ATC categoryNeurology. Psychiatry
Generic nameAmitriptyline hydrochloride
Amitriptyline Tablets belongs to a group of medicines known as tricyclic antidepressants.
This medicine is used to treat:
Do not take Amitriptyline Tablets:
This medicine should not be used for children below 6 years of age.
Talk to your doctor or pharmacist before taking 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:
Thoughts of suicide and worsening of your depression
If you are depressed, you can sometimes have thoughts of harming or killing themselves. 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 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
If you use antidepressants such as SSRIs, your doctor might consider changing the dose of your medicine.
Elderly are more likely to suffer from certain side effects, such as dizziness when you stand up due to low blood pressure.
Children and adolescents
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
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 or have recently taken any other medicines, such as:
You should also tell your doctor if you take or have recently taken medicine that may affect the heart´s rhythm. e.g.:
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 alcohol
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 new born 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.
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 (milk sugar); If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
Not all dosage schemes can be achieved with all the pharmaceutical forms/strengths. The appropriate formulation/strength should be selected for the starting doses and any subsequent dose increases.
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 in two doses. If you receive doses in the range 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 or adolescents for treatment of depression.
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.
The recommended initial dose is 10 mg – 25 mg in the evening.
The recommended daily dose is 25 mg – 75 mg.
Depending on your response to the medicine, your doctor may gradually increase the 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 you whether to take the doses once daily or divide into two doses.
Depending on your response to the medicine, your doctor may gradually increase the dose. If you receive doses above 75 mg daily, your doctor may need to do more frequent follow-up with you.
This medicine should not be given to children or adolescents for treatments of neuropathic pain, chronic tension type headache prophylaxis and migraine prophylaxis.
Use in children and adolescents
The recommended doses for children:
The dose should be increased gradually.
Take this medicine 1-1½ 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 special risks
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.
How and when to take Amitriptyline Tablets
This medicine can be taken with or without food.
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.
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.
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:
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 this product, 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:
Very rare: may affect up to 1 in 10,000 people
You should immediately have an eye examination before the treatment with this medicine can be continued. This condition may be signs of acute glaucoma.
Common side effect: may affect up to 1 in 10 people
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
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Rare: may affect up to 1 in 1,000 people
Not known: frequency cannot be estimated from the available data
An increased risk of bone fractures has been observed in patients taking this type of medicines.
Additional side effects in children
Store at a temperature 15-25°C, out of the reach of children. Protect from light and moisture.
Shelf life – 3 years. Do not use this medicine after the expiry date
What Amitriptyline Tablet contains
Each coated tablet contains:
active ingredient: amitriptyline hydrochloride – 25 mg;
tablet core: microcrystalline cellulose, lactose monohydrate, povidone, maize starch, sodium starch glycolate, magnesium stearate, talc purified.
tablet coating: hypromellose, titanium dioxide, propylene glycol, talc purified, color yellow (riboflavin).
Yellow biconvex coated tablets.
2 blister packets with 24 tablets in each (48 tablets) with the leaflet in the cardboard box.