If you are using ALCOPHYLLEX Mixture (oral liquid), this guide is here to help you understand it in a clear, practical way so you can use it as safely as possible. ALCOPHYLLEX is a Schedule 2 (S2) medicine used to help relieve a tight chest linked to asthma, colds, bronchitis and similar chest conditions. It is an oral liquid, which means you swallow it rather than inhale it.
What it is and what it is used for
ALCOPHYLLEX is a mixture (oral liquid) used to relieve a tight chest caused by:
- asthma
- colds
- bronchitis
- similar chest-related illnesses
The active ingredients in each 5 mL are:
- Theophylline 16,667 mg
- Hydroxyethyl theophylline (etofylline) 1,667 mg
- Diphenhydramine hydrochloride 6,667 mg
- Ammonium chloride 120 mg
- Sodium citrate 50 mg
In simple terms, this is a combination medicine used to help when your chest feels tight and breathing is uncomfortable because of certain chest conditions. It is meant for mild illness, but you still need to use it carefully.
Important: If your symptoms worsen, or if they do not improve after 5 days, you should see a doctor.
How it works (simple explanation)
ALCOPHYLLEX contains a combination of ingredients that work in different ways.
The theophylline and hydroxyethyl theophylline (etofylline) are part of a group called xanthines. In everyday terms, these ingredients help to open the airways in your lungs so that breathing may feel easier when your chest is tight.
Diphenhydramine hydrochloride is an antihistamine. In this medicine, it may also make you feel drowsy, which is why you need to be careful with driving or using machinery.
Ammonium chloride and sodium citrate are included as part of the mixture as described in the source. Their exact role is not specified in the source.
Because ALCOPHYLLEX contains several ingredients, it can affect more than one part of the body. That is why it is important to follow the dose carefully and pay attention to warnings, side effects, and possible interactions.
Who should NOT use this medicine
Do not use ALCOPHYLLEX if you:
- are allergic to theophylline, hydroxyethyl theophylline (etofylline), diphenhydramine hydrochloride, ammonium chloride, sodium citrate, or any of the other ingredients
- have a baby who was born alive before 37 weeks of pregnancy being considered for this medicine
- have porphyria (a group of rare enzyme disorders)
- have a serious lung disease, for example asthma attacks
- have liver problems
- have kidney problems
- have a buildup of acid in the body due to kidney disease, kidney failure, or because the lungs cannot remove enough carbon dioxide
- have an electrolyte imbalance, for example hypocalcaemia (low calcium in the blood)
- have hypochlorhydria (very low or absent stomach acid)
- have epilepsy, or have had fits in the past
- are giving it to a baby or child under 2 years
- are taking monoamine oxidase inhibitors (MAOIs), which are certain antidepressants
- have had a recent heart attack
- have an acute onset of a heart rate faster than normal resting rate
- are using ALCOPHYLLEX with certain antihistamines, for example ephedrine
Warning: Do not use this medicine outside the situations described in the source. If you are unsure whether any of these apply to you or the person you care for, speak to a doctor or pharmacist before using it.
Warnings and precautions (Read before use)
Before using ALCOPHYLLEX, take extra care if any of the following apply to you.
Speak to a doctor or pharmacist first if you have:
- a persistent cough that lasts more than a week
- a stomach ulcer
- an overactive thyroid gland
- high blood pressure
- an irregular heartbeat
- any heart disease
- glaucoma
- urinary retention (difficulty passing urine)
- prostatic hypertrophy (an enlarged prostate)
- an acute febrile illness (a sudden illness with fever)
- severe hypoxia (low oxygen levels in body tissues)
- cor pulmonale (failure of the right side of the heart)
- acute pulmonary oedema (too much fluid in the lungs)
- chronic lung disease
- liver or kidney problems
- alcoholism
Extra caution if you are older
If you are elderly, you may be more likely to develop:
- dizziness
- sedation
- confusion
- hypotension (low blood pressure)
- dry mouth
- blurred vision
- dry eyes
- constipation
- urinary problems
Special caution in children
- ALCOPHYLLEX may cause excitability, especially in children.
- It is not suitable for children with diabetes mellitus.
- It must not be given to children under 2 years.
High doses can be dangerous
Using high doses of diphenhydramine-containing medicines, including ALCOPHYLLEX, may lead to very serious problems such as:
- serious heart problems
- seizures
- coma
- death
This is one reason why you should never exceed the recommended dose.
Driving and using machines
ALCOPHYLLEX can make you drowsy and affect your concentration. Because of this, you should not:
- drive a motor vehicle
- operate dangerous machinery
- climb dangerous heights
Impaired judgement or slower reaction times can lead to accidents.
Alcohol
The source states that the drowsy effect of ALCOPHYLLEX may be increased when taken with alcohol.
Note: The medicine itself contains a small amount of alcohol (ethanol), but the source says this small amount is not expected to have noticeable effects.
Sugar and sodium content
This medicine contains:
- Sucrose
- Sodium
- a small amount of alcohol
If you have been told that you have an intolerance to some sugars, speak to your doctor before using it.
Each 5 mL contains 50 mg sodium, which is equal to 0,5% of the recommended maximum daily dietary sodium intake for an adult.
Pregnancy, planning pregnancy, and breastfeeding
The source says that safety during pregnancy and breastfeeding has not been established.
If you are:
- pregnant
- breastfeeding
- think you may be pregnant
- planning to have a baby
you should speak to your doctor, pharmacist, or other healthcare professional before taking ALCOPHYLLEX.
Note: Information about fertility is not specified in the source.
Interactions
ALCOPHYLLEX can interact with a number of medicines, drinks, vaccines, and even some tests. This matters because interactions may:
- increase side effects
- reduce how well the medicine works
- affect test results
- increase the risk of low potassium levels
Tell your healthcare provider if you take any other medicine
This includes:
- prescription medicines
- over-the-counter medicines
- complementary medicines
- traditional medicines
Medicines that should be avoided or used with caution
Avoid using with other xanthines
The source says the use of ALCOPHYLLEX with other xanthines, such as aminophylline, should be avoided.
Medicines that may keep ALCOPHYLLEX in the body for longer
These can increase the chance of side effects:
- allopurinol
- cimetidine
- propranolol
- verapamil
- erythromycin
- tetracycline
- quinolones
- isoniazid
- disulfiram
- fluvoxamine
- interferon alfa
- oral contraceptives
- caffeine
- thiabendazole
- BCG vaccination
- influenza vaccination
Medicines that may make ALCOPHYLLEX less effective
These may reduce how well it works:
- phenytoin
- other convulsants used for epilepsy
- ritonavir
- rifampicin
- sulfinpyrazone
- cigarette smoking
Medicines that may increase the risk of low potassium
ALCOPHYLLEX can cause hypokalaemia (low potassium in the blood) if used with:
- beta2-agonists
- corticosteroids
- diuretics (water tablets)
Medicines whose side effects may be increased
ALCOPHYLLEX may increase the side effects of:
- lithium
- halothane
- ketamine
- adenosine
Drowsiness may be worse with certain medicines or substances
Its drowsy effects may be stronger if taken with:
- hypnotics such as flunitrazepam
- alcohol
- barbiturates such as phenobarbital
- sedatives such as zolpidem
Other important interactions
- ALCOPHYLLEX may mask warning signs of damage caused by aminoglycoside antibiotics such as gentamicin.
- It may interfere with skin test results and should be stopped several days before the tests.
- It can enhance the absorption of aluminium from the gastrointestinal tract.
- Xanthine-containing drinks such as tea, coffee and cocoa may interfere with some laboratory tests for theophylline.
Practical advice
If you are taking other medicines regularly, do not assume they are safe to mix with ALCOPHYLLEX. Check with your pharmacist or doctor first, especially if you use asthma medicines, TB treatment, HIV treatment, antidepressants, epilepsy treatment, or sleeping tablets.
How to take (Step-by-step)
Always take ALCOPHYLLEX exactly as directed in the source or as your doctor, pharmacist, or nurse has told you.
Before you take a dose
- Shake the bottle before use.
- Measure the dose carefully.
- Take it by mouth only.
- Take it with food to help reduce possible side effects.
- Take each dose with an adequate amount of fluid, which the source describes as half to one glass.
Usual dosing
Adults
The usual dose is:
- 2 to 3 medicine measures (10 to 15 mL) every 4 hours
Children aged 2 to 6 years
The usual dose is:
- ½ to 1 medicine measure (2,5 to 5 mL) every 4 hours
Children aged 7 to 12 years
The usual dose is:
- 1 to 2 medicine measures (5 to 10 mL) every 4 hours
Important dose reminders
- Do not exceed the recommended dose.
- Do not take extra or higher doses unless your doctor tells you to.
- Do not share your medicine with anyone else.
- If the medicine feels too weak or too strong, speak to your doctor or pharmacist.
- If it does not seem to work as well as usual, speak to your doctor as soon as possible because your chest condition may be getting worse.
If you miss a dose
If you forget a dose:
- Do not take a double dose to make up for the missed dose.
The source does not specify any other missed-dose instructions.
If you take too much
In the event of an overdose:
- contact your doctor or pharmacist
- if neither is available, go to the nearest hospital or poison control centre
Symptoms of overdose may include:
- nausea
- vomiting
- diarrhoea
- rapid breathing
- shortness of breath
- muscle weakness
- shivering
- restlessness
- high or low blood pressure
- drowsiness
- irregular heartbeat
- coma
- convulsions
Simple adherence tips based on the source
Because doses are taken every 4 hours, it may help to:
- keep the bottle in its correct storage place where you can safely remember it
- use the correct medicine measure each time
- take it with food as directed
- avoid guessing the amount
The source does not specify a maximum number of doses per day.
Dosing table
| Age group | Dose | Frequency | Maximum daily dose |
|---|---|---|---|
| Adults | 10 to 15 mL | Every 4 hours | Not specified in the source |
| Children 2 to 6 years | 2,5 to 5 mL | Every 4 hours | Not specified in the source |
| Children 7 to 12 years | 5 to 10 mL | Every 4 hours | Not specified in the source |
| Children under 2 years | Do not use | Not applicable | Not applicable |
Possible side effects
Like all medicines, ALCOPHYLLEX can cause side effects, although not everyone gets them.
If your general health worsens while taking it, speak to your healthcare professional.
Common
The source does not label side effects by frequency, so the groups below are arranged for practical use rather than by exact rate. The following side effects are listed in the source as effects you should tell your doctor about if you notice them:
- difficulty falling asleep
- ringing in the ears
- feeling anxious
- restlessness or nervousness
- headache
- dizziness
- change in appetite
- nausea
- vomiting
- stomach pains
- diarrhoea
- constipation
- dry mouth
- fatigue
- slight drowsiness
- deep sleep
- excessive bruising or bleeding when you cut your skin
Less common
Not specified in the source.
Serious—seek urgent help
Stop using ALCOPHYLLEX and get medical help immediately if you develop signs of a serious allergic reaction, such as:
- swelling of the hands, feet, ankles, face, lips, mouth or throat
- difficulty swallowing
- difficulty breathing
- rash
- itching
- fainting
Go to a doctor or the nearest casualty department urgently if you notice:
- tight chest
- changes in the way your heart beats
- difficulty urinating
- less urine than usual
- blurred vision
- muscle weakness
- incoordination
- convulsions
Warning: High doses of diphenhydramine-containing medicines may lead to serious heart problems, seizures, coma, and death.
Reporting side effects in South Africa
If you get side effects, talk to your doctor, pharmacist, or nurse. You can also report side effects to SAHPRA through the Med Safety App (Medsafety X SAHPRA) and the eReporting platform on the SAHPRA website.
Storage and disposal
To keep ALCOPHYLLEX safe and effective:
- store it at or below 25 °C
- keep it in the original container
- keep the container tightly closed
- protect it from light
- keep all medicine out of reach of children
Do not use it after the expiry date printed on the bottle.
If you have medicine left over that you no longer need:
- return unused medicine to your pharmacist
- do not throw it into drains or sewerage systems such as toilets
What the medicine contains
Active ingredients per 5 mL
| Ingredient | Amount per 5 mL |
|---|---|
| Theophylline | 16,667 mg |
| Hydroxyethyl theophylline (etofylline) | 1,667 mg |
| Diphenhydramine hydrochloride | 6,667 mg |
| Ammonium chloride | 120 mg |
| Sodium citrate | 50 mg |
Other ingredients and important excipients
The source lists the following other ingredients or excipients:
- sucrose
- ethanol
- caramel colourant [E150]
- citric acid monohydrate [E330]
- methylparaben [E218]
- propylparaben [E216]
- purified water
- raspberry flavour
It also states that the medicine contains:
- Methylparaben 0,1% m/v
- Propylparaben 0,015% m/v
- Alcohol 0,5% v/v
- Sucrose 3,266 g
If sugar, sodium, alcohol, or preservatives matter for your health condition, check with your healthcare provider before using the medicine.
Pack information and appearance
ALCOPHYLLEX is described as:
- a dark brown liquid
- with an odour of raspberry
The pack sizes listed are:
- 100 mL
- 200 mL
- 2,5 L
The source says not all pack sizes may be marketed at the same time.
Container types listed in the source
For 100 mL and 200 mL packs:
- amber PVC bottle with LLDPE pilfer-proof closure
- amber glass bottle with white polypropylene closure cap
- amber PET medical round bottle with white polypropylene and HDPE child-proof screw-on cap
For 2,5 L packs:
- amber HDPE container with white polypropylene screw-on closure with EXPE liner
Practical FAQs (based ONLY on the source)
Can I give ALCOPHYLLEX to a child under 2 years?
No. It must not be given to babies or children under 2 years.
Should I take it with food?
Yes. The source says it should be taken with food to help minimise possible side effects.
Do I need to shake the bottle?
Yes. You should shake the bottle before use.
Can I drive after taking it?
No, you should not drive, operate dangerous machinery, or climb dangerous heights because it can cause drowsiness and impaired concentration.
Can I drink alcohol while taking this?
The source says alcohol can increase the drowsy effect of ALCOPHYLLEX. The medicine itself contains a very small amount of alcohol, which is not expected to have noticeable effects.
What should I do if I forget a dose?
Do not take a double dose to make up for a forgotten dose. No further missed-dose advice is specified in the source.
What should I do if I take too much?
Contact your doctor or pharmacist straight away. If they are not available, go to the nearest hospital or poison control centre.
Is it safe in pregnancy or while breastfeeding?
Safety during pregnancy and breastfeeding has not been established. Speak to your doctor, pharmacist, or another healthcare professional before use.
Can I use it if I have diabetes?
The source says ALCOPHYLLEX is unsuitable for children suffering from diabetes mellitus. It also contains sucrose.
What if my symptoms do not improve?
If your symptoms get worse or do not improve after 5 days, you should see a doctor.
Plain-language summary
If you are taking ALCOPHYLLEX, the main things to remember are to use the correct dose, take it with food, shake the bottle first, and never give it to children under 2 years. It is used to help relieve a tight chest linked to asthma, colds, bronchitis and similar conditions, but it is not suitable for everyone.
Seek medical help urgently if you develop swelling, trouble breathing, fainting, changes in your heartbeat, convulsions, or severe trouble passing urine. If you are pregnant, breastfeeding, taking other medicines, or have liver, kidney, heart, or eye problems, speak to a healthcare professional before using it.
