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FOSINOPRIL SODIUM 10MG TABLETS

Active substance(s): FOSINOPRIL SODIUM

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Package leaflet: Information for the patient

Fosinopril sodium
10mg and 20mg tablets
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.
• I f you have any further questions, ask your doctor,
pharmacist or nurse.
•  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.
• I f you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.

• if you think you are (or might become) pregnant.
Fosinopril sodium is not recommended in early
pregnancy, and must not be taken if you are more
than 3 months pregnant, as they may cause serious
harm to your baby if used at that stage (see pregnancy
section).
• If you are taking any of the following medicines used
to treat high blood pressure:
• An angiotensin II receptor blocker (ARBs) (also known
as sartans – for example valsartan, telmesartan,
irbesartan), in particular if you have diabetes-related
kidney problems.
• Aliskerin

What is in this leaflet
1 What Fosinopril Sodium Tablets are and
what they are used for
2 What you need to know before you take
Fosinopril Sodium Tablets
3 How to take Fosinopril Sodium Tablets
4 Possible side effects
5 How to store Fosinopril Sodium Tablets
6 Contents of the pack and other
information

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 Sodium Tablets’

1 What Fosinopril Sodium Tablets are and

what they are used for

Each tablet contains the active ingredient fosinopril
sodium which is used to treat high blood pressure
(hypertension) and heart failure. Fosinopril Sodium
Tablets belong to a group of medicines called ACE
inhibitors and make it easier for the heart to pump
blood around the body.

2 What you need to know before you take

Fosinopril Sodium Tablets

Do not take Fosinopril Sodium Tablets:

• if you are allergic (hypersensitive) to fosinopril
sodium, other ACE inhibitors or any of the other
ingredients of this medicine (listed in section 6).
• if you or a member of your family have previously had
swelling of the legs, arms, face, mucous membranes
or tongue and/or throat (angioedema), with or
without ACE inhibitor treatment
• if you have narrowing of the blood vessels in one or
both kidneys
• if you are in shock due to heart problems (cardiogenic
shock)
• if you are more than 3 months pregnant. (It is also
better to avoid fosinopril sodium in early pregnancy –
see ‘Pregnancy and breast feeding’ section.)
• if you have diabetes or impaired kidney function
and you are treated with a blood pressure lowering
medicine containing aliskiren.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking
Fosinopril Sodium Tablets:
• if you have kidney problems
• if you have liver problems
• if you are having dialysis
• if you are going to undergo treatment for
hypersensitivity to bee or wasp stings
(hyposensitisation)
• if you have problems with your immune system
due to some diseases (e.g. scleroderma, lupus
erythematosus), white blood cell counts will need to
be monitored
• if you have high levels of sugar in your blood
(diabetes)
• if you have narrowing of some blood vessels in the
heart or cardiomyopathy (enlarged heart muscle)
• if you have become dehydrated from having recently
suffered from vomiting or diarrhoea
• if you are on a low salt diet
• if you are Afro-Caribbean. If you are taking Fosinopril
Sodium Tablets as the only treatment for your high
blood pressure, you may have a reduced response to
this medicine. This may mean that you may need a
higher dose than usually recommended.

Tell your doctor or dentist before undergoing any
surgery or dental treatment that you are being treated
with fosinopril sodium, as there is a risk of your blood
pressure sinking very low during the anaesthetic.

Other medicines and Fosinopril Sodium Tablets
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.
It is especially important for your doctor to know if you
are already being treated with any of the following
medicines:
• other blood pressure lowering medicines including
methyldopa, betablockers (e.g. atenolol), calcium
antagonists (e.g. verapamil) or diuretics (water tablets)
(e.g. furosemide) as it may lead to an increase in the
blood pressure lowering effects
•p
 otassium-sparing diuretics (e.g. spironolactone,
triamterene or amiloride), potassium supplements or
potassium-containing salt substitutes, as fosinopril
sodium may increase potassium levels. Patients will
need their blood potassium levels measured by their
doctor
•p
 ainkillers and anti-inflammatory medicines of the
NSAID type (e.g. aspirin or indometacin) as they can
reduce the effect of fosinopril sodium
•a
 ntacids (to relieve indigestion) stop the body
absorbing fosinopril sodium. There should be at least
2 hours between taking the antacid and fosinopril
sodium
• i nsulin and tablets used in diabetes, as fosinopril
sodium may increase the effect of these especially
during the first week of combination treatment
• l ithium (used for manic depression), as fosinopril
sodium may increase the concentration of lithium in
the blood
• i mmunosuppressants (these reduce the body’s
natural defence system) such as azathioprine as using
them together may affect some blood counts.
•d
 iuretic (water tablet) taken with fosinopril sodium
may cause a reduction in blood pressure
Your doctor may need to change your dose and/or 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 Sodium Tablets’ and
‘Warnings and precautions’)

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 Fosinopril Sodium Tablets before
you become pregnant or as soon as you know you are
pregnant and will advise you to take another medicine
instead of Fosinopril Sodium Tablets. Fosinopril sodium
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 sodium 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.
Continued over page

Continued top of next column
AAAI3696

Fosinopril Sodium 10mg & 20mg 28 Tablets PIL - UK
item no: AAAI3696

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 01.10.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 12.01.16

Technical Approval

revised by: S.Anson

date sent: 01.10.15

supplier: Actavis Iceland

technically app. date: 01.10.15

Non Printing Colours
1.
2.
3.

Driving and using machines

If you experience dizziness, low blood pressure, lightheadedness or vertigo (‘spinning’ sensation), do not
drive or use machinery during treatment with fosinopril
sodium.

Fosinopril Sodium Tablets contain lactose

If your doctor has told you that you have an intolerance
to some sugars, contact your doctor before taking this
medicine (see section 6 for further information).

Blood tests

Fosinopril sodium may interfere with the results of
some blood tests. Tell your doctor that you are taking
Fosinopril sodium Tablets.

3 How to take Fosinopril Sodium Tablets
Always take Fosinopril Sodium Tablets exactly as your
doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
Swallow the tablets whole with at least ½ a glass of
water in the morning with or without food. Do not
chew or crush the tablets.
The recommended dose is:
Adults: The usual dose is 10mg once daily, up to a
maximum of 40mg once daily.
Fosinopril Sodium Tablets may be taken alone or in
combination with a diuretic (water tablet) or digitalis
(digoxin). If you are already taking diuretics, your doctor
may tell you to reduce the dose of the diuretic or to
stop taking them for several days before beginning
treatment with fosinopril sodium.
Occasionally some people start their treatment in
hospital.

Use in children and adolescents under 18 years
old:
Not recommended.

If you take more Fosinopril Sodium Tablets
than you should:

Symptoms associated with overdose may include
severe hypotension and renal failure. Immediately
contact your doctor, the nearest hospital casualty
department or the centre for poison information for
advice.

If you forget to take Fosinopril Sodium Tablets

Do not take the missed dose, just carry on with the next
one as normal. Do not take a double dose to make up
for a forgotten dose.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

If you stop taking Fosinopril Sodium Tablets

Do not stop taking Fosinopril Sodium Tablets unless
your doctor advises you to do so. If you stop taking
fosinopril sodium, your blood pressure may increase.

•U
 ncommon (may affect up to 1 in 100 people):
fainting, shock
•N
 ot known (frequency cannot be estimated from
the available data): changes in types and number of
blood cells (you may experience sore throat, recurring
infections, nose bleeds, increased bruising), lack of
appetite, appetite disorders, weight fluctuation,
gout, raised levels of potassium in the blood,
depression, abnormal behaviour, confusion, stroke,
tremor, memory problems, problems with balance,
sleepiness or drowsiness, ear ache, tinnitus (ringing
in the ear), vertigo (‘spinning’ sensation), heart
attack, problems with heart rhythm or heart rate,
flushing, high blood pressure or severe high blood
pressure, bleeding, narrowing of the arteries in the
legs, difficulty breathing or wheezing, congestion
of the lungs, disorder of the voice (hoarse or weak
voice), nosebleeds, inflammation of the sinuses,
chest pain (not related to the heart), inflammation of
the pancreas, swollen tongue, difficulty swallowing,
constipation, dry mouth, flatulence, inflammation
of the liver (causing yellowing of the skin or eyes
or tiredness, pain in abdomen, joint or muscles),
excessive sweating, bruising, itching, dermatitis (skin
problems/inflammation of the skin), skin rash that may
be itchy (caused by an allergic reaction, pale or red
irregular raised patches on the skin (hives)), weakness
of the muscles, arthritis (pain and swelling of the
joints), kidney failure, problems with sexual function,
abnormality or disease of the prostate gland, swelling
of the soft tissue, fever with pain, increase in weight,
abnormal liver function tests, bloating of the stomach,
mouth problems.

Reporting of side effects

If you get any side effects, talk to your doctor,
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:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Fosinopril Sodium Tablets
Keep this medicine out of the sight and reach of
children.
Do not store Fosinopril Sodium Tablets above 25°C.
Do not transfer to another container.
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last
day of that month.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help to protect the environment.

6 Contents of the pack and other

information

What Fosinopril Sodium Tablets contain

4 Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
Stop taking Fosinopril Sodium Tablets and contact
your doctor immediately if you experience swelling
of the face, lips, tongue and/or throat, rash, itching,
breathlessness or difficulty swallowing (angioedema).

Tell your doctor if you notice any of the
following side effects or they get worse:

•C
 ommon (may affect up to 1 in 10 people): infection
of the upper respiratory tract (mouth, nose, throat or
voice box), sore throat, runny nose, viral infections,
bacterial infection of the lungs (pneumonia), laryngitis
(Inflammation of larynx (voice box) lining and
vocal cords), sinusitis (inflammation of the sinus),
inflammation of the trachea and the bronchi, altered
moods, sleep disorders, dizziness, headaches, pins
and needles, eye disorders or problems with sight,
quick or irregular heart beat, chest pain, feeling
faint on standing up due to reduced blood pressure,
low blood pressure, cough, sinus disorder, feeling
or being sick, diarrhoea, stomach pain, indigestion,
taste disturbance, rash, pain in the muscles, tendons,
ligaments and bone, problems urinating, fatigue,
water retention (causing swelling in the body),
weakness or loss of strength,

• The active substance is fosinopril sodium. Each tablet
contains either 10mg or 20mg of fosinopril sodium.
• The other ingredients are lactose monohydrate,
croscarmellose sodium, pregelatinised starch (maize),
microcrystalline cellulose, glycerol dibehenate and
magnesium stearate.
• The sodium content is 0.67mg per 10mg tablet and
1.06mg per 20mg tablet.

What Fosinopril Sodium Tablets look like and
contents of the pack

Fosinopril Sodium Tablets are white to off-white, round,
uncoated tablets, which come in two strengths.
Each pack contains 28 tablets.
Marketing Authorisation Holder & Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in: January 2016

If you would like a
leaflet with larger
text, please contact
01271 385257.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAI3696

Fosinopril Sodium 10mg & 20mg 28 Tablets PIL - UK
item no: AAAI3696

dimensions: 190 x 380

print proof no: 4

pharmacode:

origination date: 01.10.15

min pt size: 9

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 12.01.16

Technical Approval

revised by: S.Anson

date sent: 01.10.15

supplier: Actavis Iceland

technically app. date: 01.10.15

Non Printing Colours
1.
2.
3.

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.

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