Amitriptyline 25mg Tablets Bp
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AMITRIPTYLINE 25 mg TABLETS BP
Read all of this leaflet carefully before you start taking this medicine.
• 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. 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
Amitriptyline belongs to a group of drugs called tricyclic antidepressants (TCADs).It prolongs the effects of noradrenaline and serotonin (substance which transmit nerve impulses). Amitriptyline is used:-
• To treat depression
• For the relief of night bed-wetting in children
2. BEFORE YOU TAKE AMITRIPTYLINE TABLETS
Do not take Amitriptyline tablets and tell your doctor if you or your child (if they are the patient):-
• Are allergic (hypersensitive) to Amitriptyline, other tricyclic antidepressants or any of the other ingredients (see Section 6).
• Suffer from any liver or heart problems (e.g. abnormal heart rhythm).
• Have you suffered a heart attack within the last three months.
• Are taking monoamine oxidase inhibitors (MAOI) or you have taken MAOIs within the previous 14 days for depression.
• Are you pregnant, trying to become pregnant, or breastfeeding
• If the child is under 7 years old.
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 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 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.
Take special care with Amitriptyline Tablets
Check with your doctor or pharmacist before taking
Amitriptyline tablets if you or your child (if they are the patient):
• Have any blood disorders
• Have difficulty in passing water
• Have you had prostate trouble
• Have an overactive thyroid gland
• Have a history of epilepsy or suffered recently from convulsions
• Suffer from any mental illness other than depression
• Have porphyria
• Have increased pressure in the eye (glaucoma)
If you are to undergo any surgery or receive anaesthetics (even at the dentist) or have electroconvulsive therapy (ECT), you should make the doctor or dentist treating you aware that you are taking amitriptyline.
If you experience symptoms such as drowsiness, confusion or fits, tell your doctor immediately because this may indicate a low sodium level in the blood.
Taking other Medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, especially:-
• Other medicines used to treat depression including monoamine oxidase inhibitors (MAOIs)
• Drugs that depress the central nervous system including barbiturates (e.g. phenobarbitone)
• Sedatives (medicines that relieve anxiety and have a calming effect)
• Thyroid harmone therapy
• Altretamine a drug used for the treatment of advanced ovarian cancer
• Baclofen a drug used for muscle spasm resulting from disorders such as multiple sclerosis
• Disulfiram (to treat alcoholism)
• Certain painkillers, including nefopam and tramadol
• Medicines to treat irregular heart rhythm, such as amiodarone, disopyramide, procainamide, propafenone, quinidine and sotalol
• Medicines used in the treatment of angina
• Rifampicin (an antibiotic)
• Medicines used to treat epilepsy
• Medicines used to relieve: asthma, gastrointestinal upset (e.g.vomiting or cramps) and allergies (antihistamines e.g.terfenadine)
• Any medicines to treat high blood pressure such as guanethidine, debrisoquine, bethanidine, clonidine or methyldopa
• Medicines used to treat mental illness, including thioridazine and pimozide
• Cimetidine (a medicine used to treat ulcers)
• Methylphenidate, a drug used to treat sleeping problems
• Entacapone or selegiline (to treat Parkinson’s disease)
• Oral contraceptives
• Sibutramine, a medicine used for weight loss
• Medicines such as adrenaline, ephedrine, phenylephrine, or phenylpropanolamine. These may be present in many medicines for colds and nasal stuffiness. Tell your pharmacist that you are taking amitriptyline before buying such products
• Ritonavir (to treat HIV)
• Fluconazole (to treat fungal infections)
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
• 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 you are breast feeding Driving and using machines
If you feel dizzy or drowsy when you start taking this medicine, do not drive or operate machinery until these effects wear off.
Important information about some of the ingredients
If you have been told you have an intolerance to some sugars, contact your 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.
3. HOW TO TAKE AMITRIPTYLINE TABLETS
Always take Amitriptyline tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.
Swallow the tablets with a glass of water *
You are advised not to drink alcohol with this medicine. |
You may not notice any improvement in your symptoms for up to 4 weeks after starting treatment.
Doses
Depression
Adults - 50-75mg a day either in divided doses or a single night time dose increasing to 150-200mg a day. A maintenance dose of 50-10Qmg at night should be given to lessen the chances of relapse. Adolescents and elderly - 25-S0mg a day either in divided doses or as a single night time dose. A maintenance dose of 25-50mg may be sufficient.
Nightly bedwetting:-
Children only (for no longer than 3 months)
11-16 years - 25-50mg at night 7-10 years - 10-20mg at night Under 7 years - not recommended Treatment should not exceed three months.
Not recommended for treatment of depression in children under 16 years of age.
• Amitriptyline tablets are not suitable for children under 7 years.
• This medicine should only be used for up to 3 months to treat night bed-wetting.
• If you are elderly you will be advised by your doctor specifically on how many and how often to take the tablets.
• This medicine is not suitable for the treatment of depression in children under 12 years
If you take more than you should
If you or the patient (or someone else) swallows a lot of tablets at the same time, or you think a child may have swallowed any, contact your nearest hospital casualty department, or tell your doctor immediately.
If you forget to take the tablets
Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take another as soon as you remember and then your next dose at the usual time.
If you stop taking the tablets
Talk to your doctor before you stop taking the tablets and follow their advice as you may experience unwanted effects such as nausea, headache or weakness
4. POSSIBLE SIDE EFFECTS
Like all medicines, amitriptyline tablets can cause side effects, although not everybody gets them. If you experience any of the following, please tell your doctor immediately
• allergic reaction (swelling of face and tongue, rash, itching)
• thoughts of harming or killing yourself
• yellowing of the skin and whites of the eyes
• epileptic fits or convulsions
• unusual muscle movements or twitching
• blood disorders (characterised by fever or chills, sore throat, ulcers in the mouth or throat, tiredness or weakness, unusual bleeding or bruising).
• paralysis of your intestine (which may lead to severe constipation, swollen stomach, fever and vomiting).
• stroke (symptoms may include severe headache, problems with vision, muscle weakness usually on one side of the body, speech problems)
• palpitations or changes in your heartbeat
The following side effects may also occur. If they are severe or last for more than a few days, please tell your doctor: Endocrine system and metabolism:
• 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 you urinate more frequently
Brain and central nervous system:
• 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 you are)
• restlessness
• pins and needles
• lack of co-ordination
• tremor
• Anticholinergic effects (dry mouth, fever, constipation, blurred or double vision, difficulty passing water (urine), dilation of the pupil of the eye and glaucoma)
Heart:
• 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
Stomach and intestines:
• 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
Liver:
• hepatitis, including changes in liver function (as seen in blood tests)
Other:
• increased sweating
• hair loss
• ringing in the ears
• increased need to urinate
• An increased risk of bone factures has been observed in patients over 50 years of age 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 above).
Tell your doctor if you notice any of the above side effects or
any other effects not listed.
5. HOW TO STORE AMITRIPTYLINE TABLETS
• Keep out of the reach and sight of children.
• Do not store above 25°C. Store in the original container. Keep the container tightly closed.
• Do not use Amitriptyline tablets after the expiry date stated on the label/carton. The expiry date refers to the last day of that month.
• Remember: This medicine has been prescribed for you. Do not give it to anybody else if their symptoms appear to be the same as yours,since it may be harmful to them.
• Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Amitriptyline tablets contain
• The active substance (the ingredient that makes the tablets work) is Amitriptyline Hydrochloride. Each tablet contains 25mg of the active ingredient.
• The other inactive ingredients are Lactose Monohydrate, Povidone, Magnesium Stearate, Stearic Acid, Maize Starch, Calcium Carbonate, Talc, Acacia, Sucrose, Polyvinyl acetate Phthalate, Yellow Camauba Wax,White Besswax,Shellac and the colours Titanium Dioxide, Quinoline Yellow Aluminium Lake (E104) and Sunset Yellow Aluminium Lake. The sugar coat contains the preservative Sodium Benzoate (E211).
What Amitriptyline tablets look like and contents of the
pack
• Amitriptyline 25mg Tablets are pale yellow, circular, deep convex sugar-coated tablets.
• They are available in packs of 50, 100, 250 & 500 tablets.
• Not all pack sizes may be marketed.
MA Holder:
Special Concept Development (UK) Limited,
Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR
Manufacturer
Bristol Laboratories Ltd
Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG
Telephone: 0044 (0) 1442 200922
Fax: 0044(0) 1442 873717
E-mail: info@bristol-labs.co.uk
Amitriptyline 25mg Tablets; PL 36722/0055
This leaflet was last revised in July 2014