PATIENT INFORMATION ARTICLE
Scheduling Status
S2
Product Name
PHENERGAN 10 coated tablets
PHENERGAN 25 coated tablets
Active Ingredient
Promethazine hydrochloride
Composition
| Product | Active ingredient |
|---|---|
| PHENERGAN 10 | Each tablet contains 10 mg promethazine hydrochloride |
| PHENERGAN 25 | Each tablet contains 25 mg promethazine hydrochloride |
Sugar Content
PHENERGAN contains sugar.
| Product | Sugar content |
|---|---|
| PHENERGAN 10 | Each tablet contains 11,7 mg lactose monohydrate and 13,7 mg sucrose |
| PHENERGAN 25 | Each tablet contains 29,3 mg lactose monohydrate and 29,6 mg sucrose |
1. What PHENERGAN Is and What It Is Used For
PHENERGAN contains promethazine hydrochloride.
Promethazine hydrochloride is a phenothiazine derivative and a potent histamine antagonist with a prolonged action. It also has local analgesic, anti-epinephrine and atropine-like effects.
PHENERGAN has been shown to be of value in many allergic disorders and anaphylactic reactions, including:
| Allergic condition or use |
|---|
| Hay fever |
| Vasomotor rhinorrhoea |
| Urticaria |
| Angioneurotic oedema |
| Sensitisation reactions to various medicines and other substances |
| Symptomatic relief of pruritus |
2. What You Need to Know Before Taking PHENERGAN
Do Not Take PHENERGAN
Do not take or give PHENERGAN in the following situations:
| Do not take PHENERGAN if | Details |
|---|---|
| You are allergic to promethazine hydrochloride | This includes allergy to other phenothiazines |
| You are allergic to any other ingredient in PHENERGAN | Check the contents section |
| The patient is younger than 2 years | PHENERGAN is contraindicated because of the risk of fatal respiratory depression |
| The patient has signs and symptoms suggestive of Reye’s syndrome | PHENERGAN should not be used |
| You have an acute asthma attack | PHENERGAN should not be used |
| You are in a coma | PHENERGAN should not be used |
| You have central nervous system depression from any cause | PHENERGAN should not be used |
| You are taking monoamine oxidase inhibitors | PHENERGAN should not be used |
| You have taken monoamine oxidase inhibitors within the previous 14 days | PHENERGAN should not be used |
Warnings and Precautions
Take Special Care With PHENERGAN
Special care is required with PHENERGAN in the following situations:
| Condition or situation |
|---|
| Liver dysfunction |
| Renal dysfunction |
| Parkinson’s disease |
| Hypothyroidism |
| Cardiac failure |
| Pheochromocytoma |
| Myasthenia gravis |
| Prostate hypertrophy |
| History of narrow-angle glaucoma |
| History of agranulocytosis |
| Severe coronary artery disease |
| Bladder neck obstruction |
| Pyloro-duodenal obstruction |
| Epilepsy |
| Asthma |
| Bronchitis |
| Bronchiectasis |
| History of drug abuse |
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.
PHENERGAN must not be used in children below two years of age because of the potential for fatal respiratory depression.
PHENERGAN is not suitable for children younger than 5 years in the available 10 mg and 25 mg tablet strengths.
Allergic Reactions
Hypersensitivity reactions, including anaphylaxis, urticaria and angioedema, have been reported with PHENERGAN.
If an allergic reaction occurs, PHENERGAN should be stopped and appropriate medical treatment should be started.
Sedation and Central Nervous System Effects
PHENERGAN may cause sedation. Combined use with other sedative medicines is not recommended.
Phenothiazines may increase the effects of other central nervous system depressants, such as:
| CNS depressant |
|---|
| Opiates |
| Other analgesics |
| Barbiturates |
| Other sedatives |
| General anaesthetics |
| Alcohol |
Alcohol and medicines containing alcohol should be avoided while taking PHENERGAN.
Sunlight and Photosensitivity
PHENERGAN may cause photosensitivity. Exposure to the sun or ultraviolet light should be avoided during or shortly after treatment.
Heart Rhythm Warning
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.
The risk may be higher in the presence of:
| Risk factor |
|---|
| Bradycardia |
| Hypokalaemia |
| Medicine-induced QT prolongation |
| Use with other medicines that prolong the QT interval |
Medical and laboratory evaluation may be needed before and during treatment if risk factors are present.
Blood Count Monitoring
Agranulocytosis has been reported. Regular monitoring of the complete blood count is recommended when clinically required.
Tell a medical practitioner immediately if any of the following occur:
| Warning symptom |
|---|
| Fever |
| Sore throat |
| Any other infection |
Treatment should be stopped if marked changes in the blood count are observed.
Neuroleptic Malignant Syndrome
Neuroleptic malignant syndrome may occur with PHENERGAN.
Possible symptoms include:
| Possible symptoms |
|---|
| Hyperthermia |
| Extrapyramidal disorders |
| Muscle rigidity |
| Altered mental status |
| Autonomic nervous system instability |
| Elevated CPK |
This syndrome is potentially fatal. Promethazine must be stopped immediately and intensive medical monitoring and symptomatic treatment should be started.
Other Important Precautions
PHENERGAN may:
| Effect |
|---|
| Precipitate epileptiform seizures in patients with focal lesions of the cerebral cortex |
| Delay early diagnosis of intestinal obstruction or increased intracranial pressure by suppressing vomiting |
| Mask warning signs of ototoxicity caused by medicines such as aminoglycoside antibiotics and salicylates |
| Thicken or dry lung secretions and impair expectoration |
PHENERGAN should not be used for longer than 7 days without seeking medical advice.
PHENERGAN Contains Sugar
PHENERGAN contains lactose monohydrate and sucrose.
Patients with rare hereditary problems of fructose intolerance, galactose intolerance, total lactase deficiency, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take PHENERGAN.
Other Medicines and PHENERGAN
Always tell your healthcare provider if you are taking any other medicine, including complementary or traditional medicines.
PHENERGAN may interact with the following medicines or medicine groups:
| Medicine or medicine group | Possible interaction |
|---|---|
| Monoamine oxidase inhibitors | PHENERGAN is contraindicated if taken within the previous 14 days |
| Medicines known to cause QT prolongation | May increase the risk of QT prolongation |
| Antidysrhythmics | May increase the risk of QT prolongation |
| Antimicrobials | Some may increase the risk of QT prolongation |
| Antidepressants | Some may increase QT risk or interact through CYP2D6 |
| Antipsychotics | May increase QT risk or sedative effects |
| Anticholinergic medicines | Anticholinergic effects may be increased |
| Tricyclic antidepressants | Effects may be enhanced; plasma concentrations may increase |
| Sedatives and hypnotics | Sedative effects may be enhanced |
| Amitriptyline or amitriptylinoxide | Plasma levels may increase |
| Seizure-inducing or seizure threshold-lowering medicines | Use requires careful consideration |
| Gastrointestinal medicines containing magnesium, aluminium or calcium salts, oxides or hydroxides | Reduced absorption of phenothiazines may occur |
| Antihypertensive medicines | Hypotensive effect may be increased |
| Alcohol | Sedative effects may be enhanced |
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, if possible.
PHENERGAN and Tests
PHENERGAN should be stopped at least three days before a skin test, because it may inhibit the cutaneous histamine response and produce false-negative results.
PHENERGAN may interfere with immunological urine pregnancy tests and may produce false-positive or false-negative results.
Pregnancy, Breastfeeding and Fertility
Pregnancy
Safety in pregnancy has not been established.
PHENERGAN is not recommended during pregnancy.
PHENERGAN is also not recommended in the 2 weeks prior to delivery because of the risk of irritability and excitement in the newborn baby.
Breastfeeding
PHENERGAN crosses the placenta and is distributed in breast milk.
There are risks of neonatal irritability and excitement. PHENERGAN is not recommended for use during breastfeeding.
Fertility
There are no relevant fertility data in animals.
Driving and Using Machines
PHENERGAN may cause:
| Possible effect |
|---|
| Drowsiness |
| Dizziness |
| Blurred vision |
These effects can considerably affect the ability to drive or use machines.
Do not drive, operate machinery or perform tasks requiring alertness until the effects of PHENERGAN are known.
3. How to Take PHENERGAN
PHENERGAN is given orally.
The effect of a single dose is maintained for an average of 16 to 18 hours.
If gastric upset or other side effects occur, PHENERGAN may be taken with food or with a well-sweetened drink.
The initial dose should be small, and later doses should be adjusted according to the needs of the patient.
Dosage
| Patient group / use | Dose |
|---|---|
| Adults: initial daily dose | One 25 mg tablet given late in the evening |
| Adults: if necessary | 50 mg to 100 mg, equal to two to four 25 mg tablets, on the following evenings |
| Adults: when daytime dosage is indicated | 10 mg three times daily initially |
| Children 5 to 10 years: as an antihistaminic | 10 mg to 25 mg |
| Children 5 to 10 years: twice daily dosing | The smaller amount is generally sufficient if the dose is to be given twice in 24 hours |
| Children younger than 5 years | PHENERGAN 10 and PHENERGAN 25 are not suitable |
If You Take More PHENERGAN Than You Should
The main symptom of overdose is unconsciousness, which is commonly delayed.
Convulsions may occur, with periods of unconsciousness in between.
Symptoms of severe overdose can vary.
| Patient group | Possible overdose symptoms |
|---|---|
| Children | Excitation, ataxia, incoordination, athetosis, hallucinations |
| Adults | Drowsiness, coma |
| Adults and children | Convulsions, coma or excitement before convulsions, tachycardia |
| High doses | Ventricular dysrhythmias, QT prolongation and torsades de pointes |
Cardiorespiratory depression is uncommon.
In the event of overdose, take all appropriate medical measures immediately.
4. Possible Side Effects
PHENERGAN can have side effects.
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.
Side Effects Table
| System organ class | Frequency | Side effects |
|---|---|---|
| Immune system disorders | Frequency unknown | Allergic reactions, including anaphylactic reaction, urticaria and angioedema |
| Blood and lymphatic system disorders | Frequency unknown | Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia and thrombocytopenia, including thrombocytopenic purpura |
| Metabolism and nutrition disorders | Frequency unknown | Decreased appetite |
| Psychiatric disorders | Frequency unknown | Agitation, confusional state and anxiety |
| Psychiatric disorders | Frequency unknown | Infants, newborns and premature infants may be susceptible to anticholinergic effects, while other children may show paradoxical hyperexcitability and disorientation |
| Nervous system disorders | Frequent | 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 |
| Nervous system disorders | Less frequent | Drowsiness, restlessness and nightmares |
| Nervous system disorders | Frequency unknown | Paradoxical central nervous system stimulation, especially in children, with insomnia, nervousness, tachycardia, tremors, convulsions and euphoria |
| Nervous system disorders | Frequency unknown | Neuroleptic malignant syndrome |
| Nervous system disorders | Frequency unknown | 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 |
| Nervous system disorders | Frequency unknown | Extrapyramidal effects including muscle spasm and tic-like movements of the head and face |
| Nervous system disorders | Frequency unknown | Anticholinergic effects such as paralytic ileus, risk of urinary retention, dry mouth, constipation and accommodation disorder |
| Nervous system disorders | Frequency unknown | Elderly patients are particularly susceptible to anticholinergic effects and confusion |
| Eye disorders | Frequency unknown | Blurred vision |
| Ear and labyrinth disorders | Frequency unknown | Tinnitus |
| Cardiac disorders | Frequency unknown | Palpitations, arrhythmias, QT prolongation and torsades de pointes |
| Vascular disorders | Frequency unknown | Hypotension |
| Respiratory, thoracic and mediastinal disorders | Frequency unknown | Respiratory depression and nasal congestion |
| Gastrointestinal disorders | Frequency unknown | Nausea, diarrhoea or constipation, vomiting, increased appetite, epigastric pain, epigastric discomfort and dry mouth |
| Hepatobiliary disorders | Frequency unknown | Cholestatic jaundice |
| Skin and subcutaneous tissue disorders | Less frequent | Allergic reactions including urticaria, rash, pruritus and anaphylaxis |
| Skin and subcutaneous tissue disorders | Frequency unknown | Photosensitive skin reactions; strong sunlight should be avoided during treatment |
| Musculoskeletal and connective tissue disorders | Frequency unknown | Muscular weakness and restless legs syndrome |
| Renal and urinary disorders | Frequency unknown | Urinary retention |
| General disorders and administration site conditions | Frequency unknown | Tiredness |
Reporting of Suspected Adverse Reactions
Reporting suspected adverse reactions after authorisation of PHENERGAN is important. It allows continued monitoring of the benefit/risk balance of PHENERGAN.
Healthcare providers may report suspected adverse reactions to the Pharmacovigilance Unit at Sanofi or to SAHPRA.
5. How to Store PHENERGAN
Store at or below 25 °C.
Protect from light.
Keep all medicines out of reach of children.
6. Contents of the Pack and Other Information
What PHENERGAN Contains
The active substance is promethazine hydrochloride.
| Product | Active substance |
|---|---|
| PHENERGAN 10 | Each tablet contains 10 mg promethazine hydrochloride |
| PHENERGAN 25 | Each tablet contains 25 mg promethazine hydrochloride |
List of Excipients
The excipients are:
| Excipients |
|---|
| Acacia powder |
| Brilliant Blue FCF colourant, E133 |
| Carnauba wax |
| Dextrin white |
| Kaolin light |
| Lactose monohydrate |
| Magnesium stearate |
| Sucrose |
| Talcum powder |
| Vinnapas B60 |
Pharmaceutical Form
PHENERGAN is supplied as coated tablets.
| Product | Description |
|---|---|
| PHENERGAN 10 | Round, blue sugar-coated tablet, approximately 2,7 mm thick and approximately 4,5 mm in diameter |
| PHENERGAN 25 | Round, blue sugar-coated tablet, approximately 3,6 mm thick and approximately 6,1 mm in diameter |
Shelf Life
2 years
Nature and Contents of Container
PHENERGAN 10 and PHENERGAN 25 tablets are packed in securitainers of 100 and 500 tablets.
Holder of Certificate of Registration
sanofi-aventis south africa (pty) ltd
Hertford Office Park, Building I, 5th Floor
90 Bekker Road, Vorna Valley
Midrand 2196
South Africa
Registration Numbers
| Product | Registration number |
|---|---|
| PHENERGAN 10 | C855, Act 101/1965 |
| PHENERGAN 25 | C858, Act 101/1965 |
Date of First Authorisation / Renewal of the Authorisation
Old Medicine, Act 101/1965
Date of Revision of the Text
06 November 2023
Medical Disclaimer
This article is intended as patient information based on the approved professional information structure. It does not replace advice from a doctor, pharmacist or other healthcare professional. For regulated medical product use, follow the approved leaflet or professional information and healthcare professional guidance.
