Quetiapine 300 Mg Film-Coated Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 Quetiapine
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, please 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 Quetiapine film-coated tablets are and what they are used for
2. 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. Further information
1. WHAT QUETIAPINE FILM-COATED TABLETS ARE AND WHAT THEY ARE USED FOR
Quetiapine film-coated tablets contain a substance called quetiapine. This belongs to a group of medicines called anti-psychotics. These medicines help with the effects of some types of mental illness such as:
• Schizophrenia: You may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
• Mania: You may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive or aggressive behaviours.
• Bipolar depression: Effects on your mood whereby you feel sad. You may find that you need to sleep less than usual. You may find that you feel depressed, feel guilty, lack energy, lose your appetite and/or can’t sleep.
Your doctor may continue to give you Quetiapine film-coated tablets when you are feeling better to prevent your symptoms from returning.
2. BEFORE YOU TAKE QUETIAPINE FILM-COATED TABLETS
Do not take Quetiapine film-coated tablets if
■ You are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine film-coated tablets. (see section 6: further information)
■ You are taking any of the following medicines:
o some medicines for HIV (medicines taken against AIDS), o azole medicines (for fungal infections) o antibiotics for infections (erythromycin or clarithromycin) o nefazodone (against depression).
Do not take Quetiapine film-coated tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine film-coated tablets.
Take special care with Quetiapine film-coated tablets
Before you take your medicine, tell your doctor if:
■ You, or someone in your family, have or have had any heart problems such as a very fast heart beat or prolonged QT on an ECG (heart tracing), or if you are taking any medicines that may have an impact on the way your heart beats.
■ You have low blood pressure.
■ You have had a stroke, especially if you are elderly.
■ You have problems with your liver.
■ You have ever had a fit (seizure).
■ You have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine film-coated tablets.
■ You know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
■ You are an elderly person with dementia. If you are, Quetiapine Torrent should not be taken because the group of medicines that Quetiapin Torrent belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
■ 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.
Tell your doctor immediately if you experience
■ 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, mainly of your face or tongue
■ Dizziness or feeling very drowsy. This could increase the 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.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your medication. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
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, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Weight gain has been seen in patients taking Quetiapin Torrent. You and your doctor should check your weight regularly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, because it may affect the way this medicine works. This includes medicines that you buy without a prescription and herbal medicines.
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).
In particular, tell your doctor if you are taking any of the following medicines:
■ Epilepsy medicines (like phenytoin or carbamazepine).
■ High blood pressure medicines.
■ Barbiturates (for difficulty sleeping).
■ Thioridazine (another anti-psychotic medicine).
■ Medicines that affect the heart, for example, drugs that can cause an imbalance in some of the chemicals in your blood such as diuretics (water pills) or certain antibiotics.
Before you stop taking any of your medicines, please talk to your doctor first.
Taking Quetiapine film-coated tablets with food and drink
■ Quetiapine film-coated tablets can be taken with or without food.
■ Be careful how much alcohol you drink. This is because the combined effect of Quetiapine film-coated tablets and alcohol can make you sleepy.
■ Do not drink grapefruit juice while you are on Quetiapine film-coated tablets treatment. It can affect the way the medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Quetiapine film-coated tablets. You should not take Quetiapine film-coated tablets during pregnancy unless this has been discussed with your doctor.
The following symptoms may occur in newborn babies, of mothers that have used Quetiapine film-coated tablets 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. Quetiapine film-coated tablets should not be taken if you are breast-feeding.
Driving and using machines
Quetiapine film-coated tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how these tablets affect you.
Important information about some of the ingredients of Quetiapine film-coated tablets
Quetiapine film-coated tablets contain lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Effect on Urine Drug Screens
If you have a urine drug screen, taking Quetiapine Torrent could cause positive results for methadone or drugs for depression called tricyclic antidepressants (TCAs), even though you may not be taking methadone or TCAs. The result will need to be confirmed by a more specific test.
3. HOW TO TAKE QUETIAPINE FILM-COATED TABLETS
Always take Quetiapine film-coated tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose and how many Quetiapine tablets to take each day. This will depend on your illness and needs but will usually be between 150 mg and 800 mg.
• You will take your tablets once a day, at bedtime or twice a day, depending on your illness
• Swallow your tablets whole with a drink of water.
• You can take your tablets with or without food.
• Do not drink grapefruit juice while you are on Quetiapine Torrent treatment. It 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
If you have liver problems your doctor may give you a lower dose.
Elderly people
If you are elderly your doctor may give you a lower dose.
Children and adolescents under 18 years
Quetiapine film-coated tablets should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine film-coated tablets than you should
If you take more Quetiapine film-coated tablets than prescribed by your doctor, you may experience sleepiness, dizziness and abnormal heart beats. Contact your doctor or nearest hospital straight away. Take this leaflet or some tablets with you so your doctor will know what you have taken.
If you forget to take Quetiapine film-coated tablets
If you forgot to take a dose, take it as soon as you remember. If it is almost time to take the next dose, wait until then. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Quetiapine film-coated tablets • Do not stop taking your tablets even if you feel better, unless your doctor tells you.
If you suddenly stop taking Quetiapine film-coated tablets, you may be unable to sleep (insomnia), you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your doctor may suggest you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Quetiapine film-coated tablets can cause side effects, although not everybody gets them.
Tell your doctor, nurse or pharmacist if you think you have any of these or any other problems with Quetiapine film-coated tablets. If any of the following side effects get serious, or if you notice side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common (affects more than 1 patient in 10):
■ Dizziness (may lead to falls), headache, dry mouth.
■ Feeling sleepy (this may go away with time, as you keep taking Quetiapine film-coated tablets) (may lead to falls).
■ Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine film-coated tablets) include not being able to sleep (insomnia), feeing sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
■ Putting on weight
Common (affects 1 to 10 patients in 100)
■ Rapid heartbeat.
■ Feeling like your heart is pounding, racing or has skipped beats.
■ Stuffy nose.
■ Constipation, upset stomach (indigestion).
■ Feeling weak, fainting (may lead to falls).
■ Swelling of arms or legs.
■ Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
■ Increased levels of sugar in the blood.
■ Blurred vision.
■ Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
■ Abnormal dreams and nightmares
■ Increased appetite
■ Feeling irritated
■ Disturbance in speech and language.
■ Suicidal thoughts and worsening of your depression
■ Shortness of breath.
■ Vomiting (mainly in the elderly).
■ Fever.
Uncommon (affects 1 to 10 patients in 1,000)
■ Fits or seizures
■ Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth
■ Unpleasant sensations in the legs (also called restless legs syndrome)
■ Difficulty swallowing
■ Uncontrollable movements, mainly of your face or tongue.
■ Sexual dysfunction
■ Worsening of pre-existing diabetes
■ Change in the electrical activity of the heart seen on ECG (QT prolongation)
Rare (affects 1 to 10 patients in 10,000)
■ A combination of high temperature (fever), , sweating, stiff muscles, feeling very drowsy or faint (a disease called “neuroleptic malignant syndrome”).
■ Yellowing of the skin and eyes (jaundice).
■ 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.
■ Walking, talking, eating or other activities while you are asleep.
■ Body temperature decreased (hypothermia).
■ Pancreatitis.
Very rare (affects less than 1 patient in 10,000)
■ Severe rash, blisters, or red patches on the skin.
■ A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
■ Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
■ Inappropriate secretion of a hormone that controls urine volume.
■ Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).
Not known (frequency cannot be estimated from the available data)
■ Skin rash with irregular red patches (erythema multiforme)
■ Severe, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis)
The class of medicines to which Quetiapine film-coated tablets belong can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
Some side effects are only seen when a blood test is taken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, changes in the amount of thyroid hormones in the blood, elevated liver enzymes, decreases in the number of certain types of blood cells, increased blood creatine phosphokinase (a substance in the muscles), decreases in the amount of sodium in the blood and increases in the amount of a hormone called 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.
■ Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
Children and adolescents (10 to 17 years of age)
The same side effects that may occur in adults may also occur in children and adolescents.
The following side effect has been seen only in children and adolescents:
Very Common (affects more than 1 patient in 10):
■ Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (affects more than 1 patient in 10):
■ Increase in the amount of a hormone called prolactin, in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
O Boys and girls to have swelling of breasts and unexpectedly produce breast milk O Girls to have no monthly period or irregular periods
■ Increased appetite
■ Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
5. HOW TO STORE QUETIAPINE FILM-COATED TABLETS
Keep out of the reach and sight of children.
Do not use Quetiapine film-coated tablets after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater 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 Quetiapine film-coated tablets contain
The active ingredient is quetiapine. Each film-coated tablet contains 25/100/150/200/300 mg quetiapine as quetiapine fumarate.
The other ingredients are:
Tablet core: calcium hydrogen phosphate dihydrate, cellulose, microcrystalline, lactose monohydrate, sodium starch glycolate (type-A), povidone (K-30), silica, colloidal anhydrous, magnesium stearate
Film-coating: hypromellose, macrogol 400, titanium dioxide (E 171), ferric oxide red (E172) (25 mg film-coated tablets), ferric oxide yellow (E172) (25 mg, 150 mg film-coated tablets).
What Quetiapine film-coated tablets look like and contents of the pack
Quetiapine 25 mg film-coated tablets
Brownish red coloured, round, biconvex film-coated tablets, plain on both sides.
Quetiapine 100 mg film-coated tablets
White to off-white, round, biconvex film-coated tablets with cross break line on both sides. The tablet can be divided into equal quarters.
Quetiapine 150 mg film-coated tablets
Yellow coloured, round, biconvex film-coated tablets plain on both sides.
Quetiapine 200 mg film-coated tablets
White to off-white, round, biconvex film-coated tablets with break line on one side and plain on other side.
The tablet can be divided into equal halves.
Quetiapine 300 mg film-coated tablets
White to off-white, capsule shaped, biconvex film-coated tablets with break line on both sides.
The tablet can be divided into equal halves.
Pack sizes: 60 film-coated tabletss
Marketing Authorisation Holder and Manufacturer
TORRENT PHARMA (UK) Ltd Unit 4, Charlwood Court County Oak Way Crawley RH11 7XA United Kingdom
This medicinal product is authorised in the Member States of the EEA under the following names:
DE: Quetiapin Heumann 25/50/100/150/200/300/400 mg Filmtabletten
LT: Quetiapine Torrent 25/50/100/150/200/300/400 mg plevele dengtos tabletes
RO: Q Mind 25/100/150/200/300 mg comprimate filmate
This leaflet was last approved in 12/2012.
Quetiapine film-coated tablets 25 mg - PL 36687/0041 100 mg - PL 36687/0042 150 mg - PL 36687/0043 200 mg - PL 36687/0044 300 mg - PL 36687/0045