Enalapril Maleate 10mg Tablets
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• Swelling of the hands, face, lips or tongue
• Difficulty in breathing
• A sudden, unexpected rash or burning, red or peeling skin
• Sore throat or fever
If you experience any of the above side effects tell your doctor IMMEDIATELY or go to a casualty department at your nearest hospital.
Other possible side effects
Very common side effects (affecting 1 in 10 people)
• Blurred vision
• Feeling dizzy, weak or sick
• Cough
Common side effects (affecting between 1 in 10 and 1 in 100 people)
• Headache, depression
• Low blood pressure, fainting
• Chest pain, irregular heartbeat, chest pain, fast heart beat
• Shortness of breath
• Diarrhoea, stomach pain,
• Decrease in ability to taste food
• Allergic reactions with swelling of the hands, lips, tongue or throat with difficulty in swallowing or breathing
• Tiredness (fatigue)
• Increased blood potassium level, increase levels of creatinine in your blood
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 people)
• Iron deficiency (anaemia) including aplastic and haemolytic
• Low blood sugar (hypoglycaemia)
• Confusion, sleeplessness or sleepiness or nervousness
• Tingling or burning sensation of the skin (paraesthesia)
• Runny nose, sore throat and hoarseness
• Asthma
• Vomiting, indigestion, constipation, anorexia
• Irritated stomach, dry mouth, ulcer
• Excessive sweating
• Itchy skin, hives
• Hair loss or baldness
• Impaired kidney function, kidney failure
• Impotence, decrease libido
• Muscle cramps, flushing, generally feeling unwell, fever
• Ringing of the ears
• Low level of blood sugar or sodium, high level of blood urea
Rare side effects (affecting between 1 in 1000 and 1 in 10000 people)
• Strange dreams or sleep problems
• Raynaud's phenomenon, where your hands and feet may become very cold and white due to low blood flow
• Pulmonary infiltrates
• Inflammation of the nose and lung
• Inflammation of the mouth, tongue, lips, throat, lips
• Inflammation of the liver, increase in liver enzymes, jaundice (yellowing of the skin and/or eyes)
• Mild skin condition caused by an allergic reaction or infection) erythema multiforme)
• Life threating skin condition (Stevens-Johnson syndrome) where you have reddening, scaling of your skin, blisters or raw sores or detachment of top layer of skin from bottom layer
• Peeling of the skin (exfoliative dermatitis, erythroderma)
• Blistering of autoimmune disease (pemphigus)
• Low amount of urine produced (oliguria)
• Enlarged breasts in men (gynecomastia)
• High levels of liver enzymes and high levels of serum bilirubin.
Very rare (affecting less than one person in 10,000):
• Swelling of the intestine.
Not known:
• Excessive release of antidiuretic hormone from the pituitary gland or other source.
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.
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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/ yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Enalapril Tablets
• Do not store above 25 °C. Store in the original package. Do not put them into another container as they might get mixed up. Keep them in the pack in which they are supplied.
• Keep out of sight and reach of children.
• Do not use Enalapril Tablets after the expiry date which is stated on the blister and the carton after EXP or EXP. DATE:
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• 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 Tablets contains
The active substance is Enalapril Maleate. The other ingredients are lactose, maize starch and glycerol distearate
What Enalapril Tablets look like and contents of the pack
Enalaprl tablets are white circular biplanar uncoated with 5, 1 0 or 20 embossed on one face and a score line on the other. They are supplied in blister packs of 28 tablets
Enalapril 5 mg Tablets - PL 21 880/0003 Enalapril 10 mg Tablets - PL 21880/0004 Enalapril 20 mg Tablets - PL 21 880/0005
Marketing Authorisation Holder and Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent,
Feltham TW13 7HF, UK.
E-mail: info@medreich.co.uk
This leaflet was last approved
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL Maleate 5/10/20 mg Tablets
Enalapril Maleate
Read all of this leaflet carefully before you start taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine 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.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Enalapril Maleate 5, 1 0 and 20 mg Tablets (referred to as Enalapril Tablets in this leaflet) are and what they are used for
2. Before you take Enalapril Tablets
3. How to take Enalapril Tablets
4. Possible side effects
5. How to store Enalapril Tablets
6. Further information
1. WHAT ENALAPRIL MALEATE TABLETS ARE AND WHAT THEY ARE USED FOR
Enalapril Tablets contains an active ingredient called enalapril maleate. This belongs to a group of medicines called Angiotensin converting enzyme inhibitors (ACE inhibitors). It works by causing blood vessels to relax, lowering blood pressure and increasing the supply of blood and oxygen to the heart.
Enalapril Tablets are used:
• to treat high blood pressure (hypertension).
• to treat heart failure.
• to prevent signs of heart failure.
2. BEFORE YOU TAKE ENALAPRIL TABLETS Do not take Enalapril Tablets if:
• If you are allergic (hypersensitive) to enalapril maleate or any of the other ingredients of Enalapril tablets (see Section 6 and end of Section 2).
• If you have ever had an allergic reaction to a type of medicine similar to Enalapril tablets called an Ace inhibitor (see section 2)
• If you have or have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing when the reason why was not known or it was inherited.
• If you are or think you might be pregnant or you are breastfeeding (see end of section 2)
Do not take Enalapril Tablets if any of the above applies to you. If
you are not sure talk to your doctor or pharmacist before taking
Enalapril Tablets.
Take special care with Enalapril maleate Tablets
You should let your doctor know:
• If you have low blood pressure
• If you have any of the following heart diseases: heart failure, narrowing (stenosis) of the opening of the aortic or mitral valve or enlarged heart (hypertrophic cardiomyopathy).
• If you have kidney disease, have had recent kidney transplantation, are dialysis patients, are taking diuretics (water tablets).
• If you have a liver problem or failure
• If you have a blood problems such as lower or lack of white blood cells neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia), decreased number of red blood cells (anaemia)
• If you have a history of "angioeodema" while taking other medicines. The signs may have been itching, wheezing or swelling of the face, lips, hands, mouth and throat with difficulty in swallowing or breathing. You should note that black patients are at increased risk of these types of reactions to Ace inhibitors
• if you have diabetes
• If you are on a salt restriction diet, or have suffered from excessive vomiting, diarrhoea or dehydration.
• If you develop a dry cough which is persistent for a long time
• If you have abnormally high levels of potassium in the blood or if you are taking potassium containing medicines or supplements, salt substitutes or low-salt milk.
• If you are taking lithium, used for the treatment of some psychiatric illnesses.
• If you develop jaundice (yellowing of the skin and white of the eyes)
• If you are receiving desensitisation treatment with hymenoptera venom (e.g. bee or wasp venom)
• If you are receiving a treatment called LDL apheresis to remove cholesterol from your blood by machine
• If you need to undergo surgery or receive anaesthetics (even at dentist).
You should be aware that Enalapril Tablets lowers the blood pressure in
black patients less effectively than in non-black patients
If any of the above apply to you, talk to your doctor of pharmacist
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 included herbal medicines. This is because Enalapril Tablets can affect the way some medicines work. Also some medicines can affect the way Enalapril tablets work.
It is especially important to tell your doctor if you are taking any of the following:
• Medicine which contain potassium e.g. spironolactone, eplerenone, triamterene, amiloride
• Water tablets (diuretics) such as thiazides, furosemide
• Other medicine that lower blood pressure, such as nitroglycerine, nitrates and vasodilators
• Lithium, used for the treatment of some psychiatric illnesses
• Tricyclic antidepressants such as amitriptyline used to treat depression and mental problems, (antipsychotics)
• Pain killer such as morphine or anaesthetic's
• Non-steroidal anti-inflammatory drugs (NSAIDs), medicine that reduce inflammation and can be used to relieve pain such as diclofenac
• Certain pain or arthritis medicine including gold therapy
• Certain cough and cold medicines and weight reducing medicines which contain sympathomimetics agents
• Antidiabetic drugs including oral agents to lower blood sugar and insulin
• Alcohol
• Aspirin (acetyl salicylic acid)
• Medicines used to dissolve blood clots (thrombolytics)
• Barbiturates (sedatives used for sleeplessness or epilepsy)
• Cholestyramine (used to help control cholesterol levels)
• Medicines for the treatment of cancer
• Allopurinol (used to treat gout)
• Ciclosporin (Immunosuppressive agents for autoimmune disorders)
• Procainamide used to treat abnormal heart rhythms
• Corticosteroids (used to treat certain conditions such as rheumatism, arthritis, allergic conditions, asthma or certain blood disorders)
• Antacids (used for the relief of indigestion)
Taking Enalapril tablets with food and drink
Enalapril Tablets can be taken with or without a meal. Do not drink alcohol whilst taking Enalapril Tablets. It may cause your blood sugar levels to drop too much and you may experience dizziness, lightheadedness or fainting.
Pregnancy and breast feeding Pregnancy
Tell your doctor before taking Enalapril tablets if you are pregnant or planning to become pregnant. Enalapril Tablets are not recommended in early pregnancy and must not be taken when more than 3months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Breastfeeding
Tell your doctor if you are breast-feeding or about to start breast-feeding. Breast-feeding premature or new born babies is not recommended whilst taking Enalapril Tablets. In the case of older infants, your doctor should advise you on the benefits and risks of taking Enalapril 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 TABLETS
Always take your medicine exactly as directed by your doctor. If you are unsure about how to take your tablets, ask your doctor or pharmacist.
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 oral dose to be swallowed with a glass of water High Blood Pressure
• The usual starting dose is 5mg to 20mg taken once daily.
• Some patients may need a lower dose
• The usual long term dose is 20mg daily
• The maximal long term dose is 40mg daily
Heart Failure
• The usual starting dose is 2.5mg taken once daily
• 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 20mg daily, taken in one or two doses
• The maximal long term dose is 40mg daily, divided in two doses
Patients with kidney failure
You dose of medicine will be changed depending on how well your kidneys are working:
• Moderate kidney problems - 5mg to lOmg daily
• Severe kidney problems - 2.5mg daily
• If you are having dialysis - 2.5mg daily. On days which you are not having dialysis , you dose may be changed depending on how low your blood pressure is
Elderly (65 years and over)
Your dose will be decided by the doctor and will depend on how well your kidneys are working.
Children
There is limited experience of the use of Enalapril tablets in children. The usual dose is based on the weight and blood pressure of the child:
• Between 20kg to 50kg - 2.5mg daily
• More than 50kg - 5mg daily
The dose can be adjusted to the needs of the child:
• Maximum 20mg daily dose to a child who weighs between 20kg-50kg
• Maximum 40mg daily dose to a child who weighs more than 50kg
Enalapril maleate tablets are not recommended in new born babies and in children with kidney problems
If you take more Enalapril Tablets than you should
Do not take more medicine than your doctor tells you to. If you or anyone else has swallowed a lot of tablets, contact your nearest hospital casualty department or doctor immediately.
If you forget to take Enalapril Tablets
If you miss a dose just carry on with the next one as normal, but make sure you tell your doctor. Do not take an extra one to make up.
If you stop taking Enalapril Tablets
If you stop taking your medication, your blood pressure may increase. If your blood pressure becomes too high it may affect the function of your heart and kidneys. Your doctor will tell you when you should stop taking Enalapril Tablets. 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 Tablets can cause side effects, although not everybody gets them.
Serious Allergic Reactions
If you experience any of these reactions, stop taking the medicine and seek medical help immediately:
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