LISINOPRIL 5 mg Tabletka

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1. Lisinopril Mylan Generics 5 mg, 20 mg tablets
   1. What is Lisinopril Mylan Generics and what is it used for
   2. What you need to know before taking Lisinopril Mylan Generics
   3. How to take Lisinopril Mylan Generics
   4. Possible side effects
   5. How to store Lisinopril Mylan Generics
   6. Contents of the pack and other information

Lisinopril Mylan Generics 5 mg, 20 mg tablets

(lisinopril dihydrate)

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Lisinopril Mylan Generics is and what it is used for
• 2. What you need to know before you take Lisinopril Mylan Generics
• 3. How to take Lisinopril Mylan Generics
• 4. Possible side effects
• 5. How to store Lisinopril Mylan Generics
• 6. Contents of the pack and other information

1. What is Lisinopril Mylan Generics and what is it used for

Lisinopril Mylan Generics contains lisinopril which belongs to a group of medicines called Angiotensin Converting Enzyme (ACE) inhibitors. ACE inhibitors reduce blood pressure and dilate
blood vessels, this allows blood to flow more easily and reduce the effort required to pump blood
throughout the body. Lisinopril Mylan Generics is used to treat high blood pressure (hypertension),
heart failure, and, in combination with other medicines, can be administered after a heart attack.
Lisinopril Mylan Generics can also be administered to treat kidney problems in diabetic patients with
high blood pressure (hypertension).

2. What you need to know before taking Lisinopril Mylan Generics

Do not take Lisinopril Mylan Generics

• If you are allergic to lisinopril, to any other angiotensin converting enzyme (ACE) inhibitor (such as captopril, enalapril, ramipril) or to any of the other components of this medicine (listed in section 6).
• If you have previously been treated with an ACE inhibitor and have experienced an allergic reaction. The signs may include swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing (angioedema).
• If you or a family member has a history of angioedema. If you are pregnant for more than 3 months. (It is best to avoid Lisinopril during the first months of pregnancy, see section “Pregnancy and breastfeeding”).
• If you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• If you have taken or are taking sacubitril/valsartan, a medicine used to treat a type of long-term (chronic) heart failure in adults, as this increases the risk of angioedema (rapid swelling under the skin in areas such as the throat).

Warnings and precautions
Talk to your doctor or pharmacist before taking Lisinopril Mylan Generics:
If you have low blood pressure (hypotension).
If you are dehydrated following treatment with diuretics, dialysis, reduced salt intake in your diet, vomiting or
diarrhoea. You are very likely to experience a significant drop in blood pressure at the beginning of
treatment and may feel weak or dizzy.
If you suffer from abnormal heart function, heart failure or heart valve disease, of
stiffening of the arteries, aortic stenosis (narrowing of the heart valve) or enlarged heart.
If you have had a stroke or mini-stroke (also known as a transient ischaemic attack (TIA))
If you suffer from kidney disease, kidney malfunction or narrowing of blood vessels to the
kidneys, and if you have had a kidney removed.
If you are of Black race and are taking an ACE inhibitor, you are at a higher risk of angioedema than a person
who is not Black and this medicine may be less effective.
You need dialysis or have had a kidney transplant.
You need desensitisation treatment (e.g. following a wasp or bee sting) or blood purification treatment (apheresis to help remove cholesterol); your doctor may
interrupt the treatment with lisinopril to prevent a possible allergic reaction.
If you suffer from a collagen vascular disease, e.g. scleroderma, SLE (or lupus, an allergic condition that
causes joint pain, skin rash and fever). Your doctor will prescribe blood tests
to check for the possible development of infections during treatment.
If you are diabetic.
If you have high levels of potassium in your blood.
If you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin II receptor blocker (AIIRA) (also known as sartans - for example valsartan, telmisartan, irbesartan), especially if you have kidney problems related to diabetes.
• aliskiren. If you are taking any of the following medicines, the risk of angioedema (rapid swelling under the skin in areas such as the throat) is increased:
• racecadotril (a medicine used to treat diarrhoea)
• medicines used to prevent rejection of transplanted organs and to treat cancer (such as temsirolimus, sirolimus, everolimus)
• vildagliptin (a medicine used to treat diabetes).

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 section “Do not take Lisinopril Mylan Generics”.
You must tell your doctor if you think you might be pregnant or are planning to become pregnant. Lisinopril is not
recommended in the first months of pregnancy and must not be taken from the third month of pregnancy because
it can cause serious harm to your baby (see section “Pregnancy and breastfeeding”).
During treatment
Tell your doctor or hospital staff if you need surgery or an anaesthetic.

Other medicines and Lisinopril Mylan Generics
Do not take Lisinopril Mylan Generics if you have taken or are currently taking sacubitril/valsartan (see
section “Do not take Lisinopril Mylan Generics” above).
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including those available without a prescription, such as:

• Diuretics, e.g. amiloride, triamterene, spironolactone.
• Potassium supplements (including salt substitutes), potassium-sparing diuretics and other medicines that can increase the amount of potassium in your blood (such as trimethoprim and co-trimoxazole for treating bacterial infections; cyclosporine, an immunosuppressant used to prevent rejection of transplanted organs; and heparin, a medicine used to thin the blood and prevent blood clots)
• Lithium, used to treat some mental illnesses.
• Painkillers called non-steroidal anti-inflammatory drugs (NSAIDs), used to treat pain and inflammation, such as indometacin, aspirin (if taken for more than 3 days), celecoxib, rofecoxib.
• Injectable gold salts, used to treat arthritis, e.g. sodium aurothiomalate, which can cause flushing of the face, dizziness, vomiting and low blood pressure.
• Other medicines for treating high blood pressure (e.g. atenolol, glyceryl trinitrate).
• Medicines for treating depression e.g. amitriptyline.
• Antipsychotic medicines, e.g. fluphenazine.
• Medicines used to stimulate the nervous system, e.g. ephedrine or pseudoephedrine, often contained in cough and cold remedies.
• Insulin or other medicines for diabetes, e.g. gliclazide, metformin; blood glucose levels should be carefully monitored during the first month of therapy with lisinopril.
• Allopurinol, used to treat gout.
• Procainamide, used to treat irregular heart rhythms.
• Racecadotril (often used to treat diarrhoea), vildagliptin (for the treatment of diabetes) or medicines used to prevent rejection of transplanted organs (sirolimus, everolimus and other drugs belonging to the mTOR inhibitors class). The risk of angioedema (rapid swelling under the skin in areas such as the throat) may be increased. See sections “Do not take Lisinopril Mylan Generics” and “Warnings and precautions”.
• Medicines for breaking up blood clots (usually given in hospital).
• Anaesthetics, such as lidocaine.

Your doctor may need to adjust your dose and/or take other precautions:
If you are taking an angiotensin II receptor blocker (AIIRA) or aliskiren (see also sections “Do not take Lisinopril Mylan Generics” and “Warnings and precautions”).

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you think you might be pregnant or are planning to become pregnant. Your doctor will probably advise you to stop taking Lisinopril Mylan Generics before becoming pregnant or as soon as you find out you are pregnant and will advise you to take another medicine instead of Lisinopril Mylan Generics.

Lisinopril Mylan Generics is not recommended in the first months of pregnancy,and must not be taken if you
have been pregnant for more than 3 months, as it can cause serious harm to the baby if taken after the third
month of pregnancy.

Breastfeeding
Tell your doctor if you are breastfeeding or intend to start breastfeeding. Lisinopril Mylan Generics
is not recommended during breastfeeding and your doctor may choose another treatment if you wish to
breastfeed, especially if your baby is a newborn or was born prematurely.

Driving and using machines
Donot drive or operate machinery if you feel dizzy or unusually tired while taking this medicine.

3. How to take Lisinopril Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have doubts
consult your doctor or pharmacist.

• Swallow the tablets with a glass of water.
• Try to take the tablets at the same time each day.

At the beginning of treatment, your doctor will carefully monitor your condition, have blood tests done,
check your kidney function and occasionally monitor blood salt levels. These
tests will be more frequent if you have kidney problems, a connective tissue disease or have been treated with
allopurinol, probenecid or immunosuppressants.

Adults (including the elderly)
To treat high blood pressure:The recommended initial daily dose is 10 mg. In some cases the initial daily dose is 2.5 mg or 5 mg. Your doctor will gradually increase the dose until the best
possible control of your blood pressure is achieved. The recommended maintenance dose is 20 mg once a
day. The maximum dose is 80 mg once a day.
Lisinopril Mylan Generics may be less effective in lowering blood pressure in patients of
black race.
If you are already taking a diuretic for blood pressure, your doctor will ask you to stop the treatment
with the diuretic or reduce its dose before starting therapy with Lisinopril Mylan Generics. Once your
blood pressure stabilizes, your doctor may start you on the diuretic again.

To treat heart failure:The recommended initial daily dose is 2.5 mg. Based on your response
to treatment, your doctor may gradually increase the dose, but not more than 10 mg every two weeks or more.
The maximum daily dose is 35 mg.
Your doctor may also prescribe other medicines such as a diuretic and digoxin or a beta-blocker such as
atenolol to treat your condition.

To treat patients who have suffered a heart attack:The recommended dose is 5 mg on the first and
second day, then 10 mg once a day. Your doctor may start treatment with a lower daily dose of 2.5 mg if you suffer from low blood pressure.
The recommended maintenance dose is 10 mg per day. Your doctor may adjust the dose or even
interrupt the treatment based on your response to therapy.

To treat conditions related to diabetes:The recommended daily dose is 10 mg. If necessary, your
doctor will increase the daily dose to 20 mg.

Patients with kidney problemsmay require a lower dose of Lisinopril Mylan Generics. Your
doctor may adjust the treatment to the dose that best controls your blood pressure or up to a maximum
of 40 mg per day.
Treatment with lisinopril is not recommended if you have recently undergone a kidney transplant.

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

• Lisinopril Mylan Generics is not recommended in children under 6 years of age or in any child with severe kidney problems.
• The doctor will establish the correct dose for your child. The dose depends on the child's body weight.
• For children weighing between 20 kg and 50 kg, the recommended initial dose is 2.5 mg once a day up to a maximum daily dose of 20 mg.
• For children weighing more than 50 kg, the recommended initial dose is 5 mg once a day up to a maximum of 40 mg per day.
• Lisinopril Mylan Generics is not recommended in children for indications other than hypertension.

The tablet can be divided into equal parts.

If you take more Lisinopril Mylan Generics than you should
Contact immediatelyyour doctor or the nearest emergency room. Bring with you the container and all the
remaining tablets. Symptoms of overdose include low blood pressure, shock, kidney failure,
changes in blood salt levels, detectable by blood tests, difficulty breathing, or increased or decreased heartbeats, dizziness, anxiety and cough.

If you forget to take Lisinopril Mylan Generics
Take the next dose as soon as you remember unless it is almost time for the next dose. Do nottake a
double dose to make up for the missed tablet.

If you stop taking Lisinopril Mylan Generics
Do notsuddenly stop treatment with Lisinopril Mylan Generics as this may lead to serious
fluctuations in your blood pressure. If you want to stop therapy, discuss it with your doctor or
pharmacist.
If you have any doubts about the use of Lisinopril Mylan Generics, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If any of the following side effects occur, stop treatment immediatelywith this
medicine and consult your doctor immediately or go to the nearest emergency room:

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

• severe chest pain that may spread to the neck and shoulders (heart attack) or stroke (especially if you experience severe dizziness, a feeling of lightheadedness (at the beginning of treatment or if the dose is increased or when getting up). These side effects are caused by a sharp drop in blood pressure.

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

• feeling unwell, confusion and/or weakness, feeling sick (nausea), loss of appetite, irritability. This is sometimes called “syndrome of inappropriate antidiuretic hormone secretion” (SIADH).
• Kidney failure (with signs such as back pain, swelling of the legs, feet, hands and face, fatigue, difficulty urinating)
• Severe allergic reactions. Signs may include sudden onset of
• swelling of the face, lips, tongue and/or throat which can cause difficulty breathing or swallowing (more likely in patients of black race), shortness of breath and wheezing
• severe skin itching (with bumps).

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

• Inflammation of the pancreas which can cause severe abdominal pain with feeling unwell
• Severe skin reaction with blisters on the skin, in the mouth, eyes and genitals or sores
• Serious skin condition that causes red patches, often itchy, that develop on the limbs and sometimes on the face and the rest of the body. The patches may develop blisters or may progress into raised, red and pale blisters in the center. This is accompanied by fever, joint pain, sore throat, headache and/or diarrhea
• An increase in infections or fever, for example sore throat, mouth ulcers that you may contract (this is more likely in patients with kidney problems and a collagen vascular disease e.g. scleroderma, or in treatment with immunosuppressants, allopurinol or procainamide), or if you notice that bruises or bleeding appear more easily or without explanation, or yellowing of the skin or eyes or if you feel tired, pale or weak. These can be signs of changes, some serious, in the number or type of blood cells which may be due to a reduction in the activity of the bone marrow (where blood cells are produced).
• Problems with the immune system that may include attacks by the immune system on the body's normal cells.
• Yellowing of the skin and/or eyes, pale stools, dark urine or stomach pain (these may be signs of liver problems such as liver inflammation or blockage of the bile duct), which can lead to liver failure
• Inflammation of the lungs or inflammation of the airways of the lungs
• Changes in kidney function causing a reduced production of urine compared to usual or no urine production.

Other possible side effects:
Common(may affect up to 1 in 10 people):

• dizziness or lightheadedness when getting up, especially when moving from a sitting or lying position to an upright position
• headache
• cough
• diarrhea
• vomiting
• kidney problems

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

• mood changes
• itching, tingling
• sense of spinning (vertigo)
• changes in taste
• sleep disturbances
• irregular heartbeat or skipped beats
• fast heartbeat
• problems with blood circulation causing cold, painful fingers
• itchy and runny nose
• nausea
• discomfort or pain in the stomach
• hallucinations (seeing, hearing or perceiving things that are not actually there)
• indigestion
• rash or itchy skin
• impotence
• fatigue or weakness
• increased levels of urea, creatinine or liver enzymes in the blood
• increased levels of potassium in the blood which can lead to an abnormal heart rhythm

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

• decreased blood cells that carry oxygen throughout the body
• confusion
• changes in smell
• dry mouth
• urticaria
• hair loss
• skin disease with thickened, red patches of skin, often with silvery scales (psoriasis)
• high levels of urea, which can cause gout (a painful inflammation of the joints)
• enlargement of the breasts in men
• increased levels of bilirubin which can lead to yellowing of the skin
• low levels of sodium in the blood which can cause fatigue and confusion, muscle cramps, convulsions or coma

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

• swelling of the glands of the neck, armpit or groin
• low levels of sugar (glucose) in the blood which can cause sweating, weakness, hunger, dizziness, tremors, headache, flushing or paleness, numbness, having a fast heartbeat
• asthma, difficulty breathing
• inflamed and swollen sinuses causing pain, high temperature and tenderness
• bloated intestines
• sweating
• disorders of the lymphatic glands

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

• symptoms of depression
• fainting
• changes in urine production (producing more urine than usual or no urine production).

It is also possible that Lisinopril may cause a syndrome of fever, inflammation of blood vessels, often with
redness of the skin, muscle or bone pain and skin sensitivity to light.

Side effects in children
Side effects in children appear to be similar to those observed in adults.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your doctor or
pharmacist. You can also report side effects directly through
the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. How to store Lisinopril Mylan Generics

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 package and on the blister after Exp. The expiry
date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Lisinopril Mylan Generics contains
The active ingredient is lisinopril. Each tablet contains 5 mg or 20 mg of lisinopril (as lisinopril dihydrate).
The excipients are magnesium stearate, talc, mannitol, corn starch and dibasic calcium phosphate dihydrate.

Description of the appearance of Lisinopril Mylan Generics and contents of the pack
Your medicine is presented as a white tablet. The 5 mg tablets have “5” imprinted on one side and
have a fracture line on the opposite side. The 20 mg tablets have “20” imprinted on one side and
have a fracture line on the opposite side.
Lisinopril Mylan Generics 5 mg tablets is available in blisters of 14, 15, 28, 30, 50, 60 and 100 tablets.
Lisinopril Mylan Generics 20 mg tablets is available in blisters of 14, 15, 28, 30, 50 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
McDermott Laboratories Ltd (trading as Gerard Laboratories), 35/36 Baldoyle Industrial Estate Grange Road,
Dublin 13, Ireland
Generics [UK] Ltd., Station Close, Potters Bar, Hertfordshire EN6 1TL, United Kingdom

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Austria - Lisinopril "Arcana" 5 mg, 10 mg & 20 mg Tablets
Denmark - Lisinopril Mylan 2.5 mg, 5 mg, 10 mg & 20 mg tablets
Belgium - Lisinopril Mylan 5 mg & 20 mg tablets
Ireland - Zesger 2.5 mg, 5 mg, 10 mg & 20 mg Tablets
Italy - Lisinopril Mylan Generics 5 mg & 20 mg tablets
Luxembourg – Lisinopril Mylan CPR. 5 mg & 20 mg
United Kingdom - Lisinopril 2.5 mg, 5 mg, 10 mg & 20 mg Tablets

This leaflet was last approved on: