Aminophylline 250 mg Solution

AMINOPHYLLINE 250 mg IV FRESENIUS belongs to a group of medicines known as xanthines. It is used to treat breathing difficulties associated with reversible airway obstruction, as in acute asthma, chronic bronchitis (persistent coughing which can make it difficult to breath) and emphysema (a condition in which the air sacs of your lungs are damaged and enlarged, causing breathlessness).

AMINOPHYLLINE 250 mg IV FRESENIUS should not be administered to you:

• if you are hypersensitive (allergic) to aminophylline dihydrate or any of the other ingredients of AMINOPHYLLINE 250 mg IV FRESENIUS (listed in section 6)
• if you are hypersensitive (allergic) to theophyllines (used to treat wheezing, shortness of breath, and chest tightness), caffeine (used to improve mental alertness) or theobromine (used as a vasodilator, a blood vessel widener)
• if you have porphyria (a condition that affects your blood)
• if you have an active ulcer in your stomach or lining of your stomach, small intestine or oesophagus.

Warnings and precautions

Take special care with AMINOPHYLLINE 250 mg IV FRESENIUS:

• if you have epilepsy
• if you are a smoker or if you start or stop smoking while being treated with AMINOPHYLLINE 250 mg IV FRESENIUS
• if you have a virus infection, such as flu, or if you have recently received a flu injection
• if you have liver or kidney problems
• if you have heart problems
• if you have problems with your lungs
• if you are an alcoholic
• if you are a male over 55 years old with lung problems
• if you have a bacterial blood infection
• if you have high blood pressure
• if you have an overactive thyroid (the thyroid gland produces too much thyroid hormone which increases your body’s metabolism)
• if you have a history of ulcers in the lining of your stomach, small intestine or oesophagus
• if you have an eye condition called glaucoma (high pressure in your eye(s))
• if you are a diabetic (high blood sugar levels)
• if you have low blood oxygen levels (shortness of breath, bluish colour in the skin, fingernails, and lips).

Other medicines and AMINOPHYLLINE 250 mg IV FRESENIUS:

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are currently taking or receiving any of the following:

• alcohol
• aminoglutethimide (used to treat conditions which cause the body to make too much of certain hormones (Cushing's syndrome))
• barbiturates (used to treat sleeping disorders)
• rifampicin, isoniazid (used to treat tuberculosis (TB))
• phenytoin, carbamazepine, phenobarbitone, primidone (used to treat epilepsy)
• ritonavir (used in the treatment of HIV (human immunodeficiency virus) and AIDS (acquired immune deficiency syndrome))

You will not be expected to administer AMINOPHYLLINE 250 mg IV FRESENIUS to yourself. Your doctor or health care professional will administer AMINOPHYLLINE 250 mg IV FRESENIUS to you in the hospital. Your dose will be determined by your doctor based on your weight. AMINOPHYLLINE 250 mg IV FRESENIUS will be given over a period. If you have the impression that the effect of AMINOPHYLLINE 250 mg IV FRESENIUS is too strong or too weak, tell your doctor or pharmacist.

If more AMINOPHYLLINE 250 mg IV FRESENIUS is administered to you than should be: Since a health care provider will administer AMINOPHYLLINE 250 mg IV FRESENIUS, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. You may experience the following symptoms in the event of an overdosage: nausea (feeling sick), vomiting (being sick), vomiting of blood, runny loose stool, restlessness, irritability, headache, extreme thirst, slight fever, seeing things that are not real (hallucinations), convulsions (fits), changes in the way your heart beats (beating faster or slower or skipping beats).

If you missed a dose of AMINOPHYLLINE 250 mg IV FRESENIUS: Since a health care provider will administer AMINOPHYLLINE 250 mg IV FRESENIUS, it is unlikely that the dose will be missed.

AMINOPHYLLINE 250 mg IV FRESENIUS can have side effects. Not all side effects reported for AMINOPHYLLINE 250 mg IV FRESENIUS are included in this leaflet. Should your general health worsen or if you experience any untoward effects while AMINOPHYLLINE 250 mg IV FRESENIUS is administered or after administration, please consult your health care provider for advice.

If any of the following happens, while AMINOPHYLLINE 250 mg IV FRESENIUS is being administered or after administration, tell your doctor immediately or go to the casualty department at your nearest hospital:

• swelling of your hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to AMINOPHYLLINE 250 mg IV FRESENIUS. You may need urgent medical attention.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Frequent: vomiting blood, dark or red blood mixed with your stool
• convulsions (fits).

Frequency unknown:

• more urine than is normal for you
• changes in the way your heart beats, for example, if you notice it beating faster or slower or skipping beats
• yellowing of the skin and eyes, dark urine and tiredness which may be symptoms of liver problems.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor as soon as possible if you notice any of the following:

• Frequent: headache, dizziness, vertigo (sensation of spinning or swaying)
• tremors (involuntary trembling or shaking of hands and feet)
• feeling irritable, restless, nervous
• difficulty falling asleep
• nausea, vomiting, heartburn, stomach pain.

Less frequent:

• diarrhoea.

Frequency unknown:

• low blood pressure
• excessive thirst, dry mouth and skin
• feeling dizzy, lightheaded or tired
• abnormally high body temperature with symptoms such as excessive sweating, flushed or red skin, muscle cramps, spasm, and pain
• feeling depressed, anxious
• visual disturbances.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects: If you get 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 via the 6.04 Adverse Drug Reaction Reporting Form, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of AMINOPHYLLINE 250 mg IV FRESENIUS.

• Store at or below 30 °C.
• Protect from light.
• Store all medicines out of reach of children.
• Do not use after the expiry date printed on the container.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).