Depakine Hronosphere 250

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 the 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 recommendations presented in section 2 of this leaflet must also be followed.
Patients should 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.

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the patient should consult a doctor or pharmacist.
• This medication has been prescribed for a specific person. It should not be given to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their 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 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 medication in the following cases:

• if the patient is allergic to the active substance sodium valproate or any of the other ingredients of this medication (listed in section 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 caused by 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 treatment period with Depakine Chronosphere. Do not discontinue Depakine Chronosphere or contraception without discussing it with a doctor. The doctor will provide further guidance (see "Pregnancy, breastfeeding, and fertility - Important advice 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 treatment period with Depakine Chronosphere. Do not discontinue Depakine Chronosphere or contraception without discussing it with a doctor. The doctor will provide further guidance (see "Pregnancy, breastfeeding, and fertility - Important advice for women").

Warnings and precautions

Before starting to take Depakine Chronosphere, the patient should discuss it with their doctor.

THE PATIENT MUST IMMEDIATELY INFORM THEIR DOCTOR:

• In case of sudden onset 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, the patient should immediately inform their 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, patients taking other antiepileptic medications, or patients with other neurological or metabolic disorders.
• In case of acute abdominal pain, the patient should immediately inform their doctor. Depakine Chronosphere can very rarely cause pancreatitis.
• If the patient or their child taking Depakine Chronosphere experiences balance and coordination problems, drowsiness, or decreased alertness, vomiting, they should immediately inform their doctor. This may be due to increased ammonia levels in the blood.
• A small number of people taking antiepileptic medications, including sodium valproate, have thought about harming or killing themselves. If such thoughts occur, the patient should immediately contact their 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 therapy. If the patient notices any of the symptoms associated with these severe skin reactions, as described in section 4, they should immediately consult their doctor.

Before taking this medication, the patient should discuss it with their 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 medication 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.
• Depakine Chronosphere should be used with caution in patients with renal impairment. The doctor may recommend a lower dose of the medication.
• The medication 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.
• Patients treated with sodium valproate may experience increased appetite and weight gain.
• If the patient has a rare disorder called "carnitine palmitoyltransferase II deficiency", due to the increased risk of muscle disorders.
• Concomitant use of carbapenem antibiotics with valproic acid is not recommended (see "Depakine Chronosphere and other medications").
• 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 if the doctor suspects such a disorder, due to the risk of liver damage.
• As with other antiepileptic medications, the severity or frequency of seizures may increase during treatment with this medication. If seizures worsen, the patient should immediately consult their 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 exfoliative dermatitis 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 medications

The patient should tell their doctor about all medications they are currently taking or have recently taken, as well as any medications they plan to take.
Some other medications and Depakine Chronosphere may interact with each other. These medications include:

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• antidepressants;
• benzodiazepines (used as sleeping pills and to treat anxiety disorders);
• other antiepileptic medications (phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate, rufinamide);
• kanabidiol (used to treat epilepsy and other indications);
• certain anti-infective medications 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;
• medications containing estrogen (including some contraceptive medications);
• metamizole (used to treat pain and fever);
• clozapine (used to treat mental illnesses).

Depakine Chronosphere with food, drink, and alcohol

The medication 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 medication from the gastrointestinal tract.
During treatment with Depakine Chronosphere, the patient should not consume alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important advice for women

Bipolar affective disorder

• In the treatment of bipolar affective disorder, Depakine Chronosphere should not be used if the patient is pregnant.
• In the treatment of bipolar affective disorder, women of childbearing age should not take Depakine Chronosphere unless they use effective contraception (birth control) throughout the treatment period with Depakine Chronosphere. Do not discontinue Depakine Chronosphere or contraception without discussing it with a doctor. The doctor will provide further guidance.

Epilepsy

• In the treatment of epilepsy, Depakine Chronosphere should not be used 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 Chronosphere unless they use effective contraception (birth control) throughout the treatment period with Depakine Chronosphere. Do not discontinue Depakine Chronosphere or contraception without discussing it with a doctor. The 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 doctor if they plan to become pregnant or if they 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 medications.
• Valproate may cause severe 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 utero have been reported to have hearing problems or deafness.
• Children exposed to valproate in utero have been reported to have eye developmental abnormalities, often in combination with other birth defects. Eye developmental abnormalities can affect vision.
• Women taking valproate during pregnancy are at a higher risk of giving birth to a child with birth defects that require medical 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, may be less intellectually capable than other children, may have language problems, and may have memory difficulties.
• Children exposed to valproate in utero 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 medication, the doctor will explain to the patient what may threaten the child if the patient becomes pregnant while taking valproate. If the patient taking this medication decides to have a child, they should not discontinue the medication or contraception without discussing it with their doctor.
• Some contraceptive medications (estrogen-containing birth control pills) may decrease valproate levels in the blood. The patient should discuss their contraception method with their doctor.
• Parents or guardians of girls treated with valproate should contact the doctor when their child starts menstruating.
• The patient should ask their doctor about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Choose the situation that applies to the patient and read the information:

about STARTING TREATMENT WITH DEPAKINE CHRONOSPHERE
about CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WITHOUT TRYING TO CONCEIVE

CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WHILE TRYING TO CONCEIVE

about CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE WHILE TRYING TO CONCEIVE

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE

STARTING TREATMENT WITH DEPAKINE CHRONOSPHERE

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

Important information

• Before starting treatment with Depakine Chronosphere, the patient should ensure that they are not pregnant through a pregnancy test, the results of which should be confirmed by their doctor.
• The patient should use effective contraception (birth control) throughout the treatment period with Depakine Chronosphere.
• The patient should discuss their contraception method with their doctor. The doctor will provide information on pregnancy prevention and may refer the patient to a specialist for contraception advice.
• The patient should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this check-up, the 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 become pregnant, 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 CHRONOSPHERE WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with Depakine Chronosphere and does not plan to become pregnant, they must ensure that they use effective contraception throughout the treatment period with Depakine Chronosphere. If the patient needs advice on contraception, they should consult their doctor or a family planning clinic.

Important information

• The patient should use effective contraception (birth control) throughout the treatment period with Depakine Chronosphere.
• The patient should discuss their contraception method with their doctor. The doctor will provide information on pregnancy prevention and may refer the patient to a specialist for contraception advice.
• The patient should have regular check-ups (at least once a year) with a specialist experienced in treating bipolar affective disorder or epilepsy. During this check-up, the 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 become pregnant, 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 CHRONOSPHERE WHILE TRYING TO CONCEIVE

If the patient plans to become pregnant, they should first schedule a consultation with their doctor. Do not discontinue Depakine Chronosphere or contraception without discussing it with a doctor. The doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at a high risk of birth defects and developmental problems, which can significantly impair the child. The doctor will refer the patient to a specialist experienced in treating bipolar affective disorder or epilepsy to assess the need for alternative treatment options. The specialist may take steps to ensure the best possible outcome for 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 medication or discontinue Depakine Chronosphere well before the patient becomes pregnant - to ensure that the disease is stable.
The patient should ask their doctor about taking folic acid while trying to conceive. Folic acid may reduce the overall risk of spina bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that taking folic acid will reduce the risk of birth defects associated with valproate treatment.

Important information

• Do not discontinue treatment with Depakine Chronosphere unless advised by a doctor.
• Do not discontinue contraception before discussing it with a doctor and developing a plan to ensure control of epilepsy/bipolar affective disorder and minimize the risks to the child.
• First, the patient should schedule a consultation with their doctor. During this consultation, the doctor will ensure that the patient has been well-informed and understands all the risks and advice related to taking valproate during pregnancy.
• The doctor will try to switch to another medication or discontinue Depakine Chronosphere before the patient becomes pregnant.
• If the patient is pregnant or suspects they may be pregnant, they should schedule an urgent consultation with their doctor.

BECOMING PREGNANT WHILE CONTINUING TREATMENT WITH DEPAKINE CHRONOSPHERE

Do not discontinue treatment with Depakine Chronosphere 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 consultation with their doctor. The doctor will provide further guidance.
Children born to mothers who took valproate during pregnancy are at a 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 options.
In exceptional circumstances, when Depakine Chronosphere 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 the pregnancy and valproate exposure.
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 consultation with their doctor.
• Do not discontinue treatment with Depakine Chronosphere unless advised by a doctor.
• The patient should ensure that they have been referred to a specialist experienced in treating epilepsy, bipolar affective disorder, or pregnancy, to assess the need for alternative treatment options.
• The patient must receive counseling on the risks associated with taking Depakine Chronosphere 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 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 the doctor.

The doctor will discuss and have the patient sign and keep a yearly confirmation form regarding the risks and benefits of valproate treatment. The patient will also receive a patient card from the pharmacist to remind them of the risks associated with valproate treatment 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 medications that may be used to treat the patient's condition). The risk to children whose fathers discontinued valproate treatment at least 3 months (the time needed to produce new sperm) before conception is unknown. The study has limitations, and it is not clear whether the suggested increased risk of developmental delays is caused by valproate. The study was not large enough to show what specific types of motor disorders and developmental delays are associated with this risk.
As a precaution, the doctor will discuss with the patient:

• the possible risk to children whose fathers were treated with valproate;
• the need to consider using effective contraception (birth control) during treatment and for 3 months after discontinuing treatment;
• the need to consult a doctor when planning to conceive and before discontinuing contraception;
• the possibility of using alternative treatments for the patient's condition, depending on their individual situation.

Do not donate sperm while taking valproate and for 3 months after discontinuing treatment.
If the patient plans to have children, they should discuss this with their doctor.
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 this, they should contact their doctor. Do not discontinue treatment without consulting a doctor. If the patient discontinues treatment, their symptoms may worsen.
The patient should have regular check-ups with the doctor prescribing the medication. During these check-ups, the doctor will discuss the precautions associated with valproate treatment and the possibility of using alternative treatments for the patient's condition, depending on their individual situation.
Read the patient guide provided by the doctor. The patient will also receive a patient card from the pharmacist to remind them of the possible risks associated with valproate treatment.
Breastfeeding

Valproate is excreted in small amounts into breast milk. The patient should consult their doctor to determine if they can breastfeed while taking this medication.

Driving and using machines

Some patients, especially at the beginning of treatment with Depakine Chronosphere or concomitant treatment with other antiepileptic medications or benzodiazepines, may experience drowsiness.
Before driving or operating machinery, the patient should ensure that they know how they 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 medication 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 the doctor. In case of doubts, the patient should consult their doctor.
Girls and women of childbearing age
Treatment with Depakine Chronosphere should be initiated and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.
Male patients
It is recommended that treatment with Depakine Chronosphere be initiated and supervised by a specialist with experience in the treatment of epilepsy or bipolar affective disorder - see "Important advice for male patients".
The pharmaceutical form of Depakine Chronosphere, prolonged-release granules, 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 the doctor based on the patient's 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 medications, the dose should be increased every 2 or 3 days to achieve the optimal dose within a week.
• In patients taking other antiepileptic medications, treatment with Depakine Chronosphere should be introduced gradually, achieving the optimal dose within 2 weeks, and then the doses of other antiepileptic medications should be reduced until they are discontinued.
• If it is necessary to use other antiepileptic medications concomitantly, 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 Depakine Chronosphere can be increased; patients should be closely monitored if they receive a dose above 50 mg/kg body weight.
Children over 17 kg body weight
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 medication 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 adjusted 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.
Administration

• Depakine Chronosphere has no taste and should be administered by pouring 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 and drinks (soup, coffee, tea, etc.).
• If necessary, the contents of the sachet can also be administered directly into the mouth, followed by 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 Depakine Chronosphere 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 sides of the glass.
• The prepared medication should be taken immediately and not chewed.
• Do not leave the medication for later use.
• Duration of treatment
• The medication should be taken for as long as the doctor recommends.
• Do not discontinue treatment or change the dose of the medication without consulting a doctor.
• If the patient feels that the effect of Depakine Chronosphere is too strong or too weak, they should consult their doctor.
• Patients with renal impairment
• The doctor may decide to modify the dose in patients with renal impairment.

Overdose of Depakine Chronosphere

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 medication) and monitoring of cardiovascular and respiratory function.
In some cases, the use of naloxone has been shown to be effective.
In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missing a dose of Depakine Chronosphere

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

Discontinuing Depakine Chronosphere

Without consulting a doctor, the patient should not discontinue treatment with Depakine Chronosphere or change the dose of the medication.
Discontinuing treatment without consulting a doctor may worsen the patient's condition.

4. Possible side effects

Like all medications, Depakine Chronosphere can cause side effects, although not everybody gets them. Patients may need appropriate treatment if they experience 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 kept 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 silicon dioxide.

What Depakine Chronosphere looks like and what the pack contains

Depakine Chronosphere is a prolonged-release granule.
The pack 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 update 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