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LISINOPRIL 5 MG TABLETS

Active substance(s): LISINOPRIL DIHYDRATE

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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

CONFIDENTIAL

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PL 04416/1034-1037

Package leaflet: Information for the patient

Lisinopril 2.5 mg Tablets
Lisinopril 5 mg Tablets
Lisinopril 10 mg Tablets
Lisinopril 20 mg Tablets
Active substance: 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 Lisinopril is and what it is used for
2.
What you need to know before you take Lisinopril
3.
How to take Lisinopril
4.
Possible side effects
5.
How to store Lisinopril
6.
Contents of the pack and other information

1.

What Lisinopril is and what it is used for
Lisinopril is used to treat:

high blood pressure

reduced heart pumping ability

patients recovering from a heart attack

kidney disease resulting from diabetes and high blood pressure.

Lisinopril is recommended in children (above 6 years old) only for the treatment of
high blood pressure (hypertension).
Lisinopril contains a medicine called Lisinopril. This belongs to the ACE inhibitor medicine
group (angiotensin-converting enzyme inhibitors). Lisinopril expands your blood vessels. This
reduces your blood pressure and makes it easier for your heart to pump blood to all body parts.

2.

What you need to know before you take Lisinopril
Do not take Lisinopril

if you are allergic to lisinopril or to
any of the other ingredients of this medicine (listed in section 6) or to other ACE
inhibitors.

if during earlier ACE inhibitor use you had swelling of the face, lips, tongue and/or
throat with difficulty swallowing, breathing or with joints.
Do not take Lisinopril if you had any of these reactions

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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets





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without a known cause or
if it has been confirmed that you have a hereditary or
other form of fluid accumulation (angiooedema).
if you have diabetes or impaired kidney function and you are treated with a blood pressure
lowering medicine containing aliskiren.
if you are more than 3 months pregnant. (It is also better to avoid Lisinopril in early
pregnancy – see pregnancy section.)

Warnings and precautions
Talk to your doctor before taking Lisinopril

if you suffer from dehydration due to treatment with „water tablets“ (diuretics), dialysis,
a low salt diet, vomiting or diarrhoea.
If this applies to you, on starting medication you may frequently have a large drop in blood
pressure.

if you suffer from heart disorders such as heart failure, narrowing of the aortic or mitral
valves (aortic or mitral stenosis), or an increase in the thickness of the heart muscle
(hypertrophic cardiomyopathy or ‘HOCM’) or if you have a condition involving the

blood vessels in the brain.













PIL.10341037.007.2.0d

if you have kidney problems
if you are undergoing dialysis treatment
with high flux membranes
blood separation treatment to remove cholesterol from your blood by machine with
dextran sulphate
or
desensitisation treatment to reduce the effects of an allergy to a bee or wasp sting.
In these cases tell your doctor that you are taking Lisinopril. He may wish to interrupt
your Lisinopril treatment to prevent a possible allergic reaction.
if you have liver problems. If you develop jaundice during use of Lisinopril stop taking
it and consult your doctor.
if you have blood vessel disease, known as collagen vascular disease
if you are Black of Afro Caribbean origin have a higher risk of having:
sudden fluid accumulation in the skin and mucous membranes such as throat or
tongue
breathing difficulties
itching and rash, often as an allergic reaction
a reduction of the effect of Lisinopril.
if you have a cough.
Inform your doctor if this becomes worse.
if you need to have surgery or an anaesthetic, remind your doctor or dentist that you are
taking Lisinopril.
if taking other medicines, such as potassium supplements, lithium (for mental disorders)
or medicines against diabetes.
if you are taking any of the following medicines used to treat high blood pressure:
- an angiotensin II receptor blocker (ARBs) (also known as sartans - for example
valsartan, telmisartan, irbesartan), in particular if you have diabetes-related kidney
problems.
- aliskiren.
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 Lisinopril”.
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Lisinopril 2.5mg/5mg/10mg/20mg Tablets

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if you experience an infection with symptoms such as fever and serious deterioration of
your general condition, or fever with local infection symptoms such as sore
throat/pharynx/mouth or urinary problems you should see your doctor immediately
If you are unsure if any of the above apply to you, please discuss this with your doctor.
You must tell your doctor if you think that 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
section).
Children and adolescents
Lisinopril has been studied in children. For more information, talk to your doctor. This medicine
is not recommended in children under 6 years of age or in any child with severe kidney
problems.
Other medicines and lisinopril
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
This particularly applies to:

Diuretics (“water tablets”) which are used to treat high blood pressure including
potassium-sparing diuretics such as spironolactone, triamterene or amiloride.

Other medicines used to treat high blood pressure.
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 Lisinopril” and “Warnings and
precautions”).

Medicines that reduce inflammation and treat pain or arthritis , such as acetylsalicylic
acid doses over 3 grams daily ibuprofen, indomethacin or selective cyclooxygenase-2
inhibitors (COX-2 inhibitors)

Medicines for mental disorders or depressions such as
lithium
medicines to treat psychoses
tricyclic antidepressants, such as amitriptiline

Potassium containing supplements or salt substitutes.

Blood sugar lowering medicines, such as insulin or those taken orally.
The antidiabetic medicine dose may need adjusting.

Central nervous system stimulative medicines, such as
ephedrine or pseudoephedrine, which could be included in decongestants or
cough/cold remedies or
salbutamol, a medicine for treating asthma.

Medicines to suppress the body’s immune system

Allopurinol, a medicines to treat gout

Procainamide, used to treat abnormal heartbeats

Gold injections (sodium aurothiomalate), a medicine to injection against rheumatic
arthritis
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicines.
Pregnancy
You must tell your doctor if you think that you are (or might become) pregnant.
Your doctor will normally advise you to stop taking Lisinopril before you become pregnant or
as soon as you know you are pregnant and will advise you to take another medicine instead of
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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

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Lisinopril. 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 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
Dizziness or tiredness may occur when using Lisinopril. Do not drive or operate machinery if
this affects you.

3.

How to take Lisinopril
Always take this medicine exactly as your doctor has told you. Check with your doctor or
pharmacist if you are not sure.
Lisinopril should be taken once daily preferably every morning. Take the tablets whole with a
glass of water independent of meal.
The tablets are not intended to be broken.
Lisinopril 5 mg tablets
The tablets can be divided into equal doses.
Lisinopril 10 mg tablets
The tablets can be divided into equal doses.
Lisinopril 20 mg tablets
The tablets can be divided into equal doses.
Taking your first dose
 Take special care when you have your first dose of this medicine or if your dose is
increased. It may cause a greater fall in blood pressure than later doses.
 This may make you feel dizzy or light-headed. If this happens, it may help to lie down.
If you are concerned, please talk to your doctor as soon as possible
Adults
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.



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For high blood pressure
The recommended starting dose is 10 mg once a day.
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V050: Safety update – SPC, PIL and Labelling + RFI

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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

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For severe conditions your doctor may decide to start you on between 2.5mg and 5mg
once a day.
Once optimal control of blood pressure has been reached, the usual effective maintenance
dose is 20mg once a day.

Diuretic-Treated Patients
If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with
lisinopril. Patients with high blood pressure who cannot discontinue the diuretic therapy,
should begin Lisinopril treatment with 5mg once a day.


Heart conditions such as heart failure
The recommended starting dose is 2.5mg once a day.
The usual long-term dose is 5 to 35 mg once a day.



After 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.



Diabetic patients with kidney problems
The recommended dose is either 10mg or 20mg once a day.

Use in children and adolescents (6 to 16 years old) with high blood pressure
 This medicine is not recommended for children under 6 years or in any children with
severe kidney problems.
 The doctor will work out the correct dose for your child. The dose depends on the child’s
body weight.
 For children who weigh between 20 kg and 50 kg, the recommended starting dose is 2.5
mg once a day. The dose can be increased to a maximum of 20 mg once daily.
 For children who weigh more than 50 kg, the recommended starting dose is 5 mg once a
day. The dose can be increased to a maximum of 40 mg once daily.
Patients with reduced kidney function
If you suffer from a kidney disorder, the doctor should prescribe the lowest possible dose and
monitor your kidney function.
Patients following recent kidney transplant
The use of Lisinopril tablets is not recommended.
.
Elderly, over 65 years
No special dosage adjustment is necessary. In case of reduced kidney function the dose should
be adjusted carefully.

If you take more Lisinopril than you should
Contact your doctor or the nearest hospital casualty department immediately.
Take this leaflet or some tablets with you so that people will know what you have taken.
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V050: Safety update – SPC, PIL and Labelling + RFI

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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

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If you forget to take Lisinopril
Take the missed dose as soon as you remember. Do not take a double dose to make up for a
forgotten dose.
If you stop taking Lisinopril
Do not stop treatment before talking to your doctor, as this will reduce the treatments effect.
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.
Stop taking Lisinopril and seek medical advice immediately, if you develop any of the
following reactions:
 Severe allergic reactions (rare, may affect up to 1 in 1,000 people). The signs may include
sudden onset of:
- swelling of the face, hands, feet, lips, tongue and/or throat
- difficulties in breathing and swallowing
- severe skin itch with raised lumps.
 Severe skin disorders including Stevens-Johnson Syndrome and pemphigus (the symptoms
include a sudden, unexpected rash or burning, red skin, blistering of the lips, eyes or
mouth, genitals, skin peeling, fever) and aggregate of mature or abnormal looking
lymphocytes in the dermis (cutaneous pseudolymphoma) (very rare, may affect up to 1 in
10,000 people).
 Inhibition of the formation of blood in the bone marrow which can cause weakness,
bruising or make infections more likely. Other symptoms may include sudden sore throat,
fever, tiredness, paleness, mouth sores (very rare, may affect up to 1 in 10,000 people).
 An infection with symptoms such as fever and serious deterioration of your general
condition, or fever with local infection symptoms such as sore throat/pharynx/mouth,
abnormalities of the lymph glands or urinary problems (very rare, may affect up to 1 in
10,000 people).
 Inflammation of the liver (hepatitis). This can cause loss of appetite, yellowing of the skin
and eyes, and dark coloured urine (very rare, may affect up to 1 in 10,000 people).
 Inflammation of the pancreas. This causes moderate to severe pain in the stomach (very
rare, may affect up to 1 in 10,000 people).
 Possible heart attack (chest pressure or ache) or stroke (weakness or paralysis of limbs or
face, difficulty speaking) in high risk patients, increased heart rate and quick and irregular
heart beat (palpitations) (uncommon, may affect up to 1 in 100 people).

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

dizziness

headache

fall in blood pressure as a result e.g. of standing up rapidly from a sitting or lying
position, sometimes accompanied by dizziness

a dry cough that does not go away

diarrhoea

vomiting

kidney problems
Uncommon: may affect up to 1 in 100 people
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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

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mood changes

the sensation of pins and needles

spinning feeling

taste abnormalities

difficulty in sleeping

seeing, feeling or hearing things that are not there (hallucinations)


heart palpitations
numbness or tingling in the fingers and toes•
runny nose

feeling sick (nausea)

abdominal pain

indigestion

skin rash and/or itching

inability to maintain an erection (impotence)

tiredness

general weakness

change in blood tests that show how well your liver and kidneys are working

too much potassium in the blood, sometimes manifesting itself as muscle cramps,
diarrhoea, nausea, dizziness, headache (hyperkalaemia)
Rare: may affect up to 1 in 1,000 people

decrease of the red blood pigment haemoglobin and number of red blood cells
(haematocrit)

mental confusion

dry mouth

nettle rash

hair loss

psoriasis, a skin disorder

kidney failure leading to excessive urea in the blood

enlargement of one or both breasts in men


increase of bilirubin, a substance produced in the liver

low sodium level in the blood (signs are tiredness, confusion and muscle twitching)

sudden accumulation of fluid in the skin and mucous membranes (e.g. throat or tongue),
breathing difficulties and/or itching and rash, often as an allergic reaction
(hypersensitivity/angioneurotic oedema)

changes in the way things smell

feeling unwell, confused, irritable or weak, loss of appetite. This could be a sign of a
build up of fluid in the body and low concentration of salt in the blood (SIADH,
syndrome of inappropriate antidiuretic hormone secretion),
Very rare: may affect up to 1 in 10,000 people



low blood sugar levels
difficulty in breathing, inflammation of nasal sinuses, certain forms of pneumonia






allergic reaction in the small intestine (intestinal angioedema)
yellowing of the skin and/or the whites of the eyes (jaundice)
excessive sweating
passing less water (urine) than normal and/or passing urine less frequently.

Not known: frequency cannot be estimated from the available data
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Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets



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symptoms of depression
fainting

Skin reactions may be accompanied by fever, inflammation of a blood vessel (vasculitis) ,
muscle pains (myalgia), pains in the joints (arthralgia) and inflammation of the joints (arthritis),
increased quantity of antibodies (ANA), increased blood sedimentation rate, rash and increase in
the number of white blood cells (eosinophilia and leukocytosis), photosensitive to light or other
skin reactions can occur.
Children
Safety data from clinical studies suggest that lisinopril is generally well tolerated in
hypertensive children, and that the safety profile in this age group is comparable to that 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 report side effects directly via the Yellow Card
Scheme: 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 Lisinopril
This medicinal product does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use Lisinopril after the expiry date which is stated on the blister and on the carton after
“Exp”. The expiry date refers to the last day of that month.
Do not throw away any medicine 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 Lisinopril contains

The active substance is lisinopril
One tablet contains 2.72 mg lisinopril dihydrate, equivalent to 2.5 mg lisinopril.
One tablet contains 5.44 mg lisinopril dihydrate, equivalent to 5 mg lisinopril.
One tablet contains 10.89 mg lisinopril dihydrate, equivalent to 10 mg lisinopril.
One tablet contains 21.78 mg lisinopril dihydrate, equivalent to 20 mg lisinopril.


The other ingredients are calcium hydrogen phosphate dihydrate, mannitol, maize starch,
croscarmellose sodium and magnesium stearate.
Additional for strength 002-003-004: Ferric oxide red

What Lisinopril looks like and contents of the pack
Lisinopril 2.5 mg is a round, convex and white tablet which is available in following packs: 14,
28, 30, 50 and 100 tablets.
Lisinopril 5 mg is a round, convex slightly red tablet with a score notch on one side which is
available in following packs: 10,14, 28, 30, 30x1, 50, 56, 60, 98 and 100 tablets.
PIL.10341037.007.2.0d

26/08/2015

V050: Safety update – SPC, PIL and Labelling + RFI

SC

Sandoz Limited
Lisinopril 2.5mg/5mg/10mg/20mg Tablets

CONFIDENTIAL

9
PL 04416/1034-1037

Lisinopril 10 mg is a round, convex slightly red tablet with a score notch on one side which is
available in following packs: 10,14, 28, 30, 50, 98 and 100 tablets.
Lisinopril 20 mg is a round, convex, slightly red tablet with a score notch on one side which is
available in following packs: 10,14, 28, 30, 50, 56, 98, 100 and 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Limited
Frimley Business Park,
Frimley,
Camberley,
Surrey GU16 7SR.
Manufacturer
Lek Pharmaceuticals d.d
Verovskova 57
1526 Ljubljana, Slovenia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
391179 Barleben, Germany

This leaflet was last approved in 08/2015

PIL.10341037.007.2.0d

26/08/2015

V050: Safety update – SPC, PIL and Labelling + RFI

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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