Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Promethazine hydrochloride may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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Phenergan Injection contains a medicine called promethazine hydrochloride. This belongs to a group of medicines called phenothiazines. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. It also works directly on the brain to help you feel more relaxed.
Do not use Phenergan Injection if: X The person taking the medicine is under 2 years of age X You are allergic (hypersensitive) to promethazine hydrochloride or any of the other ingredients of this medicine (listed in section 6). The signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue X You are taking a medicine for depression called a monoamine oxidase inhibitor (MAOI). Also do not take Phenergan Injection if you have stopped taking one of these MAOI medicines within the last 14 days. If you are not sure ask your doctor, nurse or pharmacist (see "Other medicines and Phenergan Injection") X The person is unconscious (in a coma) or suffers from severe dizziness, drowsiness or headache You should not be given this medicine if any of the above applies to you. If you are not sure, talk to your doctor, nurse or pharmacist before having Phenergan Injection. Warnings and precautions Check with your doctor or nurse before having Phenergan Injection if: ▲ You have difficulty breathing, wheezing, tightness in the chest (asthma) or an infection in your lungs (bronchitis). ▲ You have a seizure disorder such as epilepsy. ▲ You experience an allergic reaction (see section Side effects), seek medical help right away.
▲ You have any serious heart problems ▲ You have any personal or family history of heart disease ▲ You have an irregular heartbeat. ▲ You develop a fever or an infection. Talk to your doctor immediately as laboratory tests to check your blood count may be required. ▲ You have liver or kidney problems. ▲ You have a stomach blockage or difficulty passing water. ▲ You have a headache due to dehydration or high blood pressure. ▲ You have increased pressure in the eye (narrow angle glaucoma). ▲ You have had something called Reye's Syndrome or possible Reye's Syndrome – signs include being sick and confused following a viral illness. Exposure to sunlight Phenergan Injection can make your skin more sensitive to sunlight. Keep out of direct sunlight while taking this medicine. Tests Having Phenergan Injection may affect the results of certain tests. These include some pregnancy tests and skin tests. Phenergan Injection should not be given at least 3 days before the start of a skin test. If you are not sure if any of the above apply to you, talk to your doctor, nurse or pharmacist before having Phenergan Injection. Children and adolescents Do not use in children less than 2 years of age. Other medicines and Phenergan Injection Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other medicines. This includes medicines you can buy without prescription, including herbal medicines. This is because Phenergan Injection can affect the way some medicines work. Also some medicines can affect the way Phenergan Injection works. In particular, do not take this medicine, and tell your doctor, if you are taking or have taken the following in the last 2 weeks:
Via G. Tartini, 2 2 0 1 5 8 – M I L A N O 02.375787 • e-mail: [email protected] CROMinFOTO s.n.c. Tel.
942020 (int. version 1)
–
GRAFICA – FOTOCOMPOSIZIONE
TYPE OF MATERIAL:
AZIENDA CERTIFICATA UNI EN ISO 9001:2015
DESCRIPTION:
COUNTRY:
LEAFLET FOLDED IS,I011,PHENERGAN,25MG/ML,GB UK CODE:
VERSION: OLD CODE:
DIE CUT:
DIMENSIONS mm:
942020
1 a 898521
I011
420 x 148 (210 x 148)
04 LUG 2025 LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
//
COLOURS N°: COLOUR 1:
1
BLACK
10 pt.
Also tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any of the following:
Driving and using machines You may feel drowsy, dizzy, confused or have blurred vision while having this medicine or in the morning after taking this medicine. If this happens, do not drive or use any tools or machines. You should not drive a vehicle or operate machinery until you know how Phenergan Injection affects you. Phenergan Injection contains:
3. How Phenergan Injection will be given Your medicine will normally be given to you by a doctor or nurse. This is because it needs to be given by a deep injection into a muscle or by a slow injection into the vein. Having this medicine
Phenergan Injection 3. How Phenergan Injection will be given 4. Possible side effects 5. How to use Phenergan Injection 6. Contents of the pack and other Information
The usual dose is: Children 5-10 years:
If you have more Phernergan Injection than you should It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will be monitoring your progress, and checking the medicine that you are given. Always ask if you are not sure why you are getting a dose of medicine. The following effects may happen: In children: Excitation, moving unsteadily or stumbling, uncontrolled writhing movements especially of the hands or feet, hallucinations, fits (seizures), loss of consciousness, uneven heart beat and breathing difficulties. In adults: Feeling sleepy or drowsy, fits, loss of consciousness, uneven heart beat and breathing difficulties. If you miss a dose of Phenergan Injection Your doctor or nurse will have instructions on when to give you this medicine. It is unlikely that you will not be given the medicine as it has been prescribed. However if you do think you have missed a dose, tell your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or nurse.
Like all medicines, Phenergan Injection can cause side effects, although not everybody gets them. Tell a doctor or nurse straight away if you have:
Phenergan Injection This medicine will be kept by your doctor or nurse in a safe place where children cannot see or reach it Do not have Phenergan Injection after the expiry date which is stated on the carton and ampoule after EXP. The expiry date refers to the last day of that month Store in the original carton in order to protect from light.
Via G. Tartini, 2 2 0 1 5 8 – M I L A N O 02.375787 • e-mail: [email protected] CROMinFOTO s.n.c. Tel.
942020 (int. version 1)
–
GRAFICA – FOTOCOMPOSIZIONE
TYPE OF MATERIAL:
AZIENDA CERTIFICATA UNI EN ISO 9001:2015
DESCRIPTION:
COUNTRY:
LEAFLET FOLDED IS,I011,PHENERGAN,25MG/ML,GB UK CODE:
VERSION: OLD CODE:
DIE CUT:
DIMENSIONS mm:
942020
1 a 898521
I011
420 x 148 (210 x 148)
04 LUG 2025 LOGO VERSION: MIN. FONT SIZE:/LINE SPACING:
//
COLOURS N°: COLOUR 1:
1
BLACK
10 pt.
Do not throw away any medicines via wastewater or household waste. These measures will help protect the environment.
What Phenergan Injection contains
Phenergan 25 mg/ml Solution for Injection comes as injection containing 25mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Phenergan 25 mg/ml Solution for Injection is promethazine hydrochloride.
This leaflet reproduces the patient information leaflet approved for Phenergan 25 mg/ml Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
• As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.
• Sedation and treatment of insomnia in adults.
• As an adjunct in preoperative sedation in surgery and obstetrics.
• As a paediatric sedative.
Posology
Adults: The usual dose is 25 – 50 mg. Maximum parenteral dose 100 mg.
Elderly: No specific dosage recommendations.
Paediatric population: 6.25 – 12.5 mg for children from 5 – 10 years by deep intramuscular injection. Not for use in children under 2 years of age (see section 4.3).
Method of administration
Deep intramuscular injection. In emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use.
• Phenergan should not be given to patients with a known hypersensitivity to promethazine, other phenothiazines, or to other ingredients in the formulation of Phenergan.
• Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.
• Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.
• Phenergan should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.
Hypersensitivity reactions including anaphylaxis, urticaria and angioedema have been reported with Phenergan use. In case of allergic reaction, treatment with Phenergan must be discontinued and appropriate symptomatic treatment initiated (see Section 4.8).
Phenergan should be avoided in patients with liver or renal dysfunction, Parkinson's disease, hypothyroidism, cardiac failure, pheochromocytoma, myasthenia gravis, or prostate hypertrophy, or in patients with a history of narrow angle glaucoma or agranulocytosis.
Caution must be exercised when using H1-antihistamines such as Phenergan due to the risk of sedation. Combined use with other sedative medicinal products is not recommended (see section 4.5).
Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene. If a patient complains of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or inadvertent intra-arterial injection. Intramuscular injection must also be performed carefully to avoid inadvertent subcutaneous injection, which could lead to local necrosis.
Close monitoring is required in patients with epilepsy or a history of seizures, as phenothiazines may lower the seizure threshold.
Phenergan Injection may increase glucose tolerance.
Caution should be used in patients with:
• asthma, bronchitis or bronchiectasis. Phenergan may thicken or dry lung secretions and impair expectoration.
• Severe coronary artery disease
• Epilepsy
• Bladder neck or pyloro-duodenal obstruction
Ototoxicity
Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates.
It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.
QT prolongation
Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment (see section 4.8).
Photosensitivity reactions
Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment.
Paediatric population
Promethazine must not be used in children below two years of age due to the potential for fatal respiratory depression (see section 4.3). The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome.
Excipient with known effect
Phenergan contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm.
Alcohol and alcohol-containing medicines should be avoided while on this medicine (see section 4.5).
Phenothiazines may be additive with, or may potentiate the action of, other CNS depressants such as opiates or other analgesics, barbiturates or other sedatives, general anesthetics, or alcohol.
The occurrence of unexplained infections or fever may be evidence of blood dyscrasia (see section 4.8), and requires immediate hematological investigation.
All patients should be advised that, if they experience fever, sore throat or any other infection, they should inform their physician immediately and undergo a complete blood count. Treatment should be discontinued if any marked changes (hyperleucocytosis, granulocytopenia) are observed in the blood count.
Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.
Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines.
Phenergan may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required.
Phenergan may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required.
Phenergan may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results.
Phenergan should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results.
Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.
Cytochrome P450 2D6 Metabolism: Some phenothiazines are moderate inhibitors of CYP2D6. There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates. Co administration of promethazine with amitriptyline/amitriptylinoxide, a CYP2D6 substrate, may lead to an increase in the plasma levels of amitriptyline/amitriptylinoxide. Monitor patients for dose-dependent adverse reactions associated with amitriptyline/amitriptylinoxide.
Phenergan should be avoided in patients taking monamine oxidase inhibitors within the previous 14 days, and monamine oxidase inhibitors should be avoided while using Phenergan.
Seizure threshold-lowering drugs: Concomitant use of seizure-inducing drugs or seizure threshold-lowering drugs should be carefully considered due to the severity of the risk for the patient (see section 4.4).
Gastro-intestinal agents that are not absorbed (magnesium, aluminium and calcium salts, oxides and hydroxides): Reduced gastro-intestinal absorption of phenothiazines may occur. Such gastro-intestinal agents should not be taken at the same time as phenothiazines (at least 2 hours apart, if possible).
Drugs with anticholinergic properties: Concomitant use of Phenergan with drugs with anticholinergic properties enhances the anticholinergic effect.
Pregnancy
The use of Phenergan is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the potential benefits outweigh the potential risks. When promethazine has been given in high doses during late pregnancy, promethazine has caused prolonged neurological disturbances in the infant.
Advise patients to inform their healthcare provider of a known or suspected pregnancy. Advise patients to avoid becoming pregnant while receiving this medicine. Advise female patients of reproductive potential to use effective contraception.
There are no available animal studies regarding reproductive toxicity.
Breast-feeding
Phenergan is excreted in breast milk (see section 5.2). There are risks of neonatal irritability and excitement. Phenergan is not recommended for use in breast-feeding.
Fertility
There are no relevant fertility data in animals.
Ambulant patients receiving Phenergan for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central nervous effects of the drug and do not suffer from disorientation, confusion, blurred vision or dizziness.
The following CIOMS frequency rating is used: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 to ≥1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).
Immune system disorders
Frequency not known: Allergic reactions, including anaphylactic reaction, urticaria, angioedema.
Skin and subcutaneous tissue disorders
Frequency not known: Rash, photosensitivity reaction.
Nervous system disorders
Very common: Sedation or somnolence
Frequency not known: Dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.
Frequency not known: Dystonia, including oculogyric crisis, usually transitory are commoner in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases.
Frequency not known: Anticholinergic effects such as ileus paralytic, risk of urinary retention, dry mouth, constipation, accommodation disorder.
The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.
Psychiatric disorders
Frequency not known: Agitation, confusional state, anxiety.
Frequency not known: Infants, newborns and premature are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability, restlessness, nightmares, disorientation
Eye disorders
Frequency not known: Blurred vision
Gastrointestinal disorders
Frequency not known: Epigastric irritation/discomfort, dry mouth
Renal and urinary disorders
Frequency not known: Urinary retention
Metabolism and nutrition disorders
Frequency not known: Decreased appetite
Cardiac disorders
Frequency not known: Palpitations, arrhythmias (including QT prolongation and torsade de pointes)
Vascular disorders
Frequency not known: Hypotension
Respiratory, thoracic and mediastinal disorders
Frequency not known: Respiratory depression (see Section 4.4), nasal congestion
Hepatobiliary disorders
Frequency not known: Jaundice cholestatic
Blood and lymphatic system disorders
Frequency not known: Blood dyscrasias including haemolytic anaemia, agranulocytosis, leukopenia, eosinophilia, thrombocytopenia (including thrombocytopenic purpura).
General disorders and administration site conditions
Frequency not known: Tiredness
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Symptoms
Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see section 4.8).
Management
If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.
Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or another suitable anticonvulsant.
In the event of overdose of Phenergan, take all appropriate measures immediately.
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about Phenergan 25 mg/ml Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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