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SPIRETIC TABLETS 25MG

Active substance(s): SPIRONOLACTONE

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PATIENT INFORMATION LEAFLET

SPIRETIC TABLETS 25mg & 100mg
Spironolactone Tablets 25 & 100 mg
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE
KEEP THIS LEAFLET UNTIL YOU HAVE FINISHED ALL THE
PRESCRIBED COURSE OF SPIRETIC
IF YOU HAVE ANY QUESTIONS CONCERNING YOUR
MEDICINE ASK YOUR DOCTOR OR PHARMACIST FOR
MORE INFORMATION
What is in your medicine?
The name of this medicine is Spiretic. It contains
Spironolactone together with the following inactive
ingredients: Calcium sulphate dihydrate, povidone, maize
starch, crospovidone, pregelatinised maize starch,
magnesium stearate, peppermint flavour and quinoline
yellow E104.
Spiretic is available in tablets of two strengths containing
either 25 mg or 100 mg of the drug.
Spiretic 25 mg tablets contain Spironolactone 25 mg and
Spiretic 100 mg tablets contain Spironolactone 100 mg.
Both strengths are packed in containers and blister packs of
28, 30, 50, 56, 60, 84, 100, 250, 500 and 1000 tablets. Not
all pack sizes may be marketed.
Spiretic 25 mg tablets are pale yellow bi-convex, engraved
SPIRETIC 25. Spiretic 100 mg tablets are pale yellow biconvex, engraved SPIRETIC 100.

• cannot pass urine
The presence of other medical problems may affect the use
of this medicine. Tell your doctor if you have any other
medical problems, especially if you:



have any liver or kidney problems
have been told you have a high level of potassium
in your blood or you are taking potassium
supplements
• have been told you have a low level of sodium in
your blood
• suffer from porphyria
• If you are taking any medicines for the treatment
of blood pressure.
You doctor may decide to monitor your fluid, potassium
and/or sodium levels.
An increase of potassium in the blood may occur if you
have reduced kidney function or with an increase in
potassium intake. This can cause you to experience muscle
weakness, palpitations, irregular heartbeat or intervals in
the normal heartbeat which can result in dizziness,
tiredness or fainting. Tell your doctor if you experience
these symptoms.
The long term use of Spiretic in young persons requires
careful consideration of the benefits and the potential
hazard involved, particularly as Spironolactone has been
shown to produce tumours in rats when given high doses
over a long period of time.

The Product Licence holder of Spiretic is:
Chelonia Healthcare Ltd,
11 Boumpoulinas,1060 Nicosia, Cyprus.
The manufacturer of Spiretic is:
Meridian Healthcare (UK) Ltd.,
208-214 York Road, Battersea, London SW11 3SD.

Use in Pregnancy
Because Spiretic or its by-products may enter the
circulation of the foetus, your doctor will decide whether
treatment with Spiretic is desirable during pregnancy.
Nursing mothers: the by-product of Spiretic (Canrenone)
appears in breast milk. An alternative method of infant
feeding will be suggested by your doctor if he considers
that the use of Spiretic is essential.

How does Spiretic work?
Spiretic belongs to a group of medicines called potassiumsparing diuretics, commonly used to help reduce the
amount of excess fluid accumulated in the body in the
following conditions:

Can you drive while taking Spiretic?
Spiretic may cause drowsiness or dizziness. Make sure that
you know how you react to this medicine before you drive,
use machines, or do anything else that could be dangerous
if you are not alert.



Kidney disease (Nephrotic syndrome).



Heart failure



Cirrhosis of the liver



Treatment of primary aldosteronism

• Collection of fluid due to certain tumours
If you are not sure why you have been prescribed Spiretic,
then please ask you doctor.
Before taking your medicine
Before taking this medicine tell your doctor if you have
ever had any unusual or allergic reactions to
Spironolactone or other diuretics. Also tell your doctor or
pharmacist if you are allergic to any substances such as
foods, preservatives or dyes.
Do not take Spiretic if you:


suffer from Addison’s disease

Can you take Spiretic with other medicines?
It is very important to tell your doctor or pharmacist
about all the medicines which you are taking, whether
prescribed by your doctor or bought without a
prescription from the pharmacy or elsewhere.
You can take Spiretic with other medicines, but there are
some medicines that can interfere with Spiretic.
Drugs which reduce blood pressure may have increased
effects when used together with Spiretic, and your doctor
may wish to reduce the dose of these other drugs.
Aspirin interferes with the effectiveness of Spiretic in
reducing excess fluid in the body.
An increase in blood potassium levels may occur when
Spiretic is taken together with other diuretics, non-steroidal
anti-inflammatory drugs or certain other medicines.
It is important to tell your doctor if you are taking:

• Digoxin, digitoxin or any other medication for heart
conditions
• Other diuretics or any other medication for high blood
pressure
• Non steroidal anti-inflammatory drugs (eg, ibuprofen,
indometacin, keterolac) or corticosteroids – for pain
and inflammation relief
• Lithium – for depression
• Amisulpride, pimozide or sertindole – to treat mania
• Terfenadine – for allergy relief
• Ciclosporin or tacrolimus – used to suppress the
immune system
• Oestrogens
• Chlorpropamide – to treat diabetes
• Carbamazepine – to treat epilepsy
• Carbenexolone – for stomach ulcers
• Aminogluthethimide
If you need to have an operation make sure the doctor or
surgeon knows that you are taking Spiretic.
When and how to take Spiretic tablets
Take this medicine by mouth with food and only in the
doses prescribed by your doctor.
Adults
Take this medicine as instructed by your doctor. The dose
will depend on your condition and may need to be
increased or decreased over time to control your
symptoms.
Elderly:
Dosage in the elderly will be adjusted by your doctor on
the basis of the response and tolerance to treatment, which
may be less than the recommended adult dose.
Children:
Spiretic can be used in children under certain
circumstances. Dosage for children will be determined by
the doctor based upon bodyweight.
What to do if too many tablets are taken at the
same time
If you think that you have taken an overdose of this
medicine obtain emergency help at once. Some signs of
overdose are:
Drowsiness, mental confusion, nausea, vomiting, dizziness
or diarrhoea.
The symptoms of increased potassium in your blood may
cause tingling in your fingers and toes, irregular heartbeat,
muscle weakness or muscle spasm.
Improvement of these conditions will occur after you stop
taking this medicine.
What if you miss a dose
Do not take more of it or take it more often, or for a longer
time than your doctor ordered.
If you feel that this medicine is not working as well after
you have taken it for a short time (1 to 2 weeks), do not
increase the dose; instead check with your doctor.

What side effects can Spiretic cause?
The majority of people who take spironolactone have no
problems, however the medicine may cause some
unwanted effects.
Check with your doctor immediately if any of these side
effects occur:






stomach upset
headache
feeling lack of energy, drowsy or confused
Skin rashes and/or itching
Swelling of the breasts in men (which will usually
return to normal when the drug is stopped)
• Women may have irregular or heavy periods and their
breasts may feel sore. Men may become impotent for
a while.
Contact your doctor immediately if any of the following
rare side effects occur:
• a change in heartbeat rhythm or regularity.
• liver or kidney problems
• an allergic reaction, generally visible as a severe skin
condition / rash
• bone or blood conditions (which may manifest as
excessive bleeding before clotting, easy bruising,
blood in the urine or stools; high fever, sore throat,
skin rash, infections or sores)
There have been reports of cancerous breast tumours in
men.
Tell your doctor if you notice any other undesirable effects
whilst taking this medicine.
Storing your medicine
You must keep this medicine in a safe place where children
cannot get hold of it.
Store below 25°C in a dry place. Keep container well
closed.
On the label you will find the words "Expiry Date"
followed by numbers indicating the day, month and year.
This is the date when the medicine is no longer fit for use.
Do not use the medicine after this date, but return it to your
doctor or pharmacist.
A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as
yours.
This leaflet does not contain the complete information
about your medicine. If you have any questions or are not
sure about anything, ask your doctor or pharmacist who
have access to additional information.
PL numbers: 33414/0105 and 0106
This leaflet was revised in April 2011

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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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