FOSINOPRIL SODIUM 20 MG TABLETS

Active substance: FOSINOPRIL SODIUM

View full screen / Print PDF » Download PDF ⇩

Transcript
PAGE 1: FRONT FACE (INSIDE OF REEL)

Read all of this leaflet carefully before you start
taking this medicine.
• 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. Do
not pass it on to others. It may harm them, even if
their symptoms are the same as yours.
• If any of the side effects get serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.

(Main)

Pharma code 960

Taking other medicines
Talk to your doctor if you are taking any of the
following:
• diuretics (“water tablets”) e.g. amiloride,
spironolactone, triamterene (see section 3, Taking
in combination with a diuretic ("water tablet"))
• other medicines for high blood pressure such as
methyldopa, beta-blockers e.g. propranolol,
atenolol, sotalol, or calcium antagonists e.g.
verapamil
IN THIS LEAFLET:
• potassium-containing salt substitutes, potassium
1. What Fosinopril is and what it is used for
supplements or heparin, as Fosinopril may
2. Before you take Fosinopril
increase potassium levels
3. How to take Fosinopril
• pain killers such as indometacin, ibuprofen or
4. Possible side effects
aspirin, as the effectiveness of Fosinopril may be
5. How to store Fosinopril
reduced
6. Further information
• antacids (to relieve indigestion), as the
effectiveness of Fosinopril may be reduced. Doses
FOSINOPRIL IS AND WHAT IT IS
of Fosinopril and antacids should be taken
1 WHAT FOR
USED
2 hours apart
• glyceryl trinitrate and other nitrates used to treat
Fosinopril belongs to a group of drugs called
angina (chest pain).
Angiotensin Converting Enzyme (ACE) Inhibitors,
which are vasodilators (drugs which widen the blood • vasodilators (drugs that cause blood vessels to
expand) e.g. minoxidil
vessels, reduce blood pressure and make it easier for
• procainamide (used to treat abnormal heart
the heart to pump blood around the body).
rhythms)
Fosinopril is used to treat:
• antidiabetics (insulin or oral hypoglycaemic
• high blood pressure
drugs) e.g. tolbutamide
• congestive heart failure (a condition where the
• lithium, as lithium levels may be increased
heart no longer pumps blood as effectively as it
• tricyclic antidepressants e.g. amitriptyline or
should).
dosulepin, or antipsychotics (used for psychiatric
problems) e.g. flupenthixol
BEFORE YOU TAKE FOSINOPRIL
2
• immunosuppressants (drugs to reduce the body’s
natural defence system) e.g. cyclosporin,
DO NOT take Fosinopril and contact your doctor
cytostatics, budesonide or procainamide
immediately if you:
• systemic corticosteroids e.g. prednisone
• are allergic to fosinopril sodium or any of the
• allopurinol (used to treat gout)
ingredients in your medicine
• medicines known as sympathomimetics e.g.
• have suffered an allergic reaction to any other
salbutamol, ephedrine and some medicines for
ACE inhibitors e.g. captopril, enalapril, which led
colds, coughs or flu symptoms which may contain
to swelling of the face, lips, tongue and/or throat
these ingredients.
• have a condition known as hereditary
angioneurotic oedema, which is a serious allergic Please tell your doctor or pharmacist if you are taking
reaction causing swelling of the face or throat, or or have recently taken any other medicines, including
have ever had a similar unexplained allergic
medicines obtained without a prescription.
reaction
Important information about some of the ingredients
• have the rare hereditary problem of galactose
of Fosinopril
intolerance, the Lapp lactase deficiency or
• Patients who are intolerant to lactose should note
glucose-galactose malabsorption
that Fosinopril tablets contain a small amount of
• are more than 3 months pregnant. (It is also better
lactose. If your doctor has told you that you have
to avoid Fosinopril in early pregnancy – see
an intolerance to some sugars, contact your
pregnancy section.)
doctor before taking this medicine.
Take special care with Fosinopril
Taking Fosinopril with food and drink
Tell your doctor before you start to take this
• DO NOT take alcohol whilst being treated with
medicine if you have:
Fosinopril.
• any of the following heart problems: narrowing of
the heart valves, cardiomyopathy (inflammation
Pregnancy and breast-feeding
of the heart muscle), ischaemic heart disease (lack Pregnancy
of blood flow and oxygen to the heart)
You must tell your doctor if you think you are (or
• cerebrovascular disease (disease affecting blood
might become) pregnant. Your doctor will normally
vessels in the brain)
advise you to stop taking Fosinopril before you
• kidney problems including disease of the arteries become pregnant or as soon as you know you are
to the kidney or are undergoing dialysis
pregnant and will advise you to take another
• collagen vascular disease e.g. rheumatoid
medicine instead of Fosinopril. Fosinopril is not
arthritis, SLE (systemic lupus erythematosus) an
recommended in early pregnancy, and must not be
autoimmune condition which causes joint pain,
taken when more than 3 months pregnant, as it may
skin rashes and fever
cause serious harm to your baby if used after the
• diabetes
third month of pregnancy.
• low blood sodium
Breast-feeding
• hypovolaemia (blood pressure falls due to fluid
Tell your doctor if you are breast-feeding or about to
loss)
start breast-feeding. Fosinopril is not recommended
• been on a low-salt diet
for mothers who are breast-feeding, and your doctor
• liver problems
may choose another treatment for you if you wish to
• become dehydrated e.g. you have recently
breast-feed, especially if your baby is newborn, or
suffered from severe diarrhoea or vomiting
• a severe reduction in number of white blood cells was born prematurely.
which makes infections more likely.
Driving and using machines:
• Fosinopril may cause dizziness and decreased
You must tell your doctor if you think you are (or
blood pressure. If affected, DO NOT drive or
might become) pregnant. Fosinopril is not
operate machinery.
recommended in early pregnancy, and must not be
taken if you are more than 3 months pregnant, as it
3 HOW TO TAKE FOSINOPRIL
may cause serious harm to your baby if used at that
stage (see pregnancy section).
Always take Fosinopril exactly as your doctor has
Tell your doctor you are taking Fosinopril if you:
told you. You should check with your doctor or
• have to go on a machine to remove cholesterol
pharmacist if you are not sure.
from the blood
• have to undergo desensitisation treatment (e.g. to In some cases, your treatment may be started in
hospital so that you can be closely monitored.
reduce the effects of an allergy to wasp or bee
stings)
The tablets should be swallowed preferably with a
• are to undergo a parathyroid test; tell your doctor glass of water at the same time each day. The tablet
you are taking Fosinopril, as you may be required should not be broken as it is available in several
to stop taking Fosinopril for a few days before the different strengths. The usual dose is:
test
• are to have an operation requiring an anaesthetic Adults (including the elderly)
• High blood pressure
(including treatment at the dentist); you should
The usual starting dose is 10 mg once daily.
tell the doctor or dentist that you are taking
Fosinopril.



Heart failure
Fosinopril is usually taken in combination with a
diuretic (”water tablet” see below), or with
,
digitalis to treat this condition.
The usual 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.





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 (affecting less than one person in 1,000 but
more than one person in 10,000):
• hoarseness/laryngitis
• dysphasia (problems in the ability to select words
in which to speak, read or write)
• Taking in combination with a diuretic (”water
• inflammation of the pancreas
tablet”)
• difficulty in swallowing accompanied by swollen
If you are already taking diuretics, your doctor
glands, swollen tongue or mouth sores
may tell you to reduce the dose of the diuretic or
• weakness in limbs, arthritis
to stop taking them for 2-3 days before beginning
• blood disorders which may be characterised by
treatment with Fosinopril.
fever or chills, sore throat, ulcers in your mouth or
Children and adolescents (under 18 years old):
throat, low blood count causing unusual tiredness
Fosinopril is not recommended for use in children
or weakness, unusual bleeding or unexplained
and adolescents under 18 years of age.
bruising
• abdominal pain and swelling
If you take more Fosinopril than you should
• hepatitis – inflammation of the liver
If you (or someone else) swallow a lot of the tablets
• flushing of skin, bleeding problems, nose bleed
all together or if you think a child has swallowed any
• peripheral vascular disease (disease of arteries)
of the tablets, contact your nearest hospital casualty
• memory disturbances, disorientation
department or your doctor immediately.
• pneumonia, congestion in the lungs
An overdose is likely to cause signs of faintness or
• difficulty in breathing
dizziness due to a drop in blood pressure, weak pulse
• low levels of salt in the blood
and clammy skin, hyperventilation, changes in heart
• raised levels of iron in the blood.
rate or rhythm, anxiety, and cough.
Very rare (affecting less than one person in 10,000):
Please take this leaflet, any remaining tablets, and
• acute liver failure
the container with you to the hospital or doctor so
• acute renal failure
that they know which tablets were consumed.
• severe reduction in number of white blood cells
If you forget to take Fosinopril
making infections more likely
If you forget to take a tablet, take one as soon as you • inflammation and swelling of the bowel.
remember, unless it is nearly time to take the next
A disorder which may include fever, vasculitis
one. DO NOT take a double dose to make up for a
(inflammation of blood vessels), muscle pain, joint
forgotten dose.
pain/arthritis, blood disorders, rash, sensitivity to
If you stop taking Fosinopril
light or other skin problems has been reported.
DO NOT stop taking Fosinopril without talking to
Fosinopril may interfere with the results of blood or
your doctor first even if you feel better.
urine tests.
If you have any further questions on the use of this
If any of the side effects become serious, or if you
product, ask your doctor or pharmacist.
notice any side effects not listed in this leaflet, please
tell your doctor or pharmacist.
POSSIBLE SIDE EFFECTS

4

Like all medicines, Fosinopril can cause side effects,
although not everybody gets them.
Stop taking the tablets and tell your doctor
immediately or go to the casualty department at your
nearest hospital if the following happens:
• allergic reactions which may include swelling of
the lips, face or neck leading to severe difficulty in
breathing; skin rash or nettle rash.
This is a very serious side effect. You may need
urgent medical attention or hospitalisation.
The following side effects have been reported at the
approximate frequencies shown:
Common (affecting less than one person in 10 but
more than one person in 100):
• cough
• dizziness, weakness
• low blood pressure which may cause fainting or
dizziness when standing up
• nausea, vomiting, diarrhoea
• rash, inflammation of the skin
• allergic reactions causing swelling of the face and
throat (may be more common in Afro-Caribbean
patients)
• headache
• fast heart rate or chest pain not related to the
heart.
Uncommon (affecting less than one person in 100
but more than one person in 1,000):
• excessive sweating, fever, runny or itchy nose,
sinusitis, bronchitis (cough which may produce
sputum), dry mouth
• itching, nettle rash
• shortness of breath and inflammation of the
airways
• increased amounts of protein in the urine
• muscle pain and pain in the thorax or chest
• flatulence, constipation
• pins and needles
• depression, confusion
• sleepiness or sleep disturbances
• chest pain associated with the heart, palpitations
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
levels
• decrease in appetite, taste changes
• fainting

5

HOW TO STORE FOSINOPRIL

Keep out of the reach and sight of children. Keep
Fosinopril out of the reach and sight of children. Do
not store above 25°C. Store in the original container.
Do not transfer to another container.
Do not use Fosinopril after the expiry date shown on
the outer packaging. Return all unused medicines to
your pharmacist for safe disposal. 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.

6

FURTHER INFORMATION

What Fosinopril tablets contain:
• The active ingredient is fosinopril sodium, 10 mg
or 20 mg.
• The other ingredients are lactose anhydrous,
povidone K30, crospovidone, microcrystalline
cellulose, sodium laurylsulphate, glycerol
dibehenate.
What Fosinopril Tablets look like and contents of the
pack
• Fosinopril 10mg Tablets are white to off-white in
colour, round tablets scored on both sides of the
tablet with “F” and “10” on each side of the score
on one side of the tablet.
• Fosinopril 20mg Tablets are whiteto off-white
capsule-shaped tablets with number embossed
“93” on one side and “7223” on the other side.
The following pack sizes are available for:
• Fosinopril 10mg: 20, 28, 30, 50, 84, 90 or 100
tablets or 20 x 20 tablets as a hospital pack.
• Fosinopril 20mg: 14, 20, 28, 30, 50, 56, 84, 90 or
100 tablets or 20 x 20 tablets as a hospital pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder and company
responsible for manufacture: TEVA UK Limited,
Eastbourne, BN22 9AG.
This leaflet was last revised: November 2008
PL 00289/0517-0518

83880-V

(Main)

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.

Pharma code 960

PACKAGE LEAFLET: INFORMATION
FOR THE USER

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.

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

FOSINOPRIL SODIUM
10 mg AND 20 mg TABLETS

PAGE 2: REAR FACE (OUTSIDE OF REEL)

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.

Hide
(web5)