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Active substance(s): FOSINOPRIL SODIUM

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16 June 2016


Pharma code 960

as it may cause serious harm to your baby if used
at that stage (see section 2: Pregnancy and
fosinopril sodium
Tell your doctor you are taking Fosinopril if you:

have to go on a machine to remove cholesterol
Package leaflet: Information
from the blood
for the user
• have to undergo desensitisation treatment (e.g. to
Read all of this leaflet carefully before you start
reduce the effects of an allergy to wasp or bee
taking this medicine because it contains important
information for you.
• are to undergo a parathyroid test; tell your doctor
• Keep this leaflet. You may need to read it again.
you are taking Fosinopril, as you may be required
• If you have any further questions, ask your doctor
to stop taking Fosinopril for a few days before the
or pharmacist.
• This medicine has been prescribed for you only. • are to have an operation requiring an anaesthetic
Do not pass it on to others. It may harm them,
(including treatment at the dentist); you should tell
even if their signs of illness are the same as yours. the doctor or dentist that you are taking Fosinopril.
• If you get any side effects talk to your doctor or
Other important information:
pharmacist. This includes any possible side effects • Fosinopril may not work as well in Afro-Caribbean
not listed in this leaflet. See section 4.
patients, and they may be at greater risk of certain
side effects (see section 4, Possible side effects).
What is in this leaflet
• Your doctor may monitor you when you first start
1. What Fosinopril is and what it is used for
taking Fosinopril. This may involve urine and blood
2. What you need to know before you take Fosinopril tests.
3. How to take Fosinopril
Other medicines and Fosinopril
4. Possible side effects
• Tell your doctor or pharmacist if you are taking,
5. How to store Fosinopril
have recently taken or might take any other
6. Contents of the pack and other information
medicines, including medicines obtained without a
prescription: diuretics (“water tablets”) e.g.
What Fosinopril is and what it is
amiloride, spironolactone, triamterene (see section
used for
3, Taking in combination with a diuretic ("water
Fosinopril belongs to a group of drugs called
Angiotensin Converting Enzyme (ACE) Inhibitors,
• other medicines for high blood pressure such as
which are vasodilators (drugs which widen the blood methyldopa, beta-blockers e.g. propranolol,
vessels, reduce blood pressure and make it easier for atenolol, sotalol, or calcium antagonists e.g.
the heart to pump blood around the body).
Fosinopril is used to treat:
• Your doctor may need to change your dose and/or
• high blood pressure
to take other precautions: If you are taking an
• congestive heart failure (a condition where the
angiotensin II receptor blocker (ARB) or aliskiren
heart no longer pumps blood as effectively as it
(see also information under the headings ‘Do not
take Fosinopril’ and ‘Warnings and precautions’)

potassium-containing salt substitutes, potassium
What you need to know before you take
supplements or heparin, as Fosinopril may
increase potassium levels
Do not take Fosinopril and contact your doctor
• pain killers such as indometacin, ibuprofen or
aspirin, as the effectiveness of Fosinopril may be
• if you are allergic to fosinopril sodium, to any
other angiotensin-converting enzyme (ACE)
• antacids (to relieve indigestion), as the
inhibitor or any of the other ingredients of this
effectiveness of Fosinopril may be reduced. Doses
medicine (listed in section 6)
of Fosinopril and antacids should be taken
• if you have suffered an allergic reaction to any
2 hours apart
other ACE inhibitors e.g. captopril, enalapril, which • glyceryl trinitrate and other nitrates used to treat
led to swelling of the face, lips, tongue and/or
angina (chest pain).
• vasodilators (drugs that cause blood vessels to
• if you have a condition known as hereditary
expand) e.g. minoxidil
angioneurotic oedema, which is a serious allergic • procainamide (used to treat abnormal heart
reaction causing swelling of the face or throat, or
have ever had a similar unexplained allergic
• antidiabetics (insulin or oral hypoglycaemic drugs)
e.g. tolbutamide
• if you have the rare hereditary problem of
• lithium, as lithium levels may be increased
galactose intolerance, the Lapp lactase deficiency • tricyclic antidepressants e.g. amitriptyline or
or glucose-galactose malabsorption
dosulepin, or antipsychotics (used for psychiatric
• if you are more than 3 months pregnant. (It is also problems) e.g. flupenthixol
better to avoid Fosinopril in early pregnancy – see • immunosuppressants (drugs to reduce the body’s
section 2: Pregnancy and breast-feeding)
natural defence system) e.g. cyclosporin,
• if you have diabetes or impaired kidney function
cytostatics, budesonide or procainamide
and you are treated with a blood pressure
• systemic corticosteroids e.g. prednisone
lowering medicine containing aliskiren
• allopurinol (used to treat gout)
• medicines known as sympathomimetics e.g.
Warnings and precautions
salbutamol, ephedrine and some medicines for
Talk to your doctor or pharmacist before taking
colds, coughs or flu symptoms which may contain
these ingredients.
• if you have any of the following heart problems:
narrowing of the heart valves, cardiomyopathy
Fosinopril with food and drink
(inflammation of the heart muscle), ischaemic heart• DO NOT take alcohol whilst being treated with
disease (lack of blood flow and oxygen to the heart) Fosinopril.
• if you have cerebrovascular disease (disease
Pregnancy and breast-feeding
affecting blood vessels in the brain)
If you are pregnant or breast-feeding, think you may
• if you have kidney problems including disease of thebe pregnant or are planning to have a baby, ask your
arteries to the kidney or are undergoing dialysis
doctor or pharmacist for advice before taking this
• if you have collagen vascular disease e.g.
rheumatoid arthritis, SLE (systemic lupus
erythematosus) an autoimmune condition which Pregnancy
You must tell your doctor if you think you are (or
causes joint pain, skin rashes and fever
might become) pregnant. Your doctor will normally
• if you have diabetes
advise you to stop taking Fosinopril before you
• if you have low blood sodium
become pregnant or as soon as you know you are
• if you have hypovolaemia (blood pressure falls
pregnant and will advise you to take another
due to fluid loss)
medicine instead of Fosinopril. Fosinopril is not
• if you have been on a low-salt diet
recommended in early pregnancy, and must not be
• if you have liver problems
taken when more than 3 months pregnant, as it may
• if you have become dehydrated e.g. you have
cause serious harm to your baby if used after the
recently suffered from severe diarrhoea or vomiting third month of pregnancy.
• if you have a severe reduction in number of white
blood cells which makes infections more likely.
Tell your doctor if you are breast-feeding or about to
• if you are taking any of the following medicines
start breast-feeding. Fosinopril is not recommended
used to treat high blood pressure:
for mothers who are breast-feeding, and your doctor
- an angiotensin II receptor blocker (ARBs) (also
may choose another treatment for you if you wish to
known as sartans – for example valsartan,
telmisartan, irbesartan), in particular if you have breast-feed, especially if your baby is newborn, or
was born prematurely.
diabetes-related kidney problems. aliskiren
Driving and using machines:
Your doctor may check your kidney function, blood
• Fosinopril may cause dizziness and decreased
pressure, and the amount of electrolytes (e.g.
blood pressure. If affected, DO NOT drive or
potassium) in your blood at regular intervals.
operate machinery.
See also information under the heading ‘Do not take
Fosinopril contains lactose
• Patients who are intolerant to lactose should note
• You must tell your doctor if you think you are (or
that Fosinopril tablets contain a small amount of
might become) pregnant. Fosinopril is not
lactose. If your doctor has told you that you have
recommended in early pregnancy, and must not
an intolerance to some sugars, contact your doctor
be taken if you are more than 3 months pregnant,
before taking this medicine.

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

Fosinopril Sodium
10 mg and 20 mg Tablets







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)
• 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.
• 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.
• Taking in combination with a diuretic (”water
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.

decrease in appetite, taste changes
sexual problems
problems with vision, ear ache, ringing in the ears,
a sensation that your surroundings are spinning
either up and down or from side to side
• high blood pressure
• collapse of the blood circulation with low blood
• sudden death
• prostatic disorders in men.
Rare (may affect up to 1 in 1,000 people):
• hoarseness/laryngitis
• dysphasia (problems in the ability to select words
in which to speak, read or write)
• inflammation of the pancreas
• difficulty in swallowing accompanied by swollen
glands, swollen tongue or mouth sores
• weakness in limbs, arthritis
• blood disorders which may be characterised by
fever or chills, sore throat, ulcers in your mouth or
throat, low blood count causing unusual tiredness
or weakness, unusual bleeding or unexplained
• abdominal pain and swelling
• hepatitis – inflammation of the liver
• flushing of skin, bleeding problems, nose bleed
• peripheral vascular disease (disease of arteries)
• memory disturbances, disorientation
• pneumonia, congestion in the lungs
• difficulty in breathing
• low levels of salt in the blood
• raised levels of iron in the blood.
Very rare (may affect up to 1 in 10,000 people):
• acute liver failure
• acute renal failure
• severe reduction in number of white blood cells
making infections more likely
• inflammation and swelling of the bowel.
A disorder which may include fever, vasculitis
(inflammation of blood vessels), muscle pain, joint
pain/arthritis, blood disorders, rash, sensitivity to
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: By reporting side
effects you can help provide more information on the
safety of this medicine.


How to store Fosinopril

Keep this medicine out of the sight and reach of
children. Keep Fosinopril out of the reach and sight of
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
• allergic reactions which may include swelling of
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.
6 Contents of the pack and other information
This is a very serious side effect. You may need
urgent medical attention or hospitalisation.
What Fosinopril tablets contain:
The following side effects have been reported at the
• The active substance is fosinopril sodium, 10 mg
approximate frequencies shown:
or 20 mg.
• The other ingredients are lactose anhydrous,
Common (may affect up to 1 in 10 people):
povidone K30, crospovidone, microcrystalline
• cough
cellulose, sodium laurilsulfate, glycerol
• dizziness, weakness
• low blood pressure which may cause fainting or
dizziness when standing up
What Fosinopril Tablets look like and contents of the
• nausea, vomiting, diarrhoea
• rash, inflammation of the skin
• Fosinopril 10mg Tablets are white to off-white in
• allergic reactions causing swelling of the face and
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
on one side of the tablet.
• headache
• Fosinopril 20mg Tablets are whiteto off-white
• fast heart rate or chest pain not related to the heart.
capsule-shaped tablets with number embossed
“93” on one side and “7223” on the other side.
Uncommon (may affect up to 1 in 100 people):
• excessive sweating, fever, runny or itchy nose,
The following pack sizes are available for:
sinusitis, bronchitis (cough which may produce
• Fosinopril 10mg: 20, 28, 30, 50, 84, 90 or 100
sputum), dry mouth
tablets or 20 x 20 tablets as a hospital pack.
• itching, nettle rash
• Fosinopril 20mg: 14, 20, 28, 30, 50, 56, 84, 90 or 100
• shortness of breath and inflammation of the
tablets or 20 x 20 tablets as a hospital pack.
Not all pack sizes may be marketed.
• increased amounts of protein in the urine
Marketing Authorisation Holder and Manufacturer
• muscle pain and pain in the thorax or chest
Marketing Authorisation holder and company
• flatulence, constipation
responsible for manufacture: TEVA UK Limited,
• pins and needles
Eastbourne, BN22 9AG, England.
• depression, confusion
• sleepiness or sleep disturbances
This leaflet was last revised: June 2016
• chest pain associated with the heart, palpitations
PL 00289/0517-0518
or changes in heart rhythm
• swelling of hands and feet
• weight increase
• heart attack or stroke
• kidney problems
• decrease in red blood cells, high blood potassium

16 June 2016

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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.