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AMITRIPTYLINE TABLETS BP 10 MG

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE / AMITRIPTYLINE HYDROCHLORIDE / AMITRIPTYLINE HYDROCHLORIDE

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Package leaflet: Information for the patient

Amitriptyline 10mg, 25mg and 50mg tablets
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 or
pharmacist.
•  T his medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their symptoms
are the same as yours.
•  If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4.

What is 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 is used:
• to treat the symptoms of depression.
• for the relief of bed-wetting at night by children aged 6 years and above.

2 What you need to know before you take Amitriptyline

tablets

Do not take Amitriptyline tablets if you or your child (if they are the patient):
• a re allergic to amitriptyline, other tricyclic antidepressants or any of the other
ingredients (listed in section 6). The 25mg tablets contain sunset yellow (E110),
which may cause allergic-type reaction.
• have heart disease such as irregular heart beats, 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
• a re taking monoamine oxidase inhibitors (MAOI) or you have taken MAOIs
within the previous 14 days for depression
• are breast-feeding
• if the child is under 6 years old.
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 young adults (less than 25 years old) 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.

Continued top of next column

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. Tell your doctor if you:
• have slow heart rate,
• h ave 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
• h ave a problem that gives you a low level of potassium or magnesium, or a
high level of potassium in your blood.

Warnings and precautions

Talk to your doctor or pharmacist before taking Amitriptyline tablets 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 (eg schizophrenia or manic depression)
• have liver or cardiovascular disease
• are not able to pass water 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
• are being given electroconvulsive therapy (ECT)
• have increased pressure in the eye (glaucoma)
• are due to have any surgery, including dental, that involves an anaesthetic
• are elderly.

Other medicines and Amitriptyline tablets

Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines. Especially:
• altretamine (to treat some types of cancer)
• apraclonidine and brimonidine (to treat glaucoma)
• 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 (eg
glyceryl trinitrate “GTN”, isosorbide dinitrate)
• rifampicin or linezolid (to treat infections), fluconazole (to treat fungal
infections)
• carbamazepine or phenobarbital (to treat epilepsy)
• terfenadine (to treat allergies or hayfever)
• methylphenidate (to treat attention deficit/hyperactivity disorder (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)
• anaesthetics (used in surgery)
• anticholinergic medicines e.g. atropine, benzatropine, dicyclomine or
doxyamine
• antidepressants

Amitriptyline tablets and alcohol
Do not 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 breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or
Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Amitriptyline Tablets
all strengths x 28’s (UK)

Amitriptyline 10mg, 25mg and 50mg tablets
approved for print/date

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Item no:

BBBA0609

Originator:
Origination Date:
Revision Date:
Revised By:

C.Grant
15/03/17
26/04/17
C.Grant

Dimensions:
148x210
Min Body Text Size: 7pt
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
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Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
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50927648

Dimensions: 148x210 (Reel Fed)
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Pharmacode: 4174
Date Sent:
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Technologist: R.Wrey
Technically Approved
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are planning to have a baby, ask your doctor or pharmacist for advice before taking
this medicine.

Driving and using machines

Amitriptyline may impair your alertness. Make sure you are not affected before you
drive or operate machinery.

Amitriptyline tablets contain lactose and sunset yellow

If you have been told you have an intolerance to some sugars, contact your doctor
before taking this medicine, as it contains a type of sugar called lactose.
The 25mg tablets also contain a colour called ‘sunset yellow’ which may cause allergic
reactions.

3 How to take Amitriptyline tablets

Always take Amitriptyline tablets exactly as your doctor has told you. Check with your
doctor or pharmacist if you are not sure.

Swallow the tablets with a glass of water.
You may not notice any improvement in your symptoms for up to 4 weeks after
starting treatment.
The recommended dose is
Depression:
Adults - 50-75mg a day either in divided doses or as a single night time dose
increasing to 150-200mg 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.
Nightly bedwetting:
Children only (for no longer than 3 months)
11-16 years - 25-50mg at night.
6-10 years - 10-20mg at night.
Under 6 years - Not recommended.

If you take more Amitriptyline tablets than you should

If you or the patient (or someone else) swallow 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 regular heart beat, dilated pupils, drowsiness, coma, difficulty breathing, jerky
movements, hot dry skin, dry mouth and tongue, difficulty passing water, intestinal
blockage, uncontrolled eye movement.

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

Talk to your doctor before you stop taking the tablets and follow their advice as you
may experience withdrawal symptoms (see section 4).
If you have any further questions on the use of the medicine, ask your doctor or
pharmacist.

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
Stop taking Amitriptyline tablets and contact your doctor at once if you have:
• a n allergic reaction signs may include a skin rash, which may be itchy, sensitivity to
the sun or sun lamps, puffy, swollen face 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.
• b one marrow depression or reduction in some blood cells (you may experience a
sore throat, mouth ulcers and recurring infections, bleeding or bruising easily)
• t houghts of suicide (see section 1)
• a nticholinergic effects (dry mouth, fever, constipation, blurred or double vision,
difficulty or lack of control when urinating, dilation of the pupil of the eye, glaucoma
and blockage of the small intestine)
• stroke
• hepatitis

Not known (frequency cannot be estimated from the available data):
• rash of purple spots (purpura).
• 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.
• dizziness, tiredness or sleepiness, weakness, headache, difficulty concentrating,
confusion, difficulty sleeping, nightmares, slight hyperactivity, exaggerated
behaviour, delusions, seeing things that are not there, anxiety, excitement,
disorientation (not knowing where you are), restlessness, nerve damage, pins and
needles, lack of co-ordination, loss of control of or shaky movements, tremor, fits.
• feeling faint when getting up (postural hypotension), increased blood pressure, fast/
racing heart, palpitations, heart attack, irregular or slow heart-beats and very low
blood pressure, other changes in ECGs
• feeling or being sick, diarrhoea, loss of appetite, inflammation of the mucus
membranes in the mouth, swollen saliva glands, abdominal pains, black tongue,
impairment of taste
• including changes in liver function (as seen in blood tests), jaundice (yellowing of the
skin and/or whites of the eyes)
• increased sweating, hair loss, ringing in the ears, increased need to urinate. An
increased risk of bone fractures has been observed in patients taking this type of
medicine.
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.
If taken to treat bed-wetting: drowsiness, mild sweating, itching, changes in
behaviour and “Anticholinergic effects” (as described above).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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

Keep this medicine out of the sight and reach of children.
Store below 25°C in a dry place, protected from light.
Do not use Amitriptyline tablets after the expiry date stated on the carton. The expiry
date refers to the last day of that month.
Do not throw away any medicines via household waste. Ask your pharmacist how
to throw away medicine you no longer use. These measures will help protect the
environment.

6 Contents of the pack and other information
What Amitriptyline tablets contain

• The active substance is amitriptyline hydrochloride. Each tablet
contains either 10mg, 25mg or 50mg of the active ingredient.
• T he other ingredients are lactose monohydrate, microcrystalline
cellulose (E460), maize starch, colloidal anhydrous silica, magnesium
stearate, hypromellose (E464), titanium dioxide (E171), macrogol.
The 10mg tablet also contains: indigo carmine (E132).
The 25mg tablet also contains: talc (E553b), quinoline yellow (E104), iron
oxide (E172), sunset yellow (E110), indigo carmine (E132).
The 50mg tablet also contains: talc (E553b), quinoline yellow (E104),
iron oxide (E172).

What Amitriptyline tablets look like and contents of the
pack
Amitriptyline tablets are circular, biconvex, film-coated tablets in the
following colours:
10mg – blue, 25mg – yellow, 50mg - tan
Pack sizes are 28 tablets
Marketing Authorisation Holder and Manufacturer:
Actavis, Barnstaple, EX32 8NS, UK.
This leaflet was last revised in May 2017

Tell your doctor if you notice any of the following side effects or notice any other
effects not listed:
Common (may affect up to 1 in 10 people):
• a heart problem called prolonged QT interval (which is shown on your
electrocardiogram, ECG).
Continued top of next column
50927648 BBBA0609

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Amitriptyline Tablets
all strengths x 28’s (UK)

Amitriptyline 10mg, 25mg and 50mg tablets
approved for print/date

Proof Round

03

UK-Eire-Artwork-Support@Actavis.com

Item no:

BBBA0609

Originator:
Origination Date:
Revision Date:
Revised By:

C.Grant
15/03/17
26/04/17
C.Grant

Dimensions:
148x210
Min Body Text Size: 7pt
Supplier:
Actavis UK

JDE No.:
Colours

Non Printing Colours

1. Black

1. Profile

2.

2.

3.

3.

4.
5.

Technical
Approval

Date sent:
N/A
Date received:

6.

* Please note that only Artwork Studio is permitted to make changes to the above artwork.
No changes are permitted by any 3rd party other than added notes and mark ups for required changes.

50927648

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4174
Date Sent:
14/03/17
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

Expand Transcript

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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