INSPRA 25MG FILM-COATED TABLETS

Active substance: EPLERENONE

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Date: 19/09/2013

Package leaflet: Information for the user

Inspra® 25 mg and 50 mg
film-coated tablets
Eplerenone
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
−  eep this leaflet. You may need to read it again.
K
− f you have any further questions, ask your doctor or pharmacist.
I
−  his medicine has been prescribed for you only. Do not pass it on
T
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.
What is in this leaflet:
1. What Inspra is and what it is used for
2. What you need to know before you take Inspra
3. How to take Inspra
4. Possible side effects
5. How to store Inspra
6. Contents of the pack and other information
1. What Inspra is and what it is used for
Inspra belongs to a group of medicines known as selective
aldosterone blocking agents. These blocking agents inhibit the action
of aldosterone, a substance produced within the body, which controls
your blood pressure and heart function. High levels of aldosterone can
cause changes in your body that lead to heart failure.
Inspra is used to treat your heart failure to prevent worsening and
reduce hospitalisations if you have:
1. had a recent heart attack, in combination with other drugs that are
used to treat your heart failure, or
2. have persistent, mild symptoms despite the treatment you have
been receiving so far.
2. What you need to know before you take Inspra
Do not take Inspra
-- if you are allergic to eplerenone or any of the other ingredients of
this medicine (listed in section 6).
-- if you have high levels of potassium in your blood (hyperkalemia)
-- if you are taking groups of drugs which help you to excrete
excessive body fluid, (potassium sparing diuretics) or “salt tablets”
(potassium supplements)
-- if you have severe kidney disease
-- if you have severe liver disease
-- if you are taking medicines that are used to treat fungal infection
(ketoconazole or itraconazole)
-- if you are taking antiviral medication for treating HIV (nelfinavir or
ritonavir)
-- if you are taking antibiotics used to treat bacterial infections
(clarithromycin or telithromycin)
-- if you are taking nefazodone used to treat depression.
-- if you are taking medicines used to treat certain heart conditions
or hypertension (so called angiotensin converting enzyme (ACE)
inhibitor and an angiotensin receptor blocker (ARB)) together.



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Format 157 x 315 mm

-- Angiotensin converting enzyme (ACE) inhibitors and angiotensin
receptor blockers (ARB) together (which are used to treat high blood
pressure, heart disease or particular kidney conditions) as these
drugs may increase the risk of high potassium levels in your blood.
Please inform your doctor if you are taking any of the following
medicines:
− Lithium (usually given for manic depressive disorder, also called
bipolar disorder). Use of lithium together with diuretics and ACE
inhibitors (used to treat high blood pressure and heart disease)
has been shown to cause levels of lithium in the blood to become
too high, which may cause side effects of: loss of appetite; visual
impairment; tiredness; muscle weakness; muscle twitches.
- Cyclosporin or tacrolimus (used to treat skin conditions such
as psoriasis or eczema, and to prevent rejection after organ
transplantation). These drugs can cause kidney problems and
therefore increase the risk of high potassium levels in your blood.
-- Non-steroidal anti-inflammatory drugs (NSAIDs - certain pain killers
such as ibuprofen, used to relieve pain, stiffness and inflammation).
These drugs may lead to kidney problems and therefore increase the
risk of high potassium levels in your blood.
-- Trimethoprim (used to treat bacterial infections) may increase the
risk of high potassium levels in your blood.
-- Alpha I blockers, such as prazosin or alfuzosin (used to treat high
blood pressure and particular prostate conditions) may lead to a fall
in blood pressure and dizziness upon standing.
-- Tricyclic antidepressants such as amitryptyline or amoxapine
(for treatment of depressions), antipsychotics (also known as
neuroleptics) such as chlorpromazine or haloperidol (for the
treatment of psychiatric disorders), amifostine (used during cancer
chemotherapy) and baclofen (used to treat muscle spasm). These
drugs may lead to a fall in blood pressure and dizziness upon
standing.
-- Glucocorticoids, such as hydrocortisone or prednisone (used to
treat inflammation and certain skin conditions) and tetracosactide
(mainly used for diagnosing and treating disorders of the adrenal
cortex) may reduce the blood-pressure lowering effect of Inspra.
-- Digoxin (used in the treatment of heart conditions). Digoxin blood
levels may be increased when taken together with Inspra.
-- Warfarin (an anti-clotting drug): Caution is warranted when taking
warfarin because high levels of warfarin in the blood may cause
changes in the effect of Inspra on the body.
-- Erythromycin (used to treat bacterial infections), saquinavir
(antiviral medication for treating HIV), fluconazole (used to treat
fungal infections), amiodarone, diltiazem and verapamil (for the
treatment of heart problems and high blood pressure) reduce the
break-down of Inspra thereby prolonging the effect of Inspra on
the body.
-- St John’s Wort (herbal medicinal product), rifampicin (used to treat
bacterial infections), carbamazepine, phenytoin, and phenobarbital
(used, among others, to treat epilepsy) may increase the breakdown of Inspra and thus decrease its effect.
Inspra with food and drink
Inspra may be taken with or without food.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or pharmacist for
advice before taking this medicine. The effect of Inspra has not been
evaluated during pregnancy in humans.

Warnings and precautions

It is not known if eplerenone is excreted in human breast milk. A
decision should be made with your doctor, whether to discontinue
breast-feeding or to discontinue the drug.

Talk to your doctor or pharmacist or nurse before taking Inspra.

Driving and using machines

-- if you have kidney or liver disease (see also “Do not take Inspra”)
-- if you are taking lithium (usually given for manic depressive
disorder, also called bipolar disorder)
-- if you are taking tacrolimus or cyclosporin (used to treat skin
conditions such as psoriasis or eczema, and to prevent rejection
after organ transplantation)

You may feel dizzy after taking Inspra. If this should happen, do not
drive or operate machinery.

Children and adolescents
The safety and efficiacy of eplerenone in children and adolescents have
not been established.
Other medicines and Inspra
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
You must not take Inspra with the following medications (see section
“Do not take Inspra”):
-- Itraconazole or ketoconazole (used to treat fungal infections),
ritonavir, nelfinavir (antiviral medication for treating HIV),
clarithromycin, telithromycin (used to treat bacterial infections) or
nefazodone (used to treat depression) as these drugs reduce the
break-down of Inspra, thereby prolonging its effect on the body.
-- Potassium sparing diuretics (drugs which help you to excrete
excess body fluid) and potassium supplements (salt tablets) as
these drugs increase the risk of high potassium levels in your blood.

Inspra contains lactose monohydrate
Inspra contains lactose monohydrate (a type of sugar). If you have
been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
3. How to take Inspra
Always take this medicine exactly as your doctor or pharmacist has
told you. You should Check with your doctor or pharmacist if you are
not sure.
Inspra tablets may be taken together with food or on an empty
stomach. Swallow the tablets whole with plenty of water.
Inspra is usually administered together with other medication for heart
failure e.g., beta blockers. The usual starting dose is one 25 mg tablet
once daily, increasing after about 4 weeks to 50 mg once daily (either
as one 50 mg tablet or two 25 mg tablets). The maximum dose regimen
is 50 mg daily.
Blood potassium levels should be measured before starting Inspra
therapy, within the first week and at one month after the start of
treatment or after a change in dose. The dose may be adjusted by your
doctor, depending on the potassium levels in your blood.

If you have mild kidney disease, you should start on one 25 mg tablet every
day. And if you have moderate kidney disease, you should start on one
25 mg tablet every other day. These doses may be adjusted if your doctor
recommends and according to your blood potassium levels.

includes any possible side effects not listed in this leaflet.
5. How to store Inspra

In patients with severe kidney disease, Inspra is not recommended.

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special storage conditions.

In patients with mild-to-moderate liver disease no adjustment of the starting
dose is required. If you have liver or kidney problems, you may need more
frequent testing of your blood potassium levels (see also “Do not take Inspra”).

Do not use this medicine after the expiry date which is stated on the pack
and blister after EXP. The expiry date refers to the last day of that month.

For the elderly: no adjustment of the starting dose is required.
For children and adolescents: Inspra is not recommended.
If you take more Inspra than you should
If you take more Inspra than you should, tell your doctor or pharmacist
immediately. If you have taken too much of your medicine, the most likely
symptoms will be low blood pressure (expressed as a light feeling in your
head, dizziness, blurred vision, weakness, acute loss of consciousness) or
hyperkalemia, high levels of potassium in the blood (expressed by muscle
cramps, diarrhoea, nausea, dizziness or headache).
If you forget to take Inspra
If it is almost time for your next tablet, skip the tablet you missed and take
your next tablet when it is due.
Otherwise take the tablet as soon as you remember, providing there is more
than 12 hours to when you are due to take your next tablet. Then go back to
taking your medicine as you would normally.
Do not take a double dose to make up for the forgotten tablet.
If you stop taking Inspra
It is important to keep taking Inspra as prescribed unless your doctor tells
you to stop your treatment.
If you have any further questions on the use of this medicine ask your doctor
or pharmacist.
4. Possible side effects
Like all medicines this medicine can cause side effects, although not
everybody gets them.
If you experience any of the following:
You should seek immediate medical attention
• swollen face, tongue or throat
• difficulty swallowing
• hives and difficulties breathing
These are the symptoms of angioneurotic oedema.
Other reported side effects include:
Common side-effects (occurs between 1 and 10 out of every 100
patients):
• heart attack
• elevated potassium level in your blood (symptoms include muscle
cramps, diarrhoea, nausea, dizziness or headache)
• dizziness
• fainting
• infection
• cough
• constipation
• low blood pressure
• diarrhoea
• nausea
• abnormal functioning of your kidney
• rash
• itching
• muscle spasm and pain
• increased urea level in the blood
Uncommon side-effects (occurs between 1 and 10 out of every 1,000
patients):
• eosinophilia (increase in certain white blood cells)
• dehydration
• elevated quantity of cholesterol or triglycerides (fats) in your blood
• low sodium blood levels
• insomnia (difficulty sleeping)
• headache
• heart complaints e.g., irregular heart beat, fast heart beat and heart failure
• inflammation of the gall bladder
• decreased blood pressure that can cause dizziness upon standing
• thrombosis (blood clot) in the leg
• sore throat
• flatulence
• vomiting
• underactive thyroid
• increase in blood glucose
• reduced sense of touch
• increased sweating
• back pain
• feeling weak and generally unwell
• increased creatinine blood levels which may indicate kidney problems
• kidney inflammation
• enlargement of breasts in men
• changes in some blood test results
If you get any side effects, talk to your doctor, pharmacist or nurse. This

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 protect the environment.
6. Contents of the pack and other information
What Inspra contains
The active substance of Inspra film-coated tablets is eplerenone. Each
tablet contains 25 mg or 50 mg of eplerenone.
The other ingredients are: lactose monohydrate, microcrystalline cellulose
(E460), croscarmellose sodium (E468), hypromellose (E464), sodium
laurilsulfate, talc (E553b) and magnesium stearate (E470b).
The opadry yellow coating of Inspra 25 mg and 50 mg film-coated tablets
contains hypromellose (E464), titanium dioxide (E171), macrogol 400,
polysorbate 80 (E433), iron oxide yellow (E172), iron oxide red (E172).
What Inspra looks like and contents of the pack
The Inspra 25 mg tablet is a yellow film-coated tablet. They are marked
with “Pfizer” printed on one side of tablet and “NSR” over “25” on the other
side of tablet.
The Inspra 50 mg tablet is a yellow film-coated tablet. They are marked
with “Pfizer” printed on one side of tablet and “NSR” over “50” on the other
side of tablet.
Inspra 25 mg and 50 mg film-coated tablet are available in opaque PVC/
Al blister packs containing 10, 20, 28, 30, 50, 90, 100 or 200 tablets and
in opaque PVC/Al perforated unit dose blisters containing 10 x 1, 20 x 1,
30 x 1, 50 x 1, 90 x 1, 100 x 1 or 200 x 1 (10 packs of 20 x 1) tablets. Not
all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
The company responsible for Inspra in the UK
(the Marketing Authorisation Holder) is Pfizer Limited, Ramsgate Road,
Sandwich, Kent CT13 9NJ,
United Kingdom.
The company responsible for Inspra in Ireland (the Marketing Authorisation
Holder) is
Pfizer Healthcare Ireland
9 Riverwalk
National Digital Park
Citywest Business Campus
Dublin 24
Ireland
Manufacturers:
Pfizer PGM
Zone Industrielle
29 route des Industries,
37530 Pocé-sur-Cisse,
France
Inspra 25 mg and 50 mg film-coated tablets are authorised in the following
Member States of the EEA under the tradename Inspra
Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, United Kingdom
This leaflet was last revised in 08/2013.
Ref: IN 9_1

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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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