Quetiapine 25 Mg Film-Coated Tablets
Package leaflet: Information for the patient
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 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 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:
• Schizophrenia:You may see, hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
• Mania: You may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• Bipolar depression: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite and/or can’t sleep.
Your doctor may continue to give you Quetiapine when you are feeling better to prevent your symptoms from returning.
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:
o some medicines for HIV o azole medicines (for fungal infections) o erythromycin or clarithromycin (for infections) o 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 before taking Quetiapine.
Before you take your medicine, tell your doctor if:
- you or someone in your family have any heart problems, for example heart rhythm problems or if you are taking any madicines that may have an impact on the way your heart beats;
- you have low blood pressure;
- you have had a stroke, especially if you are elderly;
- you have problems with your liver;
- you have ever had a fit (seizure);
- you have diabetes or have a risk of getting diabetes. If you do, your doctor may check your blood sugar levels while you are taking Quetiapine;
- you know that you have had a low white blood cell count in the past (which my 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 in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots;
- if you have risk factors associated with inflammation of the pancreas (increased triglycerides, gallstones or alcohol consumption).
Tell your doctor immediately if you experience:
• A combination of high temperature (fever), severe muscle stiffness, sweating or lowered level of consciousness (a disorder called "neuroleptic malignan syndrome"). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in elderly patients.
• Fits (seizures).
• A long-lasting and painful erection (priapism).
These conditions can be caused by this type of medicine.
Thoughts of suicide and worsening of your depression
If you are depressed you may sometimes have thoughts of harming or killing yourself. These may be increased when first starting treatment, since these medicines all take time to work, usually about two weeks but sometimes longer. These thoughts may also be increased if you suddenly stop taking your medication. You may be more likely to think like this if you are a young adult. Information from clinical trials has shown an increased risk of suicidal thoughts and/or suicidal behaviour in young adults aged less than 25 years with depression.
If you have thoughts of harming or killing yourself at any time, contact your doctor or go to a hospital straight away. You may find it helpful to tell a relative or close friend that you are depressed, and ask them to read this leaflet. You might ask them to tell you if they think your depression is getting worse, or if they are worried about changes in your behaviour.
Weight gain has been seen in patients taking 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.
Do not use Quetiapine if you are already using 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 can 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 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. 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. Therefore, you should not drive or use machinery until you know how these tablets affect you.
Quetiapine contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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 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 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.
Use in children and adolescents
Quetiapine is not recommended for people aged under 18 years.
If you take more Quetiapine than you should
If you take more than your normal dose, contact your doctor or the nearest hospital as soon as possible. Keep the tablets with you.
If you take more Quetiapine than prescribed by your doctor, you may feel sleepy, feel dizzy, experience abnormal heart beats, low blood pressure, fits, fainting, muscle damage, confusion, delirium, excitation, inability to empty bladder or difficulty in breathing.
If you forget to take Quetiapine
Do not take a double dose to make up for a forgotten tablet. 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.
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.
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), feeing sick (nausea), headache, diarrhoea, being sick (vomiting), dizziness, and irritability. Gradual withdrawal over a period of at least 1 to 2 weeks is advisable.
• Putting on weight.
• Decreased amount of haemoglobin or increased amount of certain fats in blood (triglycerides and total cholesterol).
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Abnormal heart beat 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, increased level of liver enzymes, increases in the amount of a hormone in the blood called prolactin or alterations of thyroid hormones.
• Blurred vision.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• Abnormal dreams and nightmares.
• Increased appetite.
• Feeling irritated.
• Disturbance in speech and language.
• Suicidal thoughts and worsening of your depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
Uncommon (may affect up to 1 in 100 people):
• Decrease in blood sodium levels.
• 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.
• Sexual dysfunction.
• Uncontrollable movements, mainly of your face or tongue.
• Worsening of pre-existing diabetes.
• Change in electrical activity of the heart seen on ECG (QT prolongation), slower heart beat.
• Underactive thyroid gland which can cause tiredness or weight gain (hypothyroidism).
• Platelet count decresed (thrombocytopenia).
• Decreased number of red blood cells (anaemia).
Rare (may affect up to 1 in 1,000 people):
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint (a disorder called "neurleptic malignant syndrome").
• 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 (galactorrhoea).
• Menstrual disorder.
• Blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately.
• Walking, talking or eating or other activities while sleeping.
• Low body temperature.
• Inflamation of the pancreas.
• Metabolic syndrome.
• Severe reduction in number of white blood cells which makes infections more likely (agranulocytosis).
• Elevations in blood creatine phosphokinase (a substance in the muscles).
Very rare (may affect up to 1 in 10,000 people):
• Serious illness with blistering of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome).
• 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 can not 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).
• Severe reduction in number of white blood cells (neutropenia).
The class of medicines to which Quetiapine belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
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 effects have 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 lead to:
o Swelling of breasts and unexpectedly production of breast milk in boys and girls. o Irregular or no monthly period in girls.
• Increased appetite.
• Abnormal muscle movements. These 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 this medicine after the expiry date which is stated on the carton, container and blister after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
HDPE tablet container:
Shelf life after the first opening is 3 months.
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. Each tablet contains 25 mg, 100 mg, 150 mg, 200 mg or 300 mg quetiapine (as quetiapine hemifumarate).
- The other ingredients are lactose monohydrate, dihydrate calcium hydrogen phosphate, microcrystalline cellulose, povidone, sodium starch glycolate (type A), magnesium stearate in the tablet core and hypromellose, titanium dioxide (E171), macrogol 4000, yellow iron oxide (E172) (only in the 25 mg and 100 mg tablets) and red iron oxide (E172) (only in the 25 mg tablets) in the film-coating (see section 2).
What Quetiapine looks like and contents of the pack
The 25 mg tablets are round, pale red film-coated tablets with bevelled edge.
The 100 mg tablets are round, yellow-brown film-coated tablets.
The 150 mg tablets are round, white film-coated tablets with bevelled edge.
The 200 mg tablets are round, white film-coated tablets.
The 300 mg tablets are capsule-shaped, white film-coated tablets.
Quetiapine film-coated tablets are available in boxes of 6 (only the 25 mg tablets), 10, 20, 30, 30 x 1,
50, 60, 90, 98, 100, 100 x 1, 120 (only the 150 mg and 300 mg tablets), 180 (only the 150 mg and 300
mg tablets) or 240 (only the 150 mg and 300 mg tablets) tablets in blister packs and 250 tablets (only
the 100 mg and 200 mg tablets) in a container (HDPE).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia