Quetiapine 100mg Film-Coated Tablets
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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 because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please 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 effect, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Quetiapine is and what it is used for
2. What you need to know before you take Quetiapine
3. How to take Quetiapine
4. Possible side effects
5. How to store Quetiapine
6. Content of the pack and other information.
1. What Quetiapine is and what it is used for
Quetiapine belongs to a group of medicines called anti-psychotics. Quetiapine can be used to treat several illnesses, such as:
- Schizophrenia: where you may 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: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgement including being aggressive or disruptive.
- Bipolar depression: where you may feel sad all the time or you may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.
Your doctor may continue to prescribe Quetiapine even when you are feeling better.
2. What you need to know before you take Quetiapine 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 are taking any of the following medicines:
- some medicines for HIV (protease inhibitors, such as nelfinavir)
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (medicines for an infection)
- nefazodone (for depression)
Do not take Quetiapine if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine.
Warnings and precautions
Talk to your doctor before taking Quetiapine if:
• You, or someone in your family, have or have had any heart problems such as heart rhythm problems, 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 or fainting spells.
• You have ever had a fit (seizure).
• You have problems with your liver.
• 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.
• You have had a stroke, especially if you are elderly.
• 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 (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.
• 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, including face or tongue, difficulty in speaking or swallowing, loss of balance control, mask-like face, shuffling walk, stiffness of arms or legs, trembling and shaking of hands and fingers.
• 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 and/or have anxiety disorders, 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 behaviour in young adults aged less than 25 years with psychiatric conditions who were treated with an antidepressant.
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 or have an anxiety disorder, 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 quetiapine. You and your doctor should check your weight regularly.
Other medicines and Quetiapine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following medicines:
• epilepsy medicines (like phenytoin or carbamazepine).
• high blood pressure medicines.
• rifampicin (for tuberculosis).
• barbiturates (for difficulty sleeping).
• thioridazine (another anti-psychotic medicine).
Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).
Before you stop taking any of your medicines, please talk to your doctor first.
If you have a urine drug screen, taking quetiapine 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.
Quetiapine with food and drink
Quetiapine can be taken with or without food.
Do not drink grapefruit juice while you are taking Quetiapine Film-coated Tablets. It can affect the way the medicine works.
Be careful how much alcohol you drink. This is because the combined effect of quetiapine and alcohol can make you feel sleepy.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask to your doctor or pharmacist for advice before taking this medicine. You should not take Quetiapine during pregnancy unless this has been discussed with your doctor. Quetiapine should not be taken if you are breastfeeding.
The following symptoms may occur in newborn babies of mothers that have used Quetiapine 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
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or operate machinery until you know how the tablets affect you.
Quetiapine contain lactose
Quetiapine contain lactose which is a type of sugar. If you have been told by your doctor or pharmacist that you have an intolerance to some sugars, contact your doctor before taking this medicine.
If you have been on other medication for this condition, and that medication has stopped your periods, changing to Quetiapine may allow them to return.
3. How to take Quetiapine
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 decide on your starting dose and may gradually increase it. When
you are on your regular dose you will usually be taking between 150 mg and 800 mg each day. It will depend on your illness and needs.
• 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 taking Quetiapine. It can affect the way the medicine works.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Quetiapine Film-Coated Tablets come in 5 different strengths and each strength is different in colour or shape.
• Even though the dose might stay the same, it might be supplied as different strength tablets. For example, one 300 mg tablet (white) or two 150 mg (pale yellow).
• So don’t be surprised if the colour of your tablets change from time to time.
Liver Problems
If you have liver problems your doctor may change your dose.
Elderly
Your doctor may give you a lower dose if you are elderly.
Use in children and adolescents
Quetiapine should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine than you should
If you take more Quetiapine than prescribed by your doctor, you may experience the following effects:
• Feel sleepy, faint or dizzy.
• Have abnormal ECG heart tracing (QT interval prolongation).
• Seizures, fits, or continuous unremitting fits in patients with a disorder known as epilepsy.
• Abnormal muscle breakdown which can lead to kidney problems.
• Difficulty breathing.
• Difficulty in passing urine.
• Mood changes or confusion.
• Palpitations (a pounding heart beat).
• Suffer low blood pressure.
Overdose with quetiapine may be serious and result in severe effects. Contact your doctor or nearest hospital casualty department immediately. Take the container and any remaining tablets with you.
If you forget to take Quetiapine
If you forget 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 one you have missed.
If you stop taking Quetiapine
If you suddenly stop taking Quetiapine, 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 medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Quetiapine and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:
Common: may affect up to 1 in 10 people:
• Thoughts of self harm and suicide and worsening of your depression.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain
Uncommon: may affect up to 1 in 100 people:
• Diabetes mellitus: condition in which the body does not produce enough insulin or else the body tissues are not able to use the insulin present. This leads to hyperglycaemia (too much sugar in the blood). Symptoms may include excessive thirst, increased appetite with weight loss, feeling tired, drowsy, weak, depressed, irritable and generally unwell, and passing large amounts of urine
• Fits or seizures.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
• Uncontrollable movements, mainly of your face or tongue.
Rare: may affect up to 1 in 1,000 people:
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure or heartbeat (a disorder called “neuroleptic malignant syndrome”).
• Inflammation of pancreas which causes severe abdominal and back pain.
• Yellowing of the skin and eyes (Jaundice).
• Inflammation of the liver (Hepatitis).
• A 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: may affect up to 1 in 10, 000 people:
• Severe allergic reaction (called anaphylaxis) that may include difficulty in breathing, dizziness and collapse.
• A severe rash, which may develop quickly. Symptoms may include redness, blistering or peeling of skin, particularly around the mouth, nose, eyes and genitals (a condition known as Stevens-Johnson syndrome).
• Rapid swelling of the skin, usually around the eyes, lips and throat.
• Worsening of pre-existing diabetes.
Not known: frequency cannot be estimated from the available data:
• A widespread redness of skin with blisters and peeling on much of the body surface (toxic epidermal necrolysis).
Other possible side effects:
Very common: may affect more than 1 in 10 people:
• Reduction in red blood cells.
• Dizziness (may lead to falls), headache.
• Dry mouth.
• Feeling sleepy (this may go away with time, as you keep taking Quetiapine) (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking quetiapine) include not
being able to sleep (insomnia), feeling sick (nausea), headache, diarrhoea, being sick (vomiting),
dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
• Increase in fatty substance’s levels in the blood.
• Increase in the “bad” cholesterol levels in the blood.
• Decrease in the “good” cholesterol levels in the blood.
• Putting on weight.
Common: may affect up to 1 in 10 people:
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Stuffy nose.
• Indigestion or constipation.
• Feeling weak or fainting (may lead to falls).
• Swelling of arms or legs.
• High blood sugar.
• Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech or language.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
• Low white blood cells.
• Increase in blood level of a type of white blood cells (eosinophils).
• Increased levels of an enzyme (prolactin) in the blood.
• Decreased levels of thyroid hormones.
• Blood tests which show changes in the way the liver is working.
Uncommon: may affect up to 1 in 100 people:
• Abnormal ECG heart tracing (QT prolongation).
• Reduction in blood platelets, which increases risk of bleeding or bruising.
• Reduction in red blood cells which can make the skin pale and cause weakness or breathlessness
• Sexual dysfunction.
• Unpleasant sensation in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Tiredness and weight gain (caused by underactive thyroid gland).
Rare: may affect up to 1 in 1, 000 people:
• Swelling of breasts and unexpected production of breast milk (galactorrhoea).
• Menstrual disorder.
• Walking, talking, eating or other activities while you are asleep.
• Body temperature decreased (hypothermia).
• Change in some blood tests.
• Severe reduction in number of white blood cells which makes infections more likely.
• A combination of medical disorders that, when occurring together, increase the risk of developing cardiovascular disease and diabetes (also called metabolic syndrome).
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 (rhabdomyolysis).
Not known: frequency cannot be estimated from the available data:
• Decrease in some white cells of the blood called neutrophils.
A skin redness, which may blister, and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) called 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.
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, decreases in the number of certain types of blood cells, decreases in the amount of sodium in the blood, changes in the amount of thyroid hormones in the blood, increased blood creatine phosphokinase (a substance in the muscles) and increases in the amount of a hormone prolactin in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
• Men and women to have swelling of breasts and unexpectedly produce breast milk.
• Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
Additional side effects in children and adolescents:
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. Increases in the hormone prolactin could 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. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Reporting of side effects
If you get any side effect, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme via the website: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine
5. How to store Quetiapine Film-Coated Tablets
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date which is stated on the carton after Exp. The expiry date refers to the last day of that month.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Quetiapine Film-coated Tablets contain
- The active substance is quetiapine fumarate.
- Each 25 mg/100 mg/150 mg/200 mg/300 mg film-coated tablet contains 25 mg/100 mg/150 mg/200 mg/300 mg quetiapine (as quetiapine fumarate).
- The other ingredients are: lactose monohydrate, microcrystalline cellulose, povidone 30, magnesium stearate, sodium starch glycolate (Type A), calcium hydrogen phosphate dihydrate. The tablet coating contains: hypromellose, titanium dioxide (E171), macrogol 400 (25 mg, 150 mg, 200 mg, 300 mg tablets), macrogol 6000 (100 mg tablets), iron oxide red (E172) (25 mg tablets), iron oxide yellow (E172) (100 mg, 150 mg tablets), iron oxide black (E172) (150 mg tablets), talc (100 mg tablets), polysorbate 80 (150 mg, 200 mg, 300 mg tablets).
What Quetiapine Film-coated Tablets look like and contents of the pack
Quetiapine tablets are film-coated tablets. The 25 mg tablet is round, peach coloured, biconvex and engraved “Q” on one side. The 100 mg tablet is round, yellow, biconvex, and engraved “Q” over “100” on one side. The 150 mg tablet is round, pale yellow and engraved “Q” over “150” on one side. The 200 mg tablet is round, white and engraved “Q” over “200” on one side. The 300 mg tablet is capsule shaped, white and engraved “Q” breakline “300” on one side. The tablet can be divided into equal doses.
of 6 x 1 tablets (25 mg only) or 60 x 1 tablets (25 mg, 100 mg, 200 mg, 300 mg)
Quetiapine Film-coated Tablets are available in blister packs and bottles of 1, 3, 6, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100, 250, 500, 1000 tablets and in perforated unit dose blisters in pack sizes
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Generics [UK] Ltd t/a Mylan, Potters Bar, Hertfordshire, EN6 1TL
Manufacturer:
McDermott Laboratories t/a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom This leaflet was last revised in: 07/2014
Other sources of information
Detailed information on this medicine is available on the website of the Medicines and Healthcare Products Regulatory Agency (MHRA).
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