Depakine Hronosphere 750

Leaflet accompanying the packaging: information for the user

DEPAKINE CHRONOSPHERE 100

6 6.66 mg + 29.03 mg, prolonged-release granules

DEPAKINE CHRONOSPHERE 250

166.76 mg + 72.61 mg, prolonged-release granules

DEPAKINE CHRONOSPHERE 500

333.30 mg + 145.14 mg, prolonged-release granules

DEPAKINE CHRONOSPHERE 750

500.06 mg + 217.75 mg, prolonged-release granules

DEPAKINE CHRONOSPHERE 1000

666.60 mg + 290.27 mg, prolonged-release granules

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 experience. See section 4 for how to report side effects.

WARNING

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

Read the leaflet carefully before taking the medicine, 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 section 4.

Table of contents of the leaflet:

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

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

Depakine Chronosphere is a prolonged-release granule (containing microgranules with a diameter of 350 µm to 450 µm) and contains sodium valproate and valproic acid as active substances. Depakine Chronosphere is a medicine used to treat epilepsy and mania.
Depakine Chronosphere is used to treat:

• Epilepsy, in generalized seizures:
• myoclonic seizures
• tonic-clonic seizures
• atonic seizures
• mixed seizures, partial seizures:
• simple or complex seizures
• secondarily generalized seizures
• specific syndromes (West, Lennox-Gastaut).
• Mania, which is a condition where the patient feels very excited, elated, agitated, enthusiastic, or overactive. Mania occurs in a disease called bipolar affective disorder. Depakine Chronosphere may be used when lithium cannot be used.

2. Important information before taking Depakine Chronosphere

When not to take Depakine Chronosphere

Do not take the medicine in the following cases:

• if you are taking mefloquine concurrently,
• bipolar affective disorder:
• epilepsy:

Warnings and precautions

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

YOU MUST IMMEDIATELY INFORM YOUR DOCTOR:

• In case of sudden occurrence of the following symptoms: recurrent vomiting, feeling of fatigue, abdominal pain, drowsiness, weakness, loss of appetite, nausea, jaundice (yellowing of the skin and whites of the eyes) or recurrence of seizures, especially during the first 6 months of treatment, you must immediately inform your doctor. Depakine Chronosphere may cause severe liver damage, which can be fatal. Before starting treatment and during the first 6 months of treatment, liver function tests should be performed periodically. The risk of liver damage increases if Depakine Chronosphere 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 must immediately inform your doctor. Very rarely, Depakine Chronosphere may cause pancreatitis.
• If you or your child taking Depakine Chronosphere experience balance and coordination problems, drowsiness, or decreased alertness, vomiting, you must immediately inform your doctor. 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 you ever have such thoughts, you must immediately contact your 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 you notice any of the symptoms related to these severe skin reactions, as described in section 4, you must immediately consult a doctor.

Before taking this medicine, discuss it with your doctor:

• Sodium 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 medicine should be weighed against the risks before the first prescription or when a woman taking sodium valproate is planning 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 (complete blood count, platelet count, bleeding time, and coagulation tests) are recommended.
• Use with caution in patients with renal impairment. Your doctor may recommend a lower dose of the medicine.
• Use with caution in patients with systemic lupus erythematosus.
• If you suspect any metabolic disorder, especially congenital enzyme deficiencies, such as "urea cycle disorders", due to the risk of increased ammonia levels in the blood.
• Patient's treated with sodium valproate may experience increased appetite and weight gain.
• If you have 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 Chronosphere and other medicines).
• Sodium valproate is excreted mainly 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 if your 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 medicine. If seizures worsen, you must immediately consult a doctor.
• If you have inadequate carnitine intake, found in meat and dairy products, especially in children under 10 years of age.
• If you have a carnitine deficiency and are taking carnitine.
• If you have ever experienced a severe skin rash or exfoliation after taking valproate.

Children and adolescents

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

Depakine Chronosphere and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some other medicines and Depakine Chronosphere may interact with each other. These include:

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• antidepressants;
• benzodiazepines (used as sleeping pills and to treat anxiety disorders);
• other antiepileptic drugs (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 infections);
• mefloquine (used to treat and prevent malaria);
• acetylsalicylic acid (commonly known as aspirin);
• 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;
• estrogen-containing medicines (including some contraceptives);
• metamizole (used to treat pain and fever);
• clozapine (used to treat mental illnesses).

Depakine Chronosphere with food, drink, and alcohol

The medicine should be taken with a soft food (yogurt, fruit puree, cottage cheese, etc.) or drinks (fruit juices) - cold or at room temperature.
Food does not affect the absorption of the medicine from the gastrointestinal tract.
Do not consume alcohol while taking Depakine Chronosphere.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for women

Bipolar affective disorder

• In the treatment of bipolar affective disorder, do not use Depakine Chronosphere if you are pregnant.
• In the treatment of bipolar affective disorder, if you are of childbearing age, you must not take Depakine Chronosphere unless you are using effective contraception (birth control) throughout the entire treatment period with Depakine Chronosphere. Do not stop taking Depakine Chronosphere or contraception without discussing it with your doctor. Your doctor will provide further guidance.

Epilepsy

• In the treatment of epilepsy, do not use Depakine Chronosphere if you are pregnant, unless no other therapy is effective.
• In the treatment of epilepsy, if you are of childbearing age, you must not take Depakine Chronosphere unless you are using effective contraception (birth control) throughout the entire treatment period with Depakine Chronosphere. Do not stop taking Depakine Chronosphere or contraception without discussing it with your doctor. Your doctor will provide further guidance.

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

• You must immediately consult your doctor if you plan to become pregnant or if you 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 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 developmental abnormalities, often in combination with other birth defects. Eye developmental abnormalities can affect vision.
• In women taking valproate during pregnancy, there is an increased risk of birth defects requiring treatment. Valproate has been used for many years, and it is known that 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 medicine, your doctor will explain the risks to the unborn child if you become pregnant while taking valproate. If you are taking this medicine and want to have a child, do not stop taking the medicine or contraception without discussing it with your doctor.
• Certain contraceptives (estrogen-containing birth control pills) may decrease valproate levels in the blood. You should discuss contraception methods with your doctor.
• Parents or guardians of girls treated with valproate should contact the doctor when their child starts menstruating.
• You should ask your 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 you and read the information:

about STARTING TREATMENT WITH DEPAKINE CHRONOSPHERE
about CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WITHOUT TRYING FOR A CHILD

CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WHILE TRYING FOR A CHILD

about CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WHILE TRYING FOR A CHILD

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE

STARTING TREATMENT WITH DEPAKINE CHRONOSPHERE

If Depakine Chronosphere is prescribed for the first time, your doctor will explain the risks to the unborn child if you become pregnant. Women of childbearing age must ensure that they use effective contraception throughout the entire treatment period with Depakine Chronosphere. If you need advice on contraception, you should consult a doctor or family planning clinic.

Important information

• You must use effective contraception (birth control) throughout the entire treatment period with Depakine Chronosphere.
• You should discuss contraception methods with your doctor. Your doctor will provide you with information on pregnancy prevention and may refer you to a specialist for contraception advice.
• You should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this visit, your doctor will ensure that you are well-informed and understand all the risks and advice related to taking valproate during pregnancy.
• If you plan to become pregnant, you should inform your doctor.
• If you are pregnant or think you may be pregnant, you should immediately inform your doctor.

CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WITHOUT TRYING FOR A CHILD

If you continue treatment with Depakine Chronosphere and do not plan to become pregnant, you must ensure that you use effective contraception throughout the entire treatment period with Depakine Chronosphere. If you need advice on contraception, you should consult a doctor or family planning clinic.

Important information

• You must use effective contraception (birth control) throughout the entire treatment period with Depakine Chronosphere.
• You should discuss contraception methods with your doctor. Your doctor will provide you with information on pregnancy prevention and may refer you to a specialist for contraception advice.
• You should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this visit, your doctor will ensure that you are well-informed and understand all the risks and advice related to taking valproate during pregnancy.
• If you plan to become pregnant, you should inform your doctor.
• If you are pregnant or think you may be pregnant, you should immediately inform your doctor.

CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WHILE TRYING FOR A CHILD

If you plan to become pregnant, you should first schedule a visit with your doctor. Do not stop taking Depakine Chronosphere or contraception without discussing it with your doctor. Your 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. Your doctor will refer you to a specialist experienced in treating bipolar affective disorder or epilepsy to assess alternative treatment options. The specialist may take steps to ensure the best possible outcome of the pregnancy and minimize the risk to the mother and unborn child.
The specialist may decide to change the dose of Depakine Chronosphere or switch to another medicine or discontinue Depakine Chronosphere treatment well before becoming pregnant - to ensure that the disease is stable.
You should ask your 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 Chronosphere unless your doctor decides to do so.
• Do not stop using contraception methods before discussing it with your doctor and developing a plan to ensure control of epilepsy/bipolar affective disorder and minimize risks to the child.
• First, you should schedule a visit with your doctor. During this visit, your doctor will ensure that you are well-informed and understand all the risks and advice related to taking valproate during pregnancy.
• Your doctor will try to switch to another medicine or discontinue Depakine Chronosphere treatment well before becoming pregnant.
• If you are pregnant or think you may be pregnant, you should schedule an urgent visit with your doctor.

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE

Do not stop taking Depakine Chronosphere unless your doctor decides to do so, as your condition may worsen. If you are pregnant or think you may be pregnant, you should schedule an urgent visit with your doctor. Your 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.
You will be referred to a specialist experienced in treating bipolar affective disorder or epilepsy to assess alternative treatment options.
In exceptional circumstances, when Depakine Chronosphere is the only available treatment option during pregnancy, you will be closely monitored, both in terms of the underlying disease and fetal development. You and your partner will receive counseling and support regarding valproate-exposed pregnancy.
You should 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 you are pregnant or think you may be pregnant, you should schedule an urgent visit with your doctor.
• Do not stop taking Depakine Chronosphere unless your doctor decides to do so.
• You should ensure that you are referred to a specialist experienced in treating epilepsy or bipolar affective disorder to assess the need for alternative treatment methods.
• You must receive counseling on the risks of taking Depakine Chronosphere during pregnancy, including its teratogenic effects (causing birth defects) and physical and mental developmental disorders in children.
• You should ensure that you are referred to a specialist for prenatal monitoring to detect any potential developmental abnormalities.

Newborns of mothers who took Depakine Chronosphere during pregnancy may experience coagulation disorders, hypoglycemia, hypothyroidism, and withdrawal symptoms, such as: agitation, irritability, hyperactivity, 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 in 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 medicines that may be used to treat the 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.

• your doctor will discuss the possible risk to children;
• the need to consider using effective contraception (birth control) by you and your 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 and for 3 months after stopping it.
If you plan to have children, you should 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 it, you should contact your doctor. Do not stop treatment without consulting your doctor. If you stop treatment, your symptoms may worsen.
You should have regular check-ups with the doctor who prescribed the medicine. During such a visit, your doctor will discuss 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 valproate.

Breastfeeding

Valproate is excreted in small amounts into breast milk. You should consult your doctor about whether you can breastfeed while taking this medicine.

Driving and using machines

Some patients, especially at the beginning of treatment with Depakine Chronosphere or combination therapy with other antiepileptic drugs, or benzodiazepines, may experience drowsiness.
Before driving or operating machinery, you should make sure how you react to the treatment.

Depakine Chronosphere contains sodium

Depakine Chronosphere 100 contains less than 1 mmol (23 mg) of sodium per sachet, which means the medicine is considered "sodium-free".
Depakine Chronosphere 250 contains 23.07 mg of sodium (the main component of table salt) per sachet. This corresponds to 1.15% of the maximum recommended daily intake of sodium in the diet for adults.
Depakine Chronosphere 500 contains 46.08 mg of sodium (the main component of table salt) per sachet. This corresponds to 2.30% of the maximum recommended daily intake of sodium in the diet for adults.
Depakine Chronosphere 750 contains 69.20 mg of sodium (the main component of table salt) per sachet. This corresponds to 3.46% of the maximum recommended daily intake of sodium in the diet for adults.
Depakine Chronosphere 1000 contains 92.24 mg of sodium (the main component of table salt) per sachet. This corresponds to 4.61% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to take Depakine Chronosphere

Depakine Chronosphere 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 Chronosphere should be started and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.
Male patients
It is recommended that the use of Depakine Chronosphere be started and supervised by a specialist with experience in the treatment of epilepsy or bipolar affective disorder - see "Important advice for male patients" in section 2.
The prolonged-release granule form of Depakine Chronosphere can be used in all patients, especially in children (if the child can swallow a liquid food), adults with swallowing difficulties, and elderly patients.
Depakine Chronosphere can be taken once or twice a day.
The daily dose will be determined by your doctor based on your age and weight; individual sensitivity to sodium valproate should also be taken into account.
Starting treatment with Depakine Chronosphere for epilepsy

• In patients not taking other antiepileptic drugs, the dose should be increased every 2 or 3 days to achieve the optimal dose within a week.
• In patients taking other antiepileptic drugs, treatment with Depakine Chronosphere should be introduced gradually, achieving the optimal dose within 2 weeks, and then the doses of other antiepileptic drugs should be reduced until they are discontinued.
• If it is necessary to use other antiepileptic drugs concurrently, they should be introduced gradually.

The initial daily dose is usually 5 to 15 mg/kg body weight; it should then be gradually increased to achieve the optimal dose (see "Starting treatment with Depakine Chronosphere").
This dose is usually between 20 and 30 mg/kg body weight per day. If adequate control of seizures is not achieved, the dose of the medicine can be increased; patients should be closely monitored if they receive a dose above 50 mg/kg body weight.
Children with a body weight above 17 kg
Usual maintenance dose is 30 mg/kg body weight per day.
Adults
Usual maintenance dose is between 20 and 30 mg/kg body weight per day.
Elderly patients
Although the pharmacokinetics of the medicine may change in elderly patients, this has no significant clinical implications. Dosing should be based on the degree of seizure control.
Mania
Adults:
The daily dose should be determined and checked individually by the 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.
Method of administration
Depakine Chronosphere has no taste and should be administered by sprinkling it into a soft food (yogurt, fruit puree, cottage cheese, etc.) or drinks (fruit juices) - cold or at room temperature.
Depakine Chronosphere should not be administered with hot or warm foods or drinks (soup, coffee, tea, etc.).
If necessary, the contents of the sachet can also be administered directly into the mouth, and then the mouth should be rinsed with a small amount of cold drink.
Depakine Chronosphere should not be administered in a baby bottle with a nipple, as the microgranules may clog the nipple hole.
When administering the product with liquids, it is recommended to rinse the glass with a small amount of water and drink it, as the microgranules may stick to the glass walls.
The prepared medicine should be taken immediately, without chewing.
Do not leave the medicine for later use.
Duration of treatment
The medicine should be taken for as long as your doctor recommends.
Do not stop treatment or change the dose of the medicine without consulting your doctor.
In case you feel that the effect of Depakine Chronosphere is too strong or too weak, you should consult your doctor.
Patients with renal impairment
Your doctor may decide to modify the dose.

Taking a higher dose of Depakine Chronosphere than recommended

Clinical symptoms of severe overdose are usually: coma with decreased muscle tone, hyporeflexia (weak reflexes), miosis (constricted pupils), and respiratory disorders, seizures. Metabolic acidosis, hypotension, and acute cardiovascular failure may also occur. The presence of sodium in valproate formulations may lead to increased sodium levels in the blood in case of overdose.
Treatment of overdose is symptomatic and should be performed in a hospital. Treatment includes: gastric lavage (up to 10-12 hours after taking the medicine) and monitoring of cardiovascular and respiratory function.
In a few cases, the use of naloxone has been shown to be effective.
In case of taking a higher dose of the medicine than recommended, you should immediately consult a doctor or pharmacist.

Missing a dose of Depakine Chronosphere

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

Stopping treatment with Depakine Chronosphere

Do not stop treatment with Depakine Chronosphere or change the dose of the medicine without consulting your doctor.
Stopping treatment without consulting a doctor may worsen your condition.

4. Possible side effects

Like all medicines, Depakine Chronosphere 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 Chronosphere

Depakine Chronosphere sachets should be stored at a temperature below 25°C in the original packaging, in a dry place. The medicinal product should be stored out of the reach and sight of children. The medicinal product should not be used after the expiry date stated on the packaging. 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 Chronosphere contains

Depakine Chronosphere 100
1 sachet contains as active substances:
sodium valproate
66.66 mg
valproic acid
29.03 mg
which corresponds to a total of 100 mg of sodium valproate.
Depakine Chronosphere 250
1 sachet contains as active substances:
sodium valproate
166.76 mg
valproic acid
72.61 mg
which corresponds to a total of 250 mg of sodium valproate.
Depakine Chronosphere 500
1 sachet contains as active substances:
sodium valproate
333.30 mg
valproic acid
145.14 mg
which corresponds to a total of 500 mg of sodium valproate.
Depakine Chronosphere 750
1 sachet contains as active substances:
sodium valproate
500.06 mg
valproic acid
217.75 mg
which corresponds to a total of 750 mg of sodium valproate.
Depakine Chronosphere 1000
1 sachet contains as active substances:
sodium valproate
666.60 mg
valproic acid
290.27 mg
which corresponds to a total of 1000 mg of sodium valproate.
In addition, the medicinal product contains: paraffin, dibehenyl glycerol, colloidal silica.

What Depakine Chronosphere looks like and what the pack contains

Depakine Chronosphere is a prolonged-release granule.
The packaging contains 30 sachets of Depakine Chronosphere.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Sanofi Sp. z o.o.
ul. Marcina Kasprzaka 6
01-211 Warsaw
Manufacturer:
Sanofi-Winthrop Industrie
196, avenue du Marechal Juin
45200 Amilly
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 with a smartphone. The same information is also available on the website: www.qr.walproinianija.pl