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

Amitriptyline belongs to a group ofmedicmes known as tricyclic antidepressants.

This medicine is used to treat:

• Depressionin adults(major depressive episodes)
• Neuropathic pain in adults
• Chronictensiontype headacheprophylaxis in adults
• Migraine prophylaxis in adults
• Bed-wetting at night in children aged 6 years and above, only when organic causes, suchas spina bifida and related disorders, have been excluded andno response has been achieved to all other non-drug and drug treatments, including muscle relaxants and desmopressin. This medicine should only be prescribed by doctors with expertise intreatingpatients withpersistentbed-wetting.

• 2. Whatyouneed­toknowbeforey­outake Amitriptyline Tablets

Do nottake Amitriptyline Tablets and tell your doctor:

• if you are allergic to amitnptyline or any of the otheringredients ofthis medicine (listed in section 6)
• if you recently have had a heart attack (myocardial infarction)
• if you have heart problems such as disturbances in heart rhythm which are seen onan electrocardiogram (ECG), heart block, or coronary artery disease
• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• ifyouhavetaken­MAOIswithinthe­last 14 days
• if you have taken moclobemide the day before if you have a severe liver disease Ifyouaretreatedwith Amitriptyline Tablets, you have to stop taking this medicine and wait for 14 days before you starttreatmen­twithaMAOI. This medicine should not be used for children belowb years ofage.

Warnings andprecautions

• Talk to your doctor or pharmacist or nurse before taking Amitriptyline Tabletsifyou have: Used Buprenorphine together with Amitriptyline tablets can leadto serotonin syndrome, a potentially life-threatening condition(see"Other medicines and Amitriptyline Tablets).
• Heart rhythm disorders and hypotension may occur if you receive a high dosage of amitriptyline. Thismightalso occurinusual doses ifyouhave pre-existingheart disease.

prolonged QT interval

A heart problem called "prolonged QT interval” (whichis shown onyour electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heartbeat) have been reported with Amitnptyline 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 conditioncalled­heartfailure),
• 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,
• have a surgery planned as it might be necessary to stop the treatment with amitnptyline before you are given anaesthetics. In the case ofacute surgery, the anaesthetist should be informed about the treatment of amitriptyline,
• have an over active thyroid gland or receive thyroid medication.

Thoughts of suicide and worsening of your depression

If you are depressed, you can sometimes have thoughts ofharming or killing themselves. Thesemaybe increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.

You maybe morelikely to thinklike this:

• If you have previously had thoughts about killing orharmingyourself.
• Ifyouareayoung adult. Information from

clinical trials has shown an increased risk of suicidal behaviour in young adults (less than 25 years old) withpsychiatric conditions who were treated with an antidepressant.

If you have thoughts of harming or kiUing yourself at any time, contact your doctor or go to a hospital straight away

You may find it helpful to tell arelative or close friend that you are depressed and ask themto read this leaflet. Youmightask them to tell you if they think your depression or anxietyis gettingworse, oriftheyare womed about changes in yourbehaviour

Episodes ofmania

Some patients withmanic-depressive illness may enterinto a manicphase. Thisis characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity In such cases, it isimportant to contact your doctor who probably will change your medication.

• TeU your doctor if you have, or have had in the past any medical problems, especially if you have narrowangle glaucoma (lossofvision due to abnormally high pressure in the eye)
• epilepsy,ahistory of convulsions orfits
• difficultyinpassing unne
• enlarged prostate
• thyroid disease
• bipolar disorder
• schizophrenia
• severe liver disease
• severe heart disease
• pylorus stenoas(nain:wing ofthe gastric outlet) and paralyticileus(bloc­ked intestine)
• diabetes as you might needanadjustment of your antidiabetic medicine

Ifyouuse antidepressants suchas SSRIs, your doctor might consider changing the dose of your medicine(see alsosection2 and section 3).

Elderlyaremore­likelyto suffer from certain side effects, suchas dizziness when you standup due to lowbloodpressu­re(seealso section4).

Children and adolescents

Depression, neuropathic pain, chronic tension type. headache and migraine prophylaxis Do not givethis medicine to children and adolescents aged below 18 years for these treatments as safety and efficacyhavenot been established inthis age group.

Bed-wetting at night

• An ECG should be performedpriorto initiating therapy with amitriptyline to exclude'longQT syndrome.
• This medicine should not be taken at the same time as an anticholinergic drug (see also section 2).
• Suicidal thoughts and behaviours may also develop during early treatment with antidepressants for disorders other than depression, the same precautions observed when treating patients with depression should therefore be followed when treating patients with enuresis.

Other medicines and Amitriptyline Tablets Somemedicines may affectthe action of other medicines and this can sometimes cause senous side effects.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:

• valproic acid
• monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide ortranylcypromine (used to treat depression) or selegiline (usedto treat Parkinson’s di­sease). These shouldnot be taken at the same time as Amitnptyline Tablets (see section 2)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (thesemay be present in cough or cold medicine, and in some anaesthetics)
• medicine to treat high blood pressure for example calcium-channel blockers (e.g. dilhazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
• Anticholinergic drugs such as certain medicines to treatParkinson’s di­sease and gastrointestinal disorders (e.g. atropine, hyoscyamine)
• thioridazine(usedto treat schizophrenia)
• tramadol (painkillers)
• medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressan­ts(e.g. SSRIs(fluoxetine, duloxetine, paroxetine, fluvoxamine), and bupropion)
• medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics)
• cimetidine (usedto treat stomachulcers)
• methylphenidate (used to treatADHD)
• ritonavir(used to treatHIV)
• oral contraceptives
• rifampicin (to treatinfechons)
• phenytoin and carbamazepine (usedto treat epilepsy)
• St. John's Wort (hypericum perforatum) -a herbal remedy used for depression
• thyroid medication

You should also tell your doctorifyou take or have recently taken medicine thatmay affect theheart’srhyt­hm. e.g.:

• medicines to treatirregular­heartbeats (e.g. quinidine and sotalol)
• astemizoleandter­fenadine(used­to treat allergies and hay fever)
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• cisapride (used to treat certain types of

indigestion)

• halofantnne(used to treat malana)
• methadone (used to treat pain and for

detoxification)

• diuretics ("water tablets” e.g. furosemide)

Some medicmesmayincrease theside effects of Amitnptyline Tabletsand may sometimes cause very serious reactions. Do nottakeany other medicines whilst taking Amitnptyline Tablets withoutfirsttal­kingto your doctor, especially: – buprenorphine/cpi­ods – These medicines may interact with Amitnptyline Tablets and you may expenence symptoms suchas involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweatmg,tremor, exaggeration ofreflexes, increased muscle tension, body temperature above38°C. Contactyourdoc­torwhen expenencingsuch symptoms.

If you are going to have an operation and receive general or local anaesthetics, you should tell your doctorthatyou are takingthis medicine. Likewise, you should tell your dentist that you take this medicine if you are to receive a local anaesthetic.

Amitriptyline Tablets withalcohol

It is not advised to drink alcohol during treatment with this medicine as it might increase the sedative effect.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Amitnptylineis not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration ofthebenefit and nsk Ifyou have taken this medicine during the last part of the pregnancy, the new-born may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor dnnking, loud crying, urinary retention, and constipation.

Your doctor will adviseyou whetherto starts continue/ stop breast-feeding or stop using this medicine taking into accountthe benefit of breast-feeding for your child and the benefit of therapy for you.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially in the beginning of the treatment. Do not dnve orworkwithtools or machineryifyou are affected.

Amitnptyline tablets contains Lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctorbefore takingthis medicinal product.

3. How totake Amitriptyline Tablets

Always take this medicine exactly as your doctorhas toldyou. Check with your doctorif you are not sure. Not all dosage schemes can be achieved with all the pharmaceutical forms/ strengths. Theappropriate­formulation/stren­gth should be selected for the starting doses and any subsequent doseincreases.

Depression

Adults

The recommended initial dose is 25 mg two times daily Depending on the response to the medicine, your doctor may gradually increase the dose to 150 mg per day divided in two doses.

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10 mg – 25 mg daily Depending on your response to the medicine, your doctor may gradually increase the dose to a total daily dose of 100 mg divided intwo doses. If youreceive doses in therange of 100 mg – 150 mg, your doctor may need to do more frequent follow-up with you.

Use in children and adolescents

This medicine should not be given to children oradolescents fortreatment of depression. For lurthermformation please see section 2. Neuropathic pain, chronic tension type headache and migraine prophylaxis Your doctor will adjust the medication according to your symptoms and your response to the treatment.

Adults

The recommended initial dose is 10 mg – 25 mg in the evening.

The recommended daily doseis25mg-75 mg. Depending onyourresponse to the medicine, your doctor may graduallyincre­asethe dose.

If you receive doses above 100 mg daily, your doctor may need to do more frequent follow-up with you. Your doctor will instruct youwhether to take the doses once daily or divide into two doses.

Elderly (above 65 years ofage) and patients

S with cardiovascular disease

The recommended initial dose is 10 mg -__ 25mgintheevenmg.

:|J Dependingonyou­rresponsetothe­medicine,

:a yourdoctormay­graduallymcre­asethedose.

If you receive doses above 75 mg daily, your doctor may need to do more frequent follow-up with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. For furtherinforma­tionplease see section 2.

Bed-wetting at night

Use in children and adolescents

• The recommended doses for children: aged below 6 years: see section 2 aged 6to10 years: 10mg –20mg daily A suitable dosage form shouldbe used for this age group.
• aged 11 years andabove: 25 mg –50 mg. The dose should beincreased gradually Take this medicine 1–1% hoursbefore bedtime. Before starting treatment, your doctor will conductanECG ofyour heartto check for sign of unusual heartbeat.

Your doctor will re-evaluateyourtre­atment after 3 months and if needed perform a new ECG.Do not stop the treatmentwithout consulting your doctor first.

Patients with special risks

Patients withliverdiseases orpeopleknown as “poormetabolisers” usuallyreceive lower doses. Your doctor may take blood samples to deteimme the level of amitriptyline in the blood (see also section 2).

How and when to take Amitriptyline Tablets This medicine can be taken with or without food.

Swallow thetablets with a drink of water Donot chewthem.

Duration of treatment

Donot changethe dose ofthe medicine or stop taking the medicine without consulting your doctor first.

Depression

Aswith othermedicines forthe treatment of depression it may take a few weeks before you feel any improvement.

In treating depression, the duration of treatment is individual, and is usually at least 6 months. The duration oftreatment is decided byyourdoctor Continuetotaket­hismedicine for as long as your doctor recommends.

The underlying iUness may persist for a long time. Ifyou stop yourtreatment too soon, your symptoms may return.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

It might take a few weeks before you feel any improvement of your pain.

Talk to your doctor about the duration of your treatment and continue to take this medicine for as long as your doctor recommends.

Bed-weiiing at night

Yourdoctorwill evaluateifthe­treatment shouldbe continuedafter 3 months.

Ifyoutakemore Amitriptyline Tablets than you should

Contactyour doctor ornearesthospital casualty departmentimme­diately Do this even if there are no signs of discomfort or poisoning. Take the container ofthis medicine with youifyou go to a doctor or hospital.

Symptoms of overdose include:

• dilated pupils
• fast or irregular heartbeats
• difficulties passing water
• dry mouth and tongue
• intestinal blockage
• fits
• fever
• agitation
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• difficulty breathing
• blue discolouration of the skin
• decreased heart rate
• drowsiness
• loss of consciousness
• coma
• various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia.

Overdosewith Amitriptyline Tablets in children couldhave senous consequences. Children are especially susceptibleto coma, cardiac symptoms, difficulty inbreathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and high blood sugarlevel.

Ifyouforgetto take Amitriptyline Tablets Take thenext dose at theusual time. Do not take a double dose to make up for a forgotten dose.

Ifyoustop taking Amitriptyline Tablets

Your doctor will decide whenandhowto stop your treatment to avoid any unpleasant symptoms that might occur if it is stopped abruptly (e.g. headache, feelingunwell, sleeplessness and irritability).

If you have any further questions on the use of this medicine, askyour doctor orpharmacist.

• 4. Possible side efiects

Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.

Ifyougetany ofthefollowing symptoms you should see your doctor immediately:

• – Attacks ofintermittent blurnmg ofvision, rainbowvision, and eye pain.

You should immediatelyhave an eye examinationbelore the treatmentwith this medicine canbe continued. This condition maybe signs ofacute glaucoma. Veryrare side effect may affectup to1in1O,O0O people.

• – A heart problem called “prolonged QT rnterval” (whichis shown on your electrocardio­giamECG). Common side effectmay affectup to 1 in 10people.

• – Bad constipation, a swollen stomach, fever

and vomiting.

These symptoms may be due to parts of theintestne becoming paralysed. Rare side effectmay affectup to1in1,000 people.

• – Anyyellowing ofthe skinand thewhite in

the eyes (jaundice).

Your Ever maybe affected. Rare side effect mayaffect upto 1in 1,000people.

• – Bruising, bleeding, pallor or persistent sore throat and fever

These symptoms canbe the first signs that your blood or bone marrow may be affected.

Effects ontheblood could bea decrease m the number ofred cells (which carry oxygen around thebody), white cells (which help to fight infection) and platelets (whichhelp with clotting).Rare­sideeffectmay­affectupto 1in 1,00°peop‘e....... „ .

• Suicidal thoughts orbehaviour Rare side effect may affectup to1in1,000 people.

Side effects listedbelowhave been reported in the following frequencies:

Verycommon: mayaffectmore than 1 in

10 people

• sleepiness/drow­siness
• shakiness of hands or other body parts
• dizziness
• headache
• irregular, hard, or rapid heartbeat
• dizziness when you stand up due to low

bloodpressure (orthostatichy­potension)

• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• slurred or slow speech
• aggression
• congestednose.

Common: may affectup to 1 in 10people

• confusion
• sexualdisturban­ces(decreased­sex-drive, __ problems with erection)
• disturbance in attention
• changes m taste
• numbness or tingling in the arms or legs H
• disturbed coordination
• dilated pupils
• heart block
• fatigue
• low sodium concentration in the blood
• agitation
• urination disorders
• feeling thirsty
• Uncommon: may affectup to 1in 100 people excitement, anxiety, difficulties sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhoea, vomiting
• skin rash, nettle rash(urticanalj, swelling of the face and tongue
• difficulties passingurine
• increased production of breast milk or breast milk ouffiowwilhou­tbreast feeding
• increased pressure in the eye ball
• collapse conditions
• worsening of cardiac falure
• liverfuncUonim­pairment(e.g cholestatic

liver disease).

Rare: may affectup to1in 1,000 people

• decreased appetite
• delirium(especially in elderly patients),

hallucinations

• abnormality in the heart’s rhythm, or

heartbeat pattern

• swelling of the salivary glands
• hair loss
• increased sensitivity to sunlight
• breast enlargement in men
• fever
• weight loss
• abnormal results ofliver function tests.

Veryrare: mayaffectup to1in 10,000people

• heart muscle disease
• feeling of inner restlessness and a compelling need to be in constant motion
• disorder of the peripheral nerves
• acute increase of pressure in the eye
• particular forms of abnormal heart rhythm (so calledtorsades depointes)
• allergic inflammation ofthe lungalveoli

and of the lung tissue

Notknown: frequency cannot be estimated from the available data

• absent sensation of appetite
• elevation or lowering of blood sugar levels
• paranoia
• movement disorders (involuntary

movements or decreased movements)

• hypersensitivity inflammation ofheart

muscle

• hepatitis
• hot flush
• dry eyes

Anincreased nsk ofbone fractures has been observed in patients taking this type of medicines.

Reporting of side effects

If you get any side effects, talkto your doctor, pharmacist ornurse. This includes any possible side effects notlistedinthis leaflet. You can also report side effects directly via theyeUow card scheme at Website: www mhra.gov uk/yeUowcard or search forMHRA Yellow Card intheGoogle Play or Apple App Store. 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.

Do not use thismedicineaf­terthe expiry date stated onthe label afterEXP The expiry date refers to the last day ofthatmonth.

This medicinal product does not require any special storage conditions.

Do not throwaway anymedicrnes via wastewater or household waste Ask your pharmacist how to throw awy medicines you no longeruse. These measures will help protect the environment.

• 6. Contentsof­thepackandother information

What Amitriptyline Tablets contains

• The active substance is amitriptyline

hydrochloride.

Amitriptyline 10mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 10 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadryblue(85F99075),­hypromellose, macrogol 6000, purified water Composition of'Opadry Blue (85F99075): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, FD&.C Blue (E133).

Amitriptyline 25mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 25 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry II yellow(85F92349), hypromellose, macrogol 6000, purified water Corm>osition of'Opadry IIyellow (85F92349): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow(E172).

Amitriptyline 50mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 50 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry IIbrown(85F565015), hypromellose, macrogol 6000, purified water

Corm>osition of'Opadry IIbrown (I5F565015): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow(E172), iron oxide red (E172).

Amitriptyline 10mg Tablets

90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Amitriptyline 25mg Tablets

Round yellow colored biconvextablets plain onboth sides.

Blister pack: Packedinblisters ofPVCiPVDC/ Aluin 20's, 24's, 28s, 30's, 56's, 60's, 84's, 90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Amitriptyline 50mg Tablets

Round brown coloredbiconvex tablets plain on both sides.

Blisterpack: Packedinblisters iWhYTI' Aluin 20's, 24's, 28's, 30's, 56's, 60's, 84's, 90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Notall pack sizes may bemarketed.

Marketing Authorization Holder and Manufacturer

StndesPharmaUK Ltd.,

WD18 9SSUnitedKingdom

This leafletwas last revised in Jan 2022.

IIIIIIIIIIIU___________­_____

Back Side

below 18years forthesetreatments as safetyand efficacy have not been establishedinthis age group.

Bed-wetting at night

• AnECG shouldbe performed pnorto initiating therapy with amitnptyline to exclude long QT syndrome.
• This medicine should not be taken at the same time as an anticholinergic drug (see also section 2).
• Sncidalthoughtsan­dbehavioursma­yalso develop

during early treatment with antidepressants for disorders other than depression, the same precautions observed when treating patients with depression should therefore be followedwhentre­atrngpatients with enuresis.

Other medicines and Amitriptyline Tablets

Some medicines may affect theachon of othermedicines andthis can sometimes cause serious side effects.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:

• valproic acid
• monoamine oxidaseinhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (usedto treat depression) or selegiline (used to treat Parkinson’s di­sease). These shouldnotbe taken atthe same time as Amitnptyline Tablets (see section 2)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• medicineto treathighblood pressure for example calcium-channelblocker­s(e.g. dilhazemandve­rapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
• Anticholinergic drugs suchas certain medicines to treat

Parkinson’s disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)

• thioridazine (used to treat schizophrenia)
• tramadol (painkillers)
• medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressan­ts(e.g. SSRIs (fluoxetine, duloxetine,

paroxetine, fluvoxamine), and bupropion)

• medicines for certainheart conditions (e.g. betablockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir(used to treat HIV)
• oral contraceptives
• rifampicin(to treat infections)
• phenytoinand carbamazepine (used to treat epilepsy)
• St.John's Wort (hypericum perforatum) -aherbalreme-dy used for depression
• thyroid medication

You shouldalso tell your doctorifyoutake orhave recently takenmedicinet­hatmay affectthehear­t’srhythm. e.g­.:

• medicines to treatirregular­heartbeats (e.g. quinidine and sotalol)
• astemizole and terfenadine (used to treataUergies and hay fever)
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• cisapride (usedto treat certain typesof indigestion)
• halofantrine (usedto treatmalaria)
• methadone(usedto treat painand for detoxification)
• diuretics(“wa­terta.blets" e.g. furosemide)

Some medicines mayincreasethe side effects of Amitriptyline Tablets andmay sometimes causevery serious reactions.

Do not take any other medicines whilsttaking Amitriptyline Tablets withoutfirsttalking to your doctor, especially:

– buprenorphine/o­piods – These medicines may interact with Amitriptyline Tablets andyoumay experience symptoms such as involuntary, thythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration ofreflexes, increased muscle tension, body temperature above 38°C. Contactyour doctorwhen experiencing such symptoms.

If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine.

Likewise, you should tell your dentist that you take this medicine ifyou are to receivealocal anaesthetic.

Amitriptyline Tablets withalcohol

It is not advised to drink alcohol dunng treatment with this medicine as itmight increase the sedative effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advicebefore taking this medicine.

Amitriptyline is notrecommended during pregnancyunless your doctor considers it clearly necessary and only after careful considerationof­thebenefitandris­k. Ifyouhave taken this medicine during the last part of the pregnancy, the new-born may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, unnary retention, and constipation.

Your doctor will advise youwhetherto startdcontinuef stop breast-feeding or stop using this medicine taking into accountthe benefit ofbreast-feeding foryour childand the benefit oftherapy foryou.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially inthe beginning ofthe treatment. Donot drive or work with toolsor machineryifyou are affected.

Amitriptyline tablets contains Lactose

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

3. how to take amitriptyline tablets

Alwaystakethis medicine exactly as your doctorhas told you. Check with your doctorifyou are not sure. Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. Theappropriate formulation/stren­gth should be selected for the starting doses and any subsequent dose increases.

Depression

Adults

The recommendedinitial doseis25 mgtwo times daily Depending on the response to themedicine, your doctor may gradually increase the dose to 150 mg per day divided in two doses.

Elderly (above 65 years ofage.) and patients with cardiovascular disease

The recommendedinitial doseis 10 mg – 25 mg daily Depending on yourresponse to the medicine, your doctor may gradually increase the dose to a total daily dose of 100 mg dividedintwo doses. Ifyoureceive dosesin therange of 100 mg – 150 mg, your doctor may need to do more frequent follow-up withyou.

Use in children and adolescents

This medicine should not be given to children or adolescents fortreatment of depression. For furtherinforma­tionplease see section 2.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

Your doctor will adjustthe medication accordingto your symptoms and yourresponseto thetreatment.

Adults

The recommended initial dose is 10 mg – 25 mg in the evening.

The recommended daily doseis25 mg – 75 mg. Depending on yourresponse to the medicine, your doctor may graduallyincre­asethe dose. Ifyou receive doses above 100 mg daily, your doctor may need to do more frequent follow-up withyou. Your doctor wiU instructyou whetherto take the doses once daily or divide into two doses.

Dimension – 180 × 550 mm

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10 mg – 25 mg in the evening.

Depending onyourresponse to the medicine, your doctor may gradually increase the dose. Ifyou receive doses above 75 mg daily, your doctor may need to do more frequent follow-up with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. For further informahonplease see section 2.

Bed-wetting at night

Use in children and adolescents

The recommended doses for children:

• aged below 6 years: see section 2
• aged 6 to lOyears 10 mg – 20 mg daily A suitable dosage form should be used for this age group.
• aged 11 years and above: 25 mg – 50 mg.

The dose shouldbe increased gradually

Takethis medicine 1–1% hours before bedtime.

Before starting treatment, your doctor will conductanECG ofyourheart to check for sign ofunusual heartbeat.

Your doctor will re-evaluate yourtreatmentafter 3 months and ifneeded performanewECG. Do not stop the treatment without consulting your doctor first.

Patients with special risks

Patients with liver diseases or peopleknown as "poor metabolisers” usually receive lower doses.

Your doctor may take blood samples to determine thelevel ofamitnptyline intheblood(seealso section 2).

How and when to take Amitriptyline Tablets

This medicine can be takenwith orwithout food.

Swallowthe tablets witha drink ofwater Do not chewthem.

Duration of treatment

Do not change the dose ofthemedicrne or stop takingthe medicine without consulting your doctor first.

Depression

As with other medicines for the treatment of depression it may takea few weeks before you feel any improvement.

In treating depression, the duration of treatment is individual, and isusuallyatleast 6 months. The duration oftreatmentis decided byyour doctor Continue to takethis medicine foras longasyour doctorrecommends. The underlyingillness may persist foralong time. Ifyou stop yourtreatmenttoo soon, your symptoms may return.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

It might take a few weeks before you feel any improvement ofyour pain.

Talk to your doctor about the duration of your treatment and continue to take this medicrne for as long as your doctor recommends.

Bed-wetting at night

Your doctor will evaluateifthe treatment should be continued after 3 months.

If youtakemor Amitriptyline Tabletsthanyou should Contactyour doctor ornearesthospital casualty department immediately Dothis evenifthere are no signs of discomfort orpoisoning. Takethe container of this medicine withyou if you go to a doctor orhospital.

Symptoms of overdoseinclude

• dilated pupils
• fast or irregular heartbeats
• difficulties passingwater
• dry mouth and tongue
• intestinal blockage
• fits
• fever
• agitation
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• difficulty breathing
• blue discolouration of the skin
• decreased heart rate
• drowsiness
• loss of consciousness
• coma
• various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia.

Overdose with Amitnptylne Tablets in children could have serious consequences. Childrenare especially susceptible to coma, cardiac symptoms, difficulty inbreathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and hi^blood sugarlevel.

If you forgettotake Amitriptyline Tablets

Takethe next dose atthe usual time. Do not takea double dose to makeup fora forgotten dose.

If youstop taking Amitriptyline Tablets

Your doctor will decide when and howto stop your treatment to avoid any unpleasant symptoms that might occur ifitis stopped abruptly feg headache, feelingunweU, sleeplessness and irritability).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.

If yougetanyof the followingsynptoms youshould see your doctor immediately:

• – Attacks of rntermittentblumng ofvision, rainbow vision, and eye pain.

You shouldimmediately havean eye examination before the treatmentwiththis medicine can be continued. This condition maybe signs ofacute glaucoma. Veryrare side effect mayaffect upto 1in10,000 people.

• – A heart problem called"prolonged QT interval” (which is shown on your electrocardiogram, ECG). Common side effect mayaffect upto 1in10 people.

• – Bad constipation, a swollen stomach, feverandvomiting. These symptoms may be due to parts of the intestine becoming paralysed. Rare side effect may affect up to 1 in 1,000 people.

• – Any yellowing ofthe skin andthe whitein the eyes (jaundice).

Yourlivermay beaffected. Rare side effect may affect upto1rn 1,000 people.

• – Bruising bleeding, pallor orpersistent sore throat andfever. These symptoms canbe thefirst signs thatyourblood or bone marrowmaybe affected.

Effects ontheblood couldbe a decrease inthe number of red cellsfwhich carry oxygen around thebody), white cells (whichhelp to fightinfechon) and platelets (whichhelp with clotting). Rare side effect mayaffect upto 1 in 1,000 people.

• Suicidal thoughts orbehaviour Rare side effect may affectupto 1in 1,000people.

Side effects listed belowhavebeen­reported in the following frequencies:

Very common: may affectmorethan 1 in 10people

• sleepiness/drow­siness
• shakiness of hands or other body parts
• dizziness
• headache
• irregular, hard, or rapid heartbeat
• dizzrness when you standup dueto lowbloodpressure (orthostatic hypotension)
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• slurred or slow speech
• aggression
• congested nose.

Common: mayaffect upto1in10 people

• confusion
• sexual disturbances (decreased sex-drive, problems with erection)
• disturbance m attention
• changes in taste
• numbness or tingling in the arms or legs
• disturbed coordination
• dilated pupils
• heart block
• fatigue
• low sodium concentration in the blood
• agitation
• urination disorders
• feeling thirsty

Uncommon: mayaffectup to 1 in100 people

• excitement, anxiety, difficulties sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhoea, vomiting
• skinrash, nettlerash (urticarial), swelling ofthe face and tongue
• diffi culhespassingunne
• ncreased production of breast milk or breast milk outflow without breast feeding
• ncreased pressure in the eye ball
• collapse conditions
• worsening of cardiac failure
• Ever function impairment (e.g. cholestahcliver disease).

Rare: mayaffect upto 1 in 1,000 people

• decreased appetite
• delirium(espe­ciallym elderlypahents), hallucinations
• abnormality in the heart’s rhythm, or heartbeat pattern swelling of the salivary glands hair loss
• ncreased sensitivity to sunlight
• breast enlargement in men
• fever
• weight loss
• abnormal results ofliver function tests.

Veryrare: mayaffectup to 1 in 10,000 people

• heart muscle disease
• feeling of inner restlessness and a compelling need to be

in constant motion

• disorder of the peripheral nerves
• acute ncrease of pressure in the eye
• particular forms ofabnormal heart rhythm(so called torsades de pointes)
• allergic inflammation ofthelung alveoli and ofthe lung tissue

Not known: frequency cannot be estimated from the available data

• absent sensation of appetite
• elevation or lowering of blood su^r levels
• paranoia
• movement disorders (involuntarymo­vements or de-creasedmovements)
• hypersensitivi­tyinffammation ofheartmuscle
• hepatitis
• hot flush
• dry eyes

An increasedrisk ofbone fractures has been observed in patients taking this type ofmedicines.

Reporting of side effects

Ifyou getany side effects, talk to your doctor, pharmacist ornurse. This includes anypossible side effects notlisted in this leaffet You canalso report side effects directly via the yellow card schemeat Website: wwwmhra.gov.uk/ yeUowcard or search forMHRA YellowCardinthe­Google Play or Apple App Store. 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.

Do not use thismedicineaf­terthe expiry date stated onthe label afterEXP The expiry date refers to the last day ofthatmonth.

This medicinal product does not require any special storage conditions.

Do not throwaway anymedicrnes via wastewater or household waste Ask your pharmacist how to throw awy medicines you no longeruse. These measures will help protect the environment.

• 6. Contentsof­thepackandother information

What Amitriptyline Tablets contains

• The active substance is amitriptyline

hydrochloride.

Amitriptyline 10mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 10 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadryblue(85F99075),­hypromellose, macrogol 6000, purified water Composition of'Opadry Blue (85F99075): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, FD&.C Blue (E133).

Amitriptyline 25mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 25 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry II yellow(85F92349), hypromellose, macrogol 6000, purified water Corm>osition of'Opadry IIyellow (85F92349): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow(E172).

Amitriptyline 50mg Tablets

Each film-coated tabletcontains

Amitriptyline hydrochloride 50 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, corn maize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry IIbrown(85F565015), hypromellose, macrogol 6000, purified water

Corm>osition of'Opadry IIbrown (I5F565015): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow(E172), iron oxide red (E172).

Amitriptyline 10mg Tablets

90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Amitriptyline 25mg Tablets

Round yellow colored biconvextablets plain onboth sides.

Blister pack: Packedinblisters ofPVCiPVDC/ Aluin 20's, 24's, 28s, 30's, 56's, 60's, 84's, 90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Amitriptyline 50mg Tablets

Round brown coloredbiconvex tablets plain on both sides.

Blisterpack: Packedinblisters iWhYTI' Aluin 20's, 24's, 28's, 30's, 56's, 60's, 84's, 90's, 98's, 100's, 112's, 120's, 168's, 180's, 250's size packs.

Notall pack sizes may bemarketed.

Marketing Authorization Holder and Manufacturer

StndesPharmaUK Ltd.,

WD18 9SSUnitedKingdom

This leafletwas last revised in Jan 2022.

IIIIIIIIIIIU___________­_____

Back Side

below 18years forthesetreatments as safetyand efficacy have not been establishedinthis age group.

Bed-wetting at night

• AnECG shouldbe performed pnorto initiating therapy with amitnptyline to exclude long QT syndrome.
• This medicine should not be taken at the same time as an anticholinergic drug (see also section 2).
• Sncidalthoughtsan­dbehavioursma­yalso develop

during early treatment with antidepressants for disorders other than depression, the same precautions observed when treating patients with depression should therefore be followedwhentre­atrngpatients with enuresis.

Other medicines and Amitriptyline Tablets

Some medicines may affect theachon of othermedicines andthis can sometimes cause serious side effects.

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, such as:

• valproic acid
• monoamine oxidaseinhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (usedto treat depression) or selegiline (used to treat Parkinson’s di­sease). These shouldnotbe taken atthe same time as Amitnptyline Tablets (see section 2)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• medicineto treathighblood pressure for example calcium-channelblocker­s(e.g. dilhazemandve­rapamil), guanethidine, betanidine, clonidine reserpine and methyldopa
• Anticholinergic drugs suchas certain medicines to treat

Parkinson’s disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)

• thioridazine (used to treat schizophrenia)
• tramadol (painkillers)
• medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)
• sedatives (e.g. barbiturates)
• antidepressan­ts(e.g. SSRIs (fluoxetine, duloxetine,

paroxetine, fluvoxamine), and bupropion)

• medicines for certainheart conditions (e.g. betablockers and antiarrhythmics)
• cimetidine (used to treat stomach ulcers)
• methylphenidate (used to treat ADHD)
• ritonavir(used to treat HIV)
• oral contraceptives
• rifampicin(to treat infections)
• phenytoinand carbamazepine (used to treat epilepsy)
• St.John's Wort (hypericum perforatum) -aherbalreme-dy used for depression
• thyroid medication

You shouldalso tell your doctorifyoutake orhave recently takenmedicinet­hatmay affectthehear­t’srhythm. e.g­.:

• medicines to treatirregular­heartbeats (e.g. quinidine and sotalol)
• astemizole and terfenadine (used to treataUergies and hay fever)
• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)
• cisapride (usedto treat certain typesof indigestion)
• halofantrine (usedto treatmalaria)
• methadone(usedto treat painand for detoxification)
• diuretics(“wa­terta.blets" e.g. furosemide)

Some medicines mayincreasethe side effects of Amitriptyline Tablets andmay sometimes causevery serious reactions.

Do not take any other medicines whilsttaking Amitriptyline Tablets withoutfirsttalking to your doctor, especially:

– buprenorphine/o­piods – These medicines may interact with Amitriptyline Tablets andyoumay experience symptoms such as involuntary, thythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration ofreflexes, increased muscle tension, body temperature above 38°C. Contactyour doctorwhen experiencing such symptoms.

If you are going to have an operation and receive general or local anaesthetics, you should tell your doctor that you are taking this medicine.

Likewise, you should tell your dentist that you take this medicine ifyou are to receivealocal anaesthetic.

Amitriptyline Tablets withalcohol

It is not advised to drink alcohol dunng treatment with this medicine as itmight increase the sedative effect.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advicebefore taking this medicine.

Amitriptyline is notrecommended during pregnancyunless your doctor considers it clearly necessary and only after careful considerationof­thebenefitandris­k. Ifyouhave taken this medicine during the last part of the pregnancy, the new-born may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, unnary retention, and constipation.

Your doctor will advise youwhetherto startdcontinuef stop breast-feeding or stop using this medicine taking into accountthe benefit ofbreast-feeding foryour childand the benefit oftherapy foryou.

Driving and using machines

This medicine may cause drowsiness and dizziness, especially inthe beginning ofthe treatment. Donot drive or work with toolsor machineryifyou are affected.

Amitriptyline tablets contains Lactose

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

3. how to take amitriptyline tablets

Alwaystakethis medicine exactly as your doctorhas told you. Check with your doctorifyou are not sure. Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. Theappropriate formulation/stren­gth should be selected for the starting doses and any subsequent dose increases.

Depression

Adults

The recommendedinitial doseis25 mgtwo times daily Depending on the response to themedicine, your doctor may gradually increase the dose to 150 mg per day divided in two doses.

Elderly (above 65 years ofage.) and patients with cardiovascular disease

The recommendedinitial doseis 10 mg – 25 mg daily Depending on yourresponse to the medicine, your doctor may gradually increase the dose to a total daily dose of 100 mg dividedintwo doses. Ifyoureceive dosesin therange of 100 mg – 150 mg, your doctor may need to do more frequent follow-up withyou.

Use in children and adolescents

This medicine should not be given to children or adolescents fortreatment of depression. For furtherinforma­tionplease see section 2.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

Your doctor will adjustthe medication accordingto your symptoms and yourresponseto thetreatment.

Adults

The recommended initial dose is 10 mg – 25 mg in the evening.

The recommended daily doseis25 mg – 75 mg. Depending on yourresponse to the medicine, your doctor may graduallyincre­asethe dose. Ifyou receive doses above 100 mg daily, your doctor may need to do more frequent follow-up withyou. Your doctor wiU instructyou whetherto take the doses once daily or divide into two doses.

Dimension – 180 × 550 mm

Elderly (above 65 years of age) and patients with cardiovascular disease

The recommended initial dose is 10 mg – 25 mg in the evening.

Depending onyourresponse to the medicine, your doctor may gradually increase the dose. Ifyou receive doses above 75 mg daily, your doctor may need to do more frequent follow-up with you.

Use in children and adolescents

This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis. For further informahonplease see section 2.

Bed-wetting at night

Use in children and adolescents

The recommended doses for children:

• aged below 6 years: see section 2
• aged 6 to lOyears 10 mg – 20 mg daily A suitable dosage form should be used for this age group.
• aged 11 years and above: 25 mg – 50 mg.

The dose shouldbe increased gradually

Takethis medicine 1–1% hours before bedtime.

Before starting treatment, your doctor will conductanECG ofyourheart to check for sign ofunusual heartbeat.

Your doctor will re-evaluate yourtreatmentafter 3 months and ifneeded performanewECG. Do not stop the treatment without consulting your doctor first.

Patients with special risks

Patients with liver diseases or peopleknown as "poor metabolisers” usually receive lower doses.

Your doctor may take blood samples to determine thelevel ofamitnptyline intheblood(seealso section 2).

How and when to take Amitriptyline Tablets

This medicine can be takenwith orwithout food.

Swallowthe tablets witha drink ofwater Do not chewthem.

Duration of treatment

Do not change the dose ofthemedicrne or stop takingthe medicine without consulting your doctor first.

Depression

As with other medicines for the treatment of depression it may takea few weeks before you feel any improvement.

In treating depression, the duration of treatment is individual, and isusuallyatleast 6 months. The duration oftreatmentis decided byyour doctor Continue to takethis medicine foras longasyour doctorrecommends. The underlyingillness may persist foralong time. Ifyou stop yourtreatmenttoo soon, your symptoms may return.

Neuropathic pain, chronic tension type headache and migraine prophylaxis

It might take a few weeks before you feel any improvement ofyour pain.

Talk to your doctor about the duration of your treatment and continue to take this medicrne for as long as your doctor recommends.

Bed-wetting at night

Your doctor will evaluateifthe treatment should be continued after 3 months.

If youtakemor Amitriptyline Tabletsthanyou should Contactyour doctor ornearesthospital casualty department immediately Dothis evenifthere are no signs of discomfort orpoisoning. Takethe container of this medicine withyou if you go to a doctor orhospital.

Symptoms of overdoseinclude

• dilated pupils
• fast or irregular heartbeats
• difficulties passingwater
• dry mouth and tongue
• intestinal blockage
• fits
• fever
• agitation
• confusion
• hallucinations
• uncontrolled movements
• low blood pressure, weak pulse, pallor
• difficulty breathing
• blue discolouration of the skin
• decreased heart rate
• drowsiness
• loss of consciousness
• coma
• various cardiac symptoms such as heart block, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalaemia.

Overdose with Amitnptylne Tablets in children could have serious consequences. Childrenare especially susceptible to coma, cardiac symptoms, difficulty inbreathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and hi^blood sugarlevel.

If you forgettotake Amitriptyline Tablets

Takethe next dose atthe usual time. Do not takea double dose to makeup fora forgotten dose.

If youstop taking Amitriptyline Tablets

Your doctor will decide when and howto stop your treatment to avoid any unpleasant symptoms that might occur ifitis stopped abruptly feg headache, feelingunweU, sleeplessness and irritability).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine can cause side effects, althoughnot everybody gets them.

If yougetanyof the followingsynptoms youshould see your doctor immediately:

• – Attacks of rntermittentblumng ofvision, rainbow vision, and eye pain.

You shouldimmediately havean eye examination before the treatmentwiththis medicine can be continued. This condition maybe signs ofacute glaucoma. Veryrare side effect mayaffect upto 1in10,000 people.

• – A heart problem called"prolonged QT interval” (which is shown on your electrocardiogram, ECG). Common side effect mayaffect upto 1in10 people.

• – Bad constipation, a swollen stomach, feverandvomiting. These symptoms may be due to parts of the intestine becoming paralysed. Rare side effect may affect up to 1 in 1,000 people.

• – Any yellowing ofthe skin andthe whitein the eyes (jaundice).

Yourlivermay beaffected. Rare side effect may affect upto1rn 1,000 people.

• – Bruising bleeding, pallor orpersistent sore throat andfever. These symptoms canbe thefirst signs thatyourblood or bone marrowmaybe affected.

Effects ontheblood couldbe a decrease inthe number of red cellsfwhich carry oxygen around thebody), white cells (whichhelp to fightinfechon) and platelets (whichhelp with clotting). Rare side effect mayaffect upto 1 in 1,000 people.

• Suicidal thoughts orbehaviour Rare side effect may affectupto 1in 1,000people.

Side effects listed belowhavebeen­reported in the following frequencies:

Very common: may affectmorethan 1 in 10people

• sleepiness/drow­siness
• shakiness of hands or other body parts
• dizziness
• headache
• irregular, hard, or rapid heartbeat
• dizzrness when you standup dueto lowbloodpressure (orthostatic hypotension)
• dry mouth
• constipation
• nausea
• excessive sweating
• weight gain
• slurred or slow speech
• aggression
• congested nose.

Common: mayaffect upto1in10 people

• confusion
• sexual disturbances (decreased sex-drive, problems with erection)
• disturbance m attention
• changes in taste
• numbness or tingling in the arms or legs
• disturbed coordination
• dilated pupils
• heart block
• fatigue
• low sodium concentration in the blood
• agitation
• urination disorders
• feeling thirsty

Uncommon: mayaffectup to 1 in100 people

• excitement, anxiety, difficulties sleeping, nightmares
• convulsions
• tinnitus
• increased blood pressure
• diarrhoea, vomiting
• skinrash, nettlerash (urticarial), swelling ofthe face and tongue
• diffi culhespassingunne
• ncreased production of breast milk or breast milk outflow without breast feeding
• ncreased pressure in the eye ball
• collapse conditions
• worsening of cardiac failure
• Ever function impairment (e.g. cholestahcliver disease).

Rare: mayaffect upto 1 in 1,000 people

• decreased appetite
• delirium(espe­ciallym elderlypahents), hallucinations
• abnormality in the heart’s rhythm, or heartbeat pattern swelling of the salivary glands hair loss
• ncreased sensitivity to sunlight
• breast enlargement in men
• fever
• weight loss
• abnormal results ofliver function tests.

Veryrare: mayaffectup to 1 in 10,000 people

• heart muscle disease
• feeling of inner restlessness and a compelling need to be

in constant motion

• disorder of the peripheral nerves
• acute ncrease of pressure in the eye
• particular forms ofabnormal heart rhythm(so called torsades de pointes)
• allergic inflammation ofthelung alveoli and ofthe lung tissue

Not known: frequency cannot be estimated from the available data

• absent sensation of appetite
• elevation or lowering of blood su^r levels
• paranoia
• movement disorders (involuntarymo­vements or de-creasedmovements)
• hypersensitivi­tyinffammation ofheartmuscle
• hepatitis
• hot flush
• dry eyes

An increasedrisk ofbone fractures has been observed in patients taking this type ofmedicines.

Reporting of side effects

Ifyou getany side effects, talk to your doctor, pharmacist ornurse. This includes anypossible side effects notlisted in this leaffet You canalso report side effects directly via the yellow card schemeat Website: wwwmhra.gov.uk/ yeUowcard or search forMHRA YellowCardinthe­Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store amitriptyline tablets

Keepthis medicine out ofthe sightandreach of children. Do notusethis medicine afterthe expiry date stated on the label afterEXP. The expiry date refers to the last day ofthat month.

This medicinal product does not require any special storage conditions.

Do notthrowawayany medicines via wastewater or household waste Ask your pharmacist how to throwaway medicinesyou no longer use. These measures will help protect the environment.

• 6. Contentsof­thepackandother information What Amitriptyline Tablets contains

• The active substance is amitriptyline hydrochloride.

Amitriptyline 10 mg Tablets

Each film-coated tabletcontains Amitriptylinehydro-chloride 10 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, cornmaize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadryblue(85F99075),­hypromellose,ma­crogol 6000, purified water.

Composition of Opadry Blue (85F99075): polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, FD&CBlue(E133).

Amitriptyline 25 mg Tablets

Each film-coated tabletcontains Amitriptylinehydro-chloride 25 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, cornmaize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, Opadry II yellow(85F92349), hypromellose, macrogol 6000, purifiedwater Composition of Opadry IIyellow (85F92349): polyvinyl alcohol-parthydrolysed, titanium dioxide(E171), macrogol, talc,iron oxide yellow (E172).

Amitriptyline 50 mg Tablets

Each film-coated tabletcontains Amitriptylinehydro-chloride 50 mg.

The other ingredients are: lactose monohydrate, micro crystalline cellulose, cornmaize starch, croscarmellose sodium, colloidal silicon dioxide, talc, magnesium stearate, OpadryIIbrown(85F565015), hypromellose,ma­crogol 6000, purifiedwater

Composition of Opadry II brown (85F565015): polyvinyl alcohol-parthydrolysed, titanium dioxide(E171), macrogol, talc,iron oxide yellow (E172), iron oxide red (E172).

What Amitriptyline Tablets bokslikeandcontents ofthe pack

Amitriptyline 10 mg Tablets

Round blue coloredbiconvex tablets debossed 1 on one side andplain on other side.

Blisterpack: Packedinblisters ofPVC/PVDC/Alu­in20's, 24’s, 28’s, 30’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s, 112’s, 120’s, 168’s, 180’s, 250’s size packs.

Amitriptyline 25 mg Tablets

Roundyellow coloredbiconvex tablets plain on both sides. Blisterpack: Packedinblisters ofPVC/PVDC/Alu­in20’s, 24’s, 28s, 30’s, 56’s, 60’s, 84’s, 90’s, 98’s, 100’s, 112’s, 120’s, 168’s, 180’s, 250’s size packs.

Round brown colored biconvextablets plain onboth sides. ■___

Marketing Authorization Holder andManufacturer

Strides Pharma UK Ltd., Unit4,Metro Centre, Tolpits Lane, Watford, Hertfordshire, WD18 9SS United Kingdom

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Font size: Times New Roman 9 pt.