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AMINOPHYLLINE HYDRATE 25MG/ML SOLUTION FOR INJECTION

Active substance(s): AMINOPHYLLINE HYDRATE

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Version No:
Product Name:

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aminophylline Hydrate 25mg/ml
Solution for injection
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
The name of your medicine is Aminophylline Hydrate 25mg/ml solution for Injection. It will
be referred to as Aminophylline Injection for ease of use hereafter.

100400/LF/021/02

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Aminophylline
Hydrate 25mg/ml Sol
for Inj
10 Ampoules
Leaflet
100400
UK
B Braun
2
13/11/2015
ADD
QA.CRF.363.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

155 x 447 mm
N/A
N/A
N/A
N/A
Black

Non-Print Colours: Cutter

What is in this leaflet
1.
2.
3.
4.
5.
6.

What Aminophylline Injection is and what it is used for
What you need to know before you are given Aminophylline Injection
How you are given Aminophylline Injection
Possible side effects
How to store Aminophylline Injection
Contents of the pack and other information

1. WHAT AMINOPHYLLINE INJECTION IS AND WHAT IT IS USED FOR
Aminophylline belongs to a group of medicines called xanthines. It expands the air
passages of the lungs, which helps relieve chest tightness and wheezing
(bronchospasm).
This medicine may be used to relieve difficulty breathing due to asthma and long term
obstruction to the flow of air in the lungs.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN AMINOPHYLLINE INJECTION

You should not be given Aminophylline Injection if you:
• are allergic to ethylenediamine, theophyllines, caffeine or theobromine or any of the
other ingredients of this medicine (listed in section 6).
• suffer from porphyria.
• are treated with other xanthine drugs (used to treat chronic bronchitis, asthma or
emphysema e.g caffeine, theophylline, theobromine).
Aminophylline should not be given to children under 6 months of age.
Make sure your doctor knows if this is the case.

Your doctor will take special care if any of the following situations apply to
you:
• you are elderly
• you have a heart problem or liver disease
• you are a smoker
• you have ever had an ulcer
• you have chronic lung disease or renal disease
• you are an alcoholic
• you have an overactive thyroid gland (hyperthyroidism)
• you have diabetes or high blood pressure
• you have glaucoma (raised pressure in the eyes)
• you have ever suffered from seizures/fits (e.g. epilepsy)
• you are suffering from a virus infection, such as flu or have recently had a flu injection.
Even though some of these may be obvious, tell your doctor if any apply to you.
Care should also be taken when this medicine is given to children.

Other medicines and Aminophylline Injection
Tell your doctor or pharmacist if you are taking, or have recently taken, or might take any
other medicines. This includes medicines obtained without a prescription.
In particular, tell your doctor if you are taking any of the following:
• medicines for heartburn or an ulcer (e.g. cimetidine)
• certain antibiotics for an infection (e.g. erythromycin, ciprofloxacin, rifampicin,
clarithromycin, norfloxacin)
• medicines for gout (e.g. allopurinol or sulphinpyrazone)
• medicines for high blood pressure or chest pain, called angina (e.g. diltiazem,
propranolol, verapamil)
• oral contraceptive pills
• antidepressants (e.g. fluvoxamine)
• medicines for fits (e.g. phenytoin, carbamazepine, primidone, phenobarbital)
• ephedrine or medicines with similar effects (present in various medicines, including
cough mixtures and decongestants)
• beta-2 agonist drugs to relieve asthma or chronic bronchitis
• steroids to treat various inflammatory conditions such as arthritis
• diuretics (“water tablets”)
• other medicines from this group known as xanthines, e.g. theophylline
• other medicines like disulfiram, thyroid hormones, interferon alfa, methotrexate,
mexiletine, propafenone, ritonavir, tacrine, ticlopidine, fluconazole, isoniazid, St John's
Wort, zafirlukast, aminoglutethimide, lithium, benzodiazepines, general anaesthetics
(ketamine or halothane), pancuronium, adenosine, digoxin, doxapram and alcohol
• Regadenoson- a medicine used in diagnosis of heart condition.

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. As with
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Pharmacode

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Pharmacode
PACKAGE LEAFLET: INFORMATION
FOR THE USER

Aminophylline Hydrate
25mg/ml
Solution for injection

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Pharmacode

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Pharmacode

continued overleaf

Tech App. Date:
Min. Font Size:

13/11/2015
9 pt

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 1 OF 2

100400/LF/021/02

other drugs, aminophylline should only be used during pregnancy and breastfeeding if
your doctor considers it essential. Aminophylline passes into the breast milk.
Ask your doctor or pharmacist for advice before taking any medicine.

Version No:
Product Name:

Driving and using machines:

Pack Size:
Component:
SKU:
Market:
Production Site:
Revision No.:
Revision Date:
Revised by:
CRF:

Aminophylline
Hydrate 25mg/ml Sol
for Inj
10 Ampoules
Leaflet
100400
UK
B Braun
2
13/11/2015
ADD
QA.CRF.363.2015

Dimension:
Commodity No.:
Pharma Code:
Core Spec Ref:
DCMF:
Print Colours:

155 x 447 mm
N/A
N/A
N/A
N/A
Black

Aminophylline should not affect your ability to drive or use machinery.

3. HOW YOU ARE GIVEN AMINOPHYLLINE INJECTION
Aminophylline is only given in the hospital by a doctor.
Aminophylline is usually given by slow injection into a vein. It may also be given slowly by
a drip into a vein. After you are given the initial dose, you may need further doses. Your
doctor will decide the best doses for you Your doctor may want to take blood samples to
make sure that you have the correct blood levels of this medicine.
Aminophylline is not for use in infants under six months old.

If you are given more Aminophylline Injection than you should:
As aminophylline is administered by a healthcare professional it is unlikely that you will be
given too much. If you are at all concerned, speak to your doctor.
In this event, you will be treated in the hospital and you will be given the necessary
treatment.

Non-Print Colours: Cutter

If you miss a dose of Aminophylline Injection:
This is unlikely as the injection is given by a healthcare professional but if you are
concerned about missing a dose, speak to your doctor.

Tech App. Date:
Min. Font Size:

13/11/2015
9 pt

4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side-effects, although not everybody gets
them. How often these side effects occur is unknown.
The most likely side-effects are (Frequency- Not known: frequency cannot be estimated
from the available data):
• hypersensitivity reactions like any sudden wheeziness, difficulty in breathing, swelling
of the eyelids, face or lips, rash or itching (especially affecting your whole body)
• abnormal level of electrolyte’s in blood eg. Deficiency of potassium, phosphate,
sodium
• feeling anxious, restless or not being able to sleep, delirium(restlessness), violent
behavior (maniacal behavior)
• headache, confusion, restlessness, tremors, heavy breathing (Hyperventilation),
spinning sensation (Vertigo), lightheadedness (dizziness), convulsions
• visual disturbances
• feeling your heart beat (palpitations) or a change in your normal heart beat , increased
heart rate(tachycardia), irregular heartbeat(cardiac arrythmia), fall in blood
pressure(hypotension)
• feeling sick or being sick, tummy pain, diarrhoea, heartburn, gastrointestinal bleeding
• rash, redness of skin, itching of skin, allergic rash, itching and skin redness could be
due to condition known as exfoliative dermatitis
• pain at the site of injection, extreme thirst, fever.
Please tell your doctor as soon as possible if any of these have occurred.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via
Yellow Card Scheme at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

5. HOW TO STORE AMINOPHYLLINE INJECTION
These instructions apply mainly to the healthcare professional administering the
injection.
Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Keep the ampoules in the outer carton in order to protect from light. It should not be used
after the expiry date that is shown on the carton. The expiry date refers to the last day of
that month.
If only part of the solution is used, or if the contents of the ampoule are discoloured, the
rest should be thrown away.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aminophylline Injection contains
Each 10ml clear solution contains 250mg of aminophylline hydrate (equivalent to
239.73mg of the active ingredient, aminophylline).
The other ingredients are ethylenediamine and water for injection.

What Aminophylline Injection looks like and contents of pack:
Clear glass ampoules containing 10ml of clear solution for injection. Each carton contains
10 ampoules.

Marketing authorisation holder:
Mercury Pharma International Ltd.,
4045, Kingswood Road, City west Business park,Co Dublin,Ireland.

Manufacturer:
B. Braun Melsungen AG, Mistelweg 2, 12357 Berlin, Germany.
This leaflet was last revised in October 2015.
100400/LF/021/02

REGULATORY AUTHORITY
APPROVAL CONFIRMATION
Confirmation that this artwork has been approved by
the appropriate market authority (if applicable, e.g.
MHRA, HPRA, etc ) and that Mercury Pharma have
license approval to distribute this component for
sale in the relevant market.

Accept Artwork / Reject Artwork
(Please strike off whichever NOT applicable)

Signature .......................................................................
Name .............................................................................
Date ...............................................................................

PAGE 2 OF 2

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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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