Sibutramine is only licensed to aid weight loss in people with a body mass index
(BMI) of 30 or higher, and those with a BMI of 27 or higher who also have other
obesity related risk factors, such as type 2 diabetes or high cholesterol. It is
only prescribed to people in these categories who have had difficulty achieving
or maintaining weight loss of more than five per cent of their body weight over
three months, using conventional weight loss programmes alone (eg diet and
exercise).
You will need to
continue with an appropriate diet and exercise programme while taking this
medicine, so that you are able to maintain your new weight after you have
stopped treatment. Your doctor should give you advice to assist you with this.
What
is it used for?
Obesity
Warning!
This medicine may reduce your ability to drive or operate machinery safely. Do
not drive or operate machinery until you know how this medicine affects you and
you are sure it won't affect your performance.
This medicine may be harmful
to an unborn baby. Women of child-bearing age should use a reliable
contraceptive method to prevent pregnancy while using this medicine.
Take
this medicine in the morning.
Blood pressure and pulse rate should be
monitored in all people taking this medication; every two weeks for the first
three months, then once a month for the next three months, then regularly at
maximum intervals of three months after that. Your doctor may ask you to stop
taking this medicine if your blood pressure or pulse rate increase too much.
You should change your lifestyle in terms of eating habits and physical activity
while taking this medicine, so that you are able to maintain your new weight
after you have stopped treatment. Your doctor should advise you on the changes
you need to make and continue to monitor your weight after you stop treatment.
If you don't change your lifestyle you may regain the weight you have lost.
Consult your doctor if you experience shortness of breath, chest pain or ankle
swelling while taking this medicine.
Your weight should be monitored
while you are taking this medicine. If you are not responding adequately to this
medicine, ie if you have not lost at least five per cent of your body weight
within three months, or if you put on more than 3kg at any stage after
previously losing weight, you will need to stop taking this medicine. This
medicine should not be taken for longer than one year.
Use with caution in
Controlled high blood pressure (hypertension)
Epilepsy
Family history of
glaucoma
Family history of involuntary, recurrent muscle twitches or
vocalisations (motor or verbal tics)
History of depression
Mild to
moderately decreased kidney function
Mild to moderately decreased liver
function
Open angle glaucoma
People at increased risk of bleeding
People taking medicine to prevent blood clotting (anticoagulants, eg warfarin)
Syndrome involving short spells when breathing stops during sleep (sleep apnoea
syndrome)
Not to be used in
Breastfeeding
Children and
adolescents under 18 years of age
Closed angle glaucoma
History of
blocked arteries in the extremities (peripheral arterial occlusive disease)
History of coronary artery disease
History of drug, alcohol or medication
abuse
History of heart failure
History of increased heart rate
(tachycardia)
History of irregular heart beats (arrhythmias)
History of small temporary strokes (transient ischaemic attacks)
History of
stroke
Hyperthyroidism
Obesity caused by a medical condition
People
over 65 years of age
People who have taken antidepressant, antipsychotic or
appetite suppressant medicines, or tryptophan to aid sleep, in the last 14 days
(see below)
People with a history of anorexia nervosa
People with a
history of bulimia nervosa
Pregnancy
Psychiatric disorders
Severely decreased kidney function
Severely decreased liver function
Syndrome characterised by involuntary repetition of speech, particularly obscene
or vulgar words (Gilles de la Tourette's syndrome)
Tumour of the adrenal
gland (phaeochromocytoma)
Uncontrolled high blood pressure (hypertension)
Urinary retention caused by an enlarged prostate gland (benign prostatic
hyperplasia)
This medicine should not be used if you are allergic
to one or any of its ingredients. Please inform your doctor or pharmacist if you
have previously experienced such an allergy.
If you feel you have experienced an allergic reaction, stop using this medicine
and inform your doctor or pharmacist immediately.
Pregnancy and Breastfeeding
Certain medicines should not be used during pregnancy or breastfeeding. However,
other medicines may be safely used in pregnancy or breastfeeding providing the
benefits to the mother outweigh the risks to the unborn baby.Always inform your
doctor if you are pregnant or planning a pregnancy, before using any medicine.
The safety of this medicine in pregnancy has not been established. It should
not be taken by women who are pregnant, and women who could get pregnant should
use an effective method of contraception to prevent pregnancy while taking this
medicine. Seek further medical advice from your doctor.
There is no
information available about the safety of this medicine during breastfeeding.
For this reason, the manufacturer states that it should not be used during
breastfeeding. Seek medical advice from your doctor.
Side effects
Medicines and their possible side effects can affect individual people in
different ways. The following are some of the side effects that are known to be
associated with this medicine. Because a side effect is stated here, it does not
mean that all people using this medicine will experience that or any side
effect.
Headache
Dry mouth
Difficulty in sleeping (insomnia)
Depression
Impotence
Sweating
Disturbances of the gut such as diarrhoea,
constipation, nausea, vomiting or abdominal pain
Pins and needles
(paraesthesia)
Awareness of your heartbeat (palpitations)
Alteration in taste
Hot
flushes
Seizures
Lightheadedness
Decrease in the number of platelets
in the blood (thrombocytopenia)
High blood pressure (hypertension)
Increased heart rate (tachycardia)
Anxiety
Aggravation of haemorrhoids
Kidney disorders
The side effects listed above may not include all of the side effects reported
by the drug's manufacturer.
For more information
about any other possible risks associated with this medicine, please read the
information provided with the medicine or consult your doctor or pharmacist.
How can this medicine affect other medicines?
This medicine must not be taken at the same time as, or within two weeks of, any
of the following:
- monoamine oxidase inhibitor antidepressants (MAOIs)
-
medicines acting on the brain for the treatment of psychiatric disorders, eg any
antidepressants, antipsychotics
- medicines acting on the brain to aid weight loss (appetite suppressants)
-
tryptophan to aid sleep.
Sibutramine should also not be used at the same time as other medicines that
increase serotonin levels in the brain, as this may result in a serious side
effect called the serotonin syndrome. These medicines include:
- some
antimigraine medicines, eg sumatriptan, dihydroergotamine
- some opioid
painkillers, eg pentazocine, fentanyl, pethidine, dextromethorphan.
The following medicines may increase the blood level of sibutramine, which may
increase the risk of side effects:
- ketoconazole, itraconazole (antifungals)
- erythromycin, clarithromycin (antibiotics)
- ciclosporin.
The following medicines may decrease the blood level of sibutramine, making it
less effective:
- antiepileptics, eg phenobarbitone, phenytoin, carbamazepine
- rifampicin
- dexamethasone.
Consult your doctor or pharmacist before taking cough, cold and allergy
medicines with sibutramine. This is because the ingredients of some of these
medicines, eg pseudoephedrine, ephedrine, xylometazoline, can also increase
blood pressure and heart rate, and should be used with caution with sibutramine.
Antidepressants that increase serotonin activity in the brain have been
associated with bleeding abnormalities, and for this reason sibutramine should
be used with caution in people taking the following medicines, which affect the
ability of the blood to clot:
- anticoagulant medicines, such as warfarin
- aspirin and non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen
- ticlopidine
- dipyridamole.
Tell your doctor or pharmacist if you are taking any
medicines before you start sibutramine, and also consult
them before taking any new medicines during treatment.
