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FOSINOPRIL SODIUM 20 MG TABLETS

Active substance(s): FOSINOPRIL SODIUM

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TEVA UK Ref:

231-30-83880-X LEA FOSINOPRIL A/S TAB TUK

Version:

2

23 SEPTEMBER 2014

PAGE 1: FRONT FACE (INSIDE OF REEL)

0!#+!'%,%!&,%4: INFORMATION
FOR THE USER
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTOR
or pharmacist.
s 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.
s )FYOUGETANYSIDEEFFECTSTALKTOYOURDOCTOROR
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

WHAT IS IN THIS LEAFLET:
1. What Fosinopril is and what it is used for
2. What you need to know before you take Fosinopril
3. How to take Fosinopril
4. Possible side effects
5. How to store Fosinopril
6. Contents of the pack and other information

1

What Fosinopril is and what it is
used for

Pharma code 960

Fosinopril belongs to a group of drugs called
Angiotensin Converting Enzyme (ACE) Inhibitors,
which are vasodilators (drugs which widen the blood
vessels, reduce blood pressure and make it easier for
the heart to pump blood around the body).
Fosinopril is used to treat:
s HIGHBLOODPRESSURE
s CONGESTIVEHEARTFAILUREACONDITIONWHERETHE
heart no longer pumps blood as effectively as it
should).

2

What you need to know before you take
Fosinopril

Do not take Fosinopril and contact your doctor
immediately:
s IFYOUAREALLERGICTOFOSINOPRILSODIUM, to any
other angiotensin-converting enzyme (ACE)
inhibitor or any of the other ingredients of this
medicine (listed in section 6)
s IFYOUHAVESUFFEREDANALLERGICREACTIONTOANY
other ACE inhibitors e.g. captopril, enalapril, which
LEDTOSWELLINGOFTHEFACE LIPS TONGUEANDOR
throat
s IFYOUHAVEACONDITIONKNOWNASHEREDITARY
angioneurotic oedema, which is a serious allergic
reaction causing swelling of the face or throat, or
have ever had a similar unexplained allergic
reaction
s IFYOUHAVETHERAREHEREDITARYPROBLEMOF
galactose intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption
s IFYOUAREMORETHANMONTHSPREGNANT)TISALSO
better to avoid Fosinopril in early pregnancy – see
section 2: Pregnancy and breast-feeding)
s IFYOUHAVEDIABETESORIMPAIREDKIDNEYFUNCTION
and you are treated with a blood pressure
lowering medicine containing aliskiren.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Fosinopril:
s IFYOUHAVEANYOFTHEFOLLOWINGHEARTPROBLEMS
narrowing of the heart valves, cardiomyopathy
(inflammation of the heart muscle), ischaemic heart
disease (lack of blood flow and oxygen to the heart)
s IFYOUHAVECEREBROVASCULARDISEASEDISEASE
affecting blood vessels in the brain)
s if you have kidney problems including disease of the
arteries to the kidney or are undergoing dialysis
s IFYOUHAVECOLLAGENVASCULARDISEASEEG
rheumatoid arthritis, SLE (systemic lupus
erythematosus) an autoimmune condition which
causes joint pain, skin rashes and fever
s IFYOUHAVEDIABETES
s IFYOUHAVELOWBLOODSODIUM
s IFYOUHAVEHYPOVOLAEMIABLOODPRESSUREFALLS
due to fluid loss)
s IFYOUHAVEBEENONALOW SALTDIET
s IFYOUHAVELIVERPROBLEMS
s if you have become dehydrated e.g. you have
recently suffered from severe diarrhoea or vomiting
s IFYOUHAVEASEVEREREDUCTIONINNUMBEROFWHITE
blood cells which makes infections more likely.
s IFYOUARETAKINGANYOFTHEFOLLOWINGMEDICINES
used to treat high blood pressure:
sANANGIOTENSIN))RECEPTORBLOCKER!2"S 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
Fosinopril’.
s you must tell your doctor if you think you are (or
might become) pregnant. Fosinopril 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 section 2: Pregnancy and

breast-feeding).
Tell your doctor you are taking Fosinopril if you:
s HAVETOGOONAMACHINETOREMOVECHOLESTEROL
from the blood
s HAVETOUNDERGODESENSITISATIONTREATMENTEGTO
reduce the effects of an allergy to wasp or bee
stings)
s ARETOUNDERGOAPARATHYROIDTESTTELLYOURDOCTOR
you are taking Fosinopril, as you may be required
to stop taking Fosinopril for a few days before the
test
s ARETOHAVEANOPERATIONREQUIRINGANANAESTHETIC
(including treatment at the dentist); you should tell
the doctor or dentist that you are taking Fosinopril.
Other important information:
s Fosinopril may not work as well in Afro-Caribbean
patients, and they may be at greater risk of certain
side effects (see section 4, Possible side effects).
s 9OURDOCTORMAYMONITORYOUWHENYOUFIRSTSTART
taking Fosinopril. This may involve urine and blood
tests.
Other medicines and Fosinopril:
s Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without a
prescription: diuretics (“water tablets”) e.g.
amiloride, spironolactone, triamterene (see section
3, Taking in combination with a diuretic ("water
tablet"))
s other medicines for high blood pressure such as
methyldopa, beta-blockers e.g. propranolol,
atenolol, sotalol, or calcium antagonists e.g.
verapamil
s 9OURDOCTORMAYNEEDTOCHANGEYOURDOSEANDOR
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 Fosinopril’ and ‘Warnings and precautions’)
s potassium-containing salt substitutes, potassium
supplements or heparin, as Fosinopril may
increase potassium levels
s pain killers such as indometacin, ibuprofen or
aspirin, as the effectiveness of Fosinopril may be
reduced
s antacids (to relieve indigestion), as the
effectiveness of Fosinopril may be reduced. Doses
of Fosinopril and antacids should be taken
2 hours apart
s glyceryl trinitrate and other nitrates used to treat
angina (chest pain).
s vasodilators (drugs that cause blood vessels to
expand) e.g. minoxidil
s procainamide (used to treat abnormal heart
rhythms)
s antidiabetics (insulin or oral hypoglycaemic drugs)
e.g. tolbutamide
s lithium, as lithium levels may be increased
s tricyclic antidepressants e.g. amitriptyline or
dosulepin, or antipsychotics (used for psychiatric
problems) e.g. flupenthixol
s immunosuppressants (drugs to reduce the body’s
natural defence system) e.g. cyclosporin,
cytostatics, budesonide or procainamide
s systemic corticosteroids e.g. prednisone
s allopurinol (used to treat gout)
s MEDICINESKNOWNASSYMPATHOMIMETICSEG
salbutamol, ephedrine and some medicines for
colds, coughs or flu symptoms which may contain
these ingredients.
Fosinopril with food and drink
s $/./4TAKEALCOHOLWHILSTBEINGTREATEDWITH
Fosinopril.
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 Fosinopril before you
become pregnant or as soon as you know you are
pregnant and will advise you to take another
medicine instead of Fosinopril. Fosinopril 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. Fosinopril 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:
s &OSINOPRILMAYCAUSEDIZZINESSANDDECREASED
blood pressure. If affected, DO NOT drive or
operate machinery.
Fosinopril contains lactose
s 0ATIENTSWHOAREINTOLERANTTOLACTOSESHOULDNOTE
that Fosinopril tablets contain a small amount of
lactose. If your doctor has told you that you have
an intolerance to some sugars, contact your doctor
before taking this medicine.

Top of page cut-off to middle of registration mark: 44 mm.

FOSINOPRIL SODIUM
10 mg AND 20 mg TABLETS

TEVA UK Ref:

Version:

231-30-83880-X LEA FOSINOPRIL A/S TAB TUK

2

PAGE 2: REAR FACE (OUTSIDE OF REEL)

3

How to take Fosinopril

Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
In some cases, your treatment may be started in
hospital so that you can be closely monitored.
The tablets should be swallowed preferably with a
glass of water at the same time each day. The tablet
should not be broken as it is available in several
different strengths. The usual dose is:
Adults (including the elderly)
s High blood pressure
The recommended starting dose is 10 mg once daily.
Your doctor may then alter the dose as necessary
depending on your response to treatment, up to a
maximum of 40 mg per day. Fosinopril may be
taken alone or in combination with a diuretic (”water
tablet”, see below) to treat this condition.
s Heart failure
Fosinopril is usually taken in combination with a
diuretic (”water tablet”, see below), or with digitalis
to treat this condition. The recommended starting
dose is 10 mg once daily. Your doctor may then alter
the dose as necessary depending on your response
to treatment, up to a maximum of 40 mg per day.
s Taking in combination with a diuretic (”water
tablet”)
If you are already taking diuretics, your doctor may
tell you to reduce the dose of the diuretic or to
stop taking them for 2-3 days before beginning
treatment with Fosinopril.
Children and adolescents (under 18 years old):
Fosinopril is not recommended for use in children
and adolescents under 18 years of age.
If you take more Fosinopril 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 signs of faintness or
dizziness due to a drop in blood pressure, weak pulse
and clammy skin, hyperventilation, changes in heart
rate or rhythm, anxiety, and cough.
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 Fosinopril
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 Fosinopril
DO NOT stop taking Fosinopril without talking to
your doctor first even if you feel better. If you have
any further questions on the use of this medicine, ask
your doctor or pharmacist.

s
s
s
s
s

DECREASEINAPPETITE TASTECHANGES
FAINTING
SEXUALPROBLEMS
GOUT
PROBLEMSWITHVISION EARACHE RINGINGINTHEEARS
a sensation that your surroundings are spinning
either up and down or from side to side
s HIGHBLOODPRESSURE
s COLLAPSEOFTHEBLOODCIRCULATIONWITHLOWBLOOD
pressure
s SUDDENDEATH
s PROSTATICDISORDERSINMEN
Rare (may affect up to 1 in 1,000 people):
s HOARSENESSLARYNGITIS
s DYSPHASIAPROBLEMSINTHEABILITYTOSELECTWORDS
in which to speak, read or write)
s INFLAMMATIONOFTHEPANCREAS
s DIFFICULTYINSWALLOWINGACCOMPANIEDBYSWOLLEN
glands, swollen tongue or mouth sores
s WEAKNESSINLIMBS ARTHRITIS
s BLOODDISORDERSWHICHMAYBECHARACTERISEDBY
fever or chills, sore throat, ulcers in your mouth or
throat, low blood count causing unusual tiredness
or weakness, unusual bleeding or unexplained
bruising
s ABDOMINALPAINANDSWELLING
s HEPATITISnINFLAMMATIONOFTHELIVER
s FLUSHINGOFSKIN BLEEDINGPROBLEMS NOSEBLEED
s PERIPHERALVASCULARDISEASEDISEASEOFARTERIES
s MEMORYDISTURBANCES DISORIENTATION
s PNEUMONIA CONGESTIONINTHELUNGS
s DIFFICULTYINBREATHING
s LOWLEVELSOFSALTINTHEBLOOD
s RAISEDLEVELSOFIRONINTHEBLOOD
Very rare (may affect up to 1 in 10,000 people):
s ACUTELIVERFAILURE
s ACUTERENALFAILURE
s SEVEREREDUCTIONINNUMBEROFWHITEBLOODCELLS
making infections more likely
s INFLAMMATIONANDSWELLINGOFTHEBOWEL
A disorder which may include fever, vasculitis
(inflammation of blood vessels), muscle pain, joint
PAINARTHRITIS BLOODDISORDERS RASH SENSITIVITYTO
light or other skin problems has been reported.
Fosinopril may interfere with the results of blood or
urine tests.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
WWWMHRAGOVUKYELLOWCARD"YREPORTINGSIDE
effects you can help provide more information on the
safety of this medicine.

5

How to store Fosinopril

Keep this medicine out of the sight and reach of
children+EEP&OSINOPRILOUTOFTHEREACHANDSIGHTOF
children. Do not store above 25°C. Store in the
4 Possible side effects
original container. Do not transfer to another
container. Do not use this medicine after the expiry
Like all medicines, this medicine can cause side
date which is stated on the outer packaging. The
effects, although not everybody gets them.
expiry date refers to the last day of that month.
Stop taking the tablets and tell your doctor
Return all unused medicines to your pharmacist for
immediately or go to the casualty department at your
safe disposal. Do not throw away any medicines via
nearest hospital if the following happens:
wastewater or household waste. Ask your pharmacist
s ALLERGICREACTIONSWHICHMAYINCLUDESWELLINGOF
how to throw away medicines you no longer use.
the lips, face or neck leading to severe difficulty in
These measures will help protect the environment.
breathing; skin rash or nettle rash.
This is a very serious side effect. You may need
6 Contents of the pack and other information
urgent medical attention or hospitalisation.
What Fosinopril tablets contain:
The following side effects have been reported at the
s 4HEACTIVESUBSTANCEISFOSINOPRILSODIUM MG
approximate frequencies shown:
or 20 mg.
Common (may affect up to 1 in 10 people):
s 4HEOTHERINGREDIENTSARELACTOSEANHYDROUS
s COUGH
POVIDONE+ CROSPOVIDONE MICROCRYSTALLINE
s DIZZINESS WEAKNESS
cellulose, sodium laurylsulphate, glycerol
s LOWBLOODPRESSUREWHICHMAYCAUSEFAINTINGOR
dibehenate.
dizziness when standing up
What Fosinopril Tablets look like and contents of the
s NAUSEA VOMITING DIARRHOEA
pack
s RASH INFLAMMATIONOFTHESKIN
s &OSINOPRILMG4ABLETSAREWHITETOOFF WHITEIN
s ALLERGICREACTIONSCAUSINGSWELLINGOFTHEFACEAND
colour, round tablets scored on both sides of the
throat (may be more common in Afro-Caribbean
tablet with “F” and “10” on each side of the score
patients)
on one side of the tablet.
s HEADACHE
s &OSINOPRILMG4ABLETSAREWHITETOOFF WHITE
s fast heart rate or chest pain not related to the heart.
capsule-shaped tablets with number embossed
Uncommon (may affect up to 1 in 100 people):
“93” on one side and “7223” on the other side.
s EXCESSIVESWEATING FEVER RUNNYORITCHYNOSE
The following pack sizes are available for:
sinusitis, bronchitis (cough which may produce
s &OSINOPRILMG     OR
sputum), dry mouth
tablets or 20 x 20 tablets as a hospital pack.
s ITCHING NETTLERASH
s &OSINOPRILMG       OR
s SHORTNESSOFBREATHANDINFLAMMATIONOFTHE
100 tablets or 20 x 20 tablets as a hospital pack.
airways
Not all pack sizes may be marketed.
s INCREASEDAMOUNTSOFPROTEININTHEURINE
Marketing Authorisation Holder and Manufacturer
s MUSCLEPAINANDPAININTHETHORAXORCHEST
Marketing Authorisation holder and company
s FLATULENCE CONSTIPATION
RESPONSIBLEFORMANUFACTURE4%6!5+,IMITED
s PINSANDNEEDLES
Eastbourne, BN22 9AG, England.
s DEPRESSION CONFUSION
s SLEEPINESSORSLEEPDISTURBANCES
This leaflet was last revised: September 2014.
s CHESTPAINASSOCIATEDWITHTHEHEART PALPITATIONS
or changes in heart rhythm
0, 
s SWELLINGOFHANDSANDFEET
s WEIGHTINCREASE
s HEARTATTACKORSTROKE
s KIDNEYPROBLEMS
s DECREASEINREDBLOODCELLS HIGHBLOODPOTASSIUM
levels
83880-X

23 SEPTEMBER 2014

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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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