Patient Leaflet Updated 30-Aug-2023 | Roma Pharmaceuticals Limited
Ethosuximide Roma 250 mg/5 ml Oral Solution
Ethosuximide Roma 250mg/5ml oral solution
Ethosuximide
1. What Ethosuximide Roma is and what it is used for
2. What you need to know before you take Ethosuximide Roma
3. How to take Ethosuximide Roma
4. Possible side effects
5. How to store Ethosuximide Roma
6. Contents of the pack and other information
Ethosuximide Roma 250mg/5ml 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).
Ethosuximide Roma is used to treat
Talk to your doctor before taking Ethosuximide Roma, if:
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.
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.
Psychic side effects (anxiety, illusion) can occur in particular in patients with a history of psychiatric disorders. Special caution is required when Ethosuximide Roma is administered to this group of patients.
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.
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.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking 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:
If ethosuximide is being used to replace another medicine for epilepsy your doctor will withdraw these gradually to stop you getting seizures.
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 become pregnant while taking ethosuximide:
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.
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.
This medicine contains:
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will decide the dose appropriate for you or your child.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Children are at higher risk of the effects.
Stop using Ethosuximide Roma and seek medical attention immediately if you notice any of the following symptoms:
Tell your doctor or pharmacist straight away if you have any of the following side effects:
Common (affects between 1 in 10 and 1 in 100 people)
Uncommon (affects between 1 in 100 and 1 in 1,000 people)
Rare (affects between 1 in 1000 to 1 in 10,000 people)
Not known (frequency cannot be estimated from the available data)
Note: Long-term treatment may affect the patient's performance, e.g. the performance in school of children and adolescents.
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 two 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.
Ethosuximide Roma is a strawberry flavoured clear, colourless solution.
Ethosuximide Roma is packed in amber glass bottles containing 200ml sealed with a child-resistant, tamper-evident screw cap.
It comes with a 10ml oral syringe, with 0.5ml graduations, and a bottle neck adaptor.
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Manufacturer
This leaflet was last revised in August 2023
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