Medine.co.uk

Triptafen 25mg/2mg Tablets

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MercuryPharma


PATIENT INFORMATION LEAFLET

Triptafen® 25mg/2mg Tablets

Amitriptyline Hydrochloride/Perphenazine


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 become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

The name of your medicine is Triptafen1’ 25mg/2mg Tablets. It will be referred to as Triptafen Tablets for ease of use hereafter.

In this leaflet:

1.    What Triptafen Tablets are and what they are used for

2.    Before you take Triptafen Tablets

3.    How to take Triptafen Tablets

4.    Possible side effects

5.    How to store Triptafen Tablets

6.    Further 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. BEFORE YOU TAKE TRIPTAFEN TABLETS


DO NOT take Triptafen Tablets if you:

•    Know that you are allergic to Amitriptyline hydrochloride or Perphenazine or any of the other ingredients in the tablets (see section 6 of this leaflet)

•    Suffer from glaucoma (increased pressure in the eye)

•    Have a shortage of white blood cells (your doctor will advise you)

•    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

•    Suffer from epilepsy (fits)

•    Have severe liver problems

•    Suffer from the psychiatric disorder mania which causes extreme mental agitation or activity.

Speak to your doctor if any of these apply to you before you take your medicine.

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.

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.

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. 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. Taking with food and drink:

You should not drink alcohol whilst you are taking this medicine as it may increase the effects of Triptafen Tablets.

Pregnancy and breast feeding:

Ask your doctor or pharmacist for advice before taking any medicines. You should let your doctor know if you are pregnant, think you are pregnant or are planning to become pregnant, or if you are breast feeding. 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. 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.

Important information about some of the ingredients of Triptafen Tablets:

This medicine contains:

•    Lactose and sucrose, which are sugars: If you have been told by your doctor that you have an intolerance to sugars, contact your doctor before taking this medicine

•    Butyl hydroxybenzoate: May cause allergic reactions (possibly delayed).


3. HOW TO TAKE TRIPTAFEN TABLETS


It is important to take your medicine at the right time. You must take it as directed by your doctor. The label will tell you how much to take and how often. If it doesn’t or you are not sure, ask your doctor or pharmacist.

•    The usual dose is one tablet taken three times a day. Your doctor will advise you if this needs to be increased

•    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

•    Triptafen Tablets are not suitable for children under 18 years

•    If you have to go to another doctor or to hospital tell them you are taking Triptafen Tablet.


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 agitation, coma, high body temperature, jerky movements (clonus), fast or irregular heartbeat, low blood pressure, nausea, vomiting, long and deep breathing, difficulty in breathing and increased levels of some blood test parameters

•    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.

If you forget to take your 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.

If you have any further questions about these tablets, ask your doctor or pharmacist.


4. POSSIBLE SIDE EFFECTS


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.

Like all medicines, Triptafen tablets can cause side effects although not everybody gets them.

Amitriptyline:

Stop taking the tablets and see a doctor straight away if you have:

•    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 low sodium levels. Signs may include fever or chills, sore throat, ulcers in your mouth or throat, unusual tiredness or weakness, unusual bleeding or unexplained bruises.

If you notice any of these, tell your doctor straight away.

Serious side effects: tell doctor straight away:

•    If you feel more depressed, including thinking about suicide.

If you get any of the following side effects, see your doctor as soon as possible:

•    feeling faint and dizzy when standing up

•    changes in blood pressure

•    fast or unusual heart beats

•    heart attack

•    stroke

•    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)

•    difficulty in co ordination of movements

•    fits

•    tremors, abnormal involuntary movements

•    unconsciousness

•    slow or slurred speech

•    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)

•    change in sexual function and sex drive, breast swelling in men and women

•    swelling of your testicles, breast enlargement or production of breast milk in men

•    increased or decreased blood sugar levels

•    pass water (urinate) more frequently.

Tell your doctor if you get any of these side effects:

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.

•    buzzing or ringing in the ears

•    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, blockage of the gut, problems with digestion

•    skin rashes, skin rash due to sunlight

•    blurred or double vision, changes in eyesight

•    headache, dizziness, weakness, tiredness, change in weight, drowsiness, increased sweating, hair loss, widely dilated pupils, difficulty passing water (urine)

•    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:

WHILE TAKING Perphenazine:

•    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:

•    allergic reactions, signs may include: a rash, swallowing or breathing problems, wheezing, swelling of your lips, face, throat or tongue

•    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.

•    restlessness, agitation, excitement

•    muscle spasms

•    difficulty in walking, loss of balance, twitching or abnormal movements of the body, fece or eyes, increased reflexes, inability to open the mouth, stiff neck

•    headache, confusion

•    difficulty speaking

•    epileptic fits

•    sleepiness

•    excessive drowsiness

•    difficulty in sleeping

•    constipation feeling sick, dry mouth, saliva altered

•    blurred vision

•    difficulty in passing urine

•    low blood pressure (feinting, light headedness), excessive sweating, dizziness

•    blocked nose

•    jaundice (yellowing of the skin and whites of the eyes)

•    increased blood cholesterol

•    increased blood sugar

•    false positive pregnancy tests (though your medication is not recommended in pregnancy)

•    blood disorders (these may be seen as fever or chills, sore throat, ulcers in the mouth, being prone to infections, unusual tiredness or weakness)

•    increased sensitivity of the skin to light

•    abnormal secretion of breast milk in men

•    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

•    heart attack

•    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. STORING YOUR MEDICINE


Keep this medicine out of the sight and reach of children.

If you have any of your medicine left after finishing your treatment, return it to your pharmacist.

Do not use your medicine if the pack is damaged or after the expiry date printed on the blister strip and carton. The expiry date refers to the last day of that month.


6. FURTHER INFORMATION


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, erythrosine ariavit, 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 January 2015.    100050/LF/034/04

Triptafen is a registered trade mark of Mercury Pharma Group Ltd.