Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I being treated with DBL Aminophylline Injection?
DBL Aminophylline Injection contains the active ingredient aminophylline (theophylline
and ethylenediamine). DBL Aminophylline Injection is used to relieve breathing problems
which may occur with asthma, emphysema, bronchitis, chronic obstructive pulmonary
disease (COPD), or left-sided heart failure.
For more information, see Section
1. Why am I being treated with DBL Aminophylline Injection? in the full CMI.
2. What should I know before treatment with DBL Aminophylline Injection?
Do not start treatment if you have ever had an allergic reaction to aminophylline,
theophylline, ethylenediamine or any medicines or substances.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before treatment with DBL Aminophylline Injection? in the full CMI.
3. What if I am taking other medicines?
4. How is DBL Aminophylline Injection given?
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight. This medicine is given as a slow injection
or a slow infusion (eg. a ‘drip’) into a vein. It must only be given by a doctor or
a nurse.
5. What should I know during treatment with DBL Aminophylline Injection?
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Things you should do
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Tell your doctor or nurse straight away if you notice any of the following: anxiety,
headache, feeling sick or need to vomit, feeling dizzy, faint or light-headed, your
heart beating very slowly or stabbing pains in your chest with heavy, rapid, irregular
heartbeat, or fever/hot flushes.
Remind any doctor, nurse, pharmacist or dentist you visit that you are using this
medicine, especially if you are planning to have surgery that needs a general anaesthetic.
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Things you should not do
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Do not stop taking this medicine or change the dosage without consulting with your
doctor.
Do not use this medicine to treat any other complaints unless your doctor or pharmacist
tells you so.
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Driving or using machines
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Avoid driving or using any machines or tools until you know how this medicine affects
you, as it may cause dizziness, light-headedness or fits/convulsions.
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Drinking alcohol
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Drinking alcohol while using DBL Aminophylline Injection can affect the way it works
or make any side effects (such as dizziness or light-headedness) worse.
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6. Are there any side effects?
Side effects include: nausea (feeling sick), vomiting/diarrhoea, unable to sleep,
headache/fever, irritability/restlessness, nervousness/anxiety or excitement, tremor
(shaking/trembling), muscle jerking, changes in the amount of urine produced, hot
flushes, skin rashes/redness, swelling/itching or peeling, feeling weak/tired, dizzy/faint
and thirsty with muscle cramps, heartburn, abdominal pain/cramps, anorexia. Serious
side effects include: persistent vomiting, diarrhoea and/or vomiting blood, continuing/severe
stomach pain, especially if it spreads to your back/chest, fast/fluttery or irregular
heartbeat, or extremely slow heartbeat with rapid/shallow breathing, agitation, confusion
or altered behaviour, extreme thirst, unable to urinate, especially in males, buzzing/whistling/ringing
in your ears (tinnitus), convulsions (fits).
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s): aminophylline (theophylline and ethylenediamine)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using DBL Aminophylline Injection.
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 DBL Aminophylline Injection.
Where to find information in this leaflet:
1. Why am I being treated with DBL Aminophylline Injection?
DBL Aminophylline Injection belongs to a group of medicines known as "xanthines" and
contains the active ingredient aminophylline (theophylline and ethylenediamine).
DBL Aminophylline Injection is used to relieve breathing problems which may occur
with asthma, emphysema, bronchitis, COPD or left-sided heart failure.
Aminophylline works by helping to open up your airways, allowing more air into your
lungs.
Your doctor may have prescribed it for another reason.
Ask your doctor if you have any questions about why it has been prescribed for you.
2. What should I know before treatment with DBL Aminophylline Injection?
Warnings
You must not be given DBL Aminophylline Injection if:
1. you are allergic to aminophylline, theophylline (or other "xanthines" such as caffeine,
linagliptin, pentoxifylline or theobromine), or to ethylenediamine or any of the ingredients
listed at the end of this leaflet.
Symptoms of an allergic reaction may include:
shortness of breath, wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
Always check the ingredients to make sure you can use this medicine.
2. You have heart disease caused by poor blood flow in the blood vessels of the heart
(coronary artery disease)
3. You have bronchiolitis (bronchopneumonia, a serious lung infection with fever, chills
and coughing).
4. You are already taking similar medicines, such as aminophylline or theophylline tablets,
capsules or syrups.
DBL Aminophylline Injection should be given with caution to newborns or babies (<
1 year old) and the elderly (> 60 years old). If given, your doctor or pharmacist
should monitor more closely.
If you are not sure whether you should be given DBL Aminophylline Injection, talk
to your doctor or pharmacist.Check with your doctor if you:
have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes.
have or have had any other medical conditions, especially the following:
liver disease, including hepatitis or cirrhosis
kidney disease eg. you are receiving dialysis
over- or under-active thyroid gland (hyperthyroidism or hypothyroidism)
heart disease or chest pain (angina)
irregular or fast heartbeat (tachyarrhythmia)
seizures, fits or convulsions (epilepsy)
lung problems, including pneumonia or serious lung infection
stomach ulcer (burning or gnawing stomach pain or indigestion)
diabetes mellitus (sugar in your blood)
gastric reflux (pain while swallowing, heartburn, hoarseness, nausea, chest pain,
loss of appetite).
alcohol abuse problems
high blood pressure (hypertension)
glaucoma (high pressure in your eyes)
poor circulation
low blood oxygen
take any medicines for any other condition.
Tell your doctor if have or have recently had:
the flu or flu vaccine
a fever
Tell your doctor if you smoke, are currently trying to give up or have recently given
up:
cigarettes or e-cigarettes
marijuana
or are regularly exposed to tobacco smoke
Tell your doctor if you are due to have blood tests or heart scans, as this medicine
may interfere with the results of several tests, including blood sugars and cholesterol
or other fats.
If you have not told your doctor about any of the above, tell them before you are
given this medicine.
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 if you are pregnant or intend to become pregnant.
Your doctor will discuss the risks and benefits of being given aminophylline during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the risks and benefits of being given aminophylline when
breast-feeding.
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 DBL Aminophylline Injection and affect how it works.
These include:
other "xanthines" ie. caffeine, theophylline, linagliptin, pentoxifylline or theobromine
alcohol and disulfiram (a medicine for alcohol problems)
tobacco or marijuana smoking
allopurinol or sulfinpyrazone (medicines to prevent gout)
cimetidine (used for gastric reflux ie. heartburn or indigestion)
"beta-agonists" (medicines used for asthma or other breathing issues) such as salbutamol,
albuterol, levalbuterol, formoterol, salmeterol or indacaterol
oral contraceptives ("The Pill")
certain antibiotics (eg. erythromycin, clarithromycin, azithromycin, fidaxomicin,
ciprofloxacin, moxifloxacin, enoxacin, ofloxacin, lomefloxacin and rifampicin)
alpha-interferon (used to treat some viral infections)
some medicines used to treat depression and/or OCD, including lithium and fluvoxamine
St John's Wort (hypericum perforatum)
some medicines used to treat epilepsy, including phenytoin, phenobarbital (phenobarbitone),
primidone and carbamazepine
some medicines used to treat heart disease eg. digoxin, diltiazem, dobutamine, dopamine
or verapamil
"beta-blockers" (medicines used to treat heart disease or glaucoma) such as propranolol,
bisoprolol, carvedilol, nebivolol, metoprolol), timolol, betaxolol or nebivolol
sedatives known as "benzodiazepines" (eg. alprazolam, chlordiazepoxide, clobazam,
clonazepam, clorazepate, diazepam, lorazepam, midazolam, oxazepam, temazepam and triazolam)
halothane or ketamine (general anaesthetics)
pancuronium, atracurium, rocuronium or vecuronium (muscle relaxants used during surgery)
certain stimulant medicines such as adrenaline, noradrenaline, phenylephrine, isoprenaline,
ephedrine and amphetamine
aminoglutethimide (used to treat certain hormone conditions, such as Cushing's syndrome)
propylthiouracil (PTU), carbimazole, levothyroxine or other thyroid hormones (used
to control thyroid diseases)
other medicines such as methotrexate, mexiletine, tacrine, adenosine, thiabendazole
or ticlopidine.
These medicines may be affected by DBL Aminophylline Injection or may affect how well
it works. You may need different amounts of your medicine, or you may need to take/use
different medicines. Your doctor or pharmacist will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with
or avoid while you are being given this medicine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect DBL Aminophylline Injection.
4. How is DBL Aminophylline Injection given?
How much is given
Your doctor will decide what dose you will receive. This depends on your condition
and other factors, such as your weight.
How it is given
DBL Aminophylline Injection may be given as a slow injection or a slow infusion (eg.
a ‘drip’) into a vein.
It must only be given by a doctor or nurse.
How many injections will you need
Your doctor will decide how long you should continue to be given DBL Aminophylline
Injection. After you are given the initial dose, you may need further doses.
Your doctor may want to take blood samples to make sure that you have the correct
blood levels of this medicine.
If you are given too much DBL Aminophylline Injection
As DBL Aminophylline Injection is given to you under the supervision of your doctor,
it is very unlikely that you will receive too much.
However, if you feel anxious, develop a headache, feel sick or need to vomit, feel
dizzy, faint or light-headed, notice your heart beating very slowly, or get stabbing
pains in your chest with your heart beating heavily, rapidly or missing beats, get
feverish or have hot flushes when you are being given DBL Aminophylline Injection,
tell the person who is giving you the injection straight away.
These may be signs that the injection is being given too quickly or may need to be
stopped.
If you think that you have been given too much DBL Aminophylline Injection and/or
if you experience severe side effects, you should immediately:
contact your doctor, or
phone the Poisons Information Centre
(by calling
13 11 26), or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
Ask your doctor or pharmacist if you have any concerns.
5. What should I know during treatment with DBL Aminophylline Injection?
Things you should do
Remind any doctor, nurse, pharmacist or dentist you visit that you are using DBL Aminophylline
Injection.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are being given this medicine.
If you plan to have surgery that needs a general anaesthetic, tell your doctor or
dentist that you are being given this medicine.
If you become pregnant while being given DBL Aminophylline Injection, tell your doctor
or pharmacist.
Things you should not do
Do not stop taking this medicine or change the dosage without consulting with your
doctor.
Do not give your medicine to anyone else, even if they have the same condition as
you.
DBL Aminophylline Injection should not be used to treat any other complaints unless
your doctor or pharmacist tells you so.
Driving or using machines
Avoid driving or using any machines or tools until you know how DBL Aminophylline
Injection affects you.
Aminophylline may cause dizziness, light-headedness or fits (convulsions) in some
people.
Make sure you know how you react to this medicine before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy or light-headed.
If this occurs, do not drive.
Drinking alcohol
Tell your doctor if you drink alcohol.
Drinking alcohol while using this medicine may interfere with the way aminophylline
works or make dizziness, lightheadedness or other side effects worse.
Looking after your medicine
DBL Aminophylline Injection will be stored in the pharmacy or on the ward.
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.
If you are over 60 years of age you may have an increased chance of getting side effects.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Side effects
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Side effect
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What to do
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feeling anxious
feeling sick or need to vomit
headache
dizziness, faintness or light-headedness
slow, irregular heartbeat, heavy or rapid heartbeat
stabbing pain in your chest
fever or hot flushes
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Tell your doctor or nurse immediately if you notice any of the following while you
are being given the injection.
These may be signs that the injection is being given too quickly or may need to be
stopped.
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Side effect
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What to do
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nausea (feeling sick), vomiting or diarrhoea
unable to sleep
headache or fever
irritability, restlessness, nervousness, anxiety or excitement
tremor (unintentional shaking or trembling) or muscle jerking
changes in the amount of urine produced by your body
feeling hot or having flushes
skin rashes, redness,swelling or itching or peeling of skin
feeling weak/tired, dizziness, severe headache, muscle cramps, turning pale, vision
disturbances
dizziness or faintness, especially when standing up
heartburn or other abdominal pain or cramps
loss of appetite
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Tell your doctor or nurse if you notice any of the following during treatment with
aminophylline
These side effects are usually mild.
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Side effect
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What to do
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persistent vomiting, diarrhoea and/or vomiting blood
continuing or severe stomach pain, especially if it spreads to your back or chest
fast, fluttery or irregular heartbeat or extremely slow heartbeat
rapid, shallow breathing
agitation, confusion or altered behaviour
extreme thirst
unable to urinate, especially in males
buzzing, whistling or ringing in your ears (tinnitus)
convulsions (fits)
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Tell your doctor or nurse immediately if you notice any of the following
These may be more serious side effects. You may need urgent medical attention. Serious
side effects are rare.
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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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
treatment with any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What DBL Aminophylline Injection contains
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Active ingredient
(main ingredient)
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Aminophylline (theophylline and ethylenediamine)
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Other ingredients
(inactive ingredients)
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Water for Injections
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DBL Aminophylline Injection does not contain lactose, sucrose, gluten, tartrazine
or any other azo dyes.
Do not use this medicine if you are allergic to any of these ingredients.
What DBL Aminophylline Injection looks like
DBL Aminophylline Injection is a clear, colourless solution.
It is available as follows:
250 mg/10 mL ampoules (AUST R 16355)
How is DBL Aminophylline Injection stored
DBL Aminophylline Injection will usually be stored in the pharmacy or on the ward.
The injection should be kept in a cool dry place, protected from light, where the
temperature stays below 25°C.
Who distributes DBL Aminophylline Injection
Pfizer Australia Pty Ltd
Sydney NSW
Toll Free Number: 1800 675 229
This leaflet was prepared in August 2023.
™ Trademark
© Pfizer Australia Pty Ltd 2023