comprises the lively ingredient spironolactone
CONSUMER MEDICINE INFORMATION
What’s on this leaflet
This leaflet solutions some frequent questions on SPIRONOLACTONE VIATRIS.
It doesn’t comprise all the out there info. It doesn’t take the place of
speaking to your physician or pharmacist.
All medicines have advantages and dangers. Your physician has weighed the dangers of you taking
SPIRONOLACTONE VIATRIS towards the advantages they anticipate it is going to have for you.
In case you have any considerations about taking this drugs, speak to your physician or pharmacist.
Maintain this leaflet along with your drugs. It’s possible you’ll have to learn it once more.
What SPIRONOLACTONE VIATRIS is used for
SPIRONOLACTONE VIATRIS is used:
to deal with important hypertension (hypertension with an unknown trigger)
to deal with oedematous problems (swelling with fluid), together with congestive cardiac
failure
to assist carry potassium ranges within the blood again to regular when the degrees change into
too low
to deal with hyperaldosteronism (a hormone dysfunction inflicting fluid retention)
as add on remedy in malignant hypertension (a really critical type of hypertension)
deal with extra facial or physique hair in girls.
Ask your physician when you’ve got any questions on why this drugs has been prescribed
for you.
Your physician might have prescribed it for one more cause.
This drugs is offered solely with a health care provider’s prescription.
There isn’t any proof that SPIRONOLACTONE VIATRIS is addictive.
How SPIRONOLACTONE VIATRIS works
In fluid build-up and hypertension
SPIRONOLACTONE VIATRIS is a fluid pill or diuretic. It helps cut back the quantity of
extra fluid within the physique by rising the quantity of urine produced. This additionally helps
to decrease blood stress.
In hyperaldosteronism and low potassium ranges within the blood
In hyperaldosteronism, the adrenal glands produce an excessive amount of of a hormone referred to as aldosterone.
SPIRONOLACTONE VIATRIS works by stopping the results of aldosterone.
By stopping the results of aldosterone, SPIRONOLACTONE VIATRIS additionally helps to take care of
regular ranges of potassium within the blood by retaining potassium within the physique.
In girls with extra hair
All girls produce small quantities of the male intercourse hormone, testosterone. Girls with
extra facial or physique hair are typically particularly delicate to the motion of testosterone
on hair development. SPIRONOLACTONE VIATRIS reduces the expansion of hair by stopping the
results of testosterone. Elevated urine stream is unlikely to be an issue when SPIRONOLACTONE
VIATRIS is used to deal with hirsutism. It’s because aldosterone ranges will not be usually
excessive in sufferers with hirsutism.
Earlier than you are taking SPIRONOLACTONE VIATRIS
When you will need to not take it
Don’t take SPIRONOLACTONE VIATRIS if you’re allergic to any drugs containing
spironolactone or any of the elements listed on the finish of this leaflet.
A number of the signs of an allergic response might embrace:
shortness of breath
wheezing or problem respiratory
swelling of the face, lips, tongue or different components of the physique
rash, itching or hives on the pores and skin.
Don’t take SPIRONOLACTONE VIATRIS when you’ve got any of the next medical situations:
excessive potassium ranges in your blood (hyperkalaemia)
extreme kidney illness or not passing urine.
Addison’s illness, a situation the place the adrenal glands don’t work correctly.
The protection of SPIRONOLACTONE VIATRIS for the remedy of hirsutism in girls of child-bearing
age has not been established by particular research.
Your physician might advocate mixed use with oral contraceptives to supply each common
menstrual cycles and satisfactory contraception.
Don’t take this drugs if you’re pregnant or assume you is perhaps pregnant.
SPIRONOLACTONE VIATRIS can have an effect on your growing child should you take it throughout being pregnant.
Don’t take this drugs if you’re breastfeeding.
SPIRONOLACTONE VIATRIS passes into breast milk and should have an effect on your child.
Don’t take this drugs after the expiry date printed on the pack or if the pack
or if the packaging is torn or exhibits indicators of tampering.
If it has expired or is broken, return it to your pharmacist for disposal. When you
will not be positive whether or not you need to begin taking this drugs, speak to your physician.
Earlier than you begin to take it
Inform your physician when you’ve got allergic reactions to every other medicines, meals, dyes or preservatives.
Inform your physician when you’ve got or have had any of the next medical situations:
liver issues
kidney issues
extreme coronary heart failure.
Inform your physician should you plan to change into pregnant or breastfeed.
Inform your physician should you plan to have surgical procedure.
In case you have not instructed your physician about any of the above, inform him/her earlier than you begin
taking SPIRONOLACTONE VIATRIS .
Taking different medicines
Inform your physician or pharmacist if you’re taking every other medicines, together with any
that you just purchase with or with no prescription from a pharmacy, grocery store or well being
meals store.
Some medicines and SPIRONOLACTONE VIATRIS might intervene with one another. These embrace:
different medicines used to deal with hypertension, together with ACE inhibitors
diuretics, that are fluid eradicating medicines also referred to as water tablets
digoxin, a drugs used to deal with coronary heart situations
potassium dietary supplements or potassium-containing salt substitutes
colestyramine, a drugs used to decrease levels of cholesterol within the blood
ammonium chloride, which is contained in some cough and chilly medicines
medicines to forestall blood clots, together with aspirin
non-steroidal anti-inflammatory medication (NSAIDs), or different medicines used to alleviate
ache, swelling and different signs of irritation, together with arthritis (e.g. aspirin,
indometacin or mefenamic acid)
carbenoxolone, a drugs used to deal with mouth ulcers
regional or normal anaesthetics.
These medicines could also be affected by SPIRONOLACTONE VIATRIS or might have an effect on how nicely it
works. It’s possible you’ll want completely different quantities of your medicines, or chances are you’ll have to take completely different
medicines.
Your physician and pharmacist have extra info on medicines to watch out with or
keep away from whereas taking SPIRONOLACTONE VIATRIS .
The right way to take SPIRONOLACTONE VIATRIS
Observe all instructions given to you by your physician and pharmacist rigorously.
They could differ from the knowledge contained on this leaflet.
If you don’t perceive the directions on the bottle, ask your physician or pharmacist
for assist.
How a lot to take
Your physician will let you know what number of tablets you must take every day. Every day doses
of SPIRONOLACTONE VIATRIS in adults can vary from 25mg to 400mg. This is determined by
your situation and whether or not or not you take different medicines.
Doses of SPIRONOLACTONE VIATRIS in youngsters are measured based on physique weight
and can be calculated by your physician.
Observe your physician’s directions precisely concerning the dose you need to take and the way
typically you need to take it.
The right way to take it
Swallow the tablets with a glass of water.
When to take it
Relying on the dose and your situation, SPIRONOLACTONE VIATRIS could also be taken as soon as
a day or divided into separate doses.
Take SPIRONOLACTONE VIATRIS with or instantly after meals.
How lengthy to take it for
Proceed taking your drugs for so long as your physician tells you to.
The size of remedy will rely in your situation. SPIRONOLACTONE VIATRIS is normally
taken long run.
When you overlook to take it
Whether it is nearly time in your subsequent dose, skip the dose you missed and take your subsequent
dose if you end up meant to.
In any other case, take it as quickly as you keep in mind, after which return to taking your drugs
as you’d usually.
Don’t take a double dose to make up for the dose that you just missed.
In case you are undecided what to do, ask your physician or pharmacist.
When you take an excessive amount of (overdose)
Instantly phone your physician or the Poisons Data Centre (phone 13
11 26) for recommendation, or go to Accident and Emergency on the nearest hospital should you
assume you or anybody else might have taken an excessive amount of SPIRONOLACTONE VIATRIS. Do that even
if there are not any indicators of discomfort or poisoning.
It’s possible you’ll want pressing medical consideration.
When you take an excessive amount of SPIRONOLACTONE VIATRIS , chances are you’ll really feel drowsy, weak, confused
or sick, vomit, have diarrhoea or pins and needles of the arms or ft.
While you’re taking SPIRONOLACTONE VIATRIS
Issues you will need to do
In case you are about to be began on any new drugs, remind your physician and pharmacist
that you’re taking SPIRONOLACTONE VIATRIS.
Inform every other medical doctors, dentists and pharmacists who deal with you that you’re taking
this drugs.
That is particularly essential if you’ll obtain an anaesthetic agent whereas
being handled with SPIRONOLACTONE VIATRIS. When you change into pregnant whereas taking this
drugs, inform your physician instantly.
Whether it is doable so that you can change into pregnant, you need to use satisfactory contraception
if you are taking SPIRONOLACTONE VIATRIS. Examples of satisfactory contraception are
oral contraceptives (“the Tablet”) or intra-uterine units (IUDs). Cease taking SPIRONOLACTONE
VIATRIS should you change into pregnant otherwise you assume chances are you’ll be pregnant.
In case you are about to have any blood checks, inform your physician that you’re taking this
drugs.
It could intervene with the outcomes of some checks.
Maintain your whole physician’s appointments in order that your progress might be checked.
Your physician might ask you to have blood checks to examine your sodium and potassium ranges
and see how your kidneys are working.
Issues you will need to not do
Don’t take SPIRONOLACTONE VIATRIS to deal with every other complaints until your physician
tells you to.
Don’t give your drugs to anybody else, even when they’ve the identical situation as
you.
Don’t cease taking your drugs or decrease the dose with out checking along with your physician.
Don’t take potassium dietary supplements or use salt substitutes that comprise potassium.
Don’t eat a weight-reduction plan wealthy in potassium.
Dried fruit, bananas and oranges are some meals that comprise excessive quantities of potassium.
Consuming a few of these meals is normally secure however don’t eat extreme quantities.
In case you are taking SPIRONOLACTONE VIATRIS, an excessive amount of potassium could cause critical issues,
reminiscent of disturbances to the guts rhythm.
Issues to watch out of
Watch out driving or working equipment till you understand how SPIRONOLACTONE VIATRIS
impacts you.
This drugs might trigger drowsiness or dizziness in some individuals. In case you have any of
these, don’t drive, function equipment or do the rest that may very well be harmful.
Way of life measures that assist cut back coronary heart illness threat
By following these easy measures, you’ll be able to additional cut back the chance from coronary heart illness.
Stop smoking and keep away from second-hand smoke.
Restrict alcohol consumption.
Take pleasure in wholesome consuming by:
consuming loads of greens and fruit;
lowering your saturated fats consumption (eat much less fatty meats, full fats dairy merchandise,
butter, coconut and palm oils, most take-away meals, commercially-baked merchandise).
Be lively. Progress, over time, to at the least half-hour of moderate-intensity bodily
exercise on 5 or extra days every week. Might be gathered in shorter bouts of 10 minutes
period. In case you have been prescribed anti-angina drugs, carry it with you when
being bodily lively.
Keep a wholesome weight.
Talk about your way of life and way of life plans along with your physician.
For extra info and instruments to enhance your coronary heart well being, name Heartline, the Coronary heart
Basis’s nationwide phone info service, on 1300 36 27 87 (native name
value).
Know warning indicators of coronary heart assault and what to do:
Tightness, fullness, stress, squeezing, heaviness or ache in your chest, neck, jaw,
throat, shoulders, arms or again.
You may additionally have problem respiratory, or have a chilly sweat or really feel dizzy or mild
headed or really feel like vomiting (or really vomit).
In case you have coronary heart assault warning indicators which are extreme, worsen or final for 10 minutes
even when they’re gentle, name triple zero (000). Each minute counts.
Unwanted side effects
Inform your physician or pharmacist as quickly as doable if you don’t really feel nicely when you
are taking SPIRONOLACTONE VIATRIS.
Like different medicines, SPIRONOLACTONE VIATRIS might trigger undesirable unwanted effects in some
individuals. Typically they’re critical, more often than not they aren’t. It’s possible you’ll want medical
consideration should you get among the unwanted effects.
Don’t be alarmed by the next checklist of unwanted effects.
It’s possible you’ll not expertise any of them.
Ask your physician or pharmacist to reply any questions you might have.
Inform your physician or pharmacist should you discover any of the next they usually fear you:
vomiting, feeling sick (nausea)
abdomen cramps or ache
diarrhoea
headache
drowsiness, lethargy or typically feeling unwell
pores and skin rash, itchiness, hives
unsteadiness when strolling
leg cramps
hair loss or thinning
extreme hair development
menstrual issues in girls
post-menopausal bleeding
breast ache
change in intercourse drive
impotence (incapability to get or keep an erection in males)
breast enlargement in males. This usually goes away when SPIRONOLACTONE VIATRIS is
stopped. In uncommon situations some breast enlargement might persist.
Inform your physician as quickly as doable should you discover any of the next:
psychological confusion or dizziness
frequent an infection reminiscent of fever, extreme chills, sore throat or mouth ulcers
bleeding or bruising extra simply than regular.
breast lumps and breast most cancers have been reported in sufferers taking SPIRONOLACTONE
VIATRIS though SPIRONOLACTONE VIATRIS has not been proven to trigger breast most cancers.
The above checklist contains critical unwanted effects that will require medical consideration.
If any of the next occur, inform your physician instantly or go to Accident and
Emergency at your nearest hospital:
yellow pores and skin and eyes (jaundice). SPIRONOLACTONE VIATRIS could cause impairment of liver
perform.
abdomen bleeding, ulcers or gastritis (irritation of the abdomen)
vomiting blood or materials that appears like espresso grounds, bleeding from the again
passage, black sticky bowel motions (stools) or bloody diarrhoea
irregular heartbeat, tingling sensation, paralysis or problem in respiratory, which
could also be signs of raised potassium ranges in your blood
The above checklist contains very critical unwanted effects. It’s possible you’ll want pressing medical consideration
or hospitalisation.
Inform your physician or pharmacist should you discover something that’s making you are feeling unwell.
Different unwanted effects not listed above might also happen in some sufferers.
After taking SPIRONOLACTONE VIATRIS
Storage
Maintain your tablets within the bottle till it’s time to take them.
When you take the tablets out of the bottle they could not preserve nicely.
Maintain your tablets in a cool dry place the place the temperature stays beneath 30°C.
Don’t retailer SPIRONOLACTONE VIATRIS or every other drugs within the rest room or close to
a sink. Don’t go away it within the automotive or on a window sill.
Warmth and dampness can destroy some medicines.
Maintain it the place youngsters can not attain it.
A locked cabinet at the least one-and-a-half metres above the bottom is an effective place
to retailer medicines.
Disposal
In case your physician tells you to cease taking this drugs, or the expiry date has handed,
ask your pharmacist what to do with any drugs that’s left over.
Product description
What it appears to be like like
SPIRONOLACTONE VIATRIS is available in two strengths of tablets:
SPIRONOLACTONE VIATRIS 25 – spherical, pale orange, peppermint flavoured pill, marked
SP/1 and a Greek alpha image
SPIRONOLACTONE VIATRIS 100 – spherical, pale orange, peppermint flavoured pill, marked
SP/2 and a Greek alpha image.
Every bottle comprises 100 tablets.
Components
The lively ingredient in SPIRONOLACTONE VIATRIS is spironolactone
every SPIRONOLACTONE VIATRIS 25 pill comprises 25 mg of spironolactone
every SPIRONOLACTONE VIATRIS 100 pill comprises 100 mg of spironolactone.
The tablets additionally comprise the next inactive elements:
lactose monohydrate
microcrystalline cellulose
maize starch
sodium starch glycollate
purified talc
magnesium stearate
polysorbate 80
povidone
quinoline yellow
erythrosine
sundown yellow FCF
peppermint oil.
SPIRONOLACTONE VIATRIS comprises sugars as lactose and hint portions of galactose
and sulfites.
Provider
SPIRONOLACTONE VIATRIS is made in Australia by:
Alphapharm Pty Ltd buying and selling as Viatris
Stage 1, 30 The Bond
30-34 Hickson Highway
Millers Level NSW 2000
Cellphone: 1800 274 276
This leaflet was ready in November 2021.
Australian registration numbers:
SPIRONOLACTONE VIATRIS 25: AUST R 338091
SPIRONOLACTONE VIATRIS 100: AUST R 338092
SPIRONOLACTONE VIATRIS_cmiNov21/00