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TRIPTAFEN 25MG/2MG TABLETS

Active substance(s): AMITRIPTYLINE HYDROCHLORIDE / PERPHENAZINE / AMITRIPTYLINE HYDROCHLORIDE / PERPHENAZINE

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Package leaflet: Information for the user
Triptafen® 25mg/2mg Tablets
Amitriptyline Hydrochloride/Perphenazine
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, pharmacist or nurse.
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 or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
The name of your medicine is Triptafen® 25mg/2mg Tablets. It will be referred to as Triptafen
Tablets for ease of use hereafter.
What is in this leaflet

1. What Triptafen Tablets are and what they are used for
2. What you need to know before you take Triptafen Tablets
3. How to take Triptafen Tablets
4. Possible side effects
5. How to store Triptafen Tablets
6. Contents of the pack and other information
1. What Triptafen Tablets are and what they are used for
Triptafen Tablets contain two active substances:
• Amitriptyline hydrochloride belongs to a group of medicines called tricyclic antidepressants, which
are used to treat depression
• Perphenazine is a phenothiazine which is a group of medicines used to treat anxiety
• Triptafen Tablets are used to treat depression, particularly when anxiety is also present.
2. What you need to know before you take Triptafen Tablets
DO NOT take Triptafen Tablets if you:
• Are allergic to Amitriptyline hydrochloride or Perphenazine or any of the other ingredients of this
medicine (listed in section 6).
• Suffer from glaucoma (increased pressure in the eye)
• Have a shortage of white blood cells (your doctor will advise you) and have or had a history of fever
with chills, rash, diarrhea, easy bruising, bleeding of nose, gums or mouth, extreme tiredness that
doesn't get better with rest (signs of Bone Marrow Suppression)
• Suffer from an inherited disease of the blood known as porphyria
• Are unable to pass water
• Have heart disease or have recently had a heart attack
• Have had heart failure
• Suffer from epilepsy (fits)
• Have severe liver problems
• Suffer from the psychiatric disorder mania which causes extreme mental agitation or activity
• If you are taking other antidepressant drugs such as citalopram, fluoxetine, paroxetine, duloxetine
and especially monoamine oxidase inhibitors (MAOI’S) like phenelzine and isocarboxazid.
Speak to your doctor if any of these apply to you before you take your medicine.
Warnings and precautions:
Talk to your doctor or pharmacist or nurse before taking Triptafen Tablets
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 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 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.
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 Triptafen Tablets.
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.
Take special care with Triptafen Tablets if you:
• Have a past history of a psychiatric disorder such as schizophrenia
• Suffer from an overactive thyroid gland
• Are having electroconvulsive therapy
• Have any problems with your blood (your doctor will advise you)
• If you or someone else in your family has a history of blood clots, as medicines like these have been
associated with formation of blood clots. If any of these conditions apply to you, speak to your doctor
before you take these tablets. Your doctor will want to monitor your response to this medicine
carefully, particularly if you are young or elderly. This medicine may cause restlessness in the elderly.
Children and adolescents
Triptafen tablets are not suitable for use in children under 18 years of age.
Other medicines and Triptafen Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines, including medicines obtained without a prescription. The effects of any of these medicines
may change, particularly if you are taking:
• Medicines for treating depression, particularly Monoamine Oxidase Inhibitors (MAOI’s) such as
phenelzine and isocarboxazid, or citalopram, fluoxetine, paroxetine, duloxetine
• Medicines to reduce blood pressure and treat heart failure such as diazoxide, clonidine, methyldopa,
doxazosin and guanethidine
• Medicines called anticholinergics (such as hyoscine and propantheline) to treat problems with the
gut
• Pain killers such as aspirin, paracetamol, pentazocine, tramadol
• Adrenaline and noradrenaline used to resuscitate severely ill patients
• Anaesthetic medicines used during surgery (tell your anaesthetist you are taking Triptafen)
• Anti-anxiety treatments such as diazepam, lorazepam, temazepam
• Medicines to regulate your heart beat such as amiodarone, disopyramide, flecainide, procainamide,
propafenone, quinidine, sotalol
• Medicines to treat fits, such as phenytoin, primidone, carbamazepine, barbiturates and sodium
amytal

• Antihistamines to treat allergies and hayfever, such as acrivastine, cetirizine and chlorphenamine,
terfenadine
• Medicines to manage your state of mind, such as chlorpromazine, clozapine, haloperidol, sulpiride,
trifluoperazine, lithium, pimozide
• Cimetidine, to treat stomach ulcers
• Medicines to stop your blood clotting excessively, such as warfarin
• Nitrates to treat angina (chest pains), such as glyceryl trinitrate
• Diltiazem or verapamil, to treat angina or high blood pressure
• Disulfiram, to help withdrawal from drinking excess alcohol
• Diuretics – medicines to make you pass more water (urine), such as amiloride, triamterene,
spironolactone
• Antibiotics such as moxifloxacin and rifampicin
• Ritonavir to treat HIV infection
• St. John’s Wort often used to treat depression
• Selegeline, to treat Parkinson’s disease
• Sibutramine an appetite suppressant used to treat obesity
• Thioridazine used to treat schizophrenia
• Thyroid hormones, namely levothyroxine or liothyronine, to increase the amount of thyroxine that
you have in your body
• Medicines found in cough and cold remedies such as phenylephrine.
Triptafen Tablets with food, drink and alcohol

You should not drink alcohol whilst you are taking this medicine as it may increase the effects of
Triptafen Tablets.
Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking this medicine.
Pregnancy

As with all drugs, this medicine should only be given in pregnancy if absolutely necessary. You must
speak to your doctor about the possible effects this medicine might have on your baby before you take
this medicine. The following symptoms may occur in newborn babies, of mothers that have used
Perphenazine in the last trimester (last three months of their pregnancy): shaking, muscle stiffness
and/or weakness, sleepiness, agitation, breathing problems and difficulty in feeding. If your baby
develops any of these symptoms you may need to contact your doctor.
Breast-feeding

You should not take this medicine if you are breast-feeding.
Driving and using machines
Triptafen Tablets may make you feel drowsy, give you blurred vision or affect your concentration.
You should not drive or use machines when you first start to take this medicine until you are certain
that you are not getting these side effects. If in any doubt, speak to your doctor before you drive or use
machines.
Triptafen Tablets contain lactose, sucrose, tartrazine and butyl hydroxybenzoate:
• Lactose and sucrose, which are sugars: If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine
• Tartrazine: May cause allergic reactions
• Butyl hydroxybenzoate: May cause allergic reactions (possibly delayed).
3. How to take Triptafen Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or
pharmacist if you are not sure. It is important to take your medicine at the right time.

The recommended dose is:
• One tablet three times a day. Your doctor will advise you if this needs to be increased
Method of administration:
• Swallow the tablets with a glass of water
• Your doctor will advise you on how long you should take the tablets. This will usually be between 1
and 3 months
• If you have to go to another doctor or to hospital tell them you are taking Triptafen Tablet.
Use in children and adolescents

Triptafen Tablets are not suitable for children under 18 years.
If you take more Triptafen Tablets than you should
If you take too many tablets, contact your nearest hospital casualty department or doctor
immediately. Take any remaining tablets and this leaflet with you so that the medical staff know
exactly what you have taken.
Symptoms of an overdose may include fast or irregular heartbeat, hot dry skin, dry mouth and tongue,
widened pupils and inability to pass urine (urinary retention), abnormality in ECG report, where heart
problems may occur.
There may be a loss of full control of bodily movements (ataxia), involuntary eye movement
(nystagmus), drowsiness which may lead to coma and respiratory depression. There may be increased
reflexes and squint. Low blood pressure, drop in body temperature and fits may occur.
Patients with early or mild intoxication with Perphenazine may experience restlessness, confusion and
excitement. Other symptoms include tremors, muscle twitching, spasm, rigidity, difficulty in
swallowing and breathing, bluish discoloration of the skin, miosis (excessive constriction of the pupil
of the eye) and respiratory failure.
Treatment is symptomatic and supportive. There is no specific antidote. The patient should be induced
to vomit.
Vomiting by the administration of ipecac syrup is a preferred method. If emesis does not occur within
15 minutes, the dose of ipecac should be repeated. Standard measures (oxygen, i.v. fluids,
corticosteroids) should be used to manage shock or metabolic acidosis.
Your medicine is very dangerous if taken by young children and care should be taken to keep the
medicine safely out of the reach of children.
The effects of overdose will be increased by simultaneous ingestion of alcohol and other
psychotrophic drugs (medicines used to treat psychiatric conditions).
If you forget to take Triptafen Tablets
Take your dose as soon as you remember, then go on as before. If it is almost time for the next dose,
then do not take the missed dose at all.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Triptafen tablets
Talk to your doctor, pharmacist or nurse before you may think of stopping the treatment. Acute
withdrawal symptoms including headache, muscular pain, tiredness, nausea, vomiting and insomnia
have been reported after abrupt cessation of high doses of phenothiazines, and gradual withdrawal is
advised. Withdrawal symptoms, shallow or slow breathing and agitation may occur in new born

infants whose mothers have taken tricyclic antidepressants in the last three months of pregnancy.
Gradual dose reduction may result in irritation, restlessness and sleep disturbances.
If you have any further questions about these tablets, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Be sure to take the tablets as your doctor tells you. Keep taking them until your doctor tells you to
stop.
Your doctor may change your dose. This medicine sometimes causes side effects in some people. The
side effects listed below have not all been reported after treatment with your medicine, but have been
reported after treatment with similar medicines:
.
Amitriptyline:
Stop taking the tablets and see a doctor straight away if you have:
• a feeling of being more depressed, including thinking about suicide
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the
leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in
breathing. If you notice any of these symptoms seek medical advice immediately
• an allergic reaction. Signs may include swelling of your face, lips, tongue or throat or difficulty
breathing or swallowing, severe itching of your skin with raised lumps
• a serious effect on your blood, such as abnormal blood counts. Signs may include fever or chills,
sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or
unexplained bruises
• heart attack
• stroke
• fits
• unconsciousness
• yellowing of the skin and the whites of your eyes (jaundice). These may be early signs of liver
problems
• inflammation of the liver (hepatitis), including changes in liver function (as seen in blood tests)
• difficulty in walking, loss of balance, twitching or abnormal movements of the body, face or eyes,
increased reflexes, inability to open the mouth, stiff neck, slow or slurred speech.
• ringing in the ears.
• blockage of the gut
If you notice any of these, tell your doctor straight away.
Other side effects include:
- Common: may affect up to 1 in 10 people
• A heart problem called “prolonged QT interval” (which is shown on your electrocardiogram, ECG)
Not known: frequency cannot be estimated from the available data
• feeling faint and dizzy when standing up
• changes in blood pressure
• fast or unusual heart beats
• feeling confused
• difficulty concentrating
• feeling disorientated
• delusions(false beliefs)
• hearing or seeing things that are not there (hallucinations)
• feeling excited, restless or stressed
• difficulty in sleeping, nightmares, feeling slightly hyperactive, numbness or tingling or pins and
needles (particularly in the hands and feet)
• change in sexual function and sex drive, breast swelling in men and women
• swelling of testicles
• milky discharge in females (galactorrhea)
• increased or decreased blood sugar levels
• syndrome of inappropriate ADH (antidiuretic hormone) secretion leading to low sodium levels
• pass water (urinate) more frequently.
• Changes in EEG results (an EEG is a recording of brain activity)
• feeling or being sick
• change in appetite
• loose stools, constipation
• swollen saliva glands, black tongue, pain in and around your tummy area (the abdomen), dry mouth,
fever, difficulty in passing stools, , problems with digestion
• skin rashes, skin rash due to sunlight
• blurred or double vision, changes in eyesight, increased pressure in the eye
• headache, dizziness, weakness, tiredness, change in weight, drowsiness, increased sweating, hair
loss, widely dilated pupils
• in elderly people with dementia, a small increase in the number of deaths has been reported for
patients taking antipsychotics compared with those not receiving antipsychotics
• an increased risk of bone fractures has been observed in patients taking this type of medicines
Perphenazine:
Stop taking the tablets and see a doctor straight away if you have:
• heart attack
• epileptic fits
• allergic reactions, signs may include: a rash, swallowing or breathing problems, wheezing,
swelling of your lips, face, throat or tongue
• jaundice (yellowing of the skin and whites of the eyes)
• lowering of white blood cell count with fever or chills, sore throat, ulcers in your mouth or throat,
unusual tiredness or weakness, unusual bleeding or unexplained bruises
• patients may develop Neuroleptic Malignant Syndrome. This causes a high temperature, rigid
muscles, drowsiness, agitation, occasional loss of consciousness, paleness, rapid heart rate or
changes in blood pressure and requires emergency admission to hospital for treatment
• ‘lupus’ with symptoms like severe tiredness, painful and swollen joints, headache, rash on cheeks
and nose, hair loss, anemia, problems with clotting of blood, blue or white discoloration of fingers
in cold.
• blockage of the gut
• Symptoms of parkinsonism including involuntary shaking of hands, stupor, shuffling toe walk
• Repetitive, rapid jerky, involuntary movements of muscles including mouth jaw and facial muscles
(Choreiform movements)

Other side effects include
Not known: frequency cannot be estimated from the available data
• restlessness, agitation, excitement
• muscle spasms
• headache, confusion
• difficulty speaking
• sleepiness
• excessive drowsiness
• difficulty in sleeping
• constipation feeling sick, dry mouth, saliva altered
• blurred vision, changes in colour of the retina (the innermost layer in the eye),involuntary upward
movement of the eye
• difficulty in passing urine

• low blood pressure (fainting, light headedness), excessive sweating, dizziness
• blocked nose
• increased blood cholesterol
• increased blood sugar
• false positive pregnancy tests (though your medication is not recommended in pregnancy)
• increased sensitivity of the skin to light
• raised prolactin levels (a hormone produced in a gland in the brain)
• changes in your weight
• breast enlargement (in males)
• irregularity or complete cessation of periods
• water retention
• impotence, impaired ejaculation
• changes in the rhythm of the heart
• eye disorders
• unexplained deaths have been reported.
If you have any side-effect, or are worried about other effects not listed above, contact your doctor or
pharmacist. Acute withdrawal symptoms including nausea, vomiting and insomnia have been reported
after abrupt cessation of high doses of phenothiazines, and gradual withdrawal is advised. Withdrawal
symptoms, shallow or slow breathing and agitation may occur in new born infants whose mothers
have taken tricyclic antidepressants in the last three months of pregnancy.
If these side effects get serious, or if you notice any other side effect not listed in this leaflet,
please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Triptafen Tablets
Keep this medicine out of the sight and reach of children.
Do not use your medicine if the pack is damaged or after the expiry date which is stated on the blister
strip and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Triptafen Tablets contains
The active substances are amitriptyline hydrochloride and perphenazine.
Each tablet contains 25mg amitriptyline hydrochloride and 2mg perphenazine.
The other ingredients are lactose, magnesium stearate, maize starch, maize starch pregelatinised,
acacia, gelatin, butyl hydroxybenzoate, calcium phosphate, calcium sulphate dihydrate, tartrazine
ariavit (E102), erythrosine ariavit (E127), purified water, beeswax white, carnauba wax yellow,
polysorbate, sorbic acid, sugar, mineral water.
The printing ink contains shellac glaze, iron oxide black (E172), n-butyl alcohol, purified water,
propylene glycol (E1520), industrial methylated spirit and isopropyl alcohol.
What Triptafen Tablets look like and contents of pack
Each sugar coated tablet is pink in colour, printed with 1D on one face of the tablet. Triptafen Tablets
are supplied in cartons of 100 tablets with 10 foil strips of 10 tablets.
Marketing authorisation holder:
Mercury Pharmaceuticals Ltd., Capital House, 85 King William Street, London EC4N 7BL, UK
Manufacturer: Custom Pharmaceuticals Ltd., Tecore House, Conway Street, Hove, East Sussex,
BN3 3LW, UK
This leaflet was last revised in September 2016.
Triptafen is a registered trade mark of Mercury Pharma Group Ltd.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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