Sodium valproate Aurobindo Italia: detailed information

Package leaflet: Information for the user

Sodium Valproate Aurobindo Italia 200 mg/ml oral solution

Generic medicine
This medicine is under 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 Aurobindo Italia can seriously harm the unborn baby if taken during pregnancy. If you are a woman of childbearing potential, you must use an effective method of birth control (contraception) continuously throughout your treatment with Sodium Valproate Aurobindo Italia. Your doctor will discuss this with you, but you must also follow the recommendations in section 2 of this leaflet.
If you are planning a pregnancy or think you may be pregnant, contact your doctor urgently.
Do not stop taking Sodium Valproate Aurobindo Italia unless your doctor tells you to, as your condition may worsen.
Please 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 questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
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:

What Sodium Valproate Aurobindo Italia is and what it is used for
What you need to know before taking Sodium Valproate Aurobindo Italia
How to take Sodium Valproate Aurobindo Italia
Possible side effects
How to store Sodium Valproate Aurobindo Italia
Contents of the pack and other information

1. What Sodio Valproato Aurobindo Italia is and what it is used for

Sodio Valproato Aurobindo Italia 200 mg/ml oral solution belongs to a category of medicines indicated for the treatment of:

Generalized or partial epilepsy;
Primary generalized epilepsy: convulsive seizures (clonic, tonic, tonic-clonic, myoclonic) and non-convulsive seizures or absences;
Partial epilepsy: simple or complex seizures;
Secondary generalized seizures;
Treatment of mixed-type convulsive seizures and idiopathic and/or symptomatic generalized epilepsy (West and Lennox-Gastaut syndromes).

Sodio Valproato Aurobindo Italia is a medicine used in the treatment of mania in adults, a condition in which individuals may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive. Mania occurs during a condition known as "bipolar disorder". Sodio Valproato Aurobindo Italia may be used when lithium cannot be used.

2. What you should know before taking Sodio Valproato Aurobindo Italia

Do not take Sodio Valproato Aurobindo Italia:

If you are allergic to sodium valproate or to any of the other ingredients of this medicine (listed in section 6).
If you currently have any liver or pancreatic disease.
If you have previously suffered from liver diseases.
If one of your close relatives has a history of severe liver disease (hepatitis), mainly due to medications.
If you have hepatic porphyria (a rare metabolic disorder).
If you suffer from genetic disorders causing mitochondrial disease (e.g., Alpers-Huttenlocher syndrome).
If you have metabolic disorders, e.g., urea cycle disorder.
If you have carnitine deficiency (a very rare metabolic disorder) that is untreated.

Bipolar disorder

If you are pregnant, you must not use Sodio Valproato Aurobindo Italia for bipolar disorder.
If you are a woman of childbearing potential, you must not take Sodio Valproato Aurobindo Italia for bipolar disorder unless you are using an effective method of birth control (contraceptive) throughout the entire treatment with Sodio Valproato Aurobindo Italia. Do not stop taking Sodio Valproato Aurobindo Italia or the contraceptive unless you have discussed it with your doctor. Your doctor will advise you further (see below “Pregnancy, breastfeeding and fertility – Important warning for women”).

Epilepsy

If you are pregnant, you must not use Sodio Valproato Aurobindo Italia for epilepsy unless nothing else is effective for you.
If you are a woman of childbearing potential, you must not take Sodio Valproato Aurobindo Italia for epilepsy unless you are using an effective method of birth control (contraceptive) throughout the entire treatment with Sodio Valproato Aurobindo Italia. Do not stop taking Sodio Valproato Aurobindo Italia or the contraceptive unless you have discussed it with your doctor. Your doctor will advise you further (see below “Pregnancy, breastfeeding and fertility – Important warning for women”).

If you think any of the above conditions apply to you or if you have any doubts, speak with your doctor before taking Sodio Valproato Aurobindo Italia.
Warnings and precautions
CONTACT YOUR DOCTOR IMMEDIATELY:

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme and angioedema, have been reported in association with valproate treatment. Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.
If you or your child develop a sudden illness, especially during the first 6 months of treatment, particularly if it repeatedly presents with vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite, stomach ache, nausea, jaundice (yellowing of the skin and eyes), swollen legs, worsening of epilepsy or a general feeling of being unwell. In such situations, you must consult your doctor immediately. Sodio Valproato Aurobindo Italia oral solution may affect the liver (and rarely the pancreas) in a small number of patients.
The risk of liver damage increases if Sodio Valproato Aurobindo Italia oral solution is taken by children under 3 years of age, in people taking other antiepileptic medicines simultaneously, or in those suffering from other neurological or metabolic disorders and severe forms of epilepsy.
If you or your child take Sodio Valproato Aurobindo Italia and develop problems with balance and coordination, feel drowsy or less alert, or vomit, inform your doctor immediately. This may be due to increased levels of ammonia in the blood.
A small number of people taking antiepileptic medicines such as sodium valproate/valproic acid have experienced thoughts of harming themselves or of suicide. If you have such thoughts at any time, contact your doctor immediately.
As with other antiepileptics, seizures may worsen or occur more frequently while taking this medicine. In such cases, contact your doctor immediately.

Talk to your doctor or pharmacist before taking Sodio Valproato Aurobindo Italia

Especially if your child is under 3 years of age, Sodio Valproato Aurobindo Italia oral solution must not be administered simultaneously with other medicines containing acetylsalicylic acid;
If you have systemic lupus erythematosus (a rare disease);
If you have metabolic disorders, particularly inherited enzyme deficiencies such as urea cycle disorder, due to the risk of increased blood ammonia levels.
If you have impaired renal function. Your doctor may wish to monitor your sodium valproate levels or adjust your dose;
If you gain weight due to increased appetite;
If you have carnitine palmitoyltransferase (CPT) type II deficiency, as you are at higher risk of muscle disorders;
If you know or your doctor suspects a mitochondrial disorder in your family due to a genetic problem, due to the risk of liver damage;
If you have blood disorders (coagulation disorders or thrombocytopenia). A blood test (full blood count) is recommended before starting treatment, before surgery, or if spontaneous bruising or bleeding occurs;
If you have a low dietary intake of carnitine, found in meat and dairy products, especially in children under 10 years of age;
If you have carnitine deficiency and are taking carnitine supplements;
If you have ever developed a severe rash or skin peeling, blisters and/or mouth ulcers after taking valproate.

Children and adolescents
Children and adolescents under 18 years of age:
Sodio Valproato Aurobindo Italia must not be used in the treatment of mania in children and adolescents under 18 years of age.
Other medicines and Sodio Valproato Aurobindo Italia
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Some medicines may affect how Sodio Valproato Aurobindo Italia works, or vice versa.
These include:

Products containing estrogens (including some birth control pills)
Antipsychotics (used to treat psychological disorders).
Medicines used to treat depression.
Benzodiazepines, used to treat anxiety or as sleeping tablets.
Other medicines used in the treatment of epilepsy including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, topiramate, felbamate.
Quetiapine, olanzapine (used to treat psychiatric disorders).
Clozapine (for treating mental health problems).
Zidovudine (used to treat HIV or AIDS).
Mefloquine (used to prevent and treat malaria).
Salicylates (see section “Warnings and precautions” for children under 3 years of age).
Anticoagulants (used to prevent blood clots).
Lithium.
Rufinamide.
Acetazolamide.
Protease inhibitors, such as lopinavir, ritonavir (used in the treatment of HIV).
Cholestyramine.
Cimetidine (used to treat stomach ulcers).
Erythromycin, rifampicin.
Carbapenems such as imipenem, panipenem and meropenem (antibiotics used to treat bacterial infections). The combination of valproic acid and carbapenems must be avoided as it may reduce the effects of sodium valproate.
Propofol (an anaesthetic).
Metamizole, a medicine used to treat pain and fever.
Cannabidiol (used to treat epilepsy and other conditions).
Some anti-infective drugs containing pivalate (e.g., pivampicillin, adefovir dipivoxil).
Methotrexate – used to treat tumours and inflammatory diseases.

Sodio Valproato Aurobindo Italia may increase the effects of nimodipine (a medicine used in the treatment of hypertension, angina pectoris and blood vessel disorders).
These and other medicines may be affected by Sodio Valproato Aurobindo Italia, or may affect how it works. It may be necessary to adjust your dose or to take different medicines. Your doctor or pharmacist can advise you and provide further information about medicines you should pay attention to or even avoid during treatment with Sodio Valproato Aurobindo Italia.
Sodio Valproato Aurobindo Italia with food, drinks and alcohol
Sodio Valproato Aurobindo Italia may be taken with food and/or liquids.
Alcohol intake is not recommended during treatment.
Pregnancy, breastfeeding and fertility
Important warning for women
Bipolar disorder

If you are pregnant, you must not use Sodio Valproato Aurobindo Italia for bipolar disorder.
If you are a woman of childbearing potential, you must not take Sodio Valproato Aurobindo Italia for bipolar disorder unless you are using an effective method of birth control (contraceptive) throughout the entire treatment with Sodio Valproato Aurobindo Italia. Do not stop taking Sodio Valproato Aurobindo Italia or the contraceptive unless you have discussed it with your doctor. Your doctor will advise you further.

Epilepsy

If you are pregnant, you must not use Sodio Valproato Aurobindo Italia for epilepsy unless nothing else is effective for you.
If you are a woman of childbearing potential, you must not take Sodio Valproato Aurobindo Italia for epilepsy unless you are using an effective method of birth control (contraceptive) throughout the entire treatment with Sodio Valproato Aurobindo Italia. Do not stop taking Sodio Valproato Aurobindo Italia or the contraceptive unless you have discussed it with your doctor. Your doctor will advise you further.

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 risks if taken during pregnancy. The higher the dose, the greater the risks, 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 during growth after birth.
The most frequently reported birth defects include spina bifida (incomplete development of some bones of the spine), facial and cranial malformations, heart, kidney, urinary tract and genital organ malformations, limb defects and multiple associated malformations affecting various organs and body parts. Birth defects may lead to disabilities that can be severe.
Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.
Eye malformations, sometimes associated with other congenital malformations, have been reported in children exposed to valproate during pregnancy. These eye malformations may affect vision.
Women who take valproate during pregnancy have a higher risk of having a baby with birth defects requiring medical treatment compared to other women. Because valproate has been used for many years, we know that about 10 out of 100 babies born to women taking valproate have birth defects, compared to 2-3 out of 100 babies born to women without epilepsy.
It is estimated that up to 30-40% of preschool-aged children whose mothers took valproate during pregnancy may experience developmental problems in early childhood. These children may start walking and talking later, 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, and there is some evidence that children may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
If you take valproate during pregnancy, your baby may have a lower than expected birth weight for gestational age. In women taking valproate, approximately 11-15 out of 100 babies may have a lower than expected birth weight. This compares to 5-10 out of 100 babies born to women in the general population.
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 the contraceptive method before discussing it with your doctor.
If you are the parent or caregiver of a girl treated with valproate, contact the doctor as soon as the girl has her first menstrual period.
Some contraceptive pills (estrogen-containing oral contraceptives) may decrease valproate blood levels. Make sure to discuss with your doctor the most suitable contraceptive method for you.
Consult your doctor about taking folic acid when trying to become pregnant. Folic acid may reduce the general risk of spina bifida and miscarriage, which are possible in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with valproate use.

Choose and read the situation that applies to you from the list below:

I AM STARTING TREATMENT WITH SODIO VALPROATO AUROBINDO ITALIA
I AM TAKING SODIO VALPROATO AUROBINDO ITALIA AND NOT PLANNING TO HAVE A CHILD
I AM TAKING SODIO VALPROATO AUROBINDO ITALIA AND PLANNING A PREGNANCY
I AM TAKING SODIO VALPROATO AUROBINDO ITALIA AND HAVE BECOME PREGNANT

I AM STARTING TREATMENT WITH SODIO VALPROATO AUROBINDO ITALIA
If Sodio Valproato Aurobindo Italia 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 contraceptive method continuously throughout the entire treatment with Sodio Valproato Aurobindo Italia. Talk to your doctor or visit a family planning clinic if you need advice on contraception.
Key messages:

Before starting treatment with Sodio Valproato Aurobindo Italia, pregnancy must be ruled out by a pregnancy test confirmed by your doctor.
Throughout the entire treatment with Sodio Valproato Aurobindo Italia, you must use an effective method of birth control (contraceptive).
You must discuss appropriate contraceptive methods with your doctor. Your doctor will explain how to prevent pregnancy and may refer you to a specialist for contraceptive advice.
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 AUROBINDO ITALIA AND NOT PLANNING TO HAVE A CHILD
If you are continuing treatment with Sodio Valproato Aurobindo Italia but not planning to have a child, ensure you use an effective contraceptive method continuously throughout the treatment with Sodio Valproato Aurobindo Italia. Talk to your doctor or a family planning clinic if you need advice on contraception.
Key messages:

You must use an effective method of birth control (contraceptive) throughout the entire treatment with Sodio Valproato Aurobindo Italia.
You must discuss contraception with your doctor. Your doctor will explain how to prevent pregnancy and may refer you to a specialist for contraceptive advice.
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 AUROBINDO ITALIA AND PLANNING A PREGNANCY
If you are planning to have a child, make an appointment with your doctor first.
Do not stop taking Sodio Valproato Aurobindo Italia or your contraceptive unless you have discussed it with your doctor. Your doctor will advise you further.
Children born to mothers treated with valproate have a high risk of birth defects and developmental problems that may be severely disabling. 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 several measures to facilitate the pregnancy as much as possible and minimize risks for you and your baby.
The specialist may decide to adjust the dose of Sodio Valproato Aurobindo Italia, switch to another medicine, or discontinue treatment with Sodio Valproato Aurobindo Italia well before pregnancy to ensure the disease 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 miscarriage, possible in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with valproate use.
Key messages:

Do not stop taking Sodio Valproato Aurobindo Italia unless instructed by your doctor.
Do not stop using contraceptive methods before discussing it with your doctor and agreeing on a plan to ensure disease control and minimize risks to the baby.
Make an appointment with your doctor as soon as possible. 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 medicine or discontinue treatment with Sodio Valproato Aurobindo Italia well before pregnancy.
Request an urgent appointment with your doctor if you are pregnant or think you might be pregnant.

I AM TAKING SODIO VALPROATO AUROBINDO ITALIA AND HAVE BECOME PREGNANT
Do not stop taking Sodio Valproato Aurobindo Italia unless advised by your doctor, as your condition may worsen. Request an urgent appointment with your doctor if you are pregnant or think you might be pregnant. Your doctor will advise you further.
Children born to mothers treated with valproate have a high risk of birth defects and developmental problems that may be severely disabling.
You will be referred to a specialist experienced in managing epilepsy to evaluate alternative treatment options.
In exceptional circumstances, if Sodio Valproato Aurobindo Italia is the only available treatment option during pregnancy, you will be closely monitored for both your underlying condition and fetal development. You and your partner may receive counselling and support regarding valproate exposure during pregnancy.
Ask your doctor for advice on 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 birth defects associated with valproate use.
Key messages:

Request an urgent appointment with your doctor if you are pregnant or think you might be pregnant.
Do not stop taking Sodio Valproato Aurobindo Italia 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 on the risks of Sodio Valproato Aurobindo Italia in pregnancy, including teratogenicity (birth defects) and physical and mental developmental disorders in children.
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. The Patient Card is included in the package to remind you of the risks of valproate in pregnancy.
Important warning for male patients
Potential risk associated with valproate use in the 3 months before conception
One study suggests a possible risk of motor and mental developmental disorders (problems affecting early childhood development) in children born to fathers treated with valproate in the 3 months before conception. In this study, about 5 out of 100 children had such disorders when born to fathers treated with valproate, compared to about 3 out of 100 children born to fathers treated with lamotrigine or levetiracetam (other medicines that may be used to treat your condition). The risk for children born to fathers who discontinued valproate treatment 3 months (the time required to form new sperm) or more before conception is not known. The study has limitations, and therefore it is not entirely clear whether the increased risk of motor and mental developmental disorders suggested by this study is caused by valproate. The study was not large enough to show which particular type of motor and mental developmental disorder the children may be at risk of developing.
As a precautionary measure, your doctor will discuss with you:

The potential risk for children born to fathers taking valproate
The need to consider effective contraception for you and your partner during treatment and for 3 months after stopping therapy
The need to consult a specialist if you are planning to conceive and before stopping contraception
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.
Talk to your doctor if you are thinking of having a child.
If your partner becomes pregnant while you have taken valproate in the 3 months before conception and you have questions, contact your doctor. Do not stop treatment without discussing it with your doctor.
If you stop treatment, your symptoms may worsen.
You must plan regular appointments with your prescribing doctor. During this visit, your doctor will discuss with you the precautions associated with 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 be given the Patient Card by the pharmacist to remind you of the potential risks of valproate.
Breastfeeding
Sodio Valproato Aurobindo Italia is excreted in breast milk and may cause blood disorders (haematological disorders) in infants/children breastfed by treated women (see “Possible side effects”).
Your doctor will carefully evaluate whether to discontinue breastfeeding or discontinue or abstain from therapy with Sodio Valproato Aurobindo Italia, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
If you are a woman of childbearing age, the medicine may increase the possibility of menstrual cessation (amenorrhoea), presence of multiple ovarian cysts (polycystic ovaries) and increased blood testosterone levels (see “Possible side effects”).
If you are a man, administration of valproate may impair your fertility (see “Possible side effects”). These fertility disorders are reversible after discontinuation of treatment.
Driving and using machines
Sodio Valproato Aurobindo Italia may cause drowsiness or dizziness in some people, especially at the beginning of treatment or when taken with other antiepileptic medicines or benzodiazepines. Make sure you know how you react to Sodio Valproato Aurobindo Italia before driving, using tools or machinery, or performing other activities that could become dangerous if you are drowsy or dizzy.
Sodio Valproato Aurobindo Italia contains sodium
This medicine contains 28.154 mg of sodium (a main component of table salt) per ml. This corresponds to 1.41% of the maximum recommended daily dietary intake for an adult.

3. How to take Sodio Valproato Aurobindo Italia

Take this medicine exactly as instructed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Girls and women of childbearing age
Treatment with Sodio Valproato Aurobindo Italia must be initiated and supervised by a specialist
experienced in the treatment of epilepsy or bipolar disorders.
Male patients
It is recommended that treatment with Sodio Valproato Aurobindo Italia be initiated and supervised by a
specialist experienced in managing epilepsy or bipolar disorder – see section 2 Important warning for male
patients.
Make sure you keep regular follow-up appointments for monitoring. These are very important because dose
adjustments may be necessary.
Dosage:
The daily dose is determined by the doctor according to age and body weight; however, significant inter-individual variations in sensitivity to valproate should be taken into account.
The optimal dosage will be based primarily on clinical response. Measurement of serum levels may be considered complementary to clinical monitoring in cases of poor seizure control or when adverse effects are suspected. The effective therapeutic range for serum levels of valproic acid is usually 40–100 mg/litre (300–700 micromoles/litre).
Treatment of epilepsy
Starting treatment with Sodio Valproato Aurobindo Italia (oral use):

If you are not taking other antiepileptic medicines, your doctor will increase the dose of Sodio Valproato Aurobindo Italia at intervals of 2–3 days, reaching the recommended dose within about one week.
If you are already taking another antiepileptic medicine, Sodio Valproato Aurobindo Italia should be gradually increased over approximately 2 weeks to reach the optimal dosage, while the other treatment should be gradually withdrawn until completely discontinued.
If combination therapy with other antiepileptics is required, these should be slowly reduced (see section 2 “Other medicines and Sodio Valproato Aurobindo Italia”). The initial daily dose is 10–15 mg/kg, and doses should be progressively increased until the optimal dosage is reached (see section “Starting treatment with Sodio Valproato Aurobindo Italia (oral use)”). This is generally between 20 and 30 mg/kg.

However, when adequate seizure control is not achieved with this dosage, doses may be further increased; patients must be under close monitoring (this is why follow-up appointments are important) when daily doses exceed 50 mg/kg (see section 2).

In children, the usual dosage is approximately 30 mg/kg per day.
In adults, the usual dosage is between 20–30 mg/kg per day.
Although pharmacokinetic parameters are altered in elderly patients, these changes have not been considered clinically significant; therefore, dosage should be determined based on clinical response (seizure control).

Treatment of mania associated with bipolar disorders
The daily dose must be individually determined and monitored by the doctor.
Initial dose:
The recommended initial daily dose is 750 mg.
The dose should be increased as rapidly as possible to reach the lowest therapeutic dose that provides the desired clinical effect.
Average daily dose:
The average daily dose usually ranges between 1,000 and 2,000 mg. In exceptional cases, the dose may be further increased up to 3,000 mg/day. The dose must be adjusted according to individual clinical response.
Patients with kidney problems
The doctor may decide to adjust the dose.
Always take this medicine exactly as described in this leaflet or as directed by your doctor or
pharmacist. Consult your doctor or pharmacist if you are unsure.
Method of administration:
For oral use.
The daily dose may be taken in two separate doses.
The package contains a 2 ml graduated syringe, with markings printed from 0.5 ml to 2 ml (from 50 mg to 400 mg) at 0.125 ml intervals.
The prescribed dose should preferably be administered during or after meals. The solution should be diluted in non-carbonated water, with or without sugar. After each use, close the bottle tightly.
Continue taking Sodio Valproato Aurobindo Italia for as long as your doctor considers it necessary and as long as it is prescribed.
Contact your doctor or pharmacist if you think that Sodio Valproato Aurobindo Italia is too weak or
too strong.
If you take more Sodio Valproato Aurobindo Italia than you should
An overdose of Sodio Valproato Aurobindo Italia can be dangerous. Inform your doctor or go immediately to the nearest hospital.
Signs of acute intoxication usually include coma, muscle hypotonia, hyporeflexia, miosis, impaired respiratory function, and metabolic acidosis.
However, symptoms may vary, and epileptic seizures have been reported even with very high plasma levels. Cases of intracranial hypertension associated with cerebral edema have been reported. Hospital management of overdose should be symptomatic: gastric lavage, which may be useful up to 10–12 hours after ingestion, and cardiorespiratory monitoring.
Naloxone has been successfully used in some isolated cases.
If you forget to take Sodio Valproato Aurobindo Italia
Do not take a double dose to make up for the missed dose. Continue taking the medicine as directed by your doctor.
If you miss several doses, contact your doctor immediately.
If you stop taking Sodio Valproato Aurobindo Italia
Do not change the dose or stop taking Sodio Valproato Aurobindo Italia without first consulting your doctor. Your condition may worsen if you stop treatment with Sodio Valproato Aurobindo Italia without medical advice.
If you have further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Inform your doctor immediately if you notice any of the following side effects (which are considered serious).
Urgent medical treatment may be required:

drowsiness, changes in consciousness levels (including coma), lethargic (unusual) behaviour, memory loss with or without increased frequency or severity of seizures, disorientation, particularly if taken together with medicines containing phenobarbital and topiramate or if the dose of Sodio Valproato Aurobindo Italia has been suddenly increased;
repeated vomiting, extreme tiredness, abdominal pain, drowsiness, weakness, loss of appetite, severe stomach ache, nausea, jaundice (yellowing of the skin and/or eyes), swollen legs, worsening of epilepsy or general feeling of being unwell. These may be signs of serious liver or pancreas disease (seek immediate medical evaluation for possible pancreatitis. If pancreatitis is confirmed, sodium valproate must be discontinued);
problems with balance and coordination, feeling lethargic or less alert, associated with vomiting. This may be due to increased levels of ammonia in the blood;
blood clotting problems (detected through blood tests);
spontaneous bruising or bleeding;
you have an allergic reaction which may present as:
blisters with skin peeling (blisters, peeling or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet), with or without a 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”;
swelling due to an allergic reaction, accompanied by painful, itchy lumps (most commonly around the eyes, lips, throat, and sometimes hands and feet). These may be signs of “angioedema”;
a drug-induced syndrome characterised by rash, fever, swollen lymph nodes and possible involvement of other organs. These could be signs of a condition called “drug reaction with eosinophilia and systemic symptoms (DRESS)”;
severe decrease in white blood cell count (leukocytes) or bone marrow failure, which sometimes presents with fever and breathing difficulties;
confusion which may be due to low sodium levels in the blood or a condition called “syndrome of inappropriate antidiuretic hormone secretion (SIADH)”;
underactive thyroid gland, which may cause tiredness or weight gain (hypothyroidism);
allergic reaction causing joint pain, fatigue, rash and fever (systemic lupus erythematosus);
extrapyramidal manifestations (involuntary movements);
breathing difficulties, chest pain or pressure (especially during inspiration), shortness of breath and dry cough due to fluid accumulation around the lungs (pleural effusion);
muscle pain and muscle weakness (rhabdomyolysis);
kidney disorders, urinary incontinence (involuntary loss of urine);
kidney disease (renal failure, tubulointerstitial nephritis) which may present with reduced urine output;
an increase in number and severity of seizures;
tremor, jerky muscle movements, unsteadiness when walking (parkinsonism, extrapyramidal disorders, ataxia).

These may be rare (serious), but in most cases they are not. Side effects are generally reversible, but some may require medical treatment:

vomiting, nausea or stomach pain and diarrhoea, particularly at the beginning of treatment;
headache;
tremor, drowsiness, sedation, unsteadiness when walking;
aggression, agitation, attention disturbances, abnormal behaviour and hyperactivity;
dizziness;
tingling of the hands and feet;
seeing, sensing or hearing things that do not exist (hallucinations);
skin reactions such as rash;
temporary hair loss, abnormal hair growth, abnormal hair texture, change in hair colour;
increased hair growth, particularly in women, virilism, acne (hyperandrogenism);
nail and nail bed disorders (common);
irregular or absent menstrual cycle, menstrual pain, ovarian cysts (polycystic ovary);
hearing problems or hearing loss;
gum disorders (particularly hyperplasia);
inflammation of the mouth, swollen mouth, mouth ulcers and burning sensation in the mouth (stomatitis);
rapid and uncontrollable eye movements;
double vision;
allergic reactions;
swollen feet and legs (oedema);
weight gain;
obesity (rare);
kidney problems, enuresis (bed-wetting) or increased need to urinate;
excessive urination and feeling thirsty (Fanconi syndrome) (rare);
reduction in carnitine levels (detected by blood or muscle tests) (frequency not known);
darker areas of skin and mucous membranes (hyperpigmentation);
decreased body temperature;
male infertility (usually reversible after discontinuation of treatment and potentially reversible after dose reduction); do not stop treatment without first consulting your specialist;
memory loss and cognitive disorders;
learning difficulties;
inflammation of small blood vessels (vasculitis);
reduction in body levels of vitamin B8 (biotin deficiency).

Cases of bone disorders, including osteopenia and osteoporosis (thinning of the bone), have been reported. If you are taking antiepileptic medicines long-term, have a history of osteoporosis, or are taking steroids, discuss this with your doctor or pharmacist.
Sodio Valproato Aurobindo Italia may also cause a reduction in platelet or red blood cell count, abnormally large red blood cells, or bone marrow disorders.

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, pancreas infection (pancreatitis), aggression, agitation, attention disturbances, abnormal behaviour, hyperactivity and learning difficulties.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at 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 Aurobindo Italia

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 or bottle after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Use within 3 months after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Sodio Valproato Aurobindo Italia contains

The active substance is sodium valproate.
Each ml of oral solution contains 200 mg of sodium valproate.
The other components are: sodium saccharin and purified water.

Description of the appearance of Sodio Valproato Aurobindo Italia and package contents
Oral solution.
Sodio Valproato Aurobindo Italia 200 mg/ml oral solution is available in amber-coloured containers (PET bottles with child-resistant closure) in pack sizes of 40 ml and 50 ml. Each bottle is supplied with a measuring device (i.e. a 2 ml graduated syringe). The syringe is graduated in both "mg" and "ml". It has a minimum graduation mark at 0.25 ml (corresponding to 50 mg) and subsequent graduation marks every 0.125 ml (corresponding to 25 mg) up to 2 ml (corresponding to 400 mg).
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma Italia S.r.l.
via San Giuseppe, 102
21047 – Saronno (VA)
Italy

Manufacturer
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta
Generis Farmacêutica, S.A.
Rua João de Deus, 19 Venda Nova
2700-487 Amadora,
Portugal

This medicinal product is authorized in the European Economic Area countries with the following names:
Italy: Sodio Valproato Aurobindo Italia
Portugal: Ácido Valpróico Generis
Spain: Valproato sódico Aurovitas 200 mg/ml solución oral EFG