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ELAVIL / AMITRIPTYLINE TABLETS 25MG

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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PATIENT INFORMATION LEAFLET

ELAVIL
Amitriptyline Hydrochloride
PLEASE READ THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
What is in your medicine?
The name of this medicine is ELAVIL. It is available in tablets
containing 10 mg and 25 mg of Amitriptyline Hydrochloride,
together with the following ingredients: Lactose, calcium
hydrogen phosphate, maize starch, micro crystalline cellulose,
colloidal anhydrous silica, stearic acid, magnesium stearate,
hydroxymethylpropylcellulose, ethylcellulose, diethyl phthalate
hydroxypropylcellulose (E463) titanium dioxide (E171).
The 10 mg tablet also contains indigo carmine (E132).
The 25 mg tablet also contains quinoline yellow (E104) and
sunset yellow (E110).
ELAVIL 10 mg tablets are round, blue, film-coated tablets,
engraved DDSA. ELAVIL 25 mg tablets are round, yellow, filmcoated tablets engraved DDSA.
Both strengths are available in packs of 100 and 500 tablets.
The manufacturer of ELAVIL tablets is:
DDSA Pharmaceuticals Ltd.,
Chatfield Road, off York Road, London SW11 3SE.
The product licence holder of ELAVIL tablets is:
Chelonia Healthcare Limited,
Boumpoulinas 11, 3rd Floor,
Nicosia, Cyprus, P.C.1060, Cyprus

What are ELAVIL tablets for?
ELAVIL belongs to a group of medicines known as the antidepressants and is used in the treatment of the symptoms of
depression, especially where sedation is required.
ELAVIL is also effective in treating bedwetting in children (aged
6 years and above), known as nocturnal enuresis.

Check before you take ELAVIL
Before taking this medicine, tell your doctor if you have ever
had any unusual or allergic reactions to Amitriptyline, or to any
of the other ingredients of ELAVIL.
If your doctor has told you that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.
Sunset yellow E110 may cause allergic reactions.
Also tell your doctor if you are pregnant, likely to become
pregnant, or are breast-feeding a baby.
Amitriptyline should not be given to children below 6
years.
Because the presence of other medical problems may affect
the use of ELAVIL, make sure to tell your doctor if you have
had any of the following:












Heart disease such as coronary artery disease, or heart
block which is a condition where the heart beats slowly
causing dizziness, tiredness, or fainting.
Liver disease.
Epilepsy (seizures).
Urinary problems such as being unable to pass urine.
Prostate problems, especially enlargement of the
prostate.
Glaucoma (increased eyeball pressure).
Thyroid disease.
Mania or schizophrenia.
Phaeochromocytoma (characterised by high blood
pressure).
Porphyria.

You may need an electrocardiogram (ECG) test before start of
Amitriptyline treatment.

Also tell your doctor if you are about to receive any surgical
procedure.

Precautions while using this medicine
Although you can take these tablets with other medicines, it is
important to tell your doctor or pharmacist about all the
medicines that you are taking, whether or not they are
prescribed by your doctor or bought without a prescription from
the pharmacy or elsewhere. This is because using antidepressants together with ELAVIL may possibly increase the
effect of ELAVIL. The use of drugs known as mono-amine
oxidase inhibitors (MAOIs), for example, can increase the
effects of amitriptyline and cause an increase in body
temperature and convulsions. A minimum of 14 days should
elapse between discontinuing an MAOI and starting
amitriptyline.
The drug fluoxetine increases the effects of amitriptyline.
The use of drugs known as protease inhibitors such as
ritonavir may also increase the effects of amitriptyline.
Amitriptyline may block the blood pressure-lowering action of
the following:






Guanethidine
Debrisoquine
Bethanidine
And possibly Clonidine

Amitriptyline should not be taken with the following:









Adrenaline
Ephedrine
Isoprenaline
Noradrenaline
Phenylephrine
Phenylpropanolamine

Amiodarone and dysopyramide for irregular heart beat
Amitriptyline may cause an increase in blood pressure when
used together with the above.
Amitriptyline may increase the response to alcohol,
barbiturates and depressants of the central nervous system.
Delirium has been reported in patients taking amitriptyline with
disulfiram. Barbiturates and carbamazepine may decrease the
anti-depressant action of amitriptyline and methylphenidate
may increase the anti-depressant action.
Anti-cholinergic drugs, such as atropine when combined with
Amitriptyline may cause paralysis of the small intestine,
retention of urine, or glaucoma, especially in the elderly.
Amitriptyline prescribed for bed-wetting in children should not
be combined with an anticholinergic drug.
Cimetidine can reduce the breakdown of amitriptyline, which is
necessary for this drug to be removed from the body (excreted).
The anti-convulsant effect of anti-epileptic drugs such as
Primodone may be reduced when taken with amitriptyline,
whose breakdown rate will be increased.

Caution should be used if you are taking large doses of
ethchlorvynol.
If you get a bad sore throat or high fever, or become gradually
more tired and pale, or notice bruises or nose bleeds, stop
taking Amitriptyline and contact your doctor at once.
Do not abruptly stop taking ELAVIL as there may be some side
effects such as nausea, headache and weakness.

Thoughts of suicide and worsening of your
depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can
sometimes have thoughts of harming of killing yourself. These
may be increased when first starting antidepressants, since
these medicines all take time to work, usually about two weeks
but sometimes longer.
You may be more likely to think like this:



If you have previously had thoughts about killing or
harming yourself.



If you are a young adult. Information from clinical trial
studies has shown an increased risk of suicidal behaviour
in adults aged less than 25 years with psychiatric
conditions who were treated with an anti-depressant.



If you are a child (aged 6 years and above) and treated
for bed-wetting problems (nocturnal enuresis). You may
have a risk of undesirable effects, such as suicide
attempt, thoughts of harming or killing yourselves when
treated with Amitriptyline. Furthermore, if any of the
symptoms listed above appear or worsen whilst taking
Amitriptyline, you should inform your doctor.

If you have thoughts of harming or killing yourself at any time,
contact your doctor or go to a hospital straight away.
You may find it helpful to tell a relative or close friend that
you are depressed or have an anxiety disorder and ask them
to read this leaflet. You might ask them to tell you if they think
your depression or anxiety is getting worse, or if they are
worried about changes in your behaviour.

Effects on ability to drive and use machinery
As Amitriptyline may impair your alertness, any activity made
hazardous by diminished alertness, such as driving motorised
vehicles or using machinery, should be avoided.
Amitriptyline will also enhance the effects of alcohol. It is
therefore inadvisable to drive or operate machinery.

Use in pregnancy and lactation
The safety of Amitriptyline for use during pregnancy and
lactation has not been established. Amitriptyline is not
recommended during pregnancy especially during the first and
third three months, unless there are compelling reasons.
Withdrawal symptoms including depression of breathing and
agitation have been reported in infants whose mothers have
taken Amitriptyline during the last three months of pregnancy.
As Amitriptyline passes into breast milk it should be avoided
while breast-feeding.

Proper use of this medicine
Take this medicine by mouth and only in the doses prescribed by
your doctor. Your pharmacist can also help if you are not sure.
You should take these tablets exactly as your doctor has
ordered. Do not take more of them, and do not take them more
often or for a longer time than your doctor ordered. Do not
stop the treatment without talking to your doctor first.
Dosages:
Adults:
Initial dose:
Usually 75 mg daily in divided doses (or a single dose at
night). This may be increased if necessary to a total of 150200 mg a day, with the additional doses being given in the late
afternoon and/or at bedtime.
The sedative effect is usually rapidly apparent while
antidepressant activity may be seen within three or four days
or may take up to 30 days to develop adequately.
Maintenance dosage:
The usual maintenance dosage is 50-100 mg daily. The total
dosage may be given in a single dose preferably in the
evening or at bedtime. When satisfactory improvement has
been reached, dosage should be reduced to the lowest
amount that will maintain relief of symptoms. Maintenance
therapy should be continued for three months or longer to
lessen chances of relapse.
Elderly:
In general lower dosages are recommended for these patients,
as they are more prone to side effects, especially confusion,
agitation and postural hypotension.
An initial dosage of 10-25 mg three times daily is
recommended, which should be increased slowly. A daily
dosage of 50 mg may be satisfactory in elderly patients who
may not tolerate higher dosages. The required dosage may
be administered either as divided doses or a single dose
preferably in the evening or at bedtime.

Children:
Not recommended for the treatment of depression in children
under 16 years of age due to lack of clinical experience.
Enuresis (bed-wetting):
Children under 6 years: Not recommended
Children from 6-10 years may receive 10-20 mg a day,
while those aged 11-16 years may need 25-50 mg a day.
Treatment should not exceed three months.
If you forget to take your medicine, just carry on with the next
dose as normal. Do not take an extra dose to make up for the
missed dose. If you are not sure, ask your doctor or
pharmacist for advice.

What to do in case of taking an overdose
If you should accidentally swallow a greater quantity of Amitriptyline
tablets than have been prescribed for you, contact your doctor or
the Accident & Emergency Department of your nearest hospital at
once. Always keep any remaining tablets in the labelled
container in which they were given to you so that the medicine
can be identified by the doctor or pharmacist at the hospital.
The symptoms of overdose are abnormal heartbeats,
palpitations, dilated pupils, drowsiness, a drop in body
temperature and convulsions (seizures).

Can ELAVIL tablets cause problems?
Generally Amitriptyline is well tolerated.
The most common side effects of amitriptyline are a dry mouth,
skin rashes, dizziness upon standing up, confusion,
hallucinations and inflammation of the liver with yellowing of
the whites of the eye and yellowing of the skin.
Other side effects may occur with the use of tricyclic
antidepressants including Amitriptyline. These are:
Blood related reactions: increased blood pressure, palpitations,
rapid heartbeat, fainting, heart block, stroke, and water
retention. Bone marrow depression causing a reduction in the
number of certain types of blood cells may occur.
Nervous system reaction: There may be disturbance of
concentration, insomnia, nightmares, delusions, excitement,
anxiety, restlessness, numbness, tingling and pins and
needles of the extremities, difficulty in co-ordination, unstable
walking, tremors, tics, ringing in the ears, seizures, blurred
vision, difficulty in visual focusing, increased eyeball pressure,
inability to pass urine and raised temperature.
Allergic reactions: Hives, sensitivity to light and swelling of the
face and/or tongue.
Gastro-intestinal reactions: Nausea, vomiting, diarrhoea,
constipation, paralysis of the small intestine, loss of appetite,
inflammation of the mouth and of the parotid gland, black tongue.
Hormonal reactions: enlargement of the breasts, production of
breast milk, swelling of the testicles and changes in sexual
desire and sexual function.
Other reactions weakness, fatigue, headache, fever, increased
perspiration, frequency in passing urine, hair loss and
drowsiness. Increased appetite and weight gain (or
occasionally weight loss).
An increased risk of bone fractures has been observed in
patients taking this type of medicines.
Abrupt withdrawal of Amitriptyline after prolonged treatment
has caused nausea, headaches and a feeling of being
generally unwell.
When Amitriptyline has been slowly withdrawn this has been
accompanied by passing symptoms such as irritability,
restlessness and sleep disturbances. In the first two weeks of
dosage reduction a condition known as hypermania (increased
excitement) or hypomania (reduced excitement verging on
depression) have been, rarely, reported within 2 to 7 days of
stopping treatment.
Behavioural changes have been observed in children receiving
ELAVIL for the treatment of bedwetting. Other side effects in
children receiving the treatment for this condition are
drowsiness, mild sweating and itching.

Storing your medicine
You must keep the medicine in a safe place where children
cannot get it. Your medicine could harm them.
Keep your medicine in a dry place and store below 25°C.
Keep the tablets in the closed container in which they were
given to you.
If your doctor tells you to stop the treatment, return any
remaining tablets to the pharmacist. Only keep the medicine if
the doctor tells you to.
On the label you will find the words "Expiry Date" followed by
some numbers indicating the month and year. This is the date
when the medicine is no longer fit for use. Do not use the
medicine after this date, but return it to your pharmacist.

A reminder
REMEMBER this medicine is for you. Never give it to
someone else, even if their symptoms are the same as yours.
This leaflet does not contain the complete information about
your medicine. If you have any questions or are not sure
about anything, ask your doctor or pharmacist who have
access to additional information.
This leaflet was revised in March 2016.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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