FOSINOPRIL SODIUM 20MG TABLETS

Active substance: FOSINOPRIL SODIUM

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Fosinopril sodium
10mg and 20mg tablets
Read all of this leaflet carefully before you start
taking this medicine.
•  eep this leaflet. You may need to read it again.
K
•   f you have further questions, please ask your
I
doctor or your pharmacist.
•   his medicine has been prescribed for you.
T
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•   f any of the side effects gets serious, or if you
I
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

In this leaflet
1  hat Fosinopril sodium is and what it is
W
used for
2  efore you take Fosinopril sodium
B
tablets
3 How to take Fosinopril sodium tablets
4 Possible side effects
5 How to store Fosinopril sodium tablets
6 Further Information
1

 hat Fosinopril sodium is and what it is
W
used for

Each tablet contains 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

 efore you take Fosinopril sodium
B
tablets

Do not take Fosinopril sodium tablets and
tell your doctor if you:

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

Take special care with Fosinopril sodium
tablets and tell your doctor if you:

• have kidney problems
• have liver problems
• are having dialysis
•  re going to undergo treatment for
a
hypersensitivity to bee or wasp stings
(hyposensitisation)
•  ave problems with your immune system
h
due to some diseases (e.g. scleroderma, lupus
erythematosus), white blood cell counts will need
to be monitored
• have high levels of sugar in your blood (diabetes)
• have narrowing of some blood vessels in the
heart or cardiomyopathy (enlarged heart muscle)
•  ave become dehydrated from having recently
h
suffered from vomiting or diarrhoea
• are on a low salt diet
• 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.

•  hink you are (or might become) pregnant.
t
Fosinopril tablets are 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).
•  f you are taking any of the following medicines
I
used to treat high blood pressure:
-  n angiotensin II receptor blocker (ARBs) (also
A
known as sartans – for example valsartan,
telmesartan, irbesartan), in particular if you have
diabetes-related kidney problems.
- Aliskerin
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’
Tell your doctor or dentist before undergoing
any surgery or dental treatment that you are
being treated with Fosinopril, as there is a risk of
your blood pressure sinking very low during the
anaesthetic.

Taking other medicines

If Fosinopril is taken with certain other medicines,
your treatment can be affected. Tell your doctor
before using other medicines at the same time as
Fosinopril. Please tell your doctor if you are taking or
have recently taken any other medicines, including
medicines obtained without a prescription.
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
• potassium-sparing diuretics (e.g. spironolactone,

triamterene or amiloride), potassium supplements
or potassium-containing salt substitutes, as
Fosinopril may increase potassium levels. Patients
will need their blood potassium levels measured
by their doctor
• painkillers and anti-inflammatory medicines of

the NSAID type (e.g. aspirin or indometacin) as
they can reduce the effect of Fosinopril
• antacids (to relieve indigestion) stop the body

absorbing Fosinopril. There should be at least 2
hours between taking the antacid and Fosinopril
• insulin and tablets used in diabetes, as

Fosinopril may increase the effect of these
especially during the first week of combination
treatment
• lithium (used for manic depression), as Fosinopril

may increase the concentration of lithium in the
blood
• immunosuppressants (these reduce the body’s

natural defence system) such as azathioprine
as using them together may affect some blood
counts.
• diuretic (water tablet) taken with fosinopril 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 breastfeeding

You must tell your doctor if you think you are (or
might become) pregnant. Your doctor will normally
advise you to stop taking Fosinopril 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 tablets. Fosinopril
tablets are not recommended in early pregnancy,

Continued top of next column
AAAH3831

Continued over page

Fosinopril Sodium 10mg & 20mg 28 Tablets PIL - UK
item no: AAAH3831

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 27.10.14

min pt size: 9.5

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 03.11.14

Technical Approval

revised by: S.Anson

date sent: 27.10.14

supplier: Actavis Iceland

technically app. date: 28.10.14

Non Printing Colours
1.
2.
3.

• Uncommon (occurring in less than 1 in 100

patients): fainting, shock

and must not be taken when more than 3 months
pregnant, as they may cause serious harm to your
baby if used after the third month of pregnancy.

• Not known (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.

Tell your doctor if you are breast-feeding or about
to start breast-feeding. Fosinopril tablets are 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

If you experience dizziness, low blood pressure,
light-headedness or vertigo (‘spinning’ sensation),
do not drive or use machinery during treatment
with Fosinopril.

Important information about some of the
ingredients of Fosinopril

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

Blood tests

Fosinopril may interfere with the results of some
blood tests. Tell your doctor that you are taking
Fosinopril sodium tablets.
3

 ow to take Fosinopril sodium tablets
H

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.
Always take Fosinopril exactly as your doctor
has told you. If you are not sure, check with your
doctor or pharmacist
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.
Occasionally some people start their treatment in
hospital.

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

Children under 18 years old: Not recommended.
If you take more Fosinopril sodium than you
should:
Immediately contact your doctor, the nearest
hospital casualty department or the centre for
poison information for advice.

4

Possible side effects

Like all medicines, Fosinopril can cause side effects,
although not everybody gets them. The following
side effects may occur.
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:

• Common (occurring in less than 1 in 10 patients):

infection of the upper respiratory tract (mouth,
noise, 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.

Keep out of the reach and sight of children.
Do not store Fosinopril above 25°C.
Do not transfer to another container.

Do not use Fosinopril after the expiry date stated on
the carton. The expiry date refers to the last day of
that month.
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.

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

How to store Fosinopril sodium tablets

6

Further information

What Fosinopril sodium tablets contain

•  he active substance is fosinopril sodium. Each
T
tablet contains either 10mg or 20mg of fosinopril
sodium.
•  he other ingredients are lactose monohydrate,
T
croscarmellose sodium, pregelatinised starch
(maize), microcrystalline cellulose, glycerol
dibehenate and magnesium stearate.
•  he sodium content is 0.67mg per 10mg tablets
T
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: October 2014

If you would like a
leaflet with larger
text, please contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAH3831

Fosinopril Sodium 10mg & 20mg 28 Tablets PIL - UK
item no: AAAH3831

dimensions: 190 x 380

print proof no: 2

pharmacode:

origination date: 27.10.14

min pt size: 9.5

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

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 03.11.14

Technical Approval

revised by: S.Anson

date sent: 27.10.14

supplier: Actavis Iceland

technically app. date: 28.10.14

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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