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Primylis


Package leaflet: Information for the patient


Primylis 2.5 mg Tablets

Primylis 5 mg Tablets

Primylis 10 mg Tablets

Primylis 20 mg Tablets


lisinopril


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. See section 4.


What is in this leaflet

1. What Primylis is and what it is used for

2. What you need to know before you take Primylis

3. How to take Primylis

4. Possible side effects

5. How to store Primylis

6. Contents of the pack and other information


1. What Primylis is and what it is used for


Primylis contains lisinopril, which belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. ACE inhibitors lower blood pressure by widening your blood vessels. This allows the blood to flow more easily and reduces the effort needed to pump blood around the body. Primylis can be used for the following conditions:


2. What you need to know before you take Primylis


Do not take Primylis:


Do not take Primylis if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking this medicine.


Warnings and precautions

Talk to your doctor or pharmacist before taking Primylis

if you are taking any of the following medicines used to treat high blood pressure:


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 Primylis”


You must tellyour doctor if you think you are (or might become) pregnant. Lisinopril 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 and breast-feeding section).


During treatment

Talk to your doctor or hospital staff if:

you need to have surgery (including dental surgery) or need anaesthesia. This is because you can get low blood pressure (hypotension) if you are given certain local or general anaesthetics while you are taking this medicine.

you develop a dry cough which is persistent for a long time after starting treatment with lisinopril,


If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Primylis.


Children and adolescents

Lisinopril has only been studied in children with high blood pressure (see section 3, How to take Primylis). For more information, talk to your doctor. Lisinopril is not

recommended in children under 6 years of age or in any child with severe kidney problems.


Other medicines and Primylis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This is because lisinopril can affect the way some medicines work and some medicines can have an effect on lisinopril.


In particular, tell your doctor or pharmacist if you are taking any of the following medicines:



Your doctor may need to change your dose and/or to take other precautions if you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not take Primylis” and “Warnings and precautions”).


Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.


Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Primylis before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of this medicine.Lisinopril 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 it is used after the third month of pregnancy.


Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Lisinopril is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.


Driving and using machines



3. How to take Primylis


Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.


At the start of treatment your doctor may monitor your condition closely, take blood tests, check how your kidneys are working and monitor the level of salts in your blood from time to time.


Adults (including the Elderly)

Your dose depends on your medical condition and whether you are taking any other medicines. Your doctor will tell you how many tablets to take each day. Check with your doctor or pharmacist if you are unsure.


To treat high blood pressure: The recommended starting dose is 10 mg daily although, in some cases, this can be lower. Your doctor will slowly increase this to a dose which best controls your blood pressure. The recommended maintenance dose is 20 mg once daily. The maximum dose is 80 mg once daily.


If you are already taking a ‘water’ tablet (diuretic) for your blood pressure, your doctor may ask you to stop taking your diuretic or to reduce the dose before starting lisinopril. Your doctor may restart the water tablets once your blood pressure is stable.


To treat heart failure: The recommended starting dose is 2.5 mg daily. Based on your response to the treatment your doctor may slowly increase this dose by no more than 10 mg every two weeks or more. The maximum dose is 35 mg once daily. Your doctor may also ask you to take other medicine for your heart problems such as a diuretic, digoxin or a beta-blocker e.g. atenolol.


To treat patients who have suffered a heart attack: The recommended starting dose is 5 mg within 24 hours of your attack and 5 mg one day later. The usual long-term dose is 10 mg once a day. If you have low blood pressure a lower dose of 2.5 mg daily may be given. You should take this medicine for at least 6 weeks.


For kidney problems caused by diabetes: The recommended dose is 10 mg daily. If needed, your doctor will increase this to 20 mg once daily.


Patients with kidney problems may be given a lower dose of lisinopril. Your doctor may adjust to a dose which best controls your blood pressure or to a maximum of 40 mg daily.


Lisinopril is not recommended in patients who have recently had a kidney transplant.


Use in children and adolescents (6 to 16 years old) with high blood pressure


Taking your medicine


Taking your first dose


If you take more Primylis than you should

Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining tablets with you. Symptoms of overdose include low blood pressure, shock (a dangerous decrease of blood pressure which, if untreated, may lead to collapse or loss of consciousness), kidney failure, changes in blood salts which may be seen in blood tests, difficulty breathing, increased or decreased heart beat, dizziness, anxiety and cough.


If you forget to take Primylis

Take the next dose as soon as you remember unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.


If you stop taking Primylis

Do not suddenly stop taking your medicine. If you want to stop the treatment discuss this with your doctor or pharmacist first.


If you have any further questions on the use of this medicine, ask your doctor or pharmacist.


4. Possible side effects


Like all medicines, this medicine can cause side effects, although not everybody gets them.


If any of the following happen, stop taking lisinopril and tell your doctor immediately or go to your nearest hospital emergency department:


Uncommon (may affect up to 1 in 100 people):

severe sudden chest pain which may spread to the neck, shoulders and arms with shortness of breath and a clammy feeling (these may be signs of a heart attack) or weakness or numbness down one side of the body, confusion, difficulty speaking or loss of coordination (these may be signs of a stroke). These may occur due to a large drop in blood pressure especially if you have symptoms such as severe dizziness, light-headedness at the start of the treatment, when the dose has increased or when you stand up.


Rare (may affect up to 1 in 1,000 people):


Very rare (may affect up to 1 in 10,000 people):


Other possible side effects include:


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):

a disease where your immune system (which defends your body against diseases) does not recognise healthy cells and attacks them. This is called an autoimmune disease and can affect any part of the body.

Not known(frequency cannot be estimated from the available data):


One or more of the following have also been seen in patients taking lisinopril: fever, inflamed veins (vasculitis), muscle pain, inflamed or painful joints, rash or other skin problems such as sensitivity to sunlight or blood tests that suggest an increase in white blood cells or inflammation.


Side effects in children

Side effects in children with high blood pressure appear to be comparable to those seen in adults.


Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also reportsideeffectsdirectlyvia[to be completed nationally]. By reportingsideeffectsyou can help providemoreinformation on thesafetyofthismedicine.


5. How to store Primylis


Do not throw away 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.


6. Contents of the pack and other information


What Primylis contains

The active substance is lisinopril dihydrate. The other ingredients are: calcium hydrogen phosphate dihydrate, mannitol, pregelatinised maize starch, croscarmellose sodium, povidone, magnesium stearate/sodium laurilsulfate (94/6) and colloidal anhydrous silica. In addition 5mg, 10 mg & 20 mg tablets also contain iron oxide red (E172).


Primylis is supplied in four strengths containing 2.5 mg, 5 mg, 10 mg or 20 mg of lisinopril (as dihydrate).


What Primylis looks like and contents of the pack


2.5 mg: A white to off white, round, biconvex tablet debossed with “L over 22” on one side of the tablet and M on the other side.

5 mg: A light pink coloured, mottled, round, biconvex tablet debossed with “L and 23” on either side of the breakline on one side and “M” on the other side.

10 mg: A light pink coloured, mottled, round, biconvex tablet debossed with “M over L 24” on one side of the tablet and breakline on the other side.

20 mg: A pink coloured, mottled, round, biconvex tablet debossed with “M over L 25” on one side of the tablet and breakline on the other side.


Primylis is packed in blisters in packs of 10, 14, 28, 30, 50, 56, 60, 84, 98 & 100 tablets and bottles containing silica gel dessicant for hospital use containing 500 & 1000 tablets.


Primylis is packed in perforated unit dose blisters in packs of 28 x 1 tablets and 60 x 1 tablets.


Not all pack sizes may be marketed.


Marketing Authorisation Holder


[To be completed nationally]


Manufacturer

McDermott Laboratories Ltd. T/A Gerard Laboratories.

35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13

Ireland


Mylan Hungary Kft.

Mylan utca1., Komárom, 2900

Hungary


Mylan B.V.,

Dieselweg 25,

BUNSCHOTEN SPAKENBURG,

3752LB,

Netherlands


This medicinal product is authorised in the Member States of the EEA under the following names:


Belgium: Lisijenson 5 mg, 20 mg tabletten

Denmark: Primylis 5mg/10mg/20mg tablett

Spain: Lisinopril MYLAN Pharmaceuticals 5 mg comprimidos EFG, Lisinopril MYLAN Pharmaceuticals 20 mg comprimidos EFG

France: Lisinopril Mylan Pharma 5 mg, 20 mg comprimé sécable

Ireland: Lisinopril 2.5 mg, 5 mg, 10 mg & 20 mg Tablets

Luxembourg: LisiJenson 5 mg, 20 mg comprimés

Netherlands: Lisinopril Mylan 2.5/5/10/20 mg tabletten

Poland: Lisigen

Portugal: Lisinopril Mylan

Sweden: Primylis, 2,5 mg/5 mg/10 mg/20 mg tablett

United Kingdom: Lisinopril 2.5 mg, 5 mg, 10 mg and 20 mg Tablets


This leaflet was last revised in 2016-06-17

[To be completed nationally]