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Aminophylline Injection Bp.

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Patient Information Leaflet

Aminophylline Injection 250 mg in 10 ml

Important information about your medicine

►    Your doctor or nurse will give you the injection

►    If this injection causes you any problems talk to your doctor, nurse or pharmacist

►    Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine

►    Please tell your doctor or pharmacist, if you are taking any other medicines

   Read all of this leaflet carefully before you start using this medicine because it contains important information for you. In some circumstances this may not be possible

and this leaflet will be kept in a safe place should you wish to read it.

   Keep this leaflet. You may need to read it again

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

•    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

•    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Aminophylline Injection 250 mg in 10 ml is and what it is used for

2.    What you need to know before you use Aminophylline Injection 250 mg in 10 ml

3.    How to use Aminophylline Injection 250 mg in 10 ml

4.    Possible side effects

5.    How to store Aminophylline Injection 250 mg in 10 ml

6.    Contents of the pack and other information

1.    What Aminophylline Injection 250 mg in 10 ml is and what it is used for

Aminophylline Injection 250 mg in 10 ml belongs to a group of medicines known as xanthines, which can stimulate breathing. It is used to treat breathing difficulties associated with:

•    heart failure

•    reversible airway obstruction, as in acute asthma or acute spasm of the airways (bronchial spasm).

2.    What you need to know before you use Aminophylline Injection 250 mg in 10 ml

Do NOT use Aminophylline Injection 250 mg in 10 ml:

•    if you are sensitive or allergic to Aminophylline Injection ethylenediamine, theophylline, caffeine or theobromine or any of the other ingredients in this injection.

•    if you are taking similar medicines e.g. theophylline or Aminophylline tablets.

•    if you have Porphyria (a condition that affects your blood).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Aminophylline Injection 250 mg in 10 ml:

•    if you have a peptic ulcer

•    if you have an overactive thyroid

•    if you have pressure in the eyes (known as glaucoma)

•    if you are a diabetic

•    if you are epileptic

•    if you have high blood pressure or heart disease

•    if you have low blood oxygen

•    if you suffer from poor circulation

•    if you have heart or lung failure

•    if you have chronic bronchitis

•    if you are a smoker or you are regularly exposed to tobacco smoke.

•    if you have liver or kidney disease

•    if you have an alcohol problem

•    if you have flu or have recently had a flu injection or you have a fever.

Other medicines and Aminophylline Injection 250 mg in 10 ml:

Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Aminophylline Injection 250 mg in 10 ml:

•    Aminophylline or theophylline

•    Antibiotics (e.g.erythromycin or ciprofloxacin).

•    Medicines for your heart (e.g. digoxin, propranolol, diltiazem)

•    Medicines for the prevention of gout (Allopurinol and Sulfinpyrazone)

•    Disulfiram (a medicine for an alcohol problem)

•    Oral Contraceptives

•    Medicines for epilepsy (e.g. carbamazepine, i phenytoin)

•    Medicines to thin your blood (e.g. warfarin)

•    Any medicines that you may have bought yourself including St John's Wort (a medicine for depression) or medicines for colds and nasal congestion

•    Lithium (a medicine to regulate your moods)

•    Fluvoxamine (a medicine for depression)

•    Benzodiazepines (e.g. diazepam)

•    Cimetidine (a medicine for stomach ulcers)

•    Antiviral medicines (e.g. ritonavir)

•    A recent flu vaccination

•    Medicines to treat tuberculosis (e.g.isoniazid, rifampicin)

•    Fluconazole (a medicine to treat fungal infections)

•    Corticosteroids (medicines used to treat inflammation in your body e.g. in asthma)

•    Zafirlukast (a medicine for asthma).

•    Thyroid hormones

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.

Driving and using machines:

You should not drive or use machinery

if you are affected by the administration of Aminophylline Injection 250 mg in 10 ml.

3.    How to use Aminophvlline Injection 250 mg in 10 ml

Your nurse or doctor will give you the injection.

Your doctor will decide the correct dosage for you and how and when the injection will be given.

Since the injection will be given to you by a doctor or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you feel thirsty, have ringing in your ears or feel palpitations you must tell the person giving you the injection.

4.    Possible side effects

Like all medicines, Aminophylline Injection 250 mg in 10 ml can cause side effects, although not everybody gets them. The following unwanted side effects have been reported for aminophylline injection:

•    Allergic reactions involving rash and redness and flakiness of the skin

•    Feeling sick or being sick,

•    Stomach bleeding, heartburn and diarrhoea

•    Visual disorders

•    Sleeplessness, headache

•    Anxiety, confusion, restlessness

•    Fast breathing

•    Spinning sensation

•    Higher doses may lead to maniacal behaviour, delirium and convulsions

•    Low levels of potassium, phosphate or salt

in the blood

   Palpitations (a sensation of your heart beating)

   Fever and extreme thirst

Your doctor will monitor your blood to see if this medicine is causing you any problems.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme - website: www.mhra.gov.uk/ yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy. By reporting side effects you can help provide more information on the safety of this medicine.

5.    How to store Aminophylline Injection 250 mg in 10 ml

Your injection will be stored at less than 25°C and protected from light. The nurse or doctor will check that the injection is not past its expiry date before giving you the injection.

6. Contents of the pack and other information

What Aminophylline Injection 250 mg in 10 ml contains:

The active ingredient is aminophylline (theophylline - ethylenediamine). Each 1 ml of solution contains 25 mg aminophylline.

The other ingredient is Sterile Water for Injections

What Aminophylline Injection 250 mg in 10 ml looks like and contents of the pack:

Aminophylline Injection 250 mg in 10 ml is supplied in 10 ml clear glass ampoules. 10 ampoules supplied in each carton.

The marketing authorisation number of this medicine is: PL 01502/0009R

Marketing Authorisation Holder:

hameln pharmaceuticals ltd

Gloucester

United Kingdom

Manufacturer:

hameln pharmaceuticals gmbh Langes Feld 13 31789 Hameln Germany

hameln rds a.s.

Horna 36

900 01 Modra, Slovak Republic

For any information about this medicine, please contact the Marketing Authorisation Holder

This leaflet was last approved December 2014.

44177/49/14

44177_49_14_leaflet_AMN_hamelnpharma.indd 2 02/12/2014 15:41:30