Ethosuximide neuraxpharm 50 mg/ml oral solution

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Ethosuximide neuraxpharm is and what it is used for
2. What you need to know before you take Ethosuximide neuraxpharm
3. How to take Ethosuximide neuraxpharm
4. Possible side effects
5. How to store Ethosuximide neuraxpharm
6. Contents of the pack and other information

• if you are allergic to ethosuximide, other succinimides (group of medicines to which ethosuximide belongs) or any other ingredients of this medicine (listed in section 6).

Talk to your doctor before taking Ethosuximide neuraxpharm.

• If you experience movement disorders (see section 4) do not continue taking Ethosuximide neuraxpharm. Please contact the nearest doctor who, in the event of significant disturbances, can administer diphenhydramine as an antidote by the intravenous route.
• Pay special attention to symptoms of bone marrow damage such as fever, inflammation of throat or pharynx tonsils as well as haemorrhagic tendency, and consult your doctor if you experience any of these symptoms.
  Your blood count should be checked regularly (initially monthly, after one year every six months) to identify potential bone marrow damage. At a leucocyte count (number of white blood cells) of less than 3500/mm3 or a granulocyte ratio of less than 25% the dose should be reduced or Ethosuximide neuraxpharm discontinued completely. Your liver enzymes should also be checked regularly.
• Psychiatric side effects (anxiety, illusion) can occur in particular in patients with a history of psychiatric disorders. Special caution is required when Ethosuximide neuraxpharm is administered to this group of patients.
• A small number of patients treated with anti-epileptics such as ethosuximide have developed thoughts about self-harm or suicidal thoughts. If at any time during the treatment you have such thoughts, tell your doctor immediately.
• Serious skin reactions including Stevens-Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with ethosuximide treatment. Stop using Ethosuximide neuraxpharm and seek medical attention immediately if you notice any of the symptoms described in section 4.

Note:

To prevent grand mals which are often associated with complex and atypical absences, ethosuximide can be combined with effective anti-epileptics (e.g. primidone or phenobarbital). Additional grand mal prophylaxis can be dispensed with only in the case of pyknoleptic absence epilepsies in children of school age.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

What other medicines affect the efficacy of Ethosuximide neuraxpharm?

In patients also taking carbamazepine (medicine for the treatment of epileptic fits), the plasma clearance (excretion rate) of ethosuximide, the active substance of Ethosuximide neuraxpharm, may be elevated. In patients taking valproic acid (medicine for the treatment of epileptic fits), the concentration of ethosuximide in blood may rise.

It cannot be excluded that CNS depressants and Ethosuximide neuraxpharm mutually potentiate their sedative (calming and sleep inducing) effects.

The efficacy of what other medicines is affected by Ethosuximide neuraxpharm?

Ethosuximide, the active substance of Ethosuximide neuraxpharm, normally does not change the concentration of other medicines for the treatment of epileptic fits (e.g. primidone, phenobarbital, phenytoin) in blood. In individual cases the phenytoin level in blood may rise, however.

Alcohol can change and potentiate the effects of Ethosuximide neuraxpharm in an unforeseeable manner.

Do not drink alcohol or consume alcohol-containing food while you take Ethosuximide neuraxpharm!

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are of childbearing age, you should be advised by your doctor regarding the necessity of planning and monitoring any pregnancy before starting the treatment with Ethosuximide neuraxpharm. Do not discontinue Ethosuximide neuraxpharm without first consulting your doctor as epileptic seizures might recur, which could harm you and/or your unborn child.

No specific malformations of babies are known, which were caused by the treatment with ethosuximide. However, patients treated with medicines against epileptic seizures generally have a higher risk for malformations than other women. The most commonly reported malformations are cleft lip, cardiovascular malformation and neural tube defects (spina bifida). This risk is even higher in patients treated with more than one anti-epileptic, and therefore combination treatment should be avoided during pregnancy.

Prenatal diagnostic measures like high level ultrasound and the determination of α-fetoprotein are recommended for the early detection of foetal damage.

The lowest effective ethosuximide dose ensuring seizure control must not be exceeded, particularly from the 20^th to the 40^th day of pregnancy. Your ethosuximide serum concentration must be checked regularly. You should take extra folic acid, if you are planning to have a baby or if you are pregnant.

To prevent vitamin K1 deficiency in your baby and bleeding caused by this deficiency, you should also be given vitamin K1 during the last month of your pregnancy.

Breast-feeding

Ethosuximide passes into breast milk and might lead to sedation, poor suckling and irritability in breast-fed infants. Therefore, you should stop breast-feeding during treatment with Ethosuximide neuraxpharm.

Ethosuximide can impair reactivity. Therefore, the following should be considered throughout the treatment period, in particular, however, during the adjustment phase: You are not able to respond quickly and purposefully to unexpected and sudden events. Do not drive cars or other vehicles! Do not operate dangerous electric tools or machines! Do not work without a secure hold!

The decision about whether you are able to drive and use machines will be taken in each case by your doctor considering your individual response to the medicine. Be advised that alcohol further impairs your driving capacity.

• Methyl-4-hydroxybenzoate may cause allergic reactions (possibly delayed).
• This medicine contains 1.0 mg propylene glycol in each 1 ml. If this medicine has been prescribed for a baby that is less than 4 weeks old, talk to your doctor or pharmacist before giving them this medicine, in particular if the baby is given other medicines that contain propylene glycol or alcohol.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults, elderly patients and children over 6 years of age:

The treatment is started at a daily dose of 500 mg (10 ml). Depending on the patient’s tolerance, the dose is increased every five to seven days in increments of max. 250 mg (5 ml) until the fits are controlled by a daily dose of 1000-1500 mg (20-30 ml). In an individual case, a daily dose of 2000 mg (40 ml), divided into several single doses, may be required.

The therapeutic plasma level of ethosuximide is normally between 40 and 100 μg/ml. However, the dose depends on the patient’s clinical response. The half-life of ethosuximide in plasma is more than 24 hours and the daily dose can be taken as a single dose provided the medicine is well tolerated. Higher daily doses should be divided and taken in 2 or 3 single doses, however. The decision about changes to the dosage regimen can be taken by your doctor only.

The risk of side effects which depend on the dose taken can be reduced by taking small initial doses of Ethosuximide neuraxpharm and increasing them gradually to optimum amounts (increasing the amounts slowly from day to day) and by taking them during or after meals.

Haemodialysis patients

Ethosuximide is dialysable. Haemodialysis patients therefore require a supplementary dose or a modified dosage regimen. During a dialysis period of four hours, 39% to 52% of the dose taken is removed.

Children

Children under 2 years: The treatment is started at a daily dose of 125 mg (2.5 ml). The dose is increased gradually in small increments every few days until the fits are controlled.

Children between 2 and 6 years of age: The treatment is started at a daily dose of 250 mg (5 ml). The dose is increased gradually in small increments every few days until the fits are controlled. The optimum daily dose for most children is 20 mg/kg. The maximum dose is 1000 mg (20 ml).

Ethosuximide neuraxpharm is for oral use.

The solution can be taken during or after meals.

• The pack contains a graduated oral syringe (0.5 ml steps) and an adapter for the oral syringe.
• Opening of the bottle: Turn the screw cap anti-clockwise.
• Insert the adapter in the bottle neck (Fig. 1). Make sure that the adapter is tightly fitted.
• Insert the oral syringe in the opening of the adapter (Fig. 1).

• Turn the bottle upside down (Fig. 2).

• Transfer a small amount of the solution into the syringe by pulling out the piston a short distance (Fig. 3A). Push the piston back to remove any air bubbles (Fig. 3B). Now pull the piston as far as to the millilitre (ml) level corresponding to the dose prescribed by your doctor (Fig. 3C).

• Place the bottle in upright position. Remove the syringe from the adapter.
• Transfer the content of the syringe into a glass of water by pushing the piston into the syringe as far as to stop position (Fig. 4). The dose can also be mixed with milk pudding.

• Drink up the glass.
• Alternatively, the drug dose can directly be applicated into the mouth. The patient should sit upright and the syringe piston should slowly be pressed into the syringe so that the patient can swallow well (Fig. 5). After having taken the medicine, the patient should drink half a glass of water.

• Rinse the syringe using water only (Fig. 6).

• Close the bottle with the screw cap.

How long to take Ethosuximide neuraxpharm

The treatment of epileptic fits is principally a long-term treatment. The dose, the distribution of the daily dose, the duration of treatment and discontinuation of Ethosuximide neuraxpharm are determined by a specialist with experience in the treatment of epilepsy.

If by mistake you have taken a double dose Ethosuximide neuraxpharm, do not change your dosage regimen, but continue taking Ethosuximide neuraxpharm as prescribed. Significantly higher doses potentiate effects such as tiredness, lethargy (lack of drive, apathy), depressive states and states of agitation, in some cases also irritability as well as any other side effects depending on the quantity taken (overdose effects may occur at concentrations over 150 μg ethosuximide per ml blood).

Overdose symptoms are potentiated by alcohol and other CNS depressants.

If any of these symptoms occur, contact the nearest doctor and, if possible, present the medicine taken and the package leaflet.

If a significant overdose was taken, the doctor will perform gastric lavage and administer medicinal charcoal. Monitoring of the cardiovascular and respiratory systems in an intensive care unit is required.

Do not take a double dose to make up for the forgotten dose.

Normally no symptoms will appear when you forgot to take a single dose. Continue taking the medicine as prescribed, i.e. do not take the forgotten dose at a later time. Be advised, however, that Ethosuximide neuraxpharm will control your state safely and appropriately only when taken regularly!

If you wish to discontinue the treatment, talk to your doctor first. Do not stop taking the medicine without checking with your doctor, as this may jeopardise the success of the treatment.

Strictly follow the treatment recommendations of your doctor, as otherwise you may have again epileptic fits! If you think that you do not tolerate Ethosuximide neuraxpharm, please contact your doctor!

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is ethosuximide.

1 ml oral solution contains 50 mg ethosuximide.

The other ingredients are: cream caramel flavour (contains propylene glycol (E1520) and vanillin), citric acid monohydrate, hypromellose, macrogol 300, methyl 4-hydroxybenzoate (E218), saccharin sodium, sodium citrate dihydrate, purified water.

Ethosuximide neuraxpharm oral solution is a clear, colourless to slightly yellow oral solution.

Brown glass bottle with screw cap.

Packs with 125 ml, 200 ml and 250 ml (2 x 125 ml) oral solution in a carton containing also a 10 ml graduated oral syringe, graduated in 0.5 ml steps, and an adapter for the oral syringe.

Not all pack sizes may be marketed.