- quetiapine fumarate
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet are: PL 18909/0318, PL 18909/0317, PL 18909/0321, PL 18909/0319, PL 18909/0320.
Quetiapine 25mg,100mg, 150mg,200mg,300mg Film-coated Tablets (Arrow)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Quetiapine 25mg Film-coated Tablets
Quetiapine 100mg Film-coated Tablets
Quetipaine 150mg Film-coated Tablets
Quetiapine 200mg Film-coated Tablets
Quetiapine 300mg Film-coated Tablets
Read all of this leaflet carefully before you start taking this medicine.
In this leaflet:
1. What Quetiapine Tablets are and what they are used for
2. Before you take Quetiapine Tablets
3. How to take Quetiapine Tablets
4. Possible side effects
5. How to store Quetiapine Tablets
6. Further information.
1.WHAT QUETIAPINE TABLETS ARE AND WHAT THEY ARE USED FOR
Quetiapine belongs to a group of medicines called antipsychotics. These medicines help with conditions that cause symptoms such as:
2.BEFORE YOU TAKE QUETIAPINE TABLETS
Do NOT take Quetiapine Tablets
Do not take Quetiapine Tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Tablets.
Take special care with Quetiapine Tablets
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:
Tell your doctor if you experience:
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.
Taking other medicines
Please tell your doctor if you are taking or have recently taken any other medicines because it may affect the way the medicine works. This includes medicines that you buy without a prescription and herbal medicines.
Tell your doctor if you are taking any of the following:
Before you stop taking any of your medicines, please talk to your doctor first.
Taking Quetiapine Tablets with food and drink
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. Quetiapine should not be taken if you are breast-feeding.
The following symptoms may occur in newborn babies, of mothers that have used Quetiapine Tablets 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
If you feel drowsy after taking this medicine, do not drive or operate any tools or machines. Tell your doctor.
Important information about some of the ingredients of Quetiapine Tablets
These tablets contain 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.
Quetiapine 25mg Tablets contains Sunset Yellow (E110) and Allura Red (E129) which may cause allergic reactions.
Quetiapine 150mg Tablets contain Allura Red (E129) which may cause allergic reactions.
3.HOW TO TAKE QUETIAPINE TABLETS
Always take Quetiapine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
The usual starting dose is 50 mg daily. You will take an increasing number of tablets for the first 4 days of treatment. From day 4 onwards the dose may be increased further, depending on how you respond to the treatment. Your doctor will tell you how many tablets you should take each day. The usual effective dose is between 300 mg and 450 mg daily. The maximum daily dose is 750 mg daily.
Manic episodes associated with bipolar disorder
The usual starting dose is 100 mg daily. You will take an increasing number of tablets for the first 4 days of treatment. From day 4 onwards the dose may be increased further, depending on how you respond to the treatment. Your doctor will tell you how many tablets you should take each day. The usual effective dose is between 400 mg and 800 mg daily. The maximum daily dose is 800 mg daily.
Depressive episodes associated with bipolar disorder
The usual starting dose is 50 mg daily. You will take an increasing number of tablets for the first 4 days of treatment. The recommended daily dose is 300 mg. Take your tablets once daily at bedtime. Your doctor will tell you how many tablets you should take each day.
Children or adolescents under 18 years should not take this medicine.
If you take more Quetiapine Tablets than you should
You may get the following symptoms:
Contact your doctor or nearest hospital casualty department immediately.
Remember to take the pack and any remaining tablets with you.
If you forget to take Quetiapine Tablets
If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. Do not take a double dose to make up for the one you have missed.
If you stop taking Quetiapine Tablets
Do not suddenly stop taking this medicine without talking to your doctor first, even if you feel better, as you might experience withdrawal symptoms such as feeling sick, being sick and being unable to sleep.
Your doctor will suggest that 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, Quetiapine Tablets can cause side effects, although not everybody gets them.
Very common (affects more than 1 patient in 10):
Common (affects 1 to 10 patients in 100):
Uncommon (affects 1 to 10 patients in 1,000):
Rare (affects 1 to 10 patients in 10,000):
Very rare (affects less than 1 patient in 10,000):
Also reported are:
These occurred with the entire group of medicines called antipsychotics and not with quetiapine in particular.
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 TABLETS
This medicinal product does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use Quetiapine Tablets after the expiry date which is stated on the outer carton after Exp. The expiry date refers to the last day of that month.
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.
What Quetiapine Tablets contain
Quetiapine Tablets contain 25mg, 100mg, 150mg , 200mg or 300mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core: cellulose, microcrystalline, calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A), povidone, lactose monohydrate and magnesium stearate.
25mg Tablets: polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, sunset yellow (E110), allura red (E129) and indigo carmine (E132).
100mg Tablets: polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc and iron oxide yellow (E172).
150mg Tablets: polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol, talc, iron oxide yellow (E172), indigo carmine (E132), and allura red (E129).
200mg and 300mg Tablets: polyvinyl alcohol-part hydrolysed, titanium dioxide (E171), macrogol and talc.
What Quetiapine Tablets look like and contents of the pack
Quetiapine 25 mg Tablets:
Peach, round, biconvex tablet with 'QT' on one side and ' ' on the other side.
Quetiapine 100 mg Tablets:
Yellow, round, biconvex tablet with 'QT' over '100' on one side and ' ' on the other side.
Quetiapine 150 mg Tablets:
Pale yellow, round, biconvex tablet with 'QT' over '150' on one side and ' ' on the other side.
Quetiapine 200 mg Tablets:
White to off white, round, biconvex tablet with 'QT' over '200' on one side and ' ' on the other side.
Quetiapine 300 mg Tablets:
White to off-white, capsule-shaped, biconvex tablet with 'QT' over '300' on one side and ' ' on the other side.
Quetiapine Tablets are packed in foil blister packs containing 6, 10, 14, 20, 28, 30, 50, 56, 60, 90, 100 and 100 (5 x 20) tablets per carton.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
This leaflet was last approved in November 2011.