Seotiapim Xl 50 Mg Prolonged-Release Tablets
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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. See section 4.
What is in this leaflet
1. What Seotiapim XL is and what it is used for
2. What you need to know before you take Seotiapim XL
3. How to take Seotiapim XL
4. Possible side effects
5. How to store Seotiapim XL
6. Contents of the pack and other information
Seotiapim XL contains the active substance quetiapine. This belongs to a group of medicines called anti-psychotics. Seotiapim XL can be used to treat several illnesses, such as:
• Bipolar depression and major depressive episodes in major depressive disorder: where you feel sad. You may find that you feel depressed, feel guilty, lack energy, lose your appetite or can’t sleep.
• Mania: where you may feel very excited, elated, agitated, enthusiastic or hyperactive or have poor judgment including being aggressive or disruptive.
• Schizophrenia: where you may hear or feel things that are not there, believe things that are not true or feel unusually suspicious, anxious, confused, guilty, tense or depressed.
When Seotiapim XL is being taken to treat major depressive episodes in major depressive disorder, it will be taken in addition to another drug being used to treat this illness.
Your doctor may continue to prescribe Seotiapim XL even when you feel better.
Do not take Seotiapim XL:
• If you are allergic to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• 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)
Do not take Seotiapim XL if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Seotiapim XL.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Seotiapim XL
• If you, or someone in your family, have or have had any heart problems, for example heart rhythm problems, weakening of the heart muscle or inflammation of the heart or if you are taking any medicines that may have an impact on the way your heart beats.
• If you have low blood pressure.
• If you have had a stroke, especially if you are older.
• If you have problems with your liver.
• If you have ever had a fit (seizure).
• If 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 Seotiapim XL.
• If 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).
• If you are an older person with dementia (loss of brain function). If you are, Seotiapim XL should not be taken because the group of medicines that Seotiapim XL belongs to may increase the risk of stroke, or in some cases the risk of death, in older people with dementia.
• If 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.
Tell your doctor immediately if you experience any of the following after taking Seotiapim XL
• A combination of fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”). Immediate medical treatment may be needed.
• Uncontrollable movements, mainly of your face or tongue.
• Dizziness or a severe sense of feeling sleepy. This could increase the risk of accidental injury (fall) in older people.
• Fits (seizures).
• A long-lasting and painful erection (Priapism).
These conditions can be caused by this type of medicine.
Tell your doctor as soon as possible if you have:
• A fever, flu-like symptoms, sore throat, or any other infection, as this could be a result of a very low white blood cell count, which may require Seotiapim XL to be stopped and/or treatment to be given.
• Constipation along with persistent abdominal pain, or constipation which has not responded to treatment, as this may lead to a more serious blockage of the bowel.
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. These thoughts may also be increased if you suddenly stop taking your medication. 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
Weight gain has been seen in patients taking Seotiapim XL. You and your doctor should check your weight regularly.
Children and adolescents
Seotiapim XL is not for use in children and adolescents below 18 years of age.
Other medicines and Seotiapim XL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Seotiapim XL 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 or lithium (other anti-psychotic medicines).
• Medicines that have an impact on the way your heart beats, for example, drugs that can cause an imbalance in electrolytes (low levels of potassium or magnesium) such as diuretics (water pills) or certain antibiotics (drugs to treat infections).
• Medicines that can cause constipation.
Before you stop taking any of your medicines, please talk to your doctor first.
Seotiapim XL with food, drink and alcohol
• Food: see section 3 under “Method of administration” Be careful how much alcohol you drink. This is because the combined effect of Seotiapim XL and alcohol can make you sleepy.
• Do not drink grapefruit juice while you are taking Seotiapim XL. 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.
You should not take Seotiapim XL during pregnancy unless this has been discussed with your doctor. The following symptoms which can represent withdrawal may occur in newborn babies, of mothers that have used Seotiapim XL 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.
Seotiapim XL 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.
Seotiapim XL contains lactose
Seotiapim XL contains lactose which is a type of sugar.
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Effect on Urine Drug Screens
If you are having a urine drug screen, taking quetiapine may cause positive results for methadone or certain drugs for depression called tricyclic antidepressants (TCAs) when some test methods are used, even though you may not be taking methadone or TCAs. If this happens, a more specific test can be performed.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Not all dosing regimens are practical/possible with the present strength of Seotiapim XL and other authorised medicinal products containing quetiapine are available
The recommended dose is:
Adults
Your doctor will decide on your starting dose. The maintenance dose (daily dose) will depend on your illness and needs but will usually be between 150 mg and 800 mg.
Older people
If you are older your doctor may change your dose. Patients with liver problems
If you have liver problems your doctor may change your dose.
Use in children and adolescents
Seotiapim XL should not be used by children and
adolescents aged under 18 years.
Method of administration:
Oral use.
• You will take your tablets once a day.
• Do not split, chew or crush the tablets.
• Swallow your tablets whole with a drink of water.
• Seotiapim XL can be affected by food. Take your tablets without food (at least one hour before a meal or at bedtime, your doctor will tell you when.
• Do not drink grapefruit juice while you are taking Seotiapim XL. It can affect the way the medicine works.
Duration of treatment:
This will be decided by your doctor. Do not stop taking your tablets even if you feel better, unless your doctor tells you.
If you take more Seotiapim XL than you should
If you take more Seotiapim XL than prescribed by your doctor, you may feel sleepy, feel dizzy and experience abnormal heart beats. Contact your doctor or nearest hospital straight away. Keep the Seotiapim XL with you.
If you forget to take Seotiapim XL
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 Seotiapim XL
If you suddenly stop taking Seotiapim XL, you may be unable to sleep (insomnia), or 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 medicine, ask your doctor, pharmacist or nurse.
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
STOP taking Seotiapim XL and contact your doctor immediately or go to the nearest hospital if you experience any of the following serious side effects:
Uncommon (may affect up to 1 in 100 people):
• Fits or seizures
• Uncontrollable movements, mainly of your face or tongue.
Rare (may affect up to 1 in 1,000 people):
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint (a disorder called “neuroleptic malignant syndrome”).
• A long-lasting and painful erection (priapism).
• 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.
• A combination of fever, flu-like symptoms, sore throat, or any other infection with very low white blood cell count (a condition called agranulocytosis).
Very rare (may affect up to 1 in 10,000 people):
• 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).
• A serious blistering condition of the skin, mouth, eyes and genitals (Stevens-Johnson syndrome)
Not known (frequency cannot be estimated from the available data):
• Serious, sudden allergic reaction with symptoms such as fever and blisters on the skin and peeling of the skin (toxic epidermal necrolysis).
• Skin rash with irregular red spots (erythema multiforme).
The class of medicines to which Seotiapim XL belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
You may experience any of the following side effects listed below. If the side effect is severe or persistent, you should contact your doctor.
Very common (may affect 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 Seotiapim XL (may lead to falls).
• Discontinuation symptoms (symptoms which occur when you stop taking Seotiapim XL) 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.
• Changes in the amount of certain fats (triglycerides and total cholesterol).
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Constipation, upset stomach (indigestion).
• Feeling weak.
• Swelling of arms or legs.
• 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 and language.
• Thoughts of suicide and worsening of your depression
• Shortness of breath.
• Vomiting (mainly in older people).
• Fever.
• Changes in the amount of thyroid hormones in your blood
• Decreases in the number of certain types of blood cells
• Increases in the amount of liver enzymes measured in the blood
• 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 breasts and unexpectedly produce breast milk.
- Women to have no monthly period or irregular periods.
Uncommon (may affect up to 1 in 100 people):
• 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.
• Sexual dysfunction.
• Diabetes
• Change in electrical activity of the heart seen on ECG (QT prolongation).
• A slower than normal heart rate which may occur when starting treatment and which may be associated with low blood pressure and fainting.
• Difficulty in passing urine
• Fainting (may lead to falls)
• Stuffy nose
• Decrease in the amount of red blood cells
• Decrease in the amount of sodium in the blood.
Rare (may affect up to 1 in 1,000 people):
• Yellowing of the skin and eyes (jaundice).
• 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).
• Inflammation of the pancreas.
• A condition called “metabolic syndrome” where you may have a combination of three or more of the following: an increase in fat around your abdomen, a decrease in “good cholesterol” (HDL-C), an increase in a type of fat in your blood called triglycerides, high blood pressure and an increase in your blood sugar.
• Bowel obstruction
• Increased blood creatine phosphokinase (a substance from the muscles)
Very rare (may affect up to 1 in 10,000 people):
• Severe rash, blisters, or red patches on the skin.
• Inappropriate secretion of a hormone that controls urine volume.
• Breakdown of muscle fibers and pain in muscles (rhabdomyolysis).
• Worsening of pre-existing diabetes.
Not known (frequency cannot be estimated from the available data)
• Symptoms of withdrawal may occur in newborn babies of mothers who have used Seotiapim XL during their pregnancy.
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, changes in the amount of thyroid hormones in your blood, increased liver enzymes, decreases in the number of certain types of blood cells, decrease in the amount of red blood cells, increased blood creatine phosphokinase (a substance in the muscles), decrease in the amount of sodium in the blood 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 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.
Side effects in children and adolescents
The same side effects that may occur in adults may also occur in children and adolescents.
The following side effects have been seen more often in children and adolescents or have not been seen in adults:
Very Common (may affect 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
• Vomiting
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
• Increase in blood pressure.
Common (may affect up to 1 in 10 people):
• Feeling weak, fainting (may lead to falls)
• Stuffy nose
• Feeling irritated
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
• 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 label after EXP. The expiry date refers to the last day of that month.
• Seotiapim XL does not require any special storage conditions.
• Do not use this medicine if you notice visible signs of deterioration.
• 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 to protect the environment.
What Seotiapim XL contains
The active substance is quetiapine. Each Seotiapim XL 50 mg Prolonged-release Tablet contains 50 mg of quetiapine (as quetiapine fumarate).
The other ingredients are:
Tablet core:
Lactose monohydrate, Hypromellose (K4M and K100 Premium LV CR) (E464), Sodium chloride, Povidone K-30 (E1201), Silicified Microcrystalline Cellulose (Microcrystalline cellulose and Silica Colloidal Anhydrous), Talc (E553b), Magnesium stearate (E470b),
Tablet coating:
Opadry II 85F540003 Pink contains: Poly (Vinyl alcohol) (E1203), Titanium dioxide (E171), Macrogol 3350 (E1521), Talc, Iron oxide red (E172), Iron oxide yellow (E172).
What Seotiapim XL looks like and contents of the pack
Quetiapine prolonged-release Tablet 50 mg is peach coloured, round shaped, biconvex film coated tablets, debossed with ‘Q50’ on one side and plain on the other.
White opaque PVC/PVdC-ALU blister or ALU-ALU blister pack. Pack size of 6, 10, 20, 28, 30, 50, 60, 90 and 100 tablets per pack.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder Sandoz Ltd,
Frimley Business Park, Frimley,
Camberley, Surrey, GU16 7SR, UK.
Manufacturer
Lek Pharmaceuticals d.d., Verovskova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals d.d., Trimlini 2D, 9220 Lendava, Slovenia
or
Lek Pharmaceuticals d.d., ul. Domaniewska 50 C, 02672 Warszawa, Poland
or
Salutas Pharma GmbH, Otto-von-Guericke-Allee 1, 39179 Barleben, Germany
or
S.C. Sandoz, S.R.L., Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania
or
Pharmacare Premium Ltd, HHF 003, Hal Far Industrial Estate, Birzebbugia, BBG 3000, Malta.
This leaflet was last revised in 09/2014.
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