QUETIAPINE 300 MG FILM-COATED TABLET
Active substance: QUETIAPINE HEMIFUMARATE
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Quetiapine
Quetiapine 100 mg Film-coated Tablets Quetiapine 150 mg Film-coated Tablets Quetiapine 200 mg Film-coated Tablets Quetiapine 300 mg Film-coated Tablets
SZ00000LT000
In this leaflet: 1. What Quetiapine is and what it is used for 2. Before you take Quetiapine 3. How to take Quetiapine 4. Possible side effects 5. How to store Quetiapine 6. Further information
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Quetiapine belongs to a group of medicines called antipsychotics.
1
What Quetiapine is and what it is used for
Quetiapine is used to treat: schizophrenia Symptoms include: - hallucinations, such as hearing unexplained voices - strange and frightening thoughts - changes in your behaviour - feeling alone and confused manic episodes associated with a disease called bipolar disorder Symptoms are: - feeling very high or excited - needing less sleep than usual - being more talkative with racing thoughts or ideas - feeling more irritable than usual depressive episodes associated with a disease called bipolar disorder Symptoms are: - feeling very down or sad - feeling guilty - lacking energy - losing appetite - can not sleep. Your doctor may continue to give you Quetiapine when you are feeling better to prevent your symptoms from returning.
medicines which reduce quetiapine levels in the blood and its effect, such as: - carbamazepine and phenytoin: medicines to treat epilepsy or other illnesses. Your doctor may consider prescribing another medicine to treat epilepsy or adjust your Quetiapine dose - thioridazine: a medicine to treat psychiatric disorders. medicines which act on the central nervous system. medicines which may cause certain cardiac disorders such as: - other antipsychotics, used to treat mental disorders - those used to treat irregular heartbeats in class IA or III - antibiotics, used to treat bacterial infections - medicines to treat malaria. medicines which may cause electrolyte imbalance such as: hydrochlorothiazide or similar medicines which increase your water output. medicines which influence hepatic enzymes such as: - rifampicin: a medicine to treat tuberculosis or certain other infections - barbiturates: medicines to treat sleeplessness. Taking Quetiapine with food and drink Quetiapine can be taken with or without food. Do not drink alcohol during treatment with Quetiapine, the combined effect might make you feel drowsy. Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works.
Do not take Quetiapine if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine as listed in chapter 6 Further information. if you take any of the following medicines: - medicines to treat HIV infections with active substance names ending in navir - medicines to treat fungal infections with active substance names ending in azole such as ketoconazole - erythromycin and clarithromycin: medicines to treat bacterial infections - nefazodone: a medicine to treat depression.
2
Before you take Quetiapine
Pregnancy and breast-feeding Pregnancy Do not take Quetiapine if you are pregnant unless your doctor has told you to. Inform your doctor immediately if you are pregnant or think you may be. The following symptoms may occur in newborn babies, of mothers who have used Quetiapine 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 Quetiapine when breast-feeding. Driving and using machines Only drive or operate machines if your doctor has approved it. This will depend upon how this therapy affects you, because Quetiapine may make you feel sleepy and dizzy and thus impair your mental alertness. Ask your doctor or pharmacist for advice before taking any medicine.
Take special care with Quetiapine Before you take your medicine inform your doctor or pharmacist if you have poor circulation in the heart or brain, or other conditions inclined to cause low blood pressure. have or have had diseases of the heart and/or blood vessels (or a family history of heart problems), such as heart failure or irregular heart beat, especially an abnormality known as prolonged QT-interval. are taking any medicines that may have an impact on the way your heart beats. have had a stroke previously, especially if you are elderly. are an elderly person with dementia (loss of brain function). If you are, Quetiapine should not be taken because the group of medicines that Quetiapine belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia. have had low levels of white blood cells previously which may or may not have been caused by other medicines. have ever suffered from convulsions. have diabetes mellitus, tend to have high blood sugar levels or are at risk of developing diabetes mellitus. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine. have high cholesterol values and so called triglyceride levels, which are certain fats, in your blood. have experienced considerable weight gain during an earlier treatment with a medicine belonging to the same group as Quetiapine does. have a liver function disorder. See chapter 3 How to take Quetiapine. or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots. Inform your doctor or pharmacist immediately if you notice any involuntary movements or experience abnormal movements especially of the tongue, mouth and face while taking this medicine. If so your doctor might reduce your dose or discontinue treatment. develop fever, accelerated breathing, excessive sweating, changes in consciousness or stiff muscles. Immediate medical treatment may be needed; see chapter 4, first paragraph neuroleptic malignant syndrome. have dizziness or a severe sense of feeling sleepy. This could increase the risk of accidential injury (fall) in elderly patients. experience fits or seizures. have a long-lasting and painful erection.
Effect on urine drug screens If you are having a urine drug screen, taking Quetiapine may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.
Important information about some of the ingredients of Quetiapine Quetiapine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Quetiapine.
Medicinal products containing lower strengths of quetiapine are available for doses not realizable/ practicable with this medicine.
Your doctor will tell you how many Quetiapine tablets you should take and how long you should continue to take them.
Always take Quetiapine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Quetiapine
The usual dose is: Adults To treat schizophrenia Take the following total daily doses divided into two separate doses per day. - Day 1: 50 mg quetiapine - Day 2: 100 mg quetiapine - Day 3: 200 mg quetiapine - Day 4: 300 mg quetiapine - After day 4: Your doctor will gradually increase the total daily dose from 300 mg to 450 mg quetiapine. Depending on your individual response and tolerance, the total daily dose may vary between 150 mg and 750 mg quetiapine. To treat manic episodes Take the following total daily doses divided into two separate doses per day. - Day 1: 100 mg quetiapine - Day 2: 200 mg quetiapine - Day 3: 300 mg quetiapine - Day 4 and following days: 400 mg quetiapine - From day 6: Your doctor may gradually increase the daily dose up to a maximum of 800 mg quetiapine. The daily dose increase should not exceed 200 mg quetiapine. Depending on your individual response and tolerance, the total daily dose may vary between 200 mg and 800 mg quetiapine.
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.
To treat depressive episodes Take the following doses once daily every evening at bedtime. - Day 1: 50 mg quetiapine - Day 2: 100 mg quetiapine - Day 3: 200 mg quetiapine - Day 4 and following days: 300 mg quetiapine Average dose: 300 mg quetiapine per day. Children and adolescents under 18 years Quetiapine should not be used by children and adolescents aged under 18 years.
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 following medicines can particularly influence or be influenced by Quetiapine: medicines which must not be taken together with Quetiapine - see chapter 2 Do not take Quetiapine: - medicines to treat HIV infections with active substance names ending in navir - medicines to treat fungal infections with active substance names ending in azole such as ketoconazole - erythromycin and clarithromycin: medicines to treat bacterial infections - nefazodone: a medicine to treat depression.
Weight gain Weight gain has been seen in patients taking Quetiapine. You and your doctor should check your weight regularly.
Patients over 65 years Lower doses and slower dose increases may be sufficient for this age group.
Patients with impaired liver function Starting dose: 25 mg quetiapine per day. This dose is increased slowly by 25 mg to 50 mg quetiapine each day until the optimal dose is reached. Method of administration For oral use. Swallow the tablets with a glass of water preferably at the same time each day.
If you take more Quetiapine than you should If you have accidentally taken too much Quetiapine contact your doctor or a hospital at once. Always take the tablets, leaflet and/or carton with you so the doctor will know what you took. Immediate medical care is necessary if the following signs occur: drowsiness, sedation, rapid heart beat and low blood pressure.
Continued on the next page >>
If you forget to take Quetiapine If you forget a dose continue by taking your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Quetiapine Do not stop taking Quetiapine unless advised by your doctor, as this may harm the success of therapy. If you suddenly stop taking the tablets, symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness might occur. To avoid such symptoms, it is important to reduce the dose gradually according to your doctors instructions. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Very rare, affects less than 1 user in 10,000: so called angioedema, also see the first paragraph in this chapter serious skin condition with blisters, also inside the mouth, and fever (Stevens-Johnson syndrome) severe allergic reaction, also see the first paragraph in this chapter inappropriate secretion of a hormone that controls urine volume breakdown of muscle fibres and pain in muscles.
Stop taking Quetiapine immediately and contact your doctor at once or go to the nearest hospital if any of the following events happen to you: a combination of fever, persistent sore throat or mouth ulcers, faster breathing, sweating, muscle stiffness and reduced consciousness all of these are symptoms of a severe disorder called neuroleptic malignant syndrome a severe allergic reaction, which involves difficulty breathing, low blood pressure, swelling in the mouth or throat, skin rash and itching symptoms of angioedema such as swollen face, tongue or pharynx, difficulties to swallow and to breath and hives fits or seizures long-lasting and painful erection 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 serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
Like all medicines, Quetiapine can cause side effects, although not everybody gets them.
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Possible side effects
Not known, frequency cannot be estimated from the available data decrease in the number of certain blood cells called neutrophilic granulocytes. These belong to the white blood cells, see above under Common. This occurs particularly after treatment has ended, is temporary and not severe. skin rash with irregular red spots (erythema multiforme) serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin, (toxic epidermal necrolysis).
Children and adolescents (10 to 17 years) 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 user in 10: increase in blood pressure.
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 your blood, increased liver enzymes, changes in the number of certain types of blood cells, increased blood creatine phosphokinase (a substance in the muscle), decrease in the amount of sodium in the blood and increases in the amount of a hormone called prolactin in the blood. Thus your doctor may ask you to have blood tests from time to time.
Also reported are: heart arrest specific heart rhythm disorders sudden unexplained death. These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.
Reported side effects listed according to the frequencies are: Very common, affects more than 1 user in 10: dizziness (may lead to falls) feeling sleepy (may lead to falls) headache dry mouth These symptoms usually occur when beginning therapy and gradually disappear as treatment continues. increased values for fats called triglycerides and total cholesterol (predominantly LDL cholesterol) in the blood decreased values for fats called HDL cholesterol in the blood discontinuation symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness. These occur when you suddenly stop taking Quetiapine. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable weight gain decrease of a certain protein called haemoglobin in your blood.
The following side effects have been seen more often in children and adolescents: Very common, affects more than 1 user in 10: increase in the amount of a hormone called prolactin in the blood. This can in rare cases lead 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 abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
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.
Common, affects 1 to 10 users in 100: particularly at the beginning of treatment: - rapid heart beat - fainting (may lead to falls) - fall in blood pressure especially when sitting or standing up after lying down. This can cause dizziness (may lead to falls) and increased heart beat feeling like your heart is pounding, racing or has skipped beats decrease in the total number of white blood cells and of a specific subgroup called neutrophils This leads to an increased susceptibility to infections and may occur after therapy has ended. It is temporary and not severe increase in the number of certain blood cells called eosinophilic granulocytes. This indicates that your bodys immune system is highly activated stuffy nose indigestion, constipation feeling weak swelling of arms or legs due to accumulation of fluid in the tissues blurred vision abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain temporary increase of the liver enzymes called ALT and AST in the blood temporary increase of the liver enzyme called gamma-GT in the blood increase in the amount of sugar in the blood increase in the amount of a hormone called prolactin in the blood This can 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 decrease in the amount of thyroid gland hormones in the blood increase in the amount of a hormone which stimulates the hormone production by the thyroid gland abnormal dreams and nightmares increased appetite feeling irritated disturbance in speech and language thoughts of suicide and worsening of your depression shortness of breath vomiting, mainly in the elderly fever. Uncommon, affects 1 to 10 users in 1,000: decrease in the number of certain blood cells called thrombocytes and platelets. This can lead to an increased tendency to bruise and to bleed deficiency in red blood cells allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth seizure heart rhythm disorder known as QT-prolongation and seen on ECG slow heartbeat unpleasant sensations in the legs, so called restless legs syndrome difficulty swallowing sexual dysfunction decrease in the amount of sodium in the blood during or after a prolonged course of treatment: movement disorders including uncontrollable tongue, mouth and facial movements known as tardive dyskinesia diabetes mellitus or worsening of pre-existing diabetes mellitus decrease in the amount of a specific hormone produced by the thyroid gland, called triiodothyroxine, in the blood deficiency in thyroid gland function. Rare, affects 1 to 10 users in 10,000: jaundice long lasting and painful erection so called neuroleptic malignant syndrome, see also first paragraph in this chapter increase of an enzyme called creatine phosphokinase in the blood swelling of breasts and unexpected production of breast milk 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 of these symptoms seek medical advice immediately hepatitis walking, talking, eating or other activities while you are asleep decrease in body temperature inflammation of the pancreas serious decrease in the number of certain white blood cells called agranulocytosis. This may occur at any time during treatment metabolic syndrome. This is a combination of metabolic risk factors such as high blood pressure, obesity, high cholesterol and insulin resistance and requires appropriate medical treatment.
Do not use Quetiapine after the expiry date which is stated on the carton and on the blister/on the label of the bottle. The expiry date refers to the last day of that month. Plastic bottles: Do not use after 6 months have elapsed from first opening. 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.
Keep out of the reach and sight of children.
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How to store Quetiapine
What Quetiapine contains The active substance is quetiapine. Each film-coated tablet contains 100, 150, 200 or 300 mg quetiapine (as quetiapine fumarate).
6
Further information
What Quetiapine looks like and contents of the pack Quetiapine 100 mg film-coated tablets are yellow and round (8.8 mm diameter). They have a score line on one side and can be divided into equal quarters. Quetiapine 150 mg film-coated tablets are cream coloured and round (10.5 mm diameter). They have a score line on one side and can be divided into equal halves. Quetiapine 200 mg film-coated tablets are white and round (11.5 mm diameter). They have a score line on one side and can be divided into equal quarters.
The other ingredients are: Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K 29/32), silica colloidal hydrated, sodium starch glycolate (type A). Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171). Quetiapine 100 and 150 mg Film-coated Tablets also contain iron oxide yellow (E172).
Quetiapine 300 mg film-coated tablets are white and oval (18 mm length and 8.8 mm width). They have a score line on both sides and can be divided into equal halves.
Quetiapine 100 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 120, 250 or 500 film-coated tablets.
Quetiapine 150 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 250 or 500 film-coated tablets.
Quetiapine 200 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 250 or 500 film-coated tablets.
Quetiapine 300 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 120, 250 or 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder UK: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Malta: Sandoz d.d., Verovkova 57, 1000 Ljubljana, Slovenia. Manufacturer Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Verovkova 57, 1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or LEK S.A.,Ul. Podlipie 16 C, 95 010 Strykow, Poland or LEK S.A.,Ul. Domaniewska 50 C, 02-672 Warszawa, Poland or S.C. Sandoz S.R.L., 7A Livezeni Street, 540472 Targu Mures, Jud. Mures, Romania. This leaflet was last revised in 03/2013.
SZ00000LT000
Quetiapine
Quetiapine 100 mg Film-coated Tablets Quetiapine 150 mg Film-coated Tablets Quetiapine 200 mg Film-coated Tablets Quetiapine 300 mg Film-coated Tablets
SZ00000LT000
In this leaflet: 1. What Quetiapine is and what it is used for 2. Before you take Quetiapine 3. How to take Quetiapine 4. Possible side effects 5. How to store Quetiapine 6. Further information
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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Quetiapine belongs to a group of medicines called antipsychotics.
1
What Quetiapine is and what it is used for
Quetiapine is used to treat: schizophrenia Symptoms include: - hallucinations, such as hearing unexplained voices - strange and frightening thoughts - changes in your behaviour - feeling alone and confused manic episodes associated with a disease called bipolar disorder Symptoms are: - feeling very high or excited - needing less sleep than usual - being more talkative with racing thoughts or ideas - feeling more irritable than usual depressive episodes associated with a disease called bipolar disorder Symptoms are: - feeling very down or sad - feeling guilty - lacking energy - losing appetite - can not sleep. Your doctor may continue to give you Quetiapine when you are feeling better to prevent your symptoms from returning.
medicines which reduce quetiapine levels in the blood and its effect, such as: - carbamazepine and phenytoin: medicines to treat epilepsy or other illnesses. Your doctor may consider prescribing another medicine to treat epilepsy or adjust your Quetiapine dose - thioridazine: a medicine to treat psychiatric disorders. medicines which act on the central nervous system. medicines which may cause certain cardiac disorders such as: - other antipsychotics, used to treat mental disorders - those used to treat irregular heartbeats in class IA or III - antibiotics, used to treat bacterial infections - medicines to treat malaria. medicines which may cause electrolyte imbalance such as: hydrochlorothiazide or similar medicines which increase your water output. medicines which influence hepatic enzymes such as: - rifampicin: a medicine to treat tuberculosis or certain other infections - barbiturates: medicines to treat sleeplessness. Taking Quetiapine with food and drink Quetiapine can be taken with or without food. Do not drink alcohol during treatment with Quetiapine, the combined effect might make you feel drowsy. Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works.
Do not take Quetiapine if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of Quetiapine as listed in chapter 6 Further information. if you take any of the following medicines: - medicines to treat HIV infections with active substance names ending in navir - medicines to treat fungal infections with active substance names ending in azole such as ketoconazole - erythromycin and clarithromycin: medicines to treat bacterial infections - nefazodone: a medicine to treat depression.
2
Before you take Quetiapine
Pregnancy and breast-feeding Pregnancy Do not take Quetiapine if you are pregnant unless your doctor has told you to. Inform your doctor immediately if you are pregnant or think you may be. The following symptoms may occur in newborn babies, of mothers who have used Quetiapine 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 Quetiapine when breast-feeding. Driving and using machines Only drive or operate machines if your doctor has approved it. This will depend upon how this therapy affects you, because Quetiapine may make you feel sleepy and dizzy and thus impair your mental alertness. Ask your doctor or pharmacist for advice before taking any medicine.
Take special care with Quetiapine Before you take your medicine inform your doctor or pharmacist if you have poor circulation in the heart or brain, or other conditions inclined to cause low blood pressure. have or have had diseases of the heart and/or blood vessels (or a family history of heart problems), such as heart failure or irregular heart beat, especially an abnormality known as prolonged QT-interval. are taking any medicines that may have an impact on the way your heart beats. have had a stroke previously, especially if you are elderly. are an elderly person with dementia (loss of brain function). If you are, Quetiapine should not be taken because the group of medicines that Quetiapine belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia. have had low levels of white blood cells previously which may or may not have been caused by other medicines. have ever suffered from convulsions. have diabetes mellitus, tend to have high blood sugar levels or are at risk of developing diabetes mellitus. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine. have high cholesterol values and so called triglyceride levels, which are certain fats, in your blood. have experienced considerable weight gain during an earlier treatment with a medicine belonging to the same group as Quetiapine does. have a liver function disorder. See chapter 3 How to take Quetiapine. or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots. Inform your doctor or pharmacist immediately if you notice any involuntary movements or experience abnormal movements especially of the tongue, mouth and face while taking this medicine. If so your doctor might reduce your dose or discontinue treatment. develop fever, accelerated breathing, excessive sweating, changes in consciousness or stiff muscles. Immediate medical treatment may be needed; see chapter 4, first paragraph neuroleptic malignant syndrome. have dizziness or a severe sense of feeling sleepy. This could increase the risk of accidential injury (fall) in elderly patients. experience fits or seizures. have a long-lasting and painful erection.
Effect on urine drug screens If you are having a urine drug screen, taking Quetiapine may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.
Important information about some of the ingredients of Quetiapine Quetiapine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Quetiapine.
Medicinal products containing lower strengths of quetiapine are available for doses not realizable/ practicable with this medicine.
Your doctor will tell you how many Quetiapine tablets you should take and how long you should continue to take them.
Always take Quetiapine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
3
How to take Quetiapine
The usual dose is: Adults To treat schizophrenia Take the following total daily doses divided into two separate doses per day. - Day 1: 50 mg quetiapine - Day 2: 100 mg quetiapine - Day 3: 200 mg quetiapine - Day 4: 300 mg quetiapine - After day 4: Your doctor will gradually increase the total daily dose from 300 mg to 450 mg quetiapine. Depending on your individual response and tolerance, the total daily dose may vary between 150 mg and 750 mg quetiapine. To treat manic episodes Take the following total daily doses divided into two separate doses per day. - Day 1: 100 mg quetiapine - Day 2: 200 mg quetiapine - Day 3: 300 mg quetiapine - Day 4 and following days: 400 mg quetiapine - From day 6: Your doctor may gradually increase the daily dose up to a maximum of 800 mg quetiapine. The daily dose increase should not exceed 200 mg quetiapine. Depending on your individual response and tolerance, the total daily dose may vary between 200 mg and 800 mg quetiapine.
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.
To treat depressive episodes Take the following doses once daily every evening at bedtime. - Day 1: 50 mg quetiapine - Day 2: 100 mg quetiapine - Day 3: 200 mg quetiapine - Day 4 and following days: 300 mg quetiapine Average dose: 300 mg quetiapine per day. Children and adolescents under 18 years Quetiapine should not be used by children and adolescents aged under 18 years.
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 following medicines can particularly influence or be influenced by Quetiapine: medicines which must not be taken together with Quetiapine - see chapter 2 Do not take Quetiapine: - medicines to treat HIV infections with active substance names ending in navir - medicines to treat fungal infections with active substance names ending in azole such as ketoconazole - erythromycin and clarithromycin: medicines to treat bacterial infections - nefazodone: a medicine to treat depression.
Weight gain Weight gain has been seen in patients taking Quetiapine. You and your doctor should check your weight regularly.
Patients over 65 years Lower doses and slower dose increases may be sufficient for this age group.
Patients with impaired liver function Starting dose: 25 mg quetiapine per day. This dose is increased slowly by 25 mg to 50 mg quetiapine each day until the optimal dose is reached. Method of administration For oral use. Swallow the tablets with a glass of water preferably at the same time each day.
If you take more Quetiapine than you should If you have accidentally taken too much Quetiapine contact your doctor or a hospital at once. Always take the tablets, leaflet and/or carton with you so the doctor will know what you took. Immediate medical care is necessary if the following signs occur: drowsiness, sedation, rapid heart beat and low blood pressure.
Continued on the next page >>
If you forget to take Quetiapine If you forget a dose continue by taking your next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop taking Quetiapine Do not stop taking Quetiapine unless advised by your doctor, as this may harm the success of therapy. If you suddenly stop taking the tablets, symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness might occur. To avoid such symptoms, it is important to reduce the dose gradually according to your doctors instructions. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Very rare, affects less than 1 user in 10,000: so called angioedema, also see the first paragraph in this chapter serious skin condition with blisters, also inside the mouth, and fever (Stevens-Johnson syndrome) severe allergic reaction, also see the first paragraph in this chapter inappropriate secretion of a hormone that controls urine volume breakdown of muscle fibres and pain in muscles.
Stop taking Quetiapine immediately and contact your doctor at once or go to the nearest hospital if any of the following events happen to you: a combination of fever, persistent sore throat or mouth ulcers, faster breathing, sweating, muscle stiffness and reduced consciousness all of these are symptoms of a severe disorder called neuroleptic malignant syndrome a severe allergic reaction, which involves difficulty breathing, low blood pressure, swelling in the mouth or throat, skin rash and itching symptoms of angioedema such as swollen face, tongue or pharynx, difficulties to swallow and to breath and hives fits or seizures long-lasting and painful erection 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 serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
Like all medicines, Quetiapine can cause side effects, although not everybody gets them.
4
Possible side effects
Not known, frequency cannot be estimated from the available data decrease in the number of certain blood cells called neutrophilic granulocytes. These belong to the white blood cells, see above under Common. This occurs particularly after treatment has ended, is temporary and not severe. skin rash with irregular red spots (erythema multiforme) serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin, (toxic epidermal necrolysis).
Children and adolescents (10 to 17 years) 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 user in 10: increase in blood pressure.
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 your blood, increased liver enzymes, changes in the number of certain types of blood cells, increased blood creatine phosphokinase (a substance in the muscle), decrease in the amount of sodium in the blood and increases in the amount of a hormone called prolactin in the blood. Thus your doctor may ask you to have blood tests from time to time.
Also reported are: heart arrest specific heart rhythm disorders sudden unexplained death. These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.
Reported side effects listed according to the frequencies are: Very common, affects more than 1 user in 10: dizziness (may lead to falls) feeling sleepy (may lead to falls) headache dry mouth These symptoms usually occur when beginning therapy and gradually disappear as treatment continues. increased values for fats called triglycerides and total cholesterol (predominantly LDL cholesterol) in the blood decreased values for fats called HDL cholesterol in the blood discontinuation symptoms such as nausea, headache, diarrhoea, vomiting, dizziness, irritability and sleeplessness. These occur when you suddenly stop taking Quetiapine. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable weight gain decrease of a certain protein called haemoglobin in your blood.
The following side effects have been seen more often in children and adolescents: Very common, affects more than 1 user in 10: increase in the amount of a hormone called prolactin in the blood. This can in rare cases lead 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 abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
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.
Common, affects 1 to 10 users in 100: particularly at the beginning of treatment: - rapid heart beat - fainting (may lead to falls) - fall in blood pressure especially when sitting or standing up after lying down. This can cause dizziness (may lead to falls) and increased heart beat feeling like your heart is pounding, racing or has skipped beats decrease in the total number of white blood cells and of a specific subgroup called neutrophils This leads to an increased susceptibility to infections and may occur after therapy has ended. It is temporary and not severe increase in the number of certain blood cells called eosinophilic granulocytes. This indicates that your bodys immune system is highly activated stuffy nose indigestion, constipation feeling weak swelling of arms or legs due to accumulation of fluid in the tissues blurred vision abnormal muscle movements which include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain temporary increase of the liver enzymes called ALT and AST in the blood temporary increase of the liver enzyme called gamma-GT in the blood increase in the amount of sugar in the blood increase in the amount of a hormone called prolactin in the blood This can 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 decrease in the amount of thyroid gland hormones in the blood increase in the amount of a hormone which stimulates the hormone production by the thyroid gland abnormal dreams and nightmares increased appetite feeling irritated disturbance in speech and language thoughts of suicide and worsening of your depression shortness of breath vomiting, mainly in the elderly fever. Uncommon, affects 1 to 10 users in 1,000: decrease in the number of certain blood cells called thrombocytes and platelets. This can lead to an increased tendency to bruise and to bleed deficiency in red blood cells allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth seizure heart rhythm disorder known as QT-prolongation and seen on ECG slow heartbeat unpleasant sensations in the legs, so called restless legs syndrome difficulty swallowing sexual dysfunction decrease in the amount of sodium in the blood during or after a prolonged course of treatment: movement disorders including uncontrollable tongue, mouth and facial movements known as tardive dyskinesia diabetes mellitus or worsening of pre-existing diabetes mellitus decrease in the amount of a specific hormone produced by the thyroid gland, called triiodothyroxine, in the blood deficiency in thyroid gland function. Rare, affects 1 to 10 users in 10,000: jaundice long lasting and painful erection so called neuroleptic malignant syndrome, see also first paragraph in this chapter increase of an enzyme called creatine phosphokinase in the blood swelling of breasts and unexpected production of breast milk 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 of these symptoms seek medical advice immediately hepatitis walking, talking, eating or other activities while you are asleep decrease in body temperature inflammation of the pancreas serious decrease in the number of certain white blood cells called agranulocytosis. This may occur at any time during treatment metabolic syndrome. This is a combination of metabolic risk factors such as high blood pressure, obesity, high cholesterol and insulin resistance and requires appropriate medical treatment.
Do not use Quetiapine after the expiry date which is stated on the carton and on the blister/on the label of the bottle. The expiry date refers to the last day of that month. Plastic bottles: Do not use after 6 months have elapsed from first opening. 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.
Keep out of the reach and sight of children.
5
How to store Quetiapine
What Quetiapine contains The active substance is quetiapine. Each film-coated tablet contains 100, 150, 200 or 300 mg quetiapine (as quetiapine fumarate).
6
Further information
What Quetiapine looks like and contents of the pack Quetiapine 100 mg film-coated tablets are yellow and round (8.8 mm diameter). They have a score line on one side and can be divided into equal quarters. Quetiapine 150 mg film-coated tablets are cream coloured and round (10.5 mm diameter). They have a score line on one side and can be divided into equal halves. Quetiapine 200 mg film-coated tablets are white and round (11.5 mm diameter). They have a score line on one side and can be divided into equal quarters.
The other ingredients are: Tablet core: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, lactose monohydrate, magnesium stearate, povidone (K 29/32), silica colloidal hydrated, sodium starch glycolate (type A). Tablet coating: hypromellose, lactose monohydrate, macrogol 4000, titanium dioxide (E171). Quetiapine 100 and 150 mg Film-coated Tablets also contain iron oxide yellow (E172).
Quetiapine 300 mg film-coated tablets are white and oval (18 mm length and 8.8 mm width). They have a score line on both sides and can be divided into equal halves.
Quetiapine 100 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 120, 250 or 500 film-coated tablets.
Quetiapine 150 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 250 or 500 film-coated tablets.
Quetiapine 200 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 250 or 500 film-coated tablets.
Quetiapine 300 mg film-coated tablets are available in blister packs containing 6, 10, 20, 30, 50, 60, 90, 100, 120 or 180 film-coated tablets perforated unit dose blister packs containing 1x100 film-coated tablets plastic bottles with screw caps and desiccant containing 100, 120, 250 or 500 film-coated tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder UK: Sandoz Ltd, Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK. Malta: Sandoz d.d., Verovkova 57, 1000 Ljubljana, Slovenia. Manufacturer Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany or Salutas Pharma GmbH, Dieselstrasse 5, 70839 Gerlingen, Germany or Lek Pharmaceuticals d.d., Verovkova 57, 1526 Ljubljana, Slovenia or Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia or LEK S.A.,Ul. Podlipie 16 C, 95 010 Strykow, Poland or LEK S.A.,Ul. Domaniewska 50 C, 02-672 Warszawa, Poland or S.C. Sandoz S.R.L., 7A Livezeni Street, 540472 Targu Mures, Jud. Mures, Romania. This leaflet was last revised in 03/2013.
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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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
