Contraceptive tablets Cilest are being recalled due to a reported slower than expected solubility of an active ingredient, which can lead to a decreased contraceptive effect.

It has been reported that the likelihood of women experiencing adverse reactions due to the decreased solubility of the active ingredient “appears to be very low”.

Stock of Cilest will be withdrawn from pharmacies.

The Inspectorate and Enforcement Directorate within the Medicines Authority was informed that the manufacturer, Janssen-Cilag International N.V., is initiating a voluntary preventative product recall of Cilest 250/35 Oral Contraceptive Tablets (250μg norgestimate 35μg ethinyl estradiol).

Gynaecologist Isabelle Saliba told Times of Malta that women taking Cilest should contact their doctors to switch to an alternative contraceptive pill.

“Consumption of this particular batch of Cilest will not result in any adverse reactions to a woman’s health. There might be a chance, however, that it won’t be as effective as a method of contraception.”

Only a particular batch is being recalled, she noted, adding that the recall of contraceptive pills was not a common occurrence.

“I think it’s very responsible of the manufacturer to issue the recall. That means they conduct regular testing of each batch issued.”

Taking the contraceptive pill usually results in lighter, less painful and more regular menstrual bleeding. This means it is sometimes also prescribed for women who have problems with particularly heavy, painful or irregular periods.

Cilest is a monophasic pill, meaning that each tablet has the same dose of hormones in it. One tablet is taken every day for 21 days, followed by a seven-day break from pill-taking.

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