Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2007 Publisher: Sanofi-aventis, One Onslow Street, Guildford, Surrey GU1 4YS
Modalim tablets are recommended for the treatment of primary dyslipoproteinaemias, including types IIa, IIb, III and IV (hypercholesterolaemia, hypertriglyceridaemia and combined forms) - refractory to appropriate dietary treatment.
Dietary measures should be continued during therapy.
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. Modalim should not be used in severe renal impairment.
Not recommended since safety and efficacy in children has not been established.
Modalim tablets are for oral administration only.
Overdosage with ciprofibrate has been rarely reported. Associated adverse events reflect those seen in routine use. 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.
5 years when packed in blister strips.
There are no special storage precautions.
Clear PVC / Aluminium blister strips in packs of 28 tablets.
None stated.
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