VALPROIC ACID SEACROSS 100 mg/mL INJECTABLE SOLUTION AND PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Valproic AcidSeacross 100 mg/ml Solution for Injection and Infusion

sodium valproate

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 have. The last section of section 4 will tell you how to report side effects.

Read all of this package leaflet carefully before you start taking this medicine

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Valproic Acid Seacross and what is it used for
2. What you need to know before you start taking Valproic Acid Seacross
3. How to take Valproic Acid Seacross
4. Possible side effects
5. Storage of Valproic Acid Seacross
6. Package contents and further information

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

What is Valproic Acid Seacross

The name of the medicine is Valproic Acid Seacross 100 mg/ml Solution for Injection and Infusion (called ValproicAcidin this package leaflet).

What Valproic Acid Seacross contains

This medicine contains the active substance sodium valproate. It belongs to a group of medicines called anticonvulsants or antiepileptics. It works by helping to calm the brain.

What Valproic Acid Seacross is used for

Valproic Acid is used to treat:

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

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

2. What you need to know before taking Valproic Acid Seacross

Do not take Valproic Acid Seacross:

• If you are pregnant, unless nothing else works for you.
• If you are a woman of childbearing age, unless you use an effective contraceptive method throughout 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 below in "Pregnancy, breastfeeding, and fertility - Important advice for women").

• If you are allergic (hypersensitive) to sodium valproate or any of the other components of this medication (included in section 6: Additional information). The signs of an allergic reaction include: skin rash, swallowing or breathing problems, 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 suffer from a rare disease called porphyria.
• If you have a genetic problem that causes a mitochondrial disorder (e.g., Alpers-Huttenlocher syndrome).
• If you have a known metabolic disorder, for example, a disorder of the urea cycle.
• If you have a carnitine deficiency (a very rare metabolic disease) that is not being treated.
• If you are taking:

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

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

Warnings and precautions

Be especially careful with Valproic Acid Seacross

Contact your doctor immediately:

• If you have thoughts of harming yourself or committing suicide. A small number of people being treated with antiepileptics like sodium 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, pain in the upper part of the stomach, nausea, jaundice (yellowing of the skin or whites of the eyes), swelling of the legs, worsening of epilepsy, or a general feeling of discomfort. This medication may affect the liver and pancreas (see section 4).
• If this medication is being taken by a child under 3 years of age who is taking acetylsalicylic acid (aspirin). Sodium valproate should not be administered with acetylsalicylic acid (aspirin).
• If you experience a worsening of your symptoms (more frequent or severe seizures) when taking this medication.
• The risk of liver damage increases if valproate is taken by children under 3 years of age, in people who take another antiepileptic medication at the same time, or who have another neurological or metabolic disease and severe forms of epilepsy.
• If you or your child have balance and coordination problems, feel lethargic or less alert, or vomit, inform your doctor immediately. This may be due to an increase in the amount of ammonia in the blood.
• Severe skin reactions, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), erythema multiforme, and angioedema, have been reported in association with valproate treatment. Seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

• You have diabetes. This medication may affect urine test results.
• You have kidney problems. Your doctor may give you a lower dose.
• You have seizure disorders (epilepsy), brain diseases, or a metabolic disease that affects your brain. The addition of sodium valproate may increase the risk of liver damage.
• You are taking other antiepileptic medications. The addition of sodium valproate may increase the risk of liver damage.
• You are suspected of having a metabolic disorder, in particular, hereditary enzyme deficiency disorders such as "urea cycle disorder". The addition of sodium valproate may increase the risk of high blood ammonia levels.
• You have a disease called 'systemic lupus erythematosus (SLE)', an immune system disease that affects the skin, bones, joints, and internal organs.
• You have an underlying disease 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 problem causing a mitochondrial disorder in your family. The addition of sodium valproate may increase the risk of liver damage.
• This medication is being taken by a child under 3 years of age. 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 of age.
• You have a carnitine deficiency and are taking carnitine.
• If you have ever developed a severe skin rash or peeling, blisters, and/or sores in the mouth after taking valproate.

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 Valproic Acid Seacross

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication. This includes medications purchased without a prescription, including herbal medicines. Some other medications may affect the effects of valproate or vice versa. These include:

• Certain medications used for pain and inflammation (salicylates) such as aspirin (see "Be especially careful with Valproic Acid Seacross").
• 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, rufinamida, 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.
• Monoamine 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.
• Certain medications used for the prevention and treatment of malaria, such as mefloquine and chloroquine.
• Cimetidine: used for stomach ulcers.
• Colestyramine used to reduce blood fat (cholesterol) levels.
• Certain antibiotics (such as aztreonam, rifampicin, and erythromycin).
• Lopinavir and ritonavir: used for HIV treatment.
• Carbapenem agents (antibiotics used to treat bacterial infections).
• Products containing estrogens (including some hormonal contraceptives that contain estrogens).
• Metamizole (used to treat pain and fever).
• Cannabidiol (used to treat epilepsy and other conditions).
• Methotrexate (used to treat cancer and inflammatory diseases).
• Certain anti-infectives that contain pivalate (such as pivampicillin, adefovir dipivoxil).
• Etosuximide.
• Bupropion.
• Clozapine (for treating mental health conditions).

Valproic Acid Seacross and alcohol

Alcohol consumption is not recommended 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 going to have surgery or if you experience unexplained bruising or bleeding.

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, you should not use this medication if you are pregnant, unless nothing else works for you.

• In the case of epilepsy, if you are a woman of childbearing age, you should not take valproic acid unless you use an effective contraceptive method throughout 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 higher the dose, the greater the risks, but all doses carry a risk, even when valproate is used in combination with other medications to treat epilepsy.
• It can cause serious congenital defects and affect the physical and mental development of the child as they grow 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, kidney, urinary tract, and genital malformations, limb defects, and multiple malformations associated with several organs and parts of the body. Congenital defects can lead to disabilities that can be severe.
• Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.
• Eye malformations have been reported in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations can affect vision.
• If you take valproate during pregnancy, you have a higher risk than other women of having a child with congenital defects that require medical treatment. Because valproate has been used for many years, we know that in women who take it, about 11 out of 100 babies will have congenital defects. This compares to 2-3 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 early childhood. Affected children may be slow to walk and talk, less intellectually capable than other children, and have difficulties with language and memory.
• Autism spectrum disorders are more frequently diagnosed in children exposed to valproate during pregnancy, and 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 what could happen to your baby if you become pregnant while taking valproate. If you later decide you want to have a baby, do not stop taking the medication or your contraceptive method until you have consulted with your doctor.
• If you are the parent or caregiver of a girl being treated with valproate, you should contact the doctor once your daughter using valproate experiences menarche.
• Some contraceptive methods (hormonal contraceptives that contain estrogens) may reduce valproate levels in the blood. Make sure to talk to your doctor about the most suitable contraceptive method for you.
• Consult your doctor about taking folic acid when you are trying to have a baby. Folic acid may reduce the overall risk of spina bifidaand early spontaneous abortion that exists in all pregnancies. However, it is unlikely to reduce the risk of congenital defects associated with valproate use.
• Coagulation disorders, such as poor blood clotting that can manifest as bruises or bleeding that takes a long time to stop, hypoglycemia (low blood sugar levels), hypothyroidism (underactive thyroid gland, which can cause fatigue or weight gain) may occur in newborns whose mothers have taken valproate during pregnancy.
• A withdrawal syndrome (such as agitation, irritability, hyperexcitability, nervousness, excessive restlessness, and uncontrolled movements (hyperkinesia), muscle disorders, tremors, seizures, and feeding disorders) may occur in newborns whose mothers have taken 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 you are being prescribed this medication for the first time, your doctor will have explained the risks to the fetus if you become pregnant. Once you can have a baby, you must ensure that you use an effective contraceptive method without interruption throughout treatment with valproic acid. Consult your doctor or family planning clinic if you need advice on contraception.

Key messages:

• Pregnancy must be ruled out before starting treatment with this medication, confirmed by your doctor with a pregnancy test result.
• You must use an effective contraceptive method throughout valproic acid treatment.
• You should discuss suitable contraceptive methods with your doctor. Your doctor will give you information on pregnancy prevention and may refer you to a specialist for contraceptive advice.
• You should attend regular consultations (at least once a year) with a specialist experienced in the treatment of epilepsy. During this visit, your doctor will ensure that you understand and have comprehended all the risks and advice related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Inform your doctor immediately if you are pregnant or think you might 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, ensure that you use an effective contraceptive method without interruption throughout 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 throughout treatment with this medication.
• You should discuss contraceptive methods with your doctor. Your doctor will give you information on pregnancy prevention and may refer you to a specialist for contraceptive advice.
• You should attend regular consultations (at least once a year) with a specialist experienced in the treatment of epilepsy. During this visit, your doctor will ensure that you understand and have comprehended all the risks and advice related to the use of valproate during pregnancy.
• Tell your doctor if you want to have a baby.
• Inform your doctor immediately if you are pregnant or think you might be.

I AM TAKING VALPROIC ACID AND PLAN TO HAVE A BABY

If you are planning to have a baby, schedule 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 have taken valproate are at serious risk of suffering from congenital defects and developmental problems that can be severely debilitating. Your doctor will refer you to a specialist with experience in the treatment of epilepsy, who can evaluate other treatment options from the start. Your specialist may implement several measures to ensure that your pregnancy proceeds as well as possible and minimize the risks to you and the fetus.

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

Consult your doctor about taking folic acid when you are planning to have a baby. Folic acid may reduce the overall risk of spina 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 contraceptive methods before you have talked to your doctor and developed a plan together to ensure control of your disease and minimize the risks to your baby.
• Schedule an appointment with your doctor first. During this visit, your doctor will ensure that you understand and have comprehended all the risks and advice related to the use of valproate during pregnancy.
• Your doctor will try to switch you to another medication or interrupt treatment with valproic acid long before you become pregnant.
• Schedule an urgent appointment with your doctor if you are or think you might 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. Schedule an urgent appointment with your doctor if you are or think you might be pregnant. Your doctor will give you more advice.

The babies of mothers who have taken valproate are at serious risk of suffering from congenital defects and developmental problems that can be severely debilitating.

3. How to Take Valproic Acid Seacross

Girls and Women of Childbearing Age

Treatment with this medication should be initiated and supervised by a doctor specialized in treating epilepsy.

Male Patients

It is recommended that valproic acid be initiated and supervised by a specialist with experience in treating 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 as a slow injection or intravenous infusion. If you are unsure why you are being given valproic acid or have any doubts about the amount of this medication being administered, ask your doctor or nurse.

Your doctor will stop giving you valproic acid and switch you to valproate sodium in tablets, granules, syrup, or liquid as soon as possible. Treatment with this medication should be initiated and supervised by a doctor specialized in treating epilepsy.

How Much Will Be Administered

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

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

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

• Children (from 28 days of age to 11 years): 20 - 30 mg of valproate sodium per kg of body weight
• Adolescents (from 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

• Patient 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 one-hour infusions per day.

• Patient not yet treated with valproate sodium may receive 10 mg/kg in slow intravenous injection over 3-5 minutes, followed by a 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 between 20 and 30 mg/kg/day. If adequate control is not achieved within this range, the dose may be increased up to 40 mg/kg/day, but only in patients where valproic acid plasma levels can be monitored.

Patient with Renal Impairment

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

If You Take More Valproic Acid Seacross Than You Should

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

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

Taking too much medication may cause an excess of 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 Valproic Acid Seacross

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

If You Stop Taking Valproic Acid Seacross

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

Tests

Make sure you or your child attend your scheduled appointments for a review. They are very important, as it may be necessary to change your dose or your child's dose. Valproic Acid may alter liver enzyme levels that appear in blood tests. This may mean that your liver or your child's liver is not functioning properly. If you or your child go to the hospital or visit another doctor or dentist, tell them that you are taking valproic acid.

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

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Report immediately to your doctor if you notice any of the following serious adverse effects - you may need urgent medical treatment:

• You have an allergic reaction that can manifest as:

• Blisters with skin peeling (blisters, scaling or bleeding in any part of the skin (including lips, eyes, mouth, nose, genitals, hands or feet) with or without a rash, sometimes with flu-like symptoms such as fever, chills or muscle pain - can be signs of diseases called 'toxic epidermal necrolysis' or 'Stevens-Johnson syndrome'. This can occur more frequently in people who also take lamotrigine.
• Skin rash or skin lesions with a pink/red ring and a pale center that can cause itching, be scaly or be filled with fluid. The rash can appear especially on the palms of the hands or on the soles of the feet. Can 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): can be signs of 'angioedema'.
• Syndrome with skin rash, fever, lymph node enlargement, and possible involvement of other organs: can be signs of a condition called 'DRESS' or drug hypersensitivity syndrome with eosinophilia and systemic symptoms.

• Drowsiness, changes in level of consciousness (including coma), confusion, slowness or abnormal behavior, and memory loss, associated or not with more frequent or severe seizures, particularly if phenobarbital and topiramate are taken at the same time or if the dose of valproic acid has been suddenly increased.
• Confusion, which could be due to a decrease in sodium levels in the blood or a disease called 'SIADH' or Syndrome of Inadequate Secretion of Antidiuretic Hormone.
• Balance and coordination disorders, feeling of lethargy or less alertness, associated with vomiting. This can be due to an increase in the amount of ammonia in the blood.
• Increase in the number and severity of seizures.
• Repeated vomiting, extreme fatigue, abdominal pain, drowsiness, weakness, or loss of appetite, severe pain in the upper abdomen, nausea, jaundice (yellowing of the skin or the whites of the eyes), swelling of the legs, or worsening of epilepsy or general feeling of discomfort. These can be signs of serious liver or pancreas disorders (see section 2).
• Bruises or spontaneous bleeding, due to blood coagulation problems that appear in blood tests.
• Severe decrease in white blood cells or bone marrow failure, as shown in blood tests, sometimes revealed by fever and difficulty breathing, and by contracting more infections than usual.
• Underactive thyroid gland, which can cause fatigue or weight gain (hypothyroidism).
• Joint pain, fever, fatigue, skin rash. Can be signs of systemic lupus erythematosus.
• Tremors, uncontrolled muscle contractions, instability when walking (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 failure, tubulointerstitial nephritis, and Fanconi syndrome), which can manifest as decreased urine output, loss of appetite, feeling of discomfort, seizures, or loss of consciousness.

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

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

• Nausea.
• Tremors.

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

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

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

• Gum 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 disorders, and nail bed disorders.

• Urinary incontinence (involuntary emission of urine).

• Pain during the menstrual period in women.
• Feeling of nausea or dizziness

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

• Tingling or numbness of 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 hairiness, especially in women, hair growth with a male pattern (virilization), acne (hyperandrogenism).
• Bone disorders. Cases of bone disorders, including osteopenia and osteoporosis (thinning of the bones) and fractures, have been reported. Consult your doctor or pharmacist if you are taking any long-term antiepileptic medication, have a history of osteoporosis, or are taking steroids.
• Irregular menstrual period or absence of it.
• Swelling of feet and legs (edema).
• Decrease in body temperature.
• Difficulty breathing, pain or pressure in the chest (especially when inhaling), difficulty breathing and dry cough due to fluid accumulation around the lungs (pleural effusion).

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

• Aggression, agitation, attention disorder, abnormal behavior, and psychomotor hyperactivity.
• Learning disorder.
• Memory impairment and cognitive disorders.
• Double vision.
• Bedwetting or increased need to urinate.
• Urinating a lot and feeling thirsty (Fanconi syndrome).
• Male infertility is usually reversible after treatment interruption and may be reversible after dose reduction. Do not stop treatment without talking to your doctor first.
• Ovarian cysts (polycystic ovaries).
• Reduced body levels of vitamin B8 (biotin deficiency), symptoms include skin rash around the eyes, nose, and mouth, weak and brittle nails, hair loss, loss of appetite, nausea, feeling of depression or hallucinations.

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

• Breast enlargement in men.

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

• Decrease in carnitine levels (demonstrated in blood or muscle tests).
• Darker areas of skin and mucous membranes (hyperpigmentation).

Blood tests

Valproic acid may alter liver enzyme levels, blood coagulation factors, salts, or sugars that appear in blood and urine tests.

Other adverse effects in children

Some adverse effects of valproate are more frequent in children or more severe than in adults. These include liver damage, pancreatitis, aggression, agitation, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not mentioned in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Valproic Acid Seacross

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

Do not use this medicine 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 medicine 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 point of view, the product should be used immediately. If not used immediately, the storage times in use and storage conditions before use are the responsibility of the user and will normally not exceed 24 hours at 2-8 °C, unless the dilution has been carried out in controlled and validated aseptic conditions.

Only transparent and particle-free solutions should be used.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Valproic Acid Seacross

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

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

Appearance of the product and package contents

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

Only some package sizes may be marketed.

Marketing authorization holder and 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, Oficina 7

29007 Málaga, (Spain)

Phone: 676295501

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of the last revision of this leaflet: 05/2025

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