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Artwork Creative' Desians	Artwork No.		250408/1			Colours Used
	Customer		Relon Chem		■	Balck
	Descri ption		Amitriptyline 25mg Pi 1		■	Keyline (not to print)
	Market		UK
_c	Language		English
	Size		140 x 210 mm
Si	Min. Font Size		9 pt
V	Page No.		1 of 2
s e-mail : prasad.pdp@gmail.com Ph : +91-9845609386	Version No.		10
	Date		12-09-12
	Software		Illustrator 10			Pharma Code - 121
Packaging Development		Quality Assurance (QA)		Quality Control (QC)		Production

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 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.

•    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.

•    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 ofyoursmall 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, increased pressure in the eye.

•    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.

An increased risk of bone fractures has been observed in patients taking this type of medicines.

When used for children, 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). 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.

5.    Howtostore Amitriptyline Tablets

Keep out of the reach and sight of children.

Do not use Amitriptyline Tablets after the expiry date which is stated on the carton or the pack. The expiry date refers to the last day of that month.

Store in the original container or packaging.

Do not store the tablets above 25°C.

6.    Further information

What Amitriptyline Tablets contain

The active substance is Amitriptyline hydrochloride.

Each tablet contains 25mg of active ingredient Amitriptyline hydrochloride.

The other inactive ingredients are lactose monohydrate, maize starch, povidone, magnesium stearate, Stearic acid, hypomellose 5 cF; ethylcellulose I0 cF) diethyl phthalate, isopropyl alcohol, purified water and the colours titanium dioxide (EI7I), Quinoline yellow aluminium lake (EI04) and sunset yellow FCF aluminium lake (EIIO).

What Amitriptyline Tablets look like and contents of the pack

Amitriptyline Tablets are yellow, circular, film coated tablets with A2 embossed on one side.

The tablets are supplied in blister packs of 28 tablets or pots of 500 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Relonchem Limited, 27, Old Gloucester Street, London, WCI 3XX.

Date leaflet last revised: September 20I2 | POM |

PL 20395/0029    =

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z

LU

Q-

Patient Information Leaflet

Read all of this leaflet carefully before you start taking these tablets

•    Keep this leaflet. You may need to read it again.

•    If you have any further questions, ask your doctor or pharmacist.

•    Your doctor has prescribed these tablets for you. Do not pass them on to others. They may harm them even if their symptoms are the same as yours.

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

In this leaflet:

1.    What Amitriptyline Tablets are and what they are used for

2.    Before you take Amitriptyline Tablets

3.    How to take Amitriptyline Tablets

4.    Possible side effects

5.    Howto store Amitriptyline Tablets

6.    Further information

1.    What Amitriptyline Tablets are and what they are used for

Amitriptyline belongs to a group of drugs called Tricyclic Antidepressants. It prolongs the effects of noradrenaline and serotonin that occur naturally in the body (substances which transmit nerve impulses).

Amitriptyline may be used:

•    To treat the symptoms of depression.

•    For the relief of bed-wetting at night by children.

2.    Before you take Amitriptyline Tablets

Do not take Amitriptyline Tablets and tell your doctor if:

•    you 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 (EIIO), 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.

•    you have heart disease such as irregular heartbeats, heart block or failure, coronary

Relon 3 tern

artery disease or have recently had a heart attack

•    you suffer from periods of increased and exaggerated behaviour (mania)

•    you have severe liver disease

•    you are taking monoamine oxidase inhibitors (MAOI) or you have taken MAOIs within the previous I4 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.

Before taking Amitriptyline tablets, tell your doctor if:

•    you have any blood disorders (you may bruise easily, frequently suffer from infections or be anaemic)

•    you have any psychiatric disorder (e.g. schizophrenia or manic depression)

•    you have liver or cardiovascular disease

•    you cannot pass urine or have an enlarged prostate gland

•    you have an overactive thyroid gland and are taking medicines to treat a thyroid disorder

•    you have a history of epilepsy

•    you are being given electroconvulsive therapy (ECT)

•    you have increased pressure in the eye (known as narrow-angle glaucoma)

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 maybe more likely to think like this:

•    If you have previously had thoughts about killing or harmingyourself.

•    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.

	Artwork No.		250408/1			Colours Used
Artwork Creative' Desians	Customer		Relon Chem		■	Balck
	Descri ption		Amitriptyline 25mg Pi 1		■	Keyline (not to print)
	Market		UK
_c	Language		English
/T	Size		140 x 210 mm
	Min. Font Size		9 pt
V	Page No.		2 of 2
r	Version No.		10
e-mail : prasad.pdp@gmail.com Ph : +91-9845609386	Date		12-09-12
	Softwa	re	Illustrator 10
Packaging Development		Quality Assurance (QA)		Quality Control (QC)		Production

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.

Taking other medicines:

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, including herbal 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 oryou have taken MAOIs within the last I4days

•    other medicines used to treat depression, includingthe 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 orclonidine 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 helpyou 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).

Taking Amitriptyline Tablets with food and drink:

Amitriptyline should not be taken with alcohol as it will increase the sedative effects of this medicine and therefore should be avoided.

It is not necessary to take these tablets with food. These tablets are taken with a glass of water.

Pregnancy and Breastfeeding:

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 Amitriptylinetablets ifyou are breast-feeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

If you feel dizzy or drowsy when you start taking this medicine, do not drive or operate machinery until these effects wear off.

Important information about some of the ingredients of Amitriptyline Tablets

This product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

The 25mg tablets contain sunset yellow (EIIO), which may cause allergic-type reactions including asthma.

3. How to take Amitriptyline Tablets

Always take Amitriptyline Tablets exactly as your doctor has told you. The pharmacist's label should tell you how much to take and how often. If you are unsure, check with your doctor or pharmacist.

For treatment of depression in:-

Adult and adolescents (children over 16

years of age)

An initial dose of 75mg is usually given and is either divided up into doses throughout the day or may be given as a single night time dose. This may be increased to I50mg daily. A maintenance dose of 50-l00mg a day may be given to be taken preferably at night.

The Elderly

An initial dose of 10-25 mg three times a day is recommended, preferably given as a single dose in the evening or at bedtime. This may be increase slowly. A daily dose of 50mg may be sufficient in elderly patients who may not tolerate higher dosages.

Your doctor will advise you on how many and how often to take these tablets.

This medicine is not recommended fortreatment of depression in children under 16 years.

Fortreatment of night-time bedwetting in: Children

6-IOyears    I0-20mgadaytobetakenat

night for not more than three months

11-16 years    25-50mg a day to be taken at

night for not more than three months

Under6years    Not recommended.

•    The tablets should be swallowed with a glass ofwater.

•    You should keep taking the medicine until yourdoctor tells you to stop.

•    This medicine may take up to 30 days to be fully effective incase of depression.

If you take more Amitriptyline Tablets than you should:

Ifyou swallow too many tablets or someone else accidentally takes your medicine, contact your doctor, pharmacist or nearest hospital straight away.

Symptoms of an overdose include hypothermia (very low body temperature which may show as shivering, feeling cold, low energy, and cold pale skin), irregular heartbeat, wide pupils, convulsions (fits), stupor (decreased mental alertness and consciousness) or coma.

If forget to take Amitriptyline Tablets:

Try to take Amitriptyline Tablets daily as prescribed. Ifyou forget to take a dose, take the next dose at the usual time. Do not take two doses together.

Ifyou stop taking Amitriptyline Tablets:

Do not stop taking this medicine suddenly, unless your doctor tells you to, as this may lead to unwanted effects such as nausea, headache or weakness.

•    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 you have any further questions on the use of Amitriptyline Tablets ask your doctor or pharmacist.

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 maybe 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.

Ifyou notice any of these, tell your doctor straight away.

Serious side effects: tell your doctor straight away

•    Ifyou feel more depressed, including thinking about suicide.

•    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