Ethosuximide Essential Generics 250 Mg/5 Ml Syrup
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250 mg/5 ml Syrup
Ethosuximide EP00120
Read all of this leaflet carefully before you start using this medicine.
• 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 symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What this medicine Is and what It Is used for
2. Before you take Emeside Syrup
3. How to take Emeside Syrup
4. Possible side effects
5. How to store Emeside Syrup
6. Further information
Emeside syrup contains ethosuximide which is an anti-epileptic.
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 Emeside syrup if you:
• are allergic to ethosuximide, other similar medicines called succinimides, or to any of the other ingredients (see Section 6)
• 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.
Take special care with Emeside syrup
Before taking Emeside syrup, tell your doctor if you:
• have liver or kidney disease
• are pregnant or planning a pregnancy, or if you are breast-feeding.
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, immediately contact your doctor.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, and herbal preparations.
Some medicines may be affected by Emeside or they may affect how well Emeside will work. Tell your doctor or pharmacist if you are taking:
• isoniazid, a medicine used for certain types of infections
• other medicines to control epilepsy, in particular carbamazepine, phenytoin, sodium valproate. If Emeside is to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.
Pregnancy
Emeside may affect the unborn baby.
However, it is very important to control your fits while you are pregnant.
If you need to take Emeside, your doctor can help you decide whether or not to take it during pregnancy.
Breast-feeding
DO NOT take Emeside syrup if you are breastfeeding, as it can pass into breast milk.
Ask your doctor for advice before taking any medicine.
Driving and using machines
Emeside syrup may cause drowsiness.
If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.
Important information about some of the ingredients of Emeside syrup • sucrose (and other sugars)
Emeside syrup contains sucrose and other sugars which should be taken into account in patients with diabetes.
- Each 5 ml of Emeside syrup contains 3.06 g sucrose.
- Emeside syrup also contains other sugars. Each 5 ml of Emeside syrup contains between 0.16 g and 0.22 g of other sugars.
Always take Emeside syrup exactly as your doctor has told you and always read the label. Your doctor will decide on the appropriate dose to suit your condition. Ask 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 Emeside syrup, rinse the mouth -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.
Doses
Adults, elderly and children over 6 years:
the usual starting dose is 10 ml a day.
Your doctor may increase your dose by 5 ml a day every 5 to 7 days until your epilepsy is well controlled.
A maximum dose of 40 ml a day, taken in divided doses, may occasionally be necessary. Do NOT change the dose yourself.
Children under 6 years: 5 ml a day.
Your doctor may increase the dose slowly to a maximum of 20 ml daily.
Blood tests may be carried out to check the level of ethosuximide in your body.
If you take more than you should
If you take more Emeside syrup than you should you may feel very drowsy or confused.
1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.
2. Take the bottle and any remaining syrup with you so that people can see what you have taken.
3. Do this even if you feel well.
If you forget to take
If you forget to take a dose take it as soon as you remember, but if it is almost time for your next dose, skip the missed dose and continue as usual.
Do not use a double dose to make up for a missed dose.
If you stop taking
Stopping this medicine suddenly may make your seizures worse. The doctor will advise you how to stop the medicine gradually. Keep taking this medicine for as long as the doctor tells you to. Emeside helps to control your condition, but does not cure it. Therefore you must take your medicine every day, even if you feel well.
Do not let yourself run out of medicine, especially over the weekends or on holidays.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Emeside syrup can cause side effects, although not everybody gets them. Do not be alarmed by this list of possible side effects. You may not experience any of them.
STOP taking the syrup and seek medical help immediately if you have any of the following allergic reactions:
• difficulty breathing or swallowing, swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised lumps
• blistering of the mouth, eyes, and genital region, and patchy areas of rash, peeling skin.
Seek immediate medical attention if you have any of the following symptoms:
• fever, sore throat, mouth ulcers, bruising or bleeding, repeated infections or infections that will not go away. This may be due to changes in your blood. Blood tests may be carried out to test for this
• increased seizures (fits). Blood tests may be carried out and your doctor may adjust the dose
• fever, rash, painful joints, or kidney inflammation (you may not be able to feel this) which is a general reaction affecting many of the body organs, called a Lupus-like reaction reported in children.
Your doctor may wish to perform repeated blood or urine tests.
Tell your doctor if you get any of the following side effects:
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
EP00120
• swelling of the tongue
• irritability
• hyperactivity
• sleep disturbances, night terrors
• inability to concentrate
• aggressiveness
• feeling paranoid or suspicious
• increased sexual drive
• short-sightedness
• vaginal bleeding.
The following side effects usually settle without changing the dose:
• nausea, vomiting, distaste for food, anorexia or stomach ache
• feeling of extreme happiness, irritability or excitement
• lack of emotion or interest
• depression
• feeling tired or drowsy, dizzy
• headache
• unusual limb movements, problems with body co-ordination
• dislike of bright light.
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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme www .mhra.gov.uk/yellowcard
5. How to store Emeside Syrup
• Keep out of the reach and sight of children.
• Do not take after the expiry date which is stated on the bottle label and on the carton. The expiry date refers to the last day of that month.
• Store below 30°C. Do not refrigerate or freeze.
• Do not throw it away with your household waste or in water. Return all the unwanted medicine to your pharmacist. This will help to protect the environment.
6. Further information
What Emeside Syrup contains
• The active ingredient is ethosuximide (250 mg per 5 ml).
• The other ingredients are:
sucrose, water, blackcurrant juice, saccharin sodium.
(See end of Section 2 for further information on sucrose).
What Emeside Syrup looks like and contents of the pack
Emeside Syrup is a dark red liquid with the smell and flavour of blackcurrant.
It is available in amber glass bottles of 200 ml.
Marketing Authorisation Holder
Essential Pharma Ltd., 7 Egham Business Village, Crabtree Road, Egham, Surrey TW20 8RB.
Manufacturer
Famar Nederland B.V., Industrieweg 1,5531 AD Bladel, The Netherlands.
This leaflet was last revised in
January 2015
'Emeside','Essential Pharma' and the Essential Pharma logo are registered trade marks.