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The product code(s) for this leaflet is: PL 00025/0220.
Innovace tablets
Innovace® 2.5 mg, 5 mg, 10 mg or 20 mg tablets
enalapril maleate
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
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:
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.
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.
Talk to your doctor or pharmacist before taking Innovace:
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 Innovace.”
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 this medicine 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 any of the following, tell your doctor that you are taking Innovace:
If any of the above applies to you, talk to your doctor or dentist before the procedure.
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. Your doctor may need to change your dose and/or to take other precautions.
In particular tell your doctor or pharmacist if you are taking any of the following medicines:
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Innovace.
Innovace can be taken with or without food. Most people take Innovace with a drink of water.
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 this medicine. In the case of an older baby your doctor should advise you on the benefits and risks of taking this medicine whilst breast-feeding, compared to other treatments.
You may feel dizzy or sleepy while taking this medicine. If this happens, do not drive or use any tools or machines.
Innovace contains lactose, which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your dose of medicine will be changed depending on how well your kidneys are working:
Your dose will be decided by your doctor and will be based on how well your kidneys are working.
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:
The dose can be changed according to the needs of the child:
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, 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-headedness or dizziness. This is due to a sudden or excessive drop in blood pressure.
Do not stop taking your medicine unless your doctor tells you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:
You should be aware that black patients are at increased risk of these types of reactions. If any of the above happen, stop taking Innovace and talk to a doctor straight away.
When you start taking this medicine 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)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Very Rare (may affect up to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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 and the carton after ‘EXP’. The expiry date refers to the last day of that month.
Do not store above 25°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Innovace tablets are available in 4 strengths.
The white round shaped tablet, one side marked ‘MSD 14’, the other side plain, contain 2.5 mg of enalapril maleate.
The white, rounded triangle shaped tablet, one side scored* and the other side marked ‘MSD 712’ contain 5 mg enalapril maleate.
The rust-red, rounded triangle shaped tablet, one side scored*, the other side marked ‘MSD 713’ contain 10 mg enalapril maleate.
The peach, rounded triangle shaped tablet, one side scored*, the other side marked ‘MSD 714’ contain 20 mg enalapril maleate.
*The scoreline is only to facilitate breaking for ease of swallowing and not to divide into equal doses.
Innovace is supplied in the following pack sizes:
Innovace 2.5 mg – All-aluminium blister packages containing 2, 11, 20, 28, 30, 40, 49 x 1, 50, or 100 tablets.
Innovace 5 mg - All-aluminium blister packages containing 2, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 98, or 100 tablets.
Innovace 10 mg - All-aluminium blister packages containing 28, 49 x 1, 30, 50, 98 or 100 tablets.
Innovace 20 mg - All-aluminium blister packages containing 10, 14, 20, 28, 28 x 1, 30, 49 x 1, 50, 56, 60, 84, 90, 98, 100 or 500 tablets.
Not all pack sizes may be marketed.
The holder of the Marketing Authorisation is:
The product is manufactured by
This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Finland, France, Greece, Luxembourg, Netherlands, Portugal, Spain, Sweden:
RENITEC
Germany:
XANEF
Italy:
ENAPREN
United Kingdom (Northern Ireland), Ireland:
INNOVACE
This leaflet was last revised in December 2022.
© 2022 Organon group of companies. All rights reserved.
PIL.RNT.22.UK.0187.IA-SNC-CRAM.NORCN