Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherland
Optruma is indicated for the treatment and prevention of osteoporosis in postmenopausal women. A significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.
When determining the choice of Optruma or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits (see section 5.1).
The recommended dose is one tablet daily by oral administration, which may be taken at any time of the day without regard to meals. Due to the nature of this disease process, Optruma is intended for long term use.
Generally calcium and vitamin D supplements are advised in women with a low dietary intake.
No dose adjustment is necessary for the elderly.
Optruma should not be used in patients with severe renal impairment (see section 4.3). In patients with moderate and mild renal impairment, Optruma should be used with caution.
Optruma should not be used in patients with hepatic impairment (see section 4.3 and 4.4).
Optruma should not be used in children of any age. There is no relevant use of Optruma in the paediatric population.
In some clinical trials, daily doses were given up to 600 mg for 8 weeks and 120 mg, for 3 years. No cases of raloxifene overdose were reported during clinical trials.
In adults, symptoms of leg cramps and dizziness have been reported in patients who took more than 120 mg as a single ingestion.
In accidental overdose in children younger than 2 years of age, the maximum reported dose has been 180 mg. In children, symptoms of accidental overdose included ataxia, dizziness, vomiting, rash, diarrhea, tremor, and flushing, and elevation in alkaline phosphatase.
The highest overdose has been approximately 1.5 grams. No fatalities associated with overdose have been reported.
There is no specific antidote for raloxifene hydrochloride.
3 years.
Store in the original package. Do not freeze.
Optruma tablets are packed either in PVC/PE/PCTFE blisters or in high density polyethylene bottles.
Blister boxes contain 14, 28, or 84 tablets. Bottles contain 100 tablets.
Not all pack sizes may be marketed in all countries.
No special requirements.
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