EPISENTA 300 MG PROLONGED-RELEASE CAPSULE

Active substance: SODIUM VALPROATE

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Desitin Arzneimittel GmbH mm – Laetus-Code: –
150/300 mg PL, 04/2014
Format: 145 x 594

1.3.2.EN-PL-UK page 1 of 2
PROOF

Package leaflet: Information for the patient

Episenta® 150 mg prolonged-release capsule
Episenta® 300 mg prolonged-release capsule
sodium valproate
(Referred to in this leaflet as Episenta)

Read all of this leaflet carefully before you start to 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 or nurse.
T
•  his 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.
• f you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side
I
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Episenta is and what it is used for
2. What you need to know before you take Episenta
3. How to take Episenta
4. Possible side effects
5. How to store Episenta
6. Contents of the pack and other information
1. What Episenta is and what it is used for
Episenta contains the active substance sodium valproate, which belongs to a group of medicines called
antiepileptics which are used to control epileptic
seizures and mania.
Episenta is used in the treatment of
•  arious types of epilepsy (seizures)
v
•  ania, where you may feel very excited, elated,
m
agitated, enthusiastic or hyperactive. Mania occurs
in an illness called „bipolar disorder“. Episenta can
be used when lithium cannot be used.
2.  hat you need to know before you take
W
Episenta
Do not take Episenta:
• f you are allergic to sodium valproate or any of
i
the other ingredients of this medicine (listed in
section 6).
• f you, or a member of your family, have or have had
i
severe problems with your liver and pancreas
• f your sister or brother has died from liver problems
i
during sodium valproate treatment
• f you suffer from a disease called porphyria (a rare
i
condition that affects the breakdown of components of red blood cells)
• f you have a blood clotting disorder, i. e. abnormal
i
bleeding or tendency to bruise more easily or a
reduced number of blood platelets (thrombocytopaenia)
Warnings and precautions
Talk to your doctor before taking Episenta
• f it is given to toddlers, especially if several antiei
pileptics need to be given at the same time
• f it is given to children and adolescents with muli
tiple handicaps and severe form of epilepsy
• f you are pregnant, think you might be, or are
i
planning to become pregnant
• f you are a woman of childbearing age. You should
i
be informed of the risks and benefits of treatment
with Episenta in pregnancy
• f you are breast feeding
i
• f you have damage to your bone barrow
i
• f you have any metabolic disorders, particularly
i
inherited enzyme deficiency disorders such as urea
cycle disorder, because of a risk of an increased
ammonia level in your blood
• f you have reduced kidney function. Your doctor
i
may want to monitor the levels of sodium valproate
in your blood and change your dose as necessary
• f the protein content in your blood is too low (hypoi
proteinaemia)
• f you have systemic lupus erythematosus (an alli
ergic condition which causes joint pain, skin rashes
and fever)
• f you notice that you gain weight, particularly at the
i
beginning of the treatment, because of excessive
appetite (see „Possible side effects“). You should
monitor your weight and limit a possible weight
gain to a minimum
Please consult your doctor, even if you have suffered
from any of the conditions at any time in the past.
A small number of people being treated with antiepileptics such as sodium valproate have had thoughts
of harming or killing themselves. If at any time you
have these thoughts, immediately contact your doctor.
Sodium valproate treatment must be discontinued
immediately if severe liver dysfunction or pancreatic
damage is suspected.
Special attention must be paid to the following signs
of liver damage:
Contact your doctor immediately, if you experience
•  reduction in the antiepileptic effect, expressed
a
as a recurrence or increase of the frequency of
seizures
•  eneral feeling of illness, persistent signs of illness
g
such as apathy and lethargy, physical weakness
• oss of appetite, aversion to foods normally eaten,
l
aversion to the medication, nausea or repeated
vomiting, unspecific abdominal complaints,
•  welling of eyelids/legs (oedema)
s
•  ellow colouring of the skin or white of the eyes
y
(jaundice)
•  onfusion, restlessness and abnormal movements
c
h
•  aematoma, bleeding
This is especially true in children during the first
months of treatment.
In very rare cases, similar symptoms have been
observed caused by damage to the pancreas.
During using the product, at the beginning of the
treatment and also following that, regular laboratory
tests for the control of blood count including platelets,
liver and pancreas function should be done.
Episenta may give false positive urine tests (for ketosis) in patients with diabetes.
Episenta may lead to increased ammonia levels in the
blood (see also section  4 „Possible side effects“). If
you have symptoms like absence of interest to emotional, social or physical life, somnolence, vomiting,
low blood pressure or worsening of epilepsy, contact
your doctor.
As with other anti-epileptic drugs, some patients may
experience worsening of seizures with Episenta.
Children and adolescents
Children and adolescents under 18  years of age:
Episenta should not be used in children and adolescents under 18  years of age for the treatment of
mania.
Other medicines and Episenta
Tell your doctor or pharmacist or nurse if you are
taking, have recently taken or might take any other
medicines.
Effects of Episenta on other medicines
•  ther antiepileptic medicines e. g. phenytoin, primio
done, carbamazepine, phenobarbital, lamotrigine,
felbamate, ethosuximide
•  ntipsychotics – used to treat psychological disora
ders e. g. olanzapine
•  ntidepressant – used to treat depression, inclua
ding monoamine oxidase inhibitors
•  enzodiazepines – used as sleeping tablets and to
b
treat anxiety
•  alicylates e. g. aspirin
s
•  idovudine – used to treat HIV and AIDS
z
•  imodipine – used to increase the circulation of
n
blood in the brain
•  nticoagulation therapy – used to thin the blood
a
e. g. warfarin
• emozolomide – used to treat cancer
t
Effects of other drugs on Episenta
•  ther antiepileptic medicines e. g. phenytoin, primio
done, carbamazepine, phenobarbital, lamotrigine,
felbamate

•  efloquine and chloroquine – used to prevent and
m
treat malaria
a
•  ntibiotics e.g. erythromycin, imipenem, meropenem
•  arbapenem agents (antibiotic used to treat bactec
rial infections). The combination of valproic acid and
carbapenems should be avoided because it may
decrease the effect of sodium valproate.
c
•  olestyramine – used to reduce the level of blood
lipids (fats)
•  ifampicin – used to treat tuberculosis and other
r
infections.
•  imetidine – used to treat ulcers
c
a
•  cetylsalicylic acid – used for the treatment of pain,
fever or to thin the blood
Other medicines which require caution
• f used in combination with topiramate (antiepii
leptic). In some cases increased concentration of
ammonia with and without brain damage (encephalopathy) has been observed.
•  pisenta may affect the levels of codeine in your
E
blood (if you use medicines containing the active
substance codeine)
•  edicines which are potentially toxic for the liver,
m
incl. alcohol, may increase the toxic effects Episenta
exerts on the liver
• f taken concomitantly with lithium, the concentratiI
ons of both drugs in your blood may be affected
• f taken in combination with clonazepam, absence
I
status may occur in patients with a history of seizures involving short periods of unresponsiveness
(absence seizures)
I
• n combination treatment with sertraline (for treatment of depression) and risperidone (for treatment
of psychosis), inability to move accompanied by
abnormal behaviour and stupor occurred in a patient with mental disorder
The effect of the oral contraceptive pill is not reduced
by Episenta.
It may still be possible for you to take Episenta; your
doctor will advise you on what is suitable for you.
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.
If you are a woman of child-bearing age, you have to
use effective contraception during treatment.
Your doctor should discuss with you the problems that
may arise if Episenta is used in pregnancy because of
the potential risk to the foetus.
Women who are receiving treatment for epilepsy are 2
to 3 times more likely to have babies with deformities
than in the general population. The deformities most
frequently seen are cleft palate and heart or blood
vessel defects. Developmental delay has also been
reported in children born to mothers with epilepsy.
Women who take sodium valproate during the first
months of pregnancy to control their epilepsy have
a small risk (1 to 2  %) of having a baby with spina
bifida, an abnormality of the spinal cord. Taking folic
acid 5  mg daily as soon as you stop contraception
may lower the risk of having a baby with spina bifida.
There is also an increased risk of other skeletal deformities in your baby (facial dysmorphia – also in conjunction with mental retardation, finger, toe and nail
anomalies, limb malformations) and other congenital
abnormalities such as a male birth defect of the urethra that involves an abnormally placed urinary orifice
(hypospadia) as well as various anomalies affecting a
wide range of organ systems. A birth defect of one of
the two bones in the lower arm (bilateral aplasia of
the radius) appears to be a rare but specific effect of
valproic acid.
These can usually be detected in the first part of
pregnancy by the routine antenatal screening tests.
The concentration of valproic acid in your blood should
be checked in regular intervals as it changes considerably during pregnancy even if you take a constant
dose.
Some babies may develop less quickly than normal
and rarely, some may have blood clotting problems
if the mother has taken sodium valproate during
pregnancy.
Autism spectrum disorders have been reported in
children whose mothers used sodium valproate during
pregnancy.
If treatment with Episenta is considered necessary,
the lowest effective dose will be used, which may be
given as several small doses during the day. During
pregnancy, specialised prenatal monitoring should be
given to detect any deformities.
It is important, however, not to stop Episenta suddenly
as this may result in seizures, which may harm you or
your unborn baby.
Manic episodes in bipolar episodes
You should not take this medicine if you are pregnant
or a woman of child-bearing age unless explicitly
advised by your doctor. If you are a woman of childbearing age, you have to use effective contraception
during treatment.
Breast-feeding
Sodium valproate, the active substance of Episenta,
enters the mother’s breast milk. To date no clinical
symptoms have occurred in children, who have been
watched during the breast-feeding period. In any case
talk to your doctor about possible risks, before you
start breast-feeding.
Fertility
Abnormal sperm production with reduced number
and/or activity of sperm as well as male infertility have
been reported with the use of valproate.
Driving and using machines
You may experience drowsiness when you first start
taking Episenta, or if you are taking it with other
medicines, such as other antiepileptic drugs or
benzodiazepines. If affected you should not drive or
operate machinery.
Important information about some of the ingredients of Episenta
Episenta 300 mg contains 1.8 mmol (41.4 mg) sodium per capsule.
Take this into consideration if you are on a controlled
sodium diet.
3. How to take Episenta
Always take this medicine exactly as your doctor has
told you. Check with your doctor or pharmacist if you
are not sure.
Dosage
Epilepsy
Your doctor will decide the number of capsules you
should take. This will depend on your age and weight
and will be adjusted to achieve adequate control of
your seizures.
The daily dosage may be taken as one single or two
divided doses (half in the morning and half in the
evening).

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Desitin Arzneimittel GmbH mm – Laetus-Code 620
150/300 mg PL, 04/2014
Format: 145 x 594

Adults including the elderly
The recommended starting dose is 600  mg daily
increasing by 150 – 300  mg every three days until
the seizures are controlled.
This dose is usually within the range of 1,000 mg to
2,000 mg daily, but can be increased to a maximum
of 2,500 mg daily if necessary. Your doctor may alter
your dose if you are taking other antiepileptic drugs,
have poor kidney function, a reduced amount of protein in your blood or you are an elderly patient.
Children and adolescents
The dose for children will depend on their weight:
For children over 20  kg the recommended starting
dose is 300 mg daily. This can be increased up to a
maximum of 35 mg for each kg of bodyweight daily to
control the seizures.
For children under 20 kg the usual dose is 20 mg for
each kg of bodyweight which can be increased up to
a maximum of 40 mg for each kg of bodyweight daily.
Mania
The daily dosage should be established and controlled
individually by your doctor. Initial dose: The recommended initial daily dose is 750 mg. Mean daily dose:
The recommended daily doses usually range between
1,000 and 2,000 mg.
Method of administration
The capsules should be swallowed whole without
chewing with plenty of liquid, e. g. a full glass of water.
If you have difficulty in swallowing, the contents of the
capsule may be sprinkled or stirred into soft food or
drinks and swallowed immediately without chewing
or crushing the granules. The food or drink should be
cold or at room temperature. A mixture of the granules
with liquid or soft food should not be stored for future
use. If the granules are taken in a drink, some may
stick to the glass after the drink has been finished,
you should rinse the glass with a small amount of
water and drink this as well. The granules should not
be given in babies’ bottles as they can block the teat.
If you take more Episenta than you should
If you take more Episenta than you should or if someone else accidentally takes your medicine contact your
nearest casualty department or tell your doctor or
pharmacist immediately. Remember to take the pack,
this leaflet and any remaining capsules with you.
Symptoms of overdose can be:
Nausea, vomiting, dizziness, sedation or even coma,
muscle weakness, reduced reflexes, contracted
pupils (miosis), low blood pressure (hypotension),
confusion and impaired respiratory or heart function.
Furthermore, in both, adults and children, high dosages caused abnormal neurological disturbances, such
as increased tendency to seizures and behavioural
changes.
If you forget to take Episenta
Take it as soon as you remember. If your next dose is
due within 2 hours, take a single dose now and do not
take the next dose. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Episenta
Do not stop taking Episenta without consulting your
doctor. If you stop, your seizures may return. You
should continue to
take Episenta for as long as your doctor tells you to.
If you have any further questions on the use of this
medicine, ask your doctor, pharmacist or nurse.
4. Possible side effects
Like all medicines this medicine can cause side
effects, although not everybody gets them.
Tell your doctor IMMEDIATELY if you notice any
of the following serious side effects. You may
require urgent medical attention.
•  ou suddenly feel ill, particularly in the first
Y
6 months of treatment, which may include:
•  epeated vomiting, stomach pain, nausea, dislike of
r
usual food, loss of appetite
e
•  xtreme tiredness, drowsiness, weakness
• aundice (yellowing of the skin or white of the eyes)
j
•  welling of the feet, legs or eyelids, bruising, noses
bleed
w
•  orsening of your epilepsy
These symptoms may indicate a serious effect on your
liver. Your blood may be taken before or during treatment to check for any effects on the liver, particularly
in very young children and those at risk.
•  evere pain in abdomen and back, nausea and
S
vomiting. You may have a serious, rare problem
with your pancreas.
•  listering of the skin, mouth, eyes and genitals
B
which may be symptoms of servere skin reactions
such as Stevens-Johnson syndrome (SJS), toxic
epidermal necrolysis (TEN) or erythema multiforme
Common side effects (may affect up to 1 in 10 people)
•  ecreased number of blood platelets (thrombocytod
penia)
•  eight gain (risk factor for polycystic ovary synw
drome (state leading to the formation of cysts of
different sizes in the ovaries)) as your appetite may
be increased
•  eight loss, decreased appetite
w
• iredness and confusion which may rarely progress
t
to hallucinations and loss of consciousness
•  eadache
h
•  leeding (haemorrhage)
b
•  ausea, stomach ache or diarrhoea, especially
n
when starting the treatment
• ncreased liver functional parameters
i
• emporary hair loss, which may be more curly on
t
re-growth, hair fading
•  ainful menstrual periods (dysmenorrhoea)
p
Uncommon side effects (may affect up to 1 in 100
people)
•  welling of face, mouth, tongue or other body parts
s
that may cause breathing difficulties (angioedema)
•  yndrome with water retention in the blood and
s
reduced urine output (SIADH)
• rritability
i
•  skin sensation, such as burning, prickling, itching,
a
or tingling, with no apparent physical cause (paresthesia)
•  hakiness (tremor), unsteadiness when walking
s
(ataxia)
•  uscle spasticity
m
• mmune disorders e.  g. inflammation of the blood
i
vessels (vasculitus, often with skin rash)
• luid around the lungs (eosinophilic pleural effusion)
f
• ncreased salivation
i
•  bsence of menstrual period (amenorrhoea)
a
Rare side effects (may affect up to 1 in 1,000 people)
•  educed number of red blood cells (anaemia)
r
•  educed number of white blood cells (leukopenia) or
r
reduction in all types of blood cells (pancytopenia)
•  one marrow failure
b
•  educed or stopped production of red blood cells
r
(red cell aplasia)
•  evere reduction in number of white blood cells
s
(agranulocytosis) which makes infections more
likely

1.3.2.EN-PL-UK page 2 of 2
PROOF

•  disorder of the immune system causing joint pain,
a
skin rashes and fever (systemic lupus erythematosus)
s
•  yndrome consisting of drug rash, enlarged lymph
nodes, fever and possible involvement of other
organs (DRESS syndrome)
•  xcess levels of insulin in the blood (hyperinsulie
naemia)
•  omiting and reduced levels of consciousness may
v
indicate changes in the amount of ammonia in the
blood (hyperammonaemia)
•  ondition with listlessness and/or reduced wakec
fulness (lethargy), at times advancing to a state
of physical immobility whilst conscious (stupor),
sometimes with associated hallucinations or convulsions
• ncreased alertness, and occasionally aggression,
i
hyperactivity and worsening behaviour
• oss of hearing (reversible or irreversible)
l
• iver dysfunction
l
•  kin reactions such as rashes or exanthema
s
•  idney problems (Fanconi’s syndrome, reversible
k
after discontinuation) which will be detected by
testing your urine
•  tate leading to the formation of cysts of different
s
sizes in the ovary (polycystic ovary syndrome,
PCOS)
•  ale infertility
m
• ow body temperature (hypothermia)
l
• ncrease in the blood level of male hormones
i
•  ecrease in the blood level of a certain protein
d
(insulin-like growth factor binding protein)
r
•  educed level of blood clotting proteins (coagulation
factors)
Very rare side effects (may affect up to 1 in 10,000
people)
•  ecreased number of certain white blood cells
d
(lymphopenia, neutropenia) due to impaired bone
marrow function
• ow blood levels of sodium (hyponataemia)
l
•  rain disorder (encephalopathy)
b
s
•  tate of unconsciousness lacking any reaction
when spoken to and often also to pain stimulation
(coma)
•  eversible extrapyramidal symptoms, e.  g. parkinr
sonism, or reversible dementia associated with
reversible shrinkage of the brain (cerebral atrophy)
i
• nflammation of the pancreas (pancreatitis), sometimes with fatal outcome
•  xcessive growth of hair on the face and body in
e
female persons (hirsutism), which might be a result
of polycystic disease of the ovary, a state leading to
the formation of cysts of different sizes in the ovary)
•  kin reactions such as acne
s
•  edwetting or an increased need to pass urine
b
(enuresis)
•  reast enlargement in men (gynecomastia)
b
Side effects with a frequency that is not known (frequency cannot be estimated from the available data)
b
•  lood coagulation disorder (reduced platelet aggregation, reduced amount of blood clotting proteins
(fibrinogen)), prolonged bleeding time
a
•  llergic reactions (ranging from rash to hypersensitivity reaction)
•  ee your doctor if you develop bruising or bleeding
s
•  llergic reactions
a
•  orsening of seizures
w
•  inging in the ears (tinnitus)
r
•  evere liver damage, including hepatic failure,
s
sometimes with fatal outcome
•  xcessive growth of hair (hypertrichosis)
e
•  here have been reports of bone disorders incluT
ding osteopenia and osteoporosis (thinning of the
bone) and fractures. Check with your doctor or
pharmacist if you are on long-term antiepileptic
medication, have a history of osteoporosis, or take
steroids.
•  idney failure, inflammation of the kidney tissue
k
(interstitial nephritis), worsening of kidney function
•  hange in women’s periods (e. g. irregular periods)
c
a
•  bnormal sperm production (with reduced number
and/or activity of sperm)
•  bnormal thyroid function test
a
Many of these effects will normally reverse when you
stop taking Episenta.
You may notice the remains of the white shells of the
granules in your stools (faeces). This is normal and
the active part of the medicine will already have been
released from the granule.
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 national reporting system (see
details below). By reporting side effects you can help
provide more information on safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
5. How to store Episenta
Keep this medicine out of the sight and reach of
children.
Store in the original package.
Store below 30 °C.
Keep the container tightly closed.
Do not use this medicine after the expiry date which
is stated on the container label and carton after Expiry
date:. The expiry date refers to the last day of that
month.
6. Contents of the pack and other information
What Episenta contains
The active substance is sodium valproate.
E
•  pisenta 150 mg: Each capsule contains 150 mg
sodium valproate (equivalent to 130 mg valproic
acid)
•  pisenta 300 mg: Each capsule contains 300 mg
E
sodium valproate (equivalent to 260 mg valproic
acid)
•  he other ingredients are calcium stearate, colloidal
T
anhydrous silicon dioxide (methylated), ammonio
methacrylate copolymer type B, sorbic acid, sodium
hydroxide, ethyl cellulose, dibutyl sebacate, oleic
acid, gelatin, sodium lauryl sulfate, indigo carmine
(E  132) and (for 300  mg capsules only) quinoline
yellow (E 104).
What Episenta looks like and contents of the
pack
Episenta 150 mg capsules are blue/transparent hard
gelatine capsules containing white granules.
Episenta 300 mg capsules are green/transparent hard
gelatine capsules containing white granules.
Each pack contains 50, 100 or 200 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Desitin Arzneimittel GmbH
Weg beim Jäger 214
22335 Hamburg
Germany
e-mail: medinfo@desitin.co.uk
This leaflet was last revised in June 2013

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Orfiril long 150/300/500/1000 mg

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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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