Microsoft word - 912001rj pdf pil update

Important new safety information

Please read this information carefully as it may be relevant to you and
may need to discuss it with your doctor.
The new safety information affects Chapters 2 and 4 of the alli package
leaflet. The updated sections are below.

2. Before you take alli


Do not take alli

• If you are pregnant or breast-feeding. • If you are taking ciclosporin, used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions. • If you are taking warfarin or other medicines used to thin the blood. • If you are allergic (hypersensitive) to orlistat or any of the ingredients of alli: see Chapter 6 for further information.
• If you have cholestasis (condition where the flow of bile from the liver is • If you have problems absorbing food (chronic malabsorption syndrome)
Take special care with alli

If you have diabetes. Tell your doctor who may need to adjust your
anti-diabetic medicine.
If you have kidney disease. Talk to your doctor before taking alli if you have
problems with your kidneys. The use of orlistat may be associated with kidney
stones in patients suffering from chronic kidney disease
Taking other medicines
alli may affect some medicines you have to take.
Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
alli 60 mg hard capsules are a weight loss aid containing orlistat. For overweight adults with a
BMI of 28 or over. Follow a reduced calorie, lower-fat diet. Always read the label.
Do not take alli with these medicines
• Ciclosporin: ciclosporin is used after organ transplants, for severe rheumatoid arthritis and some severe skin conditions. • Warfarin or other medicines used to thin the blood.
The oral contraceptive pill and alli
• The oral contraceptive pill may be less effective if you get severe
diarrhoea. Use an extra method of contraception if you get severe diarrhoea.
Multivitamins and alli
• You should take a multivitamin, every day. alli can lower the levels of
some vitamins absorbed by your body. The multivitamin should contain
vitamins A, D, E and K. You should take the multivitamin at bedtime,
when you will not be taking alli, to help ensure that the vitamins are
absorbed.

Talk to your doctor before taking alli if you are taking
• amiodarone, used for heart rhythm problems.
• a thyroid medicine (levothyroxine) as it may be necessary to adjust your dose and take your medicines at different times of the day. • a medicine for epilepsy as any changes in the frequency and severity of your convulsions should be discussed with your doctor.
Talk to your doctor or pharmacist when taking alli
• If you are taking a medicine for high blood pressure as it may be
• If you are taking a medicine for high cholesterol as it may be necessary to

Taking alli with food and drink

alli should be used along with a reduced calorie, lower-fat diet. Try to start
this diet before beginning treatment. For information on how to set your
calorie and fat targets, see Further helpful information in the blue pages in
Chapter 6.
Take alli at mealtimes. This usually means one capsule at breakfast, lunch
and dinner. If you miss a meal, or your meal contains no fat, do not take a
capsule. alli does not work unless there's some fat in the meal.
If you eat a high-fat meal, do not take more than the recommended dose.
Taking the capsule with a meal containing too much fat may increase your
chance of getting diet-related treatment effects (see Chapter 4). Make every
effort to avoid any high-fat meals while taking alli.
alli 60 mg hard capsules are a weight loss aid containing orlistat. For overweight adults with a
BMI of 28 or over. Follow a reduced calorie, lower-fat diet. Always read the label.
Pregnancy and breast-feeding
Do not take alli if you are pregnant or breast-feeding.


Driving and using machines
No effect on ability to drive or use machines has been observed.
alli 60 mg hard capsules are a weight loss aid containing orlistat. For overweight adults with a
BMI of 28 or over. Follow a reduced calorie, lower-fat diet. Always read the label. 4. Possible side effects

Like all medicines, alli can cause side effects, although not everybody gets
them.
Most of the common side effects related to alli (for example, wind with or
without oily spotting, sudden or more frequent bowel motions and soft stools)
are caused by the way it works (see Chapter 1). Eat lower-fat meals to help
manage these diet-related treatment effects.

Serious side effects

It is not known how frequently these side effects occur

Severe allergic reactions
• Signs of a severe allergic reaction include: severe breathing difficulties,
sweating, rash, itching, swollen face, rapid heart beat, collapse. Î Stop taking the capsules. Get medical help immediately.

Other serious side effects
• Bleeding from the back passage (rectum)
• Diverticulitis (inflammation of the large intestine). Symptoms may include lower stomach (abdominal) pain, particularly on the left side, possibly with fever and constipation • Pancreatitis (inflammation of the pancreas). Symptoms may include severe abdominal pain sometimes radiating towards the back, possibly with fever, nausea and vomiting • Skin blistering (including blisters that burst) • Severe stomach pain caused by gallstones. • Hepatitis (inflammation of the liver). Symptoms can include yellow skin and eyes, itching, stomach pain and liver tenderness. Î Stop taking the capsules. Tell your doctor if you get any of these.

Very common side effects
These may affect more than 1 in 10 people taking alli
• Wind (flatulence), with or without oily spotting
Î Tell your doctor or pharmacist if any of these side effects gets severe or troublesome. alli 60 mg hard capsules are a weight loss aid containing orlistat. For overweight adults with a
BMI of 28 or over. Follow a reduced calorie, lower-fat diet. Always read the label. Common side effects

These may affect up to 1 in 10 people taking alli
• Stomach (abdominal) pain
• Anxiety
Î Tell your doctor or pharmacist if any of these side effects gets severe or
troublesome.

Effects seen in blood tests

It is not known how frequently these effects occur
• Increases in the levels of some liver enzymes
• Effects on blood clotting in people taking warfarin or other blood-thinning Î Tell your doctor that you are taking alli when you have a blood test.
If any of the side effects become serious, or if you notice any side effects not
listed in this leaflet, tell your doctor or pharmacist.

Learn to deal with diet-related treatment effects

The most common side effects are caused by the way the capsules work and
result from some of the fat being passed out of your body. Such effects
typically occur within the first few weeks of using the capsules, before you
may have learnt to limit the amount of fat in your diet. Such diet-related
treatment effects may be a signal that you have eaten more fat than you
should have done.
You can learn to minimise the impact of diet-related treatment effects by
following these guidelines:
• Start your lower-fat diet a few days, or even a week, before you begin
• Find out more about how much fat your favourite foods typically contain, and the size of your portions. By familiarising yourself with portions you will be less likely to accidentally exceed your fat target. • Distribute your fat allowance evenly across your meals for the day. Do not “save up” fat and calorie allowances and then splurge on a high-fat meal or dessert, as you may have done on other weight loss programmes. • Most users who experience these effects find that they can manage and Do not be concerned if you do not experience any of these problems. This does not mean that the capsules aren’t working. alli 60 mg hard capsules are a weight loss aid containing orlistat. For overweight adults with a
BMI of 28 or over. Follow a reduced calorie, lower-fat diet. Always read the label.

Source: http://www.alli.co.uk/Global/updates/912001rj_PDF_PIL_Update.pdf