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AMITRIPTYLINE TABLETS BP 25MG

Active substance(s): 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.

to tell you if they think your depression or anxiety is getting worse, or if
they are worried about changes in your behaviour.

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

Talk to your doctor or pharmacist before taking Amitriptyline tablets if
you or your child (if they are the patient):
• h ave 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
• h ave 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)
• a re due to have any surgery, including dental, that involves an
anaesthetic.

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
• are 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

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

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
•m
 edicines to treat some heart conditions such as amiodarone,
diltiazem, disopyramide, procainamide, propafenone, quinidine,
sotalol, verapamil
•m
 edicines to treat angina that you spray or dissolve under your tongue
(eg glyceryl trinitrate “GTN”, isosorbide dinitrate)
• r ifampicin or linezolid (to treat infections), fluconazole (to treat fungal
infections)
• carbamazepine or phenobarbital (to treat epilepsy)
• terfenadine (to treat allergies or hayfever)
•m
 ethylphenidate (to treat attention deficit/hyperactivity disorder
(ADHD))
• a ny medicines to treat high blood pressure such as guanethidine,
debrisoquine, bethanidine or clonidine or diuretics (“water” tablets)
•m
 edicines 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)
• s ympathomimetic 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)
• a nticholinergic medicines e.g. atropine, benzatropine, dicyclomine or
doxyamine
• antidepressants

Amitriptyline tablets and alcohol

Do not to drink alcohol with this medicine.

Continued top of next column

Continued over page

148x210 Leaflet Reel Fed Profile (BST)

Amitriptyline 10mg, 25mg & 50mg 28 Tablets PIL - UK
item no: AAAJ0676

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 26.05.16

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 13.06.16

Technical Approval

revised by: S.Anson

date sent: N/A

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe area
2.
3.

Amitriptyline Tablets
All strengths x 28’s (UK)
JDE No.:

50901093

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4180
Date Sent:
16/05/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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
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.
Tell your doctor if you notice any of the following side effects or notice any
other effects not listed:
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), rash of purple spots (purpura)
Endocrine system and metabolism: 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
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 are not there, anxiety, excitement, disorientation (not knowing
where you are), thoughts of suicide (see section 1), restlessness, nerve damage,
pins and needles, lack of co-ordination, loss of control of or shaky movements,
tremor, fits. Anticholinergic effects (dry mouth, fever, constipation, blurred or
double vision, diffi culty or lack of control when urinating, dilation of the pupil
of the eye, glaucoma and blockage of the small intestine)
Heart: feeling faint when getting up (postural hypotension), increased blood
pressure, fast/racing heart, palpitations, heart attack, stroke, irregular or slow
heart-beats and very low blood pressure, a heart problem called prolonged
QT interval (which is shown on your electrocardiogram, ECG) (frequency
common), other changes in ECGs
Stomach and intestines: 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
Liver: hepatitis, including changes in liver function (as seen in blood tests),
jaundice (yellowing of the skin and/or whites of the eyes)
Other: 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.
• The 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 June 2016

Continued top of next column
50901093 AAAJ0676

Actavis, Barnstaple, EX32 8NS, UK

148x210 Leaflet Reel Fed Profile (BST)

Amitriptyline 10mg, 25mg & 50mg 28 Tablets PIL - UK
item no: AAAJ0676

dimensions: 148 x 210

print proof no: 2

pharmacode:

origination date: 26.05.16

min pt size: 7

1. Black
2.
3.
4.
5.
6.

originated by: S.Anson
approved for print/date

colours/plates:

revision date: 13.06.16

Technical Approval

revised by: S.Anson

date sent: N/A

supplier: Actavis UK

technically app. date:

Non Printing Colours
1. Text Safe area
2.
3.

Amitriptyline Tablets
All strengths x 28’s (UK)
JDE No.:

50901093

Dimensions: 148x210 (Reel Fed)
Component: Leaflet for Blisters
Pharmacode: 4180
Date Sent:
16/05/16
Technologist: R.Wrey
Technically Approved
Actavis BST - Packing Technical
BSTCutterGuideReq@actavis.com

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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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