Sodium valproate Aurobindo

Package leaflet: Information for the user

Sodium Valproate Aurobindo 300 mg prolonged-release tablets, 500 mg prolonged-release tablets

Generic medicine
Medicinal product subject to additional monitoring. This will allow rapid identification of new safety information. You can help by reporting any side effects you may experience while taking this medicine. See the end of section 4 for information on how to report side effects.
WARNING
Sodium Valproate Aurobindo can seriously harm the unborn baby if taken during pregnancy. 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 Aurobindo. 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 may be pregnant, seek an urgent appointment with your doctor.
Do not stop taking Sodium Valproate Aurobindo unless your doctor tells you to, because your condition could worsen.
Please read all of this leaflet carefully before you start taking this medicine, as 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, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Sodio Valproato Aurobindo belongs to a group of medicines used to treat:

• Generalized or partial epilepsy:
• Primary generalized epilepsy: convulsive seizures (clonic, tonic, tonic-clonic, myoclonic) and non-convulsive or absence seizures;
• 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 is a medicine used to treat mania, a condition in which a person may feel highly excited, euphoric, agitated, enthusiastic, or hyperactive. Mania occurs during an illness called "bipolar disorder". Sodio Valproato Aurobindo may be used when lithium cannot be used.

2. What you need to know before taking Sodium Valproate Aurobindo

Do not take Sodium Valproate Aurobindo:

• If you are allergic to sodium valproate, valproic acid, or any of the other ingredients of this medicine (listed in section 6).
• If you have hepatitis or inflammation of the liver.
• If you have a personal or family history of severe hepatitis, particularly if caused by medicines.
• 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 Sodium Valproate Aurobindo for bipolar disorder.
• If you are a woman of childbearing age, you must not take Sodium Valproate Aurobindo for bipolar disorder unless you are using an effective method of birth control (contraception) throughout treatment with Sodium Valproate Aurobindo. Do not stop taking Sodium Valproate Aurobindo or your contraceptive unless you have discussed this 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 Sodium Valproate Aurobindo for epilepsy, unless there is nothing else effective for you.
• If you are a woman of childbearing age, you must not take Sodium Valproate Aurobindo for epilepsy unless you are using an effective method of birth control (contraception) throughout treatment with Sodium Valproate Aurobindo. Do not stop taking Sodium Valproate Aurobindo or your contraceptive unless you have discussed this 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 Sodium Valproate Aurobindo.
Warnings and precautions
CONTACT A DOCTOR IMMEDIATELY:

• Serious skin reactions have been reported with valproate treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), erythema multiforme, and angioedema. Seek immediate medical advice if you notice any 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 cases, you must consult a doctor immediately. Sodium Valproate Aurobindo may affect the liver (and rarely the pancreas) in a small number of patients.

• The risk of liver damage increases if Sodium Valproate Aurobindo 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 Sodium Valproate Aurobindo and develop problems with balance and coordination, feel drowsy or less alert, or vomit, inform your doctor immediately. This may be due to increased ammonia levels in the blood.

• A small number of people treated with antiepileptic medicines such as sodium valproate/valproic acid have had thoughts about harming themselves or suicide. If you experience 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 Sodium Valproate Aurobindo.

• Especially if your child is under 3 years of age, Sodium Valproate Aurobindo must not be administered simultaneously with other medicines containing acetylsalicylic acid (aspirin).
• 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 kidney 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 or your doctor suspect a mitochondrial disorder in your family due to a genetic problem, due to the risk of liver damage.
• If you have a reduced 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 skin rash, skin peeling, blisters, and/or mouth ulcers after taking valproate.

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

• Antipsychotics (used to treat psychological disorders).

• Medicines used to treat depression.

• Benzodiazepines, used to treat anxiety or as sleeping tablets.

• Lithium.

• Rufinamide.

• Acetazolamide.

• Protease inhibitors, such as lopinavir, ritonavir (used in the treatment of HIV).

• Cholestyramine.

• Other medicines used to treat epilepsy including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, topiramate, felbamate.

• Quetiapine, olanzapine (used to treat psychiatric disorders).

• Clozapine (to treat 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).

• 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 (used for anaesthesia).

• Metamizole, a medicine used to treat pain and fever.

• Products containing estrogens (including some birth control pills).

• Sodium Valproate Aurobindo may increase the effects of nimodipine.

• Cannabidiol (used to treat epilepsy and other conditions).

• Methotrexate – used to treat tumours and inflammatory diseases.

• Some anti-infective agents containing pivalate (e.g., pivampicillin, adefovir dipivoxil).

These and other medicines may be affected by Sodium Valproate Aurobindo, or may alter how it works. It may be necessary to adjust the dose of your medicine or to take different medicines. Your doctor or pharmacist can advise you and provide further information on medicines you need to be cautious about or even avoid during treatment with Sodium Valproate Aurobindo.
Sodium Valproate Aurobindo with food, drinks and alcohol
Sodium Valproate Aurobindo may be taken with food and/or drinks.
Alcohol consumption is not recommended during treatment.
Pregnancy, breastfeeding and fertility
Important warning for women
Bipolar disorder

• If you are pregnant, you must not use Sodium Valproate Aurobindo for bipolar disorder.
• If you are a woman of childbearing age, you must not take Sodium Valproate Aurobindo for bipolar disorder unless you are using an effective method of birth control (contraception) throughout treatment with Sodium Valproate Aurobindo. Do not stop taking Sodium Valproate Aurobindo or your contraceptive unless you have discussed this with your doctor. Your doctor can give you further advice.

Epilepsy

• If you are pregnant, you must not use Sodium Valproate Aurobindo for epilepsy, unless there is nothing else effective for you.
• If you are a woman of childbearing age, you must not take Sodium Valproate Aurobindo for epilepsy unless you are using an effective method of birth control (contraception) throughout treatment with Sodium Valproate Aurobindo. Do not stop taking Sodium Valproate Aurobindo or your contraceptive unless you have discussed this with your doctor. Your doctor can give you further advice.

Risks of taking valproate during pregnancy (regardless of the condition for which it is used)

• Talk to your doctor immediately if you are planning a pregnancy or are pregnant.

• Valproate carries risks if taken during pregnancy. All doses carry a risk, but the risk is higher with higher doses, 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 as they grow after birth. The most frequently reported birth defects include spina bifida (incomplete development of some bones of the spine), facial and skull 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 have been reported in children exposed to valproate during pregnancy, often in association with other congenital malformations. These eye malformations may affect vision.

• Women taking valproate during pregnancy have a higher risk of having a child 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 who do not have 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 than others, 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 weight for their age at birth. In women taking valproate, about 11-15 out of 100 babies may have a lower than expected weight at birth. 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 your contraceptive method before discussing it with your doctor.

• If you are the parent or caregiver of a girl treated with valproate, you must contact the doctor as soon as the girl has her first menstrual period.

• Some contraceptive pills (containing estrogens) may reduce valproate levels in the blood. 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 SODIUM VALPROATE AUROBINDO
• I AM TAKING SODIUM VALPROATE AUROBINDO AND NOT PLANNING TO HAVE A CHILD
• I AM TAKING SODIUM VALPROATE AUROBINDO AND PLANNING A PREGNANCY
• I AM TAKING SODIUM VALPROATE AUROBINDO AND HAVE BECOME PREGNANT

I AM STARTING TREATMENT WITH SODIUM VALPROATE AUROBINDO
If Sodium Valproate Aurobindo 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 duration of treatment with Sodium Valproate Aurobindo. Talk to your doctor or visit a family planning clinic if you need advice on contraception.
Key messages:

• Before starting treatment with Sodium Valproate Aurobindo, pregnancy must be ruled out by a pregnancy test confirmed by your doctor.
• During the entire treatment with Sodium Valproate Aurobindo, you must use an effective method of birth control (contraception).
• You must discuss with your doctor appropriate methods of birth control (contraceptives). 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 the 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 SODIUM VALPROATE AUROBINDO AND NOT PLANNING TO HAVE A CHILD
If you are continuing treatment with Sodium Valproate Aurobindo but do not plan to have a child, ensure you use an effective contraceptive method continuously throughout the entire duration of treatment with Sodium Valproate Aurobindo. Talk to your doctor or visit a family planning clinic if you need advice on contraception.
Key messages:

• You must use an effective method of birth control (contraception) throughout the entire treatment with Sodium Valproate Aurobindo.
• 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 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 the 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 SODIUM VALPROATE AUROBINDO AND PLANNING A PREGNANCY
If you are planning to have a child, make an appointment with your doctor first.
Do not stop taking Sodium Valproate Aurobindo or your contraceptive unless you have discussed it with your doctor. Your doctor can give you further advice.
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 various 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 Sodium Valproate Aurobindo, switch to another medicine, or discontinue treatment with Sodium Valproate Aurobindo 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 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 Sodium Valproate Aurobindo unless your doctor tells you to.
• Do not stop using birth control methods (contraceptives) before discussing it with your doctor and agreeing on a plan to ensure your condition is controlled and risks to the baby are minimized.
• Make an appointment with your doctor as soon as possible. During this visit, your doctor will ensure you are fully aware and understand all the risks and advice related to valproate use in pregnancy.
• Your doctor will try to change your medicine or discontinue treatment with Sodium Valproate Aurobindo well before pregnancy.
• Request an urgent appointment with your doctor if you are pregnant or think you might be.

I AM TAKING SODIUM VALPROATE AUROBINDO AND HAVE BECOME PREGNANT
Do not stop taking Sodium Valproate Aurobindo 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. Your doctor can give you further advice.
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 Sodium Valproate Aurobindo 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 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 birth 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 Sodium Valproate Aurobindo unless your doctor tells you to.
• Ensure you are referred to a specialist experienced in treating epilepsy to evaluate the need for alternative treatment options.
• You must receive detailed counselling regarding the risks of Sodium Valproate Aurobindo 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 movement and mental development 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 needed to form new sperm) or more before conception is not known. The study has limitations, so it is not entirely clear 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 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 (birth control) for you and your partner during treatment and for 3 months after stopping treatment
• The need to consult a specialist if you are 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.
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 talking to your doctor. If you stop treatment, your symptoms may worsen.
You should 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
Since only small amounts of Sodium Valproate Aurobindo pass into breast milk, there is generally no risk to the baby and weaning is not usually necessary. However, talk to your doctor to assess whether you should breastfeed your baby.
Driving and using machines
Sodium Valproate Aurobindo 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 Sodium Valproate Aurobindo before driving, using tools or machinery, or performing other activities that could become dangerous if you are drowsy or dizzy.
Sodium Valproate Aurobindo contains sodium
Sodium Valproate Aurobindo 300 mg
This medicine contains 27.8 mg of sodium (a main component of table salt) per tablet.
This is equivalent to 1.39% of the maximum daily recommended dietary intake for an adult.

3. How to take Sodium Valproate Aurobindo

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.

Female children and women of childbearing age
Treatment with Sodium Valproate Aurobindo must be initiated and supervised by a specialist
doctor experienced in the treatment of epilepsy or bipolar disorders.

Male patients
It is recommended that treatment with Sodium Valproate Aurobindo 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 check-up appointments. These are very important because your dose may
need to be adjusted.

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 valproic acid levels is usually
40–100 mg/litre (300–700 micromoles/litre).

Starting treatment with Sodium Valproate Aurobindo (oral use):

• If you are not taking other antiepileptic medicines, Sodium Valproate Aurobindo should ideally be
  increased by introducing successive doses at intervals of 2–3 days, to achieve the optimal dosage
  within one week.

• If you are already taking another antiepileptic medicine, Sodium Valproate Aurobindo should be
  gradually increased to reach the optimal dosage after about 2 weeks, while the other treatment should
  be gradually reduced until completely discontinued.

• If combination therapy with other antiepileptics is required, these should be slowly reduced (see
  section 2 “Other medicines and Sodium Valproate Aurobindo”).

Practical considerations: administration of Sodium Valproate Aurobindo (oral use)
Dosage:
The initial daily dose is 10–15 mg/kg; doses should then be progressively increased until reaching
the optimal dosage, which is generally between 20 and 30 mg/kg (see section “Starting treatment with
Sodium Valproate Aurobindo (oral use)”).
However, when adequate seizure control is not achieved with this dosage, doses may be further
increased; your doctor will keep you under close supervision (which 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 may be altered in elderly patients, these changes have not
  been considered clinically significant; dosage should therefore be determined based on clinical
  response (seizure control).

Treatment of mania associated with bipolar disorders:
The daily dose must be established 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
Your 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 divided doses.
Take Sodium Valproate Aurobindo for as long as your doctor considers necessary and until it is
discontinued by prescription.
Contact your doctor or pharmacist if you think that Sodium Valproate Aurobindo is too weak or too
strong.

If you take more Sodium Valproate Aurobindo than you should
An overdose of Sodium Valproate Aurobindo can be dangerous. Inform your doctor or go
immediately to the nearest hospital. Signs of acute intoxication usually include coma, muscular
hypotonia, hyporeflexia, miosis, impaired respiratory function, and metabolic acidosis.
However, symptoms may vary, and epileptic seizures have been reported with very high plasma levels.
Cases of intracranial hypertension associated with cerebral oedema have also 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 Sodium Valproate Aurobindo
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 Sodium Valproate Aurobindo
Do not change the dose or stop taking Sodium Valproate Aurobindo without first consulting your
doctor. Your condition may worsen if you discontinue treatment with Sodium Valproate Aurobindo
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, Sodio Valproato Aurobindo can cause side effects, although not everybody gets them.
These side effects are generally mild to moderate.
They can occasionally be rare (serious), but in most cases they are not. The side effects are generally reversible, but medical treatment may be required for some of them:

• vomiting, nausea or stomach pain and diarrhoea, particularly at the beginning of treatment;
• headache;
• tremor, drowsiness, sedation, unsteadiness when walking;
• aggression, agitation, attention disorders, abnormal behaviour and hyperactivity;
• dizziness;
• tingling of the hands and feet;
• seeing, perceiving and 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, pain during menstruation, ovarian cysts (polycystic ovaries);
• 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 (shown by blood or muscle tests) (frequency not known);
• decrease in 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;
• darker areas of the skin and mucous membranes (hyperpigmentation) (frequency not known);
• 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, if you have a history of osteoporosis or if you are taking steroids, discuss this with your doctor or pharmacist.
Inform your doctor immediately if you notice any of the following side effects (which are considered serious).
Urgent medical treatment may be needed:

• drowsiness, changes in level of consciousness (including coma), lethargic (strange) behaviour, memory loss associated (or not) with more frequent or more severe seizures, disorientation, particularly if taken concomitantly with medicines containing phenobarbital and topiramate or if the dose of Sodio Valproato Aurobindo 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 (consult a doctor immediately for assessment of 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 an increase in the amount of ammonia in the blood;
• problems with blood clotting (visible from blood tests);
• spontaneous bruising or bleeding;
• you have an allergic reaction which could present as:
• blisters with skin peeling (blisters, desquamation or bleeding on any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet) with or without rash), sometimes with 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 rash with eosinophilia and systemic symptoms (DRESS)”;
• severe reduction in white blood cell count (leucocytes) or bone marrow failure, which sometimes presents with fever and breathing difficulties;
• confusion which may be due to a reduction in 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 symptoms (involuntary movements);
• breathing difficulties, pain or pressure in the chest (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 disease, 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 while walking (parkinsonism, extrapyramidal disorders, ataxia).

Sodio Valproato Aurobindo may also cause a reduction in platelet or red blood cell count,
or an abnormal increase in the size of red blood cells and bone marrow disorders.
Additional side effects in children
Some side effects of valproate occur more frequently in children, or are more severe than in adults. These include liver damage, pancreas infection (pancreatitis), aggression,
agitation, attention disorders, 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 Sodium Valproate Aurobindo

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 pack after "EXP.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sodio Valproato Aurobindo contains

• The active substances are sodium valproate and valproic acid.
• Each prolonged-release tablet contains 199.80 mg of sodium valproate and 87 mg of valproic acid (equivalent to 300 mg of sodium valproate).
• Each prolonged-release tablet contains 333 mg of sodium valproate and 145 mg of valproic acid (equivalent to 500 mg of sodium valproate).
• The other components are: Tablet core: Anhydrous colloidal silica, hypromellose type 2208 (15000 cps), hypromellose type 2910 (4000 cps) and potassium acesulfame. Tablet coating: Sodium lauryl sulfate, dibutyl sebacate, basic butyl methacrylate copolymer, magnesium stearate and titanium dioxide (E171).

Description of the appearance of Sodio Valproato Aurobindo and pack contents
Prolonged-release tablets.
Sodio Valproato Aurobindo 300 mg prolonged-release tablets:
Film-coated tablets, white to off-white, oblong-shaped, biconvex, with a breakline on both sides.
The tablet can be divided into equal doses.

Sodio Valproato Aurobindo prolonged-release tablets are available in triple-laminated blister packs (Alu-Alu) containing 20, 30, 60 and 100 prolonged-release tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Aurobindo Pharma Italia S.r.l.
Via San Giuseppe, 102
21047 – Saronno (VA)
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
2700-487 Amadora, Portugal
This medicinal product is authorized in the European Economic Area Member States under the following
names:
Italy: Sodio Valproato Aurobindo
Portugal: Ácido Valpróico Aurovitas