Sodium valproate Seacross

Package leaflet: Information for the user

Sodio Valproato Seacross 100 mg/ml solution for injection/infusion

sodium valproate
This medicinal product is subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
WARNING
Sodium valproate taken during pregnancy can seriously harm the unborn baby. If you are a woman of childbearing age, you must use an effective method of birth control (contraception) continuously throughout your treatment with sodium valproate. Your doctor will discuss this with you, but you should also follow the recommendations in section 2 of this leaflet.
If you are planning a pregnancy or think you might be pregnant, contact your doctor urgently.
Do not stop taking sodium valproate unless your doctor tells you to, as your condition may worsen.
Please read all of this leaflet carefully before taking this medicine because it contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful to them.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of this leaflet:

1. What Sodio Valproato Seacross is and what it is used for
2. What you need to know before taking Sodio Valproato Seacross
3. How to take Sodio Valproato Seacross
4. Possible side effects
5. How to store Sodio Valproato Seacross
6. Contents of the pack and other information

1. What Sodio Valproato Seacross is and what it is used for

What Sodio Valproato Seacross is
The name of the medicine is Sodio Valproato Seacross 100 mg/ml solution for injection/infusion (called
Sodio Valproato Seacross in this patient leaflet).
What Sodio Valproato Seacross contains
Sodio Valproato Seacross contains the active substance sodium valproate. This belongs to a group of
medicines called anticonvulsants or antiepileptic agents. It works by helping to calm the brain.
What Sodio Valproato Seacross is used for
Sodio Valproato Seacross is used to treat:

• seizures affecting the whole body (generalized seizures) (absences, myoclonic seizures and tonic-clonic seizures),
• seizures affecting one part of the body (focal seizures) which may also spread to involve the whole body (secondary generalized seizures).

2. What you need to know before taking Sodio Valproato Seacross

Do not take Sodio Valproato Seacross:
if you are pregnant, unless nothing else is effective.
if you are a woman of childbearing potential, unless you are using an effective method of birth control
(contraception) throughout the entire duration of treatment with Sodio Valproato Seacross. Speak to your
doctor before stopping Sodio Valproato Seacross or your contraceptive. Your doctor will provide you with
further advice (see below “Pregnancy, breastfeeding and fertility – Important warning for women”).
if you are allergic (hypersensitive) to sodium valproate or to any of the other components of Sodio
Valproato Seacross (listed in section 6: Further information). Signs of an allergic reaction include: skin
rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
if you have liver problems or if you or your family members have a history of liver problems.
if you suffer from a rare disease called Porphyria.
if you suffer from genetic disorders causing disease in specific cellular organelles called mitochondria
(e.g., Alpers-Huttenlocher syndrome).
if you suffer from a known metabolic disorder, for example, a urea cycle disorder.
if you have untreated carnitine deficiency (a very rare metabolic disease).
if you are taking concomitantly:

• St. John’s Wort (a plant used to treat depression).

Do not take this medicine if you are in any of the situations described above. If you are unsure, discuss this
with your doctor or pharmacist before taking Sodio Valproato Seacross.
Warnings and precautions
Take special care with Sodio Valproato Seacross
Contact your doctor immediately:
if you think about harming or killing yourself. A small number of people being treated with
antiepileptic medicines, such as sodium valproate, have had thoughts of self-harm or suicide. If you
experience such thoughts at any time, please contact your doctor immediately.
if you or your child develop a sudden illness, especially if it occurs within the first six months of
treatment and particularly if it includes repeated vomiting, extreme tiredness, abdominal pain,
drowsiness, weakness, loss of appetite, upper stomach pain, nausea, jaundice (yellowing of the skin or
whites of the eyes), leg swelling, worsening of epilepsy, or a general feeling of being unwell. Sodio
Valproato Seacross may affect the liver and pancreas (see section 4).
if this medicine is taken by a child under 3 years of age who is also taking acetylsalicylic acid (aspirin). Do
not take sodium valproate together with acetylsalicylic acid (aspirin).
if you experience worsening of symptoms (more frequent or more severe seizures) while taking this
medicine.
The risk of liver damage increases when valproate is taken by children under 3 years of age, by people
taking other antiepileptic medicines concomitantly, or by those with other neurological or metabolic
diseases and severe forms of epilepsy.
If you or your child develop problems with balance and coordination, feel lethargic or less alert, or
vomit, contact your doctor immediately. This may be due to increased levels of ammonia in the blood.
Talk to your doctor or pharmacist before taking sodium valproate if:
you suffer from diabetes. This medicine may affect urine test results.
you have kidney problems. Your doctor should prescribe a lower dose.
you suffer from epileptic seizures, a brain disease, or a metabolic condition affecting the brain. Adding
sodium valproate may increase the risk of liver damage.
you are taking other antiepileptic medicines concomitantly. Adding sodium valproate may increase
the risk of liver damage.
you suspect you have metabolic disorders, particularly inherited enzyme deficiencies such as “urea
cycle disorders.” Adding sodium valproate may increase the risk of elevated ammonia levels in the
blood.
you are affected by a disease called “systemic lupus erythematosus” (SLE), an immune system disease
affecting the skin, bones, joints and internal organs.
you have an underlying condition called “carnitine palmitoyltransferase type II deficiency (CPT-II)”
which may increase the risk of muscle damage.
you or your doctor suspect a genetic disorder causing mitochondrial disease in your family. Adding
sodium valproate may increase the risk of liver damage.
this medicine is taken by a child under 3 years of age. The risk of liver damage is higher in this age group.
your dietary intake of carnitine, found in meat and dairy products, is insufficient, especially in children
under 10 years of age.
you have carnitine deficiency and are taking carnitine supplements.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking
Sodio Valproato Seacross.
Other medicines and Sodio Valproato Seacross
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines,
including those without a prescription, herbal medicines. Some other medicines may affect the effects of
valproate or vice versa. These include:
Some medicines used for pain and inflammation (salicylates), such as aspirin – see “Take special care
with Sodio Valproato Seacross”.
Some other medicines used to treat seizures (epilepsy) – see section 3, “Patients taking other medicines
for ‘seizures’”. These include medicines such as phenobarbital, primidone, phenytoin, carbamazepine,
topiramate, acetazolamide, lamotrigine, rufinamide, felbamate or zonisamide.
Medicines containing quetiapine, used to treat schizophrenia.
Medicines used to thin the blood (such as warfarin).
Zidovudine – used for HIV infection.
Medicines for depression.
Monoamine oxidase inhibitors (MAOIs) such as moclobemide, selegiline, linezolid.
Medicines used to calm emotional and mental states, such as diazepam and olanzapine.
Propofol, an anaesthetic.
Nimodipine.
Some medicines used for prevention and treatment of malaria, such as mefloquine and chloroquine.
Cimetidine – used for gastric ulcers.
Colestipol – used to lower blood fat levels (cholesterol).
Some antibiotics used for infections, such as aztreonam, rifampicin and erythromycin.
Lopinavir and ritonavir – used for HIV treatment.
Carbapenem agents (antibiotics used to treat bacterial infections).
Products containing estrogens (including some contraceptive pills).
Metamizole – used to treat pain and fever.
Cannabidiol (used to treat epilepsy and other conditions).
Methotrexate (used to treat cancer and inflammatory diseases).
Some antimicrobials containing pivalate (e.g., pivampicillin, adefovir dipivoxil).
Ethosuximide.
Bupropion.
Sodio Valproato Seacross and alcohol
Alcohol consumption is not recommended during treatment.
Weight gain
Taking Sodio Valproato Seacross may cause weight gain. Discuss this with your doctor and how it may
affect you.
Blood tests
Your doctor may want to perform blood tests before starting Sodio Valproato Seacross and during treatment.
Blood tests may be required before surgery or if you experience unexplained bruising or bleeding.
Pregnancy, breastfeeding and fertility
Important warning for women
Ask your doctor or pharmacist before stopping Sodio Valproato Seacross or stopping contraception. Your
doctor will provide further advice.
Epilepsy
If you are pregnant, you must not use Sodio Valproato Seacross for epilepsy unless nothing else is effective
for you.
For epilepsy, if you are a woman of childbearing potential, you must not take Sodio Valproato Seacross unless
you are using an effective method of birth control (contraception) throughout the entire treatment with Sodio
Valproato Seacross. Speak to your doctor before stopping Sodio Valproato Seacross or your contraceptive.
Your doctor will provide further advice.
Risks of taking valproate during pregnancy (regardless of the condition for which it is used)
Speak immediately with your doctor if you are planning a pregnancy or are pregnant.
Valproate poses a risk when taken during pregnancy. The higher the dose, the greater the risk, but all doses
carry some risk, even when valproate is used in combination with other medicines for epilepsy.
It may cause serious birth defects and may affect the child’s physical and mental development after birth.
Reported birth defects include: spina bifida (in which the bones of the spine do not develop properly); facial
and cranial malformations; heart, kidney, urinary tract and genital organ malformations; limb defects and
multiple malformations affecting various organs and body parts. Birth defects may result in severe disability.
Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.
Ocular malformations have been reported in children exposed to valproate during pregnancy, often in
association with other congenital malformations. These ocular malformations may affect vision.
If you take valproate during pregnancy, you have a higher risk than other women of having a child with birth
defects requiring medical treatment. Because valproate has been used for many years, we know that about 11
out of 100 babies born to women taking it have birth defects. This compares with 2–3 out of 100 babies born to
women who do not have epilepsy.
It is estimated that up to 30–40% of preschool-aged children whose mothers took valproate during
pregnancy may have developmental problems in early childhood. These children may be delayed in walking
and talking, may be intellectually disadvantaged compared to other children, and may have language and
memory difficulties.
Autism spectrum disorders are more frequently diagnosed in children exposed to valproate in utero, and
there is some evidence that these children have an increased risk of developing Attention Deficit Hyperactivity
Disorder (ADHD).
Before prescribing this medicine, your doctor will explain what could happen to your baby if you become
pregnant while taking valproate. If later you decide you want to have a child, do not stop taking the medicine
or your contraceptive method without first discussing it with your doctor.
If you are a parent or caregiver of a girl treated with valproate, contact your doctor as soon as the girl has her
first menstrual period.
Some contraceptive pills (containing estrogen) may reduce valproate blood levels. Be sure to discuss with your
doctor the most suitable method of contraception (birth control) for you.
Ask your doctor to take folic acid when trying to conceive. Folic acid may reduce the general risk of spina
bifida and early miscarriage present in all pregnancies. However, it is unlikely to reduce the risk of congenital
defects associated with valproate use.
In babies born to mothers treated with valproate during pregnancy, blood clotting problems may occur, such
as poor blood clotting manifesting as bruising or bleeding that takes a long time to stop, hypoglycaemia (low
blood sugar), hypothyroidism (underactive thyroid gland, which may cause tiredness or weight gain).
In babies born to mothers treated with valproate during the last trimester of pregnancy, withdrawal syndrome
may occur (including agitation, irritability, hyperexcitability, nervousness, excessive restlessness and
uncontrollable movements (hyperkinesia), muscle problems, tremors, seizures and feeding difficulties).
Read and select the situations applicable to you from those described below:
I AM STARTING TREATMENT WITH SODIO VALPROATO SEACROSS
I AM TAKING SODIO VALPROATO SEACROSS AND DO NOT PLAN TO HAVE A CHILD
I AM TAKING SODIO VALPROATO SEACROSS AND PLAN TO HAVE A CHILD
I AM PREGNANT AND TAKING SODIO VALPROATO SEACROSS
I AM STARTING TREATMENT WITH SODIO VALPROATO SEACROSS
If Sodio Valproato Seacross is prescribed to you for the first time, your doctor will explain the risks to the
fetus in case of pregnancy. If you are of childbearing age, you must ensure you use an effective method of
contraception continuously throughout the entire treatment with Sodio Valproato Seacross. Contact your
doctor or a family planning clinic if you need advice on contraception.
Key messages:
before starting treatment with Sodio Valproato Seacross, pregnancy must be ruled out by a pregnancy
test confirmed by your doctor.
during the entire treatment with Sodio Valproato Seacross, you must use an effective method of birth
control (contraception).
you must discuss with your doctor appropriate methods of birth control (contraception). Your doctor will
explain how to prevent pregnancy and may refer you to a specialist for advice on contraception.
you must schedule regular appointments (at least once a year) with a specialist experienced in managing
bipolar disorder or epilepsy. During this visit, your doctor will ensure you are fully aware and understand
all risks and advice related to valproate use in pregnancy.
inform your doctor if you wish to have a child.
inform your doctor immediately if you are pregnant or think you might be.
I AM TAKING SODIO VALPROATO SEACROSS AND DO NOT PLAN TO HAVE A CHILD
If you are continuing treatment with valproate but do not plan to have a child, ensure you use an effective
method of contraception continuously throughout the treatment with Sodio Valproato Seacross. Contact your
doctor or a family planning clinic if you need advice on contraception.
Key messages:
during the entire treatment with Sodio Valproato Seacross, you must use an effective method of birth
control (contraception).
you must discuss contraception (birth control) with your doctor. Your doctor will explain how to prevent
pregnancy and may refer you to a specialist for advice on contraception.
you must schedule regular appointments (at least once a year) with a specialist experienced in managing
bipolar disorder or epilepsy. During this visit, your doctor will ensure you are fully aware and understand
all risks and advice related to valproate use in pregnancy.
inform your doctor if you wish to have a child.
inform your doctor immediately if you are pregnant or think you might be.
I AM TAKING SODIO VALPROATO SEACROSS AND PLAN TO HAVE A CHILD
If you are planning to have a child, schedule an appointment with your doctor first.
Speak to your doctor before stopping Sodio Valproato Seacross or your contraceptive. Your doctor will
provide further advice.
Children born to mothers treated with valproate have a high risk of birth defects and developmental
problems that may result in severe disability. Your doctor will refer you to a specialist experienced in
managing bipolar disorder or epilepsy to evaluate alternative treatment options as soon as possible. The
specialist may take various measures to facilitate the pregnancy as much as possible and minimize risks for
you and your baby.
The specialist may decide to modify the dose of Sodio Valproato Seacross, switch to another medicine, or stop
treatment with Sodio Valproato Seacross well before pregnancy to ensure your condition is stable.
Ask your doctor about taking folic acid when planning to have a child. Folic acid may reduce the general risk
of spina bifida and early miscarriage present in all pregnancies. However, it is unlikely to reduce the risk of
congenital defects associated with valproate use.
Key messages:
do not stop taking Sodio Valproato Seacross unless instructed by your doctor.
do not stop using birth control (contraception) before discussing it with your doctor and agreeing on a
plan to ensure control of your condition and minimize risks to the baby.
first schedule an appointment with your doctor. During this visit, your doctor will ensure you are fully
aware and understand all risks and advice related to valproate use in pregnancy.
your doctor will try to change your medication or stop treatment with Sodio Valproato Seacross well
before pregnancy.
request an urgent appointment with your doctor if you are pregnant or think you might be.
I AM PREGNANT AND TAKING SODIO VALPROATO SEACROSS
Do not stop taking Sodio Valproato Seacross unless instructed by your doctor, as your condition may worsen.
Request an urgent appointment with your doctor if you are pregnant or think you might be. Your doctor will
provide further advice.
Children born to mothers treated with valproate have a high risk of birth defects and developmental
problems that may result in severe disability.
You will be referred to a specialist experienced in managing bipolar disorder or epilepsy to evaluate
alternative treatment options.
In exceptional circumstances, if Sodio Valproato Seacross is the only available treatment option during
pregnancy, you will be closely monitored for management of your underlying condition and fetal
development. You and your partner may receive counselling and support regarding valproate exposure
during pregnancy.
Ask your doctor about taking folic acid. Folic acid may reduce the general risk of spina bifida and miscarriage,
possible in all pregnancies. However, it is unlikely to reduce the risk of congenital defects associated with
valproate use.
Key messages:
Request an urgent appointment with your doctor if you are pregnant or think you might be.
do not stop taking Sodio Valproato Seacross unless instructed by your doctor.
ensure you are referred to a specialist experienced in treating epilepsy or bipolar disorder to evaluate
the need for alternative treatment options.
you must receive detailed counselling regarding the risks of Sodio Valproato Seacross in pregnancy,
including teratogenicity and effects on child development.
ensure you are referred to a specialist in prenatal monitoring to identify possible cases of malformation.
Make sure to read the patient guide you will receive from your doctor. Your doctor will discuss the Annual
Risk Acknowledgement Form with you and ask you to sign and keep it. You will also receive the Patient
Card from the pharmacist to remind you of the risks of valproate in pregnancy.
Breastfeeding
A very small amount of Sodio Valproato Seacross passes into breast milk. However, consult your doctor to
determine whether breastfeeding your baby is appropriate. Ask your doctor or pharmacist before taking any
medicine.
Important warning for male patients
Potential risks related to valproate use in the 3 months preceding conception of a child
One study suggests a possible risk of movement and mental development disorders (early childhood
development problems) in children born to fathers treated with valproate in the 3 months preceding
conception. In this study, about 5 out of 100 children born to fathers treated with valproate had such
disorders, compared to about 3 out of 100 children born to fathers treated with lamotrigine or levetiracetam
(other medicines used to treat the condition). It is unclear whether there is a risk for children born to fathers
who stopped valproate treatment 3 months (the time required for formation of new sperm) or more before
conception. The study has limitations, so it is unclear whether the increased risk of movement and mental
development disorders suggested by this study is caused by valproate. The study was not large enough to
show which specific type of movement and mental development disorder the children might be at risk of
developing.
As a precautionary measure, your doctor will discuss with you:
the potential risk in children born to fathers treated with valproate
the need to consider using an effective contraceptive method (birth control) for you and your partner
during treatment and for 3 months after stopping treatment
the need to consult your doctor when planning to conceive a child and before stopping contraception
(birth control)
the possibility of other treatments that may be used to treat your condition, depending on your
individual situation
Do not donate sperm while taking valproate and for 3 months after stopping valproate.
Consult your doctor if you are thinking of having a child.
If your female partner becomes pregnant while you are taking valproate in the 3 months preceding conception
and you have any concerns, consult your doctor. Do not stop treatment without discussing it with your doctor.
If you stop treatment, symptoms may worsen.
Regular appointments with your doctor are necessary. During this visit, your doctor will discuss with you the
precautions related to valproate use and the possibility of other treatments that may be used to treat your
condition, depending on your individual situation.
Make sure to read the patient guide you will receive from your doctor. You will also receive the Patient
Card from the pharmacist to remind you of the risks of valproate.
Driving and using machines
Taking Sodio Valproato Seacross may cause drowsiness. If this occurs, do not drive a vehicle or operate
machinery.
Taking other medicines used to treat seizures or to calm emotional and mental problems may increase
drowsiness.
Sodio Valproato Seacross contains sodium
This medicine contains 13.9 mg of sodium (a main component of table salt) per ml. This corresponds to 0.7%
of the maximum daily recommended sodium intake for an adult.

3. How to take Sodio Valproato Seacross

Girls and women of childbearing age
Treatment with Sodio Valproato Seacross must be initiated and supervised by a physician specialized in the treatment of epilepsy.
Male patients
It is recommended that Sodio Valproato Seacross be initiated and supervised by an experienced specialist in the treatment of epilepsy – see section 2 Important warning for male patients.
Sodio Valproato Seacross is always administered by a doctor or nurse. This is because it must be injected or infused slowly into a vein. If you are unsure why Sodio Valproato Seacross is being administered to you or if you have any doubts about the amount being given, please consult your doctor or nurse.
Your doctor will discontinue Sodio Valproato Seacross as soon as possible and switch you to oral valproate in the form of tablets, granules, syrup, or liquid. Treatment with Sodio Valproato Seacross must be initiated and supervised by a physician specialized in the treatment of epilepsy.

Dosage
Your doctor will determine the dose based on your condition. The amount of Sodio Valproato Seacross given to you or your child will depend on age or body weight.
If you are already taking oral sodium valproate, your doctor may decide to administer a continuous or repeated infusion of the same dose of Sodio Valproato Seacross.
If you have never taken Sodio Valproato Seacross before, your doctor will use the following doses:
The recommended average daily dose during long-term therapy is:
Children (from 28 days of age to 11 years): 20–30 mg of sodium valproate per kg of body weight
Adolescents (12 to 17 years): 25 mg of sodium valproate per kg of body weight
Adults (≥ 18 years): 20 mg of sodium valproate per kg of body weight

Adolescents and adults
Patients who are already satisfactorily treated with oral sodium valproate may continue to receive their current dose 4 to 6 hours after the last oral dose:

• by continuous infusion over 24 hours;
• or divided into 4 infusions of one hour each per day.
  Patients not previously treated with sodium valproate may receive 10 mg/kg as a slow intravenous injection over 3–5 minutes, followed by a continuous infusion at a rate of 1 mg/kg/hour (up to a maximum of 25 mg/kg/day), starting 30 minutes after the end of the injection.

Paediatric population
The daily requirement for children is usually between 20 and 30 mg/kg/day. If adequate control is not achieved within this range, the dose may be increased up to 40 mg/kg/day, but only in patients in whom plasma levels of valproic acid can be monitored.

Patients with kidney problems
Your doctor may decide to adjust the dose for the patient or child.

If you take more Sodio Valproato Seacross than you should
Your doctor or nurse will not administer an excessive amount of the medicine. Your doctor will monitor your progress and the medication you are receiving. Always ask if you are unsure why a dose of medication is being administered to you.
Taking too much Sodio Valproato Seacross may cause the following symptoms: feeling unwell or actual illness, constricted pupils, dizziness, loss of consciousness, muscle weakness and reduced reflexes, breathing difficulties, headache, epileptic seizures, confusion, memory loss, low blood pressure, and unusual or inappropriate behavior.
Taking too much Sodio Valproato Seacross may cause excess sodium in the blood (hypernatraemia).

If you miss a dose of Sodio Valproato Seacross
Your doctor or nurse will have instructions on when to administer the medicine. It is unlikely that the medicine will not be administered as prescribed. However, if you think a dose has been missed, speak to your doctor or nurse.

If you stop taking Sodio Valproato Seacross
It is important that you continue receiving Sodio Valproato Seacross injections until your doctor decides to stop them. If you stop taking it, seizures may recur.

Tests
Ensure that you or your child attend regular check-up appointments. These appointments are essential because it may be necessary to adjust the dose. Sodio Valproato Seacross may alter liver enzyme levels detected in blood tests. This could indicate that your or your child’s liver is not functioning properly. If you or your child are admitted to hospital or visit another doctor or dentist, inform them that you are taking Sodio Valproato Seacross.
If you have any further questions about the use of this medicine, please consult your doctor or pharmacist.

4. Possible side effects

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

Immediately inform your doctor if any of the following serious side effects occur –
urgent medical treatment may be required:

An allergic reaction occurs, which may present as:

• Blisters with skin peeling (blisters, skin shedding or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without rash, sometimes accompanied by flu-like symptoms such as fever, chills or muscle pain – these may be signs of conditions called “toxic epidermal necrolysis” or “Stevens-Johnson syndrome”. These conditions may occur more frequently in people also taking lamotrigine.
• Skin rash or skin lesions with a pink/red ring and a pale center, which may be itchy, scaly or filled with fluid. The skin reaction may appear especially on the palms of the hands or soles of the feet. These may be signs of a condition called 'erythema multiforme'.
• Swelling due to an allergic reaction, with itchy discomfort (most often around the eyes, lips, throat, and sometimes hands and feet) – these may be signs of 'angioedema'.
• Syndrome with skin reaction, fever, swollen lymph nodes, and possible involvement of other organs – these may be signs of a condition called 'DRESS' or Drug Reaction with Eosinophilia and Systemic Symptoms.
• Drowsiness, changes in level of consciousness (including coma), confusion, slowness or unusual behavior, and memory loss, with or without increased frequency or severity of seizures, particularly if phenobarbital and topiramate are taken concomitantly or if the dose of Sodium Valproate Seacross has been suddenly increased.
• Confusion, which could be due to low sodium levels in the blood or a condition called 'SIADH' or Syndrome of Inappropriate Antidiuretic Hormone secretion.
• Problems with balance and coordination, feeling of lethargy or reduced alertness, associated with vomiting. This may be due to increased levels of ammonia in the blood.
• Increase in number and severity of seizures.
• Repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, or loss of appetite, severe pain in the upper abdomen, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs, or worsening of epilepsy or a general feeling of being unwell. These may be signs of serious liver or pancreas problems (see section 2).
• Bruising or spontaneous bleeding due to blood clotting problems shown by blood tests.
• Severe reduction in white blood cells or bone marrow failure, shown by blood tests, sometimes presenting as fever and breathing difficulties, or more frequent infections than usual.
• Underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism).
• Joint pain, fever, fatigue, skin reaction. These may be signs of systemic lupus erythematosus.
• Tremors, uncontrollable muscle contractions, unsteadiness when walking (parkinsonism, extrapyramidal disorder, ataxia).
• Muscle pain and weakness (rhabdomyolysis).
• Breathing difficulties and pain due to inflammation of the lining around the lungs (pleural effusion).
• Kidney disorders (renal failure, tubulointerstitial nephritis, and Fanconi syndrome), which may present as reduced urine output, loss of appetite, feeling unwell, seizures, or loss of consciousness.

If any of the following side effects become severe or last for more than a few days, or if you experience any side effect not listed in this leaflet, consult your doctor or pharmacist:

Very common side effects (may affect more than 1 in 10 people):
Nausea.
Tremor.

Common side effects (may affect up to 1 in 10 people):
Decrease in platelet count or red blood cell count, abnormal increase in the size of red blood cells, or bone marrow disorders (shown by blood tests).
Weight gain, obesity.
Seeing, hearing or sensing things that are not there (hallucinations).
Headache.
Rapid and uncontrollable eye movements.
Hearing problems or deafness.
Vomiting, stomach ache, diarrhea, especially at the beginning of treatment – see section 2 “How to take this medicine”.
Gum problems (mainly hypertrophy (excessive growth of the gums)).
Painful mouth, swollen mouth, mouth ulcers, and burning sensation in the mouth (stomatitis).
Temporary hair loss, nail and nail bed disorders.
Urinary incontinence (involuntary leakage of urine).
Pain during menstruation.
Feeling nauseous or dizzy.

Uncommon side effects (may affect up to 1 in 100 people):
Tingling or numbness in the hands or feet.
Inflammation of small blood vessels (vasculitis).
Skin reactions, such as rashes.
Abnormal hair growth, abnormal hair texture, changes in hair color.
Excessive hairiness, particularly in women, male-pattern hair growth (virilism), acne (hyperandrogenism).
Bone disorders. Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported. Consult your doctor or pharmacist if you are taking antiepileptic medicines long-term, if you have a history of osteoporosis, or if you are taking steroids.
Irregular or absent menstrual periods.
Swelling of the feet and legs (edema).
Decrease in body temperature.

Rare side effects (may affect up to 1 in 1,000 people):
Aggression, restlessness, attention disorders, abnormal behavior, and psychomotor hyperactivity.
Learning disorders.
Memory disorders and cognitive disturbances.
Double vision.
Bedwetting or increased need to urinate.
Passing large amounts of urine and feeling thirsty (Fanconi syndrome).
Male infertility is usually reversible after stopping treatment and may be reversible after dose reduction. Do not stop treatment without first discussing it with your doctor.
Cysts in the ovaries (polycystic ovaries).
Reduction in body levels of vitamin B8 (biotin deficiency); symptoms include skin rash around the eyes, nose and mouth, weak and brittle nails, hair loss, loss of appetite, nausea, feeling depressed, or hallucinations.

Very rare side effects (may affect up to 1 in 10,000 people):
Breast enlargement in men.

Side effects with unknown frequency (frequency cannot be estimated from the available data):
Reduction in carnitine levels (shown by blood or muscle tests).

Blood tests
Sodium Valproate Seacross may alter levels of liver enzymes, blood clotting factors, salts, or sugars detected in blood and urine tests.

Additional side effects in children
Some side effects of valproate occur more frequently or are more severe in children than in adults. These include liver damage, inflammation of the pancreas (pancreatitis), aggression, restlessness, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sodio Valproato Seacross

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Chemical and physical in-use stability has been demonstrated for 96 hours at 2–8 °C and at 25 °C. From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and, under normal circumstances, should not exceed 24 hours at 2–8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.
Use only clear solutions free from particles.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Sodio Valproato Seacross contains

• The active substance is sodium valproate. Each ml contains 100 mg of sodium valproate.
• The other components are: edetate disodium, hydrochloric acid, sodium hydroxide and water for injections.

Description of the appearance of Sodio Valproato Seacross and contents of the pack
Sodio Valproato Seacross is a clear, colourless solution. It is available in glass vials containing 3 ml or 4 ml of solution. Each pack contains 5 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Seacross Pharma (Europe) Limited
POD 13, The Old Station House
15A Main Street, Blackrock
Dublin, A94 T8P8
Ireland

Manufacturer
Seacross Pharma (Europe) Limited
POD 13, The Old Station House
15A Main Street, Blackrock
Dublin, A94 T8P8
Ireland

This medicinal product is authorised in EEA Member States under the following names: