Prospect: Information for the User

Valproic Acid Aurovitas 300 mg Extended-Release Tablets EFG

valproic acid/sodium valproate

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

-Keep this prospectus, as you may need to refer to it again.

-If you have any doubts, consult your doctor or pharmacist.

-This medicine has been prescribed only for you, and you must not give it to others who may have the same symptoms as you, as it may harm them.

-If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1.What isValproic Acid Aurovitasand what is it used for

2.What you need to know before starting totakeValproic Acid Aurovitas

3.How to takeValproic Acid Aurovitas

4.Possible adverse effects

5.Storage ofValproic Acid Aurovitas

6.Contents of the package and additional information

Valproic acid belongs to a group of medications 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.

•Mixed and generalized seizures, idiopathic and/or symptomatic generalized epilepsy (West and Lennox-Gastaut).

Valproic acid is a medication 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.

Do not takeValproic Acid Aurovitas

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

Bipolar Disorder

•For bipolar disorder, do not use valproic acid if you are pregnant.

•For bipolar disorder, if you are a woman of childbearing potential, do 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 birth control until you have spoken with your doctor. Your doctor will advise you (see below in "Pregnancy, breastfeeding, and fertility - Important warning for women").

Epilepsy

•For epilepsy, do not use valproic acid if you are pregnant, unless no other treatment works.

•For epilepsy, if you are a woman of childbearing potential, do 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 birth control until you have spoken with your doctor. Your doctor will advise you.

•

•If you have active hepatitis or liver disease.

•If you have a liver or pancreas function disorder.

•If you have a personal or family history of severe hepatitis, mainly caused by medication.

•If you have porphyria hepatica (a rare metabolic disorder).

•If you have a genetic disorder that causes 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 if you are unsure, 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 develop a disease, 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 (yellow discoloration of the skin and eyes), swelling of the legs, worsening of epilepsy, or a general feeling of discomfort. 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 old who are also taking other antiepileptic medications in addition to valproic acid, or who have another neurological or metabolic disease and severe epilepsy.

•Especially in children under 3 years old, valproic acid should not be administered together with other medications that contain acetylsalicylic acid (aspirin).

•If you have systemic lupus erythematosus (a rare disease).

•If you have any metabolic disorder, particularly inherited enzyme deficiency disorders, such as urea cycle disorders, as there is a greater risk of increased blood ammonia levels.

•If you have kidney function impairment. Your doctor may want to monitor your valproate sodium levels in the blood or adjust the dose.

•If you experience weight gain, due to increased appetite.

•A small number of people taking antiepileptic medications like valproate sodium have thought about harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.

•If you have carnitine palmitoyltransferase type II deficiency (CPT II).

•If you know that there is a genetic disorder in your family that causes a mitochondrial disorder.

•As with other antiepileptic medications, seizures may worsen or occur more frequently while taking this medication. If this happens, contact your doctor immediately.

Children and adolescents

Children and adolescents under 18 years old.

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

Other medications and Valproic Acid Aurovitas

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

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

•Antipsychotics (used to treat mental disorders).

•Medications used to treat depression.

•Benzodiazepines, used to sleep or treat anxiety.

•Lithium.

•Rufinamide.

•Acetazolamide.

•Inhibitors of protease, such as lopinavir, ritonavir (used to treat HIV).

•Colestiramina.

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

•Olanzapine and quetiapine (used to treat mental disorders).

•Zidovudine (used to treat HIV or AIDS).

•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 to treat bacterial infections). Valproic acid and carbapenem antibiotics should be avoided because it may reduce the effect of valproate sodium.

•Propofol (anesthetic).

•Metamizol, a medication used to treat pain and fever.

•Medicationsthat contain estrogens (including some birth control pills).

Valproic acid may increase the effects of nimodipine (a medication used to treat hypertension, angina, and vascular disorders).

These and other medications may be affected by valproic acid, or may affect its functioning. You may need to adjust the dose of your medication, or take different medications. Your doctor or pharmacist can advise you and provide more information on medications with which you should exercise caution or avoid with valproic acid.

Administration ofValproic Acid Aurovitaswith 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, do not use valproic acid if you are pregnant.

•For bipolar disorder, if you are a woman of childbearing potential, do 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 birth control until you have spoken with your doctor. Your doctor will advise you.

Epilepsy

•For epilepsy, do not use valproic acid if you are pregnant, unless no other treatment works.

•For epilepsy, if you are a woman of childbearing potential, do 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 birth control until you have spoken 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. The higher the dose, the greater the risk, but all doses have a risk.

•It may cause severe birth defects and may affect how the child develops and grows. The most commonly reported birth defectsincludespina bifida (where the spinal vertebrae do not develop properly); cranial and facial malformations, heart malformations, kidney malformations, urinary tract malformations, genital malformations, and limb malformationsand multiple malformations associated with several organs and body parts. Birth defects may result in disabilities that can be severe.

•There have been reports of hearing or hearing loss in children exposed to valproate during pregnancy.

•There have been reports of ocular malformations in children exposed to valproate during pregnancy, in association with other congenital malformations. These ocular malformations may affect vision.

•If you take valproate during pregnancy, you have a greater 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 out of 100 babies will have birth defects. In comparison, 2 to 3 out of 100 babies born to women who do not have epilepsy will have birth defects.

•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. Affected children may speak and walk slowly, be intellectually less capable than other children, and have language and memory difficulties.

•Children exposed to valproate are more frequently diagnosed with autism spectrum disorders, 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 to you what may happen to your baby if you become pregnant while taking valproate. If you decide later that you want to have a baby, do not stop taking your medication or your birth control until you have spoken with your doctor.

•If you are a father or caregiver of a girl being treated with valproate, contact your doctor when your daughter in treatment with valproate reaches menarche (first menstruation).

•Some birth control pills (birth control pills containing estrogen) may reduce valproate levels in the blood. Make sure to talk to your doctor about the most suitable birth control method for you.

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

Choose and read the situations that affect you from the following:

•I AM STARTING TREATMENT WITH VALPROIC ACID

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

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

•I AM PREGNANT AND 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 without interruption throughout your treatment with valproic acid. Consult your doctor or family planning clinic if you need advice on contraception.

Important messages:

•Pregnancy must be ruled out before starting treatment with valproic acid, by the result of a pregnancy test, confirmed by your doctor.

•You must use an effective method of birth control throughout your treatment with valproic acid.

•You must talk to your doctor about contraception. Your doctor will give you information on how to prevent pregnancy and may refer you to a specialist to advise you on contraception.

•You must have regular consultations (at least annually) with a specialist experienced in treating bipolar disorder or epilepsy. During this visit, your doctor will ensure that you know and understand all the risks and warnings related to the use of valproate during pregnancy.

•Inform your doctor if you want to have a baby.

•Talk to your doctor immediately if you are pregnant or think you may be pregnant.

I AM TAKING VALPROIC ACID AND 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 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 throughout your treatment with valproic acid.

•You must talk to your doctor about contraception. Your doctor will give you information on how to prevent pregnancy and may refer you to a specialist to advise you on contraception.

•You must have regular consultations (at least annually) with a specialist experienced in treating bipolar disorder or epilepsy. During this visit, your doctor will ensure that you know and understand all the risks and warnings related to the use of valproate during pregnancy.

•Inform your doctor if you want to have a baby.

•Talk to your doctor immediately if you are pregnant or think you may be pregnant.

I AM TAKING VALPROIC ACID AND 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 birth control until you have spoken with your doctor. Your doctor will advise you.

The 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 experienced in treating bipolar disorder or epilepsy to evaluate alternative treatment options from the beginning. Your specialist may take several actions to ensure that your pregnancy develops as well as possible and reduces the risks for you and the fetus as much as possible.

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

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

Important messages:

•Do not stop taking valproic acid unless your doctor tells you to.

•Do not stop using your birth control methods until you have spoken with your doctor and worked together on a plan to ensure that your underlying disease is controlled and the risks for your baby are reduced.

•First schedule an appointment with your doctor. During this visit, your doctor will ensure that you know and understand 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 your treatment with valproic acid well 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 TAKING VALPROIC ACID

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

The 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 experienced in treating bipolar disorder or epilepsy to evaluate alternative treatment options.

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 regarding pregnancy with valproate exposure.

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

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 experienced in treating epilepsy or bipolar disorder to evaluate the need for alternative treatment options.

•You must have counseling about the risks of valproate during pregnancy, including teratogenicity and developmental effects in 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 you. Your doctor will discuss the Annual Risk Knowledge Form with you 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 breast milk, there is generally no risk to the baby, and breastfeeding is usually not necessary to stop. However, you should consult your doctor about the advisability of continuing or stopping breastfeeding.

Driving and using machines

Valproic acid may cause drowsiness or dizziness in some people, especially at the beginning of treatment or when taken with other antiepileptic medications or benzodiazepines. Make sure you know how you react to valproic acid before driving, using tools or machines, or engaging in other activities that may be hazardous if you are drowsy or dizzy.

Valproic Acid Aurovitas contains sodium

This medication contains 27.8 mg of sodium (main component of table salt/for cooking) in each tablet. This is equivalent to 1.39% of the maximum daily sodium intake recommended for an adult.

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

The treatment with valproic acid should be initiated and monitored by a specialized doctor in the treatment of epilepsy or bipolar disorder.

Make sure to perform regular check-ups with your doctor. This is very important, as the dose you are taking may need to be adjusted over time.

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

Initiation of 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 increased gradually to reach the optimal dose after approximately 2 weeks, and the other treatment should be gradually reduced until complete withdrawal.

•If you need a combination with other antiepileptics, these should be adjusted slowly (see section 2 "Other Medications and Aurovitas Valproic Acid").

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

Dosage:

The dose should start with 10-15 mg/kg per day, with gradual increases to achieve the ideal dose (see section "Initiation of treatment with valproic acid (oral route)). Generally, this is between 20 and 30 mg/kg.

However, if seizure control is not achieved within this range, the dose may be increased further; patients should be closely monitored (hence the importance of follow-up appointments) when daily doses exceeding 50 mg/kg are administered (see section 2).

•In children, the usual 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 the elderly, 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 daily dosage individually.

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.

Mean daily dose:

The recommended daily doses usually range from 1,000 mg to 2,000 mg. In exceptional cases, the dose may be increased further to 3,000 mg/day. The dose should be adjusted according to individual clinical response.

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

Administration form:

Oral route.

The daily dose may 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 too weak, consult your doctor or pharmacist.

Patients with renal problems

Your doctor may decide to adjust your dose.

If you take moreAurovitas Valproic Acidthan you should

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

A valproic acid overdose can be hazardous. Inform your doctor or go immediately to the nearest hospital. Acute intoxication signs usually manifest as coma, hypotonia, hyporeflexia, miosis, respiratory function alteration, metabolic acidosis.

However, symptoms may 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 until 10-12 hours after ingestion, and monitoring of cardiac and respiratory function. Naloxone has been used successfully in a few isolated cases.

If you forget to takeAurovitas Valproic Acid

Do not take a double dose to compensate for the missed 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 withAurovitas Valproic Acid

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

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

Like all medications, this medication may cause side effects, although not everyone will experience them. These side effects are usually mild or moderate.

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

-Nausea, vomiting, or stomach pain and diarrhea, especially at the beginning of treatment.

-Headache.

-Tremors, drowsiness, sedation, instability while walking.

-Extrapyramidal disorder (movement disorders).

-Aggression, agitation, attention disorders, abnormal behavior, and hyperactivity.

-Dizziness.

-Itching in hands and feet.

-Seeing, feeling, and hearing things that do not exist (hallucinations).

-Skin reactions such as skin rash.

-Temporary hair loss, abnormal hair growth, abnormal hair texture, hair color change.

-Increased hair growth, especially in women, virilization, acne (hyperandrogenism).

-Nail and skin disorders under the nail (frequent).

-Changes in menstrual cycle in women.

-Loss of hearing.

-Gingival disorder (gums) (particularly hyperplasia).

-Mouth pain, 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).

-Renal problems, enuresis (involuntary urination during sleep) or increased need to urinate.

-Decreased body temperature.

-Male infertility.

-Memory loss and cognitive disorders.

-Learning disorders.

-Diplopia (double vision).

Bone alterations, including osteopenia and osteoporosis (bone decalcification), have been reported. Consult your doctor or pharmacist if you are on long-term antiepileptic treatment, have a history of osteoporosis, or take steroids.

Inform your doctor immediately if any of the following serious side effects occur. You may need urgent medical attention:

-Change in level of consciousness, unusual behavior associated (or not) with increased frequency or severity of seizures, disorientation, especially if taken simultaneously with medications containing phenobarbital and topiramato or if the valproic acid dose has been suddenly increased.

-Repeated vomiting, extreme fatigue, abdominal pain (consult a doctor immediately to evaluate possible pancreatitis. In case of confirmed pancreatitis, valproate 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 hematomas or bleeding.

-Blisters with skin detachment.

-Severe decrease in white blood cell count (leukocytes) or bone marrow insufficiency, which may manifest with fever and difficulty breathing.

-Confusion caused by a decrease in sodium levels in the blood.

-Allergic swelling with painful rashes that cause itching (frequently around the eyes, lips, throat, and occasionally on hands and feet).

-Syndrome caused by a medication characterized by rash, fever, lymph node enlargement, and possible failure of other organs.

-Hypothyroidism, which may cause fatigue or weight gain.

-Allergic reaction causing joint pain, rash, and fever (systemic lupus erythematosus).

-Extrapyramidal disorder (involuntary movements).

-Difficulty breathing and pain due to pleural effusion (fluid accumulation in the lungs).

-Muscle pain and muscle weakness (rhabdomyolysis).

-Kidney disease; incontinence (involuntary urination).

-Increased frequency and severity of seizures.

Valproic acid may also cause a reduction in platelet count 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 not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

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

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition ofAurovitas Valproic Acid

-The active principles are sodium valproate and valproic acid. Each prolonged-release tablet contains 199.80 mg of sodium valproate and 87 mg of valproic acid (equivalent to 300 mg of sodium valproate).

-The other components are:

Tablet core:anhydrous colloidal silica, hypromellose type 2208 (15000 cps), hypromellose type 2910 (4000 cps), and potassium acesulfame.

Tablet coating:sodium laurylsulfate, dibutyl sebacate, basic butyl methacrylate copolymer, magnesium stearate, and titanium dioxide (E171).

Appearance of the product and packaging contents

Prolonged-release film-coated tablets, white or off-white, oval, biconvex, with a notch on both faces. The tablet can be divided into equal doses.

Aurovitas Valproic Acid prolonged-release tabletsare available in blister packaging (triple laminated cold-molded (Alu-Alu)) and in a bottle (high-density opaque white polyethylene bottle and opaque white polypropylene bottle, closed with a white opaque polypropylene cap with silica gel as a desiccant).

Packaging sizes in blister:

300 mg: 20, 30, 50, 60, 90, and 100 prolonged-release tablets.

Packaging sizes in bottle:

28 prolonged-release tablets.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible manufacturer

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

O

Generis Farmacêutica, S.A.

Rua João de Deus, 19

2700-487 Amadora

Portugal

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

Spain:Aurovitas Valproic Acid 300 mg prolonged-release tablets EFG

Netherlands:Natriumvalproaat Chrono Aurobindo 300 mg, prolonged-release tablets

Portugal:Valproic Acid Generis Phar

Last review date of this leaflet:March 2023

Other sources of information

You can access detailed and updated information about this medicinal product by scanning the QR code included in the leaflet with your smartphone. You can also access this information on the following internet address:https://cima.aemps.es/info/84517.

Detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).