Quetiapine 200 Mg Film-Coated Tablets
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[Invented name]
25 mg, 100 mg, 150 mg, 200 mg, 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. See section 4.
What is in this leaflet:
1. What [Invented name] is and what it is used for
2. What you need to know before you take [Invented name]
3. How to take [Invented name]
4. Possible side effects
5. How to store [Invented name]
Contents of the pack and other information
1. What [Invented name] is and what it is used for
Your medicine is called [Invented name]. Its active ingredient is quetiapine. This belongs to a group of
medicines called antipsychotics. These medicines help with conditions that cause symptoms such as:
• 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
• you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive or aggressive behaviours.
2. What you need to know before you take [Invented name]
Do not take [Invented name]
• if you are allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine.
• if you are taking any of the following medicines: HIV protease inhibitors (against AIDS), antifungal agents of the azole-type (such as ketoconazole), erthromycin or clarithromycin (macrolide antibiotics) or nefazodone (an antidepresant).
Please tell your doctor if any of the above applies to you.
Warnings and precautions
[Invented name] should not be taken by elderly people with dementia (loss of brain function).
This is because the group of medicines that [Invented name] may increase the risk of stroke, or in
some cases the risk of death, in elderly people with dementia.
Before you take your medicine, tell your doctor if:
• you, or someone in your family have or have had any heart problems, such as 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
• 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 [Invented name].
• 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 or someone else in your family has a history of blood clots, as medicines like these have been associated with formation ofblood clots.
TeU your doctor if you experience:
• a high temperature (fever), stiff muscles, feeling confused
• uncontrollable movements, mainly of your face or tongue
• dizziness or feeling of severe sleepiness
• 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 ofharming 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. 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 ofharming 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.
You can also see section 4 “Possible side effects” for further information on when to contact your doctor.
Other medicines and [Invented name]
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
[Invented name] should not be taken with:
HIV protease inhibitors (against AIDS) anti-fungal agents of the azole-type (e.g. ketoconazole) erythromycin or clarithromycin (antibiotics) nefazodone (an antidepresant).
Tell your doctor if you are taking:
carbamazepine or phenytoin (antiepileptic drugs) thioridazine (an antipsychotic)
centrally acting drugs (e.g. sleeping pills, sedative drugs or drugs for anxiety) drugs known to increase QTc interval (e.g. some antiarrythmic drugs such as sotalol or amiodarone).
[Invented name] with food, drink and alcohol
• [Invented name] can be taken with or without food.Be careful how much alcohol you drink. This is because the combined effect of [Invented name] and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are on [Invented name] treatment. It can affect the way the medicine works.
Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking [Invented name]. You should not take [Invented name] during pregnancy unless this has been discussed with your doctor.
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 and of these symptoms you may need to contact your doctor.
[Invented name] should not be taken if you are breast-feeding.
Driving and using machines
Your tablets may make you feel sleepy. This may disappear while you continue taking your tablets. You should not drive or use machinery until you know how these tablets affect you.
[Invented name] contains lactose
[Invented name] contains milk sugar (lactose). If you have been told by your doctor that you have an intolerance to some sugars (e.g. lactose intolerance), contact your doctor before using this drug.
3. How to take [Invented name]
Always take [Invented name] exactly as your doctor has told you. You should check with your doctor if you are not sure. Your doctor will decide on your starting dose and on how many [Invented name] tablets to take each day. This will depend on your illness and needs but will usually be between 300 mg and 800 mg.
Your doctor may start your treatment on a lower dose (50 mg) and increase the dose slowly if:
You are elderly, or You have liver problems.
Method of administration:
Swallow your tablets whole with a drink of water.
[Invented name] should be taken twice daily.
The usual dose is:
Adults
For the treatment of schizophrenia: the total daily dose for the first 4 days of therapy is:
|
Day 1 |
.. 50 mg |
Day 2 ... |
.....100 mg |
Day 3 ... |
......200 mg |
Day 4 ... |
......300 mg |
From Day 4 onwards, the dose should be adjusted by your doctor to the usual effective dose range of 300 to 450 mg/day. Depending on your individual needs, the dose may be adjusted by your doctor within the range 150to750 mg/day.
For the treatment of manic episodes associated with bipolar disorder: the total daily dose for the first four days of therapy is:
|
Day 1 ..... |
..... 100 mg |
Day 2 ... |
......200 mg |
Day 3 ... |
......300 mg |
Day 4 ... |
......400 mg |
Further dosage adjustments up to 800 mg per day by Day 6 should be in amounts of no greater than 200 mg per day. The dose may be adjusted by your doctor depending on your individual needs, within the range of 200 to 800 mg per day. The usual effective dose is in the range of 400 to 800 mg per day.
Use in children and adolescents
The safety and efficacy of [Invented name] have not been evaluated in children and adolescents.
If you take more [Invented name] than you should
If you take more than your normal dose, contact your doctor or nearest hospital, even if there aren’t any indispositions or symptoms of overdose. Take your medicine with you.
Some of symptoms of overdose: drowsiness and sedation, rapid heartbeat and low blood pressure.
If you forget to take [Invented name]
If you miss a dose, take the dose as soon as you remember. Do not take a double dose to make up for a forgotten dose.
If you stop taking [Invented name]
Do not stop taking your tablets even if you are feeling better, unless your doctor tells you.
If you suddenly stop taking [Invented name], symptoms such as feeling sick, vomiting, being unable to sleep or trouble with movement might occur. 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, [Invented name] can cause side effects, although not everybody gets them.
Very common (affects more than 1 patient in 10):
• Dizziness, headache, dry mouth
• feeling sleepy (this may go away with time, as you keep taking quetiapine)
• increased values for fats called triglycerides and total cholesterol (predominantly LDL cholesterol) in the blood, decreased HDL cholesterol
• 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. They usually go away after 1 week from your last dose.
• weight gain, mainly in the first weeks of treatment.
Common (affects 1 to 10patients in 100):
• Rapid heartbeat, feeling like your heart is pounding, racing or has skipped beats
• stuffy nose
• constipation, upset stomach (indigestion)
• feeling weak, fainting
• decrease in the total number of white blood cells. This may occur after therapy has ended. It is temporary and not severe
• increase in the number of certain blood cells called eosinophilic granulocytes
• swelling of arms or legs
• low blood pressure when standing up. This may make you feel dizzy or faint.
• increased levels of sugar in the blood
• blurred vision
• abnormal muscle movements. These 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
• decrease in the number of certain blood cells called neutrophilic granulocytes
• 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 ofbreasts and unexpectedly produce breast milk women to have no monthly period or irregular periods
• abnormal dreams and nightmares
• increased appetite
• feeling irritated
• disturbance in speech and language
• shortness ofbreath
• vomiting (mainly in the elderly)
• fever.
Uncommon (affects 1 to 10 patients in 1,000):
• decrease in the number of certain blood cells called thrombocytes and platelets
• fits or seizures
• allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth
• temporary increase of the liver enzyme called gamma-GT in the blood
• decrease in the amount of sodium in the blood
• unpleasant sensations in the legs (also called restless legs syndrome)
• uncontrollable movements, mainly of your face or tongue
• difficulty swallowing
• sexual dysfunction
• a slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
Rare (affects 1 to 10 patients in 10,000):
• A high temperature (fever), long lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very drowsy or faint
• yellowing of the skin and eyes (jaundice)
• a long-lasting and painful erection (priapism)
• increase of an enzyme called creatine phosphokinase in the blood
• inflammation of the liver (hepatitis)
• 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)
• 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 (affects less than 1 patient in 10,000):
• Worsening of pre-existing diabetes
• 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).
Also reported are:
• Small decrease in the blood levels of specific hormones produced by the thyroid gland
• heart arrest, specific heart rhythm disorders, which can be serious and in severe cases may be fatal.
These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.
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 (affects more than 1 patient in 10):
• increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very common (affects more than 1 in 10people):
• 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 ofbreasts 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 effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store [Invented name]
This medicinal product does not require any special storage conditions.
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 outer carton after EXP. The expiry date refers to the last day of that month.
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 [Invented name] contains
- The active substance is quetiapine. One film-coated tablet contains 25 mg, 100 mg, 150 mg,
200 mg or 300 mg of quetiapine (as the fumarate).
- The other ingredients are:
Core: povidone K30, microcrystalline cellulose, calcium hydrogen phosphate dihydrate, sodium starch glycolate type C, silica colloidal anhydrous, magnesium stearate.
Coating:
[Invented name] 25 mg
Opadry II Pink 33G34413: hypromellose 6 cP (2910) (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide red (E172), iron oxide yellow (E172)
[Invented name] 100 mg
Opadry II Yellow 33G32578: hypromellose 6 cP (2910) (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide yellow (E172)
[Invented name] 150 mg
Opadry II Yellow 33G32605: hypromellose 6 cP (2910) (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin, iron oxide yellow (E172) [Invented name] 200 mg and 300 mg
Opadry II White 33G28523: hypromellose 6 cP (2910) (E464), titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin
What [Invented name] looks like and contents of the pack
[Invented name] 25 mg tablets are pink coloured, round and biconvex.
[Invented name] 100 mg tablets are yellow coloured, round and biconvex.
[Invented name] 150 mg tablets are creamy coloured, round and biconvex.
[Invented name] 200 mg tablets are white coloured, round and biconvex.
[Invented name] 300 mg tablets are white coloured, oblong, with the score line on the one side. The tablet can be divided into equal halves.
[Inventedname] 25 mg contains 30 lilm-coatedtablets.
[Invented name] 100 mg, 150 mg, 200 mg or 300 mg contains 60 or 90 lilm-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer [To be completed nationally]
This medicinal product is authorised in the Member States of the EEA under the following names:
{Name of the Member State}> <{Name of the medicinal product}
{Name of the Member State}> <{Name of the medicinal product}
This leaflet was last revised in July 2014
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