Trifen ® Expect Paediatric Solution

TRIFEN ® EXPECT PAEDIATRIC 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 PAEDIATRIC is used for the relief of cough.

Do not give TRIFEN ® EXPECT PAEDIATRIC • if your child is allergic to pseudoephedrine hydrochloride, codeine phosphate, triprolidine hydrochloride and guaiphenesin, or any of the other ingredients of TRIFEN ® EXPECT PAEDIATRIC (listed in section 6). • if your child has heart problems. • if your child suffers from high blood pressure. • if your child has thyroid problems. • if your child has a problem with their bladder. • if your child has high pressure in the eye (glaucoma). • if your child has a condition called phaeochromocytoma (a rare tumour of the adrenal gland, which sits near the kidney). • if your child is being treated with monoamine oxidase inhibitors (medicine for depression) and within two weeks of stopping such treatment. • if your child is being given 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 your child is having an asthma attack. • if your child has or had a head injury or been told by the doctor your child has increased pressure in the brain. • if your child has lung problems including being unable to breathe with the skin turning blue or purple and having excessive phlegm. • if your child is under the age of 2 years. • if you have very high blood pressure (severe hypertension) or hypertension not controlled by their 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 PAEDIATRIC: • as exceeding the prescribed dose and continuous use of TRIFEN ® EXPECT PAEDIATRIC may lead to lead to dependency and addiction. • if you have been told by your doctor that your child has a problem with their blood vessels. • if your child has diabetes mellitus. • if your child suffers from fits. • if your child has blockages in your intestines. • if your child has liver or kidney problems. • if your child has a disorder of the muscles known as myasthenia gravis. • if your child is in shock. • if you have been told by your doctor that your child has a problem with your adrenal gland. • if your child is in a weakened state of health. • if you are elderly • if you have a personal or family history of substance abuse or mental health disorders, then there is an increased risk of addiction. • Cases of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) have been reported following use of medicines containing pseudoephedrine. PRES and RCVS are rare conditions that can involve reduced blood supply to the brain. Stop using TRIFEN® EXPECT PAEDIATRIC immediately and seek immediate medical assistance if you develop symptoms that may be signs of PRES or RCVS (see section 4 "Possible side effects" for symptoms). TRIFEN ® EXPECT PAEDIATRIC may mask the warning symptoms of damage caused by medicines which cause damage to the ear. TRIFEN ® EXPECT PAEDIATRIC may interfere with the results of some laboratory test; inform your doctor that your child is using this medicine before going for any test.

Do not share medicines prescribed for you with any other person. Always give TRIFEN ® EXPECT PAEDIATRIC 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: Children 6 to 12 years – 5 ml to 10 ml Children 2 to 5 years – 2,5 ml to 5 ml May be given three times daily. If you give more TRIFEN ® EXPECT PAEDIATRIC 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 give TRIFEN ® EXPECT PAEDIATRIC If you forget to give a dose, give it as soon as you remember. Do not give a double dose to make up for a forgotten dose.

TRIFEN ® EXPECT PAEDIATRIC can have side effects. Not all side effects reported for TRIFEN ® EXPECT PAEDIATRIC are included in this leaflet. Should your child’s general health worsen or if your child experiences any untoward effects while taking TRIFEN ® EXPECT PAEDIATRIC, please consult your healthcare provider for advice. If any of the following happens, stop giving TRIFEN ® EXPECT PAEDIATRIC 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 PAEDIATRIC 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 your child has them, your child may have had a serious reaction to TRIFEN ® EXPECT PAEDIATRIC. 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 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/document/adverse-drug-reactions-and-quality-problem-reporting-form/ By reporting side effects, you can help provide more information on the safety of TRIFEN ® EXPECT PAEDIATRIC.

• Store all medicines out of reach of children. • Store at or below 25 °C and protect from light. • 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).