Package leaflet: Information for the patient
Ketilept 25 mg film-coated tablets
Ketilept 100 mg film-coated tablets
Ketilept 150 mg film-coated tablets
Ketilept 200 mg film-coated tablets
Ketilept 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 Ketilept is and what it is used for
2.
What you need to know before you take Ketilept
3.
How to take Ketilept
4.
Possible side effects
5.
How to store Ketilept
6.
Contents of the pack and other information
1.
What Ketilept is and what it is used for
The name of the medicine prescribed for you is Ketilept. Its active substance is quetiapine. Ketilept
belongs to a group of medicines called antipsychotics, which improve the symptoms of certain types
of mental illnesses such as hallucinations (i.e. hearing unexplained voices), strange and frightening
thoughts, changes in your behaviour, feeling alone and confused.
Ketilept can also be used to treat people with an illness that affects their mood where they feel
excessively “high” or excited. People with this condition may find that they need to sleep less than
usual, are more talkative and may also feel unusually irritable.
Furthermore Ketilept can also be used to treat patients who have depressed mood, lack of energy, feel
guilty, lose their appetite or can’t sleep.
Your doctor may continue to give you Ketilept when you are feeling better to prevent your symptoms
from returning.
You may find it helpful to tell a friend or relative that you are suffering from these symptoms, and ask
them to read this leaflet. You might ask them to tell you if they think your symptoms are getting
worse, or if they are worried about any other changes in your behaviour.
2.
What you need to know before you take Ketilept
Do not take Ketilept

if you are allergic to quetiapine or any of the other ingredients of this medicine (listed in
section 6).

if you are using or have recently used HIV-protease inhibitors, azole-antifungal agents,
erythromycin, clarithromycin (antibiotics) or nefazodone (antidepressant).
Warnings and precautions
Talk to your doctor or pharmacist before taking Ketilept:
 if you have any health problems (like heart problems, “QT-interval prolongation” disorder, low
or high blood pressure)
 if you have had apoplexy, particularly if you are elderly,
 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.
 if you have problems with your liver,
 if you have ever had an epileptic seizure (fit),
 if you have fever, faster breathing, increased sweating, modified consciousness and muscle
stiffness has developed. See section 4 „neuroleptic malignant syndrome”
 if you suffer from severe sleepiness
 you suffer from diabetes, or have risk factors for diabetes (family history of diabetes or high
blood sugar levels during pregnancy),
 if you have high level of cholesterol and triglycerides. These are certain fats presents in your
blood
 if you know that you have had a low white blood cell count in the past which may or may not
have been caused by other medicines.
 if you are using concomitantly other medicines.
If you go into hospital, it is important that you let the medical staff know you are taking Ketilept.
As the group of medicines that Ketilept belongs to may increase the risk of stroke, or in some cases
the risk of death, in elderly people with dementia (loss of brain function), Ketilept should not be used
in these cases.
Thoughts of suicide and worsening of your depression
If you are depressed and/or have anxiety disorders you can sometimes have thoughts of harming or
killing yourself. These may be increased when first starting antidepressants, 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 have previously had thoughts about killing or harming yourself.
- If you are a young adult. Information from clinical trials has shown an increased risk of
suicidal behaviour in 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 or anxiety is getting worse, or if they are worried about changes in your behaviour.
Children and adolescents
The safety and efficacy of quetiapine have not been established in children and adolescents. Ketilept
is not recommended for use in children and adolescents below age 18 due to insufficient data on
safety and efficacy.
Other medicines and Ketilept
Tell your doctor 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 for an infection (such as erythromycin which is an antibiotic or ketoconazole which
is an antifungal agent, HIV-protease inhibitors)
medicines for anxiety
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-
medicines for depression
medicines for epilepsy (such as phenytoin or carbamazepine)
medicines for the treatment of high blood pressure.
rifampicin (for tuberculosis)
barbiturates (for sleeping disorders)
thioridazine (for psychotic disorders).
Before you stop taking any of your medicines, please talk to your doctor first.
Special care requires when using concomitantly Ketilept with other medicines known to cause
electrolyte imbalance or to prolong QT interval.
Ketilept with food, drink and alcohol
You can take Ketilept with or without food.
Avoid consumption of alcoholic beverages while you are using Ketilept. If you regularly drink
alcohol, tell your doctor before taking Ketilept.
Do not drink grapefruit juice while you are taking Ketilept.
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 for advice before taking this medicine.
The following symptoms may occur in newborn babies, of mothers that have used Ketilept 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.
Ketilept should not be taken if you are breast-feeding.
Driving and using machines
Ketilept may make you feel sleepy, however this may cease in long-term use. Therefore, at the
beginning of Ketilept therapy – for a period to be determined individually – driving and the use of
machines must be avoided. Following this period the extent of these restrictions should be determined
on a case-by-case basis by your doctor.
Do not drink alcohol while taking this medicine.
Ketilept contains lactose
In lactose intolerance it should be taken into account in your diet that there is 4.00 mg, 16.0 mg, 24.0
mg, 32.0 mg or 48.0 mg lactose in each Ketilept 25 mg, 100 mg, 150 mg, 200 mg or 300 mg filmcoated tablet, respectively.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3.
How to take Ketilept
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 the number of tablets you should take daily. You should follow your
doctor’s instructions on the time and mode of taking tablets. If you are not sure, ask your doctor.
The dose can range from 150 mg to 800 mg each day, depending on your individual treatment and
needs.
If you are an elderly person, or you have problems with your liver your doctor may decide to give you
a reduced dose of Ketilept.
Swallow your Ketilept film-coated tablets whole – without chewing them – with a drink of water.
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Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Use in children and adolescents
Ketilept should not be used by children and adolescents aged less than 18 years.
If you take more Ketilept than you should
If you take more than your normal dose, contact your doctor or the nearest hospital as soon as
possible. In general, reported signs and symptoms were the following: drowsiness and sedation, rapid
heart beat and low blood pressure.
If you forget to take Ketilept
If you miss a dose, take that dose as soon as you remember. Do not take the missed dose and your
next dose at the same time or shortly before. Then go on with the treatment in the way and with the
doses prescribed by your doctor.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Ketilept
Do not stop taking your Ketilept film-coated tablets even if you are feeling better, unless your doctor
tells you to do so.
If you suddenly stop taking Ketilept, symptoms such as feeling sick, being sick (vomiting),
sleeplessness, dizziness and irritability might occur, or your original illness might come back. 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 you notice any of the following side effects, stop taking Ketilept and contact a doctor or the nearest
hospital immediately.
Fever, persistent sore throat or mouth ulcers, (may be the consequence of severe
decrease of blood white cells),
High fever, faster breathing, significant increase in blood-pressure or fast heart beat,
sweating, muscle stiffness, feeling unusually drowsy or faint (the symptoms of
neuroleptic malignant syndrome),
Epileptic fits or seizures,
Allergic reactions that may include raised lumps (weals), swelling of the skin and
swelling around the mouth,
A long-lasting and painful erection.
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.
These are all rare side effects. Most of them are serious so you may need urgent medical attention.
If you have to take Ketilept for a long time, it could cause uncontrollable movements, mainly of your
face or tongue. Tell your doctor immediately if this happens.
Tell your doctor, pharmacist or nurse if you think you have any of these or any other problems with
your Ketilept tablets:
Very common side effects (affects more than 1 user in 10):
Dizziness (may lead to falls),
Headache,
Feeling sleepy (this may go away with time, as you keep taking Ketilept) (may lead to falls).
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Dry mouth
Putting on weight
Increased blood lipids (serum triglycerides, total cholesterol, LDL cholesterol,
decreased level of a certain lipid (HDL)
Discontinuation symptoms (symptoms which occur when you stop taking Ketilept) including feeling
sick, being sick, headache, diarrhoea, not being able to sleep, dizziness and irritability. The medicine
should be stopped gradually.
Common side effects (affects 1 to 10 users in 100)
Rapid heart beat
Constipation
Indigestion
Feeling weak (may lead to falls)
Swelling of arms or legs
Fainting
Stuffy nose
Low blood pressure in standing position, which may result in dizziness or feeling faint (may lead to
falls)
Reduced white blood cell count
Elevations of certain liver enzymes (transaminases)
Increased blood prolactin levels
High blood sugar
Blurred vision
Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling
restless or muscle stiffness without pain.
Nightmares
Feeling more hungry
Feeling irritated.
Disturbances in speech.
Uncommon side effects (affects 1 to 10 users in 1,000)
Allergic reactions that may include raised lump (weals), swelling of the skin and swelling around the
mouth.
Epileptic seizures (fits)
Elevations in certain liver enzymes (gamma-glutamyltransferase)
Restless legs.
High number of eosinophils – a type of white blood cells
Difficulty swallowing.
Involuntary jerky movements of the face, tongue, jaws, trunk, and limbs (tardive dyskinesia)
Abnormal electrical conduction of the heart (QT interval prolongation)
Rare side effects ( affects 1 to 10 users in 10,000)
Fever, very marked drowsiness, muscle stiffness marked changes in blood pressur or heart beat,
reduced consciousness (the symptoms of neuroleptic malignant syndrome)
Jaundice
Swelling of breasts and unexpected production of breast milk in men and women
Long-lasting and painful erection
Blood clots in the veins (see above in section „Take special care with Ketilept)
Very rare side effects (affects less than 1 user in 10,000)
Diabetes mellitus (in case of predisposition to it)
Anaphylactic reaction (severe allergic reaction, severe difficulty in breathing and shock may develop)
Inflammation of the liver (hepatitis)
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Not known (frequency cannot be estimated from the available data)
Reduction in number of certain blood cells (neutropenia)
Using Ketilept the following side-effects are only seen when a blood test is taken:
Decreases in the number of white of blood cells (this go away with discontinuation of
Ketilept treatment)
Decrease in the number of blood platelets (cells which help blood to clot)
Eosinophilia - increase in number of certain types of blood white cells, which may
cause allergic reaction.
Increase of the quantity of liver enzymes (this go away with time, as you keep taking
Ketilept)
Increase in the amount of certain fats (increase of lipid level, e.g. triglycerides and
cholesterol)
Increase of the level of creatine-phosphokinase (the constructive element of the
muscles)
Increase of the level of sugar in the blood
Increases of the level of prolactin (that may rarely cause swelling of the breast in men
and women, too, and women may have no monthly period or irregular periods).
Decreases in the amount of sodium in the blood.
Quetiapine treatment was associated with small dose-related decreases in thyroid hormone levels. In
nearly all cases, cessation of quetiapine treatment was associated with a reversal of these side effects,
irrespective of the duration of treatment. Clinically relevant reduction of thyroid hormone levels have
not been observed.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
If you have been on other medication for this condition, and that medication has stopped your periods,
changing to Ketilept may allow them to return.
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 user 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 user in 10)
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.
If you get any side effects talk to your doctor or pharmacist. This includes any side effects not listed
in this leaflet.
5.
How to store Ketilept
Store below 25°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the package. The expiry date refers to the last
day of that month.
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Do not throw away any medicines wastewater or household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will help to protect the environment.
6.
Contents of the pack and other information
What Ketilept contains
The active substance is 25 mg, 100 mg, 150 mg, 200 mg or 300 mg quetiapine (as 28.78 mg, 115.13
mg, 172.7 mg, 230.26 mg and 345.4 mg quetiapine hemifumarate) in each film-coated tablet,
respectively.
The other ingredients are:
Ketilept 25 mg film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium starch glycolate (type A),
lactose monohydrate (4.00 mg), microcrystalline cellulose.
Coating: Opadry II 33G28523 White (triacetine, macrogol 3350, lactose monohydrate, titanium
dioxide (E171) hypromellose).
Ketilept 100 mg film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium starch glycolate (type A),
lactose monohydrate (16.0 mg), microcrystalline cellulose.
Coating: Opadry II 33G28523 White (triacetine, macrogol 3350, lactose monohydrate, titanium
dioxide (E171) hypromellose).
Ketilept 150 mg film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium starch glycolate (type A),
lactose monohydrate (24.0 mg), microcrystalline cellulose.
Coating:
Opadry II 33G28523 White (triacetine, macrogol 3350, lactose monohydrate, titanium dioxide (E171)
hypromellose).
Opadry II 33G24283 Pink (yellow iron oxide (E 172), red iron oxide (E 172), triacetine, macrogol
3350, lactose monohydrate, titanium dioxide (E 171), hypromellose).
Ketilept 200 mg film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium starch glycolate (type A),
lactose monohydrate (32.0 mg), microcrystalline cellulose.
Coating:
Opadry II 33G28523 White (triacetine, macrogol 3350, lactose monohydrate, titanium dioxide (E 171)
hypromellose).
Opadry II 33G24283 Pink (yellow iron oxide (E 172), red iron oxide (E 172), triacetine, macrogol
3350, lactose monohydrate, titanium dioxide (E 171), hypromellose).
Ketilept 300 mg film-coated tablets
magnesium stearate, colloidal anhydrous silica, povidone K-90, sodium starch glycolate (type A),
lactose monohydrate (48.0 mg), microcrystalline cellulose.
Coating:
Opadry II 33G28523 White (triacetine, macrogol 3350, lactose monohydrate, titanium dioxide (E171)
hypromellose).
What Ketilept looks like and contents of the pack
Appearance
Ketilept 25 mg film-coated tablets – white, or off-white, odourless or almost odourless, round,
biconvex film-coated tablets with engraved “201” on one side and engraved stylistic “E” on the other
side.
Ketilept 100 mg film-coated tablets – white, or off-white, odourless or almost odourless, round,
biconvex film-coated tablets with engraved “E202” on one side.
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Ketilept 150 mg film-coated tablets – light pink, odourless or almost odourless, oval, biconvex filmcoated tablets with two stylized E marks in opposite position and halving score-line on one side and
halving score-line on the other side. The tablet can be divided into equal doses.
Ketilept 200 mg film-coated tablets – pink, odourless or almost odourless, round, biconvex filmcoated tablets with engraved “E204” on one side.
Ketilept 300 mg film-coated tablets – white or off-white, odourless or almost odourless, round,
biconvex film-coated tablets with engraved “E205” on one side.
Package:
Colourless, transparent PVC/PVdC//Al foil blister or in brown glass bottle (type III.) closed with
white PE cap containing 30 or 60 film-coated tablets per carton.
Marketing Authorisation Holder
EGIS Pharmaceuticals Public Limited Company
1106 Budapest, Keresztúri út 30-38.
HUNGARY
Manufacturer
EGIS Pharmaceuticals Public Limited Company
1165 Budapest, Bökényföldi út 118-120.
HUNGARY
This medicinal product is authorised in the Member States of the EEA under the following
names:
Hungary:
Czech Republic:
Lithuania:
Latvia:
Poland:
Romania:
Slovenia:
Slovakia:
Ketilept 25/100/150/200/300 mg filmtabletta
Ketilept 25/100/150/200/300 mg
Ketilept 25/100/150/200/300 mg plévele dengtos tabletés
Ketilept 25/100/150/200/300 mg film-coated tablets
Ketilept
Ketilept 25/100/150/200/300 mg comprimate filmate
Ketilept 25/100/150/200/300 mg
Ketilept 25/100/150/200/300 mg
This leaflet was lastrevised in {MM/YYYY}
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Kommentiert [11]:
RMS comment: Halving line should be corrected to score line
according to Standard Term in the SPC point 3.
Response: We agree on the proposal