Tenprolide Xl 400mg Prolonged-Release Tablets
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Tenprolide XL 50mg, 200mg, 300mg and 400mg Prolonged-release 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. See section 4.
• The full name of this medicine is Tenprolide XL 50mg, 200mg, 300mg and 400mg Prolonged-release Tablets but within the leaflet it will be referred to as Tenprolide tablets.
What is in this leaflet:
l| What Tenprolide tablets are and what they are used for
2| What you need to know before you take How to take
3 Possible side effects
_5| How to store
^| Contents of the pack and other information
j What Tenprolide tablets are and what they are used for
Tenprolide tablets contains a substance called quetiapine and belongs to a group of medicines called antipsychotics. Tenprolide tablets are prolonged-release tablets which means that the active ingredients is released slowly from the tablet so that you only have to take them once a day.
Tenprolide tablets can be used to treat several illnesses, such as:
• schizophrenia:
- schizophrenia is a mental illness associated with disturbances in thinking, emotions and behaviour.
The symptoms of schizophrenia include hallucinations (hearing or seeing things that are not there), strange and frightening thoughts, changes in your behaviour, feeling alone and confused.
• bipolar disorder, including the following:
- moderate to severe manic episodes. The symptoms of manic episodes may include feeling very 'high' or excited, needing less sleep than usual, racing thoughts or ideas, being more talkative and feeling more irritable than usual
- major depressive episodes. Symptoms include feeling very 'down' or sad, feeling guilty, lacking energy, losing appetite and sleep disturbances.
Tenprolide tablets are also used as an addition to some other antidepressant medicines in the treatment of major depressive episodes in people with major depressive disorder.
Your doctor may continue to prescribe Tenprolide tablets even when you are feeling better.
^| What you need to know before you take Do not take Tenprolide tablets if you are:
• allergic (hypersensitive) to quetiapine or any of the other ingredients of this medicine (listed in section 6)
• taking the following medicines:
- medicines to treat HIV infections (so-called protease inhibitors)
- medicines to treat fungal infections (with names of the active substance ending in 'azole' such as ketoconazole)
- erythromycin or clarithromycin (used to treat bacterial infections)
- nefazodone (used to treat depression).
Do not take Tenprolide tablets if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Tenprolide tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Tenprolide tablets. Tell your doctor if you:
• or someone in your family, have or have had any heart problems, for example heart rhythm problems or if you are taking any medicines that may have an impact on the way your heart beats
• have low blood pressure
• have had a stroke, especially if you are elderly
• have problems with your liver
• have ever suffered from convulsions (seizures)
• have diabetes, tend to have high blood sugar levels or are at risk of developing diabetes. If you do, your doctor may check your blood sugar levels while you are taking Tenprolide tablets
• know that you have had low levels of white blood cells
previously (which may or may not have been caused by other medicines)
• or someone else in your family has a history of blood clots, as medicines like these have been associated with formation of blood clots.
Tenprolide tablets should not be taken by elderly people with dementia (loss of brain function). This is because the group of medicines that Tenprolide tablets belongs to may increase the risk of stroke, or in some cases the risk of death, in elderly people with dementia.
While taking this medicine, tell your doctor immediately if you experience:
• a high temperature (fever), stiff muscles, feeling of being confused and changes in consciousness. These might be signs of a so-called 'neuroleptic malignant syndrome'
• involuntary and abnormal movements, especially of the tongue, mouth and jaw, facial grimacing, rapid eye blinking and uncontrollable movements of arms, legs, fingers and toes. These might be symptoms of 'tardive dyskinesia'
• tremor, twisting and repetitive movements or abnormal body posture, slurred speech, restlessness and stiff muscles. These might be symptoms of 'extrapyramidal symptoms'
• dizziness or a feeling of severe sleepiness. This could increase the risk of accidental injury (fall), especially in elderly patients
• trouble swallowing
• weight gain. Your doctor might need to monitor your treatment more closely.
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These conditions can be caused by this type of medicine and your doctor might need to reduce your dose or discontinue treatment.
Thoughts of suicide and worsening of your depression or anxiety disorder
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
Tenprolide tablets should not be used in children and adolescent below 18 years of age due to higher risk of side effects.
Other medicines and Tenprolide tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Do not take Tenprolide tablets if you are taking any of the following medicines:
• medicines to treat HIV infections (so-called protease inhibitors)
• medicines to treat fungal infections (with names of the active substance ending in 'azole' such as ketoconazole)
• erythromycin or clarithromycin (used to treat bacterial infections)
• nefazodone (used to treat depression).
Tell your doctor if you are taking any of the following medicines:
• carbamazepine or phenytoin (used to treat epilepsy or other illnesses)
• thioridazine (a medicine to treat psychiatric disorders)
• medicines which act on the central nervous system
• medicines used to treat high blood pressure such as diuretics
• medicines used to treat irregular heart beat.
If you are not sure about what type of medicines you are taking, talk to your doctor or pharmacist before taking Tenprolide tablets.
Tenprolide tablets with food, drink and alcohol
• Tenprolide tablets can be affected by food and you should therefore take your tablets at least one hour before a meal
• Alcohol should be consumed with caution during treatment with Tenprolide tablets as the combined effect might make you feel drowsy
• Do not drink grapefruit juice while you are being treated with Tenprolide 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 advise before taking this medicine.
• You should not take Tenprolide tablets during pregnancy unless this has been discussed with your doctor
• Tenprolide tablets should not be taken if you are breastfeeding.
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.
Driving and using machines
Do not drive or use any tools or machines until you know how Tenprolide tablets affects you. Tenprolide tablets can impair your mental alertness.
Tenprolide tablets contains lactose.
Tenprolide tablets contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Effect on urine drug screens
If you are having a urine drug screen, taking Tenprolide tablets 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.
^ How to take
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
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 150mg and 800mg. You should take your tablets once daily.
Method of administration
• Do not split, chew or crush the tablets
• Swallow your tablets whole with a drink of water
• 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 Tenprolide tablets. It can affect the way the medicine works
• Do not stop taking your tablets even if you feel better, unless your doctor tells you.
Elderly
If you are elderly, your doctor may change your dose.
Children and adolescents under 18 years of age
Tenprolide tablets should not be used by children and adolescent aged under 18 years.
Patients with impaired kidney function
The dose of Tenprolide tablets does not have to be reduced.
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Patients with impaired liver function
If you have liver problems, your doctor may change your dose.
If you take more Tenprolide tablets than you should
If you have accidentally taken too much Tenprolide tablets contact your doctor or nearest hospital straight away. Take the tablets, leaflet and/or carton with you so the doctor will know what you took.
If you take more Tenprolide tablets than prescribed by your doctor, the following symptoms may occur: drowsiness, sedation, rapid heart beat and low blood pressure.
If you forget to take Tenprolide tablets
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 Tenprolide tablets
Do not stop taking Tenprolide tablets unless advised by your doctor, as this may harm the success of treatment.
If you suddenly stop taking Tenprolide 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.
To avoid such symptoms, it is important to reduce the dose gradually according to your doctor's instructions.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
^ Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If any of the following occurs, stop taking Tenprolide tablets and contact a doctor or go to the nearest hospital straight away, as you may need urgent medical attention:
Uncommon (may affect up to 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 tongue, mouth and jaw, but also of arms, legs, fingers and toes, facial grimacing and rapid eye blinking. These might be symptoms of a condition called 'tardive dyskinesia.
Rare (may affect up to 1 in 1,000 people):
• A combination of high temperature (fever), sweating, stiff muscles, feeling very drowsy or faint, large increase in blood pressure and fast heartbeat (a disorder called 'neuroleptic malignant syndrome')
• Yellowing of the skin and eyes (jaundice)
• Inflammation of the liver (hepatitis)
• 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
• Inflammation of the pancreas (pancreatitis). Symptoms can include severe pain in the abdomen and back, nausea and vomiting.
• Slow heartbeat
• Stuffy nose (Rhinitis)
• Fainting (may lead to falls)
Rare (may affect up to 1 in 1,000 people):
• Swelling of breasts and unexpected production of breast milk (galactorrhoea)
• Menstrual disorder
• Metabolic syndrome (changes in your weight, blood glucose and certain fats in your blood that can increase the risk of heart problems and diabetes)
• Sleepwalking, sleep talking and sleep related eating disorder
• Lowering of body temperature.
• Increased levels of the enzyme creatine phosphokinase, decrease in certain types of white blood cells (agranulocytosis) as seen in blood tests.
• Intestinal obstruction (Ileus)
• Painful and/or prolonged erection of the penis.
Very rare (may affect up to 1 in 10,000 people):
• Inappropriate secretion of a hormone that controls urine volume
• Abnormal muscle breakdown (rhabdomyolysis) with symptoms such as muscle pain, weakness and swelling which can lead to kidney problems (urine can become dark).
Not known (frequency cannot be estimated from the available data):
• Decreased number of white blood cells in the blood (neutropenia).
• Drug withdrawal syndrome in new born
The class of medicines to which Tenprolide tablets belongs can cause heart rhythm problems, which can be serious and in severe cases may be fatal.
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 than in adults or have only been seen in children and adolescents:
Very common (affects more than 1 patient 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
• Vomiting
• Increase in blood pressure
Common (may affect up to 1 in 10 people):
• Feeling irritated.
• Fainting
• Stuffy nose
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 at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
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)
• Severe rash, blisters, or red patches on the skin (Stevens-Johnson syndrome).
Not known (frequency cannot be estimated from the
available data):
• Severe skin conditions called 'toxic epidermal necrolysis' (severe rash involving reddening, peeling and swelling of the skin that resembles severe burns) and 'erythema multiforme' (irregular red patches on the skin of the hands and arms).
Other possible side effects:
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 Tenprolide tablets) (may lead to falls)
• Discontinuation symptoms (symptoms which occur when you stop taking Tenprolide 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.
• Changes in the amount of certain fats (triglycerides and cholesterol) in the blood
• Decreased levels of a certain protein in red blood cells (haemoglobin).
• Abnormal muscle movements. These include difficulty starting muscle movements, shaking, feeling restless or muscle stiffness without pain.
Common (may affect up to 1 in 10 people):
• Rapid heartbeat.
• Feeling like your heart is pounding, racing or has skipped beats.
• Stuffy nose.
• Constipation, upset stomach (indigestion).
• Feeling weak, fainting (may lead to falls).
• Swelling of arms or legs.
• Low blood pressure when standing up. This may make you feel dizzy or faint (may lead to falls).
• Changes as seen in blood tests, such as increased levels of liver enzymes, decrease or increase in white blood cells (neutrophils or eosinophils, respectively), changes in the amount of thyroid hormones (total T4, free T4, total T3, TSH) and increase in blood sugar (glucose)
• 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 the elderly)
• Fever
• Increases in the amount of the hormone prolactin in the blood. In rare cases it could lead to swelling of breasts and unexpected breast milk production in both men and women. Also, it could cause absence of monthly period or irregular periods in women
Uncommon (may affect up to 1 in 100 people):
• Unpleasant sensations in the legs (also called restless legs syndrome)
• Difficulty swallowing
• Sexual dysfunction
• Difficulty in urinating
• Heart condition called 'QT-prolongation' which can affect your heart beat rhythm (measured with an electrocardiogram).
• Changes as seen in blood tests, such as increase in certain liver enzymes (ALT and gamma-GT), decreased number of red blood cells (anaemia) or platelets in the blood (thrombocytopenia), lower levels of sodium in the blood (hyponatraemia) or changes of the amount of thyroid hormones (free T3) and thyroid problems (hypothyroidism).
• Diabetes or worsening of pre-existing diabetes.
How to store
• 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 and blister after 'EXP'. The expiry date refers to the last day of that month
• Store below 25°C
• Do not take this medicine if you notice the tablets are broken or crumbled
• 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.
q Contents of the pack and other information
What Tenprolide tablets contains
• The active substance is quetiapine. Tenprolide XL Prolonged-release Tablets contains 50mg, 200mg, 300mg or 400mg of quetiapine (as quetiapine fumarate).
• The other ingredients are:
Tablet core: Lactose monohydrate, cellulose (microcrystalline), magnesium oxide, light, carrageenan lambda, povidone (K-30), magnesium stearate.
Tablet coating: Carrageenan lambda, titanium dioxide (E171), macrogol 400.
Ferric oxide yellow (E172) (50mg, 200mg and 300mg tablets), ferric oxide red (E172) (50mg tablets only). Printing ink: Opacode S-1-17823 black ink, containing shellac glaze, iron oxide black (E172), propylene glycol.
What Tenprolide tablets look like and contents of the pack
Tenprolide XL Prolonged-release Tablets are capsule shaped and biconvex.
50mg tablets are light pink to pink coloured, with dimensions of 12.4mm x 6.4mm and printed with '305' on one side with black ink.
200mg tablets are yellow coloured, with dimensions of 14.3mm x 7.2mm and printed with '243' on one side with black ink.
300mg tablets are pale yellow coloured, with dimensions of 17.9mm x 7.0mm and printed with '244' on one side with black ink.
400mg tablets are white to off-white coloured, with dimensions of 22.1mm x 8.9 mm and printed with '245' on one side with black ink.
Pack sizes:
60 tablets.
Marketing Authorisation Holder
Actavis Group PTC ehf.
Reykjavikurvegur 76-78 IS-220 Hafnarfjordur Iceland
Manufacturer
Balkanpharma-Dupnitsa AD 3, Samokovsko shosse Str.,
2600 Dupnitsa Bulgaria
This leaflet was last revised in August 2014
If you would like a leaflet with larger text, please contact 01271 311257.
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