Amitriptyline hydrochloride 25mg/5ml Oral Solution

• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or pharmacist
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

The name of your medicine is Amitriptyline hydrochloride 25mg/5ml Oral Solution but it will be referred to as Amitriptyline throughout this leaflet.

1. What Amitriptyline is and what it is used for
2. What you need to know before you take Amitriptyline
3. How to take Amitriptyline
4. Possible side effects
5. How to store Amitriptyline
6. Contents of the pack and other information

• you are allergic to amitriptyline or any of the other ingredients of this medicine (listed in section 6)
• you recently have had a heart attack (myocardial infarction)
• you have heart problems such as disturbances in heart rhythm which are seen on an electrocardiogram (ECG), heart block, or coronary artery disease
• you are taking medicines known as monoamine oxidase inhibitors (MAOIs)
• you have taken MAOIs within the last 14 days
• you have taken moclobemide the day before
• you have a severe liver disease.

If you are treated with Amitriptyline, 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.

Talk to your doctor or pharmacist before taking Amitriptyline.

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. 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

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 have, 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 an 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 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).

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

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 medicine should not be taken at the same time as an anticholinergic drug (see also section 2 Other medicines and Amitriptyline)
• 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.

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 or have recently taken any other medicines, including medicines obtained without a prescription, including herbal 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 (see section 2 Do not take Amitriptyline)
• adrenaline, ephedrine, isoprenaline, noradrenaline, phenylephrine and phenylpropanolamine (these may be present in cough or cold medicine, and in some anaesthetics)
• medicine 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. barbiturates)
• antidepressants (e.g SSRIs (fluoxetine, paroxetine, fluvoxamine), duloxetine and bupropion)
• 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.

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

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, 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.

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.

Methyl and propyl parahydroxybenzoate: May cause allergic reactions (possibly delayed). Sodium: This medicine contains less than 1mmol sodium (23 mg) per 5ml dose, that is to say essentially 'sodium-free'.

Adults

The recommended initial dose is 25mg two times daily.

Depending on the response to the medicine, your doctor may gradually increase the dose to 150mg per day divided in two doses.

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

The recommended initial dose is 10mg – 25mg daily.

Depending on your response to the medicine, your doctor may gradually increase the dose to a total daily dose of 100mg divided in two doses. If you receive doses in the range of 100mg – 150mg, 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 treatment of depression. For further information please see section 2.

Your doctor will adjust the medication according to your symptoms and your response to the treatment.

Adults

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

The recommended daily dose is 25mg - 75mg.

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 100mg daily, your doctor may need to do more frequent follow-up with you. Your doctor will instruct you whether to take the doses once daily or divide into two doses.

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

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

Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75mg 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 information please see section 2.

Use in children and adolescents:

The recommended doses for children:

• aged below 6 years: see section 2 Do not take Amitriptyline
• aged 6 to 10 years: 10mg to 20mg daily. A suitable dosage form should be used for this age group
• aged 11 years and above: 25mg to 50mg.

The dose should be increased gradually.

Take this medicine 1-1 ½ hours before bedtime.

Before starting treatment, your doctor will conduct an ECG of your heart to check for sign of unusual heartbeat.

Your doctor will re-evaluate your treatment after 3 months and if needed perform a new ECG.

Do not stop the treatment without consulting your doctor first.

Patients with liver diseases or people known as “poor metabolisers” usually receive lower doses.

Your doctor may take blood samples to determine the level of amitriptyline in the blood (see also section 2).

This medicine can be taken with or without food.

• use the double-ended spoon supplied with the pack to measure the exact quantity (see figure below)
• do not overfill the spoon
• swallow the solution
• wash the spoon with clean water after taking every dose.

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

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.

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.

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

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, heart failure, hypotension, cardiogenic shock, metabolic acidosis, hypokalemia.

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.

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

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 get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is amitriptyline hydrochloride.

Each 5ml solution contains 25mg amitriptyline hydrochloride.

The other ingredients are ascorbic acid (E300), disodium edetate, saccharin sodium (E954), methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216) and purified water.

Amitriptyline is a clear, colourless to yellow coloured solution supplied in amber glass bottles with tamper-evident child-resistant polypropylene plastic screw cap and a 2.5-5ml double ended spoon for measuring the dose.

Amitriptyline is supplied in bottles containing 150ml, 200ml, 300ml and 500ml solution.

Not all pack sizes may be marketed.