Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

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, hypokalaemia, 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 sulfite and potassium metabisulfite 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 (hyperleukocytosis, granulocytopenia) are observed in the blood count.

Effects on Driving

4.7 Effects on ability to drive and use machines
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.