Amitriptyline Tablets Bp 25mg
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P0168T
AMITRIPTYLINE Tablets 25mg
Please read all of this leaflet carefully before you start taking this medicine.
Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Amitriptyline Tablets are and what they are used for
2. Before you take Amitriptyline Tablets
3. How to take Amitriptyline Tablets
4. Possible side effects
5. How to store Amitriptyline Tablets
6. Further information
1. What Amitriptyline Tablets are and what they are used for
These tablets contain the active ingredient Amitriptyline, which is one of the group of medicines called tricyclic antidepressants.
This medicine is used for the treatment of depression in adults only (including the elderly) and for the treatment of bedwetting at night in children.
2. Before you take Amitriptyline Tablets
Do not take these tablets if:
• you are allergic to amitriptyline, other tricyclic antidepressants or to any of the other ingredients in the tablets (see section 6)
• you are taking, or have taken, a monoamine oxidase inhibitor (MAOI) to treat depression within the last 14 days e.g. phenelzine,
tranylcypromine
• you have heart disease such as heart block, heart failure, coronary artery disease, irregular heartbeat or are recovering after a heart attack
• you suffer from periods of increased and exaggerated behaviour (mania)
• you have severe liver problems
• you are pregnant or breastfeeding.
Do not give these tablets to a child under 7 years old.
Check with your doctor before taking these tablets if:
• you have ever had epileptic fits • you are having electroconvulsive therapy (ECT)
• you have ever had glaucoma (raised eye pressure) • you have an overactive thyroid
• you have ever had difficulty in urinating or prostate problems • you have diabetes
• you have ever had liver problems • you have porphyria
• you have heart problems • you are elderly
• you have a blood disorder • you are due to have any surgery, including dental surgery, that
• you have phaeochromocytoma involves having an anaesthetic.
• you have schizophrenia or manic depression
Taking other medicines:
are taking other medicines, including any that you can buy without
• sibutramine (to suppress appetite)
• apraclonidine and brimonidine (to treat glaucoma)
• entacapone or selegiline (to treat Parkinson's disease)
• medicines to treat angina that you spray or dissolve under your tongue e.g. glyceryl trinitrate
• ethchlorvynol (to help you sleep)
• anticholinergic drugs e.g. trihexyphenidyl (to treat parkinsonism), ipratropium (to treat chronic asthma) and atropine (to relax intestinal smooth muscle)
• altretamine (to treat some types of cancer)
• terfenadine (to treat allergies or hayfever)
• disulfiram (to treat alcohol dependence)
• rifampicin or linezolid (to treat infections)
• insulin (to treat diabetes)
• medicines that cause drowsiness such as certain antihistamines (e.g. diphenhydramine), tranquillisers, sedatives or sleeping drugs
• thyroid medicines e.g. carbimazole
• baclofen (a muscle relaxant)
• oral contraceptives
• cimetidine (to treat stomach ulcers)
• fluconazole (to treat fungal infections).
Check with your doctor or pharmacist before taking these tablets if you prescription. This is particularly important if you are taking:
• monoamine oxidase inhibitors (MAOIs) as stated under ‘Do not take' above
• selective serotonin re-uptake inhibitors (SSRIs) e.g. citalopram, fluoxetine, sertraline; or reboxetine (to treat depression)
• ritonavir (to treat HIV)
• medicines for pain relief such as nefopam, tramadol, levacetylmethadol, opioid analgesics e.g. codeine
• medicines to treat some heart conditions such as amiodarone, disopyramide, procainamide, propafenone, quinidine, sotalol, diltiazem, verapamil
• medicines to treat high blood pressure e.g. guanethidine, debrisoquine, betanidine, clonidine, diuretics (water tablets) e.g. bendroflumethiazide
• the sympathomimetic medicines adrenaline, noradrenaline, isoprenaline or those which may be present in cough and cold medicines ie. ephedrine, phenylephrine or phenylpropanolamine
• medicines for epilepsy e.g. sodium valproate, carbamazepine
• pimozide, thioridazine, phenothiazines or clozapine (to treat some mental illnesses)
• barbiturates (to treat severe insomnia), methylphenidate (to treat attention deficit hyperactivity disorder (ADHD))
Other special warnings:
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders 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 adults aged less than 25 years 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 straightaway.
You may find it helpful to tell a relative or close friend that you are depressed or have an anxiety disorder, 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.
Pregnancy and breastfeeding: This medicine should not be taken if you are pregnant or breastfeeding.
Effects on driving or operating machinery: This medicine may cause drowsiness and impair alertness. Do not drive or operate machinery if this medicine has this effect on you.
Alcohol: Avoid drinking alcohol when you are taking these tablets. Alcohol will increase the drowsiness produced by this medicine.
Important information about one of the ingredients of this medicine: Contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
3. How to take Amitriptyline Tablets
The tablets should be swallowed with a drink of water.
The recommended dosage should not be exceeded. Your doctor will decide the dose that is best for you. The pharmacist's label will also tell you how many tablets to take and how often. If you are not sure about anything, ask your doctor or pharmacist.
You may not notice any improvements in your symptoms for up to 30 days after starting treatment.
Do not suddenly stop taking this medicine as you may experience withdrawal symptoms (see “Stopping Amitriptyline Tablets” at the end of this section).
The usual dose for depression:
Adults: Initially 2-3 tablets daily in divided doses or as a single dose at night increasing to 6-8 tablets daily if necessary. For maintenance the dose is reduced to 2-4 tablets at night.
Adolescents and the elderly: 1 or 2 tablets daily in divided doses or as a single dose at night. A maintenance dose of 1 or 2 tablets may be sufficient.
The usual dose for nightly bedwetting in children:
11-16 years: 1-2 tablets at night.
7-10 years: A more suitable dosage form should be used e.g. oral solution.
Under 7 years: Not recommended.
Treatment should not exceed 3 months.
If you take too many Amitriptyline Tablets:
If you think you have taken too many tablets, contact your doctor straightaway or go to the nearest hospital casualty department. Take with you any remaining tablets and the pack so that the medicine can be identified.
If you forget to take Amitriptyline Tablets:
If you forget to take a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time. DO NOT TAKE TWO DOSES AT THE SAME TIME.
Stopping Amitriptyline Tablets and withdrawal effects:
This medicine should not be stopped suddenly; keep taking it until your doctor tells you how to reduce the dose slowly. If you stop taking the tablets suddenly you may experience the following withdrawal effects: nausea (feeling sick), headache, generally feeling unwell, dream and sleep disturbances, irritability and restlessness. Feeling elated or over-excited causing unusual behaviour has been reported rarely 2-7 days after stopping taking amitriptyline.
4. Possible side effects
Like all medicines, Amitriptyline Tablets can cause side effects, although not everybody gets them.
If any of the following occur STOP TAKING the tablets IMMEDIATELY and contact your doctor as these may be signs of an allergic reaction: • swelling of the face or tongue • skin rash or raised itchy, red lumps on the skin (hives) • increased sensitivity to sunlight.
If you notice any of the following effects tell your doctor straightaway:
• fever, sore throat, mouth ulcers, recurring infections, unusual tiredness or weakness, unusual bleeding or unexplained bruises. These may be signs of a blood disorder
The following other side effects have been reported:
• yellowing of the skin or whites of the eyes, pale stools and dark urine, loss of appetite, stomach discomfort caused by liver or blood problems, changes in liver function (detected by blood tests)
• low levels of sodium in the blood which may cause tiredness, disorientation, headache, muscle cramps and nausea (feeling sick)
• change in blood sugar levels, increased appetite, weight gain
• disturbances in sexual function or sex drive, breast swelling in males and females, swelling of the testicles, production or overproduction of breast milk
• inappropriate secretion of the hormone ADH (antidiuretic hormone) which may make you urinate more frequently
• dizziness, tiredness, drowsiness, weakness, headache, difficulty concentrating, confusion, disorientation (not knowing where you are)
• nervousness, anxiety, restlessness, difficulty sleeping, nightmares, delusions, seeing or hearing things that are not there, feeling overexcited
feeling more depressed, including thinking about harming or killing yourself.
numbness, tingling, lack of co-ordination, difficulty controlling movements, shaking, fits, speech difficulties, ringing in the ears anticholinergic effects i.e. dry mouth, sour or metallic taste, fever, blurred or double vision, increased pressure in the eye, dilated pupil of the eye, constipation, blockage of the small intestine, difficulty passing urine
feeling faint when getting up, high blood pressure, feeling your
heartbeat, faster heartbeat, heart attack, irregular or slow
heartbeat, stroke. Irregular heartbeat and very low blood pressure
is more likely with high doses or overdosage
feeling or being sick, diarrhoea, abdominal pain, loss of appetite,
impaired sense of taste, mouth ulcers, swollen saliva glands, black
tongue
increased sweating, hair loss, increased need to urinate.
If the tablets are taken to treat night-time bedwetting, drowsiness, mild sweating, itching, changes in behaviour and anticholinergic effects (see above) have been reported.
An increased risk of bone fracture has been observed in patients taking this type of medicine.
Do not be concerned by this list of side effects, you may not get any of them. If any of the effects get serious, or if you notice any other unusual or unexpected symptoms please tell your doctor or pharmacist.
5. How to store Amitriptyline Tablets
Keep the tablets in the pack provided and protect from heat, light and moisture.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN
Do not take the tablets if the expiry date on the pack has passed. If you have any medicines that are out of date, return them to your pharmacist for safe disposal.
6. Further information
Ingredients
Amitriptyline Tablets contain 25mg of amitriptyline as the active ingredient. They also contain the following other ingredients: lactose, povidone, magnesium stearate and maize starch. The coating contains titanium dioxide (E171), quinoline yellow (E104), hypromellose (E464) and iron oxides (E172).
What the medicine looks like
Amitriptyline Tablets are yellow, film coated round tablets, engraved on one side with the company logo and A313 on the other. The medicine is available in pack sizes of 28, 42, 50, 56, 84, 100, 112, 250, 500 or 1000 tablets.
Who makes this medicine and holds the Product Licence:
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants, RG25 3ED
Leaflet revised: July 2011
If you would like this leaflet in a different format please contact the licence holder at the above address.