Fentazin 4mg Tablets
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MercuryPharma
PATIENT INFORMATION LEAFLET
Fentazin® 2mg and 4mg Tablets
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.
In this leaflet:
1. What Fentazin Tablets are and what they are used for
2. Before you take Fentazin Tablets
3. How to take Fentazin Tablets
4. Possible side effects
5. How to store Fentazin Tablets
6. Further information
1. What Fentazin Tablets are and what they are used for
Fentazin Tablets contain the active ingredient perphenazine, which belongs to a class of drugs called phenothiazine tranquilisers. Fentazin Tablets influences the activity of certain brain cells by decreasing the effect of dopamine, a natural chemical in the brain.
Fentazin Tablets are used to help in the short term treatment of anxiety, severe agitation, excitement, violent, dangerous behaviour, schizophrenia (a serious mental illness) and psychoses (paranoia, mania and hypomania).
Fentazin tablets may also be used to treat nausea (feeling sick), vomiting (being sick). They may be of value in the treatment of uncontrollable hiccups.
2. Before you take Fentazin Tablets
DO NOT take Fentazin Tablets if:
• You know that you are allergic to perphenazine or any of the other ingredients of Fentazin Tablets (see section 6 of this leaflet)
• You are suffering from blood disorders or have a low white blood cell count
• You are taking medicines which my cause bone marrow depression such as ciprofloxacin or lisinopril.
Fentazin should not be given to patients who are in a coma.
Take special care with Fentazin Tablets and tell your doctor if you are:
• suffering from a liver or kidney problem
• suffering from high blood pressure due to a tumour near the kidney (a condition known as phaeochromocytoma)
• having problems breathing
• suffering from an underactive thyroid (hypothyroidism)
• suffering from any disease involving the heart and blood vessels (cardiovascular disease) including chest pain (angina), heart failure, and personal or family history of irregular heart beats
• suffering from a brain disorder causing tremors, rigidity and slowing of movement (Parkinson’s disease)
• suffering from fits (epilepsy) or you have a condition that might lead to an epileptic attack (such as brain damage or alcohol withdrawal)
• suffering from an eye disease called narrow angle glaucoma which causes increased pressure inside the eye or anyone if your family has suffered from this condition
• suffering from abnormal muscle weakness (Myasthenia gravis)
• suffering from an enlargement of prostate gland
• exposed to extremes in temperature as this medicine can affect body temperature control
• an elderly or frail person, as this medicine can affect body temperature control especially in extreme heat or cold
• 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.
Fentazin Tablets should not be used alone when depression is the predominant symptom.
Even though some of the above may appear obvious, it is important that your doctor is aware if any of them apply to you.
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 these medicines may change, especially if you are taking:
• other medicines used to treat mental illness e.g. fluoxetine, paroxetine
• drugs which may cause bone marrow suppression
• sleeping tablets and sedatives
• antihistamines (used to treat allergies)
• corticosteroids such as prednisolone
• strong pain killers (e.g. codeine, tramadol)
• medicines which result in lowering of blood pressure (e.g. guanethidine)
• anticholinergic medicines used to reduce saliva and lung secretions (e.g. atropine, procyclidine)
• antidepressants (e.g. other phenothiazines, tricyclic antidepressants, lithium, antipsycotics)
• medicines for fits (anticonvulsants)
• medicines for Parkinson’s disease (e.g. levodopa) or alzheimers (memantine)
• medicines to treat heart problems (e.g. quinoline, digoxin)
• blood thinning medicines (anticoagulants such as warfarin)
• medicines to treat diabetes
• ritonavir (antiviral drugs for HIV)
• drugs used to treat indigestion (antacids e.g. kaolin), nausea or vomiting (e.g. metoclopramide)
• drugs which may alter the way your heart beats e.g. amiodarone, erythromycin, haloperidol (extra monitoring may take place if you are taking any of these at the same time as Fentazin).
Taking Fentazin Tablets with food and drink
You should not drink alcohol whilst you are taking this medicine.
Fentazin should not be taken with tea or coffee and it should not be taken at the same time as antacids.
Pregnancy and breast feeding
Do not take Fentazin Tablets if you are pregnant, think you may be pregnant or are planning to become pregnant unless your doctor decides that treatment is essential. Breast feeding should be stopped if you are taking this medicine.
Ask your doctor or pharmacist for advice before taking any 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.
Driving and using machines
Fentazin Tablets may make you feel drowsy or dizzy or give you blurred vision. 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 Fentazin Tablets
This medicine also contains:
• sucrose and lactose which are sugars. If you have been told by your doctor that you are intolerant to some sugars, contact your doctor before taking this medicine
• butyl hydroxybenzoate which may cause allergic reactions (possibly delayed).
3. How to take Fentazin Tablets
Always take Fentazin Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Swallow the tablets with a glass of water. The tablets can be taken with or without food.
Your doctor will decide on a suitable dose depending on your age, condition and previous response to treatment.
Adults: The normal adult dose is 4mg Fentazin three times a day. Dose may be adjusted upwards or downwards, according to response. Total daily dose should not be more than 24mg.
Elderly: Elderly should take one quarter to one half the adult dose.
Children: Fentazin Tablets should not be given to children under 14 years.
The pharmacist’s label on your pack will tell you how many tablets you should take and how often you should take them. Please read the label carefully. Do not take more than your doctor has recommended.
Your doctor will want to watch you closely if you have a disease of any of the following: liver, heart, chest, kidney, thyroid, prostate or adrenals, or if you have epilepsy, Parkinson's disease or glaucoma.
Because your medicine may make you more susceptible to sunburn, you should therefore avoid over exposure to the sun.
If you stop taking Fentazin Tablets
• Continue to take Fentazin Tablets even if you no longer feel ill. Do not stop taking this medicine without talking with your doctor first, especially if you have taken large doses for a long time. When the time comes to stop, your doctor will probably decrease your dose gradually as stopping the tablets suddenly may cause ill-effects such as nausea (feeling sick), vomiting (being sick), sweating, restlessness, involuntary twisting or jerking of your limbs, fits and difficulty in sleeping
• For mood disorders and schizophrenia, it may take several weeks for you to feel the full benefit of this medicine. If you stop taking this medicine suddenly, your symptoms may come back.
If you take more Fentazin Tablets than you should:
If you think that you, or any other person, have taken too many tablets, contact your doctor or hospital casualty department immediately. Take this leaflet and any remaining tablets with you so that the medical staff know exactly what you have taken.
If you forget to take your Fentazin Tablets:
If you miss a dose, wait until your next dose. Do not take the dose you have missed. You can then carry on as before. Do not take more than one dose at a time.
4. Possible side effects
Like all medicines, Fentazin Tablets can sometimes cause side effects, although not everybody gets them.
All medicines can cause allergic reactions although serious allergic reactions are rare. Any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) should be reported to a doctor immediately If you get any of the following side effects, seek medical advice as soon as possible:
• 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
• heart changes including fast heart beats, unusual heart beats, heart attack. Symptoms of a heart attack are chest pain which may spread to the shoulders, neck or arms and shortness of breath. If you get these go to your local Casualty/Accident and Emergency Department straight away
• if you have angina and your pain is getting worse
• slurred speech, odd movements of the face, particularly of the tongue, eyes, head or neck (such as twisting of the neck which causes an unnatural positioning of the head, rigid muscles, tremors or restlessness and difficulty in sitting still. Some patients (especially on high doses of this medicine) experience problems with muscle control which may continue for years. Such patients may experience constant chewing or tongue movements or other gentle movements of the neck, head or trunk. Uncontrollable movements of the arms and legs have also been reported in these patients
• jaundice (yellowing of skin and whites of eyes), eye problems, skin colouring (pigmentation)
• if you suffer from a sore throat, high fever, feel very tired, become pale, develop bruises and nose bleeds. These may indicate blood problems developing as a result of using this medicine.
Neuroleptic Malignant Syndrome, signs of which are a high temperature, rigid muscles, drowsiness, occasional loss of consciousness.
Tell your doctor if you get any of these side effects:
• difficulty or inability to pass urine or a high temperature
• breast enlargement in men to inappropriate milk production or altered menstrual cycle (e.g. periods stop) in women, impaired sexual function
• feeling slowed down or being agitated
• feeling very cold or hot especially if you are frail or elderly
• weakness
• tiredness
• drowsiness, dizziness, restlessness, excitement, confusion
• difficulty in sleeping
• high blood sugar or cholesterol levels
• dry mouth, blocked nose
• blurred vision, rolling of the eyeballs, Corneal and lens deposits, Pigmented retinopathy
• muscle weakness
• constipation, nausea, saliva altered
• loss of appetite
• low blood pressure, faintness on standing up
• skin rashes (including increased sensitivity to the sun)
• weight gain, excess sweating, water retention causing swelling
• systemic lupus erythematosus, an autoimmune disease. Symptoms include fever, fatigue, joint pains and weakness.
In elderly people with dementia, a small increase in the number of deaths has been reported for patients taking antipsychotic compared with those not receiving antipsychotic. Your doctor should check your progress regularly if you are on Fentazin Tablets to make sure no unwanted effects are developing.
Fentazin Tablets may give a false positive result on pregnancy tests.
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. 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 Fentazin Tablets
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after (EXP). The expiry date refers to the last day of that month. If your tablets are out of date, take them to your pharmacist who will get rid of them safely.
Do not store above 25°C. Store in the original package.
6. Further information
The active substance in Fentazin Tablets is perphenazine. Fentazin Tablets are available in two strengths, containing either 2mg or 4mg perphenazine. Fentazin Tablets also contains lactose, maize starch, pregelatinised maize starch, magnesium stearate. The tablet coating consists of acacia, sucrose, butyl hydroxybenzoate, gelatine, calcium phosphate, maize starch, titanium dioxide (E171), talc and opaglos 6000 (shellac, beeswax white and carnauba wax yellow). The markings on your tablet are edible printing ink, opacode black, which consists of Shellac glaze, Iron oxide black (E172), n-butyl alcohol, propylene glycol (E1520), ammonium hydroxide and isopropyl alcohol.
What Fentazin Tablets look like and contents of the pack
Fentazin 2mg Tablets are white, sugar coated and printed with 1C. Fentazin 4mg Tablets are white, sugar coated and printed with 2C. Each pack contains 100 tablets as 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., Conway Street, Hove, East Sussex, BN3 3LW, UK This leaflet was last revised in December 2013.
Fentazin is the registered trade mark of Mercury Pharma Group Limited. 100021-100022/LF/8