Aminophylline Injection Bp 250mg/10ml

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Aminophylline Injection BP 250mg in 10ml

Theophylline Ethylene Diamine

Read all of this leaflet carefully before you are given this medicine.

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

•    If you have any further questions, please ask your doctor or nurse.

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

In this leaflet:

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

2.    Before you are given Aminophylline Injection

3.    How Aminophylline Injection will be given

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 is one of a group of medicines that widens the tubes that allow air to get to the lungs.

Aminophylline Injection is used to treat wheezing and difficulty breathing (reversible airways obstruction) and to treat an asthma attack that is not able to be helped by standard asthma medication (e.g. inhalers)

2.    Before you are given Aminophylline Injection

You should not be given Aminophylline Injection if you:

•    are allergic (hypersensitive) to Theophylline or Ethylene Diamine, or to any of the other ingredients listed in section 6 of this leaflet.

•    suffer from a blood disorder known as acute porphyria

•    have been given ephedrine.

Take special care with Aminophylline Injection if you:

•    have a stomach ulcer

•    suffer from thyroid problems

•    have high blood pressure

•    suffer from liver problems

•    have an irregular heart beat or other heart problems

•    suffer from epilepsy (fits)

•    have fluid on the lungs or other lung problems

•    have a fever

•    have low levels of oxygen in your body (hypoxia)

•    are suffering from a viral infection

•    are a smoker

•    suffer from alcoholism

•    are taking St Johns Wort.

If any of the above applies to you please tell your doctor before you are given Aminophylline Injection.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Medicines that may interact with Aminophylline Injection include:

•    medicines used to treat heartburn and stomach ulcers e.g. nizatidine and cimetidine

•    antibiotics (medicines used to treat bacterial infections) e.g. ciprofloxacin, norfloxacin, clarithromycin, erythromycin, and troleandomycin

•    medicines used to treat tuberculosis (TB) e.g. isoniazid and rifampicin

•    antifungals (medicines used to treat fungal infections) e.g. fluconazole and ketoconazole

•    viloxazine and fluvoxamine (medicines used to treat depression)

•    combined oral contraceptives (birth control) and oestrogens

•    carbimazole (a medicine used to treat thyroid problems)

•    thiabendazole (a medicine to treat worm infections)

•    calcium channel blockers (medicines used to treat high blood pressure) e.g. diltiazem and verapamil

•    anti-arrhythemics (medicines used to stabilise the heart beat) e.g. mexiletine and propafenone

•    medicines used to treat gout e.g allopurinol and sulfinpyrazone

•    pain killers e.g. aspirin and ibuprofen

•    cytotoxics (medicines used to treat cancer) e.g. methotrexate, and interferon alfa (a medicine used to prevent tumours or viruses)

•    oxpentifylline (a medicine used to treat a disease of the blood vessels usually affecting the legs, known as peripheral vascular disease.)

•    other medicines used to treat breathing difficulties (xanthines leukotriene antagonists, beta-adrenergic receptor agonists and corticosteroids) e.g. doxapram

•    disulfiram (a medicine used to treat alcoholism)

•    the flu vaccine

•    anticonvulants (medicines used to stop fits) e.g. carbamazepine, phenytoin, phenobarbitone and primidone

•    ritonavir (a medicine used to treat HIV)

•    aminoglutethimide (a medicine used to treat cancer and Cushing's disease)

•    medicines that make you sleep (barbiturates)

•    medicines that make you pass more urine than usual (diuretics)

•    beta-blockers (medicines used to treat high blood pressure) e.g. propanolol

•    steroids such as the adrenocorticoids glucocorticoids and mineralocorticoids

•    lithium (a medicine used to treat a type of depression)

•    anaesthetics e.g. halothane and ketamine

•    benzodiazepines (a type of medicine used to help you relax and to sleep).

If you smoke you should tell your doctor before being given Aminophylline Injection as tobacco can affect the way in which this medicine works.

If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse.

Pregnancy and breast-feeding

If you are pregnant or are breast-feeding, your doctor will advise you whether you can be given Aminophylline Injection.

Driving and using machines

There are no known effects of using Aminophylline Injection on driving or using machines.

3.    How Aminophylline Injection is given

Your doctor will give you Aminophylline Injection into the vein (intravenous) either by injection or infusion (drip).

Adults and the elderly

Your doctor will give you 250- 500 mg ( 5 mg per kilogram of bodyweight ) given over a 20 minute period by slow intravenous injection, followed by 500 micrograms per kilogram of bodyweight every hour by intravenous infusion.

Children (6 months to 16 years)

5 mg per kilogram of bodyweight given over a 20 minute period by slow intravenous infusion followed by a further intravenous infusion of 1mg per kilogram of bodyweight per hour if they are between the ages of 6 months and 9 years, or 800 micrograms per kilogram of bodyweight per hour if they are between the ages of 10 and 16 years.

If you are given more Aminophylline than you should be

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much, however, tell your doctor or pharmacist if you have any concerns.

4.    Possible side effects

Like all medicines, Amionophylline Injection can cause side effects, although not everybody gets them.

If you experience any of the following side effects you should tell your doctor immediately. These are symptoms of an allergic reaction.

•    difficulty in breathing with or without swelling of the face, lips, tongue and/or throat

•    swelling of the face, lips tongue and/or throat, which may cause difficulty in swallowing

•    severe itching of the skin (with raised lumps).

Other possible side effects include:

•    feeling sick

•    stomach pain

•    a fast or irregular heart beat

•    low blood pressure

•    difficulty sleeping

•    flushing

•    feeling dizzy

•    feeling worried or restless

•    headache

•    fits

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

Continued overleaf

5.    How to store Aminophylline Injection

Keep out of the reach and sight of children.

This medicine should not be used after the expiry date which is printed on the label. Your doctor or nurse will check that the expiry date on the label has not been passed before giving you Aminophylline Injection. The expiry date refers to the last day of the month.

Store protected from light

6.    Further Information

What Aminophylline Injection contains

The active substances are Theophylline BP 2.11% w/v and Ethylene Diamine, Anhydrous BP 0.523% w/v.

The other ingredient is water for injections.

What Aminophylline Injection looks like and contents of the pack

Aminophylline is a clear, colourless solution supplied in glass ampoules. Each ampoule contains 10ml of the solution.

Marketing Authorisation Holder and Manufacturer

Martindale Pharmaceuticals Bampton Road Romford, RM3 8UG United Kingdom

Date of last revision: July 2008 PL 01883/6167R

Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom