VALPROIC ACID AUROVITAS 500 mg PROLONGED-RELEASE TABLETS

Introduction

Package Leaflet: Information for the User

Valproic Acid Aurovitas 500 mg prolonged-release tablets EFG

sodium valproate/valproic acid

This medicinal product is subject to additional monitoring, which will allow for the quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

WARNING

Valproic Acid Aurovitas, valproic acid, and sodium valproate can seriously harm the fetus when taken during pregnancy. If you are a woman of childbearing potential, you must use an effective method of contraception (birth control) without interruption during the entire treatment with Valproic Acid Aurovitas. Your doctor will discuss this with you, but you must also follow the warning in section 2 of this package leaflet.

Schedule an urgent appointment with your doctor if you wish to become pregnant or if you think you are pregnant.

Do not stop taking Valproic Acid Aurovitas unless your doctor tells you to, as your illness may worsen.

Read the entire package leaflet carefully before starting to take this medicinal product, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicinal product has been prescribed to you only, and you should not pass it on to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Valproic Acid Aurovitas and what is it used for
2. What you need to know before taking Valproic Acid Aurovitas
3. How to take Valproic Acid Aurovitas
4. Possible side effects
5. Storage of Valproic Acid Aurovitas
6. Contents of the pack and further information

1. What is Valproic Acid Aurovitas and what is it used for

Valproic acid belongs to a group of medicinal products used for the treatment of epilepsy:

• Partial or generalized epilepsy.
• Primary generalized epilepsy: convulsive (clonic, tonic, tonic-clonic, myoclonic) and non-convulsive or absence seizures.
• Partial epilepsy: simple and complex seizures.
• Secondary generalized seizures.
• Treatment of mixed and generalized idiopathic seizures and/or symptomatic generalized epilepsy (West and Lennox-Gastaut).

Valproic acid is a medicinal product used in the treatment of mania, in which you may feel very excited, euphoric, agitated, enthusiastic, or hyperactive. Mania occurs in a disease called "bipolar disorder". Valproic acid may be used when lithium cannot be used.

2. What you need to know before starting to take Valproic Acid Aurovitas

Do not takeValproic Acid Aurovitas

If you are allergic to valproic acid, sodium valproate, or any of the other components of this medicine (listed in section 6).

Bipolar disorder

• For bipolar disorder, you should not use valproic acid if you are pregnant.
• For bipolar disorder, if you are a woman of childbearing potential, you should not take valproic acid unless you use an effective method of birth control (contraception) throughout your treatment with valproic acid. Do not stop taking valproic acid or your contraceptive until you have discussed this with your doctor. Your doctor will advise you (see below under "Pregnancy, breastfeeding, and fertility - Important warning for women").

Epilepsy

• For epilepsy, you should not use valproic acid if you are pregnant, unless no other treatment works.
• For epilepsy, if you are a woman of childbearing potential, you should not take valproic acid unless you use an effective method of birth control (contraception) throughout your treatment with valproic acid. Do not stop taking valproic acid or your contraceptive until you have discussed this with your doctor. Your doctor will advise you (see below under "Pregnancy, breastfeeding, and fertility - Important warning for women").

•

• If you currently have hepatitis or a liver disease.
• If you have a disorder of liver or pancreatic function.
• If you have a personal or family history of severe hepatitis, mainly due to medication.
• If you have hepatic porphyria (a rare metabolic disorder).
• If you have a genetic problem that produces a mitochondrial disorder (e.g., Alpers-Huttenlocher syndrome).
• If you have a known metabolic disorder, such as a urea cycle disorder.

If you think you may have any of these problems or have any doubts, consult your doctor before taking valproic acid.

Warnings and precautions

Consult your doctor or pharmacist before taking Valproic Acid Aurovitas.

• If you or your child suddenly develops an illness, especially if it appears in the first few months of treatment and, above all, if it repeatedly includes vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, loss of appetite, stomach pain, nausea, jaundice (yellowing of the skin and eyes), swelling of the legs, worsening of epilepsy, or a feeling of generalized malaise. In this case, you should consult your doctor immediately. In a small number of patients, valproic acid can affect the liver (and rarely the pancreas).
• If valproic acid is administered to children under 3 years of age who are being treated simultaneously with other antiepileptic drugs in addition to valproic acid, or who have another neurological or metabolic disease and severe forms of epilepsy.
• Especially in children under 3 years of age, valproic acid should not be administered in conjunction with other medications that contain acetylsalicylic acid (aspirin).
• If you have systemic lupus erythematosus (a rare disease).
• If you have any metabolic disorder, particularly hereditary enzyme deficiency disorders, such as alterations of the urea cycle, as there is a greater risk that the level of ammonia in the blood will increase.
• If you suffer from kidney function impairment. Your doctor may want to monitor the levels of valproate in your blood or adjust the dose.
• If you experience weight gain, as a result of increased appetite.
• A small number of people who receive treatment with antiepileptics like valproate have thought about harming themselves or committing suicide. If at any time you have these thoughts, contact your doctor immediately.
• If you have a deficiency of carnitine palmitoyltransferase (CPT) type II.
• If you know that there is a genetic problem in your family that produces a mitochondrial disorder.
• As with other antiepileptic medications, seizures can worsen or appear more frequently while taking this medication. If this happens, contact your doctor immediately.

Children and adolescents

Children and adolescents under 18 years of age.

Valproic acid should not be used in children and adolescents under 18 years of age for the treatment of mania.

Other medications and Valproic Acid Aurovitas

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

Some medications can alter the effect of valproic acid or vice versa. These medications include:

• Antipsychotics (used to treat psychological disorders).
• Medications used to treat depression.
• Benzodiazepines, used for sleeping or to treat anxiety.
• Lithium.
• Rufinamide.
• Acetazolamide.
• Protease inhibitors, such as lopinavir, ritonavir (used for HIV treatment).
• Colestyramine.
• Other medications used for the treatment of epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, topiramate, felbamate.
• Olanzapine and quetiapine (used to treat psychiatric disorders).
• Zidovudine (used to treat HIV or AIDS infection).
• Mefloquine (used to prevent and treat malaria).
• Salicylates (see also "Warnings and precautions - Children under 3 years").
• Anticoagulants (used to prevent blood clot formation).
• Cimetidine (used to treat stomach ulcers).
• Erythromycin and rifampicin.
• Carbapenems such as imipenem, panipenem, or meropenem (antibiotics used for the treatment of bacterial infections). The combination of valproic acid and antibiotics from the carbapenem group should be avoided because it can decrease the effect of valproate.
• Propofol (anesthetic).
• Metamizole, a medication used to treat pain and fever.
• Medications that contain estrogens (including some contraceptive pills).

Valproic acid may increase the effects of nimodipine (a medication used to treat high blood pressure, angina, and blood vessel disorders).

These and other medications may be affected by valproic acid or may affect its functioning. It may be necessary to adjust the dose of your medication or take different medications. Your doctor or pharmacist can advise you and provide more information about the medications you should be cautious with or avoid when taking valproic acid.

Taking Valproic Acid Aurovitas with food, drinks, and alcohol

Valproic acid can be taken with food and/or drinks.

It is recommended not to consume alcohol during treatment.

Pregnancy, breastfeeding, and fertility

Important warning for women

Bipolar disorder

• For bipolar disorder, you should not use valproic acid if you are pregnant.
• For bipolar disorder, if you are a woman of childbearing potential, you should not take valproic acid unless you use an effective method of birth control (contraception) throughout your treatment with valproic acid. Do not stop taking valproic acid or your contraceptive until you have discussed this with your doctor. Your doctor will advise you.

Epilepsy

• For epilepsy, you should not use valproic acid if you are pregnant, unless no other treatment works.
• For epilepsy, if you are a woman of childbearing potential, you should not take valproic acid unless you use an effective method of birth control (contraception) throughout your treatment with valproic acid. Do not stop taking valproic acid or your contraceptive until you have discussed this with your doctor. Your doctor will advise you.

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

• Talk to your doctor immediately if you are planning to have a baby or are pregnant.
• Valproate carries a risk when taken during pregnancy. With the highest dose, the risk is greater, but all doses have a risk.
• It can cause serious birth defects and can affect how the child develops and grows. The most frequently reported birth defects include spina bifida (where the bones of the spine do not develop properly); skull and face malformations, heart, kidney, urinary tract, genital, and limb defects, and multiple malformations that affect several organs and parts of the body. Birth defects can result in disabilities that can be severe.
• There have been reports of hearing problems or deafness 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 child with birth defects that require medical treatment. As valproate has been used for many years, it is known that of the women who take valproate, about 10 babies out of 100 will have birth defects. In comparison, 2 to 3 babies out of 100 born to women who do not have epilepsy.
• It is estimated that up to 30-40% of children in preschool age whose mothers took valproate during pregnancy may have developmental problems in childhood. The affected children may speak and walk slowly, be less intellectually capable than other children, and have language and memory difficulties.
• In children exposed to valproate, autism spectrum disorders are more frequently diagnosed, and there is some evidence that these children may develop symptoms of Attention Deficit Hyperactivity Disorder (ADHD).
• Before prescribing this medication, your doctor will have explained what can happen to your baby if you become pregnant while taking valproate. If you later decide that you want to have a baby, do not stop taking your medication or your contraceptive until you have discussed this with your doctor.
• If you are a parent or caregiver of a girl being treated with valproate, you should contact your doctor when your daughter being treated with valproate has her menarche (first menstruation).
• Some contraceptive pills (contraceptive pills that contain estrogen) can reduce the levels of valproate in the blood. Make sure to talk to your doctor about the most suitable contraceptive method (birth control) for you.
• Consult your doctor about taking folic acid when trying to have a baby. Folic acid can reduce the overall risk of spina bifida and early miscarriage that exists in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.

Choose and read the situations that apply to you from the following:

• I AM STARTING TREATMENT WITH VALPROIC ACID
• I AM TAKING VALPROIC ACID AND I DO NOT INTEND TO HAVE A BABY
• I AM TAKING VALPROIC ACID AND I INTEND TO HAVE A BABY
• I AM PREGNANT AND I AM TAKING VALPROIC ACID

I AM STARTING TREATMENT WITH VALPROIC ACID

If this is the first time you have been prescribed valproic acid, your doctor will have explained the risks to the fetus if you become pregnant. Once you are of childbearing age, you will need to ensure that you use an effective method of birth control (contraception) without interruption throughout your treatment with valproic acid. Consult your doctor or family planning clinic if you need advice on contraception.

Important messages:

• Pregnancy should be ruled out before starting treatment with valproic acid, through the result of a pregnancy test, confirmed by your doctor.
• You must use an effective method of birth control (contraception) throughout your treatment with valproic acid.
• You should talk to your doctor about suitable methods of birth control (contraception). Your doctor will give you information on how to prevent pregnancy and may refer you to a specialist for advice on birth control.
• You should have regular check-ups (at least annual) with a specialist with experience in the treatment of bipolar disorder or epilepsy. During this visit, your doctor will ensure that you know and have understood all the risks and warnings related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Consult your doctor immediately if you are pregnant or think you may be pregnant.

I AM TAKING VALPROIC ACID AND I DO NOT INTEND TO HAVE A BABY

If you continue treatment with valproic acid but do not plan to have a baby, make sure to use an effective method of birth control (contraception) without interruption throughout your treatment with valproic acid. Consult your doctor or family planning clinic if you need advice on contraception.

Important messages:

• You must use an effective method of birth control (contraception) throughout your treatment with valproic acid.
• You should talk to your doctor about birth control (contraception). Your doctor will give you information on how to prevent pregnancy and may refer you to a specialist for advice on birth control.
• You should have regular check-ups (at least annual) with a specialist with experience in the treatment of bipolar disorder or epilepsy. During this visit, your doctor will ensure that you know and have understood all the risks and warnings related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Consult your doctor immediately if you are pregnant or think you may be pregnant.

I AM TAKING VALPROIC ACID AND I INTEND TO HAVE A BABY

If you are planning to have a baby, first schedule an appointment with your doctor.

Do not stop taking valproic acid or your contraceptive until you have discussed this with your doctor. Your doctor will advise you.

Babies born to mothers who have been treated with valproate have significant risks of birth defects and developmental problems that can be severely debilitating. Your doctor will refer you to a specialist with experience in the treatment of bipolar disorder or epilepsy, so that alternative treatment options can be evaluated from the start. Your specialist may take several actions to ensure that your pregnancy develops as well as possible and the risks to you and the fetus are reduced as much as possible.

Your specialist may decide to change the dose of valproic acid or switch to another medication, or stop treatment with valproic acid long before you become pregnant - to ensure that your disease is stable.

Consult your doctor about taking folic acid when trying to have a baby. Folic acid can reduce the overall risk of spina bifida and early miscarriage that exists in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.

Important messages:

• Do not stop taking valproic acid unless your doctor tells you to.
• Do not stop using your contraceptives (birth control) before you have discussed this with your doctor and worked together on a plan to ensure that your disease is controlled and the risks to your baby are reduced.
• First, schedule an appointment with your doctor. During this visit, your doctor will ensure that you know and have understood all the risks and warnings related to the use of valproate during pregnancy.
• Your doctor will try to switch you to another medication or stop treatment with valproic acid long before you become pregnant.
• Schedule an urgent appointment with your doctor if you are pregnant or think you may be pregnant.

I AM PREGNANT AND I AM TAKING VALPROIC ACID

Do not stop taking valproic acid unless your doctor tells you to, as your disease may worsen. Schedule an urgent appointment with your doctor if you are pregnant or think you may be pregnant. Your doctor will advise you.

Babies born to mothers who have been treated with valproate have significant risks of birth defects and developmental problems that can be severely debilitating.

Your doctor will refer you to a specialist with experience in the treatment of bipolar disorder or epilepsy, so that alternative treatment options can be evaluated.

In exceptional circumstances when valproic acid is the only treatment option during pregnancy, you will be closely monitored, both for the management of your underlying disease and to check how the fetus is developing. You and your partner may receive counseling and support related to pregnancy with valproate exposure.

Consult your doctor about taking folic acid. Folic acid can reduce the overall risk of spina bifida and early miscarriage that exists in all pregnancies. However, it is unlikely to reduce the risk of birth defects associated with the use of valproate.

Important messages:

• Schedule an urgent appointment with your doctor if you are pregnant or think you may be pregnant.
• Do not stop taking valproic acid unless your doctor tells you to.
• Make sure you are referred to a specialist with experience in the treatment of epilepsy or bipolar disorder to evaluate the need for alternative treatment options.
• You should have counseling about the risks of valproic acid during pregnancy, including teratogenicity and developmental effects on children.
• Make sure you are referred to a prenatal monitoring specialist to detect possible malformations.

Make sure to read the Patient Guide that your doctor will provide. Your doctor will discuss the Annual Risk Acknowledgement Form and ask you to sign and keep it. Your pharmacist will also provide you with a Patient Card to remind you of the risks of valproate if you take it during pregnancy.

Breastfeeding

Since only small amounts of valproic acid pass into the

3. How to take Valproic Acid Aurovitas

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Treatment with valproic acid should be initiated and supervised by a doctor specializing in the treatment of epilepsy or bipolar disorder.

Make sure to perform periodic reviews with your doctor. This is very important, as the dose you are taking may need modifications over time.

The daily dose of valproic acid is established by the doctor according to age and body weight; however, significant variations in inter-individual sensitivity to valproate must be taken into account. The optimal dose is established mainly based on clinical response. Serum level measurement may be considered to complement clinical monitoring if there is poor control of seizures or if adverse effects are suspected. The effective therapeutic interval for valproic acid serum levels is generally 40-100 mg/liter (300-700 micromoles/liter).

Starting treatment with valproic acid (oral route)

• If you are not taking another antiepileptic, it would be ideal to increase valproic acid by administering successive doses at intervals of 2 to 3 days to reach the optimal dose after one week.
• If you are taking another antiepileptic, valproic acid should be gradually increased to reach the optimal dose after approximately 2 weeks, and the other treatment should be gradually reduced until its complete withdrawal.
• If you need a combination with other antiepileptics, they should be slowly adjusted (see section 2 "Other medications and Valproic Acid Aurovitas").

In practical terms: administration of valproic acid (oral route)

Posology:

The dose should start with 10-15 mg/kg daily, with a gradual increase to obtain the ideal dose (see section "Starting treatment with valproic acid (oral use)"). Generally, this is between 20 and 30 mg/kg.

However, when seizure control is not achieved within this interval, the dose may be increased further; patients should be closely monitored (that's why follow-up appointments are important) when administering daily doses above 50 mg/kg (see section 2).

• In children, the normal dose is around 30 mg/kg per day.
• In adults, the usual dose is within the range of 20-30 mg/kg per day.
• Although pharmacokinetic parameters are modified in elderly individuals, they have not been considered clinically significant; therefore, the dose should be determined by clinical response (seizure control).

Treatment of mania associated with bipolar disorders

Your doctor should establish and control your individual daily dosage.

Initial dose:

The recommended initial daily dose is 750 mg.

The dose should be increased as quickly as possible to reach the lowest therapeutic dose that produces the desired clinical effect.

Average daily dose:

Recommended daily doses usually range between 1,000 mg and 2,000 mg. In exceptional cases, the dose can be increased later to 3,000 mg/day. The dose should be adjusted according to individual clinical response.

Follow the administration instructions of this medication indicated by your doctor or pharmacist exactly. In case of doubt, consult your doctor or pharmacist again.

Method of administration:

Oral route.

The daily dose can be taken in two divided doses.

Take the medication for the time your doctor considers necessary and for the time it is prescribed.

If you consider that the action of valproic acid is too strong or weak, consult your doctor or pharmacist.

Patients with kidney problems

Your doctor may decide to adjust your dose.

If you take moreValproic Acid Aurovitasthan you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

An overdose of valproic acid can be hazardous. Inform your doctor or go immediately to the nearest hospital. Signs of acute intoxication are usually manifested as coma, with muscle hypotonia, hyporeflexia, miosis, alteration of respiratory function, metabolic acidosis.

However, symptoms can be variable, and seizures have been reported in the presence of very high plasma levels. Cases of intracranial hypertension associated with cerebral edema have been reported. Hospital treatment of overdose should be symptomatic: gastric lavage, useful up to 10-12 hours after ingestion, and monitoring of cardiorrespiratory function. Naloxone has been used successfully in a few isolated cases.

If you forget to takeValproic Acid Aurovitas

Do not take a double dose to make up for forgotten doses. Continue taking the medication according to your doctor's instructions. If you have forgotten several doses, contact your doctor immediately.

If you interrupt treatment withValproic Acid Aurovitas

Do not suspend or alter the dose of valproic acid without consulting your doctor. Your illness may worsen if you interrupt treatment with valproic acid without previously consulting your doctor.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can produce side effects, although not all people suffer from them. These effects are usually mild or moderate.

Side effects can be rare (severe), but in most cases, they are not. They are usually reversible, but you may also need medical treatment for some of them:

• Vomiting, nausea, or stomach pain and diarrhea, especially at the start of treatment.
• Headache.
• Tremors, drowsiness, sedation, instability when walking.
• Extrapyramidal disorder (movement disorders).
• Aggression, agitation, attention disorders, abnormal behavior, and hyperactivity.
• Dizziness.
• Numbness in hands and feet.
• Seeing, feeling, 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 color.
• Increased hair growth, especially in women, virilization, acne (hyperandrogenism).
• Disorders of the nails and skin under the nail (frequent).
• Changes in the menstrual period in women.
• Hearing loss.
• Gingival disorder (gums) (particularly hyperplasia).
• Pain in the mouth, swelling in the mouth, mouth ulcers, and burning sensation in the mouth (stomatitis).
• Rapid and uncontrolled eye movement.
• Allergic reactions.
• Swelling of feet and legs (edema).
• Weight gain.
• Obesity (rare).
• Kidney problems, enuresis (bedwetting), or increased need to urinate.
• Decrease in body temperature.
• Male infertility.
• Memory loss and cognitive disorders.
• Learning disorders.
• Double vision.

Bone alterations, including osteopenia and osteoporosis (decalcification of bones), have been reported. Consult your doctor or pharmacist if you are undergoing prolonged treatment with antiepileptics, have a history of osteoporosis, or take steroids.

Inform your doctor immediately if any of the following side effects appear (which are considered serious). You may need urgent medical attention:

• Change in level of consciousness, strange behavior associated (or not) with increased frequency or severity of seizures, disorientation, especially if taken simultaneously with medications containing phenobarbital and topiramate or if the dose of valproic acid has been suddenly increased.
• Repeated vomiting, extreme fatigue, abdominal pain (consult a doctor immediately to evaluate possible pancreatitis. In case of confirmed pancreatitis, valproate sodium should be discontinued), drowsiness, weakness, loss of appetite, severe stomach pain, nausea, jaundice (yellowing of the skin and/or eyes), swollen legs, or worsening of epilepsy or general feeling of discomfort.
• Blood coagulation problems.
• Spontaneous appearance of bruises or bleeding.
• Blisters with skin peeling.
• Severe decrease in white blood cells (leukocytes) or bone marrow failure, which sometimes manifests with fever and respiratory difficulty.
• Confusion that can be caused by a decrease in sodium levels in the blood.
• Allergic swelling with painful hives that cause itching (frequently around the eyes, lips, throat, and sometimes on hands and feet).
• Syndrome caused by a medication characterized by rash, fever, lymph node enlargement, and possible failure of other organs.
• Underactive thyroid gland, which can cause fatigue or weight gain (hypothyroidism).
• Allergic reaction that causes joint pain, rash, and fever (Systemic Lupus Erythematosus).
• Extrapyramidal disorder (involuntary movements).
• Difficulty breathing and pain due to lung inflammation (pleural effusion).
• Muscle pain and muscle weakness (rhabdomyolysis).
• Kidney disease; urinary incontinence (involuntary urination).
• Increased number and severity of seizures.

Valproic acid can also produce a reduction in platelet or red blood cell count.

Additional side effects in children

Some side effects of valproate occur more frequently in children or are more severe compared to adults. These include liver damage, pancreatitis, aggression, agitation, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish Medication Pharmacovigilance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Valproic Acid Aurovitas

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack, carton, or bottle, after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown away through drains or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition ofValproic Acid Aurovitas

• The active ingredients are sodium valproate and valproic acid. Each prolonged-release tablet contains 333 mg of sodium valproate and 145 mg of valproic acid (equivalent to 500 mg of sodium valproate).
• Other components are:

Core of the tablet:anhydrous colloidal silica, hypromellose type 2208 (15000 cps), hypromellose type 2910 (4000 cps), and potassium acesulfame.

Coating of the tablet:sodium lauryl sulfate, dibutyl sebacate, basic butylated methacrylate copolymer, magnesium stearate, titanium dioxide (E171).

Appearance of the product and package contents

White or off-white film-coated tablets, oval, biconvex, with a score line on both sides. The tablet can be divided into equal doses.

Valproic Acid Aurovitas prolonged-release tablets are available in blister packs (triple-layer cold-molded aluminum foil) and in bottles (high-density opaque white polyethylene bottle and opaque white polypropylene bottle, closed with an opaque white polypropylene cap with silica gel as a desiccant).

Blister pack sizes:

500 mg: 30, 40, 50, 60, 90, and 100 prolonged-release tablets.

Bottle sizes:

28 prolonged-release tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

Or

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

This medication is authorized in the member states of the European Economic Area with the following names:

Spain: Valproic Acid Aurovitas 500 mg prolonged-release tablets EFG

Netherlands: Natriumvalproaat Chrono Aurobindo 500 mg, tablets with prolonged release

Portugal: Valproic Acid Generis Phar

Date of the last revision of this prospectus:March 2023

Other sources of information

You can access detailed and updated information about this medication by scanning the QR code included in the prospectus with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/info/84516.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/).