Depakine Hrono 500

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Depakine Chrono 500

333 mg + 145 mg, prolonged-release tablets

Sodium valproate + Valproic acid
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. You can help by reporting any side effects you may get. To find out how to report side effects, see point 4.

WARNING

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

Before taking Depakine Chrono 500, carefully read the contents of this leaflet, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if necessary.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. 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, including those not listed in this leaflet, inform your doctor or pharmacist. See point 4.

Table of Contents of the Leaflet:

• 1. What is Depakine Chrono 500 and what is it used for
• 2. Important information before taking Depakine Chrono 500
• 3. How to take Depakine Chrono 500
• 4. Possible side effects
• 5. How to store Depakine Chrono 500
• 6. Contents of the pack and other information

1. What is Depakine Chrono 500 and what is it used for

Depakine Chrono 500 is a prolonged-release tablet containing the active substances sodium valproate and valproic acid, which belong to the group of antiepileptic drugs and act on the central nervous system. The drug has anticonvulsant effects in various forms of epilepsy in humans.
Depakine Chrono 500 is used to treat epilepsy and mania.

Depakine Chrono 500 is used to treat:

• Epilepsy, in generalized seizures:
• myoclonic seizures,
• tonic-clonic seizures,
• atonic seizures,
• absence seizures; partial seizures:
• simple or complex partial seizures,
• secondarily generalized seizures,
• Lennox-Gastaut syndrome.
• Mania, which is a condition where the patient feels very excited, elated, agitated, enthusiastic, or overactive. Mania occurs in a disease known as bipolar affective disorder. Depakine Chrono 500 may be used when lithium cannot be used.

2. Important information before taking Depakine Chrono 500

When not to take Depakine Chrono 500

Do not take the drug in the following cases:

• if the patient is allergic to the active substance sodium valproate or any of the other ingredients of this drug (listed in point 6),
• if the patient has acute and chronic hepatitis,
• if the patient has had severe hepatitis, especially drug-induced, or if the patient's family history indicates severe hepatitis,
• if the patient has porphyria (a very rare metabolic disorder),
• concomitant use with mefloquine,
• if the patient has a genetic disorder causing mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome),
• if the patient has metabolic disorders, such as disorders of the urea cycle,
• if the patient has a carnitine deficiency (a very rare metabolic disorder) that is not being treated,
• bipolar affective disorder:
• if the patient is pregnant,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with a doctor. The treating doctor will provide further guidance.
• epilepsy:
• if the patient is pregnant, unless no other therapy is effective,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with a doctor. The treating doctor will provide further guidance.

Warnings and precautions

Before starting to take Depakine Chrono 500, discuss it with your doctor.

INFORM YOUR TREATING DOCTOR IMMEDIATELY:

• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurring vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or

seizure recurrence, especially during the first 6 months of treatment, inform your treating doctor immediately.
Depakine Chrono 500 may cause severe liver damage, sometimes resulting in death.
Before starting treatment and during the first 6 months of treatment, periodic laboratory tests of liver function should be performed.
The risk of liver damage increases if Depakine Chrono 500 is used in children under 3 years of age, patients taking other antiepileptic drugs, or patients with other neurological or metabolic disorders, as well as in patients with severe epilepsy.

• In case of acute abdominal pain, inform your treating doctor immediately. Depakine Chrono 500 can very rarely cause severe pancreatitis, sometimes resulting in death.
• If the patient or their child taking Depakine Chrono 500 experiences balance and coordination problems, drowsiness, or decreased alertness, vomiting, inform your treating doctor immediately. This may be due to increased ammonia levels in the blood.
• A small number of people taking antiepileptic drugs containing sodium valproate have thought about harming or killing themselves. If such thoughts occur, contact your treating doctor immediately.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and angioedema, have been reported with valproate treatment. If the patient notices any symptoms related to these severe skin reactions, as described in point 4, they should contact their doctor immediately.

Before taking this drug, discuss it with your doctor:

• Valproate should not be used in women with epilepsy who are planning to become pregnant, unless other treatments are ineffective or not tolerated. The benefits of using the drug should be weighed against the risks before the first prescription or when a woman treated with valproate plans to become pregnant. Women of childbearing age must use effective contraception during treatment.
• Before starting treatment, as well as before surgery and in cases of bruising or spontaneous bleeding, laboratory tests (blood morphology with smear, including platelet count, bleeding time, and coagulation tests) are recommended.
• Use with caution in patients with impaired renal function. The doctor may recommend a lower dose of the drug.
• The drug should be used with caution in patients with systemic lupus erythematosus.
• If the patient is suspected to have any metabolic disorder, especially congenital enzyme deficiencies, such as "urea cycle disorders", due to the risk of increased ammonia levels in the blood.
• Weight gain may occur in patients treated with valproate.
• If the patient has a rare disorder called "carnitine palmitoyltransferase II deficiency", due to the increased risk of muscle disorders.
• Concomitant use of carbapenem antibiotics with valproic acid is not recommended (see "Depakine Chrono 500 and other drugs").
• Sodium valproate is mainly excreted by the kidneys, partly in the form of ketone bodies, so in diabetic patients, testing for ketone bodies may give a false positive result.
• If there is a family history of mitochondrial disorders or the doctor suspects such a disorder, due to the risk of liver damage.
• As with other antiepileptic drugs, the severity or frequency of seizures may increase during treatment with this drug. In case of increased seizure severity, consult a doctor immediately.
• If the patient has insufficient carnitine intake, found in meat and dairy products, especially in children under 10 years of age.
• If the patient has a carnitine deficiency and is taking carnitine.
• If the patient has ever experienced a severe skin rash or exfoliative dermatitis after taking valproate.

Children and adolescents

Children and adolescents under 18 years:
Depakine Chrono 500 should not be used in children and adolescents under 18 years of age for the treatment of mania.

Depakine Chrono 500 and other drugs

Tell your doctor about all the drugs you are currently taking or have recently taken, as well as any drugs you plan to take.
Some drugs may affect the action of sodium valproate, and valproate may affect the action of other drugs.
These include:

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• drugs used to treat depression, MAO inhibitors;
• benzodiazepines, used to treat insomnia and anxiety disorders;
• other drugs used to treat epilepsy, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate, rufinamide;
• kanabidiol (used to treat epilepsy and other indications);
• certain anti-infective drugs containing pivampicillin (such as pivampicillin, adefovir dipivoxil);
• methotrexate (used to treat cancer and inflammatory diseases);
• zydovudine, ritonavir, and lopinavir (used to treat HIV infection and AIDS);
• mefloquine (used to treat and prevent malaria);
• salicylates (acetylsalicylic acid);
• anticoagulants;
• cimetidine (used to treat stomach ulcers);
• erythromycin, rifampicin;
• carbapenems (antibiotics used to treat bacterial infections);
• cholestyramine (used to lower cholesterol levels in the blood);
• propofol (used for general anesthesia);
• nimodipine;
• drugs containing estrogen (including some contraceptives);
• metamizole (used to treat pain and fever).
• clozapine (used to treat mental illnesses).

These drugs may affect the action of sodium valproate and vice versa. The patient may need to adjust the dose of individual drugs or use other drugs. The doctor will inform the patient about these changes in treatment.
The doctor will also provide additional information about drugs that should be used with caution or avoided during treatment with Depakine Chrono 500.

Depakine Chrono 500 with food, drink, and alcohol

The drug is recommended to be taken with meals.
It is not recommended to drink alcohol during valproate treatment.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for women

Bipolar affective disorder

• In the treatment of bipolar affective disorder, do not use Depakine Chrono 500 if the patient is pregnant.
• In the treatment of bipolar affective disorder, if the patient is of childbearing age, do not take Depakine Chrono 500 unless the patient uses effective contraception (birth control) throughout the treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with a doctor. The treating doctor will provide further guidance.

Epilepsy

• In the treatment of epilepsy, do not use Depakine Chrono 500 if the patient is pregnant, unless no other therapy is effective.
• In the treatment of epilepsy, if the patient is of childbearing age, do not take Depakine Chrono 500 unless the patient uses effective contraception (birth control) throughout the treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with a doctor. The treating doctor will provide further guidance.

Risk of taking valproate during pregnancy (regardless of the disease for which valproate is used)

• Consult a doctor immediately if the patient plans to become pregnant or is pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free, even when valproate is used in combination with other antiepileptic drugs.
• Valproate may cause serious birth defects and affect the physical and mental development of the child after birth.
• The most common 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 reported hearing problems or deafness.
• Children exposed to valproate in the womb have reported eye abnormalities, often in combination with other birth defects. Eye abnormalities can affect vision.
• In a group of children born to mothers taking valproate, about 11 children out of 100 will have birth defects. For comparison, such defects are found in 2-3 children out of every 100 born to women without epilepsy.
• It is estimated that up to 30-40% of children in preschool age 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 autism spectrum disorders. Some evidence suggests an increased risk of attention deficit hyperactivity disorder (ADHD) in these children.
• Before prescribing this drug, the treating doctor will explain to the patient what may threaten the child if the patient becomes pregnant while taking valproate. If the patient taking this drug decides to have a child, they should not discontinue Depakine Chrono 500 or contraception without discussing it with their treating doctor.
• Some contraceptives (estrogen-containing birth control pills) may decrease valproate levels in the blood. Consult a doctor about the method of contraception (birth control) that will be most suitable for the patient.
• Parents or guardians of girls treated with valproate should contact the treating doctor when their daughter starts menstruating.
• Ask your doctor 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 DEPAKINE CHRONO 500
• CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITHOUT TRYING FOR A CHILD

CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WHILE TRYING FOR A CHILD

• CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 AND BECOMING PREGNANT

STARTING TREATMENT WITH DEPAKINE CHRONO 500

If Depakine Chrono 500 is prescribed for the first time, the treating doctor will explain the risks to the unborn child if the patient becomes pregnant. Women of childbearing age should ensure that they use effective contraception throughout the treatment period with Depakine Chrono 500. If the patient needs advice on contraception, they should consult their treating doctor or a family planning clinic.
Important information:

• Before starting Depakine Chrono 500, the patient should ensure they are not pregnant through a pregnancy test confirmed by the treating doctor.
• The patient should use effective contraception (birth control) throughout the treatment period with Depakine Chrono 500.
• Discuss contraception (birth control) with the treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for contraception advice.
• Regularly (at least once a year) visit a specialist experienced in treating bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• If the patient plans to have a child, they should inform their doctor.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their doctor.

CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITHOUT TRYING FOR A CHILD

If the patient continues treatment with Depakine Chrono 500 and does not plan to become pregnant, they must ensure they use effective contraception without interruption throughout the treatment period with Depakine Chrono 500. If the patient needs advice on contraception, they should consult their doctor or a family planning clinic.
Important information:

• The patient should use effective contraception (birth control) throughout the treatment period with Depakine Chrono 500.
• Discuss contraception (birth control) with the treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for contraception advice.
• Regularly (at least once a year) visit a specialist experienced in treating bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• If the patient plans to have a child, they should inform their doctor.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their doctor.

CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WHILE TRYING FOR A CHILD

If the patient plans to have a child, they should first schedule a visit with their treating doctor. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the doctor. The treating doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high risk of birth defects and developmental problems that can significantly impair the child. The treating doctor 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 outcome of the pregnancy and minimize the risk to the mother and unborn child.
Ask your doctor 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 Depakine Chrono 500 unless advised by a doctor.
• Do not discontinue contraception before discussing it with the treating doctor and developing a plan to ensure the patient's condition is controlled and the risks to the child are minimized.
• First, schedule a visit with the treating doctor. During this visit, the treating doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• The treating doctor will try to switch to another drug or discontinue Depakine Chrono 500 well before the patient becomes pregnant.
• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their treating doctor.

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONO 500

Do not discontinue treatment with Depakine Chrono 500 unless advised by a doctor, as the patient's condition may worsen. If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their treating doctor. The treating doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high risk of birth defects and developmental problems that 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 cases, when Depakine Chrono 500 is the only available treatment option during pregnancy, the patient will be closely monitored, both in terms of the underlying disease treatment and fetal development. The patient and their partner will receive counseling and support regarding valproate-exposed pregnancy.
Ask your doctor 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

• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their treating doctor.
• Do not discontinue Depakine Chrono 500 unless advised by a doctor.
• The patient should ensure they are referred to a specialist experienced in treating epilepsy or bipolar affective disorder to assess the need for alternative treatment options.
• The patient must receive counseling about the risks of taking Depakine Chrono 500 during pregnancy, including its teratogenic effects and physical and mental developmental disorders in children.
• The patient should ensure they are referred to a specialist for prenatal monitoring to detect any developmental abnormalities. Newborns of mothers who took Depakine Chrono 500 during pregnancy may experience coagulation disorders, hypoglycemia, hypothyroidism, and withdrawal symptoms, such as agitation, irritability, overactivity, muscle tremors, seizures, and feeding problems.

Read the patient guide provided by your doctor.

Your doctor 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 the pharmacist to remind you of the risks associated with valproate during pregnancy.

Important advice 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 early childhood development) 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 drugs that may be used to treat the patient's disease). The risk to children whose fathers discontinued valproate treatment 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 are associated with this risk.
As a precaution, the doctor 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 doctor when planning to conceive and before discontinuing contraception;
• the possibility of using alternative treatments for the disease, depending on the individual situation. Do not donate sperm while taking valproate and for 3 months after its discontinuation.

If you plan to have children, discuss it with your doctor.
If your partner becomes pregnant while you are taking valproate in the 3 months before conception and you have questions about this, contact your doctor. Do not discontinue treatment without consulting a doctor. If you discontinue treatment, your symptoms may worsen.
Regularly visit your doctor, who prescribed the drug. During such a visit, the doctor will discuss with you the precautions related to taking valproate and the possibility of using alternative treatments for your disease, depending on your individual situation.
Read the patient guide provided by your doctor. You will also receive a patient card from the pharmacist to remind you of the possible risk associated with valproate.

Breastfeeding

Valproate is excreted in small amounts into breast milk. Consult your doctor about whether you can breastfeed during treatment.

Driving and using machines

In some patients, during treatment, drowsiness may occur, especially when taking several antiepileptic drugs or concomitantly with benzodiazepines. Before driving or operating machinery, the patient should ensure how they react to the treatment.

Depakine Chrono 500 contains sodium

Depakine Chrono 500 contains 46.08 mg of sodium (the main component of table salt) in each prolonged-release tablet. This corresponds to 2.3% of the maximum recommended daily sodium intake in the diet for adults.

3. How to take Depakine Chrono 500

Always take Depakine Chrono 500 as directed by your doctor.
In case of doubts, consult a doctor.
Girls and women of childbearing age
Treatment with Depakine Chrono 500 should be started and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.
Male patients
It is recommended that treatment with Depakine Chrono 500 be started and supervised by a specialist with experience in the treatment of epilepsy or bipolar affective disorder – see point 2 ("Important advice for male patients").
The use of the prolonged-release formulation allows for once-daily or twice-daily dosing of Depakine Chrono 500.
If necessary, Depakine Chrono 500 prolonged-release tablets may be used in children with a body weight above 17 kg, provided the child can swallow the tablet.
This formulation is not suitable for children under 6 years of age (risk of choking).
The daily dose of Depakine Chrono 500 should be determined based on the patient's age and body weight, and the doctor should always consider the patient's individual sensitivity to valproate.
Switching to prolonged-release formulations (Depakine Chrono 500).
When switching from conventional tablets to prolonged-release tablets, it is recommended (according to current knowledge) to maintain the same daily dose.

Starting treatment with Depakine Chrono 500 in the treatment of epilepsy

When starting treatment with Depakine Chrono 500 as the only antiepileptic drug, the dose should be increased every 2-3 days to reach the average recommended dose within a week.
When introducing Depakine Chrono 500 in patients already taking other antiepileptic drugs, the dose of Depakine Chrono 500 should be gradually increased to reach the average recommended dose within 2 weeks. Then, the dose of the other drugs should be reduced to the extent necessary to achieve optimal control of seizures or discontinued if possible.
When adding other antiepileptic drugs to the treatment, they should be introduced gradually.
The initial daily dose is usually 5 to 15 mg/kg body weight and should be gradually increased every 2-3 days by 5 mg/kg body weight to reach the optimal dose (see "Starting treatment with Depakine Chrono 500").
Usually, the daily dose is 20 to 30 mg/kg body weight, given in one or two divided doses.
If necessary, the daily dose may be higher than 50 mg/kg body weight, provided that close clinical monitoring of the patient's condition is maintained (see point 2: "Important information before taking Depakine Chrono 500").
Children over 17 kg body weight
The average dose is 30 mg/kg body weight per day.
Adults
The average dose is 20 to 30 mg/kg body weight per day.
Elderly patients
Dosage should be based on the control of seizures.

Mania

Adults:
The daily dose should be determined individually by the treating doctor.
Initial dose:
The recommended initial daily dose is 750 mg.
Average daily dose:
The average daily dose is usually between 1000 mg and 2000 mg.

Duration of treatment

Take the drug for as long as your doctor recommends.
If you feel that the action of Depakine Chrono 500 is too strong or too weak, consult your doctor.

Taking a higher than recommended dose of Depakine Chrono 500

Symptoms of severe valproate overdose include: coma, muscle weakness and decreased reflexes, pinpoint pupils, respiratory depression; metabolic acidosis, hypotension, and acute circulatory failure may also occur. Other symptoms, including seizures, have been reported at very high serum valproate levels.
Reports of increased intracranial pressure with brain edema have been received.
The presence of sodium in valproate formulations may lead to increased sodium levels in the blood in the event of an overdose.
If you have taken more than the recommended dose of the drug, contact your doctor or pharmacist immediately.
Hospital treatment in case of poisoning should include: gastric lavage (up to 10-12 hours after ingestion), constant monitoring of cardiovascular and respiratory function. In severe cases, hemodialysis or even exchange transfusion may be necessary.

Missing a dose of Depakine Chrono 500

If you miss a dose, take it as soon as possible, unless it is close to the time for the next dose. Do not take two doses at the same time or in a short period. In case of doubts, consult a doctor.

Discontinuing Depakine Chrono 500

Do not discontinue treatment with Depakine Chrono 500 or change the dose without consulting a doctor.
Discontinuing treatment without consulting a doctor may worsen the patient's condition.

4. Possible side effects

Like all medicines, Depakine Chrono 500 can cause side effects, although not everybody gets them. Patients may need appropriate treatment for some side effects.

5. How to store Depakine Chrono 500

Al/Al blisters: Store at a temperature below 30°C. Store in the original packaging, in a dry place, to protect against moisture.
PVC/PVDC/Al blisters: Store at a temperature below 25°C. Store in the original packaging, in a dry place, to protect against moisture.
The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Depakine Chrono 500 contains

1 prolonged-release tablet of Depakine Chrono 500 contains as active substances:
sodium valproate 333 mg,
valproic acid 145 mg,
which corresponds to a total of 500 mg of sodium valproate,
and excipients: copolymer of acrylic and methacrylic acid esters with quaternary ammonium chloride, ethylcellulose, hydrated silica colloidal.
Coating composition: hypromellose, macrogol 6000, talc, titanium dioxide (E 171), polyacrylate dispersion 30%.

What Depakine Chrono 500 looks like and what the pack contains

The pack contains 30 prolonged-release tablets.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Greece, the country of export:

Sanofi-Aventis Monoprósopi AEBE
Leof. Siggrou 348 - Building A
176 74 Kallithea – Athens
Greece

Manufacturer:

Sanofi Winthrop Industrie
1, rue de la Vierge
Ambarès et Lagrave
33565 Carbon Blanc CEDEX
France
Sanofi Aventis S.A.
Ctra. C-35 (La Batlloria-Hostalric Km. 63,09)
Riells i Viabrea, 17404 Girona
Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Greece, the country of export:41972/10/21-06-2011
9081/18-02-2013
Parallel import authorization number:435/15

Date of leaflet approval: 04.07.2025

A patient guide for women and a patient guide for men are available by scanning the QR code on the leaflet with a smartphone. The same information is also available on the website https://inpharm.pl/materialy-edukacyjne/#walproiniany
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