Quetiapine 200 Mg Film-Coated Tablets
Package leaflet: Information for the user 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
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, pharmacist or nurse.
- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Quetiapine Film-coated Tablets are and what they are used for
2. What you need to know before you take Quetiapine Film-coated Tablets
3. How to take Quetiapine Film-coated Tablets
4. Possible side effects
5. How to store Quetiapine Film-coated Tablets
6. Contents of the pack and other information
1. What Quetiapine Film-coated tablets are and what they are used for
Quetiapine Film-coated tablets contain a medicine called quetiapine. This belongs to a group of medicines called antipsychotics. These medicines help with the effects of some types of mental illness such as:
• Hallucinations (like hearing unexplained voices), strange and frightening thoughts, changes in how you act, and feeling alone and confused. This is also known as schizophrenia.
• Effects on your mood and feeling very ‘high’ or excited. You may find that you need to sleep less than usual. You may also be more talkative and have racing thoughts or ideas. You may also feel more irritable than usual. This is also known as bipolar mania.
• Effects on your mood whereby you feel sad all the time. You may find that you feel depressed, feel guilty, lack energy, lose your appetite and/or can’t sleep. This is also known as bipolar depression.
Your doctor may continue to give you Quetiapine 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 Quetiapine Film-coated tablets Do not take Quetiapine if:
• you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6).
• you are taking any of the following medicies:
- protease inhibitors, such as nelfinavir (for HIV infection)
- azole medicines (for fungal infections)
- medicines for an infections (like erythromycin or clarithromycin)
- nefazodone(for depression).
Do not take Quetiapine Film-coated tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Quetiapine Film-coated tablets.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Quetiapine Film-coated tablets
Quetiapine Film-coated tablets should not be taken by elderly people with dementia (loss of brain function). This is because the group of medicines that Quetiapine Film-coated tablets 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 have any health problems (like heart problems or low blood pressure) or you have had a stroke.
• You have problems with your liver, or have ever had a fit (seizure).
• 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 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 Film-coated tablets.
• 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.
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.
Other medicines and Quetiapine Film-coated tablets
Tell your doctor or pharamcist 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 anxiety or depression.
• Epilepsy medicines (like phenytoin or carbamazepine)
• High blood pressure medicines
• Rifampicin (for tuberculosis).
• Barbiturates (for difficulty sleeping).
• Thioridazine (another anti-psychotic medicine).
Before you stop taking any of your medicines, please talk to your doctor first.
Quetiapine with food, drink and alcohol
• Quetiapine Film-coated tablets 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 feel sleepy.
• Do not drink grapefruit juice while you are taking Quetiapine Film-coated tablets. 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.
The following symptoms may occur in newborn babies, of mothers that have used Quetiapine Film-coated 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
Your tablets may make you feel sleepy. You should not drive or use any tools or machines until you know how the tablets affect you.
Hospital - If you go into hospital tell the medical staff that you are taking Quetiapine Film-coated tablets. Quetiapine Film-coated tablets contains lactose
Quetiapine Film-coated tablets contains lactose which is a type of sugar. If you have been told by your doctor or pharmacist that you cannot tolerate or digest some sugars, talk to your doctor before taking this medicine.
3. How to take Quetiapine Film-coated tablets
Always take this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The recommended dose is
Your doctor will decide on the starting dose and may gradually increase it. After this the dose will usually be between 150 mg and 800 mg each day. It depends on your illness and needs.
• 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.
• Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Quetiapine Film-coated tablets come in 5 different strengths and each strength is a different colour or shape.
• Even though the dose might stay the same, it might be supplied as different strength tablets. For example, one 300 mg tablet (white) or two 150 mg tablets (pale yellow).
• So don’t be surprised if the colour of your tablets changes from time to time.
Liver problems
If you have liver problems your doctor may give you a lower dose.
Elderly people
If you are elderly your doctor may give you a lower dose.
Children and adolescents under 18 years
Quetiapine Film-coated tablets should not be used by children and adolescents aged under 18 years.
If you take more Quetiapine Film-coated tablets than you should
If you take more Quetiapine Film-coated tablets than prescribed by your doctor, go to your doctor or nearest hospital straight away. Take the Quetiapine Film-coated 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 dose.
If you stop taking Quetiapine
If you suddenly stop taking Quetiapine Film-coated tablets, 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 product, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following happen, stop taking Quetiapine Film-coated tablets and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:
Uncommon (affects less than 1 in 100 people):
• Fits or seizures.
• Allergic reactions that may include raised lumps (weals), swelling of the skin and swelling around the mouth.
• Uncontrollable movements, mainly of your face or tongue (Tardive dyskinesia).
Rare (affects less than 1 in 1,000 people):
• A high temperature (fever), long-lasting sore throat or mouth ulcers, faster breathing, sweating, stiff muscles, feeling very sleepy or faint, large increase in blood pressure or heartbeat.
• Jaundice (yellowing of the skin and eyes).
• Priapism (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.
Very rare (affects less than 1 in 10,000 people):
• Severe allergic reaction that may include difficulty in breathing, dizziness and collapse.
• Hepatitis (inflammation of the liver).
• Rapid swelling of the skin, usually around the eyes, lips and throat.
Other possible side effects:
Very common (affects 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 Film-coated tablets) (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking Quetiapine Film-coated tablets) include not being able to sleep (insomnia), feeling 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.
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Common (affects less than 1 in 10 people):
• Rapid heartbeat.
• Stuffy nose.
• Upset stomach (Indigestion) , constipation.
• Feeling weak, fainting (may lead to falls).
• Swelling of arms or legs.
• High blood sugar.
• 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.
• Blurred vision.
• Abnormal dreams and nightmares.
• Feeling more hungry.
• Feeling irritated.
• Disturbance in speech or language.
• Thoughts of suicide and worsening of your depression.
• Shortness of breath.
• Vomiting (mainly in the elderly).
• Fever.
Uncommon (affects less than 1 in 100 people):
• Restless legs.
• Difficulty swallowing.
Rare (affects less than 1 in 1,000 people):
• Swelling of breasts and unexpected production of breast milk (galactorrhoea).
Very rare (affects less than 1 in 10,000 people):
• Worsening of pre-existing diabetes.
• A severe rash, blisters or red patches on the skin.
Some side effects are only seen when a blood test is taken. These include changes in the amount of certain fats (triglycerides and total cholesterol) or sugar in the blood, decreases in the number of certain types of blood cells and increases in the amount of the hormone prolactin in the blood.
Increases in the hormone prolactin could in rare cases lead to the following:
• Men and women to have swelling of the breasts 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 you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.
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 in 10 people):
• Increase in blood pressure.
The following side effects have been seen more often in children and adolescents:
Very Common (affects more than 1 in 10 people):
• 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
5. How to store Quetiapine Film-coated tablets
• 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 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 Quetiapine Film-coated tablets contain
• The active substance is quetiapine as quetiapine fumarate
• The other ingredients are: Microcrystalline cellulose, povidone K29-32, calcium hydrogen phosphate dihydrate, sodium starch glycolate (Type A), lactose monohydrate, magnesium stearate, hypromellose 6cP, macrogol 3350, triacetin, titanium dioxide, iron oxide yellow (E-172) (in 25 mg, 100 mg and 150 mg tablets) and iron oxide red (E-172) (only in the 25 mg tablets).
What Quetiapine Film-coated tablets look like and contents of the pack
Quetiapine 25 mg film-coated tablet is round, biconvex, light orange tablet with the diameter 5.5 mm and engraved with “Q” on one side.
Quetiapine 100 mg film-coated tablet is round, biconvex, yellow tablet with the diameter 8.5 mm and engraved with “Q” on one side.
Quetiapine 150 mg film-coated tablet is oval, biconvex, pale yellow tablet with the diameter 6.9 x 13.8 mm and engraved with “Q” on one side.
Quetiapine 200 mg film-coated tablet is oval, biconvex, white tablet with the diameter 16 x 8.2 mm and engraved with “Q” on one side.
Quetiapine 300 mg film-coated tablet is oval, biconvex, white tablet with the diameter 19 x 7.6 mm, engraved with “Q” on one side and “300” on the other side.
Pack sizes*:
Blisters: 6, 10, 20, 30, 50, 60, 90, 100 tablets Tablet containers: 6, 10, 20, 30, 50, 60, 90, 100 tablets
*Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aptil Pharma Limited
9th Floor, CP House
97-107 Uxbridge Road, Ealing
London
W5 5TL
Manufacturer
Actavis Ltd.
BLB016 Bulebel Industrial Estate
Zejtun
Malta
Actavis hf.
Reykjavikurvegur 78 220 Hafnarfjordur Iceland
This leaflet was last revised in 05/2014
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