Alcophyllex Mixture

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

Do not take ALCOPHYLLEX:

• 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.

Warnings and precautions

Take special care with ALCOPHYLLEX:

• 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.

Do not share medicines prescribed for you with any other person. Do not exceed the recommended dose. Always take ALCOPHYLLEX exactly as described in this leaflet or as your doctor, or pharmacist or nurse have told you. You should check with your doctor or pharmacist if you are unsure. If you have the impression that ALCOPHYLLEX is too weak or too strong, talk to your doctor or pharmacist. If ALCOPHYLLEX does not seem to be working as well as usual, talk to your doctor as soon as possible. Your chest problem may be getting worse, and you may need other, or additional medicines. Do not take extra or higher doses of ALCOPHYLLEX unless your doctor tells you to.

The usual dose for adults: 2 to 3 medicine measures (10 to 15 mL) every four hours.

The usual dose for children 2 to 6 years: ½ to 1 medicine measure (2,5 to 5 mL) every four hours.

The usual dose for children 7 to 12 years: 1 to 2 medicine measures (5 to 10 mL) every four hours.

Oral administration only. Shake the bottle before use. Doses must be taken orally with an adequate amount of fluid (half to one glass).

ALCOPHYLLEX can have side effects. Not all side effects reported for ALCOPHYLLEX are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ALCOPHYLLEX, please consult your healthcare professional for advice. If any of the following happens, stop using ALCOPHYLLEX and 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 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.

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. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who - umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of ALCOPHYLLEX.

STORE ALL MEDICATION OUT OF REACH OF CHILDREN. Store at or below 25 °C. Store in the original container. Keep the container tightly closed. Protect from light. Do not use after the expiry date stated on the bottle. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g., toilets).