Amitriptyline Actavis

Amitriptyline Actavis





Agencia Lei Va Hong
Full Prescribing Info
Amitriptyline hydrochloride.
Each tablet contains either 10 mg or 25 mg of the active ingredient.
Excipients/Inactive Ingredients: Lactose monohydrate, microcrystalline cellulose (E460), maize starch, colloidal anhydrous silica, magnesium stearate, hypromellose (E464), titanium dioxide (E171), macrogol.
The 10mg tablet also contains: indigo carmine (E132).
The 25mg tablet also contains: talc (E553b), quinoline yellow (E104), iron oxide (E172), sunset yellow (E110), indigo carmine (E132).
Amitriptyline belongs to a group of medicines called tricyclic antidepressant drugs. These medicines alter the levels of chemicals in the brain to relieve the symptoms of depression.
Amitriptyline is used: To treat the symptoms of depression.
For the relief of bed-wetting at night by children aged 6 years and above.
Dosage/Direction for Use
Always take Amitriptyline tablets exactly as the doctor has told the patient. Check with the doctor or pharmacist if the patient is not sure.
Swallow the tablets with a glass of water.
The patient may not notice any improvement in the symptoms for up to 4 weeks after starting treatment.
The recommended dose is: Depression: Adults: 50-75 mg a day either in divided doses or as a single night time dose increasing to 150-200 mg a day. A maintenance dose of 50-100 mg at night should be given to lessen the chances of relapse.
Adolescents and elderly: 25-50 mg a day either in divided doses or as a single night time dose. A maintenance dose of 25-50 mg may be sufficient.
Nightly bedwetting: Children only (for no longer than 3 months): 11-16 years: 25-50 mg at night.
6-10 years: 10-20 mg at night.
Under 6 years: Not recommended.
If the patient forgets to take Amitriptyline tablets: Do not take a double dose to make up for a forgotten dose. If the patient forgets to take a dose, take another as soon as he/she remembers and then the next dose at the usual time.
If the patient stops taking Amitriptyline tablets: Talk to the doctor before the patient stops taking the tablets and follow their advice as he/she may experience withdrawal symptoms (see Side Effects).
If the patient has any further questions on the use of the medicine, ask the doctor or pharmacist.
If the patient (or someone else) swallow a lot of tablets at the same time, or he/she thinks a child may have swallowed any, contact the nearest hospital casualty department or tell the doctor immediately. Symptoms of an overdose include fast regular heart beat, dilated pupils, drowsiness, coma, difficulty breathing, jerky movements, hot dry skin, dry mouth and tongue, difficulty passing water, intestinal blockage, uncontrolled eye movement.
Do not take Amitriptyline tablets if the patient or the patient's child (if they are the patient): are allergic to amitriptyline, other tricyclic antidepressants or any of the other ingredients (listed in Description). The 25mg tablets contain sunset yellow (E110), which may cause allergic-type reaction.
Have heart disease such as irregular heart beats, heart block or failure, coronary artery disease or have recently had a heart attack; suffer from periods of increased and exaggerated behaviour (mania); have severe liver disease; are taking monoamine oxidase inhibitors (MAOI) or have taken MAOIs within the previous 14 days for depression; are breast-feeding; if the child is under 6 years old.
Special Precautions
Talk to the doctor or pharmacist before taking Amitriptyline tablets if the patient or the patient's child (if they are the patient): has any blood disorders (the patient may bruise easily, frequently suffer from infections or be anaemic); has any psychiatric disorder (eg schizophrenia or manic depression); has liver or cardiovascular disease; is not able to pass water or have an enlarged prostate gland; has an overactive thyroid gland and is taking medicines to treat a thyroid disorder; has a history of epilepsy; is being given electroconvulsive therapy (ECT); has increased pressure in the eye (glaucoma); is due to have any surgery, including dental, that involves an anaesthetic; is an elderly.
Thoughts of suicide and worsening of depression or anxiety disorder: If the patient is depressed and/or has anxiety disorders he/she can sometimes have thoughts of harming or killing him/herself. These may be increased when first starting antidepressants, since these medicines all take time to work, usually about two weeks but sometimes longer.
The patient may be more likely to think like this: If the patient has previously had thoughts about killing or harming him/herself.
If the patient is 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 the patient has thoughts of harming or killing him/herself at any time, contact the doctor or go to a hospital straight away. The patient may find it helpful to tell a relative or close friend that he/she is depressed or has an anxiety disorder, and ask them to read this leaflet. The patient might ask them to tell him/her if they think his/her depression or anxiety is getting worse, or if they are worried about changes in the behaviour.
A heart problem called prolonged QT interval (which is shown on the electrocardiogram, ECG) and heart rhythm disorders (rapid or irregular heart beat) have been reported with Amitriptyline. Tell the doctor if the patient: has slow heart rate; has or had a problem where the heart cannot pump the blood round the body as well as it should (a condition called heart failure); is taking any other medication that may cause heart problems; or has a problem that gives him/her a low level of potassium or magnesium, or a high level of potassium in the blood.
Amitriptyline tablets and alcohol: Do not drink alcohol with this medicine.
Amitriptyline tablets contain lactose and sunset yellow: If the patient has intolerance to some sugars, contact the doctor before taking this medicine, as it contains a type of sugar called lactose.
The 25mg tablets also contain a colour called 'sunset yellow' which may cause allergic reactions.
Driving and using machines: Amitriptyline may impair alertness. Make sure the patient is not affected before he/she drives or operate machinery.
Use In Pregnancy & Lactation
Amitriptyline tablets should not be taken in the first 3 months and last 3 months of pregnancy. If taken in the last three months, the newborn may have withdrawal symptoms. Do not take Amitriptyline tablets if the patient is breastfeeding. If the patient is pregnant or breast-feeding, thinks she may be pregnant or are planning to have a baby, ask the doctor or pharmacist for advice before taking the medicine.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Amitriptyline tablets and contact the doctor at once if the patient has: An allergic reaction signs may include a skin rash, which may be itchy, sensitivity to the sun or sun lamps, puffy, swollen face or tongue, which may be severe causing shortness of breath, swelling, shock and collapse.
A serious effect on the blood, such as low sodium levels. Signs may include fever or chills, sore throat, ulcers in the mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises.
Bone marrow depression or reduction in some blood cells (the patient may experience a sore throat, mouth ulcers and recurring infections, bleeding or bruising easily); thoughts of suicide (see Actions and Indications); anticholinergic effects (dry mouth, fever, constipation, blurred or double vision, difficulty or lack of control when urinating, dilation of the pupil of the eye, glaucoma and blockage of the small intestine); stroke; hepatitis.
Tell the doctor if the patient notices any of the following side effects or notices any other effects not listed: Common (may affect up to 1 in 10 people): A heart problem called prolonged QT interval (which is shown on the electrocardiogram, ECG).
Not known (frequency cannot be estimated from the available data): Rash of purple spots (purpura).
Disturbances in sexual function or sex drive, breast swelling in men and women, swelling of the testicles, production or over-production of breast milk, changes in blood sugar levels, increased appetite and weight gain. Inappropriate secretion of the hormone ADH (antidiuretic hormone), which may make the patient urinate more frequently.
Dizziness, tiredness or sleepiness, weakness, headache, difficulty concentrating, confusion, difficulty sleeping, nightmares, slight hyperactivity, exaggerated behaviour, delusions, seeing things that are not there, anxiety, excitement, disorientation (not knowing where he/she is), restlessness, nerve damage, pins and needles, lack of co-ordination, loss of control of or shaky movements, tremor, fits.
Feeling faint when getting up (postural hypotension), increased blood pressure, fast/ racing heart, palpitations, heart attack, irregular or slow heart-beats and very low blood pressure, other changes in ECGs.
Feeling or being sick, diarrhoea, loss of appetite, inflammation of the mucus membranes in the mouth, swollen saliva glands, abdominal pains, black tongue, impairment of taste.
Including changes in liver function (as seen in blood tests), jaundice (yellowing of the skin and/or whites of the eyes).
Increased sweating, hair loss, ringing in the ears, increased need to urinate. An increased risk of bone fractures has been observed in patients taking this type of medicine.
Withdrawal symptoms: Feeling sick, malaise and headache, dream and sleep disturbances, irritability and restlessness. Mania or hypomania (exaggerated mood and/or elation) may occur 2-7 days after stopping the tablets.
If taken to treat bed-wetting: drowsiness, mild sweating, itching, changes in behaviour and "Anticholinergic effects" (as described previously).
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed. The patient can also report side effects directly via the Yellow Card Scheme at:
By reporting side effects the patient can help provide more information on the safety of the medicine.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines. Especially: Altretamine (to treat some types of cancer); apraclonidine and brimonidine (to treat glaucoma); baclofen (a muscle relaxant); disulfiram (to treat alcohol addiction); painkillers such as nefopam, tramadol, codeine, dihydrocodeine; medicines to treat some heart conditions such as amiodarone, diltiazem, disopyramide, procainamide, propafenone, quinidine, sotalol, verapamil; medicines to treat angina that the patient sprays or dissolves under the tongue (eg glyceryl trinitrate "GTN", isosorbide dinitrate); rifampicin or linezolid (to treat infections), fluconazole (to treat fungal infections); carbamazepine or phenobarbital (to treat epilepsy); terfenadine (to treat allergies or hayfever); methylphenidate (to treat attention deficit/hyperactivity disorder (ADHD)); any medicines to treat high blood pressure such as guanethidine, debrisoquine, bethanidine or clonidine or diuretics ("water" tablets); medicines to treat some mental illnesses such as clozapine, pimozide, thioridazine chlorpromazine, haloperidol, prochlorperazine, sulpiride; cimetidine (to treat ulcers); ethchlorvynol (to help the patient sleep); entacapone or selegiline (to treat Parkinson's disease); oral contraceptives ("the pill"); sibutramine (to suppress appetite); sympathomimetic medicines such as adrenaline (epinephrine), ephedrine, isoprenaline, noradrenaline (norepinephrine), phenylephrine and phenylpropanolamine (these may be present in many cough and cold remedies); ritonavir (to treat HIV); anaesthetics (used in surgery); anticholinergic medicines e.g. atropine, benzatropine, dicyclomine or doxyamine; antidepressants.
Store below 25°C in a dry place, protected from light.
Keep this medicine out of the sight and reach of children.
Do not throw away any medicines via household waste. Ask the pharmacist how to throw away medicine the patient no longer use. These measures will help protect the environment.
MIMS Class
ATC Classification
N06AA09 - amitriptyline ; Belongs to the class of non-selective monoamine reuptake inhibitors. Used in the management of depression.
Amitriptyline Actavis film-coated tab 10 mg
Amitriptyline Actavis film-coated tab 25 mg
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