Convulex 100 mg. / ml. 5 ml. 5 ampules

What Konvulex is and what it is used for
Convulex is used for:
treatment of epilepsy (seizures);
treatment of mania, when you may feel excited, elated, excited, enthusiastic, or hyperactive. Mania is seen in a condition called 'bipolar disorder'. Convulex can be used when lithium cannot be used.
For the treatment of mania, Convulex should only be used in adult patients (18 years and older).

Convulex can be administered as an injection solution when oral administration of sodium valproate/valproic acid is temporarily impossible.

2. What you need to know before you use Convulex
Do not use Convulex:
if you are allergic to sodium valproate or any of the other ingredients of this medicine (listed in section 6);
if you have liver problems;
if you or your relatives have had severe liver problems in the past, especially as a result of treatment with certain medicines;
if you have a severe disorder of pancreatic function;
if you suffer from hepatic porphyria (a rare metabolic disease);
if you have a blood clotting disorder;
if you have impaired kidney function or suffer from insulin-dependent diabetes mellitus;
if you have a urea cycle disorder (metabolic disorder);
if you have a genetic problem causing mitochondrial disease (eg Alpers-Huttenlocher syndrome).
Warnings and precautions
Notify your doctor immediately:
if you get abdominal pain, loss of appetite, nausea and/or vomiting, drowsiness and lethargy, if you generally feel down or unwell, or have frequent nosebleeds or bruising. Contact your doctor immediately, as these may be symptoms of severe liver damage or pancreatitis (inflammation of the pancreas). The risk of these potentially life-threatening conditions is particularly high in young children (under 3 years of age), in patients receiving combined treatment (especially in the first three months);
if the seizures become more frequent. This may be a sign of liver damage or damage to brain function (for example, if you also take/use phenytoin in addition to Convulex), and sometimes too high levels of ammonia in the blood;
if you suffer from urea cycle enzyme deficiency (a rare metabolic disease), symptoms may include lethargy, drowsiness, vomiting, low blood pressure or increased seizures;
if you are about to have surgery: Tell your doctor that you are taking Convulex, as valproate can prolong bleeding time.
Tell your doctor before using Convulex:
if you have lupus (a disease of the immune system affecting the skin, bones and joints, lungs and kidneys);
if you know that there is a genetic problem causing mitochondrial disease in your family;
if you know that you have a deficiency of the enzyme carnitine palmigoyl transferase type I, because there is an increased risk of developing rhabdomyolysis during treatment with valproate;
if you have diabetes. Valproate may cause urine ketone tests to be falsely positive when this is not the case;
if this medicine has to be used in young children who need simultaneous treatment with several antiepileptic drugs;
if this medicine has to be used in children and adolescents with multiple
concomitant diseases and severe forms of seizures;
if you have bone marrow damage: close monitoring is required;
if you have an abnormally low amount of total protein in your blood.
Convulex can cause significant and progressive weight loss. This is a very common side effect. Consult your doctor about appropriate strategies to minimize this risk.

Talk to your doctor even if you no longer have these conditions but have had them in the past.
Your doctor may recommend that you have blood tests before you start using Convulex and during the first six months of treatment.

The use of Convulex may cause false results of thyroid function tests, which may therefore indicate insufficient thyroid function when this is not the case.

A small proportion of people treated with antiepileptics such as Convulex have had thoughts of harming or killing themselves. If at any time such thoughts appear, contact your doctor immediately.

Children and adolescents
In infants and young children sodium valproate is very rarely the drug of choice when needed, Convulex solution for injection/infusion should be used with special care and after careful consideration of the benefits and risks. Where possible, it should not be used together with other antiepileptics.

In children and adolescents (under 18 years of age) Convulex should not be used to treat mania.

Other medicines and Convulex
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use
Epilepsy
For epilepsy, you should not use Convulex if you are pregnant, unless no other medicine has worked for you.

In epilepsy, if you are a woman of childbearing potential, you should not take Convulex unless you are using an effective method of preventing pregnancy (contraception) during the entire period of treatment with Convulex. Do not stop taking Convulex or the method you are using to prevent pregnancy until you have discussed this with your doctor.
Your doctor will advise you further.

The risks of valproate when taken during pregnancy (regardless of the condition for which valproate is used)

Tell your doctor immediately if you are planning to have a baby or are pregnant.

Valproate carries a risk if taken during pregnancy. The higher the dose, the higher the risks, but all doses carry risk.

This medicine can cause serious birth defects and can affect the way a child develops as it grows. The most commonly reported birth defects include spina bifida (in which the bones of the spinal cord do not develop properly); facial and cranial malformations; malformations of the heart, kidneys, urinary tract and genitals; limb defects and multiple related malformations affecting several organs and parts of the body. Birth defects can lead to disabilities that can be severe.

Hearing problems or deafness have been reported in children exposed to valproate during pregnancy.

There have been reports of ocular malformations in children exposed to valproate during pregnancy in association with other congenital malformations. These eye malformations can affect vision.

If you take valproate during pregnancy, your risk of giving birth to a child with birth defects that require medical treatment is higher than for other women. Because valproate has been used for many years, it is known that in women who take valproate, about 10 babies out of every 100 will have birth defects. This corresponds to 2 to 3 babies in every 100 born to women who do not have epilepsy.

It is estimated that up to 30-40% of preschool children whose mothers took valproate during pregnancy may have developmental problems during early childhood. Affected children may have delays in walking and talking, less intellectual ability than other children, and difficulties with language acquisition and memory.

Children exposed to valproate are more often diagnosed with autistic disorders, and there is some evidence that children may more often develop symptoms of attention deficit hyperactivity disorder.

Before prescribing this medicine, your doctor will explain what could happen to your baby if you become pregnant while taking valproate. If you later decide that you want to have a baby, you should not stop your medicine or method of contraception until you have discussed this with your doctor.

If you are the parent or caregiver of a female child being treated with valproate, you should contact the doctor as soon as your child taking valproate has her first period (menarche).

Some birth control pills (oestrogen-containing birth control pills) can lower the levels of valproate in your blood. Make sure you discuss with your doctor the method of contraception (birth control) that is best for you.

Ask your doctor about taking folic acid when you are trying to conceive. Folic acid can reduce the overall risk of spina bifida and early miscarriage that exists in every pregnancy. However, this is unlikely to reduce the risk of birth defects associated with valproate use.

Please select and read the situations that apply to you from the situations described below:
I START TREATMENT WITH CONVULEX
I AM TAKING CONVULEX AND I AM NOT PLANNING TO HAVE A BABY
I AM TAKING CONVULEX AND I'M PLANNING TO HAVE A BABY
I AM PREGNANT AND I AM TAKING CONVULEX
I START TREATMENT WITH CONVULEX

If this is the first time you have been prescribed Convulex, your doctor will explain the risks to the unborn child if you become pregnant. Since you may already have a baby, you should make sure that you use an effective method of preventing pregnancy without interruption during your treatment with Convulex. Consult your doctor or family planning clinic if you need advice about preventing pregnancy.

Key messages:
Before starting treatment with Konvulex, pregnancy must be ruled out with the result of a pregnancy test confirmed by your doctor.

You must use an effective method of contraception during the entire period of treatment with Convulex.

You should discuss with your doctor the appropriate methods of preventing pregnancy. Your doctor will give you information about preventing pregnancy and may refer you to a specialist for advice on preventing pregnancy.

You should conduct regular
Do not stop taking Convulex unless your doctor tells you to, as your condition may get worse. Schedule an emergency visit to your doctor if you are pregnant or think you may be pregnant Your doctor will advise you further.

Babies born to mothers who have taken valproate are at serious risk of birth defects and developmental problems that can cause severe disability.

You will be referred to a specialist experienced in treating bipolar disorder or epilepsy so that alternative treatment options can be assessed.

In exceptional circumstances, where Convulex is the only available treatment option during pregnancy, you will be monitored very carefully, both for the treatment of the underlying disease and for the development of your baby. You and your partner may receive counseling and support regarding your valproate-exposed pregnancy.

Ask your doctor about taking folic acid. Folic acid can reduce the overall risk of spina bifida and early miscarriage that exists in every pregnancy. However, this is unlikely to reduce the risk of birth defects associated with valproate use.

Key messages:
Schedule an emergency visit to your doctor if you are pregnant or think you may be pregnant.

Do not stop taking Convulex unless your doctor tells you to.

You should make sure you are referred to a specialist experienced in the treatment of epilepsy, bipolar disorder to assess the need for alternative treatment options.

You should receive comprehensive counseling regarding the risks of Convulex during pregnancy, including teratogenicity and developmental effects in children.

You should be sure that you have been referred to a specialist in prenatal diagnosis to detect possible cases of malformations.

You should make sure that you read the patient guide that you received from your doctor. Your doctor will discuss the annual risk awareness form with you and ask you to sign and keep it. You will also receive a patient card from your pharmacist to remind you of the risks of valproate during pregnancy.

Risk to the newborn
Very rarely, bleeding disorders (in some cases even leading to death), low blood sugar levels and hypothyroidism have been reported in newborns whose mothers were treated with valproate during pregnancy.

The doctor will do appropriate blood tests if such complications are suspected.

Breastfeeding
Very small amounts of Convulex pass into breast milk, but you should consult your doctor if you should breastfeed your baby.

Driving and using machines
When you start using Konvulex for the first time, or when using it with other medicines, you may notice some drowsiness.

Do not drive or use any tools or machines until you know if using Konvulex affects you.

Convulex 100 mg/ml solution for injection/infusion contains sodium
This medicinal product contains approximately 3.54 mmol (or 81.5 mg) sodium per 5 ml ampoule. This should be considered in patients on a controlled sodium diet.

Treatment with Convulex should be started and monitored by a doctor specialized in the treatment of epilepsy or bipolar disorder.

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Convulex 100 mg/ml solution for injection is a medicine for intravenous use and should therefore be administered by medical professionals.

The dosage and duration of treatment will be determined individually by your doctor.

EPILEPSY
The daily dose and duration of treatment will be determined by your doctor. The following dosage recommendations generally apply:

Dosage in adults
When administered by slow intravenous injection, the recommended dose is between 5 and 10 mg of sodium valproate per kilogram of body weight. In adult patients, this corresponds to approximately 500 mg of sodium valproate or 1 ampoule for a patient weighing 65 kg.

When administered by infusion, the recommended dose is 0.5 - 1 mg of sodium valproate per kilogram of body weight per hour.

Use in patients already on oral valproic acid therapy: Patients can be switched from oral to intravenous administration at a 1:1 dose ratio. Convulex solution for injection is usually administered 12 hours after the last oral dose as a separate injection or infusion.

If it is necessary to quickly reach and maintain high plasma concentrations, the following approach is recommended:

Intravenous injection of 15 mg of sodium valproate per kilogram of body weight over 5 minutes. 30 minutes later, an infusion of 1 mg/kg bw is made, with constant monitoring, until reaching
Average daily dose
Recommended daily doses usually range between 1,000 mg and 2,000 mg. Patients requiring daily doses above 45 mg/kg bw. daily, should be carefully monitored.

Method and duration of application
For intravenous injection.
Convulex injection solution should be administered strictly intravenously - either by slow injection (about 3-5 minutes) or in the form of infusion (continuous or in several doses).

The following solutions can be used to prepare the infusion: isotonic sodium chloride solution;
5% glucose solution; Ringer's lactate solution.

Only a clear and colorless to slightly yellowish solution should be used.

As soon as your condition allows, your doctor will have you switch from Konvulex 100 mg/ml solution for injection to the oral dosage form, with oral administration starting 12 hours after the last treatment with Konvulex 100 mg/ml solution for injection.

If you have been given more than the required dose of Convulex
The Konvulex injection or infusion is usually given in a hospital setting, where the correct dose will be carefully chosen by your doctor. However, if you have any concerns, tell your doctor or nurse.

Information for the doctor: Advice on the symptoms and management of overdose is at the end of this leaflet.
If you have stopped using Konvulex

If you want to stop using Konvulex, tell your doctor.
Convulex should not be stopped just because you feel better, as this may lead to a sudden relapse and your condition may get worse.

If you have any further questions related to the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them.

Especially in cases of very high doses, treatment with Convulex can cause reversible (sometimes also serious) changes in the blood (e.g. reduced number of certain blood cells, reduced bone marrow function) or blood clotting disorders.

Please tell your doctor if you notice an increased tendency to bleed, or if you seem to get bruises or infections more easily.
Vomiting, impaired coordination of movements, drowsiness and progressive clouding of consciousness may be signs of increased levels of ammonia in the blood. If such symptoms appear, consult your doctor immediately.
If symptoms such as abdominal pain, nausea and/or vomiting occur, contact your doctor immediately. They may indicate inflammation of the liver or pancreas, which occurs very rarely, but in severe cases can be life-threatening (see section 2. "What you need to know before you use Konvulex").

Common (may affect up to 1 in 10 people receiving treatment):
Isolated cases of moderate hyperammonemia (increased levels of ammonia in the blood without deviations in the values of liver tests);
Disorders of the nail and nail bed.
Urinary incontinence (involuntary loss of urine)
Uncommon (may affect up to 1 in 100 people receiving treatment):
Decreased number of platelets (especially in children), transient decrease in the number of leukocytes;
Headache, drowsiness, drowsiness, tremors, abnormal sensations (eg, tingling or numbness, or numbness);
Dose-dependent weight gain or loss, increased appetite or loss of appetite, changes in taste;
Transitional hair loss;
Local reactions at the injection site; nausea or drowsiness may occur a few minutes after administration, but usually resolves within a few minutes.
Rare (may affect up to 1 in 1,000 people receiving treatment):
Bleeding;
Obesity;
Increased muscle tension, impaired coordination of movements;
Irritability, hyperactivity, hallucinations, tinnitus (ringing in the ears), sometimes hearing loss;
Confusion, stupor (impossibility of movement or even transient, coma-like states), sometimes accompanied by epileptic seizures (in most cases with a very rapid dose increase or simultaneous treatment with other antiepileptics, especially phenobarbital). These symptoms usually disappear when the dose is reduced or the treatment is stopped;
Excessive salivation, diarrhea, hiccups;
Transient gastrointestinal complaints, such as nausea or abdominal pain (especially at the beginning of treatment);
Liver function disorders, in severe cases severe liver damage (especially in children) or - very rarely - damage to the pancreas (see section 2. Warnings and precautions), Early signs may be the following: more frequent seizures, feeling sick or frequent nausea, vague abdominal pain, increase in edema (swelling due to fluid retention in the tissues), impaired consciousness with confusion, restlessness and movement disorders;
Swelling of the ankles, feet or toes (peripheral oedema);
Tissue damage when valproate is injected
Not known (frequency cannot be estimated from the available data):
Decreased concentration of fibrinogen and/or coagulation factor VIII, possibly leading to prolonged bleeding time;
Irregular menstruation;
With long-term treatment, especially in combination with phenytoin - signs of brain disease (encephalopathy): increase in seizures, lack of motor activity, disorders of consciousness, muscle weakness, movement disorders, EEG changes;
Parkinson-like symptoms that resolve after stopping treatment;
Bone disorders including osteopenia and osteoporosis (thinning of the bones) and fractures have been reported. Consult your doctor or pharmacist if you are on long-term antiepileptic drug treatment, have a history of osteoporosis or are taking/using steroids;
There have been reports of enuresis (involuntary passing of urine) in children.
Additional side effects in children
Some side effects occur more often in children and are more severe than in adults. This includes liver damage, inflammation of the pancreas (pancreatitis), aggression, agitation, attention deficit disorder, abnormal behavior, increased activity, and impaired learning ability.

Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report adverse reactions directly through the Executive Medicines Agency, 8 Damyan Gruev St., 1303 Sofia, phone: + 359 2 8903417, website: www.bda.bg. By reporting side effects, you can contribute to getting more information about the safety of this medicine.

5. How to store Convulex solution for injection
Keep out of the reach of children.

This medicinal product does not require special storage conditions as long as it is stored in the original packaging.

Stability of solution after dilution/reconstitution:
Chemical and physical in-use in-use stability has been demonstrated for 48 hours at room temperature. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution has taken place under controlled and validated aseptic conditions. Any unused portion of the infusion solution must be discarded.

Use only a clear, colorless or slightly yellow solution.

Do not use this medicine after the expiry date which is stated on the blister and carton after EXP. The expiry date corresponds to the last day of the month indicated.

Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.

6. Contents of the package and additional information
What Convulex 100 mg/ml solution for injection contains
The active substance is: sodium valproate. 1 ampoule contains 500 mg of sodium valproate (corresponding to 433.9 mg of valproic acid).
The remaining ingredients are:
sodium hydrogen phosphate dodecahydrate, sodium hydroxide, water for injections.

What Convulex 100 mg/ml solution for injection looks like and contents of the pack
Clear, colorless to slightly yellow solution (pH value 7.4).

Each package contains 5 ampoules (colorless glass, type I glass) of 5 ml.

 

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