Published: 7 September 2023
Publications
Recent data sheet updates: important new safety information
Published: 7 September 2023
Prescriber Update 44(3): 54–55
September 2023
Table 1 below provides a list of data sheets recently updated with important new safety information. Note that this is not a comprehensive list of all recently updated data sheets, nor does it describe all changes to a particular data sheet. Click on the medicine name to view the sponsor’s data sheet.
Table 1: Recently updated data sheets (by active ingredient): important new safety information
| Data sheet updates | |||
|---|---|---|---|
| Active ingredient(s) | Medicine | Section | Summary of new safety information |
| Amoxicillin |
Alphamox (capsules) Alphamox (suspension) |
4.4 | Warnings and precautions: drug-induced enterocolitis syndrome (DIES), Kounis syndrome; contains maltodextrin and sorbitol as excipients (suspension only) |
| 4.8 | Undesirable effects: DIES, Kounis syndrome, linear IgA disease | ||
| Carbamazepine | Tegretol | 4.1 | Indications: Should not be used for status epilepticus |
| 4.4 | Warnings and precautions: type I (immediate) hypersensitivity reactions; contains propylene glycol as an excipient | ||
| 4.5 | Interactions: removal of loratadine | ||
| 4.6 | Pregnancy: risk of neurodevelopmental disorders; take folic acid supplementation 4 weeks prior to and continue for 12 weeks after conception | ||
| Citalopram | Cipramil | 4.8 | Undesirable effects: hyperprolactinaemia |
| Fluconazole Fluconazole + Clotrimoxazole |
Canesoral
Canesoral Duo |
4.5 | Interactions: everolimus, ivacaftor |
| 4.6 | Pregnancy: continue contraceptive measures throughout treatment and for approximately 1 week after the final dose | ||
| 4.8 | Undesirable effects: drug reaction with eosinophilia and systemic symptoms (DRESS) | ||
| Gabapentin | Neurontin | 4.4 | Warnings and precautions: withdrawal symptoms; women of childbearing potential must use contraception during treatment |
| 4.6 | Pregnancy: inclusion of observational study data; neonatal withdrawal syndrome in newborns exposed in utero | ||
| Ibuprofen + paracetamol | Mersynofen | 4.4 | Warning and precautions: Kounis syndrome |
| 4.8 | Undesirable effects: Kounis syndrome, fixed drug eruptions (FDE) | ||
| Iodised oil | Lipiodol Ultra Fluid | 4.3 | Contraindications: hysterosalpingography in patients with known or suspected reproductive tract neoplasia |
| Methenamine | Hiprex | Newly published data sheet | |
| Mesalazine |
Asacol
Pentasa |
4.4 | Warnings and precautions: discolouration of urine after contact with sodium hypochlorite (bleach); drug reaction with eosinophilia and systemic symptoms (DRESS) |
| 4.8 | Undesirable effects: DRESS | ||
| Methylphenidate | Concerta | 4.8 | Undesirable effects: gynaecomastia |
| Omeprazole | Losec | 4.4 | Warnings and precautions: renal impairment, including acute tubulointerstitial nephritis (TIN) |
| 4.8 | Undesirable effects: TIN | ||
| Oxycodone | OxyNorm | 4.2 | Dose and method of administration: treatment goals and discontinuation |
| 4.4 | Warnings and precautions: opioid use disorder | ||
| 4.8 | Undesirable effects: drug dependence, opioid tolerance and opioid withdrawal syndrome | ||
| 4.9 | Overdose: toxic leukoencephalopathy | ||
| Rivaroxaban | Xarelto | 4.4 | Warnings and precautions: anticoagulant-related nephropathy |
| 4.8 | Undesirable effects: as per 4.4 | ||
| Valproic acid (sodium valproate) | Epilim* | 4.4 | Warnings and precautions: risk of neurodevelopmental disorders including autism spectrum disorders after paternal exposure to valproate |
| 4.6 | Pregnancy: as per 4.4 | ||
| Vitamins (A, C, D, E and B complex) | Cernevit | 4.3 | Contraindications: hypersensitivity to peanut protein |
| 4.4 | Warnings and precautions: cross‐allergic reactions between soybean and peanut proteins | ||
* See the Alert communication: Sodium valproate (Epilim) use in people who can father children: important new safety information
More information
To find out if sponsors have made any changes to their data sheets, see Section 10 ‘Date of revision of the text’ (at the end of each data sheet).
