Quetiapine 100mg Film-Coated Tablets
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PHARMACEUTICALS
Package leaflet: Information for the user
Quetiapine 25 mg film-coated tablets Quetiapine 100 mg film-coated tablets Quetiapine 150 mg film-coated tablets Quetiapine 200 mg film-coated tablets Quetiapine 300 mg film-coated tablets
Quetiapine
Read all of this leaflet carefully before you start taking this medicine 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, pharmacist or nurse.
• 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, pharmacist or nurse. 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. Contents of the pack and other information
1. What Quetiapine is and what it is used for
Quetiapine contains a substance called quetiapine. This belongs to a group of medicines called
antipsychotics. Quetiapine can be used to treat several illnesses, such as:
• 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.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• 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.
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 (hypersensitive) to quetiapine or any of the other ingredients in this medicine (listed in section 6).
• are taking any of the following medicines:
- some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarithromycin (for infections)
- 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 or pharmacist or nurse before taking Quetiapine if:
• you, or someone in your family have or have had any heart problems, for example heart rhythm problems, or if you are taking any medicines that may have an impact on the way your heart beats.
• you have low blood pressure.
• you have an increased risk of stroke or a temporary decrease in the blood supply to the brain, especially if you are elderly.
• you have problems with your liver.
• you have pancreatitis (inflammation of the pancreas) or factors associated with pancreatitis such as gallstones or increased levels of triglycerides (a type of fat) in your blood.
• you have ever had a fit (seizure).
• you have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine.
• 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 venous thrombosis (blood clots), as medicines like these have been associated with formation of blood clots.
Tell your doctor immediately if you experience:
• Fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called "neuroleptic malignant syndrome"). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• A severe sense of feeling sleepy.
• Dizziness or feeling very drowsy. This could increase the risk of accidental injury (fall) in elderly patients. These conditions can be caused by this type of medicine.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer.
These thoughts may also be increased if you suddenly stop taking your medication.
You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Weight gain has been seen in patients taking 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 because it may affect the way the medicines work. This includes medicines that you buy without a prescription and herbal medicines.
Do not take Quetiapine if you are taking any of the following medicines:
• Some medicines for HIV.
• Azole medicines (for fungal infections).
• Erythromycin or clarithromycin (for infections).
• Nefazodone (for depression).
Tell your doctor if you are taking any of the following medicines:
• Epilepsy medicines (like phenytoin or carbamazepine).
• High blood pressure medicines.
• 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.
Quetiapine with food, drink and alcohol
• Quetiapine can be taken with or without food.
• Be careful how much alcohol you drink. This is because the combined effect of Quetiapine and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works. Pregnancy, breast-feeding and fertility
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. You should not take Quetiapine during pregnancy unless this has been discussed with your doctor. Quetiapine should not be taken if you are breast-feeding.
The following symptoms may occur in newborn babies, of mothers that 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.
Driving and using machines
Your tablets may make you feel sleepy. Do not drive or use any tools or machines until you know how the tablets affect you.
Quetiapine contains lactose
Quetiapine contains lactose which is a type of sugar. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Effect on Urine Drug Screens
If you 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.
3. How to take Quetiapine
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will decide on your starting dose. The recommended maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
• You will take your tablets once a day, at bedtime or twice a day, depending on your illness.
• Swallow your tablets whole with a drink of water.
• You can take your tablets with or without food.
• Do not drink grapefruit juice while you are 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.
Liver problems
If you have liver problems your doctor may change your dose.
Elderly people
If you are elderly your doctor may change your dose.
Children and adolescents under 18 years
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 feel sleepy, feel dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the Quetiapine 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 a forgotten tablet.
If you stop taking Quetiapine
If you suddenly stop taking Quetiapine, you may be unable to sleep (insomnia), or you may feel sick (nausea), or you may experience headache, diarrhoea, being sick (vomiting), dizziness or irritability. Your doctor may suggest you reduce the dose gradually before stopping treatment.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
• 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.
• Putting on weight.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Stuffy nose.
• Constipation, upset stomach (indigestion).
• Feeling weak, fainting (may lead to falls).
• Swelling of arms or legs.
• Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
• Increased levels of sugar in the blood.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• 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):
• Reduction in red blood cells which can make the skin pale and cause weakness or difficulty in breathing (anaemia).
• Underactive thyroid gland which can cause tiredness or weight gain.
• Worsening of pre-existing diabetes.
• Fits or seizures.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
• Unpleasant sensations in the legs (also called restless legs syndrome).
• Difficulty swallowing.
• Uncontrollable movements, mainly of your face or tongue.
• Sexual dysfunction.
Rare (may affect up to 1 in 1,000 people):
• Severe reduction in the number of white blood cells which makes infections more likely.
• Increased risk of coronary artery disease, stroke, and type 2 diabetes (metabolic syndrome).
• A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very drowsy or faint.
• Walking, talking, eating or other activities while you are asleep.
• Inflammation of the pancreas, which causes severe pain in the abdomen and back (pancreatitis).
• Yellowing of the skin and eyes (jaundice).
• Inflammation of the liver (hepatitis).
• A long-lasting and painful erection (priapism).
• Swelling of breasts and unexpected production of breast milk (galatorrhoea).
• 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.
• Decrease in your internal body temperature (Hypothermia).
Very rare (may affect up to 1 in 10,000 people):
• Severe rash, blisters, or red patches on the skin.
• A severe allergic reaction (called anaphylaxis) which may cause difficulty in breathing or shock.
• Rapid swelling of the skin, usually around the eyes, lips and throat (angioedema).
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibres and pain in muscles (rhabdomyolysis).
Not known (frequency cannot be estimated from the available data):
• Serious illness with blistering of the skin.
• Allergic condition which causes joint pain, skin rashes, itching and fever.
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, decrease in the amount of sodium in the blood and increases in the amount of a hormone called prolactin in the blood. Increases in the hormone prolactin could in rare cases lead to the following:
• Men and women to have swelling of breasts and unexpectedly produce breast milk.
• Women to have no monthly period or irregular periods.
Your doctor may ask you to have blood tests from time to time.
Children and adolescents
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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Quetiapine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the blister and the carton after "Exp.". The expiry date refers to the last day of that month.
This medicinal product does not contain 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 protect the environment.
6. Contents of the pack and other information What Quetiapine contains
The active substance is quetiapine. Quetiapine tablets contain 25 mg, 100 mg, 150 mg, 200 mg or 300 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: povidone, calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycollate Type A, lactose monohydrate, magnesium stearate, colloidal anhydrous silica and talc.
Tablet coating: hypromellose, macrogol 400, titanium dioxide (E171). The 25 mg, 100 mg and 150 mg tablet also contain iron oxide yellow (E172) and the 25 mg contain iron oxide red (E172). The 100 mg, 150 mg, 200 mg & 300 mg tablets contain, also, black imprinting ink containing shellac, iron oxide black and propylene glycol.
What Quetiapine looks like and contents of the pack
Film-coated tablet.
Quetiapine 25 mg film-coated tablet
Peach, round, biconvex, film coated tablet debossed with ‘E 52’ on one side and plain on the other side. Quetiapine 100 mg film-coated tablet
Yellow, round, biconvex, film coated tablet imprinted with ‘E 53’ on one side and plain on the other side. Quetiapine 150 mg film-coated tablet
Light yellow, round, biconvex, film coated tablet imprinted with ‘E 54’ on one side and plain on the other side.
Quetiapine 200 mg film-coated tablet
White, round, biconvex, film coated tablet imprinted with ‘E 55’ on one side and plain on the other side. Quetiapine 300 mg film-coated tablet
White, capsule shaped, biconvex, film coated tablet imprinted with ‘E 56’ on one side and plain on the other side.
HDPE bottles and PVC/Alu foil blisters.
Presentations:
Bottles
Quetiapine 25mg, 100mg, 150mg & 200mg: 100, 250, 500 or 1000 tablets Quetiapine 300mg: 60, 100, 250, 500 or 1000 tablets
Blisters: 1, 10, 20, 30, 50, 60, 90, 100, 120, 180 or 240 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Amneal Pharma Europe Limited 70 Sir John Rogerson’s Quay Dublin 2 Ireland
Manufacturer
APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate,
Hal Far, Birzebbugia, BBG 3000 Malta
Pfizer Service Company BVBA Hoge Wei 10-B-1930 Zaventem,
Belgium
Pfizer Italia s.r.l.,
Localita Marino Del Tronto, 63100 - Ascoli Piceno (AP), Italy