Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
What Ethosuximide Roma is Ethosuximide Roma 500 mg/5 ml oral solution (called Ethosuximide Roma in this leaflet) contains a medicine called ethosuximide. Ethosuximide Roma is a medicine for the treatment of epileptic fits (anti-epileptic).
What Ethosuximide Roma is used for It is used to control epilepsy in children and adults. Epilepsy is a condition where you have repeated seizures (fits). Ethosuximide is used to control brief, sudden loss of consciousness (absence seizures, also called petit mal), and uncontrolled jerking movements (myoclonic seizures).
Do not take Ethosuximide Roma if: • you are allergic (hypersensitive) to ethosuximide, other succinimides or any of the other ingredients of this medicine (listed in Section 6).
• you have porphyria (a metabolism disorder which causes abdominal pain and mental disorder).
Warnings and precautions Talk to your doctor before taking Ethosuximide Roma, if:
• you have kidney or liver problems
• you are pregnant or planning a pregnancy, or if you are breast-feeding
• you have 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.
If you experience movement disorders (see section 4) do not continue taking Ethosuximide Roma. 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 depression such as fever, inflammation of the 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 injury of the medulla. Your liver enzymes should also be checked regularly.
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.
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 Roma and seek medical attention immediately if you notice any of the symptoms described in section 4.
A small number of people being treated with anti-epileptics, such as ethosuximide, have had thoughts of harming or killing themselves. If at any time you have these thoughts, contact your doctor immediately .
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ethosuximide Roma.
Other medicines and Ethosuximide Roma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking any of the following:
• Other medicines used to control epilepsy, especially carbamazepine, phenytoin, primidone, phenobarbital, lamotrigine and sodium valproate .
• Isoniazid , a medicine used for certain types of infection.
If ethosuximide is being used to replace another medicine for epilepsy your doctor will withdraw these gradually to stop you getting seizures.
Pregnancy, breast-feeding and fertility 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
Before you start taking ethosuximide:
• If you are of child bearing age and are planning to become pregnant talk to your doctor for advice before you start taking ethosuximide.
If you become pregnant while taking ethosuximide:
• Tell your doctor immediately .
• Do not stop taking Ethosuximide Roma without telling your doctor as your fits may start again. Your doctor may reduce your dose, but it is still important for your fits to be controlled.
• Ethosuximide crosses the placenta which may increase the risk of foetal abnormalities. Discuss the need for any diagnostic tests with your doctor or other healthcare professionals.
• It is recommended that pregnant women take Folic Acid and Vitamin K supplements.
Breast-feeding
Ethosuximide passes into breast milk. DO NOT breast-feed while taking Ethosuximide Roma as it will make your baby sleepy, not able to suckle properly or become irritable or unsettled.
Driving and using machines You may feel drowsy while you are taking this medicine, particularly when you first start taking it. DO NOT drive or use any tools or machines until your doctor tells you it is OK to do so.
Important information about some of the ingredients of Ethosuximide Roma This medicine can be considered as sugar-free.
This medicine contains:
• Sodium Benzoate (E211): This medicine contains 2.5 mg sodium benzoate in each 5 ml of oral solution which is equivalent to 5 mg per 10 ml of oral solution. Sodium Benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
• Sodium : This medicine contains less than 1 mmol sodium (23 mg) per 10 ml of oral solution, that is to say essentially 'sodium-free'.
• Propylene glycol (E1520): This medicine contains 3.7 mg propylene glycol in each 5 ml of oral solution. If your baby 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.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
• For oral use only. Take this medicine by mouth.
• Shake the bottle before use.
• Use the syringe provided and read the dosing instructions below.
How much to take Your doctor will decide the dose appropriate for you or your child.
Adults, the elderly and children over 6 years
• The starting dose is 500 mg (5 ml) daily.
• Your doctor may decide to increase your dose every 5-7 days until your fits are under control.
• The maximum dose is 2000mg (20ml) in divided doses.
Children between 2 and 6 years
• The starting dose is one 250 mg (2.5 ml) daily.
• Your doctor may decide to increase this every few days until your child's fits are under control.
• The dose will be calculated on the weight of your child to a maximum of 1000 mg (10 ml) each day.
Children under 2 years
• The starting dose is one 125 mg (1.25 ml) daily.
• Your doctor may decide to increase this every few days until your child's fits are under control.
• The dose will be calculated on the weight of your child to a maximum of 1000 mg (10 ml) each day.
Using the dosing syringe • When you use the medicine for the first time, place the adaptor in the neck of the bottle.
• Push the syringe firmly into the adaptor in the neck of the bottle.
• To fill the syringe, turn the bottle upside down. Whilst holding the syringe in place, gently pull the plunger down drawing the medicine to the correct mark on the syringe. Your doctor will tell you the right dose for you or your child.
• Turn the bottle the right way up, remove the syringe from the adaptor by gently twisting the syringe.
• Place the end of the syringe into the mouth and gently press the plunger down to slowly and gently release the medicine.
• After use replace the bottle cap. Wash the syringe in warm water and allow to dry. Store out of reach of children.
If you take more Ethosuximide Roma than you should • If you take more Ethosuximide Roma than you should, or if you think a child has accidently swallowed any, tell a doctor or go to a hospital casualty department straight away. Take this leaflet with you. This is so the doctor knows what you have taken.
• Taking too much ethosuximide can be very dangerous. You may feel or be sick, feel drowsy or confused or struggle to breathe.
If you forget to take Ethosuximide Roma • If you forget a dose, take the next dose as soon as you remember. However, if it is nearly time for the next dose skip the missed dose.
• Do not take a double dose to make up for the forgotten dose.
If you stop taking Ethosuximide Roma • Keep taking Ethosuximide Roma until your doctor tells you to stop.
• Do not stop taking Ethosuximide Roma just because you feel better. Your fits will not be controlled if you stop taking your medicine.
• If required, your doctor will tell you how to stop taking your medicine in a gradual way.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Children are at higher risk of the effects.
Serious side effects Stop using Ethosuximide Roma 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 (tonic-clonic seizures) (Frequency not known).
Other side effects are: Common (may affect up to 1 in 10 people)
• decreased appetite,
• headaches,
• unsteadiness,
• difficulty in controlling movements,
• dizziness,
• drowsiness,
• stomach ache and cramps,
• feeling sick or being sick (vomiting),
• skin rash including measles-like reactions which are mild,
• hives.
Uncommon (may affect up to 1 in 100 people)
• aggressive behaviour,
• nightmares,
• depression,
• thinking about suicide,
• psychotic disorder,
• disturbance to sleep patterns,
• shaking,
• abnormal or uncoordinated movements,
• sluggishness,
• inability to concentrate,
• shortsightedness,
• hiccups,
• diarrhoea,
• enlarged gums,
• swollen tongue,
• blood in the urine,
• vaginal bleeding,
• fatigue,
• irritability,
• weight loss,
• feelings of persecution,
• hyperactivity,
• changes to your blood counts, particularly white blood cells called eosinophils.
Not known (frequency cannot be estimated from the available data)
• sense of great well-being,
• an increased sex drive,
• extreme restlessness,
• loss of interest in activities,
• violent muscle contractions,
• swelling of the lymph glands.
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 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.
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
After first opening use within 6 months.
Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of that month.
Do not dispose of any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
What Ethosuximide Roma contains • Each 5 ml of oral solution contains 500 mg of the active substance ethosuximide.
• The other ingredients are: glycerol (E422), sodium benzoate (E211), sucralose (E955), citric acid (E330), sodium citrate (E331 iii), strawberry flavour (including propylene glycol, E1520), hydrochloric acid, concentrated (E507) (for pH adjustment) and purified water.
What Ethosuximide Roma looks like and contents of the pack Ethosuximide Roma is a clear, colourless solution with characteristic strawberry odour.
Ethosuximide Roma is packed in amber glass bottles containing 200 ml sealed with a child-resistant, tamper-evident screw cap. It comes with a 10 ml oral syringe, with 0.25 ml graduations, and a bottle neck adaptor.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder
ROMA Pharmaceuticals Limited
Gibraltar House
Centrum 100
Burton-upon-Trent
DE14 2WE
email: [email protected] Manufacturer
Medicair Bioscience Laboratories S.A.
Athinon-Lamias National Road 61st Km
Schimatari
320 09
Greece
This leaflet was last revised in September 2024
For information in other formats contact [email protected]
Roma Pharmaceuticals Limited
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Gibraltar House, Crown Square, First Avenue, Centrum 100, Burton upon Trent, Staffordshire, DE14 2WE
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01283 890091
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Ethosuximide Roma 500 mg/5 ml Oral solution comes as solution containing 500 mg/5. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Ethosuximide Roma 500 mg/5 ml Oral solution is ethosuximide.
Medicines with the same active substance include: Emeside 250 mg Capsules, Emeside 250 mg/5ml Syrup, Epesri 250 mg capsules, soft, Ethosuximide 250 mg Capsules, soft, Ethosuximide 250 mg/5 ml Oral solution, Ethosuximide 250 mg/5ml Oral solution. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Ethosuximide Roma 500 mg/5 ml Oral solution, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ethosuximide gives selective control of absence seizures (petit mal) even when complicated by grand mal.
It is also indicated for myoclonic seizures.
Posology
Adults, elderly patients and children over 6 years of age:
The treatment is started at a daily dose of 500 mg.
Depending on the patient's tolerance, the dose is increased every five to seven days in increments of max. 250 mg until the seizures are controlled by a daily dose of 1000- 1500 mg. In an individual case, a daily dose of 2000 mg, 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 medicinal product is well tolerated. Higher daily doses should be taken in 2 or 3 single doses, however.
The probability of dose-dependent undesirable effects can be reduced by careful dosing (small initial dose at the start of treatment, gradual increase of dose) and by taking the medicinal product during or after meals.
Anti-epileptic therapies are principally long-term therapies. A specialist (neurologist, neuropaediatrician) should decide about the start, duration and discontinuation of ethosuximide on an individual basis.
In general, reduction of the dose and discontinuation of the medicinal product should not be considered before the patient has been free from fits for 2-3 years.
The medicinal product must be discontinued by reducing the dose gradually over a period of one to two years. Children may be allowed to outgrow the dose per kg body weight instead of adjusting the dose according to their age, however, it must be ensured that the EEC findings do not deteriorate.
Special populations
Haemodialysis patients
Ethosuximide is dialysable. Haemodialysis patients therefore require a supplementary dose or a modified dose regimen. During a dialysis period of four hours, 39% to 52% of the dose taken is removed.
Paediatric population
Children under 2 years:
The treatment is started at a daily dose of 125 mg (1.25 ml). The dose is increased gradually in small increments every few days until the fits are controlled.
Children between 2 and 6 years:
The treatment is started at a daily dose of 250 mg (2.5 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 daily dose is 1000 mg.
The data available from clinical studies of the use of ethosuximide in children and adolescents are described in section 5.1.
Method of administration
Ethosuximide Oral Solution is for oral use.
The solution can be taken during or after meals.
A 10 ml graduated oral syringe and a bottle neck adaptor are provided to aid dosing.
Hypersensitivity to the active substance, other succinimides or to any of the excipients listed in section 6.1.
Porphyria.
Since ethosuximide may interact with concurrently administered antiepileptic drugs, periodic serum level determinations of these drugs may be necessary (e.g. ethosuximide may elevate phenytoin serum levels and valproic acid has been reported to both increase and decrease ethosuximide levels).
The plasma concentrations of ethosuximide may be reduced by carbamazepine, primidone, phenobarbitone and lamotrigine and increased by isoniazid. The simultaneous use of medicinal products affecting the central nervous system, alcohol or convulsion-inducing substances and ethosuximide should be avoided.
Women of childbearing potential
Women of childbearing potential should be advised by their doctor of the necessity of planning and monitoring a pregnancy before starting the treatment with ethosuximide. Patients should be advised to tell their doctor immediately if they have become pregnant during the treatment.
Pregnancy
The treatment with ethosuximide should not be interrupted during pregnancy without the consent of a physician as the sudden discontinuation of the treatment or uncontrolled reduction of the dose may result in recurrence of epileptic seizures which may harm the pregnant woman and/or the unborn child. Ethosuximide crosses the placenta. Studies in animals have shown reproductive toxicity (see section 5.3). Specific congenital malformations have not been observed in children of mothers exposed to ethosuximide monotherapy during pregnancy. The risk of malformations during anti-epileptic therapy is increased by a factor of 2 to 3 compared to the expected incidence of about 3% in the general population. Most common malformations reported are cleft lip, cardiovascular malformations and neural tube defects. Multiple antiepileptic drug therapies are associated with a higher risk of congenital malformation so that monotherapy should be practised during pregnancy whenever possible.
Patients should be informed of the increased risk of malformations and prenatal diagnostic measures should be offered.
The lowest effective dose ensuring seizure control must not be exceeded, particularly during the 20th and 40th day of pregnancy. The ethosuximide serum concentration of the pregnant woman must be regularly monitored.
Folic acid supplementation is recommended in patients planning to have a baby and during pregnancy. To prevent vitamin K1 deficiency and reduce the risk for haemorrhages in newborn infants, women should be given vitamin K1 during the last month of pregnancy.
Breast-feeding
Ethosuximide is excreted into breast milk reaching concentrations up to 94% of the maternal serum concentrations (see section 5.2). Sedation, poor suckling and irritability have been observed in individual breast-fed infants.
Breast-feeding should be discontinued during treatment with ethosuximide.
Fertility
There are no human data on the effect of the active substance ethosuximide on male or female fertility.
During the adjustment phase, at higher doses and in combination with other medicinal products affecting the central nervous system reactivity can be impaired to an extent that the ability to drive or operate machines is affected. This may even be the case when ethosuximide is taken as prescribed, and especially in connection with alcohol.
Therefore, patients should not drive, operate machines or perform any other potentially hazardous activities, at least not during the adjustment phase of the treatment. The decision will be taken in each case by the attending doctor considering the patient's individual response and the respective dose.
Whenever evaluating an overdose, potential multiple intoxication should principally not be excluded e.g. several medicinal products have been taken with a suicidal intent. The symptoms of overdose are potentiated under the influence of alcohol and other CNS depressants.
Symptoms of intoxication
Ethosuximide has a low toxicity. The symptoms listed as undesirable effects such as tiredness, lethargy, depression and agitation, also irritability, are more frequent or severe in the case of intoxication.
If intoxication is suspected, it is recommended to determine the plasma concentration of the antiepileptics.
Treatment of intoxication
Significant overdoses require initial gastric lavage and the administration of activated charcoal as well as monitoring of the cardiovascular and respiratory systems in an intensive care unit. There is no specific antidote. Haemodialysis may be useful.
Ask anything about Ethosuximide Roma 500 mg/5 ml Oral solution. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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