Convulex 300

Leaflet included in the packaging: patient information

Convulex 150, 150 mg, soft capsules

Convulex 300, 300 mg, soft capsules

Convulex, 500 mg, soft capsules

Valproic acid
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. The user of the medicinal product can also help by reporting any adverse reactions they experience while taking the medicinal product. To find out how to report adverse reactions, see point 4.

WARNING

Convulex (valproate) used during pregnancy can harm the unborn child. Women of childbearing age should use effective contraception (birth control) without interruption during the entire treatment period with Convulex. The treating doctor will discuss this with the patient, but the patient should also follow the recommendations presented in point 2 of this leaflet.
Patients should contact their treating doctor immediately if they plan to become pregnant or suspect they may be pregnant.
Convulex should not be discontinued unless advised by a doctor, as the patient's condition may worsen.
Patients should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.

• Patients should keep this leaflet to be able to read it again if necessary.
• In case of any doubts, patients should consult their doctor or pharmacist.
• This medicinal product has been prescribed to a specific individual. It should not be given to others. The medicinal product may harm another person, even if their symptoms 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 point 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 contains the active substance valproic acid, which belongs to the group of antiepileptic drugs and acts on the central nervous system.
The medicinal product has anticonvulsant effects in various forms of epilepsy in humans.
Convulex is used to treat epilepsy and mania.
Convulex is used to treat:

• epilepsy, in generalized seizures:
• myoclonic seizures,
• tonic-clonic seizures,
• atonic seizures,
• seizures of unknown origin, in partial seizures:
• simple or complex partial seizures,
• secondarily generalized seizures,
• Lennox-Gastaut syndrome.
• mania, which is a state in which the patient feels very excited, elated, agitated, enthusiastic, or overactive. Mania occurs in a disease known as bipolar affective disorder. Convulex may be used when lithium cannot be used.

2. Important information before taking Convulex

When not to take Convulex

Convulex should not be taken in the following cases:

• if the patient is hypersensitive to the active substance valproic acid or to any of the other ingredients of this medicinal product (listed in point 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.
• 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 Convulex. Convulex and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").
• epilepsy:
• if the patient is pregnant, unless no other therapy is effective,
• if the patient is of childbearing age, unless the patient uses effective contraception (birth control) throughout the treatment period with Convulex. Convulex and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance (see below "Pregnancy, breastfeeding, and fertility - Important note for women").

Warnings and precautions

• Before starting treatment and periodically during the first 6 months of treatment, laboratory tests of liver function should be performed.
• In case of sudden onset of the following symptoms: weakness, loss of appetite, drowsiness, recurrent vomiting, and abdominal pain, jaundice (yellowing of the skin and whites of the eyes), or worsening of seizures, especially during the first 6 months of treatment, the patient should immediately inform their treating doctor.
• Rarely, Convulex may cause severe liver damage, which can be life-threatening.
• In case of severe abdominal pain, the patient should immediately inform their treating doctor. Very rarely, Convulex may cause severe pancreatitis, which can be life-threatening.
• Valproic acid 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 weighed before the first prescription or when the woman being treated with valproic acid plans to become pregnant.

The patient should carefully read the contents of the leaflet before taking the medicinal product, as it contains important information for the patient.
Valproic acid is mainly excreted by the kidneys, partly in the form of ketone bodies, so in patients with diabetes, testing for ketone bodies may give a false positive result.

• A small number of people taking antiepileptic drugs containing valproic acid have thought about harming or killing themselves. If such thoughts occur, the patient should immediately contact their treating doctor.
• Before starting treatment, as well as before surgery and in case of bruising or spontaneous bleeding, laboratory tests (blood morphology with smear, including platelet count, bleeding time, and coagulation tests) are recommended.
• Convulex should be used with caution in patients with impaired renal function. The doctor may recommend a lower dose of the medicinal product.
• Convulex should be used with caution in patients with systemic lupus erythematosus.
• Convulex should be used with caution in patients with metabolic disorders, especially those with inherited enzyme deficiencies, such as disorders of the urea cycle, due to the possibility of increased blood ammonia levels.
• Weight gain may occur in patients treated with valproic acid.
• In patients with a deficiency of the enzyme palmitoyltransferase carnitine II, muscle breakdown may occur during treatment with valproic acid.
• Concomitant use of carbapenem antibiotics with valproic acid is not recommended (see point "Convulex and other medicinal products").
• Valproic acid is excreted mainly by the kidneys, partly in the form of ketone bodies, so in patients with diabetes, testing for ketone bodies may give a false positive result.
• Before starting treatment with Convulex, the patient should discuss with their doctor or pharmacist if there is a family history of mitochondrial disorders.
• As with other antiepileptic drugs, the frequency or severity of seizures may increase during treatment with this medicinal product. If the seizures worsen, the patient should immediately consult their doctor.

Children and adolescents

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

Convulex and other medicinal products

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

• neuroleptics, including quetiapine, olanzapine (used to treat psychotic disorders);
• medicinal products used to treat depression, MAO inhibitors;
• benzodiazepines, used to treat insomnia and anxiety disorders;
• other antiepileptic drugs, including phenobarbital, phenytoin, primidone, lamotrigine, carbamazepine, felbamate, topiramate, rufinamide;
• 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;
• carbapenem, imipenem, panipenem, and meropenem (carbapenem antibiotics). Concomitant use of valproic acid and carbapenems is not recommended, as it may decrease the effect of valproic acid;
• cholestyramine (used to lower blood cholesterol levels);
• 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 decrease the effectiveness of valproic acid.

These medicinal products may affect the action of valproic acid and vice versa. The patient may need to adjust the dose of the 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 or avoided during treatment with Convulex.

Convulex with food, drink, and alcohol

Convulex can be taken with or after a meal.
It is not recommended to drink alcohol during treatment with this medicinal product.

Pregnancy and breastfeeding

Pregnancy

Important note for women

Bipolar affective disorder

• In the case of bipolar affective disorder, Convulex should not be taken if the patient is pregnant.
• In the case of bipolar affective disorder, if the patient is of childbearing age, Convulex should not be taken unless the patient uses effective contraception (birth control) throughout the treatment period with Convulex. Convulex and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance.

Epilepsy

• In the case of epilepsy, Convulex should not be taken if the patient is pregnant, unless no other therapy is effective.
• In the case of epilepsy, if the patient is of childbearing age, Convulex should not be taken unless the patient uses effective contraception (birth control) throughout the treatment period with Convulex. Convulex and contraception should not be discontinued unless discussed with the doctor. The treating doctor will provide further guidance.

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

• The patient should immediately consult their treating doctor if they plan to become pregnant or suspect they may be pregnant.
• Taking valproic acid during pregnancy carries a risk. The higher the dose, the greater the risk, but no dose is risk-free.
• Valproic acid may cause serious birth defects and affect the development of the growing child. The most common birth defects reported include spinal 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; and multiple related developmental abnormalities affecting several organs and body parts. Birth defects can cause disability, which can be significant.
• Children exposed to valproic acid in utero have been reported to have hearing problems or deafness.
• Children exposed to valproic acid in utero have been reported to have eye abnormalities, often in combination with other birth defects. Eye abnormalities can affect vision.
• It is estimated that about 10 out of 100 children born to mothers taking valproic acid will have birth defects requiring treatment. For comparison, birth defects occur in about 2-3 out of 100 children born to women without epilepsy.
• It is estimated that up to 30-40% of preschool-age children whose mothers took valproic acid during pregnancy may have developmental problems. These children may start walking and talking later, be less intellectually able than other children, have language problems, and have memory problems.
• Autistic spectrum disorders are more commonly diagnosed in children exposed to valproic acid in utero. Some evidence suggests an increased risk of attention deficit/hyperactivity disorder (ADHD) in these children.
• Before prescribing this medicinal product, the treating doctor will explain the risks to the patient, including the risk of birth defects and developmental problems, if the patient becomes pregnant while taking valproic acid. 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 their treating doctor.
• Parents or guardians of girls treated with valproic acid should contact the treating doctor when their child starts menstruating.
• Some contraceptive agents (estrogen-containing oral contraceptives) may decrease valproic acid levels in the blood. The patient should discuss their contraception method with their doctor.
• The patient should ask their doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that folic acid will reduce the risk of birth defects associated with valproic acid treatment.

Please select the situation that applies to you and read the information:

• STARTING TREATMENT WITH CONVULEX
• CONTINUING TREATMENT WITH CONVULEX WITHOUT PLANNING TO BECOME PREGNANT
• CONTINUING TREATMENT WITH CONVULEX WHILE PLANNING TO BECOME PREGNANT
• UNPLANNED PREGNANCY DURING CONTINUING TREATMENT WITH CONVULEX

STARTING TREATMENT WITH CONVULEX

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

Important information:

• Pregnancy should be excluded before starting treatment with Convulex using a pregnancy test, the results of which should be confirmed by the treating doctor.
• The patient should use effective contraception throughout the treatment period with Convulex.
• The patient should discuss their contraception method with their treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist treating their bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure the patient is well-informed and understands all the risks and advice related to taking valproic acid during pregnancy.
• The patient should inform their doctor if they plan to become pregnant.
• The patient should immediately inform their doctor if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH CONVULEX WITHOUT PLANNING TO BECOME PREGNANT

If the patient continues treatment with Convulex and does not plan to become pregnant, they must ensure they use effective contraception throughout the treatment period with Convulex. The patient should consult their doctor or family planning clinic if they need advice on contraception.

Important information:

• The patient should use effective contraception throughout the treatment period with Convulex.
• The patient should discuss their contraception method with their treating doctor. The treating doctor will provide information on pregnancy prevention and may refer the patient to a specialist for advice on contraception.
• The patient should have regular check-ups (at least once a year) with a specialist treating their bipolar affective disorder or epilepsy. During this visit, the treating doctor will ensure the patient is well-informed and understands all the risks and advice related to taking valproic acid during pregnancy.
• The patient should inform their doctor if they plan to become pregnant.
• The patient should immediately inform their doctor if they are pregnant or suspect they may be pregnant.

CONTINUING TREATMENT WITH CONVULEX WHILE PLANNING TO BECOME PREGNANT

AND PLANNING TO BECOME PREGNANT

If the patient plans to become pregnant, they should first consult their treating doctor. The patient should not stop taking Convulex or contraception without discussing it with their treating doctor. The treating doctor will provide further guidance.
Children born to mothers who took valproic acid during pregnancy are at serious risk of birth defects and developmental problems, which can significantly affect the child. The treating doctor will refer the patient to a specialist treating bipolar affective disorder or epilepsy to assess alternative treatment options. The specialist may decide to change the dose of Convulex, switch to another medicinal product, or discontinue treatment with Convulex well before the patient becomes pregnant - to ensure the disease is stable.
The specialist may also decide to monitor the patient closely during pregnancy to minimize the risk to the mother and unborn child.
The patient should ask their doctor about taking folic acid when trying to conceive. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that folic acid will reduce the risk of birth defects associated with valproic acid treatment.

Important information:

• The patient should not stop taking Convulex unless advised by their doctor.
• The patient should not stop using contraception before discussing it with their treating doctor and developing a plan to ensure control of their condition and minimize the risks to the unborn child.
• The patient should have a check-up with their treating doctor as soon as possible. During this visit, the treating doctor will ensure the patient is well-informed and understands all the risks and advice related to taking valproic acid during pregnancy.
• The treating doctor may decide to switch to another medicinal product or discontinue treatment with Convulex before the patient becomes pregnant.
• The patient should immediately inform their doctor if they are pregnant or suspect they may be pregnant.

UNPLANNED PREGNANCY DURING CONTINUING TREATMENT WITH CONVULEX

The patient should not stop taking Convulex unless advised by their treating doctor, as their condition may worsen. The patient should have an urgent check-up with their treating doctor if they are pregnant or suspect they may be pregnant. The treating doctor will provide further guidance.
Children born to mothers who took valproic acid during pregnancy are at serious risk of birth defects and developmental problems, which can significantly affect the child.
The patient will be referred to a specialist treating bipolar affective disorder or epilepsy 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 pregnancy exposed to valproic acid.
The patient should ask their doctor about taking folic acid. Folic acid may reduce the overall risk of spinal bifida and early miscarriage, which applies to all pregnancies. However, it is unlikely that folic acid will reduce the risk of birth defects associated with valproic acid treatment.

Important information:

• The patient should have an urgent check-up with their treating doctor if they are pregnant or suspect they may be pregnant.
• The patient should not stop taking Convulex unless advised by their doctor.
• The patient will be referred to a specialist treating epilepsy or bipolar affective disorder to assess the need for alternative treatment options.
• The patient will receive counseling on the risks of taking Convulex during pregnancy, including its teratogenic effects and impact on child development.
• The patient will be referred to a specialist for prenatal monitoring to detect possible developmental abnormalities.

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

Patients should read the patient guide provided by their treating doctor. The treating 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 valproic acid during pregnancy.

Important note for male patients

Possible risk associated with taking valproic acid in the 3 months before conception
A study suggests a possible risk of developmental and motor disorders (problems with early childhood development) in children whose fathers were treated with valproic acid in the 3 months before conception. In this study, such disorders occurred in about 5 out of 100 children whose fathers were treated with valproic acid, compared to about 3 out of 100 children of men treated with lamotrigine or levetiracetam (other medicinal products that may be used to treat the patient's condition). The risk to children whose fathers stopped taking valproic acid 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 and motor disorders is caused by valproic acid. The study was not large enough to show what specific types of developmental and motor disorders are involved.
As a precaution, the doctor will discuss with the patient:

• the possible risk to children whose fathers were treated with valproic acid;
• the need to use effective contraception during treatment and for 3 months after stopping treatment;
• the need to consult a doctor when planning to conceive and before stopping contraception;
• the possibility of using alternative treatments for the patient's condition, depending on the individual situation.

The patient should not donate sperm while taking valproic acid and for 3 months after stopping 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 valproic acid in the 3 months before conception and the patient has questions about this, they should contact their doctor. The patient should not stop taking Convulex without consulting their doctor, as their condition may worsen. The patient should have regular check-ups with the doctor prescribing the medicinal product. During this visit, the doctor will discuss the precautions related to taking valproic acid and the possibility of using alternative treatments for the patient's condition, depending on the individual situation.
The patient should read the patient guide provided by their treating doctor. The patient will also receive a patient card from the pharmacist to remind them of the possible risk associated with taking valproic acid.

Breastfeeding

Valproic acid is excreted in small amounts into breast milk. The patient should consult their doctor about whether they can breastfeed while taking Convulex.

Driving and using machines

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

Convulex contains sorbitol

Convulex 150 contains a maximum of 5.3 mg of sorbitol per capsule.
Convulex 300 contains a maximum of 8.7 mg of sorbitol per capsule.
Convulex 500 mg contains a maximum of 14.3 mg of sorbitol per capsule.

3. How to take Convulex

Girls and women of childbearing age

Treatment with Convulex should be started and supervised by a doctor specializing in the treatment of epilepsy or bipolar affective disorder.

Male patients

It is recommended that treatment with Convulex be started and supervised by a specialist in the treatment of epilepsy or bipolar affective disorder - see point 2 "Important note for male patients".
This medicinal product should always be taken exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The dose and duration of treatment will be determined by the doctor.
Other doses and pharmaceutical forms of Convulex are available, which may be relevant when determining the dose.
This pharmaceutical form is not suitable for children under 6 years of age (risk of choking).
If Convulex 150 or Convulex 300 is indicated, or Convulex capsules, it may be used in children over 17 kg, provided they can swallow the capsules.
The capsules should be swallowed whole with a sufficient amount of liquid, with or after a meal.

Epilepsy

Treatment usually starts with a low dose, which is gradually increased by the doctor until the optimal dose is reached.
Usually, the daily dose is divided into several doses. However, if valproic acid is used as monotherapy, the doctor may recommend taking a single dose once daily in the evening.
Monotherapy
Adults:The initial dose is 5-10 mg/kg body weight per day. The dose is then increased by 5 mg valproic acid per kg body weight at 3-7 day intervals until seizures are controlled. This usually occurs at a dose of 20-30 mg/kg body weight per day. If this dose does not produce the desired effect, it may be increased to 2500 mg valproic acid per day.
Children and adolescents:

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.

Use of a higher than recommended dose of Convulex

Symptoms of acute overdose include nausea, vomiting, dizziness, and sometimes severe adverse reactions from the central nervous system and respiratory problems. In severe cases, immediate medical attention is required.
Information for doctors:
In case of overdose, hospital treatment should involve inducing vomiting, gastric lavage, and supportive measures to maintain vital functions.
In severe cases, hemodialysis or even exchange transfusion may be necessary. In individual cases, naloxone has been effective.

Missing a dose of Convulex

If a dose is missed, the patient should not take a double dose to make up for the missed dose but should continue treatment as prescribed by the doctor.

4. Possible Undesirable Effects

Like any drug, Convulex can cause undesirable effects ,although they do not occur in everyone.
Rarely are they serious; usually transient. However, patients may require appropriate treatment in the event of the occurrence of certain undesirable effects.
Very common (may occur in more than 1 in 10 people):

• dizziness
• nausea

Common (may occur in less than 1 in 10 people):

• anemia, thrombocytopenia (decreased platelet count, which increases the risk of bleeding and bruising)
• extrapyramidal disorders (e.g. dizziness, gait disturbances, muscle stiffness), stupor, drowsiness, seizures, memory disorders, headache, eye pain, dizziness
• hearing impairment
• vomiting, gastrointestinal abnormalities (mainly gastrointestinal hypertrophy), oral inflammation, stomach pain, diarrhea (common in some patients at the beginning of treatment) usually transient after a few days without the need to discontinue treatment
• hypersensitivity, transient and (or) dose-dependent hair loss, nail disorders and nail bed disorders
• hyponatremia (decreased sodium concentration in the blood), weight gain, which should be monitored, as it is associated with polycystic ovary syndrome
• bleeding
• liver damage
• irregular menstrual cycles
• confusion (disorientation), hallucinations, aggression, excitement, attention disorders
• urinary incontinence

Uncommon (may occur in less than 1 in 100 people):

• leukopenia (significant decrease in white blood cell count), pancytopenia (significant decrease in blood cell count, which can cause weakness, easy bruising, or predispose to infections)
• sepsis, encephalopathy (brain damage), lethargy (state of lethargy and lack of reaction to stimuli), transient parkinsonian symptoms, coordination disorders, tingling and numbness, increased seizure activity
• pleural effusion
• pancreatitis, sometimes fatal
• vascular purpura, rash, hair abnormalities (such as abnormal hair structure, changes in hair color, abnormal hair growth)
• decreased bone mineral density, osteopenia, osteoporosis, and fractures in patients taking valproic acid for a long time,
• syndrome of inappropriate antidiuretic hormone secretion (SIADH), hyperandrogenism (excessive male-type hair growth, virilism, hirsutism, male-type baldness, and (or) elevated androgen levels)
• vasculitis
• decreased body temperature, moderate peripheral edema
• amenorrhea
• renal failure

Rare (may occur in less than 1 in 1,000 people):

• bone marrow failure, including abnormal red blood cell formation, agranulocytosis (significant decrease in neutrophil count), macrocytic anemia (low red blood cell count), macrocytosis
• decreased activity of coagulation factors (at least one), abnormal coagulation test results (such as prolonged prothrombin time, prolonged activated partial thromboplastin time, prolonged thrombin time, prolonged INR), biotin deficiency/biotinidase deficiency
• involuntary urination, interstitial nephritis, transient renal dysfunction
• toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, severe hypersensitivity syndrome including, in particular, drug rash with eosinophilia and systemic symptoms (DRESS)
• systemic lupus erythematosus, rhabdomyolysis
• hypothyroidism
• hyperammonemia (elevated ammonia levels in the blood), obesity
• myelodysplastic syndrome
• male infertility, 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 and (or) genetic diseases

In case of occurrence of any of the following serious undesirable effects, the treating physician should be contacted immediately, as urgent medical attention may be necessary:

• changes in behavior related or unrelated to increased frequency of seizures or their severe course, especially when taking phenobarbital or during sudden increase in Convulex dose
• weakness, loss of appetite, drowsiness, recurrent vomiting and abdominal pain, jaundice (yellowing of skin and eye whites) or recurrence of seizures - these symptoms may indicate liver damage
• coagulation disorders, spontaneous bruising and bleeding
• skin and mucous membrane changes - very rarely, severe skin reactions may occur: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme

Additional Undesirable Effects in Children

Certain undesirable effects of valproic acid 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 of Undesirable Effects

If any undesirable effects occur, including any undesirable effects not mentioned in the leaflet, the doctor or pharmacist or nurse should be informed. Undesirable effects can be reported directly to the Department of Monitoring of Undesirable Effects of Medicinal Products, 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. Undesirable effects can also be reported to the marketing authorization holder. By reporting undesirable effects, more information can be gathered on the safety of the medicinal product.

5. How to Store Convulex

The medicinal product should be stored out of sight and reach of children.
The medicinal product should not be used after the expiry date stated on the carton.
The expiry date refers to the last day of the given month.
Store below 30°C.
Medicines should not be disposed of via wastewater or household waste. The pharmacist should be asked how to dispose of unused medicinal products. This will help protect the environment.

6. Contents of the Pack and Other Information

What Convulex Contains

The active substance of the medicinal product is valproic acid. One capsule contains 150 mg or 300 mg or 500 mg of valproic acid .
The other ingredients are carion 83, glycerol 85%, gelatin, titanium dioxide (E171), iron oxide red (E172), hydrochloric acid 25%; coating: methacrylic acid and ethyl acrylate copolymer (1:1) dispersion 30%, triethyl citrate, macrogol 6000, glycerol monostearate 44-55 Type II.
What Convulex Looks Like and What the Pack Contains:
Convulex 150, capsules 150 mg and Convulex 300, capsules 300 mg: Pink oval gelatin capsules.
Convulex, capsules 500 mg: Pink elongated gelatin capsules.
The pack contains 30 or 100 capsules.

Marketing Authorization Holder and Manufacturer

G.L. Pharma GmbH
Schloβplatz 1
A-8502 Lannach
Austria
To obtain more detailed information, please contact the representative of the marketing authorization holder:
G.L. PHARMA POLAND Sp. z o.o.
Al. Jana Pawła II 61/313
01-031 Warsaw, Poland
Tel: 022/ 636 52 23; 636 53 02
biuro@gl-pharma.pl

Date of Last Update of the Leaflet: