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FOSINOPRIL SODIUM 10 MG TABLETS

Active substance(s): FOSINOPRIL SODIUM / FOSINOPRIL SODIUM / FOSINOPRIL SODIUM

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ZINC Ref:

EAS1050a LEA FOSINOPRIL 10 & 20MG TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

2

Colours Used:

05 June 2017
BLACK
PANTONE® GREEN C
Template

PAGE 1: FRONT FACE (INSIDE OF REEL)

Package leaflet: Information for the user

If you are taking any of the following medicines, the
risk of angioedema (rapid swelling under the skin in
area such as the throat) is increased:
- sirolimus, everolimus and other medicines
belonging to the class of mTOR inhibitors (used to
avoid rejection of transplanted organs).

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.

Tell your doctor you are taking Fosinopril if you:
• have to go on a machine to remove cholesterol
from the blood
• have to undergo desensitisation treatment (e.g. to
reduce the effects of an allergy to wasp or bee
stings)
• are to undergo a parathyroid test; tell your doctor
you are taking Fosinopril, as you may be required to
stop taking Fosinopril for a few days before the test
• are to have an operation requiring an anaesthetic
(including treatment at the dentist); you should tell
the doctor or dentist that you are taking Fosinopril.

What is in this leaflet

Other important information:
• 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).
• Your doctor may monitor you when you first start
taking Fosinopril. This may involve urine and blood
tests.

Fosinopril sodium

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

Other medicines and Fosinopril

What Fosinopril is and what it is used for • Tell your doctor or pharmacist if you are taking,

Pharma code 639

have recently taken or might take any other
Fosinopril belongs to a group of drugs called
medicines, including medicines obtained without a
Angiotensin Converting Enzyme (ACE) Inhibitors,
prescription: diuretics (“water tablets”) e.g.
which are vasodilators (drugs which widen the blood
amiloride, spironolactone, triamterene (see section
vessels, reduce blood pressure and make it easier for
3, Taking in combination with a diuretic (”water
the heart to pump blood around the body).
tablet”))
Fosinopril is used to treat:

other medicines for high blood pressure such as
• high blood pressure
methyldopa, beta-blockers e.g. propranolol, atenolol,
• congestive heart failure (a condition where the heart
sotalol, or calcium antagonists e.g. verapamil
no longer pumps blood as effectively as it should).
• Your doctor may need to change your dose and/or
to take other precautions: If you are taking an
2 What you need to know before you take
angiotensin II receptor blocker (ARB) or aliskiren
Fosinopril
(see also information under the headings ‘Do not
Do not take Fosinopril and contact your doctor
take Fosinopril’ and ‘Warnings and precautions’)
immediately:
• Potassium supplements or salt substitutes
• if you are allergic to fosinopril sodium, to any
containing potassium, diuretics (water tablets, in
other angiotensin-converting enzyme (ACE)
particular those so called potassium sparing),
inhibitor or any of the other ingredients of this
other drugs which can increase potassium in your
medicine (listed in section 6)
body (such as heparin and co-trimoxazole also
• if you have suffered an allergic reaction to any
known as trimethoprim/sulfamethoxazole)
other ACE inhibitors e.g. captopril, enalapril, which • pain killers such as indometacin, ibuprofen or
led to swelling of the face, lips, tongue and/or
aspirin, as the effectiveness of Fosinopril may be
throat
reduced
• if you have a condition known as hereditary
• antacids (to relieve indigestion), as the
angioneurotic oedema, which is a serious allergic
effectiveness of Fosinopril may be reduced. Doses
reaction causing swelling of the face or throat, or
of Fosinopril and antacids should be taken 2 hours
have ever had a similar unexplained allergic
apart
reaction
• glyceryl trinitrate and other nitrates used to treat
• if you have the rare hereditary problem of
angina (chest pain).
galactose intolerance, the Lapp lactase deficiency
• vasodilators (drugs that cause blood vessels to
or glucose-galactose malabsorption
expand) e.g. minoxidil
• if you are more than 3 months pregnant. (It is also • procainamide (used to treat abnormal heart rhythms)
better to avoid Fosinopril in early pregnancy – see • antidiabetics (insulin or oral hypoglycaemic drugs)
section 2: Pregnancy and breast-feeding)
e.g. tolbutamide
• if you have diabetes or impaired kidney function
• lithium, as lithium levels may be increased
and you are treated with a blood pressure
• tricyclic antidepressants e.g. amitriptyline or
lowering medicine containing aliskiren
dosulepin, or antipsychotics (used for psychiatric
problems) e.g. flupenthixol
Warnings and precautions

immunosuppressants (drugs to reduce the body’s
Talk to your doctor or pharmacist before taking
natural defence system) e.g. cyclosporin,
Fosinopril:
cytostatics, budesonide or procainamide
• if you have any of the following heart problems:
• systemic corticosteroids e.g. prednisone
narrowing of the heart valves, cardiomyopathy
• allopurinol (used to treat gout)
(inflammation of the heart muscle), ischaemic
heart disease (lack of blood flow and oxygen to the • medicines known as sympathomimetics e.g.
salbutamol, ephedrine and some medicines for
heart)
colds, coughs or flu symptoms which may contain
• if you have cerebrovascular disease (disease
these ingredients.
affecting blood vessels in the brain)

medicines which are most often used to avoid
• if you have kidney problems including disease of
rejection of transplanted organs (sirolimus,
the arteries to the kidney or are undergoing
everolimus and other medicines belonging to the
dialysis
class of mTOR inhibitors). See section “Warnings
• if you have collagen vascular disease e.g.
and precautions”.
rheumatoid arthritis, SLE (systemic lupus
erythematosus) an autoimmune condition which
Fosinopril with food and drink
causes joint pain, skin rashes and fever
• DO NOT take alcohol whilst being treated with
• if you have diabetes
Fosinopril.
• if you have low blood sodium
Pregnancy
and breast-feeding
• if you have hypovolaemia (blood pressure falls
If you are pregnant or breast-feeding, think you may
due to fluid loss)
be pregnant or are planning to have a baby, ask your
• if you have been on a low-salt diet
doctor or pharmacist for advice before taking this
• if you have liver problems
medicine.
• if you have become dehydrated e.g. you have
recently suffered from severe diarrhoea or
Pregnancy
vomiting
You must tell your doctor if you think you are (or
• if you have a severe reduction in number of white might become) pregnant. Your doctor will normally
blood cells which makes infections more likely.
advise you to stop taking Fosinopril before you
• if you are taking any of the following medicines
become pregnant or as soon as you know you are
used to treat high blood pressure:
pregnant and will advise you to take another
- an angiotensin II receptor blocker (ARBs) (also
medicine instead of Fosinopril. Fosinopril is not
known as sartans – for example valsartan,
recommended in early pregnancy, and must not be
telmisartan, irbesartan), in particular if you have taken when more than 3 months pregnant, as it may
diabetes-related kidney problems.
cause serious harm to your baby if used after the
- aliskiren
third month of pregnancy.
Your doctor may check your kidney function, blood
Breast-feeding
pressure, and the amount of electrolytes (e.g.
Tell your doctor if you are breast-feeding or about to
potassium) in your blood at regular intervals.
See also information under the heading ‘Do not take start breast-feeding. Fosinopril is not recommended
for mothers who are breast-feeding, and your doctor
Fosinopril’.
may choose another treatment for you if you wish to
• You must tell your doctor if you think you are (or
breast-feed, especially if your baby is newborn, or
might become) pregnant. Fosinopril is not
was born prematurely.
recommended in early pregnancy, and must not
be taken if you are more than 3 months pregnant, Driving and using machines:
as it may cause serious harm to your baby if used • Fosinopril may cause dizziness and decreased
at that stage (see section 2: Pregnancy and
blood pressure. If affected, DO NOT drive or
breast-feeding).
operate machinery.

REG0065436

Version 3.4

Approved

Page 1 of 4

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

Fosinopril Sodium
10 mg and 20 mg Tablets

ZINC Ref:

EAS1050a LEA FOSINOPRIL 10 & 20MG TAB TUK
Dim’s Changed?:
Length:
Width:
Depth:
Foil Width:

No
323 mm
160 mm
N/A
N/A

Version:

2

Colours Used:

BLACK
PANTONE® GREEN C
Template

PAGE 2: REAR FACE (OUTSIDE OF REEL)

Fosinopril contains lactose
• Patients who are intolerant to lactose should note
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.










Always take this medicine exactly as your doctor has •
told you. Check with your doctor or pharmacist if you •
are not sure.

3

How to take Fosinopril

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:






swelling of hands and feet
weight increase
heart attack or stroke
kidney problems
decrease in red blood cells, high blood potassium
levels
decrease in appetite, taste changes
fainting
sexual problems
gout
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
pressure
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
• Heart failure
throat, low blood count causing unusual tiredness
Fosinopril is usually taken in combination with a
or weakness, unusual bleeding or unexplained
diuretic (”water tablet”, see below), or with digitalis
bruising
to treat this condition.
• abdominal pain and swelling
The recommended starting dose is 10 mg once daily. • hepatitis – inflammation of the liver
Your doctor may then alter the dose as necessary
• flushing of skin, bleeding problems, nose bleed
depending on your response to treatment, up to a • peripheral vascular disease (disease of arteries)
maximum of 40 mg per day.
• memory disturbances, disorientation
• pneumonia, congestion in the lungs
• Taking in combination with a diuretic (”water
• difficulty in breathing
tablet”)
If you are already taking diuretics, your doctor may • low levels of salt in the blood
• raised levels of iron in the blood.
tell you to reduce the dose of the diuretic or to
stop taking them for 2-3 days before beginning
Very rare (may affect up to 1 in 10,000 people):
treatment with Fosinopril.
• acute liver failure
• acute renal failure
Children and adolescents
• severe reduction in number of white blood cells
Fosinopril is not recommended for use in children
making infections more likely
and adolescents under 18 years of age.
• inflammation and swelling of the bowel.
If you take more Fosinopril than you should
A disorder which may include fever, vasculitis
If you (or someone else) swallow a lot of the tablets
all together or if you think a child has swallowed any (inflammation of blood vessels), muscle pain, joint
of the tablets, contact your nearest hospital casualty pain/arthritis, blood disorders, rash, sensitivity to
light or other skin problems has been reported.
department or your doctor immediately.
Fosinopril may interfere with the results of blood or
An overdose is likely to cause signs of faintness or
dizziness due to a drop in blood pressure, weak pulse urine tests.
and clammy skin, hyperventilation, changes in heart
Reporting of side effects
rate or rhythm, anxiety, and cough.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
Please take this leaflet, any remaining tablets, and
not listed in this leaflet. You can also report side
the container with you to the hospital or doctor so
effects directly via the Yellow Card Scheme at:
that they know which tablets were consumed.
www.mhra.gov.uk/yellowcard. By reporting side
If you forget to take Fosinopril
effects you can help provide more information on the
If you forget to take a tablet, take one as soon as you safety of this medicine.
remember, unless it is nearly time to take the next
one. Do not take a double dose to make up for a
5 How to store Fosinopril
forgotten dose.
Keep this medicine out of the sight and reach of
If you stop taking Fosinopril
children.
DO NOT stop taking Fosinopril without talking to
Do not store above 25°C. Store in the original
your doctor first even if you feel better. If you have
container. Do not transfer to another container.
any further questions on the use of this medicine, ask
Do not use this medicine after the expiry date which
your doctor or pharmacist.
is stated on the outer packaging. The expiry date
refers to the last day of that month.
4 Possible side effects
Do not throw away any medicines via wastewater or
Like all medicines, this medicine can cause side
household waste. Ask your pharmacist how to throw
effects, although not everybody gets them.
away medicines you no longer use. These measures
will help protect the environment.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department at your
of the pack and other
nearest hospital if the following happens:
6 Contents
information
• allergic reactions which may include swelling of
the lips, face or neck leading to severe difficulty in
What Fosinopril contains:
breathing; skin rash or nettle rash.
• The active substance is fosinopril sodium, 10 mg
This is a very serious side effect. You may need
or 20 mg.
urgent medical attention or hospitalisation.
• The other ingredients are lactose anhydrous,
The following side effects have been reported at the
povidone K30, crospovidone, microcrystalline
approximate frequencies shown:
cellulose, sodium laurilsulfate, glycerol
Common (may affect up to 1 in 10 people):
dibehenate.
• cough
What Fosinopril looks like and contents of the pack
• dizziness, weakness
• Fosinopril 10mg Tablets are white to off-white in
• low blood pressure which may cause fainting or
colour, round tablets scored on both sides of the
dizziness when standing up
tablet with “F” and “10” on each side of the score
• nausea, vomiting, diarrhoea
on one side of the tablet.
• rash, inflammation of the skin
• allergic reactions causing swelling of the face and • Fosinopril 20mg Tablets are white to off-white
capsule-shaped tablets with number embossed
throat (may be more common in Afro- Caribbean
“93” on one side and “7223” on the other side.
patients)
The following pack sizes are available for:
• headache

Fosinopril 10mg: 20, 28, 30, 50, 84, 90 or 100
• fast heart rate or chest pain not related to the heart.
tablets or 20 x 20 tablets as a hospital pack.
Uncommon (may affect up to 1 in 100 people):
• Fosinopril 20mg: 14, 20, 28, 30, 50, 56, 84, 90 or 100
• excessive sweating, fever, runny or itchy nose,
tablets or 20 x 20 tablets as a hospital pack.
sinusitis, bronchitis (cough which may produce
Not all pack sizes may be marketed.
sputum), dry mouth
Marketing
Authorisation Holder and Manufacturer
• itching, nettle rash
• shortness of breath and inflammation of the airways Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
• increased amounts of protein in the urine
Eastbourne, BN22 9AG England.
• muscle pain and pain in the thorax or chest
• flatulence, constipation
This leaflet was last revised: May 2017
• pins and needles
PL 00289/0517-0518
• depression, confusion
• sleepiness or sleep disturbances
160 x 323
• chest pain associated with the heart, palpitations
EAS1050a
or changes in heart rhythm
83880-Z
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.

REG0065436

Version 3.4

05 June 2017

Approved

Page 2 of 4

Expand Transcript

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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