1 What is this medicine
and what is it used for?
Orlistat is a gastrointestinal lipase inhibitor that works
locally in the gut — it is not absorbed systemically. It inhibits gastric and
pancreatic lipases, the enzymes responsible for breaking down dietary
triglycerides.
By blocking these enzymes, approximately one-third of dietary
fat passes through the gut unabsorbed and is excreted in faeces, reducing the
caloric contribution of fat to the diet.
Xenical 120 mg is used as part of a calorie-controlled diet
and exercise programme for:
• Weight management in adults with
obesity (BMI ≥ 30 kg/m2), or
• Overweight adults (BMI ≥ 27 kg/m2)
with associated risk factors such as type 2 diabetes, hypertension, or
dyslipidaemia.
2 How to take this
medicine
One 120 mg capsule is taken three times daily — with each
main meal containing fat, or up to one hour after the meal. If a meal is
skipped or contains no fat, omit that dose. Swallow the capsule whole with
water.
|
Take with (or within 1
hour of) each main meal containing fat. If you miss a meal or
eat a fat-free meal, skip that dose — no benefit and no point in taking it. A low-fat diet
significantly reduces the GI side effects — aim for no more than 30% of daily
calories from fat. Take a multivitamin
supplement at bedtime (separated from orlistat by at least 2 hours) —
orlistat reduces absorption of fat-soluble vitamins A, D, E, and K. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Oily or fatty stools,
oily spotting on underwear |
Direct result of
unabsorbed fat. Reduce dietary fat intake to minimise. A low-fat diet is the
most effective management. |
|
Very Common (>10%) |
Oily anal discharge /
faecal urgency |
Use toilet facilities
promptly; consider a panty liner. Reduces significantly with low-fat diet. |
|
Very Common (>10%) |
Flatus with discharge |
Reduce fat intake;
toilet access important. |
|
Very Common (>10%) |
Fatty/oily evacuation |
Expected
pharmacological effect; manageable with diet. |
|
Common (1–10%) |
Soft stools /
diarrhoea / urgent bowel movements |
Maintain good
hydration; low-fat diet. |
|
Common (1–10%) |
Abdominal pain /
discomfort |
Usually related to
unabsorbed fat in gut. |
|
Rare |
Kidney stones /
oxalate nephropathy |
Adequate hydration;
discuss if pre-existing kidney stones. |
|
Rare |
Severe hepatic injury
(reported post-marketing) |
Seek medical review
for jaundice, dark urine, abdominal pain. |
|
Drug interaction risk |
Reduced absorption of
ciclosporin, levothyroxine, antiepileptics, warfarin, oral contraceptive pill |
See interactions
section — important clinical implications. |
4 Contraindications
|
Do NOT use Orlistat if: You have cholestasis
(bile flow obstruction) or chronic malabsorption syndrome. You are pregnant or
breastfeeding. You have known
hypersensitivity to orlistat or any capsule excipient. You are taking
ciclosporin — orlistat variably reduces ciclosporin absorption; if
co-administration is unavoidable, monitor ciclosporin levels very closely and
separate by at least 2 hours. |
5 Drug interactions
• Ciclosporin: significantly reduced
absorption — avoid combination or monitor levels intensively.
• Levothyroxine: reduced absorption —
separate doses by at least 4 hours; monitor thyroid function.
• Warfarin: orlistat reduces vitamin K
absorption — monitor INR more frequently.
• Oral contraceptive pill: severe
diarrhoea with orlistat can reduce OCP absorption — use additional barrier
contraception if diarrhoea occurs.
• Antiepileptics (lamotrigine,
valproate): potential for reduced absorption and seizure breakthrough —
consider alternative weight management.
• Fat-soluble vitamins (A, D, E, K):
reduced absorption — supplement daily, separated from orlistat by 2 hours.
6 Storage
Store at room temperature below 25°C. Keep in original
packaging away from moisture. Keep out of reach of children. Do not use after
expiry date.
7 Prescription
requirement
|
PRESCRIPTION ONLY
MEDICINE (POM) at 120 mg dose — Prescribed by a doctor as part of a
supervised weight management programme. Note: 60 mg orlistat
(Alli) is available OTC in some countries for adults with BMI > 28. The
120 mg prescription dose is more potent and requires medical supervision. |
8 Guidance for patients
& caregivers
The GI side effects of orlistat (oily discharge, urgent bowel
movements, fatty stools) are directly related to the amount of fat in your
diet. They are not a sign of harm — they are the mechanism of the medicine
working. The single most effective way to reduce these side effects is to
follow a low-fat diet where no more than 30% of daily calories come from fat.
Spreading fat intake evenly across meals also helps.
Orlistat is a tool to support a calorie-reduced diet and
increased physical activity — it is not a substitute for dietary change. On
average, orlistat combined with a reduced-fat diet produces approximately 5–7
kg of additional weight loss over 12 months compared to diet alone.
Take your multivitamin supplement every day, at bedtime,
separated by at least 2 hours from orlistat doses. Fat-soluble vitamin
deficiency (particularly vitamin D and vitamin K) can develop over time without
supplementation.
9 Pharmacist &
prescriber notes
Orlistat is not absorbed and acts entirely in the GI lumen.
The 84-capsule pack provides exactly 4 weeks of treatment (3 capsules/day x 28
days).
Maximal weight loss benefit is seen at 6–12 months; treatment
beyond 12 months should be reassessed. Weight loss > 5% after 12 weeks
predicts longer-term success; consider discontinuation if < 5% loss at this
point. Fat-soluble vitamin supplementation is strongly recommended for all
patients — particularly vitamins D and K.
Patients on warfarin: INR changes are unpredictable; more
frequent INR monitoring is warranted. Ciclosporin interaction: highly variable
reduction in ciclosporin levels reported — avoid concomitant use if at all
possible. For patients on levothyroxine: separate doses by at least 4 hours and
recheck TSH after initiating or stopping orlistat.
10 Frequently asked
questions
Why do I have oily leakage from my bowel?
This is a direct result of unabsorbed
fat passing through your gut. It means the medicine is doing its job. The best
way to reduce this side effect is to reduce the fat content of your meals.
Spreading fat evenly across the day, rather than having one high-fat meal, also
helps.
Do I need a multivitamin?
Yes — orlistat reduces the absorption
of fat-soluble vitamins (A, D, E, K) from food. Take a daily multivitamin
supplement at bedtime, separated from your orlistat doses by at least 2 hours,
to prevent deficiency.
Will orlistat affect my contraceptive pill?
If you experience severe diarrhoea
while taking orlistat, the absorption of the oral contraceptive pill can be
reduced. Use additional barrier contraception (condoms) on any day you have
diarrhoea and for 7 days after.
How much weight should I expect to lose?
On average, adding orlistat to a
reduced-fat diet produces approximately 3–5% additional weight loss compared to
diet alone over 12 months. The amount varies considerably between individuals —
those who most strictly reduce dietary fat tend to lose the most.
Can I take orlistat long-term?
Yes — orlistat can be used for up to
4 years in clinical trials. Annual review with your doctor to assess continued
benefit and safety is recommended. Most prescribers reassess after 12 weeks —
if you have not lost at least 5% of your starting weight, continuing is
unlikely to be effective.