Quetiapine 200 Mg Film-Coated Tablet
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Quetiapine 100 mg Film-coated Tablets Quetiapine 150 mg Film-coated Tablets Quetiapine 200 mg Film-coated Tablets Quetiapine 300 mg Film-coated Tablets
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 any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Quetiapine is and what it is used for
2. What you need to before you take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Contents of the pack and other information
Quetiapine contains the active substance quetiapine. It belongs to a group of medicines called antipsychotics.
Quetiapine can be used to treat several illnesses, such as
• 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 prescribe Quetiapine even when you are feeling better to prevent your symptoms from returning.
Do not take Quetiapine
• if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• 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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Quetiapine 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. This might be associated with inflammation of your pancreas.
• 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 section “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 experience any of the following after taking Quetiapine:
• involuntary movements or abnormal movements especially of the tongue, mouth and face while taking this medicine.
If so your doctor might reduce your dose or discontinue treatment.
• a combination of fever, accelerated breathing, excessive sweating, changes in consciousness or stiff muscles.
Immediate medical treatment may be needed.
• dizziness or a severe sense of feeling sleepy.
This could increase the risk of accidential injury (fall) in elderly patients.
• fits or seizures.
• a long-lasting and painful erection.
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
Weight gain has been seen in patients taking Quetiapine. You and your doctor should check your weight regularly.
Children and adolescents under 18 years Do not give this medicine to children and adolescents below 18 years of age, due to a lack of data to support use in ths age group.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines can particularly influence or be influenced by Quetiapine:
• medicines which must not be taken together with Quetiapine - see section 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.
• medicines which reduce quetiapine levels in the blood and it’s 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 that have an impact on the way your heart beats, for example
- medicines that can cause an imbalance in electrolytes (low levels of potassium or magnesium in your blood) such as diuretics (water pills)
- certain antibiotics, medicines to treat bacterial infections
• medicines which influence hepatic enzymes such as:
- rifampicin: a medicine to treat tuberculosis or certain other infections
- barbiturates: medicines to treat sleeplessness.
Before you stop taking any of your medicines, please talk to your doctor or pharmacist first.
Quetiapine with food, drink and alcohol
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.
Pregnancy and breast-feeding
If you are pregnant, or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
• Pregnancy
Do not take Quetiapine if you are pregnant unless your doctor has told you to.
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.
Quetiapine contains lactose.
Lactose is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Quetiapine.
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.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will tell you how many tablets you should take and how long you should continue to take them.
Medicinal products containing lower strengths of quetiapine are available for doses not realizable/ practicable with this medicine.
The recommended 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.
• 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.
Elderly 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.
Children and adolescents under 18 years
Quetiapine should not be used by children and adolescents aged under 18 years.
Method of administration
For oral use. Swallow the tablets with a glass of water preferably at the same time each day.
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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.
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 doctor’s instructions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Quetiapine immediately and contact your doctor at once or go to the nearest hospital if you experience any of the following serious side effects:
Uncommon side effects, may affect up to 1 in 100 people:
• fits or seizures
• uncontrollable movements, mainly of your face or tongue (tardive dyskinesia). This can occur during or after a prolonged course of treatment.
Rare side effects, may affect up to 1 in 1,000 people:
• 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”
• long-lasting and painful erection (priapism)
• 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
Very rare side effects, may affect up to 1 in 10,000 people:
• severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome)
• severe allergic reaction (anaphylaxis), which may cause difficulty in breathing or shock
• rapid swelling of the skin, usually around the eyes, lips and throat (angioedema)
Not known, frequency of these side effects cannot be estimated from the available data:
• serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
• skin rash with irregular red spots (erythema multiforme)
The class of medicines to which Quetiapine belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
You may experience any of the reported side effects listed below according to the frequencies:
Very common, may affect more than 1 in 10 people:
• dizziness (may lead to falls)
• feeling sleepy (this may go away with time as you keep taking Quetiapine, 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.
Common, may affect up to 1 in 10 people:
• 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 body’s 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, may affect up to 1 in 100 people:
• 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
• 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
• 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, may affect up to 1 in 1,000 people:
• jaundice
• increase of an enzyme called creatine phosphokinase
in the blood
• swelling of breasts and unexpected production of breast milk
• menstrual disorder
• 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.
Very rare, may affect up to 1 in 10,000 people:
• inappropriate secretion of a hormone that controls urine volume
• breakdown of muscle fibres and pain in muscles.
Not known, frequency cannot be estimated from the available data
• decrease in the number of certain white blood cells (neutropenia).
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.
Additional side effects in 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, may affect more than 1 in 10 people:
• increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very common, may affect more than 1 in 10 people:
• 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 you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Keep this medicine out of the sight and reach of children.
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 medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
What Quetiapine contains
The active substance is quetiapine.
Each film-coated tablet contains 100, 150, 200 or 300 mg quetiapine (as quetiapine fumarate).
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).
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 four equal doses.
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 two equal doses.
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 four equal doses.
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 two equal doses.
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., Verovskova 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., Verovskova 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.
This leaflet was last revised in 08/2013.
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