. chlorpromazine, thioridazine), antibiotics (e.g. gatifloxacin, moxifloxacin) and Class IA and III antiarrhythmic medications (e.g. quinidine, procainamide, amiodarone, sotalol).
4.6 Fertility, pregnancy and lactation
Pregnancy
Animal studies are insufficient with respect to effects on pregnancy, embryofetal development, birth, or development post partum (see section 5.3). There are no or limited amount of data from the use of tetrabenazine in pregnant women and the potential risk for humans is unknown. Tetrabenazine should not be used during pregnancy unless no other treatment is available.
Breast-Feeding
Tetrabenazine is contraindicated during breast-feeding (see section 4.3). Breast feeding must be discontinued, if treatment with tetrabenazine is necessary.
Fertility
In animal studies with tetrabenazine there was no evidence of effect on pregnancy or in utero survival. Female cycle lengths were increased and a delay in fertility was seen (see section 5.3).
4.7 Effects on ability to drive and use machines
Patients should be advised that Tetrabenazine may cause somnolence and therefore may modify their performance at skilled tasks (driving ability, operation of machinery, etc.) to a varying degree, depending on dose and individual susceptibility.
4.8 Undesirable effects
The following undesirable effects are ranked according to system organ class and to their frequency:
Very common (≥ 1/10)
Common (≥1/100 to < 1/10)
Uncommon (≥1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Psychiatric disorders
Very common:
depression,
Common:
anxiety, insomnia, confusion
Nervous system disorders
Very common:
somnolence (with higher dosages), Parkinson-like syndrome (with higher dosages)
Uncommon:
altered levels of consciousness
Rare:
Neuroleptic Malignant Syndrome (NMS) (see section 4.4)
Vascular disorders
Common:
Hypotension
Gastrointestinal disorders
Common:
dysphagia, nausea, vomiting, diarrhoea, constipation
Musculoskeletal and connective tissue disorders
Uncommon:
severe extrapyramidal symptoms including muscular rigidity, autonomic dysfunction
Very rare:
Skeletal muscle damage
General disorders and administration site conditions
Uncommon:
hypothermia
For the following side-effects, it is not possible to estimate the incidence from available data:
Psychiatric disorders:
disorientation, nervousness
Nervous system disorders:
ataxia, akathisia, dystonia, dizziness, amnesia
Cardiac disorders:
bradycardia
Vascular disorders:
orthostatic hypotension
Gastro-intestinal disorders:
epigastric pain, dry mouth
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
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9 Overdose
Signs and symptoms of overdosage may include somnolence, sweating, hypotension and hypothermia. Treatment is symptomatic.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: other nervous system drugs, ATC code: N07XX06
The central effects o |
