Convulex

Leaflet included in the packaging: information for the user

Convulex

50 mg/mL, syrup

Sodium valproate
This medicinal product is subject to additional monitoring. This will allow for quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions that occur after taking the medicinal product. To find out how to report adverse reactions, see section 4.

WARNING

Convulex (sodium valproate) 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 Convulex. The doctor will discuss this with the patient, and it is also necessary to follow the recommendations presented in section 2 of this leaflet.
It is necessary to contact the doctor immediately if the patient plans to become pregnant or suspects that she is pregnant.
Do not stop taking Convulex unless the doctor advises it, as the patient's condition may worsen.
It is necessary to carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• It is necessary to keep this leaflet so that it can be re-read if necessary.
• In case of any doubts, it is necessary to consult a doctor or pharmacist.
• This medicinal product has been prescribed to a specific person. Do not pass it on to others. The medicinal product may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Convulex and what is it used for
• 2. Important information before taking Convulex
• 3. How to take Convulex
• 4. Possible adverse reactions
• 5. How to store Convulex
• 6. Contents of the packaging and other information

1. What is Convulex and what is it used for

Convulex is a syrup that contains the active substance sodium valproate. The medicinal product belongs to the group of antiepileptic drugs and has an effect on the central nervous system.
It has an antiepileptic effect in various forms of epilepsy in humans.
Convulex is used in adults and children in monotherapy or in combination with other antiepileptic drugs:

• for the treatment of generalized epileptic seizures such as: clonic seizures, tonic seizures, tonic-clonic seizures, absence seizures, myoclonic seizures, and atonic seizures;
• for the treatment of partial seizures: partial seizures that are or are not secondarily generalized.

2. Important information before taking Convulex

When not to take Convulex

Do not take the medicinal product in the following cases:

• if the patient is hypersensitive to the active substance sodium valproate or to any of the other ingredients of this medicinal product (listed in section 6),
• if the patient has acute or chronic liver disease,
• if the patient has had severe liver disease, especially drug-induced or if the patient's family history indicates severe liver disease,
• if the patient has porphyria (a very rare metabolic disorder),
• if the patient is taking mefloquine concurrently,
• if the patient has a genetic disorder causing mitochondrial disorders (e.g., Alpers-Huttenlocher syndrome),
• if the patient has metabolic disorders, such as disorders of the urea cycle,
• if the patient has a carnitine deficiency (a very rare metabolic disorder) that is not being treated,
• 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 Convulex. Do not stop taking Convulex or contraception without discussing it with the doctor. The doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Warnings and precautions

Before starting to take Convulex, it is necessary to discuss it with the doctor.

IT IS NECESSARY TO IMMEDIATELY INFORM THE TREATING DOCTOR:

• In case of sudden occurrence of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or recurrence of seizures, especially during the first 6 months of treatment, it is necessary to immediately inform the treating doctor. Convulex may cause severe liver damage, which can sometimes be fatal. Before starting treatment and during the first 6 months of treatment, it is necessary to periodically perform laboratory tests of liver function. The risk of liver damage increases if Convulex is used in children under 3 years of age, people taking other antiepileptic drugs concurrently, or people with other neurological or metabolic disorders, and in people with severe epilepsy. Children under 3 years of age should not be given sodium valproate concurrently with salicylates due to the risk of toxic liver effects.
• In case of acute abdominal pain, it is necessary to immediately inform the treating doctor. Convulex may rarely cause severe pancreatitis, which can sometimes be fatal.
• If the patient or their child taking Convulex experiences balance and coordination problems, drowsiness, or decreased sensitivity, vomiting, it is necessary to immediately inform the treating doctor. This may be caused by an increased level of ammonia in the blood.
• A small number of people taking antiepileptic drugs containing sodium valproate have thought about harming or killing themselves. If such thoughts occur, it is necessary to immediately contact the treating doctor.
• In connection with valproate treatment, severe skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), polymorphic eruption, and angioedema. If the patient notices any symptoms associated with these severe skin reactions, as described in section 4, they should immediately consult a doctor.

The patient should immediately consult a doctor if they notice any of these symptoms.

Before starting to take this medicinal product, it is necessary to discuss it with the 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 and risks of using the medicinal product should be considered before the first prescription or when the woman treated with 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, it is recommended to perform laboratory tests (blood morphology test with smear, including platelet count, bleeding time, and coagulation tests).
• Caution should be exercised when using the medicinal product in patients with impaired renal function. The doctor may recommend a lower dose of the medicinal product.
• The medicinal product should be used with caution in patients with systemic lupus erythematosus.
• If the patient is suspected to have any metabolic disorder, especially congenital enzyme deficiencies, such as "urea cycle disorder", due to the risk of increased ammonia levels in the blood.
• Patients treated with sodium valproate may experience weight gain. If the patient has a rare metabolic disorder called "carnitine palmitoyltransferase II deficiency" due to increased risk of muscle disorders.
• It is not recommended to use carbapenem antibiotics concurrently with valproic acid (see section "Convulex and other medicinal products"). Sodium valproate is excreted mainly by the kidneys, partly in the form of ketone bodies, so in diabetic patients, the test for the presence of ketone bodies may give a false positive result.
• If there is a family history of genetic disorders caused by mitochondrial disorders, due to the risk of liver damage.
• As with other antiepileptic drugs, the use of this medicinal product may worsen the condition or increase the frequency of seizures. In case of worsening of seizures, it is necessary to immediately consult a doctor.
• If the patient has insufficient carnitine intake, found in meat and dairy products, especially in children under 10 years of age.
• If the patient has a carnitine deficiency and is taking carnitine.
• If the patient has ever experienced a severe skin rash or exfoliative dermatitis after taking valproate.

Information for patients with diabetes

Convulex 50 mg/mL syrup contains artificial sweeteners and can be used in patients with diabetes. However, it is necessary to consider the carbohydrate content - 0.05 BU (bread units) per 1 mL of syrup.

Convulex and other medicinal products

It is necessary to tell the doctor about all medicinal products currently being taken or recently taken, as well as about medicinal products that are planned to be taken.
Some medicinal products may affect the action of sodium valproate, and sodium valproate may affect the action of other medicinal products.
These include:

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

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

Convulex with food, drink, and alcohol

Convulex syrup is intended for oral use and should be administered during or after a meal. To ensure proper dosing, a dosing device with a scale and plunger is included with the packaging.
It is not recommended to drink alcohol during treatment with valproate.

Pregnancy, breastfeeding, and fertility

Pregnancy

Important note for women

• Do not take Convulex if the patient is pregnant, unless no other therapy is effective.
• If the patient is of childbearing age, do not take Convulex unless the patient uses effective contraception (birth control) throughout the entire treatment period with Convulex. Do not stop taking Convulex or contraception without discussing it with the doctor. The doctor will provide further guidance.

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

• It is necessary to immediately consult the treating doctor if the patient plans to become pregnant or is pregnant.
• Taking valproate during pregnancy carries a risk. The higher the dose, the higher the risk, but no dose is risk-free, even when valproate is used in combination with other antiepileptic drugs.
• Valproate may cause severe birth defects and affect the development of the growing child. The most common birth defects reported include: spina bifida (when the spine does not develop properly); developmental abnormalities of the face and skull; developmental abnormalities of the heart, kidneys, urinary tract, and genital organs, as well as multiple related developmental abnormalities affecting several organs and body parts. Birth defects can cause disability, which can be significant.
• Children exposed to valproate in utero have reported hearing problems or deafness.
• Children exposed to valproate in utero have reported eye development abnormalities, often in combination with other birth defects. Eye development abnormalities can affect vision.
• It is estimated that approximately 10 out of 100 children born to mothers taking valproate will have birth defects. For comparison, birth defects occur in 2-3 out of 100 children born to women without epilepsy.
• Approximately 30-40% of children in preschool age whose mothers took valproate during pregnancy may exhibit early developmental problems. Children with this condition may start walking and talking later, may be less intellectually capable than other children, may have language problems, and may have memory problems.
• Children exposed to valproate are more likely to be diagnosed with autism spectrum disorders. Some evidence suggests that these children may be more likely to develop symptoms of attention deficit hyperactivity disorder (ADHD).
• Before prescribing this medicinal product, the doctor will explain the risks to the patient, including the risk of birth defects, and will discuss the benefits and risks of using the medicinal product during pregnancy.
• If the patient taking this medicinal product decides to have a child, they should not stop taking the medicinal product or contraception without discussing it with the doctor.
• Parents or guardians of girls treated with valproate should contact the treating doctor when their child starts menstruating.
• Some contraceptive agents (estrogen-containing oral contraceptives) may reduce valproate levels in the blood. It is necessary to discuss the method of contraception (birth control) with the doctor.
• It is necessary to ask the 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.

Please choose the situation that applies to the patient and read the information:

• STARTING TREATMENT WITH CONVULEX
• CONTINUING TREATMENT WITH CONVULEX WITHOUT TRYING TO CONCEIVE
• CONTINUING TREATMENT WITH CONVULEX WHILE TRYING TO CONCEIVE
• BEING PREGNANT WHILE CONTINUING TREATMENT WITH CONVULEX

STARTING TREATMENT WITH CONVULEX

If Convulex 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 entire treatment period with Convulex. It is necessary to consult a doctor or family planning clinic if the patient needs advice on contraception.

Important information:

• Before starting treatment with Convulex, it is necessary to rule out pregnancy using a pregnancy test, the results of which will be confirmed by the doctor.
• The patient should use effective contraception (birth control) throughout the entire treatment period with Convulex.
• It is necessary to discuss contraception (birth control) with the doctor. The doctor will provide information on how to prevent pregnancy and may refer the patient to a specialist for advice on contraception.
• It is necessary to regularly visit a specialist in epilepsy treatment (at least once a year). During this visit, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• It is necessary to inform the doctor if the patient plans to become pregnant.
• It is necessary to immediately inform the doctor if the patient is pregnant or suspects that they may be pregnant.

CONTINUING TREATMENT WITH CONVULEX WITHOUT TRYING TO CONCEIVE

If the patient continues treatment with Convulex and does not plan to become pregnant, they must ensure that they use effective contraception throughout the entire treatment period with Convulex. It is necessary to consult a doctor or family planning clinic if the patient needs advice on contraception.

Important information:

• The patient should use effective contraception (birth control) throughout the entire treatment period with Convulex.
• It is necessary to discuss contraception (birth control) with the doctor. The doctor will provide information on how to prevent pregnancy and may refer the patient to a specialist for advice on contraception.
• It is necessary to regularly visit a specialist in epilepsy treatment (at least once a year). During this visit, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• It is necessary to inform the doctor if the patient plans to become pregnant.
• It is necessary to immediately inform the doctor if the patient is pregnant or suspects that they may be pregnant.

CONTINUING TREATMENT WITH CONVULEX WHILE TRYING TO CONCEIVE

If the patient plans to become pregnant, they should first schedule a visit with the doctor. The patient should not stop taking Convulex or contraception without discussing it with the doctor. The doctor will provide further guidance.
Children born to mothers who took valproate are at serious risk of birth defects and developmental problems, which can significantly affect the child. The doctor will refer the patient to a specialist in epilepsy treatment to assess alternative treatment options. The specialist may decide to change the dose of Convulex, switch to another medicinal product, or stop treatment with Convulex long before becoming pregnant - to ensure that the disease is stable.
It is necessary to ask the 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 stop taking Convulex unless the doctor decides to do so.
• Do not stop using contraception before discussing it with the doctor and developing a plan to ensure control of the patient's condition and minimize risks to the child.
• First, it is necessary to schedule a visit with the doctor. During this visit, the doctor will ensure that the patient has been properly informed and understands all the risks and advice related to taking valproate during pregnancy.
• The doctor will try to switch to another medicinal product or stop treatment with Convulex long before becoming pregnant.
• It is necessary to schedule an urgent visit with the doctor if the patient is pregnant or suspects that they may be pregnant.

BEING PREGNANT WHILE CONTINUING TREATMENT WITH CONVULEX

Do not stop taking Convulex unless the doctor decides to do so, as the patient's condition may worsen. It is necessary to schedule an urgent visit with the doctor if the patient is pregnant or suspects that they may be pregnant. The doctor will provide further guidance.
Children born to mothers who took valproate are at serious risk of birth defects and developmental problems, which can significantly affect the child.
The patient will be referred to a specialist in epilepsy treatment to assess alternative treatment options.
In exceptional cases, when Convulex 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 exposed to valproate.
It is necessary to ask the 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:

• It is necessary to schedule an urgent visit with the doctor if the patient is pregnant or suspects that they may be pregnant.
• Do not stop taking Convulex unless the doctor decides to do so.
• The patient should ensure that they have been referred to a specialist in epilepsy treatment to assess the need for alternative treatment options.
• The patient must receive counseling on the risks of taking Convulex during pregnancy, including its teratogenic effects and impact on child development.
• The patient should ensure that they have been referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

Newborns of mothers who took Convulex during pregnancy may experience coagulation disorders, hypoglycemia, hypothyroidism, as well as withdrawal symptoms, such as: irritability, restlessness, hyperactivity, muscle tremors, seizures, and feeding problems.

It is necessary to read the patient guide provided by the doctor. The doctor will discuss the annual confirmation form regarding the risks and ask the patient to sign and keep it. The patient will also receive a Patient Card from the pharmacist

to remind them of the risks associated with taking valproate during pregnancy.

Important note for male patients

Possible risk associated with taking valproate in the 3 months before conception
A study suggests a possible risk of motor disorders and developmental delays (problems with early childhood development) in children whose fathers were treated with valproate in the 3 months before conception. In this study, such disorders occurred in approximately 5 out of 100 children whose fathers were treated with valproate, compared to approximately 3 out of 100 children of men treated with lamotrigine or levetiracetam (other medicinal products that may be used to treat the patient's disease). The risk to children whose fathers stopped taking valproate at least 3 months (the time needed to produce new sperm) before conception is unknown.
The study has limitations, and therefore, it is not clear whether the increased risk of developmental delays suggested by this study 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 precautionary measure, the doctor will discuss with the patient:

• the possible risk to children whose fathers were treated with valproate;
• the need to use 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 and for 3 months after stopping it. If planning to conceive, it is necessary to discuss it with the 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 the doctor. Do not stop taking the medicinal product without consulting the doctor. If the patient stops taking the medicinal product, their symptoms may worsen.
The patient should regularly visit the doctor who prescribed the medicinal product. During such a visit, the doctor will discuss the precautions associated with taking valproate and the possibility of using other treatment methods for the disease, depending on the individual situation.
It is necessary to 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 risk associated with taking valproate.

Breastfeeding

Valproate is excreted in small amounts into breast milk. It is necessary to consult a doctor about whether it is possible to breastfeed during treatment.

Driving and using machines

In some patients, during treatment, drowsiness may occur, especially when using several antiepileptic drugs or when using benzodiazepines concurrently. Before driving or using machines, the patient should make sure how they react to the treatment.

Important information about some ingredients of Convulex

The medicinal product contains methylparahydroxybenzoate and propylparahydroxybenzoate. The medicinal product may cause allergic reactions (possible late-type reactions).

3. How to take Convulex

Convulex should always be taken according to the doctor's instructions. In case of doubts, it is necessary to consult a doctor.
Girls and women of childbearing age
Treatment with Convulex should be started and supervised by a doctor specializing in epilepsy treatment.
Male patients
It is recommended that treatment with Convulex be started and supervised by a specialist in epilepsy treatment - see section 2 "Important note for male patients".
Dosage and treatment duration will be determined by the doctor.
Other doses and pharmaceutical forms of Convulex are available, which may be important when determining the dose.
Convulex syrup is intended for oral use and should be administered during or after a meal. To ensure proper dosing, a dosing device with a scale and plunger is included with the packaging.
The syrup contains maltitol liquid, a sugar substitute, and does not cause or increase tooth decay.

• Usually, the daily dose should be divided into several doses. During monotherapy with sodium valproate, the total daily dose may also be given in a single dose in the evening (up to a dose of 15 mg/kg body weight per day).

Dosage

Monotherapy

Children: The initial dose is 10-20 mg/kg body weight of valproic acid per day and is gradually increased by 5-10 mg/kg body weight at 3-7 day intervals until seizure control is achieved. This usually occurs when the dose is in the range of 20-30 mg/kg body weight per day (see also the dosage table). If seizure control is not achieved with the above dosing, the dose may be increased to 35 mg/kg body weight per day. In individual cases, doses higher than 40 mg/kg body weight per day may be considered.

For children who require doses higher than 40 mg/kg body weight per day, regular laboratory tests should be performed.

Children over 20 kg:The recommended initial dose is usually 300 mg per day.

Recommended daily doses for sodium valproate are as follows(guideline table)

• 1. Press the plunger all the way down, insert the dosing device into the bottle.
• 2. Pull the plunger up to the level where the measured dose corresponds to the dose prescribed by the doctor (in mL or mg). Repeat the action if necessary until the full required dose of syrup is drawn into the dosing device.
• 3. Empty the contents of the dosing device directly into the child's mouth or onto a spoon. Make sure that the entire prescribed dose of the medicinal product has been administered.
• 4. After each use, close the bottle and carefully rinse the dosing device with water.

The bottle and dosing device should be stored in the box.

Taking a higher dose of Convulex than recommended

Clinical symptoms of severe overdose include: drowsiness, decreased muscle tone, decreased reflexes, pupil constriction, and respiratory disorders. Metabolic acidosis, hypotension, and acute circulatory failure may also occur. Other symptoms may also occur; seizures have been reported in cases of very high valproate levels in the blood.
Hospital treatment for overdose is symptomatic; it should involve monitoring of cardiovascular and respiratory function.
In severe cases, hemodialysis or even exchange transfusion may be necessary. In individual cases, naloxone has been effective.
In case of taking a higher dose of the medicinal product than recommended, it is necessary to immediately consult a doctor or pharmacist.

Missing a dose of Convulex

In case of missing a dose, do not take a double dose to make up for the missed dose, but continue treatment according to the doctor's instructions.

4. Possible adverse reactions

Like all medicines, Convulex can cause adverse reactions, although they do not occur in every patient. They are rarely serious; usually, they are transient. However, patients may require appropriate treatment in case of certain adverse reactions.
If the patient experiences any of the following severe adverse reactions, they should
immediately contact a doctor, as the patient may urgently need medical attention:

• Seizures, encephalopathy (brain damage), lethargy (a state of lethargy and lack of reaction to stimuli), behavioral changes, related or unrelated, with an increased frequency of epileptic seizures or their severe course, especially when co-administered with phenobarbital or during a sudden increase in the dose of Convulex

Combination, weakness, dizziness, nausea, vomiting, which may be caused by decreased sodium levels in the blood or a condition called "SIADH" (Syndrome of Inappropriate Secretion of ADH) or a syndrome of inappropriate antidiuretic hormone secretion

• Balance and coordination problems, drowsiness or a feeling of reduced sensitivity, accompanied by vomiting. This may be caused by an increased amount of ammonia in the blood (hyperammonemia)
• Increased frequency and severity of seizures
• Extreme fatigue, weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, severe abdominal pain, nausea, jaundice (yellowing of the skin and whites of the eyes), swelling of the legs, or an increased frequency of seizures, or general malaise - these symptoms may indicate liver or pancreatic damage
• Allergic reactions, which may manifest as: blisters with skin peeling (formation of blisters, peeling, or bleeding from various parts of the body, including the lips, eyes, mouth, nose, genitals, hands, or feet) with or without rash, sometimes with flu-like symptoms, such as fever, chills, or muscle pain - these may be symptoms of conditions known as "toxic epidermal necrolysis" or "Stevens-Johnson syndrome" or a rash or skin changes with a red/purple border and a pale center, which may be itchy, peeling, or fluid-filled. The rash may appear especially on the hands or soles of the feet. These may be symptoms of a disease called "erythema multiforme" or angioedema (swelling caused by an allergic reaction with painful, itchy swelling, most often around the eyes, lips, throat, and sometimes hands and feet) - these may be symptoms of "angioedema"
• Blood clotting disorders confirmed by tests, which may cause spontaneous bruising and bleeding
• A significant decrease in the number of white blood cells or bone marrow failure (myelodysplastic syndrome) shown in blood tests, sometimes accompanied by fever and breathing difficulties
• Hypothyroidism, which may cause fatigue or weight gain
• Joint pain, fever, fatigue, rash. These may be symptoms of systemic lupus erythematosus
• Tremors, gait disturbances, muscle stiffness, coordination disorders (parkinsonism, extrapyramidal disorders, ataxia)
• Muscle pain and weakness (rhabdomyolysis - breakdown of striated muscle)
• Breathing difficulties, chest pain or a feeling of pressure in the chest (especially when inhaling), shortness of breath, and dry cough due to fluid accumulation around the lungs (pleural effusion)
• Kidney disease (kidney failure, interstitial nephritis), which may manifest as decreased urine output

If any of the following adverse reactions worsen or persist for more than a few days, you should inform your doctor or pharmacist; treatment may be necessary.
Adverse reactions are presented according to the following frequency classification:

• Very common(may occur more frequently than 1 in 10 patients):
• dizziness
• nausea Common(may occur less frequently than 1 in 10 patients):
• anemia (decreased red blood cell count), thrombocytopenia (decreased platelet count, which increases the risk of bleeding and bruising)
• stupor, drowsiness, seizures, memory disorders, headache, oculogyric crisis (rapid, uncontrolled eye movements), dizziness
• hearing impairment
• vomiting, stomach pain, diarrhea (frequent in some patients at the beginning of treatment) usually transient and disappearing after a few days without the need to discontinue treatment
• abnormalities related to the liver (mainly liver enlargement), oral inflammation
• transient and (or) dose-dependent hair loss, nail disorders, and nail bed disorders
• weight gain, which should be monitored, as it is associated with polycystic ovary syndrome
• irregular menstrual cycles
• confusional state (disorientation), hallucinations, aggression, excitement, attention disorders
• urinary incontinence Uncommon(may occur less frequently than 1 in 100 patients):
• leukopenia (significant decrease in white blood cell count), pancytopenia (significant decrease in blood cell count, which may cause weakness, easy bruising, or increased risk of infection)
• tingling and numbness of hands or feet
• hair disorders (such as abnormal hair structure, changes in hair color, abnormal hair growth)
• decreased bone mineral density, osteopenia, osteoporosis, and fractures in patients taking Convulex for a long time
• hyperandrogenism (excessive male-type hair growth, virilism, hirsutism, male-type baldness, and (or) elevated androgen levels)
• vasculitis
• decreased body temperature, moderate peripheral edema
• amenorrhea Rare(may occur less frequently than 1 in 1000 patients):
• macrocytic anemia (low red blood cell count), macrocytosis (abnormal increase in red blood cell size)
• biotin deficiency/biotinidase deficiency
• excessive urine output and thirst (Fanconi syndrome)
• nocturnal enuresis (bedwetting)
• obesity
• male infertility is usually transient after discontinuation of treatment and may be transient after dose reduction. Do not stop treatment without prior consultation with a doctor
• polycystic ovary syndrome
• abnormal behavior, psychomotor hyperactivity, learning disorders (observed in children and adolescents)
• transient dementia, associated with transient brain atrophy, cognitive disorders, double vision Frequency not known(frequency cannot be estimated from available data):
• congenital disorders and hereditary or genetic diseases
• decreased carnitine levels (visible in blood and muscle tests)
• darker skin and mucous membrane areas (hyperpigmentation)

Additional adverse reactions in children

Certain adverse reactions to valproate occur more frequently or have a more severe course in children than in adults. These include liver damage, pancreatitis, aggression, excitement, attention disorders, abnormal behavior, hyperactivity, and learning disorders.

Reporting adverse reactions

If any adverse reactions occur, including those not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181 C 02-222 Warsaw tel.: +48 22 49 21 301 fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Adverse reactions can also be reported to the marketing authorization holder. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Convulex

The medicine should be stored out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of the month stated. Store at a temperature below 25°C. Protect from light. Shelf life after first opening: 6 months. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Convulex contains

The active substance of the medicine is 50 mg of sodium valproate in 1 mL of syrup. Sodium valproate is obtained from valproic acid and sodium hydroxide. The other ingredients are maltitol liquid (800 mg/mL, sugar substitute), methyl parahydroxybenzoate (1.0 mg/mL), propyl parahydroxybenzoate (0.4 mg/mL), sodium saccharin (1.0 mg/mL), sodium cyclamate (3.0 mg/mL), sodium chloride, raspberry flavor, peach flavor, purified water.

What Convulex looks like and what the pack contains

Syrup. Colorless to light yellow solution in a 100 mL brown glass bottle in a cardboard box.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH Schloßplatz 1 A-8502 Lannach Austria For more detailed information about this medicine, please contact the representative of the marketing authorization holder: G.L. PHARMA POLAND Sp. z o.o. ul. Sienna 75; 00-833 Warsaw, Poland Tel: 022/ 636 52 23; 636 53 02 biuro@gl-pharma.pl

Date of last revision of the leaflet:

Other sources of information

Detailed and up-to-date information about this medicine is available by scanning the QR code on the leaflet using a smartphone. The same information is also available on the website: www.walproiniany.pl