ACIDO 300 mg Препарат С Пролонгированным Высвобождением

Содержание инструкции

1. Valproic Acid and Sodium Valproate EG 300 mg prolonged-release tablets, 500 mg prolonged-release tablets
   1. What is Acido Valproico and Sodio Valproato EG and what is it used for
   2. What you need to know before taking Acido Valproico and Sodio Valproato EG
   3. How to take Acido Valproico and Sodio Valproato EG
   4. Possible side effects
   5. How to store Acido Valproico and Sodio Valproato EG
   6. Package Contents and Other Information

Valproic Acid and Sodium Valproate EG 300 mg prolonged-release tablets, 500 mg prolonged-release tablets

Sodium valproate
Generic medicine

Medicine subject to additional monitoring. This will allow the rapid identification of new
safety information. You can contribute by reporting any adverse effects you experience during
taking this medicine. See the end of section 4 for information on how to report adverse effects.

WARNING
Valproic Acid and Sodium Valproate EG if taken during pregnancy can seriously harm the fetus. If you are
a woman of childbearing potential, you must use an effective method of contraception (contraceptive) without
interruption, for the entire duration of treatment with Valproic Acid and Sodium Valproate EG. Your doctor will
discuss this with you, but you must also follow the recommendations in section 2 of this leaflet.
If you want to plan a pregnancy or think you may be pregnant, request an urgent appointment with your
doctor.
Do not stop taking Valproic Acid and Sodium Valproate EG unless your doctor has told you to, as
your condition may worsen.

Read 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 pass it on to others, even if they have the same
symptoms as you, as it may be harmful.
If you get any side effects, see your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Acido Valproico and Sodio Valproato EG and what is it used for

Acido Valproico and Sodio Valproato EG is a medicine for the treatment of epilepsy (antiepileptic) and for the
treatment of mania (abnormally elevated mood with increased activity).
Acido Valproico and Sodio Valproato EG is used for the treatment of

• seizures that involve both hemispheres of the brain (generalized epilepsy), e.g. absence seizures, myoclonic and tonic-clonic seizures;
• seizures that involve a limited part of the brain (focal seizures) and which in some circumstances spread to both halves of the brain (secondary generalized seizures).

Acido Valproico and Sodio Valproato EG can be administered together with other medicines for epilepsy in
other convulsive forms, e.g. epileptic seizures with mixed symptoms (complex), as well as seizures that
spread to both halves of the brain from a limited part of the brain, when these convulsive forms
do not respond to usual antiepileptic treatment.

• Mania, a state in which you may feel very excited, euphoric, agitated, enthusiastic or hyperactive. Mania occurs in an illness called “bipolar disorder”. Acido Valproico and Sodio Valproato EG can be used when lithium is not usable.

Notes
When switching from previous dosage forms (immediate release) to Acido Valproico and Sodio
Valproato EG, care must be taken to ensure sufficient serum levels of valproic acid.
In young children, Acido Valproico and Sodio Valproato EG may be chosen as a first-choice
medicine only in exceptional cases. If used, Acido Valproico and Sodio Valproato EG must be used only
with particular caution after careful evaluation of the risk/benefit ratio and preferably not
together with other medicines for epilepsy.

2. What you need to know before taking Acido Valproico and Sodio Valproato EG

Do not take Acido Valproico and Sodio Valproato EG

• if you are allergic to sodium valproate or valproic acid or any of the other ingredients of this medicine (listed in section 6);
• if you or someone in your family has suffered from severe liver dysfunction or if you suffer from severe liver or pancreatic dysfunction;
• if one of your siblings has suffered from liver dysfunction that caused death during treatment with valproic acid;
• if you suffer from a congenital or acquired metabolic disorder of blood pigment (hepatic porphyria);
• if you have problems with blood coagulation;
• if you suffer from a genetic disorder that causes a mitochondrial disorder (for example, Alpers-Huttenlocher syndrome);
• if you suffer from a urea cycle disorder (a specific metabolic disorder);
• if you have an untreated carnitine deficiency (a very rare metabolic disease).

Bipolar disorder

• For bipolar disorder, if you are pregnant, you must not use Acido Valproico and Sodio Valproato EG.
• For bipolar disorder, if you are a woman of childbearing potential, you must not take Acido Valproico and Sodio Valproato EG unless you are using an effective method of birth control (contraceptive) during the entire treatment with Acido Valproico and Sodio Valproato EG. Do not stop taking Acido Valproico and Sodio Valproato EG or your contraceptive, until you have discussed this with your doctor. Your doctor will advise you further (see below in “Pregnancy, breastfeeding and fertility - Important warning for women”).

Epilepsy

• For epilepsy, if you are pregnant, you must not use Acido Valproico and Sodio Valproato EG unless nothing else is effective for you.
• For epilepsy, if you are a woman of childbearing potential, you must not take Acido Valproico and Sodio Valproato EG unless you are using an effective method of birth control (contraceptive) during the entire treatment with Acido Valproico and Sodio Valproato EG. Do not stop taking Acido Valproico and Sodio Valproato EG or your contraceptive, until you have discussed this with your doctor. Your doctor will advise you further (see below in “Pregnancy, breastfeeding and fertility - Important warning for women”).

Warnings and precautions
Talk to your doctor or pharmacist before taking Acido Valproico and Sodio Valproato EG.

Contact your doctor immediately

• Severe skin reactions including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), multiforme erythema and angioedema have been reported in association with valproate treatment. Contact your doctor immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.
• In case of symptoms of liver and/or pancreas damage (see below “Liver and/or pancreas damage”). The risk of liver damage is greater if Acido Valproico and Sodio Valproato EG is taken by children under 3 years of age, by people who are taking other antiepileptic drugs at the same time or who suffer from other neurological or metabolic diseases and severe forms of epilepsy.
• If you or your child being treated with Acido Valproico and Sodio Valproato EG develops problems with balance and coordination, feeling of lethargy or loss of alertness, vomiting, inform your doctor immediately. This may be due to an increase in the amount of ammonia in the blood.
• If your seizures worsen. As with other drugs for the treatment of epilepsy, a worsening (increase) in the frequency and severity of seizures may also occur during treatment with Acido Valproico and Sodio Valproato EG. In this case, you should inform your doctor immediately.
• A small number of patients treated with antiepileptic drugs such as valproate have thought about harming or killing themselves. If these thoughts occur at any time, contact your doctor immediately.

Consult your doctor before taking this medicine

• If you have ever developed a severe rash or skin peeling, blisters and/or mouth sores after taking valproate.
• If you have ever had bone marrow damage.
• If you suffer from systemic lupus erythematosus (a reaction of your body's own defense system against the connective tissue of the body).
• If you suspect you suffer from metabolic disorders, especially hereditary enzyme deficiency disorders such as a “urea cycle disorder” due to the risk of increased levels of ammonia in the blood.
• If you suffer from a rare disease known as “carnitine palmitoyl transferase type II deficiency”, as you are at greater risk of developing muscle disorders.
• If you know or your doctor suspects that there is a genetic disorder in your family that causes a mitochondrial disease, due to the risk of liver damage.
• If you have a reduced intake of carnitine, found in meat and dairy products, especially in children under 10 years of age.
• If you have a carnitine deficiency and are taking it.
• If your kidney function is impaired or you have a protein deficiency in your blood.
• Before surgery or dental procedures (e.g. tooth extraction) and in case of injuries or spontaneous bleeding. Because your tendency to bleed may increase, the treating doctor must be informed that you are taking Acido Valproico and Sodio Valproato EG, so that blood coagulation can be checked.
• If you are also taking medicines that prevent blood clotting (e.g. vitamin K antagonists); your tendency to bleed may increase. Blood coagulation should therefore be checked regularly.
• If you are also taking acetylsalicylic acid (“ASA”), as the concentrations of valproic acid (the active ingredient of Acido Valproico and Sodio Valproato EG) in the blood may increase.

Liver and/or pancreas damage
Severe liver damage has been observed occasionally, rarely pancreas damage. Patients, in
particular newborns, young children in early childhood and children, must be carefully
monitored by a doctor in this regard, especially during the first six months of treatment.
Liver and/or pancreatic damage may be preceded by non-specific signs that usually appear
suddenly, e.g. recurrence of seizures, increased frequency or severity of seizures, disturbances of consciousness with confusion, restlessness, movement disorders, physical agitation and
weakness, loss of appetite, aversion to usual foods, aversion to valproic acid, nausea, vomiting,
upper abdominal discomfort, apathy, drowsiness, markedly frequent bruising (hematomas), jaundice
(yellowing of the skin or whites of the eyes), nosebleeds and fluid accumulation (edema) in some
parts of the body or throughout the body. If these symptoms are persistent or severe, you should inform your doctor
to decide whether treatment with Acido Valproico and Sodio Valproato EG should be continued.
Measures for early detection of liver and/or pancreatic damage
Before starting treatment, the doctor must take a detailed medical history and perform a clinical examination and laboratory chemical tests (particularly with regard to metabolic disorders, liver or pancreatic disorders, blood count and blood coagulation disorders).
Four weeks after starting treatment, a further laboratory follow-up must be carried out.
In patients without clinical signs, but with abnormally elevated laboratory values at 4 weeks, follow-up checks must be carried out three times at intervals of a maximum of two weeks and,
subsequently, at monthly intervals up to the sixth month of treatment.
Parents/caregivers must immediately inform the treating doctor if clinical abnormalities occur, regardless of this leaflet.
In adolescents(from 15 years of age) and adults, monthly monitoring of clinical results and laboratory values is recommended during the first six months and always before starting therapy.
After 12 months of treatment without abnormal results, 2-3 further follow-up medical checks are necessary each year.
Notes
Weight gain may occur at the beginning of treatment. You should check your weight regularly and, if
necessary, agree on appropriate measures with your doctor.
Acido Valproico and Sodio Valproato EG should not be used for the prevention of migraine (see
also section “Pregnancy, breastfeeding and fertility”).

Children and adolescents
Take special care when Acido Valproico and Sodio Valproato EG is given to

• children in early childhood who are also taking other medicines for epilepsy,
• children and adolescents with multiple disabilities and severe forms of seizures,

Acido Valproico and Sodio Valproato EG should not be used in children and adolescents under
18 years of age for the treatment of mania.
In the presence of fever, Acido Valproico and Sodio Valproato EG should not be taken
simultaneously with acetylsalicylic acid by infants and children and adolescents unless specifically
instructed by a doctor.

Other medications and Valproic Acid and Sodium Valproate EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any
other medication.
The effect and, in some cases, the undesirable effects of Valproic Acid and Sodium Valproate EG are increased by

• felbamate (a medication for the treatment of epilepsy),
• cimetidine (a medication for the treatment of gastric ulcers),
• erythromycin (medication for the treatment of bacterial infections),
• acetylsalicylic acid (a medication against fever and pain): acetylsalicylic acid reduces the binding of valproic acid to blood proteins. This can increase the harmful effect of valproic acid on the liver. See also the paragraph “Children and adolescents” in section 2 “What you need to know before taking Valproic Acid and Sodium Valproate EG”.

The effect of Valproic Acid and Sodium Valproate EG is reduced by

• phenobarbital, primidone, phenytoin, carbamazepine (other medications for epilepsy),
• mefloquine (medication for malaria),
• rifampicin (medication for tuberculosis),
• carbapenems (antibiotics for the treatment of bacterial infections, such as imipenem, panipenem and meropenem). Avoid using valproic acid simultaneously with carbapenems, as this may reduce the effectiveness of valproic acid;
• protease inhibitors such as lopinavir or ritonavir (medications for the treatment of HIV infections),
• cholestyramine (medications for lowering blood fats),
• products containing estrogens (including some hormonal contraceptives),
• metamizole (medication for the treatment of pain and fever),
• methotrexate (used to treat cancer or inflammatory diseases).

The effect of Valproic Acid and Sodium Valproate EG can be increased or reduced by:

• co-administration of fluoxetine (an antidepressant). Serum concentrations of valproic acid (the active ingredient of Valproic Acid and Sodium Valproate EG) may increase, however, cases in which they have decreased have also been reported.

Valproic Acid and Sodium Valproate EG increases the effect and, in some cases, the undesirable effects of

• phenobarbital, primidone, phenytoin, carbamazepine, lamotrigine, felbamate (medications for epilepsy),
• neuroleptics (medications for treating mental disorders), benzodiazepines (medications for relieving anxiety and tension), barbiturates (sedatives), MAO inhibitors (antidepressants) and other medications for depression,
• codeine (medication for cough),
• zidovudine (a medication for the treatment of HIV infections),
• medications that prevent blood clotting (e.g. vitamin K antagonists or acetylsalicylic acid). An increased tendency to bleeding is possible;
• rufinamide (a medication for epilepsy) (caution is necessary, especially in children),
• propofol (a narcotic),
• nimodipine (medications for the treatment of brain function disorders).

In children, serum levels of phenytoin (another medication for epilepsy) may increase if co-
administered with clonazepam (a benzodiazepine, medication for relieving anxiety and tension and for
epilepsy) and valproic acid.
During combined treatment with medications containing valproic acid and clonazepam (a medication for
epilepsy), an absence status (prolonged state of semi-consciousness) has occurred in patients with a history
of absence seizures (a specific form of seizures that involves both hemispheres
of the brain).
A patient with schizo-affective disorder (mental disorder) developed catatonia (a state of rigidity
that does not respond to external stimuli) when treated simultaneously with valproic acid,
sertraline (an antidepressant) and risperidone (a neuroleptic).
Some medications can influence the effects of valproate and vice versa. These include:

• clozapine (for treating mental health problems).

Other interactions

• Valproic Acid and Sodium Valproate EG has no effect on serum lithium levels.
• The effect of hormonal contraceptive preparations (the “pill”) is not reduced.
• In patients with diabetes, false positives may occur in urine ketone tests, as valproic acid itself is partially metabolized into ketone bodies.
• Other medications that overload the liver metabolism can increase the risk of developing liver damage, such as cannabidiol (used to treat epilepsy and other conditions).
• When valproic acid was administered simultaneously with topiramate (a medication for epilepsy), signs of brain damage (encephalopathy) and/or an increase in blood ammonia levels (hyperammonemia) have been reported.
• If Valproic Acid and Sodium Valproate EG is administered together with acetazolamide (a medication used to treat glaucoma), an increase in blood ammonia levels may occur, with a risk of brain damage (encephalopathy).
• If valproic acid is used simultaneously with phenobarbital or phenytoin, ammonia levels in the blood may increase. Your doctor will monitor you closely for this.
• When used simultaneously, valproic acid and quetiapine (a medication used to treat psychiatric disorders) may increase the risk of a reduction in the number of white blood cells (leukopenia, neutropenia).
• Valproic Acid and Sodium Valproate EG may reduce plasma concentrations of olanzapine (a medication for the treatment of psychiatric disorders).
• Some anti-infectives containing pivalate (e.g. pivampicillin, adefovir dipivoxil) may increase the risk of carnitine deficiency if used in conjunction with valproate.

The doctor will decide whether it is necessary to stop taking other medications in use or whether it is possible
to continue treatment.

Valproic Acid and Sodium Valproate EG with food, beverages and alcohol
Concomitant consumption of alcohol may reduce or increase the effect of Valproic Acid and Sodium Valproate
EG, as well as increase its undesirable effects. You should therefore avoid taking alcohol during
treatment.
The bioavailability of Valproic Acid and Sodium Valproate EG is not affected by the concomitant
intake of food.

Pregnancy, breastfeeding and fertility
Important warning for women
Bipolar disorder

• If you are pregnant, you should not use Valproic Acid and Sodium Valproate EG for bipolar disorder
• For bipolar disorder, if you are a woman of childbearing potential, you should not take Valproic Acid and Sodium Valproate EG unless you are using an effective method of birth control (contraceptive) during the entire treatment with Valproic Acid and Sodium Valproate EG. Do not stop taking Valproic Acid and Sodium Valproate EG or your contraceptive, unless you have discussed this with your doctor. Your doctor will advise you further.

Epilepsy

• For epilepsy, if you are pregnant, you should not use Valproic Acid and Sodium Valproate EG unless nothing else is effective for you.
• For epilepsy, if you are a woman of childbearing potential, you should not take Valproic Acid and Sodium Valproate EG unless you are using an effective method of birth control (contraceptive) during the entire treatment with Valproic Acid and Sodium Valproate EG. Do not stop taking Valproic Acid and Sodium Valproate EG or your contraceptive, unless you have discussed this with your doctor. Your doctor will advise you further.

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

• Talk to your doctor immediately if you are planning to become pregnant or are pregnant.
• Valproate carries risks if taken during pregnancy. The risk is greater at higher doses, but all doses carry a risk, including the use of valproate in combination with other medications that treat epilepsy.
• This medicine can cause serious birth defects and can have consequences for the physical and mental development and growth of the child 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 malformations associated with affecting different organs and parts of the body. Birth defects can 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, in association with other congenital malformations. These eye malformations can affect vision.
• If you take valproate during pregnancy, you have a higher risk than other women of having a baby with birth defects requiring medical treatment. Because valproate has been used for many years, we know that in women taking valproate, about 11 out of 100 babies have birth defects, compared to 2-3 babies out of 100 born to women who do not suffer from epilepsy.
• It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may develop developmental problems in early childhood. These children may start walking and talking late, be intellectually less capable than other children, and have difficulties with language and memory.
• Autism spectrum disorders are more often diagnosed in children exposed to valproate, and there is some evidence that children exposed to valproate during pregnancy have a higher risk of developing symptoms of attention deficit hyperactivity disorder (ADHD).
• Before prescribing this medicine to you, your doctor will explain what could happen to your baby if you become pregnant while taking valproate. If you later decide you want to become pregnant, do not stop taking the medicine or the contraceptive method before discussing this with your doctor.
• If you are the parent or caregiver of a girl treated with valproate, you should contact your doctor as soon as the girl has her first menstrual period.
• Some hormonal contraceptives (birth control pills containing estrogens) can decrease the levels of valproate in the blood. Be sure to talk to your doctor about the most suitable method of contraception (birth control) for you.
• Consult your doctor about taking folic acid while trying to become pregnant. Folic acid can reduce the overall risk of spina bifidaand early miscarriage, possible in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.
• If you have taken medications containing valproic acid during pregnancy, it is necessary to check the blood coagulation values (platelets, fibrinogen) and the coagulation factors and perform coagulation tests in the newborn, due to possible blood coagulation disorders.
• Withdrawal symptoms (such as restlessness, excessive motor activity, tremors, cramps and difficulty sucking) may occur in newborns whose mothers were treated with medications containing valproic acid during the last three months of pregnancy.
• Cases of low blood sugar levels have been reported in newborns whose mothers had taken valproate during the last three months of pregnancy.
• Cases of underactive thyroid have been described in newborns whose mothers with epilepsy had taken valproate during pregnancy.

Choose and read the situations that apply to you from those described below:

• I AM STARTING TREATMENT WITH VALPROIC ACID AND SODIUM VALPROATE EG
• I AM TAKING VALPROIC ACID AND SODIUM VALPROATE EG AND DO NOT PLAN TO HAVE A CHILD
• I AM TAKING VALPROIC ACID AND SODIUM VALPROATE EG AND PLAN TO HAVE A CHILD
• I AM PREGNANT AND TAKING VALPROIC ACID AND SODIUM VALPROATE EG

I AM STARTING TREATMENT WITH VALPROIC ACID AND SODIUM VALPROATE EG
If Valproic Acid and Sodium Valproate EG 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 potential, you must ensure that you use an
effective method of contraception, without interruption, for the entire duration of treatment with Valproic Acid and Sodium
Valproate EG. Talk to your doctor or go to a family planning clinic if you need advice on
contraception.

Key messages:

• Before starting treatment with Valproic Acid and Sodium Valproate EG, a pregnancy test confirmed by your doctor must be excluded.
• During the entire treatment with Valproic Acid and Sodium Valproate EG, you must use an effective method of birth control (contraceptive).
• You must discuss appropriate methods of birth control (contraceptives) with your doctor. The doctor will explain how to prevent pregnancy and can refer you to a specialist for advice on birth control.
• You must have regular appointments (at least once a year) with a specialist experienced in managing bipolar disorder or epilepsy. On this visit, your doctor will ensure that you are fully aware and have understood all the risks and advice regarding the use of valproate during pregnancy.
• Inform your doctor if you want to have a baby.
• Immediately inform your doctor if you are pregnant or think you may be.

I AM TAKING VALPROIC ACID AND SODIUM VALPROATE EG AND I DO NOT PLAN
TO HAVE A CHILD
If you are continuing treatment with Valproic Acid and Sodium Valproate EG but do not plan to have a child, be sure to use an effective method of contraception, without interruption, for the entire duration of treatment with Valproic Acid and Sodium Valproate EG. Talk to your doctor or family planning clinic if you need advice on contraception.

Key messages:

• You must use an effective method of birth control (contraception) throughout your treatment with Valproic Acid and Sodium Valproate EG.
• You should discuss contraception (birth control) with your doctor. Your doctor will explain how to prevent pregnancy and can refer you to a specialist for advice on birth control.
• You should regularly schedule appointments (at least once a year) with a specialist experienced in managing bipolar disorder or epilepsy. During this visit, your doctor will ensure that you are fully aware of and understand all the risks and advice related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a child.
• Tell your doctor immediately if you are pregnant or think you might be.

I AM TAKING VALPROIC ACID AND SODIUM VALPROATE EG AND I PLAN
TO HAVE A CHILD
If you are planning to have a child, first make an appointment with your doctor.
Do not stop taking Valproic Acid and Sodium Valproate EG or your contraception until 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 can be severely disabling. Your doctor will refer you to a specialist experienced in managing bipolar disorder or epilepsy, in order to evaluate alternative therapeutic options as soon as possible. The specialist may take various measures to facilitate the course of pregnancy as much as possible and to reduce the risks for you and the unborn child as much as possible.
The specialist may decide to change the dose of Valproic Acid and Sodium Valproate EG or switch to another medicine, or to stop treatment with Valproic Acid and Sodium Valproate EG well before pregnancy, in order to ensure that the illness is stable.
Ask your doctor about taking folic acid when planning to have a child. Folic acid can reduce the overall risk of spina bifidaand early miscarriage, which are possible in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.

Key messages:

• Do not stop taking Valproic Acid and Sodium Valproate EG unless your doctor has told you to.
• Do not stop using birth control methods (contraceptives) before discussing it with your doctor and agreeing on a plan to ensure control of your illness and reduce risks to the baby.
• First make an appointment with your doctor. During this visit, the doctor will ensure that you are fully aware of and understand all the risks and advice related to the use of valproate during pregnancy.
• Your doctor will try to change your medicine or stop treatment with Valproic Acid and Sodium Valproate EG well before pregnancy.
• Request an urgent appointment with your doctor if you are pregnant or think you might be.

I AM PREGNANT AND I AM TAKING VALPROIC ACID AND SODIUM VALPROATE EG
Do not stop taking Valproic Acid and Sodium Valproate EG unless your doctor has established it, because your illness may worsen. Request an urgent appointment with your doctor if you are pregnant or believe you may be. Your doctor will advise you further.
Children born to mothers treated with valproate have a high risk of birth defects and developmental problems that can be severely disabling.
You will be referred to a specialist experienced in managing bipolar disorder or epilepsy, in order to evaluate alternative therapeutic options.
In exceptional circumstances, if Valproic Acid and Sodium Valproate EG is the only treatment option available during pregnancy, you will be subject to careful monitoring both for the management of your underlying illness and to monitor the development of the fetus. You and your partner may receive counseling and support regarding exposure to valproate during pregnancy.
Ask your doctor for advice on taking folic acid. Folic acid can reduce the overall risk of spina bifidaand miscarriage, which are possible in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.

Key messages:

• Request an urgent appointment with your doctor if you are pregnant or think you might be.
• Do not stop taking Valproic Acid and Sodium Valproate EG unless your doctor has told you to.
• Make sure you are referred to a specialist experienced in the treatment of epilepsy, bipolar disorder, to assess the need for alternative treatment options.
• You must receive detailed counseling regarding the risks of Valproic Acid and Sodium Valproate EG during pregnancy, including teratogenicity and effects on physical and mental development in children.
• Make sure 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 Acceptance Form with you and ask you to sign and keep it. You will also be given the Patient Card by the pharmacist to remind you of the risks of valproate during pregnancy.
Important warning for male patients

Potential risk associated with taking valproate in the 3 months before conception
One study suggests a possible risk of movement disorders and mental development problems (problems affecting development in early childhood) in children born to fathers treated with valproate in the 3 months before conception. In this study, about 5 children out of 100 had these disorders when born to fathers treated with valproate, compared to about 3 children out of 100 born to fathers treated with lamotrigine or levetiracetam (other medicines that can be used to treat your illness). The risk for children born to fathers who stopped treatment with valproate 3 months (the time it takes to form new sperm) or longer before conception is unknown. The study has limitations and therefore 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 particular type of movement and mental development disorder children may be at risk of developing.
As a precaution, your doctor will discuss with you:

• The potential risk to 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 therapy.
• The need to consult the specialist if you are planning to conceive a child and before stopping contraception (birth control).
• The possibility of other treatments that can be used to treat your illness, 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 about having a child.
If your partner becomes pregnant while you have taken valproate in the 3 months before conception and have questions, contact your doctor. Do not stop treatment without talking to your doctor. If you stop treatment, your symptoms may worsen.
You should schedule regular appointments with your prescribing doctor. During this visit, your doctor will discuss with you the precautions associated with the use of valproate and the possibility of other treatments that can be used to treat your illness, 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
Small amounts of valproic acid are excreted in breast milk. Ask your doctor for advice before taking this medicine if you are breastfeeding.
Fertility
This medicine may impair your ability to father a child. Clinical cases have shown that these effects are generally reversible upon discontinuation of the active ingredient or after a reduction in the dose. Do not stop treatment without consulting your doctor.

Driving and operating machinery
Do not drive vehicles or operate machinery before consulting your doctor.
At the beginning of therapy with Valproic Acid and Sodium Valproate EG and at higher doses or when taken simultaneously with other medicines that act on the central nervous system, effects on the central nervous system such as drowsiness or confusion may alter the ability to react to such an extent that, regardless of the effect of the underlying condition being treated, the ability to drive or operate machinery may be impaired. This is especially true in case of interaction with alcohol.

Valproic Acid and Sodium Valproate EG contains sodium

Valproic Acid and Sodium Valproate EG 300 mg
This medicine contains up to 29.1 mg of sodium (the main component of table salt) per prolonged-release tablet. This corresponds to 1.5% of the maximum recommended daily intake with the diet of an adult.

Valproic Acid and Sodium Valproate EG 500 mg
This medicine contains up to 48.5 mg of sodium (the main component of table salt) per prolonged-release tablet. This corresponds to 2.4% of the maximum recommended daily intake with the diet of an adult.

3. How to take Acido Valproico and Sodio Valproato EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist. Do not change the treatment or the dose without first
consulting your doctor.
Girls and women of childbearing potential
Treatment with Acido Valproico and Sodio Valproato EG must be initiated and supervised by a doctor
specialized in the treatment of epilepsy or bipolar disorder.
Male patients
It is recommended that treatment with Acido Valproico and Sodio Valproato EG is initiated and supervised by
a specialist with experience in the management of epilepsy or bipolar disorder - see section 2 Important
warning for male patients.

Mania
The daily dose must be established and monitored on an individual basis by your doctor.
Initial dose
The recommended initial dose is equivalent to 750 mg. The dose should be increased as quickly as
possible to reach the lowest effective dose capable of producing the desired clinical effect.
Average daily dose
The recommended daily dose is generally between 1,000 mg and 2,000 mg (equivalent to 3½ - 6½
prolonged-release tablets of Acido Valproico and Sodio Valproato EG 300 mg or 2-4 prolonged-release tablets of
Acido Valproico and Sodio Valproato EG 500 mg). The dose should be adjusted individually
to your clinical picture.
The treatment of mania must be adapted individually using the lowest effective dose.

Epilepsy
The dosage will be determined and monitored by the specialist doctor on an individual basis with the aim of
achieving a seizure-free state using the lowest dosage, especially during
pregnancy.
Dosage
It is recommended to gradually increase the dosage until the optimal effective dose is reached.
Acido Valproico and Sodio Valproato EG prolonged-release tablets can be divided to allow for
individualization of the dosage.
When valproic acid is administered alone (monotherapy), the initial dose is usually 5-10 mg of valproic acid/kg of
body weight. Subsequently, the daily dose is gradually
increased every 4-7 days by approximately 5 mg of valproic acid/kg of body weight until the
dosage for seizure control is reached.
In some cases, the full effect is observed only after 4-6 weeks. Therefore, daily doses should not
be increased above average levels too soon.
The usual average daily dose during long-term treatment corresponds to:

• 30 mg of valproic acid/kg body weight/day for children,
• 25 mg of valproic acid/kg body weight/day for adolescents,
• 20 mg valproic acid/kg body weight/day for adults and elderly patients,

For this reason, the following daily doses are recommended as guidelines:
Acido Valproico and Sodio Valproato EG 300 mg

AgeBody weight
[kg]
Average dose1 (mg/day)Number of prolonged-release
tablets
Adults from approx. 60 1,200 - 2,100 4 - 7
Adolescents from
14 years of age
approx. 40 - 60 1,000 - 1,500 3½ - 5
Children2
3-6 months approx. 5.5 - 7.5 150 See Notes
6-12 months approx. 7.5 - 10 150 - 300 See Notes
1-3 years approx. 10 - 15 300 - 450 See Notes
3-6 years approx. 15 - 25 450 - 750 1½ - 2½
7-14 years approx. 25 - 40 750 - 1,200 2½ - 4
Acido Valproico and Sodio Valproato EG 500 mg

AgeBody weight
[kg]
Average dose1 (mg/day)Number of prolonged-release
tablets
Adults from approx. 60 1,200 - 2,100 2½ - 4
Adolescents from
14 years of age
approx. 40 - 60 1,000 - 1,500 2 - 3
Children2
3-6 months approx. 5.5 - 7.5 150 See Notes
6-12 months approx. 7.5 - 10 150 - 300 See Notes
1-3 years approx. 10 - 15 300 - 450 See Notes
3-6 years approx. 15 - 25 450 - 750 See Notes
7-14 years approx. 25 - 40 750 - 1,200 1½ - 2
The details refer to mg of sodium valproate.
Notes:
For children up to 3 years of age, pharmaceutical forms available with
a lower content of active substance (e.g. solution) should preferably be used.
For children up to 6 years of age, pharmaceutical forms available with a lower content of active substance [e.g. solution or 150 mg tablets (½ tablet of Acido
Valproico and Sodio Valproato EG 300 mg)] are particularly suitable.
Patients with kidney problems
Your doctor may decide to adjust the dosage.
Patients with low blood protein levels
If you suffer from low blood protein levels, the levels of the active ingredient (valproic acid) of Acido Valproico
and Sodio Valproato EG in the blood may increase. Your doctor will need to adjust the daily dose you are receiving, if necessary reducing it.
Notes on switching from one treatment to another
If you need to switch from another antiepileptic with the same active ingredient or from an antiepileptic with a different active
ingredient to treatment with Acido Valproico and Sodio Valproato EG, this switch must be
carried out as indicated by your doctor.
In most patients pre-treated with immediate-release pharmaceutical forms, the switch
to the prolonged-release pharmaceutical form can be made immediately or within a few days. In
this case, the amount of the dose previously administered must be maintained. A reduction in the dose is possible once seizures have decreased.
If Acido Valproico and Sodio Valproato EG is taken together with other antiepileptics, the dose of
antiepileptics previously taken, especially that of phenobarbital, must be reduced
immediately. If the previously taken medicine is discontinued, this must be done gradually.
Other medicines for epilepsy accelerate the degradation of valproic acid. If treatment with these
medicines is stopped, the concentration of valproic acid in the blood will slowly increase; therefore,
it is necessary to monitor the serum concentration of valproic acid for a period of 4-6 weeks after
stopping concomitant treatment. The daily dose of Acido Valproico and Sodio Valproato EG
must be reduced as necessary.
The serum concentration (established before the first daily dose) must not exceed 100
mg/L. The success of the treatment is not directly related to the daily dose or the serum concentration
of active ingredient. The dose, therefore, must essentially be based on seizure control.
The daily dose of Acido Valproico and Sodio Valproato EG can be divided into 1-2 single administrations.

Method of administration
Prolonged-release tablets should preferably be taken 1 hour before meals (in the morning on an
empty stomach) and must be swallowed whole (or divided in half), they must not be chewed and must
be taken with a plentiful amount of liquid (e.g. a glass of water). It is not recommended
to use carbonated drinks such as mineral water or similar to take the prolonged-release tablets.

Duration of treatment
The treatment of epilepsy and mania are long-term therapies. A specialist doctor must decide
on an individual basis the duration of treatment and the interruption of therapy with Acido Valproico and Sodio
Valproato EG. Usually, a gradual reduction of the dose or the suspension
of this medicine in the treatment of epilepsy can be considered, at the earliest, not before two or three years without
seizures. The gradual reduction or suspension of this medicine must be
carried out by gradually reducing the amount taken daily over one or two years.
Experience with valproic acid in long-term use is limited, especially in children under the age of
6 years.
If you feel that the effect of Acido Valproico and Sodio Valproato EG is too strong or too weak,
consult your doctor.
Occasionally, the components of the prolonged-release tablets can be found in the form of
white residue in the stool. However, this does not mean that the effect of the medicine has been compromised,
as the active ingredient is released from the structure of the tablet (matrix) during passage
through the intestine.

If you take more Acido Valproico and Sodio Valproato EG than you should
Immediately inform a doctor, so that he/she can take the necessary measures if necessary. The side effects
listed under “Side effects” may occur more intensely, such as a
increased tendency to seizures and behavioral disorders, in both adults and children. Fatalities have
occurred in isolated cases following massive overdose.

If you forget to take Acido Valproico and Sodio Valproato EG
Do not take a double dose to make up for a forgotten tablet. Continue to take the
medicine as prescribed.

If you stop taking Acido Valproico and Sodio Valproato EG
Do not change, interrupt or discontinue treatment with Acido Valproico and Sodio
Valproato EG prematurely without authorization. First, consult your doctor if you experience intolerances or
changes in your clinical picture. Otherwise, you may risk jeopardizing the success of the treatment and
triggering new seizures.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The following frequency data have been used for the evaluation of side effects:
Very common: more than 1 in 10 patients treated
Common: From 1 to 10 in 100 patients treated
Uncommon: From 1 to 10 in 1,000 patients treated
Rare: From 1 to 10 in 10,000 patients treated
Very rare: in less than 1 in 10,000 patients treated
Not known: the frequency cannot be defined based on the available data

Contact your doctor immediately if you notice any of the following serious side effects.
You may need urgent medical attention:
Uncommon(may affect up to 1 in 100 people)

• Difficulty breathing, chest pain or pressure (especially during inhalation), shortness of breath and dry cough due to fluid accumulation around the lungs (pleural effusion).

Tell your doctor or pharmacist if any of the following side effects worsen or lasts more
than a few days; you may need medical attention:
Not known(the frequency cannot be defined based on the available data)

• darker areas of the skin and mucous membranes (hyperpigmentation).

Tell your doctor or pharmacist if any of the following side effects worsen or lasts more than
a few days; you may need to seek medical attention:

Benign, malignant and unspecified tumors (including cysts and polyps)
Rare: Malformation of red blood cell precursors in the bone marrow (myelodysplastic syndrome,
as evidenced by the blood count).

Blood and lymphatic system disorders
Common: Reduction in the number of red blood cells (anemia), platelets (thrombocytopenia) or a significantly reduced number of white blood cells (leukopenia).
Uncommon: Significantly reduced number of all blood cells (pancytopenia).
Rare: Impairment of bone marrow function with a reduced number of white blood cells
(lymphopenia, neutropenia), with a significantly reduced number of certain white blood cells
(agranulocytosis), with failure to form red blood cells (aplasia) or with the formation of
enlarged red blood cells in a normal (macrocytosis) or reduced (macrocytic anemia) number. This
is evidenced in the blood count and sometimes manifests with signs such as fever and difficulty
breathing.

Endocrine disorders
Uncommon: Increased levels of antidiuretic hormone (inappropriate secretion of
antidiuretic hormone syndrome, SIADH), excessive hair growth on the body in women, appearance of
masculine characteristics in women, acne, male-pattern hair loss and/or increased
levels of androgens.
Rare: Hypothyroidism, which can cause fatigue or weight gain.

Metabolism and nutrition disorders
Very common: Isolated and moderate increase in blood ammonia levels (hyperammonemia) without
alterations in liver function tests, but with symptoms of the central nervous system in
isolated cases, such as balance and coordination disorders, fatigue or reduced
vigilance, in association with vomiting. If you experience these symptoms, warn your
doctor immediately. You may need urgent medical attention (see also paragraph 2
“Warnings and precautions”).
Common: Weight gain (risk factor for the development of ovarian cysts) or weight loss,
increased appetite or even loss of appetite; reduced sodium concentration in the blood
(hyponatremia) which can lead to confusion.
Rare: Obesity.
Not known: Reduction in carnitine concentrations (evidenced in blood or muscle tests).

Psychiatric disorders
Common: Confusional states, hallucinations (seeing, perceiving or hearing things that are not present),
aggressiveness, restlessness, attention disorders.
Uncommon: Irritability, hyperactivity.
Rare: Abnormal behavior, learning disorder, mental and physical hyperactivity
(psychomotor).

Nervous system disorders
Very common: Tremor (tremor).
Common: Extrapyramidal disorders (movement disorders affecting muscle activity regulated
by the brain, such as involuntary muscle contractions; sometimes permanent disorders), state
of stupor, drowsiness, seizures (convulsions), memory impairment, headache, involuntary eye movements (nystagmus), dizziness and sensations of
tingling/abnormal on the skin (paresthesia).
Uncommon: Coma, brain damage (encephalopathy), apathy (lethargy), Parkinsonism, which resolves
quickly after discontinuation of valproic acid, increased muscle tone
(spasticity), impaired coordination of movements (ataxia), such as unstable gait, worsening of seizures (see also section 2 “Warnings and
precautions”).
Signs of brain damage (encephalopathy) have been described immediately after the use of medicines containing valproic acid, which resolved after discontinuation of the medicine. In some
cases, these were associated with an increase in phenobarbital levels in combination therapy with phenobarbital.
Rare: Double vision, marked deterioration of mental performance (dementia) that regresses
upon discontinuation of treatment, sometimes associated with loss of brain tissue; mild
decrease in mental performance (cognitive impairment).

Rarely, brain disorders (chronic encephalopathy) with impaired
brain function and mental performance have been reported, especially with higher doses or when
taken concurrently with other medicines for epilepsy.
Not known: Drowsiness.
In the long-termtreatment with Valproic Acid and Sodium Valproate EG, especially if taken
concurrently with phenytoin (another medicine for epilepsy), signs of brain damage (encephalopathy) may occur: increased seizures, lethargy, stupor, reduced muscle tone
(muscle hypotonia) and severe general alterations in brain wave recording
(Electroencephalogram EEG).

Ear and labyrinth disorders
Common: Hearing loss (sometimes permanent).
Not known: Tinnitus (ringing/buzzing in the ear).

Vascular disorders
Common: Bruising or spontaneous bleeding (see also paragraph 2 “Warnings and precautions” and
“Pregnancy, breastfeeding and fertility”).
Uncommon: Inflammation of blood vessels (vasculitis).

Respiratory, thoracic and mediastinal disorders
Uncommon: Difficulty breathing and pain due to pleurisy/fluid accumulation between the lungs and the chest
(pleural effusion).

Gastrointestinal disorders
Very common: Nausea.
Common: Vomiting, gum disorders (mainly excessive gum growth), inflammation
of the oral mucosa (sores, swelling, ulcers and a burning sensation in the mouth), diarrhea,
especially at the beginning of treatment, as well as upper gastrointestinal disorders, which
usually resolve after a few days without interruption of treatment.
Uncommon: Damage to the pancreas, sometimes fatal (see also paragraph 2 “Warnings and precautions”),
increased salivation (especially at the beginning of treatment).

Hepatobiliary disorders
Common: Severe liver damage (sometimes fatal) dose-independent (see also paragraph 2
“Warnings and precautions”).

Skin and subcutaneous tissue disorders
Common: Hypersensitivity, transient and/or dose-dependent hair loss, nail and
nail bed disorders.
Uncommon: Swelling (angioedema) with painful and itchy blisters, usually in the area of the eyes,
lips, throat and larynx and sometimes hands, feet and genital area; skin rash, alterations of the hair (e.g. alteration of hair structure,
change in hair color, abnormal hair growth or hair),
Rare: Severe skin reactions: blisters, detachment or bleeding 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 (Stevens Johnson syndrome or
toxic epidermal necrolysis or Lyell's syndrome); rash (especially on the palms
of the hands and soles of the feet) or skin lesions with a pink/red ring and a pale center
that may be itchy, scaly or filled with fluid (erythema multiforme);
syndrome with drug-induced rash, fever and swollen lymph nodes and with
increased certain white blood cells (eosinophilia) and possible impairment of other organs
(DRESS).

Musculoskeletal and connective tissue disorders
Cases of decreased bone density (osteopenia and osteoporosis) and even bone fractures have been reported. Consult your doctor or pharmacist if you have been using antiepileptics for a long time, if you have been diagnosed
with osteoporosis or if you are also taking corticosteroids or other steroid hormones.
Rare: Reactions of the body's defense system against connective tissue, with signs such as
joint pain, fatigue/tiredness and skin rashes (systemic lupus erythematosus,
see also paragraph 2 “Warnings and precautions”), severe muscle breakdown
accompanied by weakness and pain (rhabdomyolysis).

Renal and urinary disorders
Common: Urinary incontinence (involuntary urination).
Uncommon: Renal failure with signs such as reduced urine production. Contact your doctor immediately if this serious side effect occurs. Urgent medical assistance may be needed.
Rare: Enuresis (weak bladder) or increased urinary urgency, inflammatory kidney disease
(tubulo-interstitial nephritis), abundant urine production and feeling of thirst (Fanconi syndrome) with excretion of phosphate, glucose and some protein components, as well as too
much acid in the body (metabolic acidosis).

Reproductive system and breast disorders
Common: Painful periods (dysmenorrhea).
Uncommon: Irregular or absent periods (amenorrhea).
Rare: Male infertility, which usually resolves after discontinuation of treatment or may
resolve after dose reduction. Do not stop treatment without first
consulting your doctor.
Increased testosterone levels (a sex hormone) in the blood and ovarian cysts
(polycystic ovaries).

Congenital, familial and genetic disorders
(see paragraph “Pregnancy, breastfeeding and fertility”).

General disorders and conditions related to the site of administration
Uncommon: Decreased body temperature (hypothermia), fluid retention in the arms and/or
legs (peripheral edema).

Laboratory tests
Rare: Blood coagulation disorders, recognizable by abnormal results in laboratory tests in
blood coagulation tests (see also paragraph 2 “Warnings and precautions” and
“Pregnancy, breastfeeding and fertility”). Reduced levels of vitamin B7 in the body (biotin deficiency).

Other
If you experience dose-independentside effects or possible signs of liver or pancreatic damage
(see also paragraph 2 “What you need to know before taking Valproic Acid and Sodium Valproate EG”),
tell your doctor immediately, who will decide whether to continue treatment with Valproic Acid and Sodium
Valproate EG.

Other 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, inflammation of the pancreas (pancreatitis), aggressiveness,
restlessness, attention disorders, abnormal behavior, mental and physical hyperactivity (psychomotor) and
learning disorders.
These adverse reactions have been observed primarily in children.
Cases have been described in which a state of stupor and apathy occurred, which can progress to a
transient comatose state or brain damage (encephalopathy), sometimes associated with an increase in
seizure frequency and especially in case of concomitant administration with phenobarbital or
topiramate or when the dose was increased rapidly. These symptoms resolved after dose reduction
or discontinuation of treatment.

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

5. How to store Acido Valproico and Sodio Valproato EG

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 packaging after the wording
{SCAD}. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Acido Valproico and Sodio Valproato EG 300 mg contains
The active ingredient is sodium valproate.
1 prolonged-release tablet contains 200 mg of sodium valproate and 87 mg of valproic acid
(equivalent to 300 mg of sodium valproate).
The other ingredients are: acesulfame potassium, basic butyl methacrylate copolymer, dibutyl sebacate,
hypromellose, sodium lauryl sulfate, magnesium stearate, hydrated colloidal silica, titanium dioxide (E171).

Description of the appearance of Acido Valproico and Sodio Valproato EG 300 mg and package contents
The prolonged-release tablets of Acido Valproico and Sodio Valproato EG 300 mg are white,
elongated with a score line on both sides. The tablet can be divided into equal doses.
Brown glass bottle with a plastic closure containing 50, 100, 200 and 500 prolonged-release tablets.
Al/Al blister containing 7, 10, 20, 30, 50, 84, 90, 100, 120, 150, 200, 2 x 100 and 500 prolonged-release
tablets.
Not all pack sizes may be marketed.

What Acido Valproico and Sodio Valproato EG 500 mg contains
The active ingredient is sodium valproate.
1 prolonged-release tablet contains 333 mg of sodium valproate and 145 mg of valproic acid
(equivalent to 500 mg of sodium valproate).
The other ingredients are: acesulfame potassium, basic butyl methacrylate copolymer, dibutyl sebacate,
hypromellose, sodium lauryl sulfate, magnesium stearate, hydrated colloidal silica, titanium dioxide (E171).

Description of the appearance of Acido Valproico and Sodio Valproato EG 500 mg and package contents
The prolonged-release tablets of Acido Valproico and Sodio Valproato EG 500 mg are white,
elongated with a score line on both sides. The tablet can be divided into equal doses.
Brown glass bottle with a plastic closure containing 50, 100, 200 and 500 prolonged-release tablets.
Al/Al blister containing 7, 10, 20, 30, 50, 84, 90, 100, 120, 150, 200, 2 x 100 and 500 prolonged-release
tablets.
Polypropylene container, closure with desiccant (silicon dioxide) containing 30, 50, 100, 200 and 500
prolonged-release tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 - 20136 Milan

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2–18, 61118 Bad Vilbel - Germany
Centrafarm Services B.V. Van de Reijtstraat 31-E, 4814 NE Breda - Netherlands
Eurogenerics N.V., Heizel Esplanade B22, 1020 Brussels - Belgium

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
Belgium:Valproat(e) Retard EG 300 mg tabletten met verlengde afgifte

Germany:Valproat STADA 300 mg Retardtabletten

Italy:Acido Valproico e Sodio Valproato EG 300 mg prolonged-release tablets

Luxembourg:Co-Valproat(e) EG 300 mg Tabs PR (prolonged release)

Netherlands:Natriumvalproaat Chrono CF 300 mg, tabletten met gereguleerde afgifte

Belgium:Valproat(e) Retard EG 500 mg tabletten met verlengde afgifte

Germany:Valproat STADA 500 mg Retardtabletten

Italy:Acido Valproico e Sodio Valproato EG 500 mg prolonged-release tablets

Luxembourg:Co-Valproat(e) EG 500 mg Tabs PR (prolonged release)

Netherlands:Natriumvalproaat Chrono CF 500 mg, tabletten met gereguleerde afgifte
The entire approved educational material is available on the AIFA website, in particular here you can
download:

• the Guide for male patients: https://www.aifa.gov.it/documents/20142/2208912/Valproato_Guida_per_pazienti_sesso_maschile_aprile-
• 2024.pdf/3690edfe-0920-7dd6-aef9-a266c20aa537?t=1713877465409

• the Patient Alert Card (PAC) unique for female and male patients: https://www.aifa.gov.it/documents/20142/2208912/Valproato_Carta_paziente_F-M_aprile-
• 2024.pdf/51698567-a3d4-6ad6-9840-82ce22277990?t=1713877465966

• the Guide for female patients: https://www.aifa.gov.it/documents/20142/2208912/Valproato_Guida_per_le_pazienti_gen2024.pdf/889a0457-5f75-ccda-21b3-5f75d6a84533?t=1705059431849