Alcophyllex Side Effects

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Answer the side-effect intent for alcophyllex without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Alcophyllex?

Alcophyllex contains the active ingredient Theophylline, Hydroxyethyl theophylline (Etofylline), Diphenhydramine hydrochloride.

• Active ingredient — Theophylline, Hydroxyethyl theophylline (Etofylline), Diphenhydramine hydrochloride
• Registration holder — Adcock Ingram Limited

It is approved for:

• ALCOPHYLLEX is used to relieve a tight chest caused by asthma, colds, bronchitis etc

Common side effects of Alcophyllex

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• 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 ALCOPHYLLEX. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
• tight chest
• changes in the way your heart beats
• difficulty urinating or less urine than is normal for you
• blurred vision
• muscle weakness
• incoordination
• convulsions
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
• difficulty falling asleep
• ringing in the ears
• feeling anxious
• restlessness or nervousness
• headache
• dizziness
• change in appetite
• excessive bruising or bleeding (when you cut your skin)
• nausea and vomiting
• stomach pains
• diarrhoea
• constipation
• dryness of the mouth
• fatigue
• slight drowsiness or deep sleep

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to theophylline, hydroxyethyl theophylline (etofylline), diphenhydramine hydrochloride, ammonium chloride, sodium citrate or any of the other ingredients of ALCOPHYLLEX
• If your baby was born alive before 37 weeks of pregnancy has been completed
• If you have porphyria (a group of rare disorders of certain enzymes)
• If you have a serious lung disease (for example, asthma attacks)
• If you suffer from liver or kidney problems
• If you have a buildup of acid in the body due to kidney disease or kidney failure or when the lungs cannot remove all of the carbon dioxide the body produces
• If you suffer from an electrolyte imbalance e.g., hypocalcaemia (low level of calcium in the blood)
• If you have hypochlorhydria (production of gastric acid in the stomach is absent or low)
• If you suffer from epilepsy (fits) or have had them in the past
• Do not give ALCOPHYLLEX to babies or children under the age of 2 years
• If you are taking monoamine oxidase inhibitors (MAOIs) (anti-depressants) with ALCOPHYLLEX
• Recent heart attack/ acute onset of a heart rate that exceeds the normal resting rate
• Using ALCOPHYLLEX with certain antihistamines i.e. ephedrine

Use with care, and tell your doctor, if

• If you have a persistent cough, persisting for more than a week, please consult a doctor
• If you have a stomach ulcer
• If you have an overactive thyroid gland
• If you have high blood pressure, irregular heartbeat, or any heart disease
• If you are elderly
• If you suffer from alcoholism
• If you have glaucoma (a condition of the eye which leads to blindness), urinary retention (inability to urinate), or prostatic hypertrophy (enlargement of the prostate gland)
• If you have a type of illness characterized by a sudden onset of fever, which is an increase in internal body temperature to levels above normal (acute febrile illness)
• If you have low levels of oxygen in your body tissues (severe hypoxia)
• If you have a condition that causes the right side of the heart to fail (cor pulmonale)
• If you have a condition caused by too much fluid in the lungs (acute pulmonary oedema)
• If you have chronic lung disease, liver, and kidney problems
• If you use high doses of diphenhydramine-containing medicines, such as ALCOPHYLLEX, it may lead to serious heart problems, seizures, coma and death
• The elderly patients, are particularly prone to dizziness, sedation, confusion, hypotension (low blood pressure) and anticholinergic effects (dry mouth, blurry vision, dry eyes, constipation, or urinary problems)
• May cause excitability especially in children
• ALCOPHYLLEX is unsuitable for children suffering from diabetes mellitus

Pregnancy and breastfeeding

• Safety for use during pregnancy and breastfeeding has not been established
• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, or other healthcare professional for advice before taking ALCOPHYLLEX

Interactions and medicines to check

The approved leaflet names these interactions.

• The use of ALCOPHYLLEX with other xanthines (e.g., aminophylline) should be avoided
• The following medicines may cause ALCOPHYLLEX to stay in the body for longer and thereby increases the possibility of side effects; allopurinol (to treat gout), cimetidine (used to relieve the symptoms of heartburn), propranolol, verapamil, (used to treat heart problems), erythromycin, tetracycline, quinolones (antibiotics), isoniazid (used in the treatment of TB), disulfiram (to treat alcoholism), fluvoxamine (used to treat depression), interferon alfa (used in the treatment of some cancers), oral contraceptives (birth control pill), caffeine, thiabendazole (used to treat worms), BCG vaccination and influenza vaccination
• The following medicines may decrease the effectiveness of ALCOPHYLLEX; phenytoin and other convulsants (used to treat epilepsy), ritonavir (used in the treatment of HIV), rifampicin (used in the treatment of TB), sulfinpyrazone (used to treat gout) and cigarette smoking
• ALCOPHYLLEX can cause hypokalaemia (concentration of potassium in the blood is low) if used with beta2-agonists (used in the treatment of asthma), corticosteroids (used to treat various conditions including arthritis, rheumatism, allergic conditions, and certain skin diseases), and diuretics (water tablets)
• ALCOPHYLLEX may increase the side effects of lithium (used in the treatment of depression), halothane, ketamine and adenosine when taken together
• There is a possibility of ALCOPHYLLEX causing side effects increase when used together with monoamine oxidase inhibitors (used in the treatment of depression)
• The effect of ALCOPHYLLEX to make you feel drowsy may be increased if it is taken at the same time as hypnotics (e.g., flunitrazepam), alcohol, barbiturates (e.g., phenobarbital), and sedatives (e.g., zolpidem)
• ALCOPHYLLEX may mask the warning signs of damage caused by aminoglycoside antibacterials (e.g., gentamicin)
• ALCOPHYLLEX may interfere with the results of skin tests and should be stopped several days before the tests
• ALCOPHYLLEX can enhance the absorption of aluminium from the gastrointestinal tract
• Xanthine containing beverages (e, g: tea, coffee, cocoa) may interfere with some laboratory tests for theophylline. Taking ALCOPHYLLEX with food and drink: ALCOPHYLLEX should be taken with food to minimise possible side effects

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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