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AMITRIPTYLINE 25MG FILM-COATED TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE

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Artwork No.

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Colours Used

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Customer



Black

Customer



Black

Description

Amitriptyline

Description

Amitriptyline

Market

UK

Market

UK

Language

English

Language

English

Size

160 x 270 mm (PIL)

Size

160 x 270 mm (PIL)

Min. Font Size

7

Min. Font Size

7

Version No.

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Version No.

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Date

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Date

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Prepared By
Regulatory Affairs

Checked By
Regulatory Affairs

Approved By
Quality Assurance

PACKAGE LEAFLET: INFORMATION FOR THE USER

Amitriptyline 10 mg Film-coated Tablets
Amitriptyline 25 mg Film-coated Tablets
(Amitriptyline Hydrochloride)

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Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your
doctor,pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass
it on to others. It may harm them, even if their signs of illness
are the same as yours
If you get any side effects, talk to you doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4.

In this leaflet:
1. What Amitriptyline Tablets are and what they are used for
2. What you need to know before you take Amitriptyline Tablets
3. How to take Amitriptyline Tablets
4. Possible side effects
5. How to store Amitriptyline Tablets
6. Contents of the pack and other information

1. What Amitriptyline Tablets are and what
they are used for
Amitriptyline belongs to a group of medicines called tricyclic
antidepressant drugs. These medicines alter the levels of
chemicals in the brain to relieve the symptoms of depression.
Amitriptyline tablets are used in following conditions :
• to treat the symptoms of depression.
• for the relief of bed-wetting at night by children known as
nocturnal enuresis in children aged 6 years and above when
organic pathology has been excluded and no response has
been achieved to all other non‐drug and drug treatments.

2. What you need to know before you take
Amitriptyline Tablets
Do not take Amitriptyline Tablets and tell your doctor if you
or your child (if they are the patients):
• are allergic (hypersensitive) to amitriptyline, other tricyclic
antidepressants or any of the other ingredients of Amitriptyline
Tablets (see section 6). The 25mg tablets contain sunset
yellow (E110), which may cause allergic-type reactions
including asthma. Allergy is more common in people who are
allergic to aspirin. An allergic reaction can include a rash,
itching or shortness of breath.
• have heart disease such as irregular heartbeats, heart block or
failure, coronary artery disease or have recently had a heart attack
• suffer from periods of increased and exaggerated behaviour
(mania)
• have severe liver disease
• are taking monoamine oxidase inhibitors (MAOI) or you have
taken MAOIs within the previous 14 days for depression
• you are breast-feeding
• you have a problem with your blood called porphyria.
If this medicine has been prescribed for a child under 6 years of
age, tell your doctor as it may not be suitable for them.
Warnings and precautions
Before taking Amitriptyline tablets, tell your doctor if you or
your child (if they are the patient):
• have any blood disorders (you may bruise easily, frequently
suffer from infections or be anaemic)
• have any psychiatric disorder (e.g. schizophrenia or manic
depression)
• have liver or cardiovascular disease
• cannot pass urine or have an enlarged prostate gland
• have an overactive thyroid gland and are taking medicines
to treat a thyroid disorder
• have a history of epilepsy
• you are being given electroconvulsive therapy (ECT)
• you have increased pressure in the eye (known as
narrow-angle glaucoma)
• are due to have any surgery, including dental, that involves
an anaesthetic.
A heart problem called “prolonged QT interval” (which is
shown on your electrocardiogram, ECG) and heart rhythm
disorders (rapid or irregular heart beat) have been reported
with Amitriptyline Tablets. Tell your doctor if you:
• have slow heart rate,
• have or had a problem where your heart cannot pump the
blood round your body as well as it should (a condition called
heart failure),
• are taking any other medication that may cause heart
problems, or
• have a problem that gives you a low level of potassium or
magnesium, or a high level of potassium in your blood.
Nightly bedwetting:
1. Should not be combined with anticholinergic medicines
2. ECG (electrocardiogram) should be performed before starting
therapy with Amitriptyline
3. During initiation of treatment development of suicidal thoughts
and behaviours in patients receiving treatment for depression
combined with treament of nightly bedwetting.

If you are not sure if any of the above apply to you, talk to your
doctor or pharmacist before taking amitriptyline tablets.
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 or 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 trials has
shown an increased risk of suicidal behaviour in adults aged
less than 25 years with psychiatric conditions who were
treated with an antidepressant.
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.
Having operations and tests
Tell your doctor or dentist that you are taking amitriptyline if you are
going to have an anaesthetic for an operation or dental treatment.
Other medicines and Amitriptyline Tablets
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Please inform your doctor if you are taking or have previously
taken any of the following medicines:
• medicines to treat depression known as Monoamine Oxidase
Inhibitors (MAOIs) such as phenelzine or you have taken
MAOIs within the last 14 days
• other medicines used to treat depression, including the herbal
remedy St John’s Wort
• altretamine (to treat some types of cancer)
• apraclonidine and brimonidine (to treat glaucoma ; a condition
characterised by increased intraoccular pressure)
• baclofen (a muscle relaxant)
• disulfiram (to treat alcohol addiction)
• painkillers such as nefopam, tramadol, codeine, dihydrocodeine
• medicines to treat some heart conditions such as amiodarone,
diltiazem, disopyramide, procainamide, propafenone,
quinidine, sotalol, verapamil
• medicines to treat angina that you spray or dissolve under your
tongue (e.g. glyceryl trinitrate “GTN”, isosorbide dinitrate)
• rifampicin or linezolid (to treat infections)
• carbamazepine or phenobarbital (to treat epilepsy)
• terfenadine (to treat allergies or hay fever)
• methylphenidate (to treat attention deficit/hyperactivity
disorder in children (ADHD))
• any medicines to treat high blood pressure such as
guanethidine, debrisoquine, bethanidine or clonidine or
diuretics (“water” tablets)
• medicines to treat some mental illnesses such as clozapine,
pimozide, thioridazine chlorpromazine, haloperidol,
prochlorperazine, sulpiride
• cimetidine (to treat ulcers)
• ethchlorvynol (to help you sleep)
• entacapone or selegiline (to treat Parkinson’s disease)
• oral contraceptives (“the pill”)
• sibutramine (to suppress appetite)
• sympathomimetic medicines such as adrenaline (epinephrine),
ephedrine, isoprenaline, noradrenaline (norepinephrine),
phenylephrine and phenylpropanolamine (these may be
present in many cough and cold remedies)
• ritonavir (to treat HIV)
• fluconazole (to treat fungal infections).
• Anticholinergic medicines such as atropine, benzatropine,
dicyclomine, doxylamine when combined with Amitriptyline for
nightly bedwetting therapy in children or when used in elderly
patients.
Amitriptyline Tablets with food,drink and alcohol
You are advised not to drink alcohol with this medicine
Pregnancy and Breast-feeding
Amitriptyline tablets should not be taken in the first 3 months and
last 3 months of pregnancy. If taken in the last three months, the
newborn may have withdrawal symptoms. Do not take
Amitriptyline tablets if you are breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Amitriptyline may make you feel drowsy. If you experience this,
do not drive or use machinery.
Amitriptyline Tablets contains Lactose monohydrate
Amitriptyline Tablets contain lactose monohydrate (milk sugar); if you
have been told by your doctor that you have an intolerance to some
sugars, contact your doctor before taking this medicinal product.

Prepared By
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Checked By
Regulatory Affairs

The 25mg tablets contain sunset yellow (E110), which may cause
allergic-type reactions including asthma. Allergy is more common
in people who are allergic to aspirin.

3. How to take Amitriptyline Tablets
Always take Amitriptyline Tablets exactly as your doctor has told you.
You should check with your doctor or pharmacist if you are not sure.
Swallow the tablets with a glass of water. To be taken orally.
You are advised not to drink alcohol with this medicine.
You may not notice any improvement in your symptoms for up to
4 weeks after starting treatment.
The usual dosage is as below :Depression:
Adults
The usual dose is 50-75mg each day either in divided doses or as
a single night time dose.
Your doctor may increase this dose to a maximum of 150-200 mg
a day. A maintenance dose of 50- 100mg at night should be given
to lessen the chances of relapse.
Adolescents and elderly - 25-50mg a day either in divided
doses or as a single night time dose. A maintenance dose of
25-50mg may be sufficient.
Older people and people with kidney problems
Your doctor will start you on a lower dose and gradually increase
it as you may be more sensitive to the medicine.
Children:
Not recommended for treatment of depression in children, under
16 years of age.
Nightly bedwetting:
Children only (for no longer than 3 months, if repeated
treatment required then a medical review should be
conducted every 3 months)
11-16 years: 25-50 mg per day at night.
6-10 years: 10-20 mg per day at night.
Children less than 6 years - Not recommended.
If you take more Amitriptyline Tablets than you should
If you or the patient (or someone else) swallows a lot of tablets at
the same time, or you think a child may have swallowed any,
contact your nearest hospital casualty department or tell your
doctor immediately. Symptoms of an overdose include fast or
irregular heartbeat, low blood pressure, dilated pupils, drowsiness,
low body temperature, fits, coma, difficulty breathing, agitation,
muscle rigidity, jerky movements, hot dry skin, dry mouth and
tongue, difficulty passing water, intestinal blockage, uncontrolled
movements, being sick or fever.
If you forget to take Amitriptyline Tablets
Do not take a double dose to make up for a forgotten dose. If you
forget to take a dose, take another as soon as you remember and
then your next dose at the usual time.
If you stop taking Amitriptyline Tablets
You may not notice any improvement for up to 4 weeks. Do not
stop taking the medicine unless your doctor tells you to as you may
experience withdrawl symptoms (see section 4). If you stop taking
the medicine abruptly, you may get side effects such as headache
that makes you feel sick and feeling weak.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects
Like all medicines, Amitriptyline Tablets can cause side effects,
although not everybody gets them.
Stop taking Amitriptyline tablets and contact your doctor
straight away if you have:
• an allergic reaction. Signs may include a skin rash, which may be
itchy, sensitivity to the sun or sun lamps, puffy, swelling of your
face, lips, throat or tongue, which may be severe causing
shortness of breath, swelling, shock and collapse.
• a serious effect on your blood, such as low sodium levels.
Signs may include fever or chills, sore throat, ulcers in your
mouth or throat, unusual tiredness or weakness, unusual
bleeding or unexplained bruises.
If you notice any of these, tell your doctor straight away.
Serious side effects: tell your doctor straight away
• If you feel more depressed, including thinking about suicide.
Tell your doctor if you notice any of the following side effects
or notice any other effects not listed:
• Effects on your blood: bone marrow depression or reduction in
some blood cells (you may experience a sore throat, mouth ulcers
and recurring infections, bleeding or bruising easily)
• Effects on your hormones: disturbances in sexual function
or sex drive, breast swelling in men and women, swelling of
the testicles, production or over-production of breast milk,
changes in blood sugar levels, increased appetite and weight
gain. Inappropriate secretion of the hormone ADH (antidiuretic
hormone), which may make you urinate more frequently.
• Effects on your brain and central nervous system: dizziness,
tiredness or sleepiness, weakness, headache, difficulty
concentrating, confusion, difficulty sleeping, nightmares, slight
hyperactivity, exaggerated behaviour, delusions, seeing things that

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are not there (hallucinations), anxiety, excitement,
disorientation (not knowing where you are),
restlessness, numbness or tingling or pins and
needles (particularly in the hands and feet), lack of
co-ordination, shaky movements, tremor, fits,
unconsciousness, slow or slurred speech.
Anticholinergic effects (dry mouth, fever, constipation,
blurred or double vision, difficulty passing water
(urine), dilation of the pupil of the eye, glaucoma and
blockage of the small intestine)
• Effects on your heart: feeling faint when getting
up (postural hypotension), change in blood
pressure, fast/racing heart, palpitations, heart
attack, stroke, irregular or slow heart-beats and
very low pressure. A heart problem called “prolonged QT
interval” (which is shown on your electrocardiogram, ECG)
(frequency common)
• Effects on your stomach and intestines: feeling or being sick,
diarrhoea, change in appetite, irritation and a nasty taste in your
mouth, swollen saliva glands, abdominal pains, black tongue, dry
mouth, fever, constipation, blockage of your small intestine.
• Effects on your liver: hepatitis, including changes in liver
function (as seen in blood tests), jaundice (yellowing of the
skin and/or whites of the eyes)
• Effects on your ears: buzzing or ringing in the ears.
• Effects on your eyesight: blurred or double vision, changes
in eyesight.
• General effects: headache, dizziness, weakness, tiredness,
change in weight, drowsiness, increased sweating, hair loss,
widely dilated pupils, difficulty passing water (urine).
• Effects on the skin: skin rashes, skin rash due to sunlight.
• Withdrawal symptoms: feeling sick, malaise and headache,
dream and sleep disturbances, irritability and restlessness. Mania
or hypomania (exaggerated mood and/or elation) may occur 2-7
days after stopping the tablets.
An increased risk of bone fractures has been observed in patients
taking this type of medicines.
When used for children to treat bed wetting, the side effects are
less frequent but may still happen. The most common reported
effects amongst children are drowsiness, dry mouth, blurred
eyesight, increased pressure in the eye, changes in eyesight,
constipation, fever and difficulty in passing water (urine) changes
in behaviour and “Anticholinergic effects” (as described above).
There have also been rare reports of mild sweating and itching.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information
on the safety of this medicine.

5. How to store Amitriptyline Tablets
Container pack: Do not store above 25°C. Store in the original
container. Keep the container tightly closed.
Blister pack: Do not store above 25°C. Store in the original
package.
Keep out of the sight and reach of children.
Do not use your tablets after the expiry date stated on the label or
carton.
Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no
longer required. These measures will help to protect the
environment.

6. Contents of the pack and other information
What Amitriptyline Tablet contains
The active substance is amitriptyline hydrochloride.
The other ingredients are lactose monohydrate, maize starch,
microcrystalline cellulose (PH 102), colloidal anhydrous silica,
magnesium stearate, hydroxypropylmethylcellulose,
ethylcellulose, diethyl phthalate, titanium dioxide (E171) and
Purified Talc.
In addition to these ingredients Amitriptyline 10mg tablet contains
indigo carmine (E132) and Amitriptyline 25mg tablet contains
quinoline yellow (E104) and sunset yellow (E110) (see section 2
for Important information about some of the ingredients of
Amitriptyline tablets).
What Amitriptyline Tablets look like and contents of the pack
Amitriptyline 10 mg Tablets are Blue coloured, round biconvex
film coated tablets plain on both sides.
Amitriptyline 25 mg Tablets are Yellow coloured, round biconvex
film coated tablets plain on both sides.
Both strengths are available in packs of 100 and 500 tablets. The
tablets are also available in blister packs of 28 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner Road
North Harrow, Middlesex, HA1 4HF, United Kingdom
This leaflet was last approved in {11/2015}.

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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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