Prospect: Information for the User

Valproic AcidorSeacross 100 mg/ml Injectable Solution and for Infusion

valproate sodium

This medicine is subject to additional monitoring, which will speed up 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 prospect carefully before starting to take this medicine

• Keep this prospect. 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, even if they 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 prospect. See section 4.

What is Seacross Valproic Acid

The name of the medication is Valproic Acid Seacross 100 mg/ml injectable solution and for perfusion (called Valproic Acid in this leaflet).

What contains Seacross Valproic Acid

This medication contains the active ingredient valproate sodium. It belongs to a group of medications called anticonvulsants or antiepileptic agents. It works by helping to calm the brain.

For what is Seacross Valproic Acid used

Valproic Acid is used for the treatment of:

• Seizures that affect the whole body (generalized seizures) (absences, myoclonic seizures and tonic-clonic seizures),

• Seizures that affect a part of the body (focal seizures), which can also affect the whole body (secondary generalized seizures).

Do not take Seacross Valproic Acid:

• If you are pregnant, unless it is the only option.
• If you are a woman of childbearing age, unless you use an effective contraceptive method during the entire treatment with this medication. Do not stop taking valproic acid or your contraceptives until you have consulted with your doctor. Your doctor will give you more advice (see "Pregnancy, breastfeeding and fertility - Important advice for women" below).

• If you are allergic (hypersensitive) to sodium valproate or to any of the other components of this medication (listed in section 6: Additional information). The signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue.
• If you have liver problems or you or your family have a history of liver problems.
• If you have a rare disease called porphyria.
• If you have a genetic disorder that causes a mitochondrial disorder (e.g., Alpers-Huttenlocher syndrome).
• If you have a metabolic disorder known, for example, a urea cycle disorder.
• If you have a carnitine deficiency (a very rare metabolic disorder) that is not being treated.
• If you are taking it at the same time:

• St. John's Wort (a plant used to treat depression).

Do not take this medication if any of the above circumstances apply. If you are unsure, consult your doctor or pharmacist before taking valproic acid.

Warnings and precautions

Be especially careful with Seacross Valproic Acid

Contact your doctor immediately:

• If you have thoughts of harming yourself or committing suicide. A small number of people taking antiepileptic medications like valproate have had thoughts of harming themselves or committing suicide. If you ever have these thoughts, contact your doctor immediately.
• If you or your child develop a sudden illness, especially during the first six months of treatment, and especially if it includes repeated vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, loss of appetite, upper stomach pain, nausea, jaundice (yellowing of the skin or eyes), swelling of the legs, worsening of epilepsy, or general feeling of illness. This medication can affect the liver and pancreas (see section 4).
• If this medication is taken by a child under 3 years old who is taking aspirin. Valproate should not be administered with aspirin.
• If you experience a worsening of your symptoms (more frequent or severe seizures) while taking this medication.
• The risk of liver damage increases if valproate is taken by children under 3 years old, in people taking another antiepileptic medication at the same time, or who have another neurological or metabolic disease and severe epilepsy.
• If you or your child have balance and coordination problems, feel lethargic or less alert, or vomit, report this to your doctor immediately. This may be due to an increase in the amount of ammonia in the blood.

Consult your doctor or pharmacist before starting to take valproic acid if:

• You have diabetes. This medication may affect the results of urine tests.
• You have kidney problems. Your doctor may give you a lower dose.
• You have seizures (epilepsy), brain diseases, or a metabolic disorder that affects your brain. Adding valproate may increase the risk of liver damage.
• You are taking other antiepileptic medications. Adding valproate may increase the risk of liver damage.
• You suspect you have a metabolic disorder, particularly inherited enzyme deficiencies such as "urea cycle disorder". Adding valproate may increase the risk of high levels of ammonia in the blood.
• You have a disease called systemic lupus erythematosus (SLE), a disease of the immune system that affects the skin, bones, joints, and internal organs.
• You have a genetic disorder called "carnitine palmitoyltransferase type II deficiency", which may increase the risk of muscle damage.
• You know or your doctor suspects that there is a genetic disorder causing a mitochondrial disorder in your family. Adding valproate may increase the risk of liver damage.
• This medication is taken by a child under 3 years old. The risk of liver damage increases in this age group.
• You have a dietary deficiency of carnitine, which is found in meat and dairy products, especially in children under 10 years old.
• You have a carnitine deficiency and are taking carnitine.

If you are unsure whether any of the above points apply to your case, consult your doctor or pharmacist before taking valproic acid.

Other medications and Seacross Valproic Acid

Inform your doctor or pharmacist if you are taking, have taken recently, or may take any other medication. This includes medications purchased without a prescription, even those made from plants. Some other medications may affect the effects of valproate or vice versa. These include:

• Some medications used for pain and inflammation (salicylates) such as aspirin (see "Be especially careful with Seacross Valproic Acid").
• Other medications used to treat seizures (epilepsy) - see section 3, "Patients taking other medications for seizures". This includes medications such as phenobarbital, primidone, phenytoin, carbamazepine, topiramate, acetazolamide, lamotrigine, rufinamide, felbamate, or zonisamide.
• Medications containing quetiapine, which is used to treat schizophrenia.
• Medications used to thin the blood (such as warfarin).
• Zidovudine: used to treat HIV infection.
• Medications for depression.
• Monamine oxidase inhibitors (MAOIs) such as moclobemide, selegiline, linezolid.
• Medications used to calm emotional and mental states such as diazepam and olanzapine.
• Propofol, an anesthetic.
• Nimodipine.
• Some medications used to prevent and treat malaria, such as mefloquine and chloroquine.
• Cimetidine: used for stomach ulcers.
• Colestiramine used to reduce blood cholesterol levels.
• Some medications used to treat infections (antibiotics) such as aztreonam, rifampicin, and erythromycin.
• Lopinavir and ritonavir: used to treat HIV.
• Carbapenem agents (antibiotics used to treat bacterial infections).
• Products containing estrogens (including some hormonal contraceptives that contain estrogens).
• Metamizol (used to treat pain and fever).
• Cannabidiol (used to treat epilepsy and other conditions).
• Metotrexate (used to treat cancer and inflammatory diseases).
• Some anti-infectives containing pivalate (such as pivampicillin, adefovir dipivoxil).
• Etosuximida.
• Bupropión.

Seacross Valproic Acid and alcohol

It is not recommended to consume alcohol during treatment.

Weight gain

Taking this medication may cause you to gain weight. Consult your doctor to find out how this will affect you.

Blood tests

Your doctor may want to perform blood tests before you start taking valproic acid and during treatment. Blood tests may be necessary if you are to undergo surgery or if you experience unexplained bleeding or bruising.

Pregnancy, breastfeeding, and fertility

Important advice for women

Do not stop taking valproic acid or interrupt your contraception until you have consulted with your doctor. Your doctor will give you more advice.

Epilepsy

• In the case of epilepsy, do not use this medication if you are pregnant, unless it is the only option.

• In the case of epilepsy, if you are a woman of childbearing age, do not take valproic acid unless you use an effective contraceptive method during the entire treatment with this medication. Do not stop taking valproic acid or your contraceptives until you have consulted with your doctor. Your doctor will give you more advice.

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

• Consult your doctor immediately if you are planning to have a baby or are pregnant.
• Valproate carries a risk if taken during pregnancy. The greater the dose, the greater the risk, but all doses carry a risk, even when valproate is used in combination with other medications to treat epilepsy.
• It may cause severe congenital defects and affect the physical and mental development of the child as it grows after birth. Among the most common congenital anomalies are:spina bifida(the bones of the spine do not develop correctly); facial and cranial malformations, heart malformations, kidney malformations, urinary tract malformations, and sex organ malformations, limb defects, and multiple malformations associated with various organs and body parts. Congenital defects may lead to disabilities that can be severe.
• There have been reports of hearing or deafness problems in children exposed to valproate during pregnancy.
• There have been reports of eye malformations in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations may affect vision.
• If you take valproate during pregnancy, you have a higher risk than other women of having a child with congenital defects that require medical treatment. Because valproate has been used for many years, we know that in women taking it, about 11 out of every 100 babies will have congenital defects. This contrasts with 2-3 babies out of every 100 born to women who do not have epilepsy.
• It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have developmental problems in early childhood. Affected children may be slow to walk and talk, intellectually less capable than other children, and have difficulties with language and memory.
• There is evidence that children exposed to valproate during pregnancy have a higher risk of developing autism spectrum disorders.
• There is some evidence that children exposed to valproate during pregnancy have a higher risk of developing Attention Deficit Hyperactivity Disorder (ADHD).
• Before prescribing this medication, your doctor will have explained to you what could 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 the medication or your contraceptive until you have consulted with your doctor.
• If you are a father or caregiver of a girl treated with valproate, contact your doctor once your daughter has reached puberty.
• Some contraceptive methods (birth control pills containing estrogens) may reduce the levels of valproate in the blood. Make sure to talk to your doctor about the most suitable contraceptive method for you.
• Consult your doctor about the possibility of taking folic acid when trying to have a baby. Folic acid may reduce the general risk ofspina bifidaand early spontaneous abortion, which exists in all pregnancies. However, it is unlikely to reduce the risk of congenital defects associated with valproate use.
• There may be bleeding disorders, such as poor blood clotting that may manifest as prolonged bleeding or bruising, hypoglycemia (low blood sugar), hypothyroidism (underactive thyroid gland, which may cause fatigue or weight gain) in newborns whose mothers took valproate during pregnancy.
• There may be a withdrawal syndrome (such as agitation, irritability, hyperexcitability, excessive nervousness, and uncontrolled movements (hyperkinesia), muscle disorders, tremors, seizures, and feeding disorders) in newborns whose mothers took valproate during the last trimester of pregnancy.

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 DO NOT PLAN TO HAVE A BABY
• I AM TAKING VALPROIC ACID AND PLAN 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 are prescribed this medication, your doctor will have explained the risks to the fetus if you become pregnant. Once you can have a baby, make sure to use an effective contraceptive method without interruption during the entire treatment with valproic acid. Consult your doctor or family planning clinic if you need advice on contraception.

Key messages:

• You must exclude the possibility of pregnancy before starting treatment with this medication with the result of a pregnancy test, confirmed by your doctor.
• You must use an effective contraceptive method during the entire treatment with valproic acid.
• You must talk to your doctor about the suitable contraceptive methods. Your doctor will give you information on preventing pregnancy and may refer you to a specialist to advise you on contraceptive methods.
• You must attend regular consultations (at least once a year) with a specialist experienced in treating epilepsy. During this visit, your doctor will ensure that you are well aware and have understood all the risks and advice related to the use of valproate during pregnancy.
• Inform your doctor if you want to have a baby.
• Inform your doctor immediately if you are pregnant or think you may be.

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

If you continue treatment with valproate but do not plan to have a baby, make sure to use an effective contraceptive method without interruption during the entire treatment with this medication. Consult your doctor or family planning clinic if you need advice on contraception.

Key messages:

• You must use an effective contraceptive method during the entire treatment with this medication.
• You must talk to your doctor about the suitable contraceptive methods. Your doctor will give you information on preventing pregnancy and may refer you to a specialist to advise you on contraceptive methods.
• You must attend regular consultations (at least once a year) with a specialist experienced in treating epilepsy. During this visit, your doctor will ensure that you are well aware and have understood all the risks and advice related to the use of valproate during pregnancy.
• Inform your doctor if you want to have a baby.
• Inform your doctor immediately if you are pregnant or think you may be.

I AM TAKING VALPROIC ACID AND PLAN TO HAVE A BABY

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

Do not stop taking valproic acid or your contraceptives until you have consulted with your doctor. Your doctor will give you more advice.

Babies whose mothers took valproate are at a high risk of congenital defects and developmental problems that can be severely debilitating. Your doctor will refer you to a specialist experienced in treating epilepsy, who will evaluate alternative treatment options from the start. Your specialist may initiate several measures to ensure that your pregnancy goes as smoothly as possible and that the risks to you and the fetus are minimized.

Your specialist may decide to change the dose of valproic acid or switch you to another medication or discontinue valproic acid treatment much earlier than you become pregnant to ensure that your underlying disease is stable.

Consult your doctor about taking folic acid when planning to have a baby. Folic acid may reduce the general risk ofspina bifidaand early spontaneous abortion that exists in all pregnancies. However, it is unlikely to reduce the risk of congenital defects associated with valproate use.

Key messages:

• Do not stop taking valproic acid unless your doctor tells you to.
• Do not stop using your contraceptives until you have consulted with your doctor and developed a plan together to ensure control of your disease and minimize the risks to your baby.
• Book an appointment with your doctor first. During this visit, your doctor will ensure that you are well aware and have understood all the risks and advice related to the use of valproate during pregnancy.
• Your doctor will try to switch you to another medication or discontinue valproic acid treatment much earlier than you become pregnant.
• Book an urgent appointment with your doctor if you are or think you may be pregnant.

I AM PREGNANT AND TAKING VALPROIC ACID

Do not stop taking this medication unless your doctor tells you to, as your disease may worsen. Book an urgent appointment with your doctor if you are or think you may be pregnant.

Babies whose mothers took valproate are at a high risk of congenital defects and developmental problems that can be severely debilitating.

You will be referred to a specialist experienced in treating epilepsy, who will evaluate alternative treatment options.

In exceptional circumstances where valproic acid is the only available treatment option during pregnancy, you will be closely monitored for both the treatment of your underlying disease and the development of the fetus. You and your partner may receive counseling and support regarding the pregnancy exposed to valproate.

Consult your doctor about the possibility of taking folic acid. Folic acid may reduce the general risk ofspina bifidaand early spontaneous abortion that exists in all pregnancies. However, it is unlikely to reduce the risk of congenital defects associated with valproate use.

Key messages:

• Book an urgent appointment with your doctor if you are or think you may be pregnant.
• Do not stop taking this medication unless your doctor tells you to.
• Make sure you are referred to a specialist for prenatal monitoring to detect possible cases of malformations.
• Make sure you receive comprehensive counseling on the risks of valproate use during pregnancy, including teratogenicity (congenital defects) and developmental problems in children.

Make sure to read the patient guide that your doctor will give you. Your doctor will explain the Annual Risk Recognition Form to you and ask you to sign and keep it. You will also receive a Patient Card from your pharmacist to remind you of the risks of valproate during pregnancy.

Breastfeeding

Very little valproic acid passes into breast milk. However, consult your doctor if you need to breastfeed your baby. Ask your doctor or pharmacist for advice before taking any medication.

Important advice for male patients

Potential risks related to taking valproate in the 3 months before conception of a child

A study suggests a possible risk of movement and developmental disorders (developmental disorders in early childhood) in children born to parents treated with valproate in the 3 months before conception. In this study, about 5 children out of every 100 had these disorders when born to parents treated with valproate, compared to about 3 children out of every 100 when born to parents treated with lamotrigine or levetiracetam (other medications that may be used to treat your disease). The risk for newborns whose parents stopped taking valproate 3 months (the time needed to form new sperm) or more before conception is unknown. The study has limitations, and it is unclear whether the increased risk of movement and developmental disorders suggested by this study is caused by valproate. The study was not large enough to show which specific movement and developmental disorders may occur in children.

As a precaution, your doctor will inform you:

• The potential risk in newborns whose parents are taking valproate.
• The need to consider an effective contraceptive method for you and your female partner during treatment and for 3 months after stopping treatment.
• The need to consult your doctor when planning to conceive a child and before stopping contraception.
• The possibility of using other treatments to treat your disease, depending on your individual situation.

Do not donate sperm while taking valproate and for 3 months after stopping valproate.

Consult your doctor if you are planning to have a child.

If your female partner becomes pregnant while taking valproate in the 3 months before conception and has any doubts, contact your doctor. Do not stop treatment without consulting your doctor. If you stop treatment, your symptoms may worsen.

You must attend regular consultations with your 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 may be used to treat your disease, depending on your individual situation.

Make sure to read the patient guide that your doctor will give you. You will also receive a Patient Card from your pharmacist to remind you of the potential risks of valproate.

Driving and operating machinery

You may feel drowsy when taking this medication. If this happens, do not drive or use tools or machinery.

The use of other medications used to treat seizures or calm emotional and mental problems may increase drowsiness.

Seacross Valproic Acid contains sodium

This medication contains 13.9 mg of sodium (the main component of table salt) in each ml. This is equivalent to 0.7% of the maximum recommended daily dietary intake of sodium for an adult.

Girls and women of childbearing age

This medication should be initiated and supervised by a doctor specializing in the treatment of epilepsy.

Male patients

It is recommended that acidvalproico be initiated and supervised by a specialist with experience in the treatment of epilepsy - see section 2 Important advice for male patients.

The administration of this medication is always the responsibility of a doctor or nurse. It must be administered in the form of a slow injection or intravenous infusion. If you are unsure why you are being administered acid valproico or have any doubts about the amount ofthismedication you are being administered, ask your doctor or nurse.

Your doctor will stop giving you acid valproico and switch you to valproate sodium in tablets, granules, syrup, or liquid as soon as possible. This medication should be initiated and supervised by a doctor specializing in the treatment of epilepsy.

How much will be administered

• Your doctor will decide the amount you should receive based on your condition. The amount of acid valproico administered to you or your child will depend on your age or body weight.
• If you have been taking valproate sodium orally, your doctor may decide to administer the same amount of acid valproico through continuous or repeated infusion.

If you have not taken this medication before, your doctor will use the following doses:

The recommended daily mean dose during long-term treatment is:

• Children(28 days of age to 11 years):20 -30 mg of valproate sodium per kg of body weight
• Adolescents(12 to 17 years): 25 mg of valproate sodium per kg of body weight
• Adults(≥ 18 years): 20 mg of valproate sodium per kg of body weight

Adolescents and adults

• Patients already satisfactorily treated with oral valproate sodium may continue with their current dose between 4 and 6 hours after the last oral dose:

• either through continuous infusion for 24 hours;
• or divided into 4 infusions of one hour per day.

• Patients not yet treated with valproate sodium may receive 10 mg/kg in slow intravenous injection over 3-5 minutes, followed by continuous infusion at a rate of 1 mg/kg/h (up to a maximum of 25 mg/kg/day) starting 30 minutes after completing the bolus.

Pediatric population

The daily needs of children usually range from 20 to 30 mg/kg/day. If adequate control is not achieved within this range, the dose may be increased to 40 mg/kg/day, but only in patients in whom plasma levels of valproic acid can be controlled.

Patients with renal insufficiency

• Your doctor may decide to adjust your dose or your child's dose.

If you take more AcidoValproico Seacross than you should

It is unlikely that your doctor or nurse will administer too much medication to you. Your doctor will monitor your progress and the medication you receive. Always ask if you are unsure why you are receiving a dose of medication.

Taking too much acid valproico may produce the following symptoms: feeling or being sick, pupils of the eye become smaller, dizziness, loss of consciousness, weak muscles, and deficient reflexes, respiratory problems, headaches, seizures (convulsions), confusion, memory loss, low blood pressure, and unusual or inappropriate behavior.

Taking too much medication may produce excessive sodium in the blood (hypernatremia).

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

If you forget to take AcidoValproico Seacross

Your doctor or nurse will have instructions on when to administer this medication. It is unlikely that you will not receive the medication as prescribed. However, if you think you have forgotten to take a dose, consult your doctor or nurse.

If you stop taking AcidoValproico Seacross

It is essential that you continue to receive injections of this medication until your doctor decides to stop them. If you stop taking it, your seizures may recur.

Tests

Make sure you or your child attend your regular appointments for a review. They are very important, as your dose or your child's dose may need to be changed.Acido Valproicomay alter the levels of liver enzymes that appear in blood tests. This may meanthat your liver or your child's liver is not functioning correctly. If you or your child visit a hospital or see another doctor or dentist, tell them that you are taking acid valproico.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Inform your doctor immediately if you notice any of the following serious side effects - you may need urgent medical treatment:

• You have an allergic reaction that may manifest as:

• Abscesses with skin peeling (blisters, desquamation, or hemorrhage on any part of the skin (including lips, eyes, mouth, nose, genitals, hands, or feet) with or without skin rash, sometimes with flu-like symptoms such as fever, chills, or muscle pain - may be signs of diseases called 'toxic epidermal necrolysis' or 'Stevens-Johnson syndrome'. This may occur more frequently in people who are also taking lamotrigine.
• Skin rash or skin lesions with a pink/red ring and a pale center that may cause itching, be scaly, or be filled with fluid. The rash may appear especially on the palms of the hands or soles of the feet. May be signs of a disease called 'erythema multiforme'.
• Allergic inflammation, with painful hives that itch (especially around the eyes, lips, throat, and sometimes hands and feet): may be signs of 'angioedema'.
• Syndrome with skin rash, fever, lymph node enlargement, and possible organ involvement: may be signs of a condition called 'DRESS' or drug reaction with eosinophilia and systemic symptoms.

• Confusion, changes in level of consciousness (including coma), confusion, slowness, or abnormal behavior and memory loss, associated or not with more frequent or more severe seizures, particularly if phenobarbital and topiramate are taken together or if the valproic acid dose has been increased suddenly.
• Confusion, which may be due to a decrease in blood sodium levels or a disease called 'SIADH' or Syndrome of Inappropriate Antidiuretic Hormone Secretion.
• Balance and coordination disorders, feeling drowsy or less alert, associated with vomiting. This may be due to an increase in blood ammonia levels.
• Increased frequency and severity of seizures.
• Repeated vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, or loss of appetite, severe upper stomach pain, nausea, jaundice (yellowing of the skin or eyes), swelling of the legs, or worsening of your epilepsy or general feeling of discomfort. These may be signs of severe liver or pancreas disorders (see section 2).
• Spontaneous bruises or hemorrhages, due to blood clotting problems that appear in blood tests.
• Severe decrease in white blood cells or bone marrow insufficiency, as shown by blood tests, sometimes revealed by fever and difficulty breathing, and by catching more infections than usual.
• Underactive thyroid gland, which may cause fatigue or weight gain (hypothyroidism).
• Joint pain, fever, fatigue, skin rash. May be signs of systemic lupus erythematosus.
• Tremor, uncontrollable muscle contractions, walking instability (parkinsonism, extrapyramidal disorder, ataxia).
• Muscle pain and muscle weakness (rhabdomyolysis).
• Difficulty breathing and pain due to inflammation of the lung lining (pleural effusion).
• Kidney disease (renal insufficiency, tubulointerstitial nephritis, and Fanconi syndrome), which may manifest as decreased urine output, loss of appetite, feeling unwell, seizures, or loss of consciousness.

Inform your doctor or pharmacist if any of the following side effects worsen or last more than a few days, or if you notice any side effect not mentioned in this leaflet:

Very common (may affect more than 1 in 10 people):

• Nausea.
• Tremor.

Common (may affect up to 1 in 10 people):

• Decreased platelet count or decreased red blood cell count or abnormal increase in red blood cell size, or bone marrow disorders (shown by blood tests).
• Weight gain, obesity.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Headache.
• Rapid, uncontrolled eye movement.
• Auditory or hearing disorders.

• Vomiting, stomach pain, diarrhea, especially when starting treatment, see section 2 "How to take this medicine".

• Gingival disorder (mainly hypertrophy (excessive growth of the gums)).

• Mouth pain, swollen mouth, mouth ulcers, and burning sensation in the mouth (stomatitis).

• Temporary hair loss, nail and nail bed disorders.

• Urinary incontinence (involuntary urination).

• Menstrual pain in women.
• Feeling nauseous or dizzy

Uncommon (may affect up to 1 in 100 people):

• Tickling or numbness in hands or feet.
• Inflammation of small blood vessels (vasculitis).
• Skin reactions, such as rashes.
• Abnormal hair growth, abnormal hair texture, changes in hair color.
• Excessive hair growth, especially in women, male pattern hair growth (virilism), acne (hyperandrogenism).
• Bone disorders. Cases of bone disorders, including osteopenia and osteoporosis (bone thinning) and fractures have been reported. Consult your doctor or pharmacist if you are taking long-term antiepileptic medication, have a history of osteoporosis, or are taking steroids.
• Irregular menstrual periods or absence of menstruation.
• Swelling of feet and legs (edema).
• Decreased body temperature.

Rare (may affect up to 1 in 10,000 people):

• Aggression, agitation, altered attention, abnormal behavior, and hyperactivity.

Frequency not known (cannot be estimated from available data):

• Decreased carnitine levels (shown by blood or muscle tests).

Blood tests

Valproic acid may alter levels of liver enzymes, blood clotting factors, salts, or sugars that appear in blood and urine tests.

Other side effects in children

Some side effects of valproate are more common in children or more severe than in 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 nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging and on the label after EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Chemical and physical stability has been demonstrated during use for 96 hours at 2-8 °C and at 25°C. From a microbiological standpoint, the product should be used immediately. If not used immediately, storage times in use and conservation conditions before use are the responsibility of the user and are normally not greater than 24 hours at 2-8 °C, unless the dilution has been performed in controlled and validated aseptic conditions.

Only transparent and particle-free solutions should be used.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of Acid V alproico Seacross

• The active ingredient is valproate sodium. Each ml contains 100 mg of valproate sodium.

The other components are edetate disodium, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Aspect of the product and contents of the packaging

Acid V alproico Seacross is a transparent and colorless solution. It is presented in a glass vial containing 3 ml or 4 ml of solution. Each package contains 5 vials.

It may only be marketed in some sizes of packaging.

Holder of the marketing authorization and responsible manufacturer

Seacross Pharma (Europe) Limited

POD 13, The Old Station House

15A Main Street, Blackrock

Dublin, A94 T8P8

Ireland

Local Representative

Pharmavic Ibérica, S.L.

C/ Compositor Lehmberg Ruiz

6 Edificio Ibiza, Office 7

29007 Málaga, (Spain)

Tel: 676295501

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

Last review date of this leaflet: 06/2024

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