Innovace 5mg Tablets
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Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
The name of your medicine is Innovace 5mg Tablets but will be referred to as Innovace throughout the remainder of the leaflet.
Innovace is also available in strengths of 2.5mg, 10mg and 20mg.
What is in this leaflet:
1. What Innovace is and what it is used for
2. What you need to know before you take Innovace
3. How to take Innovace
4. Possible side effects
5. How to store Innovace
6. Contents of the pack and other information
1. What Innovace is and what it is used for
Innovace contains an active substance called enalapril maleate. This belongs to the group of medicines called ACE inhibitors (angiotensin converting enzyme inhibitors).
Innovace is used:
• to treat high blood pressure (hypertension)
• to treat heart failure (weakening of heart function). It can lower the need to go to hospital and can help some patients live longer.
• to prevent the 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.
This medicine works by widening your blood vessels. This lowers your blood pressure. The medicine usually starts to work within an hour, and the effect lasts for at least 24 hours. Some people will require several weeks of treatment until the best effect on your blood pressure is seen.
2. What you need to know before you take Innovace Do not take Innovace:
• 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 to a type of medicine similar to Innovace called an ACE inhibitor.
• if you have ever had swelling of your face, lips, mouth, tongue or throat which caused difficulty in swallowing or breathing (angioedema) when the reason why was not known or it was inherited.
• if you have diabetes or kidney problems and are taking a medicine containing aliskiren to reduce blood pressure
• if you are more than 3 months pregnant (it is also better to avoid Innovace in early pregnancy - see Pregnancy section).
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 Innovace.
Warnings and Precautions
Talk to your doctor or pharmacist before taking this medicine:
• if you have a heart problem
• if you have a condition involving the blood vessels in the brain.
• if you have a blood problem such as low or lack of white blood cells (neutropenia/agranulocytosis), low blood platelet count (thrombocytopenia) or a decreased number of red blood cells (anaemia).
• if you have a liver problem
• if you have a 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 Innovace or monitor your blood level of potassium.
• if you are having dialysis
• if you have been very sick (excessive vomiting) or had bad diarrhoea recently.
• if you are on a salt-restricted diet, are taking potassium supplements, potassium-sparing agents, or potassium-containing salt substitutes.
• if you are over 70 years of age
• if you have 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.
• if you have ever had an allergic reaction with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing. You should be aware that black patients are at increased risk of these types of reactions to ACE inhibitors.
• if you have low blood pressure (you may notice this as faintness or dizziness, especially when standing).
• if you have collagen vascular disease (e.g. lupus erthematosus, rheumatoid arthritis or scleroderma), are on therapy that suppresses your immune system, are taking the drugs allopurinol or procainamide, or any combinations of these.
You must tell your doctor if you think you are (or might become) pregnant. This medicine is 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)
You should be aware that Innovace lowers the blood pressure in black patients less effectively than in non-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 about to have a procedure
If you are about to have any of the following, tell your doctor that you are taking Innovace:
• any surgery or receive anaesthetics (even at the dentist)
• a treatment to remove cholesterol from your blood called ‘LDL apheresis'
• a desensitisation treatment, to lower the effect of an allergy to bee or wasp stings.
If any of the above applies to you, talk to your doctor or dentist before the procedure.
Other medicines and Innovace
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes herbal medicines. This is because Innovace can affect the way some medicines work. Also some other medicines can affect the way Innovace works:
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
• other medicines to lower blood pressure, such as beta-blockers, angiotensin-receptor blockers, water tablets (diuretics), or a medicine called aliskiren.
• medicines containing potassium (including dietary salt substitutes).
• medicines for diabetes (including oral antidiabetic medicines and insulin)
• lithium (a medicine used to treat a certain kind of depression)
• medicines for depression called ‘tricyclic antidepressants'.
• medicines for mental problems called ‘antipsychotics'
• certain cough and cold medicines and weight reducing medicines which contain something called a ‘sympathomimetic agent'.
• certain pain or arthritis medicines including gold therapy.
• non-steroidal anti-inflammatory drugs, 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)
• alcohol
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Innovace.
Innovace with food and drink
Innovace can be taken with or without food. Most people take Innovace with a drink of water.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Your doctor will normally advise you to stop taking Innovace before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Innovace. This medicine is 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 Innovace. In the case of an older baby your doctor should advise you on the benefits and risks of taking Innovace whilst breast-feeding, compared to other treatments.
Driving and using machines
You may feel dizzy or sleepy while taking Innovace. If this happens, do not drive or use any tools or machines.
Innovace contains lactose
Innovace contains lactose, which is a type of sugar. If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Innovace
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• It is very important to continue taking Innovace for as long as your doctor prescribes it.
• Do not take more tablets than prescribed.
High blood pressure
• The usual starting dose ranges from 5 to 20 mg taken once a day.
• Some patients may need a lower starting dose.
• The usual long term dose is 20 mg taken once a day.
• The maximal long term dose is 40 mg taken once a day.
• stroke (possibly due to very low blood pressure in high-risk patients)
• confusion, sleeplessness or sleepiness, nervousness.
• feeling your skin prickling or being numb]
• vertigo
• ringing in your ears (tinnitus)
• runny nose, sore throat or hoarseness.
• asthma
• slow movement of food through your intestine, inflammation of your pancreas.
• being sick (vomiting), indigestion, constipation, anorexia.
• irritated stomach (gastric irritations), dry mouth, ulcer, impaired kidney function, kidney failure.
• increased perspiration
• itching or nettle rash
• loss of hair
• muscle cramps, flushing, generally feeling unwell (malaise), high temperature (fever), impotence.
• high level of proteins in your urine (measured in a test)
• low level of blood sugar or sodium, high level of blood urea (all measured in a blood test).
Rare (may affect up to 1 in 1,000 people)
• ‘Raynaud's phenomenon' where your hands and feet may become very cold and white due to low blood flow.
• changes in blood values such as a lower number of white and red blood cells, lower haemoglobin, lower number of blood platelets
• bone marrow depression
• autoimmune diseases
• strange dreams or sleep problems
• pulmonary infiltrates
• inflammation of your nose.
• pneumonia.
• inflammation of the cheeks, gums, tongue, lips, throat.
• lower amount of urine produced.
• erythema multiforme
• ‘Stevens-Johnson syndrome' a serious skin condition where you have reddening and scaling of your skin, blistering or raw sores, or detachment of the top layer of skin from bottom layers.
• liver problems such as lower liver function, inflammation of your liver, jaundice (yellowing of the skin or eyes), higher levels of liver enzymes or bilirubin (measured in a blood test).
• enlargement of the mammary glands in males.
Very rare (may affect up to 1 in 10,000 people)
• swelling in your intestine (intestinal angioedema)
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 Innovace
Keep out of the reach and sight of children.
Do not use after the expiry date shown on the label.
Do not store above 25°C. Store in the original package.
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. Further Information
The active ingredient in Innovace Tablets is enalapril maleate.
Each white, rounded, triangle-shaped tablets marked ‘MSD 712' on one side and a scoreline on the reverse contains 5mg enalapril maleate.
Also contain: lactose monohydrate, magnesium stearate, maize starch, pregelatinised maize starch, sodium hydrogen carbonate.
POM
Heart Failure
• The usual starting dose is 2.5 mg taken once a day.
• 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 20 mg each day, taken in one or two doses.
• The maximal long term dose is 40 mg each day, divided in two doses. Patients with kidney problems
Your dose of medicine will be changed depending on how well your kidneys are working:
• Moderate kidney problems - 5 mg to 10 mg each day.
• Severe kidney problems - 2.5 mg each day.
• If you are having dialysis - 2.5 mg each day. On days you are not
having dialysis, your dose may be changed depending on how low
your blood pressure is.
Elderly patients
Your dose will be decided by your doctor, and will be based on how well your kidneys are working.
Use in Children
Experience in the use of Innovace in children with high blood pressure is limited. If the child can swallow tablets, the dose will be worked out using the child's weight and blood pressure. The usual starting doses are:
• Between 20 kg and 50 kg - 2.5 mg each day.
• More than 50 kg - 5 mg each day.
The dose can be changed according to the needs of the child:
• A maximum of 20 mg daily can be used in children who are between 20 kg and 50 kg.
• A maximum of 40 mg daily can be used in children who are more than 50 kg.
This medicine is not recommended in newborn babies (first few weeks after birth) and in children with kidney problems.
If you take more Innovace than you should
If you take more Innovace than you should, talk to your doctor or go to a hospital straight away. Take the medicine pack with you. The following effects may happen: feeling of light-headed or dizziness. This is due to a sudden or excessive drop in blood pressure.
If you forget to take Innovace
• 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 Innovace
Do not stop taking your medicine unless your doctor tells 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 Innovace can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
Stop taking Innovace and talk to your doctor straight away, if you notice any of the following:
• swelling of your face, lips, tongue or throat which may cause difficulty in breathing or swallowing.
• swelling of your hands, feet or ankles.
• if you develop a raised red skin rash (hives).
You should be aware that black patients are at increased risk of these types of reactions. If any of the above happens, stop taking Innovace and talk to a doctor straight away.
When you start taking Innovace you may feel faint or dizzy. 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 side effects include:
Very Common (may affect more than 1 in 10 people)
• feeling dizzy, weak or sick.
• blurred vision
• cough
Common (may affect up to 1 in 10 people)
• low blood pressure, changes in heart rhythm, fast heartbeat, angina or chest pain.
• headache, fainting (syncope)
• change in sense of taste, shortness of breath.
• diarrhoea or abdominal pain, rash.
• tiredness (fatigue), depression.
• allergic reactions with swelling of the face, lips, tongue or throat with difficulty in swallowing or breathing.
• increased blood potassium level, increased levels of creatinine in your blood (both are usually detected by a test).
Uncommon (may affect up to 1 in 100 people)
• sudden fall in blood pressure.
• fast or uneven heart beats (palpitations).
• heart attack (possibly due to very low blood pressure in certain high-risk patients, including those with blood flow problems of the heart or brain).
• anaemia (including aplastic and haemolytic).
Innovace are available in blister packs of 28 tablets.
PL 20774/1130 Innovace 5mg Tablets
Manufactured by Merck Sharp & Dohme B.V. Waarderweg 39, PO Box 581 Haarlem, 2003 PC, The Netherlands. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Ltd, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA.
Leaflet revision date: 5th August 2014
Innovace is a registered trademark of Merck Sharp & Dohme Corp.
PP3/1130/V3