There have been significant updates to several sections of the SPC, including the following:
Change to section 4.2 - Posology and method of administration
Changes to doses to major depressive disorder, panic disorder, elderly patients, patients with hepatic impairment and patients who are poor metabolisers of CYP2C19.
Change to section 4.3 - Contraindications
Citalopram is contraindicated in patients with known QT-interval prolongation or congenital long QT syndrome and is contraindicated together with medicinal products that are known to prolong the QT-interval
Change to section 4.4 - Special warnings and precautions for Use
Citalopram has been found to cause a dose-dependent prolongation of the QT-interval.
Caution is advised in patients with significant bradycardia; or in patients with recent acute myocardial infarction or uncompensated heart failure.
Electrolyte disturbances such as hypokalaemia and hypomagnesaemia increase the risk for malignant arrhythmias and should be corrected before treatment with citalopram is started.
If patients with stable cardiac disease are treated, an ECG review should be considered before treatment is started.
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Pharmacokinetic and pharmacodynamic studies between citalopram and other medicinal products that prolong the QT interval have not been performed. An additive effect of citalopram and these medicinal products cannot be excluded. Therefore, co-administration of citalopram with medicinal products that prolong the QT interval, such as Class IA and III antiarrhythmics, antipsychotics, tricyclic antidepressants, certain antimicrobial agents, certain antihistamines is contraindicated.
Cimetidine (potent CYP2D6, 3A4 and 1A2 inhibitor) caused a moderate increase in the average steady state levels of citalopram. Caution is advised when administering citalopram in combination with cimetidine. Dose adjustment may be warranted.
Please refer to SPC link below for full information on all changes.