalapril maleate 20mg Tablets
(Enalapril maleate)
Read all of this leaflet carefully before you start taking this medicine.
• Keepthis leaflet. You may need to read it again.
• Ifyouhave any further questions, ask your doctor or pharmacist.
• Thismedicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• Ifanyofthe side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What is Enalapril maleate Tablet and what is it used for.
2. Before you take Enalapril maleate Tablet
3. How to take Enalapril maleate Tablet
4. Possible side effects
5. How to store Enalapril maleate Tablet
6. Further information
1. WHAT ENALAPRIL MALEATE TABLETS ARE AND WHAT THEY ARE USED FOR
Enalapril maleate belongs to the class of medicines called Angiotensin converting enzyme inhibitors (ACE inhibitors). Tin works by causing blood vessels to relax, lowering blood pressure and increasing the supply of blood and oxygen to the heart.
Enalapril maleate Tablets are used
• Totreathigh blood pressure (hypertension)
• Totreatheart failure (weakening of heart function)
• Toprevent 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. BEFORE YOU TAKE ENALAPRIL MALEATE TABLETS
Do not take Enalapril maleate Tablets
• Ifyouare allergic (hypersensitive) to enalapril maleate, any of the other ingredients in these tablets or other ACE inhibitors (see Section 6 and end of Section 2)
• Ifyouhave previously developed swelling especially over the face, lips or mouth, rashes or difficulty breathing after taking any medicines
• Ifyouare more than 3 months pregnant. (It is also better to avoid Enalapril maleate tablets in early pregnancy - see Pregnancy section)
• Ifyouhave diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.
Do not take Enalapril Maleate if any of the above applies to you. If you are not sure, talk to your doctor
or pharmacist before taking Enalapril maleate Tablets.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before taking Lisinopril tablets
• Ifyouare 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 Enalapril maleate tablets if"
Take special care with Enalapril maleate Tablets
You should let your doctor know:
• Ifyouhave a heart problem
• Ifyouhave a condition involving the blood vessels in the brain
• Ifyouhave a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood pallet count (thrombocytopenia) or a decreased number of red blood cells (anaemia)
• Ifyouhave ever had allergic reaction with swelling of the face, lips, tongue or throat with difficulty swallowing pr breathing.
• Ifyouhave 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 Enalapril maleate Tablets or monitor you blood level of potassium
• Ifyouare on a salt restriction diet, are taking potassium containing medicines or supplements, potassium-sparing agents, salt substitutes or low-salt milk.
• Ifyouhave been very sick (excessive vomiting) or had bad diarrhoea recently
• Ifyouhave 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
• Ifyouhave a liver problem or develop jaundice (yellowing of the skin and white of the eye)
• Ifyouare having dialysis
• Ifyouare over 70 years of age
• Ifyouhave low blood pressure (you may notice this as faintness or dizziness, especially when standing)
• Ifyouhave collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses immune system, are taking drugs allopurinol or procainamide, or any combinations of these
• Ifyouthink you are (or might become) pregnant. Enalapril maleate Tablets are 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)
• Ifyouare breast-feeding or about to start breast feeding (see Breast-feeding section)
You should be aware that Enalapril maleate Tablets lowers blood pressure in black people less effectively than in non-black patients
If you are not sure of any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril maleate Tablets.
If you are about to have a procedure:
If you are bout to receive any of the following, tell your doctor that you are taking Enalapril maleate Tablets:
• anysurgery or receive anesthetics (even at dentist)
• desensitisation treatment with hymenoptera venom (e.g. bee or wasp venom)
• treatment called LDL apheresis to remove cholesterol form your blood machine If any of the above applies to you, talk to your doctor or dentist before procedure Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines including medicines obtained without a prescription. This includes herbal medicines. Some medicines can affect the way Enalapril maleate Tablets works.
It is especially important to tell your doctor if you are taking any of the following:
Your doctor may need to change your dose and/or to take other precautions:
• Ifyouare taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings "Do not take Enalapril maleate tablets" and "Warnings and precautions")
• Othermedicines that lower blood pressure, such as beta blockers, vasodilators or water tablets (diuretics)
• Medicines containing potassium (including dietary salt substitutes)
• Lithium,used for the treatment of certain kind of depression
• Tricyclicantidepressants such as amitriptyline used for treating depression
• Medicines for mental problems called 'antipsychotics'
• Certaincough and cold medicines and weight reducing medicines which contain substances called 'sympathomimetic agents'
• Certainpain or arthritis medicines including gold
• Barbiturates (sedatives used for sleeplessness or epilepsy)
• Cholestyramine (used to help control cholesterol levels)
• Medicines for the treatment of cancer
• Antidiabetic drugs including oral agents to lower blood sugar and insulin
• Allopurinol (used to treat gout)
• Ciclosporin (immunosuppressive agents for autoimmune disorders)
• Procainamide used to treat abnormal heart rhythms
• Non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain)
• Aspirin(acetylsalicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders
• Antacids (used for the relief of indigestion)
• Alcohol
If you are not sure of any of the above apply to you, talk to your doctor or pharmacist before taking Enalapril maleate Tablets.
Taking Enalapril maleate Tablets with food and drink
Enalapril maleate tablets can be taken with or without food. Do not drink alcohol while taking Enalapril maleate tablets. It may cause your blood sugar levels to drop too much and you may experience dizziness, light-headedness or faintness.
Pregnancy and breast-feeding Pregnancy
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Enalapril maleate Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Enalapril maleate Tablets. Enalapril maleate tablets are 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 Enalapril maleate Tablets. In the case of an older baby your doctor should advise you on the benefits and risks of taking Enalapril maleate Tablets whilst breast-feeding, compared to other treatments.
Driving and using machines
As this medicine may make you feel dizzy, you should not drive or operate machinery until you know how the drug affects you.
Important information about some of the ingredients of Enalapril maleate Tablets
This product contains lactose - if you know you have intolerance to some sugars, contact your doctor before use.
3. HOW TO TAKE ENALAPRIL MALEATE TABLETS
Always take your medicine exactly as your doctor told you. If you are unsure about how to take your tablets, ask your doctor or pharmacist.
• Itisvery important to continue taking Enalapril maleate Tablets for as long your doctor prescribes it.
• Donottake more tablets than prescribed.
You should take your tablet at the same time each day unless your doctor tells you otherwise. If you are taking your medicine twice daily (2 tablets a day), take one tablet in the morning and one in the evening, unless your doctor has told you otherwise.
Usual dose to be swallowed with a glass of water:
Adults
High blood pressure:
• Theusual starting dose is form 5mg to 20mg taken once a day
• Somepatients may need lower starting dose
• Theusual long term dose is 20mg taken once daily
• Themaximal long term dose is 40mg once a day Heart failure:
• Theusual starting dose is 2.5mg taken once a day
• Yourdoctor will raise this amount step by step until the dose that us right for you has been achieved
• Theusual long term dose is 20mg taken in one or two doses
• Themaximal long term dose is 40mg each day, divided in two doses Elderly (65 years and over)
Your dose will be decided by your doctor and will be based on how well your kidneys are working. Patients with kidney problems
Your dose of medicine will be changed depending on how well your kidneys are working:
• moderate kidney problems - 5mg to 10mg each day
• Severekidney problems - 2.5mg each day
• Ifyouare having dialysis - 2.5mg each day. On days you are not having dialysis, your dose may be changed depending on how low your blood pressure is.
Children: Not for use in children
If you take more Enalapril maleate Tablets than you should
Do not take more medicine than your doctor tells you to. If you or anyone else has swallowed more tablets than doctor have prescribed, contact your nearest hospital causality department or doctor immediately. Take the medicine pack with you.
If you forget to take Enalapril maleate Tablets
If you forget to take a dose, 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 Enalapril Tablets
Do not stop taking your medicine, unless your doctor has told you to.
If you have any further questions on the use of this product ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines Enalapril maleate Tablets can cause side effects, although not everybody gets them.
If you develop any of the following reactions stop taking these tablets and contact your doctor immediately:
• Ifyoudevelop severe dizziness or lightheadedness (especially at the start of the treatment or when the dose is increased)
• Swelling of the face, lips, tongue or throat which may cause difficulty in breathing or swallowing
• Swelling of your hands, feet or ankles
• A sudden, unexpected rash or burning, red or peeling skin
• Sorethroat or fever
You should be aware that black patients are at increased risk of these types of reactions. If any of the above happens, stop taking Innovance and talk to doctor straight away.
You may feel dizzy when you start taking Enalapril maleate Tablets. 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 possible side effects include:
Very common (affects more than 1 in 10 people)
• Feelingdizzy, weak or sick
• Blurredvision
• Cough
Common side effects (affecting between 1 in 10 and 1 in 100 people)
• Diarrhoea or abdominal pain, rash
• Headache, fainting (syncope)
• Lowblood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain
• Weakness or fatigue, depression
• Allergicreactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing
• Increased potassium level, increased levels of creatinine in your blood (both are detected by a test)
• Changein sense of taste, shortness of breath
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)
• Indigestion, ,vomiting, constipation, anorexia (loss of appetite)
• Slowmovement of food through your intestine, inflammation of your pancreas
• Irritatedstomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure
• Runnynose, sore throat or hoarseness
• Suddenfall in blood pressure (you may experience dizziness, fainting or light-headedness)
• Fastoruneven heart beats (palpatations)
• Heartattack (possibly due to very low blood pressure in certain high-risk patients, including those with blood flow problems of heart or brain)
• Anaemia (including aplastic and haemolytic)
• Stroke(possibly due to very low blood pressure in certain high-risk patients)
• Confusion, difficulty sleeping, sleepiness, nervousness
• Feelingyour skin prickling or being numb
• Vertigo
• Ringingin your ears (tinnitus)
• Asthma
• Increased perspiration
• Itchingor nettle rash
• Lossofhair
• Musclecramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence
• Highlevel of proteins in your urine (measured in a test)
• Lowlevel of blood sugar or sodium, high level of blood urea (all measured in blood tests)
Rare side effects (affecting between 1 in 1000 and 1 in 10000 people)
• Raynaud's phenomenon' where your hands and feet may become very cold and pale due to low blood flow
• Bonemarrow depression
• Autoimmune diseases
• Strangedreams or sleep problems
• Pulmonary infiltrates
• Inflammation of your nose
• Pneumonia
• Inflammation of the cheeks, gums, tongue, lips, throat
• Loweramount of urine produced
• Skindisorder due to an allergic reaction or infection called Erythema multiforme
• Inflammation of the liver, liver disease, increase in liver enzymes or bilirubin (measured in tests), jaundice (yellowing of the skin and/or eyes)
• Stevens-Johnson syndrome' a serious skin condition where you have reddening or scaling of your skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers
• Blooddisorders including changes in blood values such as lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets
• Enlarged breasts in men
Very rare side effects (affecting less than 1 in 10000 people)
• Swelling in your intestine (intestinal angioedema)
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE ENALAPRIL MALEATE TABLETS
Keep out of the reach and sight of children.
Do not take Enalapril maleate tablets after the expiry date on the carton; the expiry date refers to the last day of the month.
Do not store above 25°C.
Store in the original packaging.
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. FURTHER INFORMATION
What Enalapril maleate Tablets contain
The active substance is Enalapril maleate 2.5mg, 5mg, 10mg or 20mg per tablet.
The other ingredients are Lactose monohydrate, Maize starch and Glycerol palmitostearate. What Enalapril maleate Tablets looks like and contents of the pack
Enalapril maleate Tablets are white to off-white round flat beveled edged tablets marked with '2.5' (2.5mg), '5' (5mg), '10' (10mg) or '20' (20mg), on one side and break line on the other.
They are supplied in blister packs of 28 tablets and bottles containing 50 tablets
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD United Kingdom
Manufacturers:
Milpharm Limited,
Ares, Odyssey Business Park,
West End Road,
South Ruislip, HA4 6QD United Kingdom
APL Swift Services (Malta) Ltd.,
Hf26, Hal Far Industrial Estate,
Hal Farm Bizebbugia, BBG 3000
The leaflet was last revised in 10/2014.
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