EPISENTA 1000 MG PROLONGED-RELEASE GRANULES

Active substance: SODIUM VALPROATE

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Desitin Arzneimittel GmbH mm – Laetus-Code: –
Format: 190 x 594

500/1000 mg PL, 04/2014

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

Package leaflet: Information for the patient

Episenta® 500 mg prolonged-release granules
Episenta® 1000 mg prolonged-release granules
sodium valproate

(Referred to in this leaflet as Episenta)

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 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 effects not listed
I
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, agitated,
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enthusiastic or hyperactive. Mania occurs in an illness
called “bipolar disorder”. Episenta can be used when lithium cannot be used.
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2.  hat you need to know before you take
Episenta
Do not take Episenta:
• f you are allergic to sodium valproate or any of the other
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ingredients of this medicine (listed in section 6).
• f you, or a member of your family, have or have had severe
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problems with your liver and pancreas
• f your sister or brother has died from liver problems during
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sodium valproate treatment
• f you suffer from a disease called porphyria (a rare conditii
on that affects the breakdown of components of red blood
cells)
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• f you have a blood clotting disorder, i. e. abnormal 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 antiepileptics
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need to be given at the same time
• f it is given to children and adolescents with multiple hani
dicaps and severe form of epilepsy
• f you are pregnant, think you might be, or are planning to
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become pregnant
• f you are a woman of childbearing age. You should
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be informed of the risks and benefits of treatment with
Episenta in pregnancy
• f you are breast feeding
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• f you have damage to your bone marrow
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• f you have any metabolic disorders, particularly inherited
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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 may want
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to monitor the levels of sodium valproate in your blood and
change your dose as necessary
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• f the protein content in your blood is too low (hypoproteinaemia)
• f you have systemic lupus erythematosus (an allergic coni
dition which causes joint pain, skin rashes and fever)
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• f you notice that you gain weight, aprticularily at the 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 as a
a
recurrence or increase of the frequency of seizures
•  eneral feeling of illness, persistent signs of illness such as
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apathy and lethargy, physical weakness
• oss of appetite, aversion to foods normally eaten, aversion
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to the medication, nausea or repeated vomiting, unspecific
abdominal complaints,
•  welling of eyelids/legs (oedema)
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•  ellow colouring of the skin or white of the eyes (jaundice)
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•  onfusion, restlessness and abnormal movements
c
•  aematoma, bleeding
h
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, primidoo
ne, carbamazepine, phenobarbital, lamotrigine, felbamate,
ethosuximide
•  ntipsychotics – used to treat psychological disorders e. g.
a
olanzapine
•  ntidepressant – used to treat depression, including monoa
amine oxidase inhibitors
•  enzodiazepines – used as sleeping tablets and to treat
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anxiety
•  alicylates e. g. aspirin
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•  idovudine – used to treat HIV and AIDS
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•  imodipine – used to increase the circulation of blood in the
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brain
•  nticoagulation therapy – used to thin the blood e. g. wara
farin
• emozolomide – used to treat cancer
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Effects of other drugs on Episenta
•  ther antiepileptic medicines e.  g. phenytoin, primidone,
o
carbamazepine, phenobarbital, lamotrigine, felbamate
•  efloquine and chloroquine – used to prevent and treat
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malaria
•  ntibiotics e.g. erythromycin, imipenem, meropenem
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•  arbapenem agents (antibiotic used to treat bacterial infecc
tions). The combination of valproic acid and carbapenems
should be avoided because it may decrease the effect of
sodium valproate.
•  olestyramine – used to reduce the level of blood lipids
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(fats)
•  ifampicin – used to treat tuberculosis and other infections.
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•  imetidine – used to treat ulcers
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•  cetylsalicylic acid – used for the treatment of pain, fever or
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to thin the blood
Other medicines which require caution
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• f used in combination with topiramate (antiepileptic). 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 blood (if
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you use medicines containing the active substance codeine)
m
•  edicines which are potentially toxic for the liver, incl. alcohol, may increase the toxic effects Episenta exerts on the
liver
• f taken concomitantly with lithium, the concentrations of
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both drugs in your blood may be affected
• f taken in combination with clonazepam, absence status
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may occur in patients with a history of seizures involving
short periods of unresponsiveness (absence seizures)
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• 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 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 in 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 taking 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 child-bearing 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 500  mg contains 3 mmol (69.0 mg) sodium per
dose. Episenta 1000 mg contains 6 mmol (137.9 mg) sodium
per dose.
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 sachets 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) before, with
or after meals.
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.

Episenta 500-GB PROOF.indd 1

Confidential 04/2014

09.07.13 11:59

S-00-0007

Orfiril long 150/300/500/1000 mg

Desitin Arzneimittel GmbH mm – Laetus-Code: –
Format: 190 x 594

500/1000 mg PL, 04/2014

Method of administration
Episenta granules should be swallowed without chewing with
plenty of liquid, e. g. a full glass of water. Tear open the sachet
and sprinkle or stir the contents into soft food or a drink and
swallow immediately without chewing or crushing the granules. The food or drink should be cold or at room temperature.
Do not store a mixture of the granules with liquid or soft food
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 sachets 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 or 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.
Y
•  ou suddenly feel ill, particularly in the first 6  months of
treatment, which may include:
• epeated vomiting, stomach pain, nausea, dislike of usual
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food, loss of appetite
•  xtreme tiredness, drowsiness, weakness
e
j
• aundice (yellowing of the skin or white of the eyes)
•  welling of the feet, legs or eyelids, bruising, nosebleed
s
•  orsening of your epilepsy
w
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 the abdomen and back, nausea and vomiS
ting. You may have a serious, rare problem with your pancreas.
•  listering of the skin, mouth, eyes and genitals which may
B
be symptoms of servere skin reactions such as StevensJohnson 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 (thrombocytopenia)
d
•  eight gain (risk factor for polycystic ovary syndrome (state
w
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 to halt
lucinations and loss of consciousness
h
•  eadache
•  leeding (haemorrhage)
b
•  ausea, stomach ache or diarrhoea, especially when starn
ting the treatment
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• ncreased liver functional parameters
• emporary hair loss, which may be more curly on re-growt
th, hair fading
•  ainful menstrual periods (dysmenorrhoea)
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Uncommon side effects (may affect up to 1 in 100 people)
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•  welling of face, mouth, tongue or other body parts that
may cause breathing difficulties (angioedema)
•  yndrome with water retention in the blood and reduced
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urine output (SIADH)
• rritability
i
a
•  skin sensation, such as burning, prickling, itching, or
tingling, with no apparent physical cause (paresthesia)
•  hakiness (tremor), unsteadiness when walking (ataxia)
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•  uscle spasticity
• mmune disorders e. g. inflammation of the blood vessels
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(vasculitus, often with skin rash)
• luid around the lungs (eosinophilic pleural effusion)
f
• ncreased salivation
i
a
•  bsence of menstrual period (amenorrhoea)
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 reducr
tion in all types of blood cells (pancytopenia)
•  one marrow failure
b
• educed or stopped production of red blood cells (red cell
r
aplasia)
•  evere reduction in number of white blood cells (agranulos
cytosis) which makes infections more likely
•  disorder of the immune system causing joint pain, skin
a
rashes and fever (systemic lupus erythematosus)
•  yndrome consisting of drug rash, enlarged lymph nodes,
s
fever and possible involvement of other organs (DRESS
syndrome)
•  xcess levels of insulin in the blood (hyperinsulinaemia)
e
•  omiting and reduced levels of consciousness may indicate
v
changes in the amount of ammonia in the blood (hyperammonaemia)

1.3.2.EN-PL-UK page 2 of 2
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•  ondition with listlessness and/or reduced wakefulness
c
(lethargy), at times advancing to a state of physical immobility whilst conscious (stupor), sometimes with associated
hallucinations or convulsions
• ncreased alertness, and occasionally aggression, hyperaci
tivity and worsening behaviour
• oss of hearing (reversible or irreversible)
l
l
• iver dysfunction
•  kin reactions such as rashes or exanthema
s
•  idney problems (Fanconi’s syndrome, reversible after disk
continuation) which will be detected by testing your urine
•  tate leading to the formation of cysts of different sizes in
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the ovary (polycystic ovary syndrome, PCOS)
•  ale infertility
m
• ow body temperature (hypothermia)
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• ncrease in the blood level of male hormones
i
•  ecrease in the blood level of a certain protein (insulin-like
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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 (lymphoped
nia, neutropenia) due to impaired bone marrow function
• ow blood levels of sodium (hyponataemia)
l
•  rain disorder (encephalopathy)
b
•  tate of unconsciousness lacking any reaction when spos
ken to and often also to pain stimulation (coma)
• eversible extrapyramidal symptoms, e. g. parkinsonism, or
r
reversible dementia associated with reversible shrinkage of
the brain (cerebral atrophy)
• nflammation of the pancreas (pancreatitis), sometimes with
i
fatal outcome
•  xcessive growth of hair on the face and body in female
e
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 (enuresis)
b
b
•  reast enlargement in men (gynecomastia)
Side effects with a frequency that is not known (frequency
cannot be estimated from the available data)
•  lood coagulation disorder (reduced platelet aggregation,
b
reduced amount of blood clotting proteins (fibrinogen)),
prolonged bleeding time
•  llergic reactions (ranging from rash to hypersensitivity
a
reaction)
•  ee your doctor if you develop bruising or bleeding
s
•  llergic reactions
a
w
•  orsening of seizures
r
•  inging in the ears (tinnitus)
•  evere liver damage, including hepatic failure, sometimes
s
with fatal outcome
•  xcessive growth of hair (hypertrichosis)
e
•  here have been reports of bone disorders including
T
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.
k
•  idney failure, inflammation of the kidney tissue (interstitial
nephritis), worsening of kidney function
•  hange in women’s periods (e. g. irregular periods)
c
•  bnormal sperm production (with reduced number and/or
a
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 or 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 the sachets 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 sachet 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
•  he active substance is sodium valproate.
T
E
•  pisenta 500 mg granules: Each sachet contains 500 mg
sodium valproate (equivalent to 435 mg valproic acid).
•  pisenta 1000 mg granules: Each sachet contains 1000 mg
E
sodium valproate (equivalent to 870 mg valproic acid).
•  he other ingredients are calcium stearate, colloidal anhyT
drous silicon dioxide (methylated), ammonio methacrylate
copolymer type B, sorbic acid, sodium hydroxide, ethyl
cellulose, dibutyl sebacate and oleic acid.
What Episenta looks like and contents of the pack
Episenta prolonged-release granules are white to off-white
granules packed in sachets. The sachets are available in
packs of 50, 100 and 200 for both the 500  mg and the
1000 mg strengths. 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

07/13 Episenta5-1-GB

Episenta 500-GB PROOF.indd 2

Confidential 04/2014

09.07.13 11:59

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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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