Trifen Expect Paediatric 5 mg/5 ml Solution

TRIFEN u00ae EXPECT PAEDIATRIC is indicated for the alleviation of cough.

Children 6 to 12 years u2013 5 ml to 10 ml
Children 2 to 5 years u2013 2,5 ml to 5 ml
May be given three times daily.

• Hypersensitivity to pseudoephedrine hydrochloride, codeine phosphate, triprolidine hydrochloride, guaiphenesin or to any of the excipients listed in section 6.1.
• Cardiovascular disease,
• Hypertension.
• Thyrotoxicosis.
• Bladder dysfunction.
• Narrow angle glaucoma.
• Phaeochromocytoma.
• Patients being treated with monoamine oxidase inhibitors and within two weeks of stopping such treatment.
• Ephedrine and other sympathomimetic medicines as a hypertensive response may result.
• During the acute attack of bronchial asthma.
• Head injuries and where the intracranial pressure is raised.
• Heart failure secondary to chronic lung disease.
• Respiratory failure, especially in the presence of cyanosis and excessive bronchial secretion.
• Children under the age of 2 years.
• Severe hypertension or uncontrolled hypertension.
• Severe acute or chronic kidney disease/renal failure.

Exceeding the prescribed dose, together with prolonged and continuous use of this medication, may lead to dependency and addiction. Pseudoephedrine HCl should be given with caution to patients with organic heart disease, cardiac decompensation or angina of effort. In patients with prostatic enlargement, it may cause difficulty with micturition. TRIFEN u00ae EXPECT PAEDIATRIC should be used with caution in patients with aneurisms, cardiac arrhythmias (e.g. tachycardia), diabetes mellitus and occlusive vascular disorders (arteriosclerosis). Tolerance may develop when given to asthmatics for their asthmatic effects. Large doses may precipitate fits in epileptics. Codeine should be used with caution in patients with obstructive bowel disorders, liver impairment, myasthenia gravis, prostatic hypertrophy, impaired renal function or shock. It should be used with caution or in reduced doses in patients with adrenocortical insufficiency and hypothyroidism. Dosages should be reduced in debilitated and elderly patients. TRIFEN u00ae EXPECT PAEDIATRIC may interfere with diagnostic measurements of 5-hydroxy-indoleacetic acid and vanillylmandelic acid. There is an increased risk of addiction in patients with a personal or family history of substance abuse or mental health disorders. Posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) Cases of PRES and RCVS have been reported with the use of pseudoephedrine-containing products (see section 4.8). The risk is increased in patients with severe or uncontrolled hypertension, or with severe acute or chronic kidney disease/renal failure (see section 4.3). Pseudoephedrine should be discontinued and immediate medical assistance sought if the following symptoms occur: sudden severe headache or thunderclap headache, nausea, vomiting, confusion, seizures and/or visual disturbances. Most reported cases of PRES and RCVS resolved following discontinuation and appropriate treatment. Excipients TRIFEN u00ae EXPECT PAEDIATRIC contains which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with rare glucose-galactose malabsorption should not take/be given TRIFEN u00ae EXPECT PAEDIATRIC. TRIFEN u00ae EXPECT PAEDIATRIC contains sorbitol 70 % solution. Patients with hereditary fructose intolerance (HFI) should not take/be given TRIFEN u00ae EXPECT PAEDIATRIC.

TRIFEN u00ae EXPECT PAEDIATRIC should be used with caution in patients taking other sympathomimetic medicines, such as decongestants, appetite suppressants and amphetamine-like psycho-stimulants, or antihypertensive medicines, as this may cause a rise in blood pressure largely, because of interaction with pseudoephedrine HCl. The effect of a single dose of TRIFEN u00ae EXPECT PAEDIATRIC on the blood pressure of these patients should be observed before recommending repeated or unsupervised treatment. The antibacterial medicine, furazolidone, is known to cause a dose related inhibition of monoamine oxidase. TRIFEN u00ae EXPECT PAEDIATRIC and furazolidone should not be taken together. The effects of TRIFEN u00ae EXPECT PAEDIATRIC due to pseudoephedrine HCl, are diminished by guanethidine, reserpine, methyldopa and may be diminished by tricyclic antidepressants. The effects of atropine and tricyclic antidepressants may be enhanced by triprolidine HCl. Triprolidine may enhance the central nervous system sedative effects of alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and tranquillisers. Triprolidine HCl may mask the warning symptoms of damage caused by ototoxic drugs and may affect the metabolism of medicines in the liver. Codeine may affect the activity of other medicines by delaying their absorption. The depressant effects of codeine are aggravated by alcohol, anaesthetics, hypnotics and sedatives, tricyclic antidepressants and phenothiazines. Chronic ingestion of anticonvulsants and oral steroid contraceptives induces liver enzymes and may prevent attainment of therapeutic levels by increasing first past metabolism or clearance.

The safety of TRIFEN u00ae EXPECT PAEDIATRIC during pregnancy and lactation has not been established.

The use of TRIFEN u00ae EXPECT PAEDIATRIC may lead to drowsiness and impaired concentration which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be warned against taking charge of vehicles, or operating machinery where loss of concentration may lead to accidents.

Trifen Expect Paediatric Pseudoephedrine hydrochloride Codeine phosphate Triprolidine hydrochloride Guaiphenesin Blood and the lymphatic system disorders: Frequency unknown Blood dyscrasias, agranulocytosis, haemolytic anaemia Immune system disorders: Frequency unknown Allergy, anaphylaxis Metabolism and nutrition disorders: Frequency unknown Thirst, loss of appetite, disturbance of glucose metabolism, dry mouth Dry mouth Anorexia, dry mouth Psychiatric disorders: Frequency unknown Anxiety, insomnia, confusion, fear, psychotic states, irritability, restlessness, agitation Confusion, drowsiness, euphoria, mood changes, restlessness Elation or depression, irritability, nightmares Nervous system disorders: Frequent Sedation varying from slight drowsiness to deep sleep Frequency unknown Giddiness, headache, pre-cordial pain, tremors, dizziness, cerebral haemorrhage Deepening coma, increased intracranial pressure Inability to concentrate, lassitude, dizziness, incoordination, headache, tingling, heaviness and weakness of the hands Frequency not known Posterior reversible, encephalopathy syndrome (PRES) and Reversible cerebral vasoconstriction syndrome (RCVS) (see section 4.4) Eye disorders: Frequency unknown Miosis Ear and labyrinth disorders: Frequency unknown Vertigo Tinnitus Cardiac disorders: Frequency unknown Palpitation, tachycardia, hypertension, ventricular Bradycardia, circulatory failure, hypotension, Hypotension, tightness of the chest arrhythmias, reflex bradycardia, cardiac arrest, dyspnoea, vasoconstriction which may result in hypertension, pulmonary oedema orthostatic hypotension, palpitations Vascular disorders: Frequency unknown Weakness Flushing Respiratory, thoracic and mediastinal disorders: Frequency unknown Respiratory depression Gastrointestinal disorders: Less Frequent Increased risk of abdominal pain, including pancreatitis Frequency unknown Nausea, vomiting Nausea, vomiting, constipation Nausea, vomiting, diarrhoea, constipation, epigastric pain Gastrointestinal discomfort, nausea, vomiting Skin and subcutaneous tissue disorders: Frequency unknown Fixed drug eruption, taking the form of erythematous nummular patches Pruritus, urticaria Lichenoid skin eruption Musculoskeletal, connective tissue and bone disorders: Frequency unknown Muscular weakness Muscle rigidity Muscular weakness Renal and urinary disorders: Frequency unknown Difficulty with micturition Urinary retention, ureteric and biliary spasm, antidiuretic effect Difficulty with micturition General disorders and administrative site conditions: Frequency unknown Sweating, fainting, blushing Sweating, hypothermia

Symptoms of overdosage with codeine phosphate include the following: nausea, vomiting, restlessness, sensory disturbances, muscle tremor, diuresis, palpitations, stupor, shock, central stimulation with exhilaration, convulsions, drowsiness, respiratory depression, hypotension with circulatory failure, respiratory collapse, cyanosis and coma. In acute poisoning the stomach should be emptied by aspiration and lavage. Intensive supportive therapy may be necessary to correct respiratory failure and shock. The specific antagonist naloxone may be used to counteract severe respiratory depression. Symptoms of pseudoephedrine HCl overdosage may include paranoid psychosis, delusions and hallucinations. Further treatment is symptomatic and supportive.