ENALAPRIL MALEATE 5 MG TABLETS

Active substance: ENALAPRIL MALEATE

View full screen / Print PDF » Download PDF ⇩

Transcript
Elle
Brown

Digitally signed by Elle
Brown
DN: cn=Elle Brown,
o=TEVA UK Ltd.,
ou=Artwork
Origination, email=elle.
brown@teva.com,
c=GB
Date: 2011.03.23
11:19:19 Z

ENALAPRIL MALEATE
2.5 mg, 5 mg, 10 mg AND 20 mg
TABLETS
PACKAGE LEAFLET: INFORMATION FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

Digitally signed by James
McGarrigle
DN: cn=James
McGarrigle, o=TEVA UK
Ltd, ou=Artwork
Originator, email=james.
mcgarrigle@tevauk.com,
c=GB
Date: 2011.03.23 11:50:06
Z

• If you are to undergo any desensitisation
treatment to reduce the effects of an allergy to
bee or wasp stings, you should tell the doctor
before treatment that you are taking Enalapril
Maleate. The doctor may wish to stop your
medicine to prevent a possible allergic reaction
• If you are going to have an anaesthetic (even at
the dentist) or undergo any surgery you should
tell the doctor or dentist treating you that you
are taking Enalapril Maleate.

Taking other medicines
Please tell your doctor or pharmacist if you are
taking or have recently taken any other
medicines, including medicines obtained without
a prescription and herbal medicines. This includes
herbal medicines. This is because Enalapril
maleate can affect the way some medicines work
IN THIS LEAFLET:
and some other medicines can affect the way
1. What Enalapril Maleate is and what it is used for Enalapril maleate works.
2. Before you take Enalapril Maleate
In particular, talk to your doctor if you are taking
3. How to take Enalapril Maleate
any of the following:
4. Possible side effects
• diuretics (also known as ‘water tablets’) e.g.
5. How to store Enalapril Maleate
amiloride, spironolactone, eplerenone
6. Further information
or triamterene
• potassium supplements or potassium
WHAT ENALAPRIL MALEATE IS AND WHAT
containing salt substitutes
IT IS USED FOR
• other medicines to lower blood pressure e.g.
• Enalapril Maleate belongs to a group of drugs
nitroglycerin
called Angiotensin Converting Enzyme (ACE)
• non-steroidal anti-inflammatory drugs (usually
Inhibitors which are vasodilators (drugs which
taken to relieve pain, inflammation and/or
widen the blood vessels). This lowers your
stiffness) e.g. ibuprofen or diclofenac
blood pressure
• anti-diabetic medicines, tablets as well as insulins
• This medicine works by widening the blood
• immunosuppressants (medicines that reduce the
vessels, making it easier for the heart to pump
body’s natural defence system) e.g. ciclosporins
blood around the body. This helps to lower
• hypnotics (medicines to help you sleep) e.g.
blood pressure.
temazepam
• Enalapril Maleate is used:
• narcotics (medicines used to relieve moderate
• in the treatment of high blood pressure
to severe pain) e.g. morphine or pethidine
• in the treatment of heart failure. This is when • tricyclic antidepressants e.g. amitriptyline
your heart is not coping with its workload
• antipsychotics (medicines to treat
properly. This can make you feel tired after
schizophrenia, manic depression and paranoia)
light exercise, breathless, or cause swelling
e.g. chlorpromazine, haloperidol, clozapine
of your ankles or legs. This medicine should
• lithium (used to treat depression)
improve your symptoms, prevent your heart • allopurinol (used to treat gout)
failure from getting worse and reduce the
• heparin (used to thin the blood)
likelihood that you will need to go into
• procainamide (used to treat some heart
hospital for the treatment of heart failure
conditions)
• To prevent the signs of heart failure in patients • sympathomimetics e.g. dopamine, terbutaline,
with asymptomatic left ventricular dysfunction.
salmeterol, salbutamol, ephedrine, adrenaline
The signs include shortness of breath,
or phenylpropanolamine (phenylpropanolamine
tiredness after light physical activity such as
and ephedrine may be present in medicines for
walking, or swelling of the ankles and feet.
colds and nasal stuffiness)
• therapy with gold
BEFORE YOU TAKE ENALAPRIL MALEATE
• acetylsalicylic acid (aspirin)
• thrombolytics (medicines
DO NOT take Enalapril Maleate and talk to your
used to dissolve blood
doctor if you:
clots)
• are allergic (hypersensitive) to Enalapril
• alcohol.
Maleate or any of the other ingredients of this
medicine (listed in section 6. List of excipients) Important information about
• have ever experienced an allergic reaction to an some of the ingredients of
ACE-inhibitor drug e.g. captopril, ramipril
Enalapril Maleate
• have ever experienced an allergic reaction
• Patients who are
involving swelling of hands, lips, tongue or throat
intolerant to lactose
• are more than 3 months pregnant (it is also
should note that Enalapril
better to avoid Enalapril Maleate in early
Maleate tablets contain a small amount of
pregnancy – see ‘Pregnancy’ section)
lactose. If your doctor has told you that you
• if you were born with a tendency for tissue
have an intolerance to some sugars, contact
swelling (hereditary angioedema) or if you
your doctor before taking this medicine.
have tissue swelling with no known cause
Taking Enalapril Maleate with food and drink
(idiopathic angioedema).
• You should keep your alcohol intake to a
Do not take Enalapril maleate if any of the above
minimum while you are taking this medicine, as
apply to you. If you are not sure, talk to your doctor
alcohol increases the blood pressure lowering
or pharmacist before taking Enalapril maleate.
effects of Enalapril Maleate, and this medicine
Take special care with Enalapril Maleate
may increase the effects of alcohol. Enalapril
Tell your doctor before you start to take this
maleate can be taken with or without food.
medicine if you:
Driving and using machines
• may be dehydrated, for example, you have
• Enalapril Maleate may cause blurred vision,
suffered from excessive vomiting or diarrhoea
dizziness or weariness. If you are affected, DO
recently
NOT drive or operate machinery.
• suffer from narrowing of the blood vessels
leading to your kidneys
Pregnancy and breast-feeding
• have a condition called ‘aortic stenosis’ or
Pregnancy
‘outflow obstruction’ (a narrowing of the main
• DO NOT take Enalapril Maleate if you are more
artery leading from your heart)
than 3 months pregnant
• have any other serious heart problems (apart
• You must tell your doctor if you think you are
from heart failure) or suffer from
(or might become) pregnant. Your doctor will
cerebrovascular insufficiency (insufficient blood
normally advise you to stop taking Enalapril
supply to the brain)
Maleate before you become pregnant or as
• suffer from kidney problems or you are on
soon as you know you are pregnant and will
dialysis
advise you to take another medicine instead of
• have had a kidney transplant
Enalapril Maleate. Enalapril Maleate is not
• suffer from liver problems
recommended in early pregnancy, and must not
• are diabetic. You should monitor your blood for
be taken when more than 3 months pregnant,
low blood glucose levels, especially during the
as it may cause serious harm to your baby if
first month of treatment. The level of potassium
used after the third month of pregnancy.
in your blood can also be higher
Breast-feeding
• have previously had an allergic reaction with
swelling of the face, lips, tongue or throat with • Tell your doctor if you are breast-feeding or
about to start breast-feeding. Breast-feeding
difficulty in swallowing or breathing. You should
newborn babies (first few weeks after birth),
be aware that black patients are at increased
and especially premature babies, is not
risk of these types of reactions to ACE inhibitors
recommended whilst taking Enalapril Maleate
• have low blood pressure (you may notice this as
faintness or dizziness, especially when standing) • In the case of an older baby your doctor should
advise you on the benefits and risks of taking
• are on a low salt diet, are taking potassium
Enalapril Maleate whilst breast-feeding,
supplements, potassium- sparing agents or
compared with other treatments.
potassium containing salt substitutes
• suffer from a collagen vascular disease such as
HOW TO TAKE ENALAPRIL MALEATE
lupus erythematosus, rheumatoid arthritis or
scleroderma, are on therapy that suppresses your Always take Enalapril Maleate exactly as your
immune system, are taking the drugs allopurinol doctor has told you. You should check with your
or procainamide, or any combinations of these doctor or pharmacist if you are not sure.
• you have a blood problem that includes one of The tablets should be swallowed preferably with
the following: low white blood cells count, low a drink of water. The tablets should usually be
platelet count or decreased number of red
taken once a day, in the morning, but your doctor
blood cells (anaemia)
may ask you to take them twice a day e.g. in the
• are breast feeding or about to start
morning and in the evening.
breast-feeding (see Breast-feeding section).
The usual dose for:
• Adults:
You must tell your doctor if you think you are (or
High Blood Pressure
might become) pregnant. Enalapril Maleate is not
Treatment will usually start with 5–20 mg per
recommended in early pregnancy, and must not be
day. This may be gradually increased to a
taken if you are more than 3 months pregnant, as it
maintenance dose of 20 mg per day. The
may cause serious harm to your baby if used at that
maximum maintenance dose is 40 mg per day.
stage (see ‘Pregnancy and breast-feeding’ section).
Heart Problems
Other precautions you should remember whilst
Treatment will usually start with 2.5 mg per day.
taking this medicine:
This may be gradually increased to a maximum
• If you are about to have a treatment called ‘LDL
dose of 40 mg per day given in divided doses.
apheresis’, which is the removal of cholesterol
The usual long term dose is 20 mg each day,
from your blood by a machine, you should tell
taken in one or two doses.
the doctor who is treating you that you are
Dialysis patients
taking Enalapril Maleate. The doctor may wish
On dialysis days, you should take your usual
to stop your medicine to prevent a possible
dose after dialysis.
allergic reaction

1

2

3

Sarah Bell
2011.03.2
9 13:15:31
+01'00'

• Elderly patients or patients with kidney
problems:
If you are elderly or have kidney problems the
dose may be lower.
• Use in Children:
Experience with the use of this medicine in
children with high blood pressure is limited.
For children who can swallow the tablets,
Enalapril Maleate is given once a day.
The doctor will decide the dose depending on
the child’s weight and blood pressure response.
As a guide, the recommended initial dose is:
• children weighing from 20 kg to 50 kg = 2.5 mg
• children weighing over 50 kg = 5 mg.
The maintenance dosage should be adjusted
according to the needs of the child to a maximum
of 20 mg daily in children weighing 20 kg to 50 kg
and 40 mg in children weighing over 50 kg.
Enalapril Maleate is not recommended in babies
or children with kidney problems.
If you take more Enalapril Maleate than you should
If you (or someone else) swallow a lot of the tablets
all together or if you think a child has swallowed
any of the tablets, contact your nearest hospital
casualty department or your doctor immediately.
An overdose is likely to cause low blood pressure
and you may feel light headed and dizzy.
Please take this leaflet, any remaining tablets and
the container with you to the hospital or doctor so
that they know which tablets were consumed.
If you forget to take Enalapril Maleate
If you forget to take a tablet, take one as soon as
you remember, unless it is nearly time to take the
next one. DO NOT take a double dose to make up
for a forgotten dose.
If you stop taking Enalapril Maleate
DO NOT stop taking your medicine without talking
to your doctor first even if you feel better. If you see
another doctor or go into a hospital, let the doctor
or the staff know what medicines you are taking.
If you have any further questions on the use of
this product, ask your doctor or pharmacist.

4

POSSIBLE SIDE EFFECTS

Like all medicines, Enalapril Maleate can cause
side effects, although not everybody gets them.
You may feel dizzy or light-headed, have visual
problems for a short time after you take your first
dose, or when you first take an increased dose. It
may help to lie down until you feel better. If you
are worried, or if these effects continue, talk to
your doctor or pharmacist.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department at
your nearest hospital if you experience any of the
following side effects:
• an allergic reaction causing itchy, raised rash,
swelling of the lips, face, tongue or neck
leading to severe difficulty in breathing or
severe skin rash or hives
• blisters which may burst easily becoming raw
and painful or may bleed, red itchy spots,
peeling skin leaving red raw patches over the
body, blisters/bleeding of the lips, eyes, nose,
mouth and genitals
• a swollen painful abdomen, constipation, being
sick, indigestion, loss of appetite, dry mouth;
this could be a sign of an obstruction or
blockage of the bowel
• severe pain in the abdomen and back; this
could be a sign of pancreatitis
• blood disorders including anaemia (low blood
count causing unusual tiredness or weakness) or
bone marrow problems. Symptoms may include
fever, chills, sore throat, ulcers in your mouth or
throat or unexplained bruising or bleeding
• lung problems including inflammation of the
lung (pneumonia). You may feel unwell or less
hungry, have a high temperature (fever)
difficulty breathing, shortness of breath, cough
• high temperature, tiredness, loss of appetite,
stomach pain, feeling sick, jaundice (yellowing
of the skin or whites of the eyes), liver failure.
These may be symptoms of hepatitis
(inflammation of the liver)
• a complex side effect, which may include some
or all of the following symptoms: fever,
inflammation of the blood vessels often with
skin rash, muscle pain and inflammation, joint
pain and inflammation, abnormal blood test
results, blood disorders, rash, sensitivity to
light, other skin conditions and serositis
inflammation of membranes lining the lungs,
heart, stomach and some organs).

(especially when standing up)
• low blood sugar levels or sodium levels, high
level of blood urea, confusion, sleepiness,
difficulty sleeping, nervousness, pins and
needles and numbness, vertigo (a sensation
that your surroundings are spinning, either up
and down or from side to side)
• anaemia (low blood count causing unusual
tiredness or weakness)
• heart attack, stroke (these are more common in
high risk patients)
• palpitations (awareness of your heartbeat)
• runny nose, sore throat and hoarseness,
wheezing
• inflammation of your pancreas (swollen painful
abdomen), constipation, back pain and
vomiting, indigestion, loss of appetite, dry
mouth, stomach ulcer
• sweating, itching, nettle rash, hair loss
• kidney problems including kidney failure
• protein in the urine giving the urine a frothy
appearance
• impotence (inability to get or maintain an
erection)
• muscle cramps, flushing, ringing in the ears,
general feeling of being unwell, fever.
Rare (affecting less than one person in 1,000 but
more than one person in 10,000):
• blood disorders (characterised by fever, chills,
sore throat, ulcers in the mouth or throat or
unexplained bruising or bleeding)
• bone marrow depression, swollen glands,
autoimmune diseases (where the body attacks
itself)
• erythema multiforme
• “Stevens-Johnson syndrome” (a serious skin
condition with reddening, scaling of your skin,
blistering or detachment of the top layer of skin)
• abnormal dreams and other sleep disturbances
• Raynaud’s phenomenon (poor blood circulation
which makes the toes and fingers numb and pale)
• runny and itchy nose, pneumonia, pulmonary
infiltrates
• inflammation and ulceration of the mouth and
tongue
• higher levels of liver enzymes or bilirubin in
blood, liver failure, hepatitis (inflammation of
the liver), jaundice (yellowing of the skin and
whites of the eyes)
• blisters which may burst easily becoming raw
and painful or may bleed, red itchy spots,
peeling skin leaving red raw patches over the
body, blisters/bleeding of the lips, eyes, nose,
mouth and genitals
• breast swelling in men
• the production of a reduced amount of urine.
There have also been reports of a symptom
complex which may include some or all of the
following:
Fever, inflammation of the blood vessels, muscle
pain and inflammation, bone pain and
inflammation, abnormal blood test results, blood
disorders, rash, sensitivity to light and other skin
conditions.
Very rare:
• swelling in your intestine (intestinal
angioedoema)
If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

5

HOW TO STORE ENALAPRIL MALEATE

Keep out of the reach and sight of children.
Store in the original container. Do not store
above 30°C.
Do not use Enalapril Maleate after the expiry date
that is stated on the outer packaging. The expiry
date refers to the last day of that month.
Do not transfer them to another container. Keep
them in a secure place where children cannot get
at them.
This medicine is for you ONLY, do not give it to
anyone else.
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 Enalapril Maleate Tablets contain(s):
• The active ingredient is Enalapril Maleate,
2.5 mg, 5 mg, 10 mg, or 20 mg
• The other ingredients are colloidal anhydrous
silica, magnesium stearate, sodium hydroxide,
povidone, talc, crospovidone, microcrystalline
These are very serious but rare side effects. You may
cellulose, lactose monohydrate.
need urgent medical attention or hospitalisation.
What Enalapril Maleate Tablets look like and
The following side effects have been reported at
contents of the pack:
the approximate frequencies shown:
• The 2.5 mg tablets are white or almost white,
Very common (affecting more than one person
round tablets engraved with ED 2.5 on one side
in 10):
and a breakline on the other side
• blurred vision
• The 5 mg tablets are white or almost white,
• dizziness
round tablets engraved with ED 5 on one side
• cough
and a breakline on the other side
• nausea (feeling sick)
• The 10 mg tablets are white or almost white,
• lethargy.
round tablets engraved with ED 10 on one side
Common (affecting less than one person in 10 but
and a breakline on the other side
more than one person in 100):
• The 20 mg tablets are white or almost white,
• headache, depression
round tablets engraved with ED 20 on one side
• low blood pressure (you may feel light-headed
and a breakline on the other side
or faint), fainting
• The tablets are available in pack sizes of 28, 30,
• chest pain, changes in heart/pulse rate
50, 90, and 100 tablets
including a fast heart rate
• The 5 mg tablets are also available in pack sizes
• shortness of breath
of 10, 60, and 500 tablets
• diarrhoea, abdominal pain, changes in sense of • The 20 mg tablets are also available in pack
taste
sizes of 14 and 500 tablets.
• rash
Not all pack sizes may be marketed.
• tiredness
Marketing Authorisation Holder and Manufacturer
• allergic reactions with swelling of the face,
Marketing Authorisation holder and company
extremities, lips, tongue, throat with difficulty
responsible for manufacture:
swallowing or breathing
TEVA UK Limited, Eastbourne, BN22 9AG.
• change in some blood tests (increased
potassium and creatinine level in blood).
This leaflet was last revised: March 2011
Uncommon (affecting less than one person in 100
PL 00289/0328-0331
but more than
one person in
1,000):
• sudden fall in
51008-W
blood
UKI-004/C
pressure

Expand view ⇕

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.

Hide
(web4)