LISINOPRIL 20 MG TABLETS

Active substance: LISINOPRIL DIHYDRATE

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PATIENT INFORMATION LEAFLET
LISINOPRIL 2.5 MG, 5 MG, 10 MG
AND 20 MG TABLETS
Lisinopril Dihydrate
Please read all of this leaflet carefully before you start taking
this medicine. It is an important source of information about
your medicine and how to take it safely.
- 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 personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side ef fects gets serious, or if you notice any side
ef fects not listed on this leaflet, please tell your doctor or
pharmacist.
In This Leaflet:
1 What Lisinopril Tablets are and what they are used for.
2 Before you take Lisinopril Tablets.
3 How to take this medicine.
4 Possible side ef fects.
5 How to store this medicine.
6 Further information.
1. WHAT LISINOPRIL TABLETS ARE AND
WHAT THEY ARE USED FOR
Lisinopril belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme inhibitors). Lisinopril works by
widening your blood vessels, which helps reduce your blood
pressure and makes it easier for your heart to pump blood to all
parts of your body. Your doctor has prescribed Lisinopril for one of
the following reasons:
·
Your blood pressure is too high (hypertension).
· have a heart condition known as symptomatic heart failure,
You
where the heart does not pump your blood around your body as
well as it should.
·
You have had a heart at tack (myocardial infarction) that may
lead to a weakening of your heart. Lisinopril slows the
weakening down.
·
You have kidney problems related to your diabetes and high
blood pressure.
·
Lisinopril

is recommended in children (above 6 years old) only
for the treatment of high blood pressure (hypertension).

·
Lisinopril

should not be used in children with severe kidney
impairment.
2. BEFORE YOU TAKE LISINOPRIL TABLETS

Do not take Lisinopril
· you are more than 3 month pregnant. (It is also bet ter to avoid
If
Lisinopril tablets in early pregnancy - see pregnancy section).
· you have previously been treated with a medicine in the same
If
group of drugs as Lisinopril (ACE inhibitors) and have had an
allergic reaction which caused swelling of the hands, feet, or
ankles, the face, lips, tongue and/or throat with dif ficulty in
swallowing or breathing or if you or a member of your family
have had a similar reaction.
· you have ever had an allergic reaction to Lisinopril or to any of
If
its other ingredients.

If you are not sure whether to start taking Lisinopril, talk to your
doctor.
Take special care with Lisinopril
Tell your doctor if you have or have had any medical condition,
especially the following:
· narrowing of the aorta (aortic stenosis), the kidney artery
A
(renal artery stenosis) or the heart valves (mitral valve stenosis),
or an increase in the thickness of the hear t muscle
(hypertrophic cardiomyopathy, 'HOCM').
·
Other health problems such as:
- Low blood pressure (you may notice this as d i z z i n e s s o r
lightheadedness especially when standing).
- Kidney disease or you are undergoing dialysis.
- Liver disease.
- Blood vessel disease (collagen vascular disease) and/or
treatment with allopurinol (for gout), procainamide (for
abnormal heartbeats), immunosuppressants (medicines
which suppress the body's immune response), diuretics
and drugs which increase potassium levels (including
heparin).
- Diarrhoea or vomiting.
- A salt-restricted diet or you are taking potassium
supplements.
- You must tell your doctor if you think you are (or might
become) pregnant. Lisinopril tablets 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)
Stop taking Lisinopril and seek medical at tention immediately if
any of the following situations occur (an allergic reaction):
· you develop dif ficulty in breathing with or without swelling of
If
the face, lips, tongue and/or throat.
· you develop swelling of the face, lips, tongue and/or throat
If
which may cause dif ficulty in swallowing.
· you develop severe itching of the skin (with raised lumps).
If
Tell your doctor if you are undergoing/or will undergo
desensitisation treatment for an allergy, for example, to insect
stings. The desensitisation treatment reduces the ef fects of the
allergy (e.g. bee or wasp stings) but sometimes it can cause a more
severe allergic reaction if you are taking ACE inhibitors during the
desensitisation treatment.
Tell your doctor if you are going into hospital for an operation.
Tell your doctor or dentist that you are taking Lisinopril before you
are given a local or general anaesthetic. Lisinopril, combined with
some anaesthetics, may cause a short-term drop in blood pressure
soon af ter taking the tablets.
Take special care when taking the first dose of Lisinopril. It may
cause a greater fall in blood pressure than will occur following
continued treatment. You may notice this as dizziness or
lightheadedness and it may help to lie down. If you are concerned,
please consult your doctor.
There is limited information on the safety and ef fectiveness of
Lisinopril in children.
Taking Lisinopril with other medicines
Tell your doctor if you are taking or have recently taken any other
medicines, including herbal remedies, health foods or supplements
that you have bought yourself. This also applies to medicines used
some time ago. Some medicines may af fect the actions of other

medicines. Talk to your doctor if you are taking any of the following
medicines:
·
Diuretics (water tablets including those which conserve
potassium).
· ther medicines for your high blo od pressure
O
(antihypertensives).
·
Non-steroidal anti-inflammatory medicines (NSAIDs) such as
indometacin and high doses of aspirin (more than 3 grams per
day), which are used to treat arthritis or muscle pain.
·
Medicines that contain gold, such as sodium aurothiomalate,
which may be given to you as an injection.
·
Medicines for mental disorders such as lithium, antipsychotics
or tricyclic antidepressants.
·
Potassium tablets or potassium containing salt substitutes.
·
Medicines for the treatment of diabetes, such as insulin or those
taken orally, to lower blood sugar.
·
Medicines that stimulate the central ner vous system
(sympathomimetics). These include ephedrine,
pseudoephedrine and salbutamol and may be found in some
decongestants, cough/cold remedies and asthma medication.
·
Medicines that suppress the body's immune response
(immunosuppressants), treatment with allupurinol (for gout) or
procainamide (for abnormal heartbeats).
Pregnancy and breast-feeding
Pregnancy:
You must tell your doctor if you think you are (or might become)
pregnant. Your doctor will normally advise you to stop taking
Lisinopril tablets before you become pregnant or as soon as you
know you are pregnant and will advise you to take another medicine
instead of Lisinopril tablets. Lisinopril tablets are 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
af ter the third month of pregnancy.
Breast feeding:
Tell your doctor if you are breast-feeding or about to start breastfeeding. Lisinopril tablets are 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.
Safety and ef fectiveness have been studied in 6-16 year old
children with high blood pressure. Lisinopril has not been studied
in children under 6 years of age. Lisinopril is not recommended in
children under the age of 6 years or in children with severe kidney
problems.
Driving and using machines
Lisinopril may have a minor or moderate ef fect on ability to drive and
use machines. If you experience side ef fects like dizziness or
tiredness, you should not drive or operate machines.
If you are not sure whether you should start taking Lisinopril,
contact your doctor.
3. HOW TO TAKE LISINOPRIL TABLETS
How much to take
Your doctor will tell you how many tablets to take each day. The
dosage is individual and it is important that you take it as prescribed
by your doctor. Your starting dose and long term dose will depend
on your medical condition and whether you are taking any other
medicines. Check with your doctor or pharmacist if you are unsure.

Children under 6 years
The use of Lisinopril is not recommended.
For raised blood pressure
The usual recommended starting dose is 10 mg taken once a day.
The usual long-term dose is 20 mg taken once a day.
Children and adolescents aged 6 to 16 years
The dose depends on your weight. The usual starting dose is
between 2.5mg and 5mg once daily, which can be increased to a
ma ximum of 20mg to 40mg once daily. Patients with kidney
problems should take a lower dose. Your doctor will decide the
correct dose for you.
For symptomatic heart failure
The usual recommended starting dose is 2.5 mg taken once a day.
The usual long term dose is 5 to 35 mg taken once a day.
Af ter a heart at tack
The usual recommended starting dose is 5 mg on day 1 and day 2,
then 10 mg taken once a day.
For problems related to diabetes
The usual dose is either 10 mg or 20 mg taken once a day.
How to take Lisinopril
·
Swallow the tablet with a drink of water.
· to take your tablets at the same time each day. It does not
Try
mat ter if you take Lisinopril before or af ter food.
· not stop taking your tablets if you are feeling well, unless
Do
your doctor tells you.
·
Remember, the first dose of Lisinopril may cause a greater fall in
blood pressure than will occur following continued treatment.
This is especially likely if patients are also taking diuretics. You
may notice this as dizziness or lightheadedness and it may help
to lie down. If concerned, please consult your doctor as soon as
possible.
· you have the impression that the ef fect of Lisinopril is too
If
strong or too weak, talk to your doctor or pharmacist as soon as
possible.
If you take more Lisinopril than you should
Contact your doctor or nearest hospital immediately if you have
taken more than you should (overdose).
If you forget to take a dose
If you miss a dose, do not take an ex tra dose to make up for the
missed dose. Just resume your usual schedule.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Lisinopril can cause side ef fects. Do not be
alarmed by this list of possible side ef fects, you may not have any of
them. Most patients do not notice any side ef fects. However if you
do and they bother you, talk to your doctor.
Common side ef fects that may occur (between 1 in 10 and 1 in
100 patients):
Headache
Dizziness or light-headedness especially when standing up quickly
Diarrhoea
Cough
Vomiting

Mood changes
Change of colour (pale blue followed by redness) and/or numbness
or tingling in the fingers or toes
Changes in the way things taste
Feeling sleepy or dif ficulty in going to sleep, strange dreams
Rapid heartbeat
Running nose
Nausea
Stomach pain or indigestion
Skin rash
Itching
Impotence
Tiredness
Weakness (loss of strength).
An excessive drop in blood pressure may be experienced in
patients with coronary heart disease, or those with a narrowing of
the aorta (aortic stenosis), the kidney artery (renal artery stenosis)
or the heart valves (mitral valve stenosis), or those patients with an
increase in the thickness of the heart muscle (hypertrophic
cardiomyopathy).
Rare side ef fects that may occur (between 1 in 1,000 and 1 in
10,000 patients):
Allergic reactions: Stop taking Lisinopril and seek medical
at tention immediately if any of the following situations occur:
· you develop dif ficulty in breathing with or without swelling of
If
the face, lips, tongue and/or throat.
· you develop swelling of the face, lips, tongue and/or throat
If
which may cause dif ficulty in swallowing.
·you develop severe itching of the skin (with raised lumps).
If
Rarely, there may be changes to some of the cells or other parts of
your blood. It is possible that your doctor may occasionally take
blood samples to check whether Lisinopril has had any ef fect on
your blood. Sometimes these changes may show themselves as
tiredness or a sore throat, or they may be accompanied by a fever,
joint and muscle pains, swelling of the joints or glands, or sensitivity
to sunlight.
Other rare side ef fects are:
Confusion
Dry mouth
Hair loss
Skin rash
Psoriasis
Development of breasts in men.
Low levels of sodium in your blood (the symptoms may be
tiredness, headache, nausea, vomiting)
Very rare side ef fects that may occur (less than 1 in 10,000
patients)
Sinus pain
Wheezing
Inflammation of the lungs
Yellow skin and/or eyes (jaundice)
Inflammation of the liver or pancreas
Severe skin disorders (symptoms of which include redness,
blistering and peeling)
Sweating.

Not known (frequency cannot be estimated from the available
data)
Symptoms of depression
Uncommon side ef fects that may occur (between 1 in 100 and 1 Fainting
in 1,000 patients):
Lisinopril may af fect the kidneys, causing abnormally low or no
urine to be passed.

Tell your doctor if you have any side ef fects that are not mentioned in
this leaflet.
5. HOW TO STORE LISINOPRIL TABLETS
Store below 25°C. Store in the original package.
Do not take your tablets af ter the expiry date stated on the label. The
expiry date refers to the last day of that month.
Return any unused Lisinopril tablets to your pharmacist.
Keep out of the reach and sight of children.
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
What Lisinopril Tablet contains
The active substance is Lisinopril Dihydrate.
The other ingredients are Mannitol, Calcium Hydrogen Phosphate,
Maize Starch, Pregelatinised Starch, Colloidal Anhydrous Silica,
Magnesium Stearate and in the case of 5mg, 10 mg and 20 mg
tablets, Red Iron Oxide (E172).
What Lisinopril Tablets looks like and contents of the pack
Lisinopril tablets are supplied in 4 strengths:
2.5 mg, 5 mg, 10 mg, 20 mg
The 2.5 mg tablets are white, round tablets and the 5mg, 10 mg and
20 mg tablets are pink, round tablets. The tablets have a number
denoting tablet strength on one side and a scoreline on the other.
They are supplied as PVC / PVDC Aluminium blister packs in a
carton in pack sizes of 28 tablets.
Marketing Authorization Holder and Manufacturer
The Marketing Authorisation Holder:
Lupin (Europe) Limited,
Victoria Court,
Bex ton Road,
Knutsford,
Cheshire, WA16 0PF
United Kingdom
Tel.: + 44 (0) 1565 751378.
Manufacturer:
Lupin Limited,
15 B, Phase 1A,
Verna Industrial Area, Verna,
Goa 403722,
India.
Tel: +91- 83-26682222
For any information about this medicinal product, please contact the
local representative of the Marketing Authorization Holder.
Lupin (Europe) Limited,
Victoria Court,
Bex ton Road,
Knutsford,
Cheshire, WA16 0PF
United Kingdom
Tel.: + 44 (0) 1565 751378.
MANUFACTURER CODE NO. GO/DRUGS/654
This leaflet was last revised in October 2011.
ID#: 222328

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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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