What it is and what it is used for

for Ethosuximide Strides is a medicine for the treatment of epileptic fits (antiepileptic). Ethosuximide Strides is used to treat

• Pyknoleptic absences and complex and atypical absences.
• Myoclonic-astatic petit mal and myoclonic fits of adolescents (impulsive petit mal), if other medicines are not effective and/or are not tolerated. You should consult your doctor if you are unsure why you have been given Ethosuximide Strides, if you do not feel better or if you feel worse.

What you need to know before you take it

e Ethosuximide Strides Do not take ethosuximide Strides

• 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.
• if you have porphyria (a metabolism disorder which causes abdominal pain and mental disorder). If any of the above apply to you, speak to your doctor or pharmacist. Warnings and precautions Talk to your doctor before taking ethosuximide Strides If you experience movement disorders (see section 4) do not continue taking Ethosuximide Strides. Please contact the nearest doctor who, in the event of significant disturbances, can administer diphenhydramine as an antidote by the intravenous route. These symptoms often occur within 28 days of starting this medicine, but can happen later. Talk to your doctor or pharmacist before taking Ethosuximide Strides if you suffer from or have suffered in the past from any of the following conditions:
• Liver disease.
• Kidney disease.
• Bruising, fever, looking pale or a severe sore throat. These may be the first signs of a potentially serious blood disorder, which could be fatal if not detected. Your doctor may take regular blood and/or urine samples to test for these. Pay special attention to symptoms of bone marrow depression 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. The blood count should be checked regularly (initially monthly, after one year every six months) to identify potential injury of the medulla. 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 Strides discontinued completely. The liver enzymes should also be checked regularly.

Ethosuximide Strides 250mg/5ml Syrup 1054194

Ethosuximide Strides 250mg/5ml Syrup 1054194

Package leaflet: Information for the patient

Psychic side effects (anxiety, illusion) can occur in particular in patients with a history of psychiatric disorders. Special caution is required when Ethosuximide Strides is administered to this group of patients. If you are taking anti-epileptic drugs, your doctor will routinely assess you for depression, anxiety and suicidality. If you are taking anti-epileptic drugs and you feel depressed and anxious, the symptoms of which are feeling low, loss of interest in everyday activities, lack of energy and a general feeling of unease, please consult your doctor. A small number of people 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. 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. 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 Strides and seek medical attention immediately if you notice any of the symptoms described in section 4. Other medicines and ethosuximide Strides 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 Strides? In patients also taking carbamazepine (medicine for the treatment of epileptic fits), the plasma clearance (excretion rate) of ethosuximide, the active substance of Ethosuximide Strides, 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 Strides mutually potentiate their sedative (calming and sleep inducing) effects. The efficacy of what other medicines is affected by Ethosuximide Strides? Ethosuximide, the active substance of Ethosuximide Strides, 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. Ethosuximide Strides with alcohol Alcohol can change and potentiate the effects of Ethosuximide Strides in an unforeseeable manner. Do not drink alcohol or consume alcohol-containing food while you take Ethosuximide Strides! Pregnancy and breast-feeding 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 Strides. Do not discontinue Ethosuximide Strides 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

-fetoprotein are recommended for the early detection of foetal damage. The lowest effective ethosuximide dose ensuring seizure control must not be exceeded, particularly during the 20th and 40th 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 Strides. Driving and using machines Ethosuximide Strides 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. Ethosuximide Strides contains sucrose, glucose, sodium benzoate (E211), and sodium This medicine contains sucrose and glucose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. This medicine may be harmful to the teeth. This medicine contains 10 mg sodium benzoate (E211) in each 5 ml syrup which is equivalent to 2 mg/ml. Sodium benzoate (E211) may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). This medicine contains less than 1 mmol sodium (23 mg) per 5 ml syrup, this is to say essentially 'sodium-free'.

How to take it

ethosuximide Strides Always take this medicine exactly as your doctor has told you. Your doctor will decide on the appropriate dose to suit your condition. Check with your doctor or pharmacist if you are not sure.

• It is important to take the medicine at the right time and regularly, as directed by your doctor.
• After taking Ethosuximide Strides, rinse the mouth or brush the teeth – the syrup contains sucrose which may be harmful to the teeth.
• Take the syrup with or without food, whichever you prefer.
• Older children and adults may be given ethosuximide in a capsule form. Dosage 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), taken in 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 so that the daily dose can be taken as a single dose provided the medicine is well tolerated. Higher daily doses should be 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 Strides and increasing them gradually to optimum amounts (increasing the amounts slowly from day to day) and by taking them during or after meals.

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Ethosuximide Strides 250 mg/5ml Syrup SPUK

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400 x 340 mm 1054194 BLACK PC-ODF/2025/851 – Record Number: 477169

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Other side-effects Common (may affect up to 1 in 10 patients) to very common (may affect more than 1 in 10 patients):

• decreased appetite, headaches, unsteadiness, difficulty in controlling movements, dizziness, drowsiness, feeling sick, skin rash including measleslike reactions which are mild, hives. Nausea, vomiting, hiccup and abdominal pain and cramps Uncommon (may affect up to 1 in 100 patients):
• Severe headache, sleep disturbances, lethargy (lack of drive, apathy), ataxia (movement disorders)
• Withdrawal, anxiety
• Loss of appetite, loss of weight
• Diarrhoea, constipation
• aggressive behaviour, nightmares, depression, thinking about suicide, psychotic disorder, disturbance to sleep patterns, shaking, abnormal or uncoordinated movements, sluggishness, inability to concentrate, short sightedness, hiccups, enlarged gums, swollen tongue, blood in the urine, vaginal bleeding, fatigue, irritability, feelings of persecution, hyperactivity, changes to your blood counts, particularly white blood cells called eosinophils. Rare (may affect up to 1 in 1000 patients):
• Paranoid and hallucinatory phenomena developing over days and weeks (illusion, persecution complex)
• Lupus erythematodes* of varying extent (skin disease that may involve internal organs)
• Leucopenia* (shortage of white blood cells), eosinophilia* (increase of a certain type of white blood cells), thrombocytopenia* (shortage of blood platelets) or agranulocytosis* (absence of certain defensive cells) Not known (frequency cannot be estimated from the available data):
• In individual cases dyskinesias (movement disorders, see section 2) may occur during the first 12 hours of the treatment
• Allergic skin reactions* such as rash, Stevens-Johnson syndrome (very severe allergic skin reaction) or DRESS (drug reaction with eosinophilia and systemic symptoms)
• In individual cases aplastic anaemia* (shortage of red blood cells due to failure of body to produce new cells) and pancytopenia* (shortage of all blood cells) may occur (see section 2).
• Sense of great well-being, an increased sex drive, extreme restlessness, loss of interest in activities, violent muscle contractions, swelling of the lymph glands.

*Side effects which are independent of the dose of the medicine If side effects occur which are independent of the dose taken, the medicine is usually discontinued and the side effects disappear. They may reappear when Ethosuximide Strides is taken again. Note: Long-term treatment may affect the patient's performance, e.g. the performance in school of children and adolescents. Reporting of side effects 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 Website: 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.

Possible side effects

Like all medicines, this medicine can cause side effects too, although not everybody gets them. Serious side effects Stop using Ethosuximide Strides and seek medical attention immediately if you notice any of the following symptoms:

• Reddish patches on the trunk, the patches are target-like macules or circular, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome) (Uncommon (may affect up to 1 in 100 people)).
• Widespread rash, high body temperature and enlarged lymph nodes (drug reaction with eosinophilia and systemic symptoms (DRESS)) (Frequency not known). If these are severe and you also experience pain and inflammation of the joints this could be related to a condition called Systemic Lupus Erythematosus (Uncommon (may affect up to 1 in 100 people)). Seek medical attention if you notice any of the following symptoms:
• Changes in your blood (bruising or bleeding more easily, fever, you are looking pale or you have a severe sore throat, mouth ulcers, fatigue, repeated infections or infections that will not go away). These may be the first signs of an abnormality of the blood, including decreases in the number of red cells, white cells or platelets and bone marrow suppression, please consult your doctor. Your doctor may take regular blood samples to test for these effects (Uncommon (may affect up to 1 in 100 people)).
• If you experience an increase in the number of your generalized fits (tonicclonic seizures) (Frequency not known)

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400 x 340 mm

NON PRINTING COLOUR

Ethosuximide Strides 250 mg/5ml Syrup SPUK

Pack Insert

400 x 340 mm 1054194 BLACK PC-ODF/2025/851 – Record Number: 477169

-1052865 1 2.0

Front & Back Side Printing. To be supplied in FOLDED BOOKLET form with pasting & folded size: 50 x 35 mm. 40 GSM Bible Paper. Printing clarity to be clear and sharp NA

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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 and adolescents 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). Method of administration Ethosuximide Strides is for oral use. The solution can be taken during or after meals. Instructions for use

• The pack contains a graduated oral measuring cup (20 ml steps).
• Opening of the bottle: Turn the screw cap anti-clockwise.
• Use the graduated oral measuring cup (marked in 20 ml steps) to measure the required dose of the solution.
• Transfer the content of the measuring cup into a glass of water. The dose can also be mixed with milk pudding
• Drink up the glass.
• Alternatively, the drug dose can directly be applied into the mouth. The patient should sit upright, and the measured dose slowly pour into patient mouth so that the patient can swallow well. After having taken the medicine, the patient should drink half a glass of water.
• Rinse the measuring cup using water only
• Close the bottle with the child-resistant cap. How long to take Ethosuximide Strides 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 Strides are determined by a specialist with experience in the treatment of epilepsy. If you take more Ethosuximide Strides than you should If by mistake you have taken a double dose Ethosuximide Strides, do not change your dosage regimen, but continue taking Ethosuximide Strides 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. If you forget to take Ethosuximide Strides 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 Strides will control your state safely and appropriately only when taken regularly! If you stop taking Ethosuximide Strides 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 Strides, please contact your doctor! If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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How to store it

ethosuximide Strides Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage condition. After first opening, use within 35 days. Do not use this medicine after the expiry date which is stated on the label and the carton after EXP. The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What ethosuximide Strides contains The active ingredient is ethosuximide. Each 5 ml contains 250 mg of ethosuximide. The other ingredients are: sodium benzoate (E211), citric acid monohydrate, sodium citrate, saccharin sodium, glycerol, sucrose, raspberry flavour (including propylene glycol (E1520), glyceryl triacetate (E1518), triethyl citrate (E 1505), flavouring substances, flavouring preparations), and purified water (see section 2) What ethosuximide Strides looks like and contents of the pack Ethosuximide Strides 250 mg/5ml syrup is a clear, colourless to slightly yellowish solution with an aroma of raspberry flavour. Ethosuximide Strides is available in 200 ml amber glass bottles with a child-resistant cap and a polypropylene 20ml measuring cup graduated from 2.5 ml to 15 ml. Marketing Authorisation Holder and Manufacturer Strides Pharma UK Limited Unit 4, The Metro Centre Dwight Road, Watford WD18 9SS United Kingdom This leaflet was last revised in 02/2026

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