Depakine Hrono 500

Leaflet accompanying the packaging: information for the user

Warning! The leaflet should be kept. 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. 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

The Depakine Chrono 500 medicinal product (sodium valproate + valproic acid) used during pregnancy can
seriously harm the unborn child. Women of childbearing age should use effective contraception (birth control)
continuously throughout the entire period of treatment with Depakine Chrono 500. The treating physician will
discuss this with the patient, and the recommendations presented in section 2 of this leaflet should also be
followed.
Patients should contact their treating physician immediately if they plan to become pregnant or suspect they
are pregnant.
Depakine Chrono 500 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 so that it can be re-read if necessary.
• In case of any doubts, the patient should consult a physician or pharmacist.
• This medicinal product has been prescribed specifically for the patient. 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 those not listed in this leaflet, they should inform their physician, pharmacist, or nurse. See section 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 adverse reactions
• 5. How to store Depakine Chrono 500
• 6. Contents of the packaging 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 medicinal product has an anticonvulsant effect 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 state in which the patient feels very excited, elated, stimulated, 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 medicinal product in the following cases:

• if the patient is allergic to the active substance sodium valproate or any of the other ingredients of this medicinal product (listed in section 6),
• if the patient has acute or chronic hepatitis,
• if the patient has had severe hepatitis, especially drug-induced or if the patient has a family history of severe hepatitis,
• if the patient has porphyria (a very rare metabolic disorder),
• if the patient is taking mefloquine concurrently,
• 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 is using effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the physician. The treating physician 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 is using effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the physician. The treating physician will provide further guidance.

Warnings and precautions

Before starting treatment with Depakine Chrono 500, the patient should discuss it with their physician.

THE PATIENT SHOULD IMMEDIATELY INFORM THEIR PHYSICIAN:

• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or worsening of seizures, especially during the first 6 months of treatment, the patient should immediately inform their physician.

Depakine Chrono 500 may cause severe liver damage, which can be fatal.
Before starting treatment and during the first 6 months of treatment, the patient should undergo periodic laboratory tests to monitor liver function.
The risk of liver damage increases if Depakine Chrono 500 is used in children under 3 years of age, patients taking other antiepileptic drugs concurrently, or patients with other neurological or metabolic disorders, as well as in patients with severe epilepsy.

• In case of acute abdominal pain, the patient should immediately inform their physician. Depakine Chrono 500 can very rarely cause severe pancreatitis, which can be fatal.
• If the patient or their child taking Depakine Chrono 500 experiences balance and coordination problems, drowsiness, or decreased alertness, vomiting, they should immediately inform their physician. This may be caused by increased ammonia levels in the blood.
• A small number of patients taking antiepileptic drugs containing sodium valproate have thought about harming or killing themselves. If such thoughts occur, the patient should immediately contact their physician.
• 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 section 4, they should immediately consult their physician.

Before taking this medicinal product, the patient should discuss it with their physician:

• 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 medicinal product should be weighed against the risks before the first prescription or when the patient plans to become pregnant. Women of childbearing age must use effective contraception during treatment.
• Before starting treatment, as well as before surgery and in case of bruising or spontaneous bleeding, laboratory tests (blood morphology with smear, including platelet count, bleeding time, and coagulation tests) are recommended.
• Depakine Chrono 500 should be used with caution in patients with impaired renal function. The physician may recommend a lower dose of the medicinal product.
• The medicinal product should be used with caution in patients with systemic lupus erythematosus.
• If the patient is suspected to have any metabolic disorder, especially inborn 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 sodium 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 section "Depakine Chrono 500 and other medicinal products").
• Sodium valproate is primarily 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 physician 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 medicinal product. If the patient experiences an increase in seizures, they should immediately consult their physician.
• 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 of age:
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 medicinal products

The patient should tell their physician about all medicinal products they are currently taking or have recently taken, as well as any medicinal products they plan to take.
Some medicinal products may affect the action of sodium valproate, and valproate may affect the action of other medicinal products.
These include:

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• medicinal products used to treat depression, MAO inhibitors;
• benzodiazepines, used to treat insomnia and anxiety disorders;
• other antiepileptic drugs, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate, rufinamide;
• kanabidiol (used to treat epilepsy and other indications);
• certain antibacterial agents that contain pivampicillin (such as pivampicillin, adefovir dipivoxil);
• methotrexate (used to treat cancer and inflammatory diseases);
• zidovudine, 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;
• medicinal products containing estrogen (including some contraceptives);
• metamizole (used to treat pain and fever);
• clozapine (used to treat mental illnesses).

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

Depakine Chrono 500 with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Important note for women

Bipolar affective disorder

• Depakine Chrono 500 should not be used in the treatment of bipolar affective disorder if the patient is pregnant.
• In the treatment of bipolar affective disorder, women of childbearing age should not take Depakine Chrono 500 unless they are using effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the physician. The treating physician will provide further guidance.

Epilepsy

• Depakine Chrono 500 should not be used in the treatment of epilepsy if the patient is pregnant, unless no other therapy is effective.
• In the treatment of epilepsy, women of childbearing age should not take Depakine Chrono 500 unless they are using effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the physician. The treating physician will provide further guidance.

Risk of taking valproate during pregnancy (regardless of the disease being treated with valproate)

• The patient should immediately consult their physician if they plan to become pregnant or suspect they are pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is completely 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; heart, kidney, urinary tract, and genital abnormalities; 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 problems or deafness.
• Children exposed to valproate in the womb have been reported to have 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 out of 100 children will have birth defects. For comparison, birth defects occur in about 2-3 out of 100 children born to women without epilepsy.
• It is estimated that up to 30-40% of children under the age of 6 whose mothers took valproate during pregnancy may experience developmental problems. Children with the disease may start walking and talking later, be less intellectually gifted, have language problems, and have memory problems.
• Children exposed to valproate in the womb are more likely to be diagnosed with various autism spectrum disorders. Some evidence suggests that these children may be at increased risk of developing attention deficit hyperactivity disorder (ADHD).
• Before prescribing this medicinal product, the physician will explain to the patient what may threaten the child if the patient becomes pregnant while taking valproate. If the patient taking this medicinal product decides to have a child, they should not discontinue Depakine Chrono 500 or contraception without discussing it with their physician.
• Some contraceptives (estrogen-containing birth control pills) may decrease valproate levels in the blood. The patient should discuss their contraception method with their physician.
• Parents or guardians of girls treated with valproate should contact the 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 DEPAKINE CHRONO 500
• •CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITHOUT PLANNING A CHILD

CHILD

• •CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITH PLANS TO HAVE A CHILD

IN MIND

• •BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONO 500

STARTING TREATMENT WITH DEPAKINE CHRONO 500

If Depakine Chrono 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 continuously throughout the entire treatment period with Depakine Chrono 500. If the patient needs advice on contraception, they should consult their physician or a family planning clinic.

Important information

• Before starting treatment with Depakine Chrono 500, the patient should ensure that they are not pregnant through a pregnancy test, the results of which should be confirmed by the treating physician.
• The patient should use effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500.
• The patient should discuss their contraception method with their treating physician. The treating physician will provide the patient with information on pregnancy prevention and may refer them to a specialist for advice on contraception.
• The patient should regularly (at least once a year) visit a specialist experienced in treating bipolar affective disorder or epilepsy. 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.
• If the patient plans to have a child, they should inform their physician.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their physician.

CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITHOUT PLANNING A CHILD

CHILD

If the patient continues treatment with Depakine Chrono 500 and does not plan to become pregnant, they must ensure that they are using effective contraception continuously throughout the entire treatment period with Depakine Chrono 500. If the patient needs advice on contraception, they should consult their physician or a family planning clinic.

Important information

• The patient should use effective contraception (birth control) throughout the entire treatment period with Depakine Chrono 500.
• The patient should discuss their contraception method with their treating physician. The treating physician will provide the patient with information on pregnancy prevention and may refer them to a specialist for advice on contraception.
• The patient should regularly (at least once a year) visit a specialist experienced in treating bipolar affective disorder or epilepsy. 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.
• If the patient plans to have a child, they should inform their physician.
• If the patient is pregnant or suspects they may be pregnant, they should immediately inform their physician.

CONTINUING TREATMENT WITH DEPAKINE CHRONO 500 WITH PLANS TO HAVE A CHILD

IN MIND

If the patient plans to have a child, they should first schedule a visit with their treating physician. Do not discontinue Depakine Chrono 500 or contraception without discussing it with the physician. The treating physician will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high 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 the need for alternative treatment methods.
The specialist may decide to change the dose of Depakine Chrono 500, switch to another medicinal product, or discontinue Depakine Chrono 500 well 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

• Do not discontinue Depakine Chrono 500 unless the physician recommends it.
• Do not discontinue contraception before discussing it with the treating physician and developing a plan to ensure the patient's condition is controlled and the risks to the child are minimized.
• First, the patient should schedule a visit with their 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 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 physician.

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONO 500

CHILD

Do not discontinue treatment with Depakine Chrono 500 unless the physician recommends it, 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 physician. The treating physician will provide further guidance.
Children born to mothers who took valproate during pregnancy are at high 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 the need for alternative treatment methods.
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 and fetal development. The patient and their partner will receive counseling and support regarding valproate-exposed pregnancy.
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

• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent visit with their treating physician.
• Do not discontinue Depakine Chrono 500 unless the physician recommends it.
• The patient should ensure that they have been referred to a specialist experienced in treating epilepsy or bipolar affective disorder to assess the need for alternative treatment methods.
• The patient must receive counseling on 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 that they have been 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, hyperactivity, tremors, seizures, and feeding problems.

The patient should read the patient guide provided by their 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 note 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 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 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 involved.

• The physician will discuss with the patient the possible risk to children whose fathers were treated with valproate;
• The need for the patient and their partner to use effective contraception during treatment and for 3 months after discontinuation;
• The need for consultation with the physician when planning to conceive and before stopping contraception;
• The possibility of using alternative treatment methods for the patient's disease, depending on the individual situation.

Men should not donate sperm while taking valproate and for 3 months after discontinuation.
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 the physician. If the patient discontinues treatment, their symptoms may worsen.
The patient should regularly visit their physician. During such a visit, the physician will discuss with the patient the precautions related to taking valproate and the possibility of using alternative treatment methods for their disease, depending on the individual situation.
The patient should read the patient guide provided by their 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 is excreted in small amounts into breast milk. The patient should consult their physician about whether they can breastfeed while taking Depakine Chrono 500.

Driving and using machines

Some patients may experience drowsiness during treatment, especially when taking multiple antiepileptic drugs or when taking benzodiazepines concurrently. Before driving or operating machinery, the patient should make sure how they react to the treatment.

Depakine Chrono 500 contains sodium

The medicinal product contains 46.08 mg of sodium (the main component of table salt) per tablet. This corresponds to 2.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Depakine Chrono 500

Depakine Chrono 500 should always be taken as directed by the physician. In case of doubts, the patient should consult their physician.
Depakine Chrono is available in the following doses: 200 mg + 87 mg (Depakine Chrono 300) and 333 mg + 145 mg (Depakine Chrono 500).

• The use of the prolonged-release formulation allows for once-daily or twice-daily dosing.

Girls and women of childbearing age
Treatment with Depakine Chrono 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 treatment with Depakine Chrono 500 be initiated and supervised by a specialist with experience in the treatment of epilepsy or bipolar affective disorder – see section "Important note for male patients".
The use of the prolonged-release formulation allows for once-daily or twice-daily dosing.
If necessary, the prolonged-release tablet form of Depakine Chrono 500 may be used in children over 17 kg in body weight, provided that the child is able to 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 physician 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 for 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 antiepileptic drugs should be reduced to ensure 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 for epilepsy).
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 the patient is closely monitored clinically (see section: Warnings and precautions).
Children over 17 kg in 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.

Taking more than the recommended dose of Depakine Chrono 500

Symptoms of severe valproate overdose include: coma, muscle weakness, and decreased reflexes; pinpoint pupils; respiratory depression; and metabolic acidosis, hypotension, and acute circulatory failure. Other symptoms may also occur, including seizures at very high serum concentrations.
There have been reports of increased intracranial pressure with brain edema.
The presence of sodium in valproate formulations may lead to increased sodium levels in the blood in the event of an overdose.
In case of overdose, the patient should immediately consult their physician or pharmacist.
Hospital treatment for 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 the patient misses a dose, they should take it as soon as possible, unless it is almost time for the next dose. Do not take two doses at the same time or in a short period. In case of doubts, the patient should consult their physician.

Discontinuing Depakine Chrono 500

Without consulting the physician, the patient should not discontinue treatment with Depakine Chrono 500 or change the dose of the medicinal product.
In case of discontinuation of treatment without consulting the physician, the patient's condition may worsen.

4. Possible adverse reactions

Like all medicinal products, Depakine Chrono 500 can cause adverse reactions, although not everybody gets them. Patients may need appropriate treatment for some adverse reactions.

5. How to store Depakine Chrono 500

Store in a temperature below 30°C, in a dry place.
The medicinal product should be stored out of sight and reach of children.
Do not use the medicinal product after the expiry date stated on the packaging.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste.
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 Depakine Chrono 500 contains

One prolonged-release tablet contains as active substances:

• sodium valproate 333 mg,
• valproic acid 145 mg, which corresponds to a total of 500 mg of sodium valproate. Excipients: copolymer of acrylic and methacrylic acid esters with quaternary ammonium chloride, ethylcellulose, colloidal silica. Coating:hypromellose, macrogol 6000, talc, titanium dioxide (E 171), polyacrylate dispersion 30%.

What Depakine Chrono 500 looks like and what the package contains

The package contains 30 prolonged-release tablets.
For more detailed information, please 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:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export:
2057/06/28-02-2007
41972/10/21-06-2011
9081/18-02-2013

Parallel import authorization number: 84/15

Date of leaflet approval:20.02.2025

Other sources of information

Detailed and up-to-date information about this medicinal product is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website:
https://sirpl.org/walproinian
[Information about the trademark]