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4.2 Posology and method of administration
Posology
Adults
The recommended dose of alli is one 60 mg capsule to be taken three times daily. No more than three 60 mg capsules should be taken in 24 hours.
Diet and exercise are important parts of a weight loss programme. It is recommended that a diet and exercise programme is started before beginning treatment with alli.
While taking orlistat, the patient should be on a nutritionally balanced, mildly hypocaloric diet that contains approximately 30% of calories from fat (e.g. in a 2,000 kcal/day diet, this equates to <67 g of fat). The daily intake of fat, carbohydrate and protein should be distributed over three main meals.
The diet and exercise programme should continue to be followed when treatment with alli is stopped.
Treatment should not exceed 6 months.
If patients have been unable to lose weight after 12 weeks of treatment with alli, they should consult their doctor or a pharmacist. It may be necessary to discontinue treatment.
Special populations
Elderly (>65 years old)
There are limited data on the use of orlistat in the elderly. However, as orlistat is minimally absorbed, no dose adjustment is necessary in the elderly.
Hepatic and renal impairment
The effect of orlistat in individuals with hepatic and/or renal impairment has not been studied.
However, as orlistat is minimally absorbed, no dose adjustment is necessary in individuals with hepatic and/or renal impairment.
Paediatric population
The safety and efficacy of alli in children below 18 years of age has not been established. No data are available.
4.6 Fertility, Pregnancy and lactation
Women of childbearing potential / Contraception in males and females
The use of an additional contraceptive method is recommended to prevent possible failure of oral contraception that could occur in case of severe diarrhoea (see sections 4.4 and 4.5).
Pregnancy For orlistat, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). alli is contraindicated in pregnancy (see section 4.3). Breastfeeding As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast-feeding (see section 4.3).
Pregnancy
For orlistat, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). alli is contraindicated in pregnancy (see section 4.3). Breastfeeding As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast-feeding (see section 4.3).
For orlistat, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
alli is contraindicated in pregnancy (see section 4.3).
Breastfeeding
As it is not known whether orlistat is secreted into human milk, alli is contraindicated during breast-feeding (see section 4.3).
Method of administration
The capsule should be taken with water immediately before, during or up to 1 hour after each main meal. If a meal is missed or contains no fat, the dose of orlistat should be omitted.
Fertility
Animal studies do not indicate harmful effects with respect to fertility.
EU/1/07/401/008 EU/1/07/401/009 EU/1/07/401/010" was changed to "EU/1/07/401/007-011" In section 10 (Date of revision of the text), the text was changed from "November 2009" to "July 2010"