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Thiazolidindions, including pioglitazon, which is a componnt ACTOPLUS MT, caus xacbat congstiv hat ailu in som patints [s WANINGS AND PCAUTIONS]. At initiation ACTOPLUS MT, and at dos incass, monitpatints caully signs and symptoms hat ailu (.g., xcssiv, apid wight gain, dyspna, and/dma). I hat ailu dvlops, it should b managd accoding tcunt standads ca and discontinuation dos duction ACTOPLUS MT must b considd [s WANINGS AND PCAUTIONS]. ACTOPLUS MT is not commndd in patints with symptomatic hat ailu. Initiation ACTOPLUS MT in patints with stablishd Nw Yok Hat Association (NYHA) Class III IV hat ailu is containdicatd [s CONTAINDICATIONS and WANINGS AND PCAUTIONS].

Pioglitazon may caus dcass in hmoglobin and hmatocit. In placbo-contolld monothapy tials, man hmoglobin valus dclind by 2% t4% in patints tatd with pioglitazon compad with a man chang in hmoglobin -1% t+1% in placbo-tatd patints. Ths changs pimaily occud within th ist ou t12 wks thapy and maind lativly constant that. Ths changs may b latd tincasd plasma volum associatd with pioglitazon thapy and a not likly tb associatd with any clinically signiicant hmatologic cts.

Thapy with pioglitazon, lik oth thiazolidindions, may sult in ovulation in som pmnopausal anovulatoy womn. As a sult, ths patints may b at an incasd isk pgnancy whil taking ACTOPLUS MT [s Us in Spciic Populations ]. This ct has not bn invstigatd in clinical tials, sth quncy this occunc is not known. Adquat contacption in all pmnopausal womn tatd with ACTOPLUS MT is commndd.

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