Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using ENDEP?
ENDEP contains the active ingredient amitriptyline hydrochloride. ENDEP is used to
treat depression. It can also be used to treat bedwetting, provided that there is
no physical cause for the problem (eg. problems with the bladder).
For more information, see Section
1. Why am I using ENDEP? in the full CMI.
2. What should I know before I use ENDEP?
Do not use if you have ever had an allergic reaction to ENDEP or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I use ENDEP? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with ENDEP and affect how it works.
4. How do I use ENDEP?
For depression, the usual starting dose is 75 mg to 150 mg per day in divided doses.
The doses recommended for bedwetting are lower than the doses used to treat depression
and usually depend on the person's age and weight.
5. What should I know while using ENDEP?
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Things you should do
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Tell your doctor immediately if you have any suicidal thoughts or other mental/mood
changes.
Keep all of your appointments with your doctor so that your progress can be checked.
Remind any doctor, dentist or pharmacist you visit that you are using ENDEP.
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Things you should not do
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Do not stop taking ENDEP, or lower the dose, without checking with your doctor.
Do not use ENDEP to treat any other conditions unless your doctor tells you to.
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Driving or using machines
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ENDEP may reduce your alertness, cause drowsiness or dizziness in some people. If
affected, do not drive, operate machinery or do anything else that could be dangerous.
Children should not ride a bike or do anything else that can be dangerous if they
are drowsy.
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Drinking alcohol
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Combining ENDEP with alcohol can make you more drowsy or dizzy.
Your doctor may suggest you avoid alcohol while being treated for depression.
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Looking after your medicine
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Keep ENDEP where children cannot reach it.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
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6. Are there any side effects?
Tell your doctor if you notice any of the following and they worry you: dry mouth,
altered sense of taste, nausea (feeling sick), vomiting, diarrhoea, constipation,
blurred vision, difficulty in focussing, drowsiness, tiredness, headache, dizziness,
lightheadedness, increased sweating, weight gain or loss and changes in sex drive.
Tell your doctor immediately or go to the Emergency department at the nearest hospital
if you notice any of the following: skin rash, itching, hives; swelling of the face
or tongue; severe sunburn, blistering or swelling of the skin, fainting or collapse,
chest pain and seizures or fits.
Active ingredient:
amitriptyline hydrochloride
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using ENDEP. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using ENDEP.
Where to find information in this leaflet:
1. Why am I using ENDEP?
ENDEP contains the active ingredient amitriptyline hydrochloride.
ENDEP is used to treat depression.
ENDEP 10 mg and ENDEP 25 mg tablets can be used at any stage in the treatment of depression.
However, the highest strength ENDEP 50 mg, is approved only for the maintenance treatment
of depression (after your symptoms have improved).
ENDEP belongs to a group of medicines called tricyclic antidepressants (TCAs). TCA
medicines work by correcting the imbalance of certain chemicals in the brain. These
chemicals, called amines, are involved in controlling mood. By correcting this imbalance,
TCAs can help relieve the symptoms of depression.
ENDEP can also be used to treat bedwetting, provided that there is no physical cause
for the problem (eg. problems with the bladder).
Ask your doctor if you have any questions about why ENDEP has been prescribed for
you.
Your doctor may have prescribed ENDEP for another reason.
ENDEP is not approved for use in children and adolescents below 18 years of age for
the treatment of depression.
The safe use and effectiveness of ENDEP in treating the above condition, for this
age group, has not been established.
2. What should I know before I use ENDEP?
Warnings
Do not use ENDEP if:
you are allergic to amitriptyline (e.g. Tryptanol), or any of the ingredients listed
at the end of this leaflet.
Some of the symptoms of an allergic reaction may include skin rash, itching or hives;
swelling of the face or tongue which may cause difficulty swallowing or breathing;
increased sensitivity of the skin to the sun.
Always check the ingredients to make sure you can use this medicine.
Do not take ENDEP if you have recently had a heart attack. Taking ENDEP could make your condition worse.
Do not take ENDEP if you are taking cisapride (Prepulsid), a medicine used to treat
stomach reflux.
Combining ENDEP with cisapride may cause serious side effects such as an abnormal
heart rhythm.
Do not take ENDEP if the packaging shows signs of tampering or the tablets do not
look quite right.
Do not take ENDEP if you are taking, or have taken within the last 14 days another
medicine for depression called a monoamine oxidase inhibitor (MAOI).
Taking ENDEP with a MAOI or taking it too soon after stopping a MAOI may cause a serious
reaction with a sudden increase in body temperature, extremely high blood pressure
and severe convulsions. Your doctor will tell you when it is safe to start taking
ENDEP after stopping the MAOI.
Ask your doctor or pharmacist if you are unsure if you are taking, or have been taking
a MAOI.
MAOIs are medicines used to treat depression and symptoms of Parkinson's disease.
Examples of MAOIs are phenelzine (Nardil), tranylcypromine (Parnate), moclobemide
(eg. Aurorix, Arima) and selegiline (Eldepryl, Selgene).
If you are not sure whether you should start taking this medicine, talk to your doctor.
Check with your doctor if you:
Have, or have had any other medical conditions, especially the following:
heart or blood vessel problems
liver problems
glaucoma, a condition characterised by an increased pressure in the eye
urinary problems such as difficulty in passing urine
thyroid problems
seizures or fits
any mental illness other than depression, for example schizophrenia or manic depression
(alternating periods of elation/overactivity and depressed mood)
Family history of suicide or mania
Tell your doctor if you plan to undergo any type of surgery or if you are undergoing
electroshock therapy.
Tell your doctor if you take any medicines for any other condition.
Tell your doctor if you are allergic to any other medicines, foods, dyes or preservatives.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
There have been reports of some babies experiencing complications immediately after
delivery. Your doctor will discuss the possible risks and benefits of taking ENDEP
during pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not take ENDEP if you are breastfeeding.
ENDEP passes into breast milk and may harm your baby.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Do not take ENDEP if you are taking:
cisapride (Prepulsid), a medicine used to treat stomach reflux
any monoamine oxidase inhibitor (MAOI) such as:
- phenelzine (Nardil) and tranylcypromine (Parnate), moclobemide (eg. Aurorix, Arima),
used to treat depression
- selegiline (Eldepryl, Selgene), used to treat symptoms of Parkinson's disease.
Wait at least 14 days after stopping your MAOI before starting ENDEP.
Tell your doctor if you are taking or have recently taken any other medicines, such
as valproic acid.
Some medicines may be affected by ENDEP or may affect how well ENDEP works. These
include:
selective serotonin reuptake inhibitors (SSRIs), a group of medicines used to treat
depression and other mental illnesses, such as fluoxetine (eg. Prozac, Lovan), sertraline
(eg. Zoloft) and paroxetine (eg. Aropax, Paxtine) This could result in "serotonin
syndrome". This condition may include feeling agitated or restless, confused, loss
of muscle coordination or twitching muscles and shivering
some medicines used to treat high blood pressure
anticholinergics, found in some medicines used to relieve stomach cramps; travel sickness;
hayfever and allergies; cough and colds. This could result in high fever, particularly
during hot weather. If you take these medicines together, you may feel drowsier and
experience dry mouth, constipation, and dizziness for a longer period of time. Also,
you may be more at risk of developing seizures and neuroleptic malignant syndrome.
Neuroleptic malignant syndrome may include sudden increase in body temperature, sweating,
fast heartbeat, muscle stiffness, high blood pressure and convulsions
medicines used to treat mental disorders such as schizophrenia
quinidine (Kinidin) and flecainide (Tambocor, Flecatab), medicines used to control
an irregular heartbeat
cimetidine (eg. Tagamet, Magicul), a medicine used to treat reflux and ulcers
sleeping tablets/sedatives, anti-anxiety medicines
medicines for epilepsy
thyroid medicines
disulfiram (eg. Antabuse), a medicine used to deter alcohol consumption
tramadol (eg. Tramal), a medicine used to relieve pain.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect ENDEP.
4. How do I use ENDEP?
How much to take
The dose varies from person to person.
Your doctor will decide the right dose for you.
Follow the instructions provided and use ENDEP until your doctor tells you to stop.
Depression
ENDEP is usually started at a low dose and then, if necessary, increased depending
on how your symptoms improve and how well you tolerate it.
For depression, the usual starting dose is 75 mg to 150 mg per day in divided doses.
For people being treated in hospital for their depression, the usual starting dose
is 100 mg to 200 mg per day.
For the elderly, lower doses are recommended, as ENDEP may not be well tolerated in
this age group.
Your doctor may then reduce your dose to 50 mg to 100 mg per day when your depressive
symptoms have improved, depending on your response to ENDEP.
Bed-wetting
Keep ENDEP out of the reach of children.
Do not give your child more ENDEP than what is recommended by your doctor.
The doses recommended for bedwetting are lower than the doses used to treat depression
and usually depend on the person's age and weight.
When to take ENDEP
ENDEP can be taken with or without food.
ENDEP can be taken as a single dose (eg. at bedtime) or as divided doses (eg. three
times a day). Your doctor will advise you.
Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you
remember when to take it.
How to take ENDEP
Swallow the tablets whole with a glass of water.
How long to take ENDEP for
Depression
Keep taking ENDEP for as long as your doctor recommends.
The length of treatment will depend on how quickly your symptoms improve.
Most medicines for depression take time to work, so do not be discouraged if you do
not feel better right away. Some people notice an improvement in their depressive
symptoms after 3 or 4 days.
However, it may take up to 4 weeks to feel the full benefits of ENDEP.
Even when you feel well, your doctor may ask you to continue taking ENDEP for 3 months
or longer to make sure that the benefits last.
Bed-wetting
Most children respond to treatment in the first few days. However, continued treatment
is usually required to maintain the response until bed-wetting ends.
If you forget to use ENDEP
If you take one dose a day (at bedtime):
If you forget to take ENDEP before going to bed and wake up late in the night or early
in the morning, do not take the missed dose until you have checked with your doctor.
You may have difficulty waking up or experience drowsiness in the morning or during
the day, if you take Endep at these times.
If you take more than one dose a day:
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 the missed dose as soon as you remember, and then go back to taking
your tablets as you would normally.
Do not take a double dose to make up for the dose you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering to take your tablets, ask your pharmacist for some
hints.
If you use too much ENDEP
Taking too much ENDEP at once can be dangerous and may cause death.
If you think that you have used too much ENDEP, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(Australia telephone 13 11 26) for advice, or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
If you take too much ENDEP, you may feel drowsy, cold, very dizzy or have a fast or
irregular heartbeat.
You may also have fits, difficulty breathing or lose consciousness.
Keep ENDEP out of the reach of children.
Children are much more sensitive than adults to medicines such as ENDEP. An accidental
overdose is especially dangerous in children.
5. What should I know while using ENDEP?
Things you must do
Tell your doctor immediately if you have any suicidal thoughts or other mental/mood
changes.
Occasionally, the symptoms of depression or other psychiatric conditions may include
thoughts of harming yourself or committing suicide. These symptoms may continue or
get worse during the first one to two months of treatment until the full antidepressant
effect of the medicine becomes apparent. This is more likely to occur in children,
adolescents and young adults under 25 years of age.
Contact your doctor or a mental health professional right away or go to the nearest
hospital for treatment if you or someone you know is showing any of the following
warning signs of suicide:
worsening of your depression
thoughts or talk of death or suicide
thoughts or talk of self-harm or harm to others
any recent attempts of self-harm
increase in aggressive behaviour, irritability or any other unusual changes in behaviour
or mood.
All mentions of suicide or violence must be taken seriously.
Tell your doctor if you feel the tablets are not helping your condition.
Keep all of your appointments with your doctor so that your progress can be checked.
Tell your doctor immediately if you become pregnant while taking ENDEP. Do not stop
taking your tablets until you have spoken to your doctor.
Before starting any new medicine, tell your doctor or pharmacist that you are taking
ENDEP.
Tell all the doctors, dentists and pharmacists who are treating you that you are taking
ENDEP.
If you plan to have surgery, including dental surgery, tell your doctor or dentist
that you are taking ENDEP.
Your doctor may ask you to temporarily stop taking ENDEP a few days before elective
surgery.
Tell your doctor if, for any reason, you have not taken your medicine exactly as prescribed.
Otherwise, your doctor may think that it was not effective and change your treatment
unnecessarily.
Things you must not do
ENDEP may reduce your alertness, cause drowsiness or dizziness in some people. For
these reasons, children should not ride a bike, climb trees or do anything else that
could be dangerous if they are drowsy.
Do not stop taking ENDEP, or lower the dose, without checking with your doctor. Do
not let yourself run out of your medicine over weekends or during holidays.
Stopping ENDEP suddenly may make you feel sick (nauseous), have headaches or feel
generally unwell.
Your doctor will tell you how to gradually reduce the amount of ENDEP you are taking
before stopping completely.
Do not use ENDEP to treat any other conditions unless your doctor tells you to.
Do not give ENDEP to anyone else, even if they have the same condition as you.
Be careful getting up from a sitting or lying position
Dizziness, lightheadedness or fainting may occur, especially when you get up quickly.
Getting up slowly may help.
Tell your doctor or dentist if your mouth continues to feel dry for more than 2 weeks.
ENDEP may cause dry mouth. This can be relieved by frequent sips of water, sucking
sugarless lollies or chewing sugarless gum. However, continuing dryness of the mouth
may increase the chance of dental disease, including tooth decay and gum disease.
Driving or using machines
Do not drive or operate machinery until you know how ENDEP affects you.
ENDEP may reduce your alertness, cause drowsiness or dizziness in some people. If
you experience any of these symptoms, do not drive, operate machinery or do anything
else that could be dangerous.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful drinking alcohol while taking ENDEP.
Combining ENDEP with alcohol can make you more drowsy or dizzy. Your doctor may suggest
you avoid alcohol while being treated for depression.
Looking after your medicine
Keep your tablets where the temperature stays below 30°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it 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.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
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Serious side effects
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What to do
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fast or irregular heartbeats
larger breast than normal (in men and women)
tingling or numbness of the hands or feet
uncontrolled movements, including trembling and shaking of the hands and fingers, twisting movements of the body, shuffling walk and stiffness of the arms and legs
difficulty in passing urine
signs of frequent infections such as fever, chills, sore throat or mouth ulcers
yellowing of the eyes or skin (jaundice)
unusual bruising or bleeding
feeling anxious, restless or confused
abnormal ideas, hallucinations
sudden switch of mood to one of excitement, overactivity,
talkativeness and uninhibited behaviour.
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Tell your doctor as soon as possible if you notice any of these side effects which
are serious and may require medical attention.
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Very serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What ENDEP contains
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Active ingredient
(main ingredient)
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10 mg, 25 mg or 50 mg of amitriptyline hydrochloride
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
disodium edetate
sodium starch glycollate
pregelatinised maize starch
colloidal anhydrous silica
magnesium stearate
purified talc [10 mg and
50 mg only]
Opadry Blue OY-B-30904 (ARTG PI No: 3525)
[10 mg only]
Opadry Yellow OY-LS-32814 (ARTG PI No: 2734)
[25 mg only]
Opadry Buff OY-LS-37200 (ARTG PI No: 3249)
[50 mg only].
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Potential allergens
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Sugars as lactose, soya bean products and traces of sulfites (10mg only)
Sugars as lactose and traces of sulfites (25mg, 50mg).
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Do not take this medicine if you are allergic to any of these ingredients.
What ENDEP looks like
ENDEP 10 - 7mm, normal convex, blue film coated tablet debossed with ‘AP 10’ on one
side and α on the other (AUST R 71044).
ENDEP 25 - 7 mm yellow, film coated, normal convex tablet marked AP/25 on one side,
α on reverse (AUST R 59788)
ENDEP 50 - 8 mm hexagonal, tan film coated tablet marked AP 50 on one side, α on reverse
(AUST R 64425).
Who distributes ENDEP
Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276
This leaflet was prepared in August 2022.
ENDEP® is a Viatris company trade mark
ENDEP_cmi/Aug22/01