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QUETIAPINE 25MG/100MG/200MG FILM-COATED TABLETS

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Quetiapine 25 mg/100 mg/200 mg film-coated tablets
Quetiapine
Read all of this leaflet carefully before you start taking this medicine.
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. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

In this leaflet:
1
What Quetiapine is and what it is used for
2
Before you take Quetiapine
3
How to take Quetiapine
4
Possible side effects
5
How to store Quetiapine
6
Further information

1. What Quetiapine is and what it is used for
Quetiapine 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.
• Effects on your mood whereby you feel sad. You may find that you feel depressed, feel guilty, lack energy,
lose your appetite and/or can’t sleep.

2. Before you take Quetiapine
Do not take Quetiapine
• if you are allergic (hypersensitive) to the active substance quetiapine or any of the other ingredients;
• if you are taking any of the following medicines:
- some medicines for HIV
- azole medicines (for fungal infections)
- erythromycin or clarythromycin (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.

Take special care with Quetiapine
Quetiapine should not be taken by elderly people with dementia (loss of brain function). This is 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.
Before you take your medicine, tell your doctor if:
• You, or someone in your family have any heart problems, for example heart rhythm problems.
• 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 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. 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 there have been
associated with formulation of blood clots.

Tell your doctor immediately if you experience:
• A high temperature (fever), stiff muscles, feeling confused (a disorder called “neuroleptic malignant
syndrome”). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• A feeling of severe sleepiness
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. 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.

Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
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).
Before you stop taking any of your medicines, please talk to your doctor first.
Taking Quetiapine with food and drink
The tablets can be taken with or without food.
Do not drink grapefruit juice while you are taking Quetiapine. It can affect the way the medicine works.
When taking Quetiapine you should not drink alcohol. This is because the combined effect of Quetiapine and
alcohol can make you sleepy.

Pregnancy and breast-feeding
If you are pregnant, trying to get pregnant, or breast-feeding, talk to your doctor before taking Quetiapine.
You should not take Quetiapine 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 any of these symptoms you may need to
contact your doctor.
Quetiapine should not be taken if you are breast-feeding.

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.

Important information about some of the ingredients of Quetiapone
This medicinal product contains lactose monohydrate. If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Quetiapine
Always take Quetiapine exactly as your doctor has told you. You should check with your doctor or pharmacist if
you are not sure.
If you have the impression that Quetiapine is too strong or too weak, talk to your doctor or pharmacist.
Your doctor will decide on your starting dose and on how many Quetiapine tablets to take each day. This will
depend on your illness and needs but will usually be between 150 mg and 800 mg.
Your doctor may start your treatment on a lower dose and increase the dose slowly if:
- You are elderly, or
- You have liver problems.






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.

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 Quetiapine than prescribed by your doctor, you may experience sleepiness, dizziness and
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), 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 the medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Quetiapine can cause side effects, although not everybody gets them.
Very common (affects more than 1 user in 10):
• Dizziness, 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. They usually go away after 1 week from your last dose.
• Putting on weight.
Common (affects 1 to 10 users in 100):
• Rapid heartbeat.
• Stuffy nose.
• Constipation, upset stomach (indigestion).
• Feeling weak, fainting (may lead to falls).
• Swelling of arms or legs.
• Putting on weight, mainly in the first weeks of treatment.
• 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.
• Abnormal dreams and night mares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech or language.
Uncommon (affects 1 to 10 users in 1,000):
• 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.
• Uncontrolled movements, mainly of your face or tongue.
• Sexual dysfunction.
Rare (affects 1 to 10 users 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).
• Swelling of breast 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.
Very rare (affects less than 1 user in 10,000):
• Worsening of pre-existing diabetes.
• Inflammation of the liver (hepatitis).
• 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).

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 increases in the amount of certain fats
(triglycerides and total cholesterol) or sugar in the blood and decreases in the number of certain types of blood
cells, decrease in the amount of sodium in the blood and increase in the amount of the hormone prolactin in the
blood. Increase in the hormone prolactin could in rare cases lead to the following:.
• Men and women to have swelling of the breast 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.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your
doctor or pharmacist.

5. How to store Quetiapine
• Keep out of the reach and sight of children.
• Do not use Quetiapine after the expiry date, which is stated on the blister and the outer carton after EXP. The
expiry date refers to the last day of that month.
• This medicinal product does not require any special storage conditions.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information
What Quetiapine contains
The active substance is quetiapine.
25 mg film-coated tablets: Each film-coated tablet contains 25 mg of quetiapine (as quetiapine fumarate).
100 mg film-coated tablets: Each film-coated tablet contains 100 mg of quetiapine (as quetiapine fumarate).
200 mg film-coated tablets: Each film-coated tablet contains 200 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Core: Lactose monohydrate, calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A) (from
potato starch), povidone K29-32, microcrystalline cellulose, magnesium stearate.
Coating: Hypromellose, macrogol 400, titan dioxide (E171).
25 mg film-coated tablets: iron oxide red (E172), iron oxide yellow (E172).
100 mg film-coated tablets: iron oxide yellow (E172).

What Quetiapine looks like and contents of the pack
Quetiapine 25 mg: Peach coloured, round, biconvex, film-coated tablets engraved with ‘Q’ on one face and ‘25’
on the other.
Quetiapine 100 mg: Yellow, round, biconvex, film-coated tablets engraved with ‘Q’ on one face and ‘100’ on
the other.
Quetiapine 200 mg: White, round, biconvex, film-coated tablets engraved with ‘Q’ on one face and ‘200’ on the
other.
Quetiapine is available in packs of film-coated tablets
10 mg film-coated tablets

Marketing Authorisation Holder and Manufacturer

Regiomedica GmbH
Teichstr. 66
79539 Lörrach
Germany

This medicinal product is authorised in the Member States of the EEA under the following names:
DE
Querigio
UK
Quetiapine
This leaflet was approved in November 2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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