Trifen ® Expect Adult Solution

TRIFEN ® EXPECT ADULT contains pseudoephedrine hydrochloride, codeine phosphate, triprolidine hydrochloride and guaiphenesin. Triprolidine belongs to a group of medicines called antihistamines, which act to relieve the symptoms of allergic reactions. Pseudoephedrine hydrochloride is a decongestant which unblock your nose and sinuses helping you breathe more easily. Codeine acts on the brain to suppress a cough. Guaiphenesin is an expectorant that reduces the thickness of mucous. TRIFEN ® EXPECT ADULT is used for the relief of cough.

Do not take/give TRIFEN ® EXPECT ADULT:

• if you/your child are allergic to pseudoephedrine hydrochloride, codeine phosphate, triprolidine hydrochloride and guaiphenesin, or any of the other ingredients of TRIFEN ® EXPECT ADULT (listed in section 6).
• if you have heart problems.
• if you suffer from high blood pressure.
• if you have thyroid problems.
• if you have prostrate problems.
• if you have a problem with your bladder.
• if you have high pressure in the eye (glaucoma).
• if you have a condition called phaeochromocytoma (a rare tumour of the adrenal gland, which sits near the kidney).
• if you are being treated with monoamine oxidase inhibitors (medicine for depression) and within two weeks of stopping such treatment.
• if you are taking a medicine called ephedrine or a medicine from a group of medicines called sympathomimetics (e.g. medicines used to treat a blocked nose, appetite suppressants).
• if you drink more alcohol than normal.
• if you/your child are having an asthma attack.
• if you/your child have or had a head injury or been told to have increased pressure in the brain.
• if you have lung problems including being unable to breathe with the skin turning blue or purple and having excessive phlegm.
• if you have very high blood pressure (severe hypertension) or hypertension not controlled by your medication.
• if you have severe acute (sudden) or chronic (long-term) kidney disease or kidney failure.

Warnings and precautions

Take special care with TRIFEN ® EXPECT ADULT:

• exceeding the prescribed dose and continuous use of TRIFEN ® EXPECT ADULT may lead to dependency and addiction.
• if you have been told by your doctor that you have a problem with your blood vessels.
• if you have diabetes mellitus.
• if you are elderly or if you are in a weakened state of health.
• if you suffer from fits.
• if you have blockages in your intestines.
• if you have liver or kidney problems.
• if you have a disorder of the muscles known as myasthenia gravis.
• if you are in shock.
• if you have been told by your doctor that you have a problem with your adrenal gland.

TRIFEN ® EXPECT ADULT may mask the warning symptoms of damage caused by medicines which cause damage to the ear.

TRIFEN ® EXPECT ADULT may interfere with the results of some laboratory test; inform your doctor that you are using this medicine before going for any test.

If the patients have a personal or family history of substance abuse or mental health disorders, then there is an increased risk of addiction.

Do not share medicines prescribed for you with any other person. Always take/give TRIFEN ® EXPECT ADULT exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose is: Adults and children over 12 years: 5 ml to 10 ml three times a day.

If you take/give more TRIFEN ® EXPECT ADULT than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

If you forget to take/give TRIFEN ® EXPECT ADULT

If you forget to take/give a dose, take/give it as soon as you remember. Do not take/give a double dose to make up for a forgotten dose.

TRIFEN ® EXPECT ADULT can have side effects. Not all side effects reported for TRIFEN ® EXPECT ADULT are included in this leaflet. Should your/your child’s general health worsen or if you/your child experience any untoward effects while taking TRIFEN ® EXPECT ADULT, please consult your healthcare provider for advice.

If any of the following happens, stop taking/giving TRIFEN ® EXPECT ADULT and tell your doctor immediately or go to the casualty department at your nearest hospital:

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

Stop using TRIFEN ® EXPECT ADULT immediately and seek urgent medical attention if you develop symptoms, that may be signs of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS). These include:

• severe headache with a sudden onset
• feeling sick
• vomiting
• confusion
• seizures
• changes in vision

These are all very serious side effects. If you/your child have them, you/your child may have had a serious reaction to TRIFEN ® EXPECT ADULT. You/your child 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:

• bleeding or increased tendency to bleed, persistent sore throat and frequent infections, fever, and/or anaemia,
• anxiety, confusion, fear, seeing, hearing, or believing things that are not real, irritability, a feeling of intense excitement and happiness, mood changes, restlessness, depression, agitation
• chest pain, tightness of the chest, changes in the way your heart beats,
• prolonged unconsciousness, increase pressure in the brain, bleeding in the brain with symptoms such as a sudden, severe headache, include numbness or weakness in part of the face, difficulty speaking or difficulty walking,
• constriction of the pupil of the eye,
• difficulty in urination, less urine than is normal for you, no urination,
• sudden loss in body heat (temperature).

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

Tell your doctor if you notice any of the following:

• Frequent side effects:
• sedation varying from slight drowsiness to deep sleep,
• Less frequent side effects:
• abdominal pain that lasts and gets worse when you lie down, nausea, vomiting
• Side effects with unknown frequency:
• thirst, loss of appetite, disturbance of glucose metabolism, dry mouth, anorexia,
• insomnia, nightmares
• giddiness, headache, tremors, dizziness, inability to concentrate, lack of energy, incoordination, tingling, heaviness and weakness of the hands,
• ringing in the ears,
• increase or decrease in blood pressure,
• reddening of the skin, sweating
• nausea, vomiting, diarrhoea, constipation, stomach pain,
• muscle weakness, stiffness of the muscles.
• serious conditions affecting blood vessels in the brain known as posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS)

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

Reporting of side effects

If you/your child gets side effects, talk to your doctor or pharmacist. You can also report side effects to SAHPRA 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 TRIFEN ® EXPECT ADULT.

• Store all medicines out of reach of children.
• Store between 15 °C - 25 °C and protect from light. Do not refrigerate.
• Do not store in a bathroom.
• Do not use after the expiry date stated on the label or bottle.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).