Depakine Hrono 300

Leaflet attached to the packaging: information for the user

DEPAKINE CHRONO 300

200 mg + 87 mg, prolonged-release coated tablets

DEPAKINE CHRONO 500

333 mg + 145 mg, prolonged-release coated tablets

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

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

• Keep this leaflet, you may need to read it again.
• 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, tell your doctor or pharmacist. See point 4.

Table of contents of the leaflet:

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

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

Depakine Chrono is a prolonged-release coated 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 is used to treat epilepsy and mania.
Depakine Chrono 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 may be used when lithium cannot be used.

2. Important information before taking Depakine Chrono

When not to take Depakine Chrono

Do not take the drug in the following cases:

• if the patient is hypersensitive 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., patients with 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 entire treatment period with Depakine Chrono. Do not stop taking Depakine Chrono or contraception without discussing it with your doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").
• 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 entire treatment period with Depakine Chrono. Do not stop taking Depakine Chrono or contraception without discussing it with your doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Warnings and precautions

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

YOU MUST IMMEDIATELY INFORM YOUR TREATING DOCTOR:

• In case of sudden occurrence 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 recurrence of seizures, especially during the first 6 months of treatment, you should immediately inform your treating doctor.

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

• In case of acute abdominal pain, you should immediately inform your treating doctor. Very rarely, Depakine Chrono can cause severe pancreatitis, which can be fatal.
• If the patient or their child taking Depakine Chrono experiences balance and coordination problems, drowsiness, or decreased alertness, vomiting, they should immediately inform their treating doctor. This may be caused by 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 ever occur to the patient, they should immediately contact their treating doctor.
• Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), polymorphic eruption, and angioedema, have been reported with valproate treatment. If the patient notices any of the symptoms related to these severe skin reactions, as described in point 4, they should immediately consult a doctor.

Before taking this drug, discuss it with your doctor:

• Sodium valproate should not be used in women with epilepsy planning to become pregnant, unless other treatments are ineffective or not tolerated. The benefits of using the drug should be weighed against the risk before the first prescription or when a woman treated with sodium 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 case 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 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 point Depakine Chrono and other drugs).
• Sodium valproate is mainly excreted by the kidneys, partly in the form of ketone bodies, so in diabetic patients, the test 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 seizures, you should immediately consult a doctor.
• If the patient has inadequate 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 exfoliation after taking sodium valproate.

Children and adolescents

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

Depakine Chrono 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 sodium 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 antiepileptic drugs, 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 blood cholesterol levels);
• 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 the drugs that should be used with caution or avoided during treatment with Depakine Chrono.

Depakine Chrono with food, drink, and alcohol

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

Pregnancy, breastfeeding, and fertility

Pregnancy

Important note for women

Bipolar affective disorder

• Depakine Chrono 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 unless they use effective contraception (birth control) throughout the entire treatment period with Depakine Chrono. Do not stop taking Depakine Chrono or contraception without discussing it with your doctor. The treating doctor will provide further guidance.

Epilepsy

• Depakine Chrono 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, if the patient is of childbearing age, they should not take Depakine Chrono unless they use effective contraception (birth control) throughout the entire treatment period with Depakine Chrono. Do not stop taking Depakine Chrono or contraception without discussing it with your doctor. The treating doctor will provide further guidance.

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

• The patient should immediately consult their treating doctor if they plan to become pregnant or are pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free, 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 several 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 developmental abnormalities, often in combination with other birth defects. Eye developmental 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, such defects are found in 2-3 out of 100 children born to women without epilepsy.
• It is estimated that up to 30-40% of preschool-age children whose mothers took valproate during pregnancy may exhibit early developmental problems. Children with the disease may start walking and talking later, be less intellectually gifted 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 that these children may have an increased risk of developing attention deficit hyperactivity disorder (ADHD).
• 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 stop taking the drug or contraception without discussing it with their treating doctor.
• Some contraceptives (estrogen-containing oral contraceptives) may decrease valproate levels in the blood. The patient should discuss the method of contraception (birth control) with their doctor.
• Parents or guardians of girls treated with valproate should contact the treating doctor when their daughter starts menstruating.
• The patient should ask their doctor about taking folic acid when 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:

o

STARTING TREATMENT WITH DEPAKINE CHRONO

o

CONTINUING TREATMENT WITH DEPAKINE CHRONO WITHOUT TRYING FOR A CHILD

CONTINUING TREATMENT WITH DEPAKINE CHRONO WHILE TRYING FOR A CHILD

o

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONO

STARTING TREATMENT WITH DEPAKINE CHRONO

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

Important information

• Before starting treatment with Depakine Chrono, the patient should ensure that they are not pregnant through a pregnancy test, the results of which should be confirmed by the treating doctor.
• The patient should use effective contraception (birth control) throughout the entire treatment period with Depakine Chrono.
• The patient should discuss contraception (birth control) with their treating doctor. The treating doctor will provide the patient with information on pregnancy prevention and may refer them to a specialist for advice on birth control.
• The patient should regularly (at least once a year) visit a specialist experienced in the treatment of 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 WITHOUT TRYING FOR A CHILD

If the patient continues treatment with Depakine Chrono and does not plan to become pregnant, they must ensure that they use effective contraception without interruption throughout the entire treatment period with Depakine Chrono. 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 entire treatment period with Depakine Chrono.
• The patient should discuss contraception (birth control) with their treating doctor. The treating doctor will provide the patient with information on pregnancy prevention and may refer them to a specialist for advice on birth control.
• The patient should regularly (at least once a year) visit a specialist experienced in the treatment of 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 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 stop taking Depakine Chrono or contraception without discussing it with your 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 the treatment of 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 Depakine Chrono, switch to another drug, or stop treatment with Depakine Chrono long before the patient becomes pregnant - to ensure that the disease is stable.
The patient should ask their doctor about taking folic acid when 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 stop taking Depakine Chrono unless advised by a doctor.
• Do not stop using contraception before discussing it with your treating doctor and developing a plan of action that ensures control of the patient's condition and minimizes the risks to the child.
• First, the patient should schedule a visit with their 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 stop treatment with Depakine Chrono long 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

Do not stop taking Depakine Chrono 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 the treatment of bipolar affective disorder or epilepsy to assess alternative treatment options.
In exceptional circumstances, when Depakine Chrono 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 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 stop taking Depakine Chrono unless advised by a doctor.
• The patient should ensure that they have been referred to a specialist experienced in the treatment of epilepsy or bipolar affective disorder to assess the need for alternative treatment methods.
• The patient must receive counseling on the risks associated with taking Depakine Chrono 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 during pregnancy may experience coagulation disorders, hypoglycemia, hypothyroidism, and withdrawal symptoms, such as agitation, irritability, overactivity, tremors, seizures, and feeding problems.

Read the patient guide provided by your doctor.

Your doctor will discuss the annual confirmation form regarding the risk and ask you to sign and keep it. You will also receive a patient card from the pharmacist to remind you of the risk of taking valproate during pregnancy.

Important note 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 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 stopped taking valproate at least 3 months (the time needed to produce new sperm) before conception is unknown. The study has limitations, and therefore, it is not clear whether the suggested increased risk of developmental delays is caused by valproate. The study was not large enough to show what specific types of motor disorders and developmental delays the risk applies to.
As a precaution, the 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 stopping contraception;
• the possibility of using other treatment methods for the disease, depending on the individual situation.

Do not donate sperm while taking valproate or for 3 months after stopping it.
If you plan to have children, discuss it with your doctor.
If your partner becomes pregnant while you are taking valproate within 3 months before conception and you have questions about it, you should contact your doctor. Do not stop taking the drug without consulting your doctor. If you stop taking the drug, your symptoms may worsen.
You should regularly visit your doctor. During such a visit, the doctor will discuss with you the precautions related to taking valproate and the possibility of using other treatment methods 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 taking 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

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

Depakine Chrono contains sodium

Depakine Chrono 300 contains 27.65 mg of sodium (the main component of common salt) per tablet. This corresponds to 1.38% of the maximum recommended daily intake of sodium in the diet for adults.
Depakine Chrono 500 contains 46.08 mg of sodium (the main component of common 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

Depakine Chrono should always be taken as directed by your doctor. In case of doubts, consult your doctor.
Girls and women of childbearing age
Treatment with Depakine Chrono 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 be started and supervised by a specialist with experience in the treatment of epilepsy or bipolar affective disorder - see point 2 Important note for male patients.
The use of a prolonged-release formulation allows Depakine Chrono to be taken in a single daily dose or in 2 divided doses per day.
If necessary, Depakine Chrono prolonged-release coated tablets may be used in children with a body weight over 17 kg, 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 should be determined based on the patient's age and weight, and the doctor should always consider the patient's individual sensitivity to valproate.
Switching to prolonged-release formulations (Depakine Chrono).
When switching from conventional tablets to prolonged-release tablets, it is recommended (according to the current state of knowledge) to maintain the same daily dose.
Starting treatment with Depakine Chrono in epilepsy
When starting treatment with Depakine Chrono 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 in patients already taking other antiepileptic drugs, the dose of Depakine Chrono 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 that ensures 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 increased gradually every 2-3 days by 5 mg/kg body weight to reach the optimal dose (see: Starting treatment with Depakine Chrono).
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 under close clinical supervision (see point: Be particularly cautious when taking Depakine Chrono).
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.

Taking a higher dose of Depakine Chrono than recommended

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 may include seizures at very high drug concentrations in the blood.
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 of the medicinal product.
In case of taking a higher dose of the drug than recommended, immediately consult a doctor or pharmacist.
Hospital treatment in case of poisoning should include: gastric lavage (up to 10-12 hours after taking the drug), constant monitoring of cardiovascular and respiratory function. In severe cases, hemodialysis or even exchange transfusion may be necessary.

Missing a dose of Depakine Chrono

In case of missing a dose, take it as soon as possible, unless it is close to the time of the next dose. Do not take two doses of the drug at the same time or at short intervals. In case of doubts, consult your doctor.

Stopping treatment with Depakine Chrono

Do not stop taking Depakine Chrono without consulting your doctor, or change the dose of the drug.
Stopping treatment without consulting a doctor may worsen the patient's condition.

4. Possible side effects

Like all medicines, Depakine Chrono can cause side effects, although not everybody gets them. Patients may need appropriate treatment in case of certain side effects.

5. How to store Depakine Chrono

Store the medicinal product at a temperature below 25°C. Store in the original, tightly closed packaging to protect from light and moisture. The medicinal product should be stored in a place inaccessible and invisible to children. The medicinal product should not be used after the expiration date stated on the packaging. Medicines should not be disposed of via wastewater or household waste containers. The patient should ask their pharmacist how to dispose of unused medicinal products. This will help protect the environment.

6. Package contents and other information

What Depakine Chrono contains

Depakine Chrono 300
1 prolonged-release film-coated tablet contains as active substances:
sodium valproate
200 mg,
valproic acid
87 mg,
which corresponds to a total of 300 mg of sodium valproate
and excipients: copolymer of acrylic and methacrylic acid esters with quaternary ammonium chloride, ethylcellulose (20 mPa·s), hydrated silica colloidal.
Coating composition: hypromellose (6 mPa·s), macrogol 6000, talc, titanium dioxide (E 171), poliacrylate 30%.
Depakine Chrono 500
1 prolonged-release film-coated tablet 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 (20 mPa·s), hydrated silica colloidal.
Coating composition: hypromellose (6 mPa·s), macrogol 6000, talc, titanium dioxide (E 171), poliacrylate 30%.

What Depakine Chrono looks like and what the pack contains

The pack contains 30 prolonged-release film-coated tablets of Depakine Chrono 300 or Depakine Chrono 500.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Sanofi Aventis S.A.
Ctra. C-35 (La Batlloria-Hostalric Km. 63.09)
Riells i Viabrea, 17404 Girona
Spain
Sanofi-Winthrop Industrie
1 rue de la Vierge
33 440 Ambares
France
To obtain more detailed information about this medicinal product, please contact the marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
tel.: +48 22 280 00 00
Date of last revision of the leaflet:December 2024

Other sources of information

Detailed and up-to-date information about this medicinal product is available by scanning the QR code on the leaflet and the outer packaging using a smartphone. The same information is also available on the website: www.qr.walproinianija.pl