Quetiapine 25mg Film-Coated Tablets
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Pharma code 76 (001101)
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1. What Quetiapine Film-coated Tablets is and what it is used for
2. What you need to know before you take Quetiapine Film-coated Tablets
3. How to take Quetiapine Film-coated Tablets
4. Possible side effects
5. How to store Quetiapine Film-coated Tablets
6. Contents of the pack and other information
^4 WHAT QUETIAPINE FILM-COATED TABLETS IS AND WHAT IT IS USED FOR
♦ Quefiapine confainsasubsfance called quefiapine. This belongsfoagroup ofmedicines called antipsychotics.
Quefiapine can be usedtofreafseveral illnesses, such as:
♦ Bipolar depression: where you feel sad. You may find fhafyou feel depressed, feel guilty, lack energy, lose your appetite or can'fsleep.
♦ Mania:whereyoumayfeelveiyexcited,elated,agitated,enthusiasficorhyperactiveor have poorjudgmenf including being aggressive ordisrupfive
♦ Schizophrenia:whereyoumayhearorfeelthingsthatarenotthere,believethingsthat are noffrue or feel unusually suspicious, anxious, confused, guilty/tense ordepressed.
Your docformay confinuefo prescribe quefiapine evenwhenyou are feeling better.
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE QUETIAPINE FILM-COATED TABLETS Do not take Quetiapine Film-coated Tablets:
♦ if you are allergic to quefiapine orany offhe other ingredients of this medicine listed in section 6
♦ if you are faking any of the following medicines:
♦ some medicines for HIV
♦ azole medicines (for fungal infections)
♦ erythromycin or clarithromycin (for infections)
♦ nefazodone (for depression).
Do noffake Quefiapine Film-coated Tablets if the above applies to you. If you are not sure,falkfoyour doctor or pharmacist before taking Quefiapine Film-coated Tablets. Warnings and precautions
Talk to yourdocforor pharmacist before faking quefiapine if:
♦ You, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heartmuscle or inflammation offhe heart or if you are faking any medicines that may have an impact on the way yourheart beats
♦ Youhavelowbloodpressure
♦ You havehad a stroke, especially if you are elderly
♦ Youhaveproblemswifhyourliver
♦ You have ever had a fit (seizure)
♦ You havediabefesor have a risk of getting diabetes. Ifyou do,yourdocformay checkyour blood sugarlevelswhileyou are faking quefiapine.
♦ You knowfhafyou have had lowlevelsofwhife blood cells in the pasflwhich may or may not have been caused by other medicines)
♦ You are an elderly personwifh dementia (loss of brain function). If you are, Quefiapine Film-coated Tablets should not be taken because the group of medicines that Quefiapine Film-coated Tablets belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
♦ You orsomeone else in your family has a history of blood clots, asmedicines like these have been associated with formation of blood clots.
Tell yourdocforimmediafely ifyou experience any offhe following aftertaking Quefiapine:
♦ A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be needed.
♦ Uncontrollable movements, mainlyofyourface orfongue
♦ Dizziness or a severesense of feeling sleepy. This could increasefhe risk of accidental injury (fall) in elderly patients.
♦ Fits (seizures)
♦ A long-lasting and painful erection (priapism).
These conditions can be caused by this type of medicine.
Tell yourdocforassoon as possible ifyou have:
♦ A fever, flu-like symptoms, sore throat, or any other infection, as this could be a resulfofaverylowwhife blood cell counf,which may require Quefiapine Film-coated Tablets to be stopped and/orfreatmenffo be given.
♦ Constipation along with persisfenfabdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
Thoughts of suicide and worsening of your depression Ifyou are depressed you may somefimeshave thoughts of harming or killing yourself. These may be increasedwhen first starting treatment, sincefhese medicines all fake time to work, usually abouftwo weeks but sometimes longer. These thoughts may also be increased ifyou suddenly stoptaking your medication. You may be more likely to think like this ifyouarea young adult.
♦ Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviourinyoung adults aged lessfhan 25yearswifhdepression.
Ifyou have thoughts of harming or killing yourself afany time, confacfyourdocfor or go to a hospital straight away.
You mayfind it helpful to tell a relative or close friend fhafyouare depressed, and askfhemfo read this leaflet. You mighfask them to fell you if they think your depression is getting worse, orif they are worried about changes in your behaviour. Weight gain
Weighfgain has been seen in patients taking Quefiapine Film-coated Tablets. You and yourdocfor should check yourweighf regularly.
Children and adolescents
Quefiapine is noffor use in children and adolescents below18 years ofage.
QUETIAPINE 25 mg FILM-COATED TABLETS QUETIAPINE 100 mg FILM-COATED TABLETS QUETIAPINE 150 mg FILM-COATED TABLETS QUETIAPINE 200 mg FILM-COATED TABLETS QUETIAPINE 300 mg FILM-COATED TABLETS
PACKAGE LEAFLET: INFORMATION FORTHE USER
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 anyfurtherquestions,askyourdoctor or pharmacist.
♦ Thismedicinehas been prescribed foryou only. Do not pass it on to others. Itmay harm them, even if their signs of illness are the same as yours.
♦ If you gefany side effects, falkfoyour doctor or pharmacist. This includesany possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
Other medicines and quetiapine
Tell yourdocforor pharmacist ifyou are faking, have recently taken ormighffake any ofhermedicines.
Do not take Quetiapine Film-coated Tablets if you are taking any of the following medicines:
♦ Some medicines for HIV
♦ Azole medicines (for fungal infections)
♦ Erythromycin or clarithromycin (for infections)
♦ Nefazodone (for depression).
Tell your doctor if you are taking any of the following medicines:
♦ Epilepsy medicines (like phenyfoin or carbamazepine)
♦ High blood pressure medicines
♦ Barbiturates (for difficulty sleeping)
♦ Thioridazine or Lithium (other anti-psychotic medicines)
♦ Medicinesfhaf have an impact on the way yourheart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (wafer pills) or certain antibiotics (drugs to treat infections)
♦ Medicinesfhaf can cause constipation.
Before you stop taking any ofyourmedicines, please falkfo your doctor first. Quetiapine Film-coated Tablets with food, drink and alcohol
Quefiapine Film-coated Tablets can be taken with orwifhouffood.
♦ Be careful how much alcohol you drink. This is because the combined effect of Quefiapine Film-coated Tablets and alcohol can make you sleepy.
♦ Do not drink grapefruit juice while you are taking Quefiapine Film-coated Tablets. If can affect the way the medicine works.
Pregnancy and breast-feeding
Ifyou are pregnanfor breast-feeding, think you may be pregnanforare planning to have a baby, ask yourdocfor or pharmacisffor advice before faking this medicine. You should noffake Quefiapine Film-coated Tablets during pregnancy unless this has been discussed with yourdocfor. Quefiapine Film-coated Tablets should not be taken ifyou are breast-feeding.
The following symptoms which can represenfwifhdrawal may occur in newborn babies, of mothers that have used quefiapine in the last trimester (last three months of their pregnancy): shaking, muscle sfiffnessand/orweakness, sleepiness, agitation, breathing problems,and difficultyinfeeding. If your babydevelops any of these symptoms you may need to confacfyourdoctor.
Driving and using machines
Thismedicine can affect your ability to drive as it may make you sleepy or dizzy.
♦ Do not drive while taking this medicine until you knowhowif affecfsyou
♦ If is an offence to drive if this medicine affects yourability to drive.
However, you would not be committing an offence if:
♦ The medicine has been prescribed to treat a medical or dental problem and
♦ You have taken it according to the instructions given by the prescriber or in the information provided with the medicine and
♦ Ifwas not affecting your ability to drive safely.
Talkfo yourdocforor pharmacist ifyou are nofsure whefherifissafe foryou to drive while faking this medicine.
Quetiapine Film-coated Tablets contains lactose
Quefiapine Film-coated Tablets contain lacfosewhich is a type ofsugar: Ifyou have beenfold byyour docforfhafyou have an infolerancefo somesugars/talkfoyour doctor before faking this medicine.
Quetiapine Film-coated Tablets contains E110 (sunset yellow FCF aluminium lake)
25,100mg: This medicinal product confainssunsefyellow FCFaluminium lake (E110) and may cause allergic reactions.
Effect on Urine Drug Screens
Ifyou are having a urine drug screen/taking Quefiapine Film-coated Tablefsmay cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test mefhodsare used, even though you may not betaking methadone orTCAs. If this happens, a more specific test can be performed.
^4 HOW TO TAKE QUETIAPINE FILM-COATED TABLETS
Always fake this medicine exactly as yourdocfor has fold you. Check with your docforor pharmacist ifyou are nofsure.
Your doctor will decide on your starting dose. The maintenance dose (daily dose) will depend on your illness and needs bufwill usually be between 150mg and 800mg.
♦ You will fakeyourfablefsonce a day, at bedtime ortwice a day,depending on your illness
♦ Swallowyourfablefswholewith a drink ofwafer
♦ You canfakeyourfabletswithorwithouffood
♦ Do not drink grapefruit juice while you are taking quefiapine. If can affect the way the medicine works.
♦ Do not stop taking your tablets even if you feel better, unless your doctor tells you. Liver problems
Ifyou haveliverproblemsyourdocfor may change yourdose.
Elderly people
Ifyou are elderly yourdocfor may changeyour dose.
Use in children and adolescents
Quefiapine should not be used by children oradolescenfsaged under 18years.
If you take more Quetiapine Film-coated Tablets than you should
Ifyou fake more Quefiapine Film-coated Tablefsfhan prescribed byyourdocfor,you mayfeel sleepy, feel dizzy and experience abnormal heart beats. Confacfyour doctor or nearest hospital straight away. Keep the Quefiapine Film-coated Tablets with you.
If you forget to take a dose of Quetiapine Film-coated Tablets
If you forget to fake a dose, fake if as soon as you remember. If if is almost time to fakefhe nexfdose,waif until then. Do noffake a double dosefo make upfora forgotten dose.
If you stop taking Quetiapine Film-coated Tablets
Ifyou suddenly stoptaking quefiapine, you may be unablefo sleep (insomnia), or you mayfeel sick (nausea), oryou may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Yourdocfor may suggesfyou reduce the dose gradually before stopping treatment.
Ifyou have anyfurtherquesfions on the use of this medicine, askyourdocforor pharmacist.
^4 POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (mayaffectmorefhan 1 in 10 people):
♦ Dizziness (may lead to falls), headache dry mouth
♦ Feeling sleepy (this may go away with time, as you keep faking Quefiapine Film-coated Tablets) (may lead to falls)
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♦ Discontinuation symptoms (symptomswhich occurwhenyou stop taking Quetiapine Film-coated Tablets) include not being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness and irritability. Gradualwithdrawal overa period of at least 1 to2weeks is advisable.
♦ Puttingonweight
♦ Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain
♦ Changes in the amount of certain fats (triglycerides and total cholesterol). Common side effects (may affect uptolinlO people):
♦ Rapid heartbeat
♦ Feeling like your heart is pounding, racing or has skipped beats
♦ indigestion
♦ Constipation,upset stomach(indigestion)
♦ Feeling weak
♦ Swelling ofarms or legs
♦ Low blood pressurewhen standing up. This maymakeyou feel dizzy orfaint (may lead to falls)
♦ Increased levels of sugar in the blood
♦ Blurred vision
♦ Abnormaldreamsandnightmares
♦ Feelingmorehungry
♦ Feeling irritated
♦ Disturbance in speech and language
♦ Thoughts ofsuicide and worsening ofyourdepression
♦ Shortness of breath
♦ Vomiting (mainly in the elderly)
♦ Fever
♦ Changesinthe amount of thyroid hormones in your blood
♦ Decreases in the number of certain types of blood cells
♦ Increases in the amount of liver enzymes measured in the blood
♦ Increasesinthe amountofthe hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
♦ Men and women to have swelling of breasts and unexpectedly produce breast milk
♦ Womento have no monthly period or irregular periods.
Uncommon side effects (mayaffect uptol in 100 people):
♦ Fits or seizures
♦ Allergic reactionsthatmay include raised lumps (weals), swelling ofthe skin and swelling around the mouth
♦ Unpleasant sensations in the legs (also called restless legs syndrome)
♦ Difficulty swallowing
♦ Uncontrollable movements, mainlyofyourface ortongue
♦ Sexual dysfunction
♦ Diabetes
♦ Change in electrical activity of the heartseen on ECG (QT prolongation)
♦ A slowerthan normal heart ratewhich may occurwhen starting treatmentand which may be associated with low blood pressure and fainting
♦ Difficulty in passing urine
♦ Fainting (may lead to falls)
♦ Stuffy nose
♦ Decrease in the amount of red blood cells
♦ Decrease in the amount of sodium in the blood.
Rare side effects (may affect upto 1 in 1000 people):
♦ A combination ofhightemperature (fever), sweating, stiff muscles, feeling very drowsy or faint (a disorder called 'neuroleptic malignant syndrome')
♦ Yellowing of the skin and eyes (jaundice)
♦ Inflammation of the liver (hepatitis)
♦ A long-lasting and painful erection (priapism)
♦ Swelling of breasts and unexpected production of breast milk (galactorrhoea)
♦ Menstrual disorder
♦ 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 ofthese symptoms seek medical advice immediately.
♦ Walking, talking, eating or other activities whileyouare asleep
♦ Bodytemperature decreased (hypothermia)
♦ Inflammation of the pancreas
♦ A condition (called 'metabolic syndrome') where you may have a combination of 3 ormore ofthe following: anincrease in fat around yourabdomen,a decrease in 'good cholesterol' (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar
♦ Combination of fever, flu-like symptoms, sore throat, or any other infection with very lowwhite blood cell count, a condition called agranulocytosis
♦ Bowelobstruction
♦ Increased blood creatine phosphokinase (a substance from the muscles).
Very rare side effects (may affect uptolinlOOOO people):
♦ Severe rash, blisters, or red patches on the skin
♦ A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing orshock
♦ Rapid swelling ofthe skin, usually around the eyes, lips and throat(angioedema)
♦ A serious blistering condition of the skin, mouth, eyes and genitals (Steven-Johnson syndrome)
♦ Inappropriate secretion of a hormone that controls urine volume
♦ Breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
♦ Worsening of pre-existing diabetes.
Not known (frequency cannot be estimated from the available data):
Skin rash with irregular red spots (erythema multiforme)
♦ Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling ofthe skin (toxic epidermal necrolysis)
♦ Symptoms ofwithdrawal may occur in newborn babies ofmothers thathave used Quetiapine Film-coated Tablets during their pregnancy.
The class of medicines to which Quetiapine Film-coated Tablets belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal. Some side effects are only seenwhen a blood testistaken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormonesinyour blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance in the muscles),decrease in the amount of sodium in the blood and increases in the amount ofthe hormone prolactin in the blood.
Increases in the hormone prolactin could in rare cases lead to the following:
♦ Men and women to have swelling of breasts and unexpectedly produce breast milk
♦ Womento have no monthly period or irregular periods.
Your doctormay askyou to have blood tests fromtime to time.
Side effects in children and adolescents
The same side effects that may occurin adults may also occurin children and adolescents.
The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Very common side effects (may affect morethanl in 10 people):
♦ Increase in the amountofa hormone called prolactin,inthe blood. Increasesin the hormone prolactin could in rare caseslead to the following:
♦ boys and girls to have swelling of breasts and unexpectedly produce breast milk
♦ girls to have no monthly period or irregular periods
♦ increased appetite
♦ vomiting
♦ Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
♦ Increase in blood pressure.
Common side effects (may affect uptolinlO people):
♦ Feeling weak, fainting (may lead to falls)
♦ Stuffy nose
♦ Feeling irritated.
Reporting of side effects:
If you getany side effects, talk to your doctor, pharmacistornurse. 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 effectsyou can help provide more information on the safety of this medicine.
HOW TO STORE QUETIAPINE FILM-COATED TABLETS
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date whichis stated on the carton and bottle or blister. The expiry date refersto the last day of that month.
This medicinal product does not require any special storage conditions.
Do notthrow away any medicines via wastewater or household waste. Ask your pharmacist howto throw away medicines you no longer use. These measures will help protectthe environment.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Quetiapine Film-coated Tablets contains
♦ The active substance is quetiapine. Eachfilm-coated tablet contains25,100,150, 200,300 mg quetiapine (as quetiapine fumarate).
♦ The other ingredients are calcium hydrogen phosphate, dihydrate, lactose monohydrate, povidone K-25, cellulose microcrystalline, sodium starch glycolate (type A), silica, colloidal anhydrous, magnesium stearate. The coating contains hypromellose, titanium dioxide (E171), triacetin, 25,100,150,300 mg: lactose monohydrate, iron oxideyellow (E172), 25,100 mg: sunsetyellow FCFaluminium lake (E110),200 mg: polydextrose,macrogol 8000.
What Quetiapine Film-coated Tablets look like and contents of the pack
♦ Quetiapine 25 mg Film-coated Tablets are light-orange, round, biconvex, film-coated tablets, engraved "25" on one side and plain on the other
♦ Quetiapine 100 mg Film-coated Tabletsare light-orange, round, biconvex, film-coated tablets, engraved "100" on one side and plain on the other
♦ Quetiapine 150 mg Film-coated Tabletsare paleyellow, round, biconvex, film-coated tablets, engraved "150" on one side and plain on the other
♦ Quetiapine 200 mg Film-coated Tabletsarewhiteto off-white, round, biconvex, film-coated tablets, engraved "200" on one side and plain on the other
♦ Quetiapine 300 mg Film-coated Tablets are paleyellow, capsule-shaped, biconvex, film-coated tablets, engraved "300" on one side and plain on the other.
Quetiapine Film-coated Tablets are available in White opaque PVC/PE/Aclar-aluminium or white opaque PVC/PVdC-aluminium Blister
♦ For25mg: packsizes of 1,6,10,20,30,50,60,90and 100 (10x10) film-coated tablets, hospital packs of 50 film-coated tablets
♦ ForlOO mg: packsizesof 1,10,20,30,50,60,90and 100(10x10)film-coated tablets, hospital packs of 50 film-coated tablets
♦ For150 mg: packsizesof 1,10,20,30,50,60,90and 100(10x10)film-coated tablets, hospital packs of 50,120,180 and 240 film-coated tablets
♦ For200 mg: packsizesof 1,10,20,30,50,60,90and 100(10x10)film-coated tablets, hospital packs of 50 film-coated tablets
♦ For300 mg: packsizesof 1,10,20,30,50,60,90and 100(10x10)film-coated tablets, hospital packs of 50,120,180 and 240 film-coated tablets.
HDPE bottle with white child resistant, propylene caps, with desiccant.
For all strengths: Pack sizes of 100 and 250 film-coated tablets.
♦ Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer:
TEVA UK Limited, Eastbourne, BN22 9AG.
This leaflet was last revised in 10/2014 PL 00289/1068-72
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