AMITRIPTYLINE 10MG TABLETS

Active substance: AMITRIPTYLINE HYDROCHLORIDE

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Metwest
Pharmaceuticals

PACKAGE LEAFLET: INFORMATION FOR THE USER

AMITRIPTYLINE
10 mg & 25 mg TABLETS
Read all of this leaflet carefully before you start
taking this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or
pharmacist.
- This 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.

THIS LEAFLET CONTAINS
1. What Amitriptyline is for
2. Before you take Amitriptyline
3. How to take Amitriptyline
4. Possible side effects
5. How to store Amitriptyline
6. Further information

1. WHAT AMITRIPTYLINE IS FOR
Amitriptyline belongs to a group of medicines called tricyclic
antidepressants. These medicines alter the levels of chemicals in
your brain to relieve the symptoms of depression.
Amitriptyline can be used to treat:
 the symptoms of depression
 bed-wetting at night by children
If you are not sure why you have been prescribed these tablets
then please ask your doctor.

2. BEFORE YOU TAKE AMITRIPTYLINE
Do not take Amitriptyline and tell your doctor if you:
 are allergic to Amitriptyline or any of the other ingredients in the
tablets (listed in section 6 of this leaflet)
 have heart problems such as irregular heartbeats, heart block
or have recently had a heart attack
 have severe liver problems
 are taking other medicines to treat depression known as
Monoamine Oxidase Inhibitors (MAOIs) or you have taken
MAOIs within the last 14 days
 suffer from mania (feeling over-excited, which causes unusual
behaviour)
 are pregnant, planning a pregnancy or are breast-feeding
 have an inherited iron disorder (porphyria)
Amitriptyline should not be given to children under 7 years of
age.
Take special care with Amitriptyline
Tell your doctor before you take this medicine if you:
 have epilepsy
 have a mental health problem such as schizophrenia or manic
depression
 have problems with your liver or heart
 have increased pressure in your eye (glaucoma)
 cannot pass urine or have an enlarged prostate gland
 have an overactive thyroid gland or are taking medicines to
treat thyroid problems
 are having electroconvulsive therapy (ECT)
 have a tumour called phaeochromocytoma, which is usually
near the kidney and can cause high blood pressure
Tell your doctor or dentist that you are taking Amitriptyline if you are
going to have an anaesthetic for an operation or dental treatment.
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.
Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, even medicines bought without a
prescription.
In particular, tell your doctor or pharmacist if you are taking any of
the following medicines, as they may affect how Amitriptyline
tablets work:
 medicines to treat depression known as Monoamine Oxidase
Inhibitors (MAOIs) such as moclobemide or you have taken
MAOIs within the last 14 days
 other medicines to treat depression such as fluoxetine,
duloxetine or the herbal remedy St John’s Wort
 medicines to treat mental health problems such as lithium,
clozapine, pimozide, thioridazine, chlorpromazine or
prochlorperazine
 medicines to treat high blood pressure such as moxonidine,
guanethidine, debrisoquine, bethanidine or clonidine
 medicines to treat chest pain such as glyceryl trinitrate,
nicorandil, diltiazem or verapamil
 medicines to treat an irregular heart beat such as amiodarone, dronedarone, disopyramide, flecainide, procainamide,
propafenone or sotalol
 sympathomimetic agents such as adrenaline, apraclonidine,
brimonidine, ephedrine, isoprenaline, noradrenaline,
phenylephrine or phenylpropanolamine (these may be found
in medicines to treat heart problems and asthma as well as
cough or cold remedies)
 painkillers such as codeine, nefopam or tramadol
 medicines to help you sleep such as ethchlorvynol
 medicines to treat epilepsy such as carbamazepine,
phenytoin or barbiturates for example phenobarbital
 medicines to treat Parkinson’s disease such as entacapone,
rasagiline or selegiline
 medicines to stop blood clots from forming such as
coumarins for example warfarin
 anticholinergic drugs such as atropine to treat spasms,
shaking, stiffness or movement disorders
 atomoxetine or methylphenidate to treat Attention Deficit
Hyperactivity Disorder (ADHD)
 disulfiram to treat alcohol addiction
 pentamidine isetionate to treat pneumonia
 moxifloxacin to treat bacterial infections
 ritonavir or saquinavir to treat viral infections
 artemether and lumefantrine to treat malaria
 cimetidine to treat stomach ulcers
 medicines to treat thyroid problems
 sibutramine for weight loss.
AVOID ALCOHOL whilst taking Amitriptyline
Pregnancy and breast-feeding
Amitriptyline should not be taken if you are pregnant or planning
a pregnancy, unless your doctor has told you to.
Do not take Amitriptyline if you are breast-feeding.
Driving and using machines
Amitriptyline may make you feel less alert. If you are affected in
this way, do not drive or operate machinery.
Important information about some of the ingredients of
Amitriptyline
Amitriptyline 10 mg and 25 mg tablets contain lactose. If you
know you have an intolerance to some sugars, contact your
doctor before taking this medicine.
Amitriptyline 25 mg tablets also contain sunset yellow (E110),
which may cause allergic reactions.

3. HOW TO TAKE AMITRIPTYLINE
Always take Amitriptyline tablets exactly as your doctor has
told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets whole with a glass of water.
It may take two to four weeks of treatment before you notice an
improvement in your symptoms.
Dosage
Depression:

Adults: The usual dose is 75 mg a day, either as a single dose at
night or split into smaller doses over the day. Your doctor may
increase this to a maximum of 150-200 mg a day.
For long term treatment the usual dose is 50-100 mg a day as a
single dose at night. As your condition improves you will be
prescribed the lowest effective dose necessary to treat your
symptoms.
Elderly: Your doctor will start you on a lower dose (typically 10-25
mg three times a day) and then gradually increase your dose, as
you may be more sensitive to the effects of this medicine.
Children: Not recommended for treatment of depression in
children under 16 years of age.
Bed-wetting at night
Children (for no longer than 3 months treatment):
Under 7 years: Not recommended
7-10 years: 10-20 mg at night
11-16 years: 25-50 mg at night
If you take more Amitriptyline than you should
Contact your doctor or go to the nearest hospital immediately.
Take this leaflet and the package with you.
Symptoms of an overdose may include fast or irregular
heartbeats, difficulty breathing, low blood pressure, coma, fits,
muscle rigidity, agitation, dry mouth, dilated pupils, hallucinations,
disturbed concentration, confusion, drowsiness, vomiting, a fall in
body temperature or fever.

Tell your doctor if you get any of these side effects:
 Effects on your ears: ringing in your ears
 Effects on your stomach and intestines: nausea, vomiting,
diarrhoea, constipation, blockage of your small intestine,
pains in your stomach area (the abdomen), change in
appetite, dry mouth, inflammation or irritation in your mouth
sometimes causing mouth ulcers, taste disturbances, swollen
salivary glands or black tongue.
 Effects on your eyes: blurred vision, changes in eyesight,
dilated pupils or glaucoma.
 General effects: headache, fever, weakness, tiredness,
drowsiness, increased sweating, difficulty in passing urine,
weight gain or hair loss.
An increased risk of bone fractures has been observed in
patients taking this type of medicines
Withdrawal symptoms: As your doctor gradually reduces your
dose you may experience irritability, restlessness or dream and
sleep disturbances. Mania or hypomania (feeling elated or
over-excited) may occur 2-7 days after stopping the tablets.
Bed-wetting at night by children: The side effects are less
frequent but may still occur. The most common side effects are
drowsiness, dry mouth, blurred vision, glaucoma, changes in
eyesight, constipation, fever and difficulty in passing urine. There
have also been rare reports of mild sweating and itching, as well
changes in behaviour.

If you forget to take Amitriptyline
Don’t worry, just take it as soon as you remember. However, if it is
nearly time for your next scheduled dose, skip the missed dose.
Do not take a double dose (two doses at the same time) to make
up for the missed one.

If any of the side effects become serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

If you stop taking Amitriptyline
DO NOT STOP taking Amitriptyline unless your doctor tells you
to. If you stop taking it abruptly, you may experience withdrawal
symptoms such as headache, nausea or general illness. Your
doctor will gradually reduce your dose.

Keep out of the reach and sight of children.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Amitriptyline can cause side effects, although
not everybody gets them.
STOP TAKING Amitriptyline and see a doctor straight away if
you have:
 an allergic reaction, symptoms of which may include skin
rash, itching, red and raised lumps (hives), sensitivity to
sunlight, swelling of your face or tongue leading to difficulty in
breathing or swallowing
 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. The doctor may wish to test
your blood.
Serious side effects: Tell a doctor straight away if you:
 feel more depressed or have thoughts of harming or killing
yourself.
If you get any of the following side effects, see your doctor as
soon as possible:
 Effects on your heart: feeling faint or dizzy when standing
up, high blood pressure, fast or irregular heartbeats,
palpitations, heart attack, heart block, stroke, very low blood
pressure or altered electrocardiogram (ECG).
 Effects on your brain and nervous system: confusion,
disorientation (not knowing where you are), difficulty
concentrating, difficulty sleeping, nightmares, delusions,
hallucinations (hearing and seeing things that are not there),
feeling hyperactive, excited, anxious or restless, numbness or
tingling or pins and needles (particularly in the hands and
feet), difficulty co-ordinating movements, shaking, fits or
fainting.
 Effects on your liver: hepatitis, including changes in liver
function (as seen in blood tests) or yellowing of the skin or
whites of your eyes (jaundice).
 Effects on your hormones: changes in sexual function or
sex drive, breast swelling in men and women, swelling of your
testicles, production of breast milk, increased or decreased
blood sugar levels or inappropriate secretion of Antidiuretic
Hormone (ADH), which may make you urinate more
frequently.

5. HOW TO STORE AMITRIPTYLINE
Store below 25°C and away from light. Store in the original
package or container and keep the container tightly closed.
Do not use these tablets after the expiry date, which is stated on
the package or container. The expiry date refers to the last day of
that month.
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. FURTHER INFORMATION
What Amitriptyline tablets contain
The active ingredient in Amitriptyline 10 mg and 25 mg tablets is
amitriptyline hydrochloride. The other ingredients are lactose
monohydrate, calcium hydrogen phosphate dihydrate, maize
starch, microcrystalline cellulose, colloidal anhydrous silica,
stearic acid, magnesium stearate, hypromellose, ethylcellulose,
diethyl phthalate, hydroxypropyl cellulose (E463) and titanium
dioxide (E171).
The 10 mg tablets also contain indigo carmine (E132). The 25 mg
tablets also contain quinoline yellow (E104) and sunset yellow
(E110).
What Amitriptyline tablets look like and contents of the pack
Amitriptyline 10 mg tablets are round, blue, film-coated tablets
with the marking MP49 on one side.
Amitriptyline 25 mg tablets are round, yellow, film-coated tablets
with the marking MP50 on one side and 25 mg on the other.
The tablets come in blister packs of 28 tablets and containers of
28, 100 and 500 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Metwest Pharmaceuticals Limited,
15 Runnelfield, Harrow on the Hill,
Middlesex HA1 3NY
Manufacturer
DDSA Pharmaceuticals Limited,
310 Old Brompton Road,
London SW5 9JQ
For more information about this product, please contact the
Marketing Authorisation Holder.
This leaflet was last revised in 05/2012

M0049-50/O/PIL/G002

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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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