MercuryPharma

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.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

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.

In this leaflet:

1.    What Aminophylline Injection is and what it is used for

2.    Before you are given Aminophylline Injection

3.    How you are given Aminophylline Injection

4.    Possible side effects

5.    How to store Aminophylline Injection

6.    Further 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. BEFORE YOU ARE GIVEN AMINOPHYLLINE INJECTION

You should not be given Aminophylline Injection if you:

•    know that you are allergic to the active ingredient, aminophylline, ethylenediamine, theophylline, caffeine or theobromine

•    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.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking, or have recently taken, 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.

continued overleaf

Aminophylline Hydrate 25mg/ml

Solution for injection

C MercuryPharma	Date of Approval: 12/09/2012 To be implemented by: 11/03/2013		PROOF 1 03/04/2012
Product Description:	Originated by Date:	Tech Approved	Date:
Aminophylline Hydrate 25mg/ml Sol for Inj	David Nadar 03/04/2012	Yes	04/04/2012
Component:	Revised by	Version:
Leaflet	N/A	100400/LF/1
Manufacturer:	File Name:	CRF No.:
B Braun	100400LF Aminophylline Hyrate inj UK v1_1	| QA.CRF064.2012
Market:	Software Package:	Barcode:
UK	Quark Xpress 9	N/A
Minimum Font Size & Typeface:	Dimensions:	Pharma Code:
10pt Swiss 721BT	155 x 447 mm	N/A
	Colours: Black	Key Line:

Pregnancy and breast-feeding:

Please let the doctor know if you are pregnant, think you might be pregnant, are planning to become pregnant or are breast-feeding. As with 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.

Driving and using machines:

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.

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.

4. POSSIBLE SIDE EFFECTS

Like all medicines Aminophylline Injection can sometimes cause side-effects, although not everybody gets them. How often these side effects occur is unknown.

The most likely side-effects are:

•    hypersensitivity reactions like any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body)

•    feeling sick or being sick, tummy pain, diarrhoea, gastrointestinal bleeding, acidity, heartburn

•    feeling of dizziness or spinning

•    headache, confusion, restlessness, maniacal behavior, tremors

•    delirium, convulsions, visual disturbances

•    fever

•    feeling anxious, restless or not being able to sleep

•    abnormal levels of electrolytes in your blood

•    extreme thirst

•    feeling your heart beat (palpitations) or a change in your normal heart beat

•    feeling faint or dizzy (fall in blood pressure)

•    any signs of skin allergy such as a rash, itching or redness of skin

•    pain at the site of the injection

Please tell your doctor as soon as possible if any of these have occurred.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor (GP or hospital doctor).

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. FURTHER INFORMATION

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 September 2012

100400/LF/1

c MercuryPharma	Date of Approval: 12/09/2012 To be implemented by: 11/03/2013		PROOF 1 03/04/2012
Product Description:	Originated by Date:	Tech Approved	Date:
Aminophylline Hydrate 25mg/ml Sol for Inj	David Nadar 03/04/2012	Yes	04/04/2012
Component:	Revised by	Version:
Leaflet	N/A	100400/LF/1
Manufacturer:	File Name:	CRF No.:
B Braun	100400LF Aminophylline Hyrate inj UK v1_1	| QA.CRF064.2012
Market:	Software Package:	Barcode:
UK	Quark Xpress 9	N/A
Minimum Font Size & Typeface:	Dimensions:	Pharma Code:
10pt Swiss 721BT	155 x 447 mm	N/A
	Colours: Black	Key Line: