Brand name:
PROTHIADEN (Dothiepin, Dosulepin) (Dothiepin, Dosulepin)
(Abbott)
CONSUMER MEDICINE INFORMATION
All medicines have benefits and risks. Your doctor has weighed the risks
of you taking PROTHIADEN (Dothiepin, Dosulepin) against the benefits they expect it will have
for you.
If you have any concerns about taking this medicine, ask your doctor
or pharmacist.
What is PROTHIADEN (Dothiepin, Dosulepin) used for
PROTHIADEN (Dothiepin, Dosulepin) is used to treat depression. It belongs to a group of medicines
called tricyclic antidepressants.
Depression is longer lasting and/or more severe than the 'low moods'
that everyone has from time to time due to the stress of everyday life.
It is thought to be caused by a chemical imbalance in parts of the brain.
This imbalance affects your whole body and can cause emotional and physical
symptoms such as loss of interest in activities, being unable to enjoy
life, disturbed sleep, often waking up early, poor appetite or overeating,
loss of sex drive, lack of energy and feeling guilty over nothing.
PROTHIADEN (Dothiepin, Dosulepin) corrects this chemical imbalance and may help relieve the
symptoms of depression.
Your doctor, however, may prescribe PROTHIADEN (Dothiepin, Dosulepin) for a purpose that is
not listed above. Ask your doctor if you have any questions about why
PROTHIADEN (Dothiepin, Dosulepin) has been prescribed for you.
PROTHIADEN (Dothiepin, Dosulepin) is only available with a doctor's prescription.
Before you take PROTHIADEN (Dothiepin, Dosulepin)
When you must not take it
Do not take PROTHIADEN (Dothiepin, Dosulepin) if:
• you have an allergy to PROTHIADEN (Dothiepin, Dosulepin), or
any of the ingredients listed at the end of this page.Some of the symptoms
of an allergic reaction may be an itchy skin rash, skin blisters or discolouration
of the skin upon exposure to sunlight.• you are taking another
medicine called a monoamine oxidase inhibitor (MAOI) or have been taking
it within the last 14 days.Taking PROTHIADEN (Dothiepin, Dosulepin) with
an MAOI may cause a serious reaction with a sudden increase in body temperature,
extremely high blood pressure and severe
convulsions.Ask your doctor or pharmacist if you are not sure whether
you have been taking one of these medicines.
• you are pregnant:Medicines like PROTHIADEN (Dothiepin, Dosulepin)
may harm the developing baby.
• you are breast-feeding:Like many other medicines, PROTHIADEN
(Dothiepin, Dosulepin) can pass into breastmilk and may harm your baby.
• you have epilepsy or have had any fits or
convulsions.
PROTHIADEN (Dothiepin, Dosulepin) may increase the
chance of fitting or having convulsions.
• you have recently had a heart attack, for example within the
past two months.
PROTHIADEN (Dothiepin, Dosulepin) may cause irregular and/or rapid heart beat.
• you have liver failure:Your body may not
be able to remove PROTHIADEN (Dothiepin, Dosulepin) from your body.
If you are not sure whether you should be taking PROTHIADEN (Dothiepin, Dosulepin), consult
your doctor.
Do not take PROTHIADEN (Dothiepin, Dosulepin) if the packaging is torn or shows signs of tampering
or the tablets or capsules do not look quite right.
Do not take PROTHIADEN (Dothiepin, Dosulepin) if the expiry date (Exp) printed on the pack
has passed.
Use in children and adolescents (under 18 years)
There is not enough information available to recommend the use of PROTHIADEN
(Dothiepin, Dosulepin) in children under 18 years of age.Use in people
over 65 years:If you are 65 years or older, you should be especially
careful while taking PROTHIADEN (Dothiepin, Dosulepin). Report any side
effects promptly to your doctor.As people grow older, they are more likely
to get side effects from medicines.
If you have not told your doctor or pharmacist about any of the above,
tell them before you start taking PROTHIADEN (Dothiepin, Dosulepin).
How to take PROTHIADEN (Dothiepin, Dosulepin)
Take PROTHIADEN (Dothiepin, Dosulepin) exactly as your doctor has prescribed.
How much to take
Your doctor will tell you how many tablets or capsules you need to take
and when to take them.The dose varies from patient to patient and will
be adjusted by your doctor according to your response to treatment. The
directions should
be printed on the label.Follow all directions given to you by your doctor
and pharmacist carefully.These directions may differ from the information
contained in this leaflet.If you do not understand the instructions on
the label of the box, ask your doctor or pharmacist for help.
How to take it
Swallow PROTHIADEN (Dothiepin, Dosulepin) with water.PROTHIADEN (Dothiepin,
Dosulepin) can be taken with or apart from food or meals.If you forget
to take PROTHIADEN (Dothiepin, Dosulepin)If it is almost time for your
next dose, skip the dose you missed and take your next dose when you
are meant to. Otherwise, take it as soon
as you remember, then go back to taking it as you would normally.Do not
take a double dose to make up for the missed dose.
If you have trouble remembering when to take PROTHIADEN (Dothiepin, Dosulepin), ask your pharmacist
for some hints.
How long to take it
For depression, the length of treatment will depend on how quickly your
symptoms improve. Most antidepressants take some time to work, so do
not be discouraged if you do not feel better straight away. Some of your
symptoms may improve in 1 or 2 weeks, but it can be up to 4 to 6 weeks
before you feel any real improvement. Even when you feel well, you will
usually have to take PROTHIADEN (Dothiepin, Dosulepin) for several months or even longer to
make sure that the benefits will last. You should take PROTHIADEN (Dothiepin, Dosulepin) until
your doctor tells you to stop.
If you take too much PROTHIADEN (Dothiepin, Dosulepin) (overdose)
Immediately telephone your doctor or the Poisons Information Centre
(telephone 13 11 26) for advice, or go to the Casualty Department at
your nearest hospital, if you think that you or anyone else may have
taken too much PROTHIADEN (Dothiepin, Dosulepin) even if there are no signs of discomfort or
poisoning. You may need urgent medical attention. Keep telephone numbers
for these places handy.
Too much PROTHIADEN (Dothiepin, Dosulepin) may make you tremble, agitated and/or have difficulty
walking. Other signs include fitting or convulsions, unusual muscle movements,
difficulty breathing, a very high temperature or irregular heart beat
as well as other serious heart problems.
If you are not sure what to do, contact your doctor or pharmacist.
While you are using PROTHIADEN (Dothiepin, Dosulepin)
If you are being treated for depression, be sure to discuss with your
doctor any problems you may have on how you feel, especially feelings
of severe sadness, bursts of unusual energy or anger or any feelings
of wanting to harm yourself (suicide).
Families and caregivers of children and adolescents being treated with
PROTHIADEN (Dothiepin, Dosulepin) need to monitor these patients for the emergence of:
• anxiety •
agitation •
panic attacks• insomnia• irritability• aggressiveness• impulsivity• restlessness or difficulty sitting still• hypomania• mania
• unusual changes in behaviour
This will help your doctor determine the best way to control these feelings.
Be sure to keep all of your appointments with your doctor so that your
progress can be checked.
Your doctor may want to take some blood tests and check your heart and
blood pressure from time to time. This helps prevent unwanted side effects.
Tell your doctor or dentist if your mouth feels dry and this lasts for
more than 2 weeks.
PROTHIADEN (Dothiepin, Dosulepin) may cause dry mouth. Continuing dryness of the mouth may
increase the chance of dental disease, including tooth decay and gum
disease. This can be relieved by frequent sips of water, sucking sugarless
lollies or chewing sugarless gum.
Things you must not do
Do not stop taking PROTHIADEN (Dothiepin, Dosulepin), or lower the dose, without first checking
with your doctor.
Do not let yourself run out of medicine over the weekend or on holidays.
Suddenly stopping PROTHIADEN (Dothiepin, Dosulepin) may cause your condition to get worse and/or
cause headache, nausea, fits or blood clots.
Things to be careful of
Make sure you know how you react to PROTHIADEN (Dothiepin, Dosulepin) before you drive or operate
machinery.
PROTHIADEN (Dothiepin, Dosulepin) may cause drowsiness, sleepiness or dizziness in some people
and affect alertness. Please discuss with your doctor whether you should
be driving or operating machinery whilst taking PROTHIADEN (Dothiepin, Dosulepin).
Be careful when drinking alcohol while taking PROTHIADEN (Dothiepin, Dosulepin). Combining
PROTHIADEN (Dothiepin, Dosulepin) and alcohol can make you more sleepy, dizzy or lightheaded.
Your doctor may suggest you avoid alcohol while you are being treated
for depression.
All of the above precautions are important even after you have stopped
taking PROTHIADEN (Dothiepin, Dosulepin).
The effects of PROTHIADEN (Dothiepin, Dosulepin) may last for several days after you have stopped
it because some of the medicine may still be in your body.
Side effects
Tell your doctor or pharmacist as soon as possible if you do not feel
well while you are taking PROTHIADEN (Dothiepin, Dosulepin).
PROTHIADEN (Dothiepin, Dosulepin) helps most people with depression, but it may have unwanted
side effects in some people.
All medicines can have side effects. Sometimes they are serious, most
of the time they are not. You may need medical treatment if you get some
of the side effects.Ask your doctor or pharmacist any questions you may
have.
These are the more common side effects of PROTHIADEN (Dothiepin, Dosulepin).
If any of the following happen, stop taking PROTHIADEN (Dothiepin, Dosulepin) and tell your
doctor immediately or go to casualty at your nearest hospital:
• symptoms of allergy (eg. itchy skin rash, skin blisters or discolouration
of skin upon exposure to sunlight)
•
severe dizziness, drowsiness or disorientation
•
severe constipation
•
unusual bruising or bleeding
•
yellowing of the skin or eyes (jaundice)
•
fast or irregular heart beat
•
chest pain
•
seizures or fitting
These may be serious side effects of PROTHIADEN (Dothiepin, Dosulepin). You may need urgent
medical attention. These side effects are rare.
Other side effects not listed above may also occur in some patients.
Tell your doctor or pharmacist if you notice anything else that is making
you feel unwell.Ask your doctor or pharmacist if you don't understand
anything in this list.Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using PROTHIADEN (Dothiepin, Dosulepin)
Storage
Keep your tablets or capsules in their container until it is time to
take them.If you take them out of their container they may not keep well.Keep
PROTHIADEN (Dothiepin, Dosulepin) in a cool, dry place where the temperature
stays below 25°C.Do not store it or any other medicine, in a bathroom
or near a sink. Do not leave it in the car or on window sills.Heat and
dampness can destroy some medicines.Keep this medicine where young children
cannot reach it.A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking PROTHIADEN (Dothiepin, Dosulepin) or you find that
they have passed their expiry date, ask your pharmacist what to do with
any medicine left over.
Product description
What it looks like
PROTHIADEN (Dothiepin, Dosulepin) is available as either tablets or
capsules.PROTHIADEN (Dothiepin, Dosulepin) tablets are provided in packs
of 30 tablets.The tablets are red, marked with 'P75' on one side and
plain n the other.PROTHIADEN (Dothiepin, Dosulepin) capsules are provided
in packs of 50 capsules.The capsules are brown and red, marked 'P' on
one end and '25' on the other.
