Valprolek 300

Leaflet accompanying the packaging: patient information

ValproLEK 300, 300 mg, prolonged-release tablets

Sodium valproate
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also contribute 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 300 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 300. The treating physician will discuss this with the patient, but the patient should also follow the recommendations presented in section 2 of this leaflet.
It is necessary to contact the treating physician immediately if the patient plans to become pregnant or suspects that she is pregnant.
ValproLEK 300 should not be discontinued unless the physician recommends it, as the patient's condition may worsen.

It is necessary to carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a physician or pharmacist.
• This medicinal product has been prescribed specifically for one person. It should not be passed on to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions 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 300 and what is it used for
• 2. Important information before taking ValproLEK 300
• 3. How to take ValproLEK 300
• 4. Possible adverse reactions
• 5. How to store ValproLEK 300
• 6. Contents of the packaging and other information

1. What is ValproLEK 300 and what is it used for

ValproLEK 300 is a medicinal product used to treat epilepsy and mania.
ValproLEK 300 is used in certain forms of epilepsy, such as:
short-term loss of consciousness due to brain function disorders (petit mal),
sudden muscle contractions (myoclonus),
seizures with muscle tension (grand mal),
mixed forms of the above disorders,
seizures without accompanying muscle tension (atonic seizures).
ValproLEK 300 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 voluntary movements.
ValproLEK 300 may be used as the only medicinal product or in combination with other antiepileptic drugs.
ValproLEK 300 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 called bipolar affective disorder. ValproLEK 300 may be used when lithium cannot be used.

2. Important information before taking ValproLEK 300

When not to take ValproLEK 300

if the patient is allergic (hypersensitive) 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 300 should not be taken if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, ValproLEK 300 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 300. ValproLEK 300 and contraception should not be discontinued unless discussed with the physician. The treating physician will provide further guidance.

Epilepsy

• In the case of epilepsy, ValproLEK 300 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 300 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 300. ValproLEK 300 and contraception should not be discontinued unless discussed with the physician. The treating physician will provide further guidance.

Warnings and precautions

CONTACT YOUR PHYSICIAN IMMEDIATELY

Severe skin reactions have been reported with valproate, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), polymorphic eruption, and angioedema.
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 300, the patient should discuss with their physician or pharmacist if:
ValproLEK 300 is used in infants or children under 3 years of age with severe epilepsy (especially in children with brain damage, mental retardation, 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 higher 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 and/or internal organ diseases (systemic lupus erythematosus), as ValproLEK 300 may cause the disease to worsen;
the patient has encephalopathy due to carnitine palmitoyltransferase (CPT) type II deficiency, as the use of ValproLEK 300 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 genetic disorders that cause mitochondrial disorders;
the patient has ever experienced severe skin rash or peeling after taking valproate.
The patient should consult their physician if any of the above warnings apply to them currently or have applied in the past.
If the patient experiences any of the following symptoms while taking ValproLEK 300, such as physical or mental weakness, loss of appetite (anorexia), apathy, drowsiness, repeated vomiting, abdominal pain, or worsening of seizures, 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, the patient should inform their physician or dentist about taking ValproLEK 300. 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 the blood cell count.
If the patient taking ValproLEK 300 is to undergo a urine test for ketone bodies (substances that are produced when the body burns fat instead of sugar), the results of the test 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"). The patient 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 300, thoughts of self-harm or suicide have occurred. If such thoughts ever occur to the patient, they should contact their physician immediately.
Note
The skeleton of ValproLEK 300 tablets may be excreted in the stool.

Children and adolescents

Children and adolescents under 18 years of age:
ValproLEK 300 should not be used to treat mania in children and adolescents under 18 years of age.

ValproLEK 300 and other medicinal products

The patient should tell their physician about all medicinal products they are currently taking or have recently taken, including those that are available without a prescription.
ValproLEK 300 and other medicinal products may interact with each other, affecting their efficacy and the occurrence of adverse reactions, which may sometimes require adjusting 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 300 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 dullness). 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 300 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). They 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 300 may cause seizures;
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 300 may increase the risk of abnormal blood cell count;
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 300 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 300 or whose efficacy may be altered by ValproLEK 300 include those containing the following active substances: protease inhibitors, such as lopinavir and ritonavir (used to treat HIV infection), nimodipine, and propofol (used in anesthesia).

ValproLEK 300 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 ordinary 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 300, as it may cause seizures 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 300 should not be taken if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, ValproLEK 300 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 300. ValproLEK 300 and contraception should not be discontinued unless discussed with the physician. The treating physician will provide further guidance.

Epilepsy

• In the case of epilepsy, ValproLEK 300 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 300 should not be taken unless the patient uses effective contraception (birth control) throughout the entire treatment period with ValproLEK 300. ValproLEK 300 and contraception should not be discontinued unless 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)
The patient should consult their physician immediately if they plan to become pregnant or are pregnant.
Taking valproate during pregnancy carries a risk. The higher the dose, the higher the risk, but no dose is risk-free.
Valproate may cause serious birth defects and affect the development of the child. The most common birth defects reported 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, such defects are found in 2-3 out of 100 children born to women without epilepsy.
It is estimated that 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 have 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. If the patient decides to have a child, they should not stop taking ValproLEK 300 or contraception without discussing it with their physician. The treating physician will provide further guidance.
Parents or guardians of girls treated with valproate should contact the treating physician when their child starts menstruating.
The patient 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 300
• CONTINUING TREATMENT WITH ValproLEK 300 WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH ValproLEK 300 WHILE TRYING TO CONCEIVE
• UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH ValproLEK 300

STARTING TREATMENT WITH ValproLEK 300

If ValproLEK 300 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 (birth control) without interruption throughout the entire treatment period with ValproLEK 300. The patient should consult their physician or family planning clinic if they need advice on contraception.
Important information:

Before starting treatment with ValproLEK 300, pregnancy should be ruled out using a pregnancy test, the results of which will be confirmed by the treating physician.
The patient should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 300.
The patient should discuss effective 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.
The patient 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.
The patient should inform their physician if they plan to have a child.
The patient should immediately inform their physician if they are pregnant or suspect that they may be pregnant.

CONTINUING TREATMENT WITH ValproLEK 300 WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with ValproLEK 300 and does not plan to become pregnant, they must ensure that they use effective contraception (birth control) without interruption throughout the entire treatment period with ValproLEK 300. The patient should consult their physician or family planning clinic if they need advice on contraception.

• The patient should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 300.

Important information:

The patient should use effective contraception (birth control) throughout the entire treatment period with ValproLEK 300.
The patient 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.
The patient 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.
The patient should inform their physician if they plan to have a child.
The patient should immediately inform their physician if they are pregnant or suspect that they may be pregnant.

CONTINUING TREATMENT WITH ValproLEK 300 WHILE TRYING TO CONCEIVE

If the patient plans to have a child, they should first schedule a check-up with their treating physician. The patient should not stop taking ValproLEK 300 or contraception without discussing it with their treating physician. The treating physician will provide further guidance.
Children born to mothers who took valproate during pregnancy 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 300 or switch to another medicinal product, or discontinue treatment with ValproLEK 300 long before the patient becomes pregnant, to ensure that the disease is stable.
The patient 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:

The patient should not stop taking ValproLEK 300 unless their physician decides to do so.
The patient should not stop using contraception (birth control) before discussing it with their treating physician and developing a plan of action that will ensure control of the patient's condition and minimize the risks to the child.
First, the patient should schedule a check-up with their treating physician. 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.
The treating physician will try to switch to another medicinal product or discontinue treatment with ValproLEK 300 long before the patient becomes pregnant.
The patient should schedule an urgent check-up with their treating physician if they are pregnant or suspect that they may be pregnant.

UNPLANNED PREGNANCY WHILE CONTINUING TREATMENT WITH ValproLEK 300

The patient should not stop taking ValproLEK 300 unless their physician decides to do so, as their condition may worsen. The patient should schedule an urgent check-up with their physician if they are pregnant or suspect that they may be pregnant. The treating physician will provide further guidance.
Children born to mothers who took valproate during pregnancy are at serious risk of birth defects and developmental problems, which can significantly impair the child.
The patient will be referred to a specialist experienced in treating bipolar affective disorder or epilepsy to assess alternative treatment options.
In exceptional circumstances, when ValproLEK 300 is the only available treatment option during pregnancy, the patient will be closely monitored, both in terms of treating the underlying disease and the development of the child. The patient and their partner will receive counseling and support regarding the pregnancy and valproate exposure.
The patient 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:

The patient should schedule an urgent check-up with their treating physician if they are pregnant or suspect that they may be pregnant.
The patient should not stop taking ValproLEK 300 unless their physician decides to do so.
The patient must be referred to a specialist experienced in treating epilepsy, bipolar affective disorder, to assess the need for alternative treatment options.
The patient must receive counseling on the risks of taking ValproLEK 300 during pregnancy, including its teratogenic effects and impact on child development.
The patient must be referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

Please read the patient information leaflet provided by your physician. Your physician will discuss the annual confirmation form regarding the risks and ask you to sign and keep it. You will also receive

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

Important information for male patients
Possible risk associated with taking valproate within 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 within 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 drugs 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 motor and developmental delays is caused by valproate. The study was not large enough to show what specific types of motor and developmental delays this 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.
The patient should 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 within 3 months before conception, and the patient has questions about it, they should contact their physician. The patient should not stop taking ValproLEK 300 without consulting their physician. If the patient stops taking the medicinal product, their symptoms may worsen.
The patient 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 the disease, depending on the individual situation.
Please read the patient guide provided by your physician. You will also receive a Patient Card from your pharmacist to remind you of the possible risk associated with taking valproate.

Breastfeeding

Valproate 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, difficulty feeding, vomiting, skin rashes).
Before taking any medicinal product, the patient should consult their physician or pharmacist.

Driving and using machines

ValproLEK 300 may cause adverse reactions (such as dizziness, drowsiness, and sleepiness) that affect reaction time. This should be taken into account when driving vehicles or operating machines.
Epilepsy itself also requires caution when performing these activities, especially in patients who have not had seizure-free periods for a long time. The patient 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 300

This medicinal product contains 29.7 mg of sodium (the main component of table salt) per tablet. This corresponds to 1.5% of the maximum recommended daily intake of sodium in the diet for adults. The patient should consult their physician or pharmacist if they need to take 14 or more tablets per day for a long time, especially if they are on a low-sodium diet.

3. How to take ValproLEK 300

Girls and women of childbearing age
Treatment with ValproLEK 300 should be started 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 started and supervised by a specialist with experience in the treatment of epilepsy, bipolar affective disorder - see section 2 Important information for male patients.
ValproLEK 300 should always be taken strictly according to the physician's instructions.
In case of doubts, the patient 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, the tablets should be taken during or after a meal.
ValproLEK 300 tablets can be divided into equal doses.
The physician determines the dose of the medicinal product for each patient.
Treatment usually starts with a low dose of ValproLEK 300 and is gradually increased until the appropriate dose for the patient is reached.
Typical dosing is:

Epilepsy

Adults and children
The initial dose of valproate is 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 has been prescribed a dose of 10 mg/kg body weight per day, i.e., 2.5 tablets of prolonged-release ValproLEK 300 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 valproate is 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.
The maximum dose of valproate should not be exceeded, which is 60 mg/kg body weight per day.
Children with a body weight of less than 20 kg
In this group of patients, 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 300 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 300. The patient should not stop taking the medicinal product prematurely, as the symptoms of the disease may recur.

Taking a higher dose of ValproLEK 300 than recommended

If the patient has taken a higher dose of ValproLEK 300 than recommended, they 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 300

The patient should not take a double dose to make up for a missed dose.
If the patient has forgotten 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.

Stopping treatment with ValproLEK 300

The patient should not stop taking ValproLEK 300 without their physician's advice.
In case of any further doubts about taking this medicinal product, the patient should consult their physician or pharmacist.

4. Possible adverse reactions

Like all medicinal products, ValproLEK 300 can cause adverse reactions, although not everybody gets them.
If any of the following serious adverse reactions occur, the patient should immediately consult their physician - they may require urgent treatment:

Common (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 the ammonia smell of 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 sleepiness, followed by temporary disturbances of consciousness. Sometimes, these symptoms are accompanied by increased susceptibility to seizures. These symptoms usually occur after a sudden increase in dose or when 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 reaction, 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 a decrease in sodium levels in the blood and may cause confusion; may occur in combination with other symptoms.
Kidney failure.
Worsening of seizures.
Difficulty breathing, chest pain or feeling of pressure in the chest (especially when inhaling), shortness of breath, and dry cough due to fluid accumulation around the lungs (pleural effusion)

5. How to store ValproLEK 300

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 after EXP. The expiry date refers to the last day of the month stated.
No special precautions for storage are necessary.
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. Contents of the pack and other information

What ValproLEK 300 contains

The active substances of the medicine are sodium valproate and valproic acid.
Each prolonged-release tablet contains 200 mg of sodium valproate and 87 mg of valproic acid, which corresponds to a total of 300 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 300 looks like and contents of the pack

ValproLEK 300 prolonged-release tablets are white, bean-shaped, with a score line on both sides to facilitate breaking.
The prolonged-release tablets are packaged in aluminum/aluminum blisters and placed in a cardboard box.
Pack 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.
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 300 mg prolonged-release tablets
Czech Republic:
Valproat Chrono Sandoz
Germany:
Valproat - 1 A Pharma 300 mg retard tablets
Finland:
Valproat Sandoz 300 mg depot tablets
Netherlands:
Sodium valproate Sandoz Chrono 300, prolonged-release tablets 300 mg
Poland:
VALPROLEK 300, 300 MG, PROLONGED-RELEASE TABLETS

For more information about this medicine, please contact:

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