Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Zentiva Pharma UK Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Trading as: Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Ciprofibrate tablets are indicated as an adjunct to diet and other non-pharmacological treatment (e.g. exercise, weight reduction) for the following:
The recommended dosage is one tablet (100mg ciprofibrate) per day. This dose should not be exceeded (see Precautions).
As for adults, but see Precautions and Warnings.
In moderate renal impairment it is recommended that dosage be reduced to one tablet every other day. Patients should be carefully monitored. Ciprofibrate should not be used in severe renal impairment.
Not recommended since safety and efficacy in children has not been established.
Ciprofibrate tablets are for oral administration only.
There are rare reports of overdosage with ciprofibrate but in these cases there are no adverse events that are specific to overdosage. There are no specific antidotes to ciprofibrate. Treatment of overdosage should be symptomatic. Gastric lavage and appropriate supportive care may be instituted if necessary. Ciprofibrate is non-dialysable.
3 years when packed in blister strips (see below).
48 months when packed in amber glass bottles.
There are no special storage precautions.
Clear PVC/Aluminium blister strips in packs of 28 tablets.
Amber glass bottles of 100 tablets.
Not all pack sizes may be marketed.
None stated.
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