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TENPROLIDE XL 300MG PROLONGED-RELEASE TABLETS

Active substance(s): QUETIAPINE

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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 Prolongedrelease Tablets but within the leaflet it will be
referred to as Tenprolide tablets.

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.

What is in this leaflet:
1 What Tenprolide tablets are and what they
are used for
2 W
 hat you need to know before you take
3 H
 ow to take
4 P
 ossible side effects
5 H
 ow to store
6 C
 ontents of the pack and other
information

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

1 W
 hat Tenprolide tablets are and what they
are used for

Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines.

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.

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).

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.

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.

• 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.

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.

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.

2 W
 hat you need to know before you take
Do not take Tenprolide tablets if you are:

Pregnancy and breast-feeding

• 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.

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.

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.

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.

3 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.

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.

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.

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.

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.

Continued top of next column

Continued over page

AAAG3407

Quetiapine SR (Tenprolide XL) 50mg, 200mg, 300mg & 400mg prolonged-release tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:
approved for print/date

AAAG3407
3
16.12.13

originated by:

DR

revision date:

08.09.14

revised by:
supplier:

DR
Torrent Pharma

dimensions:

160 x 450

3.

pharmacode:
min pt size:

2.
4.

7.5pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

16.12.13

technically app. date:

20.12.13

1.
2.
3.

Patients with impaired liver function
If you have liver problems, your doctor may change your
dose.

• Slow heartbeat
• Stuffy nose (Rhinitis)
• Fainting (may lead to falls)

If you take more Tenprolide tablets than you
should

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.

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.

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).

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.

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

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

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.

4 Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

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:

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’.

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

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.

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 (StevensJohnson syndrome).

5 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.

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).

6 C
 ontents of the pack and other
information

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.

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

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

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.

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.

This leaflet was last revised in August 2014

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

If you would like a
leaflet with larger
text, please contact
01271 311257.

Actavis, Barnstaple, EX32 8NS, UK

Continued top of next column
AAAG3407

Quetiapine SR (Tenprolide XL) 50mg, 200mg, 300mg & 400mg prolonged-release tablets PIL - UK

colours/plates:
1. Black

item no:
print proof no:
origination date:
approved for print/date

AAAG3407
3
16.12.13

originated by:

DR

revision date:

08.09.14

revised by:
supplier:

DR
Torrent Pharma

dimensions:

160 x 450

3.

pharmacode:
min pt size:

2.
4.

7.5pt

5.
6.
Non Printing Colours

Technical Approval
date sent:

16.12.13

technically app. date:

20.12.13

1.
2.
3.

Expand view ⇕

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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