Consumer Information for: AA-THEO LA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

AA-THEO LA is used in adults and children 12 years of age and older for the treatment of breathing problems such as asthma, chronic bronchitis, emphysema, and other problems that cause spasms in the airway.

What it does

AA-THEO LA contains the medicine theophylline. Theophylline opens the airways in the lungs which helps prevent wheezing and shortness of breath.

When it should not be used

Do not use AA-THEO LA if:

  • You are allergic to theophylline, xanthine derivatives, or the other ingredients of AA-THEO LA
  • You have ulcers in your stomach or small intestine (peptic ulcers)
  • You have damage or disease in the heart's major blood vessels
  • You are giving this medicine to your child and they are also taking ephedrine
What the medicinal ingredient is

Medicinal ingredients: theophylline anhydrous

What the non-medicinal ingredients are

Non-medicinal ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, lactose, and magnesium stearate.

What dosage form it comes in

Sustained-release tablets: 100 mg, 200 mg and 300mg.

Warnings and precautions

Serious Warnings and Precautions

Your healthcare professional will monitor your theophylline levels, any medicines you take, and your lifestyle habits.

AA-THEO LA can cause serious side effects associated with an overdose such as:

  • abnormally fast heartbeat
  • abnormal heart rhythm
  • seizures
  • vascular collapse
  • death

These may occur without warning. Less serious side effects such as nausea or restlessness may not happen before.

Tell your healthcare professional if you:

  • have severe heart disease
  • have severe hypoxemia (low levels of oxygen in your blood)
  • have high blood pressure
  • have thyroid problems
  • have had a heart attack
  • have cor pulmonale (right sided heart enlargement and heart failure)
  • have heart failure
  • have liver disease
  • are 65 years of age or older, especially male

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take AA-THEO LA. Talk about any health conditions or problems you may have, including if you:

  • have liver or kidney problems;
  • are over 55 years of age, particularly male, and have lung disease;
  • have heart problems;
  • have history of ulcers in your stomach or small intestine (peptic ulcers);
  • are taking other theophylline derivatives or are switching from a different brand of theophylline;
  • are pregnant or plan to become pregnant;
  • are breast-feeding or are planning to breastfeed;
  • start or stop smoking;
  • have a history of seizures;
  • have cystic fibrosis;
  • have the flu (influenza) or another virus or have recently had the flu shot;
  • have a continuous high fever;
  • have a high carbohydrate and low protein diet;
  • have a condition called porphyria that affects your blood cells;
  • have prostate problems or trouble passing urine;
  • have severe asthma.

Other warnings you should know about:

Laboratory Tests and Monitoring: Your healthcare professional may perform tests while you are receiving AA-THEO LA. This is to make sure that you are receiving the correct dose.

Emergency use: APO-THEO LA is not to be used in an emergency where rapid relief of breathing problems (bronchospasm) is required.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Interactions with this medication

The following may interact with AA-THEO LA:

  • cimetidine, a medicine used to treat stomach ulcers,
  • medicines used to treat high blood pressure such as propranolol, verapamil, and diltiazem,
  • medicines used to treat fungal, bacterial and viral infections such as fluconazole, terbinafine, ciprofloxacin, erythromycin, rifampin, ritonavir, and acyclovir,
  • oral birth control,
  • alkalinizing agents used to manage disorders associated with low pH,
  • the flu shot (influenza vaccine),
  • medicines used to treat seizures such as phenytoin and carbamazepine,
  • barbiturates, medicines used to help you sleep,
  • isoproterenol, a medicine used to treat breathing problems and slow heart rate,
  • smoking (tobacco),
  • acidifying agents,
  • medicines used to treat heart problems such as digitalis glycosides and mexiletine,
  • thiazides used as diuretic agents,
  • medicines that damage the kidneys (nephrotoxic drugs),
  • lithium, a medicine used to treat mental health problems,
  • sympathomimetic amines, a medicine used to treat cardiac arrest and low blood pressure, or even delay premature labor,
  • medicine used to prevent blood clots called coumarin,
  • medicines used to treat gout such as sulfinpyrazone, allopurinol and probenecid,
  • ketamine, a medicine used as an anesthetic,
  • medicines used to treat cancer such as interferons, lomustine and methotrexate,
  • medicines used to treat breathing problems such as adenosine receptor antagonists, xanthines, B-adrenergic agonists, and roflumilast,
  • glucagon, a medicine used to treat low blood sugar,
  • carbimazole, a medicine used to treat thyroid problems,
  • disulfiram, a medicine used to support the treatment of alcohol use disorder
  • benzodiazepines, medicines used to treat anxiety, seizures, panic disorders and insomnia
  • pentoxifylline, a medicine used to treat muscle pain in people with peripheral artery disease
  • aminoglutethimide, a medicine used to treat conditions where the body makes too much of a certain hormone, for example in Cushing’s Syndrome,
  • selective serotonin re-uptake inhibitors (SSRIs) such as fluvoxamine, medicines used to treat depression
  • thiabendazole, a medicine used to kill parasites
  • halothane, a medicine used for general anaesthesia
  • St. John’s Wort (Hypericum perforatum), a herbal medicine used to treat depression
  • alcohol
  • low carbohydrate and high protein diets
  • high carbohydrate and low protein diets
  • long-term ingestion of charcoal broiled meats.

Certain beverages and food may results in false values during laboratory tests of theophylline levels. This includes coffee, tea, cola beverages, chocolate, acetaminophen, and some cephalosporin and sulfa medicines.

Proper use of this medication

How to take AA-THEO LA:

  • Take AA-THEO LA exactly as your healthcare professionals tells you. Do NOT change your dose without talking to your healthcare professional. Talk to your healthcare professional if you are unsure.
  • Swallow AA-THEO LA tablets whole.
  • Do NOT break, crush or chew the tablets.

Usual Dose:

Adults: The usual starting dose is 200-300 mg every 12 hours. Your healthcare professional will decide on the dose that is best for you. Based on how you respond and how you tolerate your medicine, your healthcare professional may change your dose.

Children (12 years of age and older): The use of AA-THEO LA in children under the age of 12 years is not recommended. For children 12 years of age and older, your dose will be decided by your healthcare professional.

Overdose:

Early symptoms of an overdose include difficulty sleeping, restlessness, mild excitement or irritability, rapid pulse, ringing in the ears, seeing flashes of light, loss of appetite, nausea, and vomiting. Other symptoms of an overdose include fever, increased amount of urine, dehydration and extreme thirst.

If you think you, or a person you are caring for, have taken too much AA-THEO LA, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you missed a dose of this medication, take it as soon as you remember. But if it is almost time for your next dose, skip the missed dose and continue with your next scheduled dose. Go back to the regular dosing schedule. Do not take two doses at the same time.

Side effects and what to do about them

These are not all the possible side effects you may have when taking AA-THEO LA. If you experience any side effects not listed here, tell your healthcare professional.

Side effects may include:

  • flushing
  • difficulty emptying your bladder
  • diarrhea
  • muscle twitching
  • rash and itching
  • being unusually or abnormally active
  • feeling restless or irritable
  • difficulty sleeping (insomnia)
  • loss of appetite (anorexia)

UNKNOWN
Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
VERY COMMON
Epigastric pain: pain in the upper abdomen ✔    
Headache ✔    
Nausea ✔    
Tremor: involuntary rhythmic shaking in one or more parts of your body   ✔  
Vomiting   ✔  
Albuminuria (presence of protein in urine): swelling of the hands, feet, face   ✔  
Allergic Reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat     ✔
Arrhythmia (abnormal heart rhythms): rapid, slow or irregular heartbeat     ✔
Diuresis (increased urine production)   ✔  
Gastrointestinal (GI) bleeding: blood in vomit, black tarry stool, bright red blood in your stool or coming from rectum, rapid pulse, low blood pressure, low urine flow, confusion, weakness, dizziness     ✔
Hematemesis: vomiting blood, black tarry stool     ✔
Hematuria (blood in the urine): pink, red or very dark urine   ✔  
Hyperglycemia: (high blood sugar): increased thirst, frequent urination, dry skin, headache, blurred vision and fatigue   ✔  
Hypotension (low blood pressure): dizziness, fainting, lightheadedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up)   ✔  
Palpitation (fast-beating, fluttering or pounding heart): skipping beats, beating too fast, pounding, fluttering rapidly   ✔  
Reactivation ofpeptic ulcer: vomiting, abdominal pain, dark stools, weight loss     ✔
Seizures (fits): uncontrollable shaking with or without loss of consciousness     ✔
Syndrome of inappropriate antidiuretic hormone secretion (SIADH): concentrated urine (dark in colour), feel or are sick, have muscle cramps, confusion and fits (seizures) which may be due to inappropriate secretion of ADH (antidiuretic hormone).     ✔
Tachycardia (abnormally fast heartbeat): dizziness, light headedness, shortness of breath, racing heart   ✔  

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

How to store

Store at controlled room temperature (15°C -30°C).

Keep out of reach and sight of children.

Reporting side effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

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