Valprolek 500

Leaflet accompanying the packaging: patient information

ValproLEK 500, 500 mg, prolonged-release tablets

Sodium valproate
This medicinal product is subject to additional monitoring. This will allow for the quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

WARNING

ValproLEK 500 used during pregnancy can harm the unborn child. Women of childbearing age should use effective contraception (birth control) without interruption throughout the entire treatment period with ValproLEK 500. The treating physician will discuss this with the patient, but the patient should also follow the recommendations presented in section 2 of this leaflet.
Patients should contact their treating physician immediately if they plan to become pregnant or suspect they are pregnant.
ValproLEK 500 should not be discontinued unless advised by a physician, as the patient's condition may worsen.

Read the leaflet carefully before taking the medicinal product

.

• Keep this leaflet to be able to read it again if necessary.
• In case of any doubts, consult a physician or pharmacist.
• This medicinal product has been prescribed specifically for one person. Do not pass it on to others. The medicinal product may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including those not listed in this leaflet, they should inform their physician or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is ValproLEK 500 and what is it used for
• 2. Important information before taking ValproLEK 500
• 3. How to take ValproLEK 500
• 4. Possible adverse reactions
• 5. How to store ValproLEK 500
• 6. Package contents and other information

1. What is ValproLEK 500 and what is it used for

ValproLEK 500 is a medicinal product used to treat epilepsy and mania.
ValproLEK 500 is used to treat certain types of epilepsy, such as:
certain types of short-term loss of consciousness due to brain function disorders (petit mal),
sudden muscle contractions (myoclonus),
rhythmic seizure attacks combined with muscle tension (grand mal),
mixed forms of the above disorders,
seizure attacks without accompanying muscle tension (atonic seizures).
ValproLEK 500 may also be used in the case of epilepsy where other antiepileptic drugs have not been effective enough, such as:
epilepsy that occurs without seizures or muscle tension,
epilepsy with symptoms that affect perception and symptoms related to intentional movements.
ValproLEK 500 may be used as a single medicinal product or in combination with other antiepileptic drugs.
ValproLEK 500 is used to treat mania - a state in which the patient feels very excited, elated, stimulated, enthusiastic, or overactive. Mania occurs in the course of a disease known as bipolar affective disorder. ValproLEK 500 may be used when lithium cannot be used.

2. Important information before taking ValproLEK 500

When not to take ValproLEK 500

if the patient is hypersensitive (allergic) to sodium valproate and/or valproic acid or to any of the other ingredients of the medicinal product (listed in section 6);
if the patient has liver or pancreas disorders;
if the patient has metabolic disorders (including disorders of the urea cycle);
if the patient has a history of severe liver damage, especially related to the use of medicinal products;
if the patient has a disease caused by a disorder of red blood cell pigment production (porphyria);
if the patient has a tendency to bleeding;
if the patient has a genetic disorder that causes mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome).
Bipolar affective disorder

• In the case of bipolar affective disorder, ValproLEK 500 should not be taken if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, ValproLEK 500 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 500. Do not discontinue ValproLEK 500 or contraception until discussed with the physician. The treating physician will provide further guidance.

Epilepsy

• In the case of epilepsy, ValproLEK 500 should not be taken if the patient is pregnant, unless no other therapy is effective.
• In the case of epilepsy, if the woman is of childbearing age, ValproLEK 500 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 500. Do not discontinue ValproLEK 500 or contraception until discussed with the physician. The treating physician will provide further guidance.

Warnings and precautions

CONTACT YOUR PHYSICIAN IMMEDIATELY

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), polymorphic erythema, and angioedema, have been reported with valproate therapy.
If the patient notices any symptoms related to these severe skin reactions, as described in section 4, they should contact their physician immediately.
Before taking ValproLEK 500, discuss with your physician or pharmacist if:
ValproLEK 500 is used in infants or children under 3 years of age with severe epilepsy (especially in children with brain damage, intellectual disability, certain genetic diseases, and/or diagnosed metabolic disorders), as there is an increased risk of toxic liver effects during the first 6 months of treatment, especially in very young children. The risk is greater during combination therapy with other antiepileptic drugs;
the patient has kidney function disorders; the physician may consider reducing the dose of the medicinal product to reduce the concentration of valproic acid in the blood;
the patient has inflammatory skin or internal organ diseases (systemic lupus erythematosus), as ValproLEK 500 may cause the disease to worsen;
the patient has encephalopathy due to carnitine palmitoyltransferase (CPT) type II deficiency; taking ValproLEK 500 increases the risk of muscle tissue breakdown with muscle cramps, fever, and brownish discoloration of urine (rhabdomyolysis);
the patient has a history of bone marrow damage;
there is a family history of mitochondrial disorders.
If the patient has ever experienced a severe skin rash or blistering after taking valproate, they should consult their physician.
Consult a physician if any of the above warnings apply to the patient now or have applied in the past.
If the patient experiences symptoms such as physical or mental weakness, loss of appetite (anorexia), apathy, drowsiness, repeated vomiting, abdominal pain, or worsening of seizure attacks, they should contact their physician immediately. These symptoms may be caused by liver or pancreas inflammation or increased ammonia levels in the blood. In patients with suspected metabolic disorders, especially those related to urea cycle enzymes, the physician will order appropriate tests before starting treatment.
Due to the possibility of prolonged bleeding, patients should inform their physician or dentist about taking ValproLEK 500. If the patient is to undergo surgery or dental procedures, as well as in cases of spontaneous bruising or bleeding (see "Possible adverse reactions"), the physician will monitor blood cell counts.
If the patient taking ValproLEK 500 is to undergo a urine test for ketone bodies (substances that form when the body burns fat instead of sugar), the results may be unreliable due to the use of this medicinal product.
If the patient's weight increases, especially at the beginning of treatment, they should inform their physician. This may be a risk factor for polycystic ovary syndrome.
The cause of weight gain may be increased appetite (see section 4 "Possible adverse reactions"). Patients should monitor their weight and try to limit its increase to a minimum.
In a small number of people taking antiepileptic drugs, such as ValproLEK 500, thoughts of self-harm or suicide have occurred. If such thoughts occur, patients should contact their physician immediately.
Note
The skeleton of ValproLEK 500 tablets may be excreted in the stool.

Children and adolescents

Children and adolescents under 18 years of age:
ValproLEK 500 should not be used to treat mania in children and adolescents under 18 years of age.

ValproLEK 500 and other medicinal products

Patients should inform their physician about all medicinal products they are currently taking or have recently taken, including those available without a prescription.
ValproLEK 500 and other medicinal products may interact with each other, affecting their efficacy and the occurrence of adverse reactions. Therefore, it may be necessary to adjust the dose of the medicinal product. This applies to, among others:
antipsychotic drugs, monoamine oxidase inhibitors (MAOIs), antidepressant drugs, and benzodiazepines (drugs used to treat mental disorders). ValproLEK 500 may enhance the effects of these drugs;
phenobarbital (an antiepileptic drug). The concentration of phenobarbital in the blood may increase (especially in children);
primidone (an antiepileptic drug). It is possible to increase both the concentration of primidone and its adverse reactions (such as confusion). This effect disappears during long-term treatment;
phenytoin (an antiepileptic drug). It is possible to increase the concentration of phenytoin (in its unbound form) in the blood and cause symptoms of overdose. This may especially apply to the concurrent use of clonazepam (an antiepileptic drug) and valproic acid in children;
carbamazepine (a drug used to treat epilepsy and mental disorders). Concurrent use of ValproLEK 500 may enhance the toxic effects of carbamazepine;
lamotrigine (an antiepileptic drug). Combination therapy increases the risk of severe skin reactions, especially in children. Valproic acid may weaken the metabolism of lamotrigine in the body;
topiramate (an antiepileptic drug);
zidovudine (a drug used to treat HIV infections). Valproic acid may increase the concentration of zidovudine in the blood;
other antiepileptic drugs (such as phenytoin, phenobarbital, and carbamazepine). These drugs may decrease the concentration of valproic acid in the blood;
rifampicin (a drug used to treat bacterial infections). It may decrease the concentration of valproic acid in the blood;
felbamate (an antiepileptic drug). Concurrent use may cause an increase in the concentration of valproic acid and felbamate;
mefloquine (a drug used to prevent and treat malaria). Concurrent use with ValproLEK 500 may cause seizure attacks;
drugs that inhibit the activity of certain liver enzymes (such as cimetidine or erythromycin). These drugs may increase the concentration of valproic acid in the blood;
carbapenem antibiotics (used to treat bacterial infections). These drugs may decrease the concentration of valproic acid in the blood;
drugs containing the active substance quetiapine, as concurrent use with ValproLEK 500 may increase the risk of abnormal blood cell counts;
acetylsalicylic acid (a drug used to thin the blood or relieve pain). Valproic acid may enhance its effects. It is not recommended to use both drugs concurrently in children under 3 years of age due to the risk of liver damage;
cholestyramine (a drug that lowers cholesterol levels), as it decreases the absorption of valproate;
preparations containing estrogens (including some oral contraceptives), as they may decrease the concentration of valproate in the blood; the use of ValproLEK 500 should not affect the efficacy of hormonal contraception ("the pill");
metamizole (a drug used to treat pain and fever);
clozapine (used to treat mental disorders)
Other medicinal products that may affect the efficacy of ValproLEK 500 or whose efficacy may be altered by ValproLEK 500 include those containing the following active substances: protease inhibitors, such as lopinavir and ritonavir (used to treat HIV infections), nimodipine, and propofol (used in anesthesia).

ValproLEK 500 with food and drink

Food
Tablets can be taken 1 hour before a meal or during a meal (but always in the same way), washed down with plain water (not a carbonated drink, such as a soft drink). Food does not significantly affect the absorption of the medicinal product.
Alcohol
It is not recommended to drink alcohol while taking ValproLEK 500, as it may cause seizure attacks and enhance the effects of alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important information for women

Bipolar affective disorder

• In the case of bipolar affective disorder, ValproLEK 500 should not be taken if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, ValproLEK 500 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 500. Do not discontinue ValproLEK 500 or contraception until discussed with the physician. The treating physician will provide further guidance.

Epilepsy

• In the case of epilepsy, ValproLEK 500 should not be taken if the patient is pregnant, unless no other therapy is effective.
• In the case of epilepsy, if the woman is of childbearing age, ValproLEK 500 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 500. Do not discontinue ValproLEK 500 or contraception until discussed with the physician. The treating physician will provide further guidance.

Risk of taking valproate during pregnancy (regardless of the disease for which valproate is used)
Patients should consult their treating physician immediately if they plan to become pregnant or are pregnant.
Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free.
Valproate may cause serious birth defects and affect the development of the child. The most commonly reported birth defects include: spina bifida (when the bones of the spine are not properly developed); developmental abnormalities of the face and skull; developmental abnormalities of the heart, kidneys, urinary tract, and genital organs; limb abnormalities and many related developmental abnormalities affecting multiple organs and body parts. Birth defects can cause disability, which can be significant.
Children exposed to valproate in the womb have been reported to have hearing disorders or deafness.
Children exposed to valproate in the womb have been reported to have eye developmental abnormalities, often in combination with other birth defects. Eye developmental abnormalities can affect vision.
The risk of birth defects requiring treatment is increased in children born to mothers taking valproate during pregnancy. Valproate has been used for many years, and it is known that in a group of children born to mothers taking valproate, about 10 out of 100 children will have birth defects. For comparison, birth defects occur in 2-3 out of 100 children born to women without epilepsy.
It is estimated that up to 30-40% of preschool-age children whose mothers took valproate during pregnancy may exhibit early developmental problems. Children with the disease may start walking and talking later, be less intellectually capable than other children, have language problems, and memory difficulties.
Children exposed to valproate in the womb are more likely to be diagnosed with various autistic disorders, and some evidence suggests that children exposed to the drug during pregnancy may be more likely to develop symptoms of attention deficit/hyperactivity disorder (ADHD).
In rare cases, children born to mothers treated with valproate during pregnancy have bleeding disorders.
A woman of childbearing age will only be prescribed valproate if nothing else helps her.
Before prescribing this medicinal product, the physician will explain the risks to the unborn child if the patient becomes pregnant while taking valproate. If the patient taking this medicinal product decides to have a child, they should not stop taking the medicinal product or contraception without discussing it with their physician.
Parents or guardians of girls treated with valproate should contact the treating physician when their child starts menstruating.
Patients should ask their physician about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Choose the situation that applies to the patient and read the information:

• STARTING TREATMENT WITH ValproLEK 500
• CONTINUING TREATMENT WITH ValproLEK 500 WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH ValproLEK 500 WHILE TRYING TO CONCEIVE
• UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH ValproLEK 500

STARTING TREATMENT WITH ValproLEK 500

If ValproLEK 500 is prescribed for the first time, the treating physician will explain the risks to the unborn child if the patient becomes pregnant. Women of childbearing age should ensure that they use effective contraception without interruption throughout the entire treatment period with ValproLEK 500. Patients should consult their physician or family planning clinic if they need advice on contraception.

Important information:

Patients should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 500.
Patients should discuss contraception (birth control) with their treating physician. The treating physician will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
Patients should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this check-up, the treating physician will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
Patients should inform their physician if they plan to have a child.
Patients should inform their physician immediately if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH ValproLEK 500 WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with ValproLEK 500 and does not plan to become pregnant, they must ensure that they use effective contraception without interruption throughout the entire treatment period with ValproLEK 500. Patients should consult their physician or family planning clinic if they need advice on contraception.

• Patients should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 500.

Important information:

Patients should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 500.
Patients should discuss contraception (birth control) with their treating physician. The treating physician will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
Patients should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this check-up, the treating physician will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
Patients should inform their physician if they plan to have a child.
Patients should inform their physician immediately if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH ValproLEK 500 WHILE TRYING TO CONCEIVE

CHILD

If the patient plans to have a child, they should first schedule a visit with their treating physician.
Do not discontinue ValproLEK 500 or contraception until discussed with the treating physician. The treating physician will provide further guidance.
Children born to mothers who took valproate are at serious risk of birth defects and developmental problems, which can significantly impair the child.
The treating physician will refer the patient to a specialist experienced in treating bipolar affective disorder or epilepsy to assess alternative treatment options. The specialist may take actions to ensure the best possible course of pregnancy and minimize the risk to the mother and unborn child.
The specialist may decide to change the dose of ValproLEK 500 or switch to another medicinal product, or discontinue ValproLEK 500 well before the patient becomes pregnant, to ensure that the disease is stable.
Patients should ask their physician about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information:

Do not discontinue ValproLEK 500 until the treating physician decides to do so.
Do not discontinue contraception before discussing it with the treating physician and developing a plan of action that ensures control of the patient's condition and minimizes the risks to the child.
First, schedule a visit with the treating physician. During this visit, the treating physician will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
The treating physician will try to switch to another medicinal product or discontinue ValproLEK 500 well before the patient becomes pregnant.
Patients should schedule an urgent visit with their treating physician if they are pregnant or suspect they may be pregnant.

UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH ValproLEK 500

Do not discontinue ValproLEK 500 until discussed with the treating physician, as the patient's condition may worsen. Patients should schedule an urgent visit with their physician if they are pregnant or suspect they may be pregnant. The treating physician will provide further guidance.
Children born to mothers who took valproate are at serious risk of birth defects and developmental problems, which can significantly impair the child.
Patients will be referred to a specialist experienced in treating bipolar affective disorder or epilepsy to assess alternative treatment options.
In exceptional cases, when ValproLEK 500 is the only available treatment option during pregnancy, patients will be closely monitored, both in terms of treating the underlying disease and the development of the child. Patients and their partners will receive counseling and support regarding pregnancy exposed to valproate.
Patients should ask their physician about taking folic acid. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information:

Patients should schedule an urgent visit with their treating physician if they are pregnant or suspect they may be pregnant.
Do not discontinue ValproLEK 500 unless the treating physician decides to do so.
Patients must be referred to a specialist experienced in treating epilepsy, bipolar affective disorder, to assess the need for alternative treatment options.
Patients must receive counseling on the risks of taking ValproLEK 500 during pregnancy, including its teratogenic effects and impact on child development.
Patients must be referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

Read the patient information brochure provided by the treating physician. The treating physician will discuss the annual confirmation form regarding the risks and ask the patient to sign and keep it. The patient will also receive a

Patient Card from the pharmacist to remind them of the risks associated with taking valproate during pregnancy.

Important information for male patients
Possible risk associated with taking valproate in the 3 months before conception
A study suggests a possible risk of motor disorders and developmental delays (problems with development in early childhood) in children whose fathers were treated with valproate in the 3 months before conception. In this study, such disorders occurred in about 5 out of 100 children whose fathers were treated with valproate, compared to about 3 out of 100 children of men treated with lamotrigine or levetiracetam (other medicinal products that may be used to treat the patient's disease). The risk to children whose fathers stopped taking valproate at least 3 months (the time needed to produce new sperm) before conception is unknown. The study has limitations, and therefore, it is not clear whether the suggested increased risk of developmental delays is caused by valproate. The study was not large enough to show what specific types of motor disorders and developmental delays the risk applies to.
As a precaution, the physician will discuss with the patient:
the possible risk to children whose fathers were treated with valproate;
the need to consider using effective contraception (birth control) by the patient and their partner during treatment and for 3 months after its completion;
the need to consult a physician when planning to conceive and before stopping contraception;
the possibility of using other treatment methods for the disease, depending on the individual situation.
Do not donate sperm while taking valproate and for 3 months after stopping it.
If the patient plans to have a child, they should discuss it with their physician.
If the patient's partner becomes pregnant while the patient is taking valproate in the 3 months before conception, and the patient has questions about it, they should contact their physician. Do not discontinue treatment without consulting a physician. If the patient stops treatment, their symptoms may worsen.
Patients should regularly visit their physician. During such a visit, the physician will discuss the precautions associated with taking valproate and the possibility of using other treatment methods for their disease, depending on the individual situation.
Read the patient guide provided by the treating physician. The patient will also receive a Patient Card from the pharmacist to remind them of the possible risk associated with taking valproate.

Breastfeeding

Valproate sodium partially passes into breast milk. If the patient wants to breastfeed, the physician will weigh the benefits of breastfeeding against the risk of adverse reactions in the child. Breastfeeding is possible if the child is closely monitored for adverse reactions (such as drowsiness, feeding difficulties, vomiting, skin bruising).
Consult a physician or pharmacist before taking any medicinal product.

Driving and using machines

ValproLEK 500 may cause adverse reactions (such as dizziness, drowsiness, and sedation) that affect reaction time. This should be taken into account when driving or operating machinery.
Epilepsy itself also requires caution when performing these activities, especially in patients who have not had seizure-free periods for a long time. Patients should consult their physician in advance.
Taking multiple antiepileptic drugs or drugs with sedative, hypnotic, and/or muscle relaxant effects (benzodiazepines) may enhance these effects.

Important information about some ingredients of ValproLEK 500

This medicinal product contains 49.2 mg of sodium (the main component of table salt) per tablet. This corresponds to 2.5% of the maximum recommended daily intake of sodium in the diet for adults. Patients should consult their physician or pharmacist if they need to take 8 or more tablets per day for a long time, especially if they are on a low-sodium diet.

3. How to take ValproLEK 500

Girls and women of childbearing age
Therapy with ValproLEK 500 should be initiated and supervised by a physician specializing in the treatment of epilepsy or bipolar affective disorder.
Male patients
It is recommended that the use of the medicinal product be initiated and supervised by a specialist with experience in the treatment of epilepsy, bipolar affective disorder - see section 2 Important information for male patients.
ValproLEK 500 should always be used strictly according to the physician's instructions.
In case of doubts, patients should consult their physician or pharmacist.
Tablets (or their halves) should be swallowed without chewing, washed down with water (not a carbonated drink, such as a soft drink). If gastrointestinal irritation occurs at the beginning or during treatment, tablets should be taken during or after a meal.
ValproLEK 500 tablets can be divided into equal doses.
The physician determines the dose of the medicinal product for each patient.
Treatment usually starts with a small dose of ValproLEK 500 and is gradually increased until the appropriate dose for the patient is reached.
Typical dosing is:

Epilepsy

Adults and children
The initial dose of sodium valproate: 10 to 20 mg/kg body weight per day. This dose should be taken in two or more divided doses, preferably during meals.
(For example: a patient weighing 75 kg was prescribed a dose of 10 mg/kg body weight per day, i.e., 1½ tablets of prolonged-release ValproLEK 500 per day).
If necessary, the physician may increase the dose by 5 to 10 mg/kg body weight per day every week until the desired effect of the medicinal product is achieved.
The maintenance dose of sodium valproate: usually 20 to 30 mg/kg body weight per day.
Adults: 9 to 35 mg/kg body weight per day.
Children: 15 to 60 mg/kg body weight per day.
The optimal maintenance dose per day is usually taken during meals, in one or two divided doses.
Do not exceed the maximum dose of sodium valproate, which is 60 mg/kg body weight per day.
Children with a body weight of less than 20 kg
In this group of patients, sodium valproate should be used in a different pharmaceutical form due to the need to adjust the dose of the medicinal product.

Mania

The daily dose should be determined and controlled by the treating physician.
Initial dose
The recommended initial daily dose is 750 mg.
Average daily dose
The recommended daily doses are usually between 1000 mg and 2000 mg.
If the patient feels that the effect of ValproLEK 500 is too strong or too weak, they should consult their physician or pharmacist.
Elderly patients
The physician may decide to modify the dose.
Patients with kidney function disorders
The physician may decide to modify the dose.
Duration of treatment
The physician will inform the patient how long they need to take ValproLEK 500. Do not discontinue treatment prematurely, as the symptoms of the disease may recur.

Taking a higher dose of ValproLEK 500 than recommended

In case of taking a higher dose of ValproLEK 500 than recommended, patients should immediately consult their physician or pharmacist. Symptoms of overdose may include: coma with decreased muscle tone, decreased reflexes, constricted pupils, low blood pressure, drowsiness, metabolic acidosis, increased sodium levels in the blood, and impaired respiratory or cardiac function.
Additionally, in adults and children, high doses can cause neurological disorders, such as increased susceptibility to seizures and changes in behavior.

Missing a dose of ValproLEK 500

Do not take a double dose to make up for a missed dose.
If the patient forgets to take the medicinal product, they should do so as soon as possible, unless it is almost time for the next dose. In this case, the patient should take the medicinal product according to the previously established schedule.

Discontinuing ValproLEK 500

Do not discontinue treatment without the physician's advice.
In case of any further doubts regarding the use of this medicinal product, patients should consult their physician or pharmacist.

4. Possible adverse reactions

Like all medicinal products, ValproLEK 500 can cause adverse reactions, although not everybody gets them.
In case of any of the following serious adverse reactions, patients should immediately consult their physician - they may require urgent treatment:

Frequent (may occur in less than 1 in 10 people)

Liver damage. It can be very serious, especially in children, and usually occurs within the first 6 months of treatment. Early detection is crucial. Sometimes symptoms occur together with drowsiness and high ammonia levels in the blood (which can be detected by an ammonia-like odor of the urine). More information - see section "Warnings and precautions".
Spontaneous bruising or bleeding due to a decrease in platelet count (thrombocytopenia). It occurs more frequently in women and the elderly.
Extrapyramidal disorders, which can be irreversible (movement disorders, such as stiffness, tremors, or involuntary movements of the lips and tongue).
Lethargy and immobility with decreased response to stimuli (stupor), significant drowsiness, and sedation, followed by brief disturbances of consciousness. Sometimes, these symptoms are accompanied by increased seizure attacks. These symptoms usually occur after a sudden increase in dose or if the patient is taking multiple antiepileptic drugs (especially phenobarbital or topiramate) at the same time.

Uncommon (may occur in less than 1 in 100 people)

Pancreatitis, which can be severe and is accompanied by nausea, vomiting, and severe radiating abdominal pain.
Severe allergic reactions, causing facial or throat swelling (angioedema).
Decreased white blood cell count with increased susceptibility to infections (leukopenia).
Excessive fluid accumulation in the body due to excessive secretion of antidiuretic hormone. This leads to decreased sodium levels in the blood; confusion may occur.
Kidney failure.
Worsening of seizure attacks.
Breathing difficulties, chest pain or tightness (especially during inhalation), shortness of breath, and dry cough due to fluid accumulation around the lungs (pleural effusion)

5. How to store ValproLEK 500

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What ValproLEK 500 contains

The active substances of the medicine are sodium valproate and valproic acid.
Each prolonged-release tablet contains 333 mg of sodium valproate and 145 mg of valproic acid, which corresponds to a total of 500 mg of sodium valproate.
The other ingredients are: anhydrous colloidal silica, hydrated colloidal silica, ethylcellulose, hypromellose, sodium saccharin (E954), macrogol 6000, methacrylic acid and ethyl acrylate copolymer (1:1), 30% dispersion, talc, titanium dioxide (E171).

What ValproLEK 500 looks like and what the pack contains

ValproLEK 500 prolonged-release tablets are white, bean-shaped, with a dividing line to facilitate breaking on both sides.
The prolonged-release tablets are packaged in aluminum/aluminum blisters and placed in a cardboard box.
Package sizes:
30, 50 prolonged-release tablets

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek S.A.
ul. Domaniewska 50 C
02-672 Warsaw
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

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

Belgium:
Valproate Sandoz 500 mg prolonged-release tablets
Czech Republic:
Valproat Chrono Sandoz
Germany:
Valproat - 1 A Pharma 500 mg prolonged-release tablets
Estonia:
Valproate sodium Sandoz 500 mg
Finland:
Valproat Sandoz 500 mg depot tablets
Lithuania:
Valproate sodium Sandoz 500 mg prolonged-release tablets
Netherlands:
Natriumvalproaat Sandoz Chrono 500, prolonged-release tablets 500 mg
Poland:
VALPROLEK 500, 500 MG, PROLONGED-RELEASE TABLETS
Slovakia:
Valproát chrono Sandoz 500 mg tablets with prolonged release

For more information about this medicine, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Date of last revision of the leaflet:12/2024
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