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FOSINOPRIL SODIUM 20MG 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
⋅ If you have any further questions, please 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
⋅ If 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.
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

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 belongs 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 (eg 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
⋅ 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
⋅ Aliskiren

Your doctor may check your kidney function, blood pressure,
and the amount of electrolytes (eg 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
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 (eg atenolol), calcium
antagonists (eg verapamil) or diuretics (water tablets)
(eg furosemide) as it may lead to an increase in the
blood pressure lowering effects
⋅ potassium-sparing diuretics (eg 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
⋅ painkillers and anti-inflammatory medicines of the
NSAID type (eg aspirin or indometacin) as they can
reduce the effect of fosinopril sodium
⋅ antacids (to relieve indigestion) stop the body
absorbing fosinopril sodium. There should be at least 2
hours between taking the antacid and fosinopril sodium
⋅ insulin and tablets used in diabetes, as fosinopril
sodium may increase the effect of these especially during
the first week of combination treatment
⋅ lithium (used for manic depression), as fosinopril sodium
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 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.
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
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.

(continued overleaf)

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.

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 above 25ºC. Keep in the original packaging.
Keep the container tightly closed to protect from moisture.

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.

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.

4. Possible side effects

6. Contents of the pack and other information

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:
⋅ Common (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

What Fosinopril Sodium Tablets contain
⋅ The active substance is fosinopril sodium. Each tablet
contains either 10mg or 20mg fosinopril sodium
⋅ The other ingredients are lactose monohydrate,
modified starch, croscarmellose sodium (E468),
microcrystalline cellulose (E460), glycerol dibehenate
and purified water.
⋅ 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, flat,
uncoated tablets.
The 10mg strength tablet is marked `FL 10'. The 20mg
strength tablet is marked `FL 20'.
Each pack contains 30 tablets.
PL holder
Manx Healthcare Ltd, Taylor Group House,
Wedgnock Lane, Warwick, CV34 5YA
PL 14251/0037 Fosinopril Sodium 10mg Tablets
PL 14251/0038 Fosinopril Sodium 20mg Tablets
Procured from within the EU
POM



Uncommon (may affect up to 1 in 100 people)
fainting, shock

Manufacturer
Actavis hf, Reykjavikurvegur 78, IS-220 Hafnarfjordur, Iceland



Not 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,

To request a copy of this leaflet in large print, audio or Braille,
please call 01926 482511.
This leaflet was last revised in September 2016
WIP URN: 200916-XXXX-PIL-02

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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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