Amitriptyline belongs to a group of medicines known as tricyclic antidepressants

This medicine is used to treat:

• Depression in adults (major depressive episodes)

• Neuropathic pain in adults

• Chronic tension type headache prevention in adults

• Migraine prevention in adults

• Bed-wetting at night in children aged 6 years and above, only when organic causes, such as spina bifida and related disorders, have been excluded and no 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 in treating patients with persistent bed-wetting

Do not take Alatript

• If you are allergic to amitriptyline or any of the other ingredients of this 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 on an electrocardiogram (ECG), heart block, or coronary artery disease

• if you are taking medicines known as monoamine oxidase inhibitors (MAOIs)

• if you have taken MAOIs within the last 14 days

• if you have taken moclobemide the day before

• if you have a severe liver disease

If you are treated with Amitriptyline Tablets, you have to stop taking this medicine and wait for 14 days before you start treatment with a MAOI

This medicine should not be used for children below 6 years of age

Warnings and precautions

Talk to your doctor or pharmacist before taking Amitriptyline Tablets

The use of Buprenorphine/opioids together with Amitriptyline tablets can lead to 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. This might also occur in usual doses if you have pre-existing heart disease

Prolonged QT interval

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 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 condition called heart failure),

• 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 amitriptyline before you are given anaesthetics. In the case of acute 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 or anxiety disorder

If you are depressed, 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, 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

Episodes of mania

Some patients with manic-depressive illness may enter into a manic phase. This is characterized by profuse and rapidly changing ideas, exaggerated gaiety and excessive physical activity. In such cases, it is important to contact your doctor who probably will change your medication

Tell your doctor if you, or have had in the past, any medical problems, especially if you have

• narrow angle glaucoma (loss of vision due to abnormally high pressure in the eye)

• epilepsy, a history of convulsions or fits

• difficulty in passing urine

• enlarged prostate

• thyroid disease

• bipolar disorder

• schizophrenia

• severe liver disease

• severe heart disease

• pylorus stenosis (narrowing of the gastric outlet) and paralytic ileus (blocked intestine)

• diabetes as you might need and adjustment of your antidiabetic medicine

If you use antidepressants such as SSRIs, your doctor might consider changing the dose of your medicine (see also section 2 other medicines and Amitriptyline Tablets and section 3)

Elderly are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure (see also section 4 Possible side effects).

Children and adolescents

Depression, neuropathic pain, chronic tension type headache and migraine prevention

Do not give this medicine to children and adolescents aged below 18 years for these treatments as safety and efficacy have not been established in this age group

Bed-wetting at night

• An ECG should be performed prior to initiating therapy with amitriptyline to exclude long QT syndrome

• This medicines should not be taking at the same time as an anticholinergic drug (see also section 2 Other medicines and Amitriptyline Tablets)

• 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 bed-wetting

Other medicines and Amitriptyline Tablets

Some medicines may affect the action of other medicines and this can sometimes cause serious side effects

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

• monoamine oxidase inhibitors (MAOIs) e.g. phenelzine, iproniazid, isocarboxazid, nialamide or tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson's disease). These should not be taken at the same time as Amitriptyline Tablets (see section 2 Do not take Amitriptyline Tablets)

• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)

• medicines to treat high blood pressure for example calcium-channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine reserpine and methyldopa

• Anticholinergic drugs such as certain medicines to treat Parkinsons disease and gastrointestinal disorders (e.g. atropine, hyoscyamine)

• thioridazine (used to treat schizophrenia)

• tramadol (painkiller)

• medicines to treat fungal infections (e.g. fluconazole, terbinafine, ketoconazole, and itraconazole)

• sedatives (e.g. babiturates)

• antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion)

• Buprenorphine/Opioids may interact with Amitriptyline tablets and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including the muscles that control movement of the eye, agitation, hallucinations, coma, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38°C. Contact your doctor when experiencing such symptoms

• medicines for certain heart conditions (e.g. beta blockers and antiarrhythmics)

• cimetidine (used to treat stomach ulcers)

• methylphenidate (used to treat ADHD)

• ritonavir (used to treat HIV)

• oral contraceptives

• rifampicin (to treat infections)

• phenytoin and carbamazepine (used to treat epilepsy)

• St. John´s Wort (hypericum perforatum) – a herbal remedy used for depression

• thyroid medication.

• Valproic acid

You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm. e.g.:

• medicines to treat irregular heartbeats (e.g. quinidine and sotalol)

• astemizole and terfenadine (used to treat allergies and hayfever)

• medicines used to treat some mental illnesses (e.g. pimozide and sertindole)

• cisapride (used to treat certain types of indigestion)

• halofantrine (used to treat malaria)

• methadone (used to treat pain and for detoxification)

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

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 if you are to receive a local anaesthetic.

Amitriptyline Tablets with food, drink and alcohol

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

Pregnancy, breast-feeding and fertility

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

Amitriptyline is not recommended during pregnancy unless your doctor considers it clearly necessary and only after careful consideration of the benefit and risk. If you have taken this medicine during the last part of the pregnancy, the newborn may have withdrawal symptoms such as irritability, increased muscle tension, tremor, irregular breathing, poor drinking, loud crying, urinary retention (withholding/retaining urine), and constipation

Your doctor will advise you whether to start/continue/ stop breast-feeding, or stop using this medicine taking into account the 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 drive or work with tools or machinery if you are affected

Amitriptyline Tablets contain lactose monohydrate, sodium and sunset yellow FCF

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product, as it contains a type of sugar called lactose.

The 50mg tablets also contain a colour called ‘sunset yellow FCF’ which may cause allergic reactions.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

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

Swallow the tablets with a drink of water. Do not chew them

Duration of treatment

Do not change the dose of the medicine or stop taking the medicine without consulting your doctor first.

Depression

As with other medicines for the 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 of treatment is decided by your doctor

Continue to take this medicine for as long as your doctor recommends

The underlying illness may persist for a long time. If you stop your treatment too soon, your symptoms may return

Neuropathic pain, chronic tension type headache and migraine prevention

It might take a few weeks before your 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-wetting at night

Your doctor will evaluate if the treatment should be continued after 3 months

If you take more Amitriptyline Tablets than you should

Contact your doctor or nearest hospital casualty department immediately. Do this even if there are no signs of discomfort or poisoning. Take the container of this medicine with you if you 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 (abnormal heart rhythm due to issue with the heart's electrical system), heart failure (failure in the functioning of the heart), hypotension (decrease in blood pressure), cardiogenic shock (a condition in which your heart suddenly can't pump enough blood to meet your body's needs), metabolic acidosis (a condition that occurs when the body produces excessive quantities of acid), hypokalemia (decrease in the potassium level in the blood)

Overdose with amitriptyline in children could have serious consequences. Children are especially susceptible to coma, cardiac symptoms, difficulty in breathing, seizures, low blood sodium level, lethargy, drowsiness, nausea, vomiting and high blood sugar level

If you forget to take Amitriptyline Tablets

Take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose

If you stop taking Amitriptyline Tablets

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

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

Like all medicines, this medicine can cause side effects, although not everybody gets them

If you get any of the following symptoms you should see your doctor immediately

Attacks of intermittent blurring of vision, rainbow vision, and eye pain.

You should immediately have an eye examination before the treatment with this medicine can be continued. This condition may be signs of acute glaucoma. Very rare side effect, may affect up to 1 in 10,000 people

- A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG). Common side effect, may affect up to 1 in 10 people

- Bad constipation, a swollen stomach, fever and vomiting.

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 of the skin and the white in the eyes (jaundice).

Your liver may be affected. Rare side effect, may affect up to 1 in 1,000 people

- Bruising, bleeding, pallor or persistent sore throat and fever.

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

Effects on the blood could be a decrease in the number of red cells (which carry oxygen around the body), white cells (which help to fight infection) and platelets (which help with clotting). Rare side effect, may affect up to 1 in 1,000 people

• Suicidal thoughts or behaviour. Rare side effect, may affect up to 1 in 1,000 people

Side effects listed below have been reported in the following frequencies

Very common: may affect more 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 blood pressure (orthostatic hypotension)

• dry mouth

• constipation

• nausea

• excessive sweating

• weight gain

• slurred or slow speech

• aggression

• Problem with ability of the eye to change its focus from distant to near objects (and vice versa)

• congested nose

Common: may affect up to 1 in 10 people

• Confusion

• sexual disturbances (decreased sex-drive, problems with erection)

• disturbance in 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: may affect up to 1 in 100 people

• excitement, anxiety, difficulties sleeping, nightmares

• convulsions

• tinnitus

• increased blood pressure

• diarrhoea, vomiting

• skin rash, nettle rash (urticarial), swelling of the face and tongue

• difficulties passing urine

• increased production of breast milk or breast milk outflow without breast feeding

• increased pressure in the eye ball

• collapse conditions

• worsening of cardiac failure

• liver function impairment (e.g. cholestatic liver disease)

Rare: may affect up to 1 in 1000 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 of liver function tests

Very rare: may affect up 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 increase of pressure in the eye (acute glaucoma)

• particular forms of abnormal heart rhythm (so called torsades de pointes)

• allergic inflammation of the lung alveoli and of the lung tissue

Not known: frequency cannot be estimated from available data

• absent sensation of appetite

• elevation or lowering of blood sugar levels

• paranoia

• movement disorders (involuntary movements or decreased movements)

• hypersensitivity inflammation of heart muscle

• Hepatitis (inflammation of the liver) with signs such as dark urine, weight loss and jaundice

• hot flush

• Dry eyes

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

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse.

·         Store below 30°C.

·         Store in the original package in order to protect from moisture.

·         Keep out of the reach and sight of children.

·         Do not use Alatript after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.

·         Do not use Alatript if you notice that the pack is damaged or shows signs of tampering.

·           Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.