2. What should I know before I use NITROSTAT?
Do not use if you have ever had an allergic reaction to NITROSTAT or any of the ingredients
listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with NITROSTAT and affect how it works.
4. How do I use NITROSTAT?
One sublingual tablet should be dissolved under the tongue or placed between the gums
and cheek at the first sign of chest pain. The dose may be repeated approximately
every 5 minutes, until the chest pain is relieved.
NITROSTAT may be used 5 to 10 minutes prior to activities that might cause chest pain.
5. What should I know while using NITROSTAT?
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Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using NITROSTAT.
Tell your doctor or pharmacist if you continue to have angina attacks or if they become
more frequent while you are using NITROSTAT
|
|
Things you should not do
|
You should not take NITROSTAT if you have the following conditions: very recent heart
attack, severe anemia, increased pressure in the head.
You should not take Nitrostat if you are taking medicine for erectile dysfunction,
like sildenafil citrate, tadalafil, or vardenafil hydrochloride.
|
|
Driving or using machines
|
Be careful if you are driving or operating machinery until you know how NITROSTAT
affects you. NITROSTAT may lower your blood pressure and make you feel dizzy or lightheaded.
|
|
Drinking alcohol
|
Do not consume alcohol while taking NITROSTAT, as this can lower your blood pressure.
|
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Looking after your medicine
|
Store in a cool dry place away from moisture, heat or sunlight below 25°C.
Keep your tablets in the original package until it is time to take them.
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6. Are there any side effects?
Common side effects include vertigo (a major symptom of balance disorder), dizziness,
weakness, heart palpitations (unusual awareness of the heartbeat), low blood pressure
upon rising from a seated position, nausea and vomiting, sweating, paleness, fainting,
flushing (warm or red condition of your skin)
Active ingredient(s):
Glyceryl trinitrate
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using NITROSTAT. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using NITROSTAT.
Where to find information in this leaflet:
1. Why am I using NITROSTAT?
NITROSTAT contains the active glyceryl trinitrate. NITROSTAT belongs to a group of medicines called nitrates and works by widening blood
vessels.
The glyceryl trinitrate causes the blood vessels to relax and increases the supply
of blood and oxygen to the heart reducing the likeliness of having an angina attack.
NITROSTAT is used to treat acute angina.
NITROSTAT may also be used to prevent acute angina if used 5-10 minutes before taking
part in an activity which may provoke an attack of angina.
Angina is a pain or discomfort that keeps coming back when part of your heart does
not get enough blood. Angina feels like a pressing or squeezing pain, usually in your
chest under the breastbone. Sometimes you can feel it in your shoulders, arms, neck,
jaws, or back.
2. What should I know before I use NITROSTAT?
Warnings
Do not use NITROSTAT if:
you are allergic to glyceryl trinitrate (the active ingredient), or any of the ingredients
listed at the end of this leaflet.
you are allergic to any medicine or food containing nitrates or nitrites.
You are taking medicine for erectile dysfunction, like sildenafil citrate, tadalafil,
or vardenafil hydrochloride, as this may lead to extreme lowering of your blood pressure.
you take medicines called guanylate cyclase stimulators, a medicine that treats pulmonary
arterial hypertension and chronic-thromboembolic pulmonary hypertension.
Always check the ingredients to make sure you can use this medicine.
You should not take NITROSTAT if you have the following conditions:
very recent heart attack
severe anemia
increased pressure in the head
Check with your doctor or pharmacist if you:
have any other medical conditions including
low blood pressure
heart problems or blood vessel disorder other than angina
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
The safety of NITROSTAT in pregnancy has not been established.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
It is unknown whether NITROSTAT passes into breast milk.
Use in Children
NITROSTAT is not recommended for use in children as there is no specific information
about such use.
Always ask your doctor or pharmacist before giving medicines to children.
Use in Elderly
Elderly patients may be more sensitive to the effects or side effects of NITROSTAT.
If you are elderly, you may need to watch carefully for signs of side effects.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with NITROSTAT and affect how it works.
medicine which expand the blood vessels
medicine which lower blood pressure
medicine used to treat impaired sexual function
medicine used to treat high blood pressure in the pulmonary artery
medications used to treat heart failure and pulmonary arterial hypertension (PAH),
a condition of high blood pressure
medicine which help to reduce the amount of excess fluid in the body by increasing
the amount of urine produced
medicine which dissolves clots that have formed in blood vessels. It’s used to treat
stroke, heart attack and blood clots in the lungs
some medicine for mental conditions
some medicine used to treat depression.
some medicine used to treat migraine headaches.
Heparin and aspirin, used to thin the blood.
Adempas® (riociguat) used for pulmonary hypertension
You may need to take different amounts of your medicine or you may need to take different
medicines.
If you have been prescribed a phosphodiesterase 5 inhibitor, medicine for the treatment
of erectile dysfunction or high blood pressure in the pulmonary artery and you experience
an acute angina attack, immediately go to the emergency department at your nearest
hospital.
Your doctor or pharmacist can advise further on the list of medicines to avoid while
taking NITROSTAT.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NITROSTAT.
4. How do I use NITROSTAT?
How much to take
Your doctor or pharmacist will tell you how much NITROSTAT to take.
Use the exact amount your doctor or pharmacist tells you to.
One sublingual tablet should be dissolved under the tongue or between the gums and
cheek at the first sign of chest pain. Do not chew, crush or swallow the tablet.
If the pain persists after five minutes, take another tablet.
If the pain persists after a total of 3 tablets in a 15-minute period, or is different
than you typically experience, call your doctor or seek emergency help.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
When to take NITROSTAT
Your doctor or pharmacist will tell you how often you should take NITROSTAT.
NITROSTAT is NOT a medication which is taken regularly. It is used when you need to
obtain relief from the pain of an acute attack of angina.
NITROSTAT may also be used 5 to 10 minutes before taking part in exercise or activities
which may provoke an acute attack of angina.
The number of times that you can use NITROSTAT in any one day will depend on how severe
your angina is, what other medicines you are taking and any other medical conditions
you may have. You should discuss this with your doctor or pharmacist.
How to take NITROSTAT
Sit down and rest before taking NITROSTAT.
The sublingual tablet should be dissolved under the tongue or between the gums and
cheek at the first sign of chest pain. Do not chew, crush or swallow the tablet.
If you use too much NITROSTAT
If you have taken too much NITROSTAT, you may suffer severe headaches. Your skin may
become flushed or clammy, cold sweats, you may have trouble seeing or you may feel
flushed, nauseous (sick), diarrhea, dizzy, lightheaded, shortness of breath or faint.
Your heart may also beat faster or slower than usual.
If you think that you have used too much NITROSTAT, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using NITROSTAT?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are taking NITROSTAT.
Tell your doctor or pharmacist that you are taking NITROSTAT if you are about to be
started on any new medicines.
Take NITROSTAT exactly as your doctor or pharmacist has recommended.
If you do not follow your doctor or pharmacist's instructions,
you may not get relief from your angina attack.
Tell your doctor or pharmacist if you continue to have angina attacks or if they become
more frequent while you are using NITROSTAT.
You may find it helpful to keep a written record of the number, causes, length and
severity of your angina attacks, so you can tell your doctor or pharmacist at your
next visit. This will help your doctor or pharmacist to choose the best possible treatment
for your angina.
NITROSTAT may produce a burning or tingling sensation when dissolving under your tongue.
Get up slowly if you feel light-headed, dizzy, or faint when getting out of bed or
standing up.
Standing up slowly, especially when you get up from bed or chairs, will help your
body get used to the change in position and blood pressure. If this problem continues
or gets worse, talk to your doctor.
Tell your doctor or pharmacist immediately if you become pregnant while using NITROSTAT.
Tell your doctor or pharmacist immediately if you are trying to become pregnant while
using NITROSTAT.
Things you should not do
Do not take NITROSTAT to treat any other complaints unless your doctor or pharmacists
tell you to.
Do not give this medicine to anyone else even if their symptoms seem similar to yours.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NITROSTAT
affects you.
NITROSTAT may cause dizziness and fainting in some patients, especially when you first
start to use it. Make sure you know how you react to NITROSTAT before you drive a
car, operate machinery or do anything else which could be dangerous.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Do not consume alcohol while taking NITROSTAT, as this can lower your blood pressure,
making you feel dizzy or faint.
Looking after your medicine
Store below 25°C.
Keep your tablets in the original container until it is time to take them.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions.
Less serious side effects
Serious side effects
Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What NITROSTAT contains
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Active ingredient
(main ingredient)
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glyceryl trinitrate
|
|
Other ingredients
(inactive ingredients)
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Lactose monohydrate, glyceryl monostearate, pregelatinised starch, calcium stearate,
and colloidal anhydrous silica.
|
|
Potential allergens
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Lactose and sulfites
|
Do not take this medicine if you are allergic to any of these ingredients.
What NITROSTAT looks like
NITROSTAT 300 micrograms sublingual tablets:
Small, round, white, tablet debossed with “3” on one side and “N” on the other side.
AUST R 438870
NITROSTAT 400 micrograms sublingual tablets:
Small, round, white, tablet debossed with “4” on one side and “N” on the other side.
AUST R 43 8851
300 micrograms are available in a glass bottle with 100 tablets.
400 micrograms are available in 4 glass bottles with 25 tablets each.
Who distributes NITROSTAT
Viatris Pty Ltd
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: 1800 274 276
This leaflet was prepared in Sep 2024.
NITROSTAT_cmi\Sep24/00