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Aminophylline Injection BP

Active Ingredient:
aminophylline
Company:  
hameln pharma ltd See contact details
ATC code: 
R03DA05
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 19 Aug 2022
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL01502/0009R.

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Aminophylline Injection BP

Package leaflet: Information for the patient

Aminophylline Injection 250 mg in 10 ml

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, 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 are given Aminophylline Injection 250 mg in 10 ml
3. How Aminophylline Injection 250 mg in 10 ml is given
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 are given Aminophylline Injection 250 mg in 10 ml
You should NOT be given Aminophylline Injection 250 mg in 10 ml:
  • if you are allergic to ethylenediamine, theophylline, caffeine or theobromine or any of the other ingredients of this medicine (listed in section 6).
  • 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
  • have an overactive thyroid
  • have pressure in the eyes (known as glaucoma)
  • are a diabetic
  • are epileptic
  • have high blood pressure or heart disease
  • have low blood oxygen
  • suffer from poor circulation
  • have heart or lung failure
  • have chronic bronchitis
  • are a smoker or you are regularly exposed to tobacco smoke.
  • have liver or kidney disease
  • have an alcohol problem
  • 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, 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
  • other medicines such as methotrexate, mexiletine, propafenone, tacrine, aminoglutethimide, general anaesthetics (ketamine or halothane), pancuronium, beta blockers, adenosine, doxapram.

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 receiving 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 Aminophylline Injection 250 mg in 10 ml is given

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 dose 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:

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:

  • hypersensitivity reactions like any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body)
  • rash, redness of skin, itching of skin, allergic rash. Itching and skin redness could be due to a condition known as exfoliative dermatitis
  • Feeling sick or being sick, tummy pain, diarrhoea, heartburn, gastrointestinal bleeding
  • Stomach bleeding, heartburn and diarrhoea
  • Visual disorders
  • Sleeplessness, headache
  • Anxiety, confusion, restlessness, heavy breathing, spinning sensation (Vertigo), light-headedness (dizziness), convulsions
  • Fast or heavy breathing (Hyperventilation)
  • Spinning sensation
  • Higher doses may lead to maniacal behaviour, delirium and convulsions
  • Low levels of potassium, phosphate or sodium in the blood
  • Palpitations (a sensation of your heart beating) or a change in your normal heart beat, increased heart rate(tachycardia), irregular heartbeat(cardiac arrhythmia), fall in blood pressure(hypotension)
  • pain at the site of injection
  • 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

Marketing Authorisation Holder
hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer
Siegfried Hameln GmbH
Langes Feld 13
31789 Hameln
Germany

hameln rds s.r.o.
Horná 36
900 01 Modra
Slovak Republic

HBM Pharma s.r.o.
Sklabinská 30
03680 Martin
Slovak Republic

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

This leaflet was last approved in April 2022.

44177/15/22

hameln pharma ltd
Company image
Address
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
WWW
https://www.hameln-pharma.com
Telephone
+44 (0)1452 621 661
Fax
+44 (0)1452 632 732
Medical Information e-mail
[email protected]