PATIENT INFORMATION ARTICLE<\/p>\n\n\n\n
Scheduling Status<\/p>\n\n\n\n
S2<\/strong><\/p>\n\n\n\n PHENERGAN 10 coated tablets<\/strong> Promethazine hydrochloride<\/strong><\/p>\n\n\n\n PHENERGAN contains sugar.<\/p>\n\n\n\n PHENERGAN contains promethazine hydrochloride<\/strong>.<\/p>\n\n\n\n Promethazine hydrochloride is a phenothiazine derivative<\/strong> and a potent histamine antagonist<\/strong> with a prolonged action. It also has local analgesic, anti-epinephrine and atropine-like effects.<\/p>\n\n\n\n PHENERGAN has been shown to be of value in many allergic disorders and anaphylactic reactions, including:<\/p>\n\n\n\n Do not take or give PHENERGAN in the following situations:<\/p>\n\n\n\n Special care is required with PHENERGAN in the following situations:<\/p>\n\n\n\n PHENERGAN should be used with care in children, especially those who are acutely ill or dehydrated, because these patients have an increased incidence of dystonias.<\/p>\n\n\n\n PHENERGAN must not be used in children below two years of age because of the potential for fatal respiratory depression.<\/p>\n\n\n\n PHENERGAN is not suitable for children younger than 5 years in the available 10 mg and 25 mg tablet strengths.<\/p>\n\n\n\n Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported with PHENERGAN.<\/p>\n\n\n\n If an allergic reaction occurs, PHENERGAN should be stopped and appropriate medical treatment should be started.<\/p>\n\n\n\n PHENERGAN may cause sedation. Combined use with other sedative medicines is not recommended.<\/p>\n\n\n\n Phenothiazines may increase the effects of other central nervous system depressants, such as:<\/p>\n\n\n\n Alcohol and medicines containing alcohol should be avoided while taking PHENERGAN.<\/p>\n\n\n\n PHENERGAN may cause photosensitivity. Exposure to the sun or ultraviolet light should be avoided during or shortly after treatment.<\/p>\n\n\n\n Phenothiazine derivatives such as PHENERGAN may prolong the QT interval. This increases the risk of serious ventricular dysrhythmias, including torsades de pointes, which may be fatal.<\/p>\n\n\n\n The risk may be higher in the presence of:<\/p>\n\n\n\n Medical and laboratory evaluation may be needed before and during treatment if risk factors are present.<\/p>\n\n\n\n Agranulocytosis has been reported. Regular monitoring of the complete blood count is recommended when clinically required.<\/p>\n\n\n\n Tell a medical practitioner immediately if any of the following occur:<\/p>\n\n\n\n Treatment should be stopped if marked changes in the blood count are observed.<\/p>\n\n\n\n Neuroleptic malignant syndrome may occur with PHENERGAN.<\/p>\n\n\n\n Possible symptoms include:<\/p>\n\n\n\n This syndrome is potentially fatal. Promethazine must be stopped immediately and intensive medical monitoring and symptomatic treatment should be started.<\/p>\n\n\n\n PHENERGAN may:<\/p>\n\n\n\n PHENERGAN should not be used for longer than 7 days<\/strong> without seeking medical advice.<\/p>\n\n\n\n PHENERGAN contains lactose monohydrate and sucrose.<\/p>\n\n\n\n Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take PHENERGAN.<\/p>\n\n\n\n Always tell your healthcare provider if you are taking any other medicine, including complementary or traditional medicines.<\/p>\n\n\n\n PHENERGAN may interact with the following medicines or medicine groups:<\/p>\n\n\n\n Gastrointestinal medicines that are not absorbed should not be taken at the same time as phenothiazines. They should be taken at least 2 hours apart<\/strong>, if possible.<\/p>\n\n\n\n PHENERGAN should be stopped at least three days before a skin test<\/strong>, because it may inhibit the cutaneous histamine response and produce false-negative results.<\/p>\n\n\n\n PHENERGAN may interfere with immunological urine pregnancy tests and may produce false-positive or false-negative results.<\/p>\n\n\n\n Safety in pregnancy has not been established.<\/p>\n\n\n\n PHENERGAN is not recommended during pregnancy.<\/p>\n\n\n\n PHENERGAN is also not recommended in the 2 weeks prior to delivery<\/strong> because of the risk of irritability and excitement in the newborn baby.<\/p>\n\n\n\n PHENERGAN crosses the placenta and is distributed in breast milk.<\/p>\n\n\n\n There are risks of neonatal irritability and excitement. PHENERGAN is not recommended for use during breastfeeding.<\/p>\n\n\n\n There are no relevant fertility data in animals.<\/p>\n\n\n\n PHENERGAN may cause:<\/p>\n\n\n\n These effects can considerably affect the ability to drive or use machines.<\/p>\n\n\n\n Do not drive, operate machinery or perform tasks requiring alertness until the effects of PHENERGAN are known.<\/p>\n\n\n\n PHENERGAN is given orally.<\/p>\n\n\n\n The effect of a single dose is maintained for an average of 16 to 18 hours<\/strong>.<\/p>\n\n\n\n If gastric upset or other side effects occur, PHENERGAN may be taken with food or with a well-sweetened drink.<\/p>\n\n\n\n The initial dose should be small, and later doses should be adjusted according to the needs of the patient.<\/p>\n\n\n\n The main symptom of overdose is unconsciousness, which is commonly delayed.<\/p>\n\n\n\n Convulsions may occur, with periods of unconsciousness in between.<\/p>\n\n\n\n Symptoms of severe overdose can vary.<\/p>\n\n\n\n Cardiorespiratory depression is uncommon.<\/p>\n\n\n\n In the event of overdose, take all appropriate medical measures immediately.<\/p>\n\n\n\n PHENERGAN can have side effects.<\/p>\n\n\n\n The following side effects have been reported, and the frequencies may be unknown. PHENERGAN is generally well tolerated at normal dosage levels, but side effects may occur in some patients.<\/p>\n\n\n\n Reporting suspected adverse reactions after authorisation of PHENERGAN is important. It allows continued monitoring of the benefit\/risk balance of PHENERGAN.<\/p>\n\n\n\n Healthcare providers may report suspected adverse reactions to the Pharmacovigilance Unit at Sanofi or to SAHPRA.<\/p>\n\n\n\n Store at or below 25 \u00b0C<\/strong>.<\/p>\n\n\n\n Protect from light.<\/p>\n\n\n\n Keep all medicines out of reach of children.<\/p>\n\n\n\n The active substance is promethazine hydrochloride<\/strong>.<\/p>\n\n\n\n The excipients are:<\/p>\n\n\n\n PHENERGAN is supplied as coated tablets.<\/p>\n\n\n\n 2 years<\/strong><\/p>\n\n\n\n PHENERGAN 10 and PHENERGAN 25 tablets are packed in securitainers of 100 and 500 tablets<\/strong>.<\/p>\n\n\n\n sanofi-aventis south africa (pty) ltd<\/strong>Product Name<\/h2>\n\n\n\n
PHENERGAN 25 coated tablets<\/strong><\/p>\n\n\n\nActive Ingredient<\/h2>\n\n\n\n
Composition<\/h2>\n\n\n\n
Product<\/th> Active ingredient<\/th><\/tr><\/thead> PHENERGAN 10<\/td> Each tablet contains 10 mg promethazine hydrochloride<\/td><\/tr> PHENERGAN 25<\/td> Each tablet contains 25 mg promethazine hydrochloride<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n Sugar Content<\/h2>\n\n\n\n
Product<\/th> Sugar content<\/th><\/tr><\/thead> PHENERGAN 10<\/td> Each tablet contains 11,7 mg lactose monohydrate and 13,7 mg sucrose<\/td><\/tr> PHENERGAN 25<\/td> Each tablet contains 29,3 mg lactose monohydrate and 29,6 mg sucrose<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n1. What PHENERGAN Is and What It Is Used For<\/h1>\n\n\n\n
Allergic condition or use<\/th><\/tr><\/thead> Hay fever<\/td><\/tr> Vasomotor rhinorrhoea<\/td><\/tr> Urticaria<\/td><\/tr> Angioneurotic oedema<\/td><\/tr> Sensitisation reactions to various medicines and other substances<\/td><\/tr> Symptomatic relief of pruritus<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n2. What You Need to Know Before Taking PHENERGAN<\/h1>\n\n\n\n
Do Not Take PHENERGAN<\/h2>\n\n\n\n
Do not take PHENERGAN if<\/th> Details<\/th><\/tr><\/thead> You are allergic to promethazine hydrochloride<\/td> This includes allergy to other phenothiazines<\/td><\/tr> You are allergic to any other ingredient in PHENERGAN<\/td> Check the contents section<\/td><\/tr> The patient is younger than 2 years<\/td> PHENERGAN is contraindicated because of the risk of fatal respiratory depression<\/td><\/tr> The patient has signs and symptoms suggestive of Reye\u2019s syndrome<\/td> PHENERGAN should not be used<\/td><\/tr> You have an acute asthma attack<\/td> PHENERGAN should not be used<\/td><\/tr> You are in a coma<\/td> PHENERGAN should not be used<\/td><\/tr> You have central nervous system depression from any cause<\/td> PHENERGAN should not be used<\/td><\/tr> You are taking monoamine oxidase inhibitors<\/td> PHENERGAN should not be used<\/td><\/tr> You have taken monoamine oxidase inhibitors within the previous 14 days<\/td> PHENERGAN should not be used<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nWarnings and Precautions<\/h2>\n\n\n\n
Take Special Care With PHENERGAN<\/h2>\n\n\n\n
Condition or situation<\/th><\/tr><\/thead> Liver dysfunction<\/td><\/tr> Renal dysfunction<\/td><\/tr> Parkinson\u2019s disease<\/td><\/tr> Hypothyroidism<\/td><\/tr> Cardiac failure<\/td><\/tr> Pheochromocytoma<\/td><\/tr> Myasthenia gravis<\/td><\/tr> Prostate hypertrophy<\/td><\/tr> History of narrow-angle glaucoma<\/td><\/tr> History of agranulocytosis<\/td><\/tr> Severe coronary artery disease<\/td><\/tr> Bladder neck obstruction<\/td><\/tr> Pyloro-duodenal obstruction<\/td><\/tr> Epilepsy<\/td><\/tr> Asthma<\/td><\/tr> Bronchitis<\/td><\/tr> Bronchiectasis<\/td><\/tr> History of drug abuse<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nAllergic Reactions<\/h2>\n\n\n\n
\n\n\n\nSedation and Central Nervous System Effects<\/h2>\n\n\n\n
CNS depressant<\/th><\/tr><\/thead> Opiates<\/td><\/tr> Other analgesics<\/td><\/tr> Barbiturates<\/td><\/tr> Other sedatives<\/td><\/tr> General anaesthetics<\/td><\/tr> Alcohol<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nSunlight and Photosensitivity<\/h2>\n\n\n\n
\n\n\n\nHeart Rhythm Warning<\/h2>\n\n\n\n
Risk factor<\/th><\/tr><\/thead> Bradycardia<\/td><\/tr> Hypokalaemia<\/td><\/tr> Medicine-induced QT prolongation<\/td><\/tr> Use with other medicines that prolong the QT interval<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nBlood Count Monitoring<\/h2>\n\n\n\n
Warning symptom<\/th><\/tr><\/thead> Fever<\/td><\/tr> Sore throat<\/td><\/tr> Any other infection<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nNeuroleptic Malignant Syndrome<\/h2>\n\n\n\n
Possible symptoms<\/th><\/tr><\/thead> Hyperthermia<\/td><\/tr> Extrapyramidal disorders<\/td><\/tr> Muscle rigidity<\/td><\/tr> Altered mental status<\/td><\/tr> Autonomic nervous system instability<\/td><\/tr> Elevated CPK<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nOther Important Precautions<\/h2>\n\n\n\n
Effect<\/th><\/tr><\/thead> Precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex<\/td><\/tr> Delay early diagnosis of intestinal obstruction or increased intracranial pressure by suppressing vomiting<\/td><\/tr> Mask warning signs of ototoxicity caused by medicines such as aminoglycoside antibiotics and salicylates<\/td><\/tr> Thicken or dry lung secretions and impair expectoration<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPHENERGAN Contains Sugar<\/h2>\n\n\n\n
\n\n\n\nOther Medicines and PHENERGAN<\/h1>\n\n\n\n
Medicine or medicine group<\/th> Possible interaction<\/th><\/tr><\/thead> Monoamine oxidase inhibitors<\/td> PHENERGAN is contraindicated if taken within the previous 14 days<\/td><\/tr> Medicines known to cause QT prolongation<\/td> May increase the risk of QT prolongation<\/td><\/tr> Antidysrhythmics<\/td> May increase the risk of QT prolongation<\/td><\/tr> Antimicrobials<\/td> Some may increase the risk of QT prolongation<\/td><\/tr> Antidepressants<\/td> Some may increase QT risk or interact through CYP2D6<\/td><\/tr> Antipsychotics<\/td> May increase QT risk or sedative effects<\/td><\/tr> Anticholinergic medicines<\/td> Anticholinergic effects may be increased<\/td><\/tr> Tricyclic antidepressants<\/td> Effects may be enhanced; plasma concentrations may increase<\/td><\/tr> Sedatives and hypnotics<\/td> Sedative effects may be enhanced<\/td><\/tr> Amitriptyline or amitriptylinoxide<\/td> Plasma levels may increase<\/td><\/tr> Seizure-inducing or seizure threshold-lowering medicines<\/td> Use requires careful consideration<\/td><\/tr> Gastrointestinal medicines containing magnesium, aluminium or calcium salts, oxides or hydroxides<\/td> Reduced absorption of phenothiazines may occur<\/td><\/tr> Antihypertensive medicines<\/td> Hypotensive effect may be increased<\/td><\/tr> Alcohol<\/td> Sedative effects may be enhanced<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPHENERGAN and Tests<\/h2>\n\n\n\n
\n\n\n\nPregnancy, Breastfeeding and Fertility<\/h1>\n\n\n\n
Pregnancy<\/h2>\n\n\n\n
Breastfeeding<\/h2>\n\n\n\n
Fertility<\/h2>\n\n\n\n
\n\n\n\nDriving and Using Machines<\/h1>\n\n\n\n
Possible effect<\/th><\/tr><\/thead> Drowsiness<\/td><\/tr> Dizziness<\/td><\/tr> Blurred vision<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n3. How to Take PHENERGAN<\/h1>\n\n\n\n
Dosage<\/h2>\n\n\n\n
Patient group \/ use<\/th> Dose<\/th><\/tr><\/thead> Adults: initial daily dose<\/td> One 25 mg tablet given late in the evening<\/td><\/tr> Adults: if necessary<\/td> 50 mg to 100 mg, equal to two to four 25 mg tablets, on the following evenings<\/td><\/tr> Adults: when daytime dosage is indicated<\/td> 10 mg three times daily initially<\/td><\/tr> Children 5 to 10 years: as an antihistaminic<\/td> 10 mg to 25 mg<\/td><\/tr> Children 5 to 10 years: twice daily dosing<\/td> The smaller amount is generally sufficient if the dose is to be given twice in 24 hours<\/td><\/tr> Children younger than 5 years<\/td> PHENERGAN 10 and PHENERGAN 25 are not suitable<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nIf You Take More PHENERGAN Than You Should<\/h2>\n\n\n\n
Patient group<\/th> Possible overdose symptoms<\/th><\/tr><\/thead> Children<\/td> Excitation, ataxia, incoordination, athetosis, hallucinations<\/td><\/tr> Adults<\/td> Drowsiness, coma<\/td><\/tr> Adults and children<\/td> Convulsions, coma or excitement before convulsions, tachycardia<\/td><\/tr> High doses<\/td> Ventricular dysrhythmias, QT prolongation and torsades de pointes<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\n4. Possible Side Effects<\/h1>\n\n\n\n
Side Effects Table<\/h2>\n\n\n\n
System organ class<\/th> Frequency<\/th> Side effects<\/th><\/tr><\/thead> Immune system disorders<\/td> Frequency unknown<\/td> Allergic reactions, including anaphylactic reaction, urticaria and angioedema<\/td><\/tr> Blood and lymphatic system disorders<\/td> Frequency unknown<\/td> Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia and thrombocytopenia, including thrombocytopenic purpura<\/td><\/tr> Metabolism and nutrition disorders<\/td> Frequency unknown<\/td> Decreased appetite<\/td><\/tr> Psychiatric disorders<\/td> Frequency unknown<\/td> Agitation, confusional state and anxiety<\/td><\/tr> Psychiatric disorders<\/td> Frequency unknown<\/td> Infants, newborns and premature infants may be susceptible to anticholinergic effects, while other children may show paradoxical hyperexcitability and disorientation<\/td><\/tr> Nervous system disorders<\/td> Frequent<\/td> Sedation or somnolence, especially when the medicine is given during the daytime; dizziness, slight disorientation, headache, twitching and jerking of limbs at night, and ataxia<\/td><\/tr> Nervous system disorders<\/td> Less frequent<\/td> Drowsiness, restlessness and nightmares<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Paradoxical central nervous system stimulation, especially in children, with insomnia, nervousness, tachycardia, tremors, convulsions and euphoria<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Neuroleptic malignant syndrome<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Dystonia, including oculogyric crisis; usually transitory, more common in children and young adults, and usually occurring within the first 4 days of treatment or after dose increases<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Extrapyramidal effects including muscle spasm and tic-like movements of the head and face<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Anticholinergic effects such as paralytic ileus, risk of urinary retention, dry mouth, constipation and accommodation disorder<\/td><\/tr> Nervous system disorders<\/td> Frequency unknown<\/td> Elderly patients are particularly susceptible to anticholinergic effects and confusion<\/td><\/tr> Eye disorders<\/td> Frequency unknown<\/td> Blurred vision<\/td><\/tr> Ear and labyrinth disorders<\/td> Frequency unknown<\/td> Tinnitus<\/td><\/tr> Cardiac disorders<\/td> Frequency unknown<\/td> Palpitations, arrhythmias, QT prolongation and torsades de pointes<\/td><\/tr> Vascular disorders<\/td> Frequency unknown<\/td> Hypotension<\/td><\/tr> Respiratory, thoracic and mediastinal disorders<\/td> Frequency unknown<\/td> Respiratory depression and nasal congestion<\/td><\/tr> Gastrointestinal disorders<\/td> Frequency unknown<\/td> Nausea, diarrhoea or constipation, vomiting, increased appetite, epigastric pain, epigastric discomfort and dry mouth<\/td><\/tr> Hepatobiliary disorders<\/td> Frequency unknown<\/td> Cholestatic jaundice<\/td><\/tr> Skin and subcutaneous tissue disorders<\/td> Less frequent<\/td> Allergic reactions including urticaria, rash, pruritus and anaphylaxis<\/td><\/tr> Skin and subcutaneous tissue disorders<\/td> Frequency unknown<\/td> Photosensitive skin reactions; strong sunlight should be avoided during treatment<\/td><\/tr> Musculoskeletal and connective tissue disorders<\/td> Frequency unknown<\/td> Muscular weakness and restless legs syndrome<\/td><\/tr> Renal and urinary disorders<\/td> Frequency unknown<\/td> Urinary retention<\/td><\/tr> General disorders and administration site conditions<\/td> Frequency unknown<\/td> Tiredness<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nReporting of Suspected Adverse Reactions<\/h2>\n\n\n\n
\n\n\n\n5. How to Store PHENERGAN<\/h1>\n\n\n\n
\n\n\n\n6. Contents of the Pack and Other Information<\/h1>\n\n\n\n
What PHENERGAN Contains<\/h2>\n\n\n\n
Product<\/th> Active substance<\/th><\/tr><\/thead> PHENERGAN 10<\/td> Each tablet contains 10 mg promethazine hydrochloride<\/td><\/tr> PHENERGAN 25<\/td> Each tablet contains 25 mg promethazine hydrochloride<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n List of Excipients<\/h2>\n\n\n\n
Excipients<\/th><\/tr><\/thead> Acacia powder<\/td><\/tr> Brilliant Blue FCF colourant, E133<\/td><\/tr> Carnauba wax<\/td><\/tr> Dextrin white<\/td><\/tr> Kaolin light<\/td><\/tr> Lactose monohydrate<\/td><\/tr> Magnesium stearate<\/td><\/tr> Sucrose<\/td><\/tr> Talcum powder<\/td><\/tr> Vinnapas B60<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nPharmaceutical Form<\/h2>\n\n\n\n
Product<\/th> Description<\/th><\/tr><\/thead> PHENERGAN 10<\/td> Round, blue sugar-coated tablet, approximately 2,7 mm thick and approximately 4,5 mm in diameter<\/td><\/tr> PHENERGAN 25<\/td> Round, blue sugar-coated tablet, approximately 3,6 mm thick and approximately 6,1 mm in diameter<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n
\n\n\n\nShelf Life<\/h2>\n\n\n\n
\n\n\n\nNature and Contents of Container<\/h2>\n\n\n\n
\n\n\n\nHolder of Certificate of Registration<\/h2>\n\n\n\n
Hertford Office Park, Building I, 5th Floor
90 Bekker Road, Vorna Valley
Midrand 2196
South Africa<\/p>\n\n\n\n
\n\n\n\nRegistration Numbers<\/h2>\n\n\n\n