Emeside® 250 mg Capsules

(ethosuximide)

This medicine is available as the above name but will be referred to as Emeside Capsules throughout the following leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. 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.

What is in this leaflet

• 1. What Emeside Capsules are and what they are used for

2. What you need to know before you take Emeside Capsules

3. How to take Emeside Capsules

4. Possible side effects

5. How to store Emeside Capsules

6. Contents of the pack and other information

• 1. What Emeside Capsules are and what they are used for

Emeside Capsules contain 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).

2. what you need to know before you take emeside capsules

Do not take Emeside Capsules:

• if you are allergic to ethosuximide, other similar medicines called succinimides, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to soya oil (see end of this section)
• if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder).

If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Emeside Capsules:

• if you have liver or kidney disease
• if you 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.

Other medicines and Emeside Capsules

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

Some medicines may be affected by ethosuximide or they may affect how well ethosuximide 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 Capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.

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 for advice before taking this medicine.

Pregnancy

Ethosuximide may affect the unborn baby.

However, it is very important to control your fits while you are pregnant.

If you need to take ethosuximide, your doctor can help you decide whether or not to take it during pregnancy.

Breast-feeding

DO NOT take Emeside Capsules if you are breast-feeding, as it can pass into breast milk.

Driving and using machines

Emeside Capsules may cause drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.

Emeside Capsules contain sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin

• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate

This medicine contains 0.6 mg sodium ethyl hydroxybenzoate and 0.3 mg sodium propyl hydroxybenzoate in each capsule, which may cause allergic reactions (possibly delayed).

• soya lecithin

This medicine contains traces of soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take emeside capsules

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.
• Swallow the capsules whole with a drink of water.
• Take the capsules with or without food, whichever you prefer.

Recommended dose

Adults, elderly and children over 6 years: the usual starting dose is 2 capsules a day.

Your doctor may increase your dose by 1 capsule a day every 5 to 7 days until your epilepsy is well controlled.

A maximum dose of 8 capsules a day, taken in divided doses, may occasionally be necessary.

Do NOT change the dose yourself.

Use in children under 6 years

Children under 6 years and those unable to swallow capsules will be given ethosuximide in liquid form.

Blood tests may be carried out to check the level of ethosuximide in your body.

If you take more Emeside Capsules than you should

If you take more capsules than you should, you may feel very drowsy or confused.

• 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

• 2. Take the container and any remaining capsules with you so that people can see what you have taken.

• 3. Do this even if you feel well.

If you forget to take Emeside Capsules

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 forgotten dose and continue as usual.

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

If you stop taking Emeside Capsules

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. Ethosuximide 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 weekend or on holidays.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 capsules 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.
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
• 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.
• 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
• 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 via the Yellow Card Scheme at: 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.

5. how to store emeside capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after Exp. The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the container tightly closed in order to protect from light and moisture. Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. If the capsules become discoloured or shows signs of any deterioration, you should seek the advice of your pharmacist.

6. contents of the pack and other information

What Emeside Capsules contain

• The active substance is ethosuximide. Each soft capsule contains 250 mg ethosuximide.
• The other ingredients are macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, medium chain triglycerides, soya lecithin and purified water. (See end of Section 2 for further information on sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin).

What Emeside Capsules look like and contents of the pack

Emeside Capsules are oval, yellowish clear soft gelatin capsules. They are available in packs of 56 capsules.

PL: 15814/1462 | POM |

Manufactured by Catalent France Beinheim SA, 74, rue Principale, 67930 Beinheim, France.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Emeside is a registered trade mark of Essential Pharma Limited. Leaflet revision and issue date (ref.): 21.01.2021.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796

Ethosuximide Essential Generics

(ethosuximide)

This medicine is available as the above name but will be referred to as Ethosuximide capsules throughout the following leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. 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.

What is in this leaflet

• 1. What Ethosuximide capsules are and what they are used for

2. What you need to know before you take Ethosuximide capsules

3. How to take Ethosuximide capsules

4. Possible side effects

5. How to store Ethosuximide capsules

6. Contents of the pack and other information

• 1. What Ethosuximide capsules are and what they are used for

Ethosuximide capsules contain 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).

2. what you need to know before you take ethosuximide capsules

Do not take Ethosuximide capsules:

• if you are allergic to ethosuximide, other similar medicines called succinimides, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to soya oil (see end of this section)
• if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder).

If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ethosuximide capsules:

• if you have liver or kidney disease
• if you 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.

Other medicines and Ethosuximide capsules

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

Some medicines may be affected by ethosuximide or they may affect how well ethosuximide 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 Ethosuximide capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.

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 for advice before taking this medicine.

Pregnancy

Ethosuximide may affect the unborn baby.

However, it is very important to control your fits while you are pregnant.

If you need to take ethosuximide, your doctor can help you decide whether or not to take it during pregnancy.

Breast-feeding

DO NOT take Ethosuximide capsules if you are breast-feeding, as it can pass into breast milk.

Driving and using machines

Ethosuximide capsules may cause drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.

Ethosuximide capsules contain sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin

• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate

This medicine contains 0.6 mg sodium ethyl hydroxybenzoate and 0.3 mg sodium propyl hydroxybenzoate in each capsule, which may cause allergic reactions (possibly delayed).

• soya lecithin

This medicine contains traces of soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take ethosuximide capsules

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.
• Swallow the capsules whole with a drink of water.
• Take the capsules with or without food, whichever you prefer.

Recommended dose

Adults, elderly and children over 6 years: the usual starting dose is 2 capsules a day.

Your doctor may increase your dose by 1 capsule a day every 5 to 7 days until your epilepsy is well controlled.

A maximum dose of 8 capsules a day, taken in divided doses, may occasionally be necessary.

Do NOT change the dose yourself.

Use in children under 6 years

Children under 6 years and those unable to swallow capsules will be given ethosuximide in liquid form.

Blood tests may be carried out to check the level of ethosuximide in your body.

If you take more Ethosuximide capsules than you should If you take more capsules than you should, you may feel very drowsy or confused.

• 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

• 2. Take the container and any remaining capsules with you so that people can see what you have taken.

• 3. Do this even if you feel well.

If you forget to take Ethosuximide capsules

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 forgotten dose and continue as usual.

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

If you stop taking Ethosuximide capsules

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. Ethosuximide 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 weekend or on holidays.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 capsules 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.
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
• 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.
• 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
• 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 via the Yellow Card Scheme at: 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.

5. how to store ethosuximide capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after Exp. The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the container tightly closed in order to protect from light and moisture. Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. If the capsules become discoloured or shows signs of any deterioration, you should seek the advice of your pharmacist.

6. contents of the pack and other information

What Ethosuximide capsules contain

• The active substance is ethosuximide. Each soft capsule contains 250 mg ethosuximide.
• The other ingredients are macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, medium chain triglycerides, soya lecithin and purified water. (See end of Section 2 for further information on sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin).

What Ethosuximide capsules look like and contents of the pack

Ethosuximide capsules are oval, yellowish clear soft gelatin capsules.

They are available in packs of 56 capsules.

PL: 15814/1462 POM

Manufactured by Catalent France Beinheim SA, 74, rue Principale, 67930 Beinheim, France.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (ref.): 21.01.2021.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796

Ethosuximide OPD 250 mg Capsules

(ethosuximide)

This medicine is available as the above name but will be referred to as Ethosuximide capsules throughout the following leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. 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.

What is in this leaflet

• 1. What Ethosuximide capsules are and what they are used for

2. What you need to know before you take Ethosuximide capsules

3. How to take Ethosuximide capsules

4. Possible side effects

5. How to store Ethosuximide capsules

6. Contents of the pack and other information

• 1. What Ethosuximide capsules are and what they are used for

Ethosuximide capsules contain 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).

2. what you need to know before you take ethosuximide capsules

Do not take Ethosuximide capsules:

• if you are allergic to ethosuximide, other similar medicines called succinimides, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to soya oil (see end of this section)
• if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder).

If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ethosuximide capsules:

• if you have liver or kidney disease
• if you 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.

Other medicines and Ethosuximide capsules

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

Some medicines may be affected by ethosuximide or they may affect how well ethosuximide 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 Ethosuximide capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.

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 for advice before taking this medicine.

Pregnancy

Ethosuximide may affect the unborn baby.

However, it is very important to control your fits while you are pregnant.

If you need to take ethosuximide, your doctor can help you decide whether or not to take it during pregnancy.

Breast-feeding

DO NOT take Ethosuximide capsules if you are breast-feeding, as it can pass into breast milk.

Driving and using machines

Ethosuximide capsules may cause drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.

Ethosuximide capsules contain sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin

• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate

This medicine contains 0.6 mg sodium ethyl hydroxybenzoate and 0.3 mg sodium propyl hydroxybenzoate in each capsule, which may cause allergic reactions (possibly delayed).

• soya lecithin

This medicine contains traces of soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take ethosuximide capsules

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.
• Swallow the capsules whole with a drink of water.
• Take the capsules with or without food, whichever you prefer.

Recommended dose

Adults, elderly and children over 6 years: the usual starting dose is 2 capsules a day.

Your doctor may increase your dose by 1 capsule a day every 5 to 7 days until your epilepsy is well controlled.

A maximum dose of 8 capsules a day, taken in divided doses, may occasionally be necessary.

Do NOT change the dose yourself.

Use in children under 6 years

Children under 6 years and those unable to swallow capsules will be given ethosuximide in liquid form.

Blood tests may be carried out to check the level of ethosuximide in your body.

If you take more Ethosuximide capsules than you should

If you take more capsules than you should, you may feel very drowsy or confused.

• 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

• 2. Take the container and any remaining capsules with you so that people can see what you have taken.

• 3. Do this even if you feel well.

If you forget to take Ethosuximide capsules

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 forgotten dose and continue as usual.

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

If you stop taking Ethosuximide capsules

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. Ethosuximide 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 weekend or on holidays.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 capsules 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.
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
• 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.
• 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
• 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 via the Yellow Card Scheme at: 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.

5. how to store ethosuximide capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after Exp. The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the container tightly closed in order to protect from light and moisture. Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. If the capsules become discoloured or shows signs of any deterioration, you should seek the advice of your pharmacist.

6. contents of the pack and other information

What Ethosuximide capsules contain

• The active substance is ethosuximide. Each soft capsule contains 250 mg ethosuximide.
• The other ingredients are macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, medium chain triglycerides, soya lecithin and purified water. (See end of Section 2 for further information on sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin).

What Ethosuximide capsules look like and contents of the pack

Ethosuximide capsules are oval, yellowish clear soft gelatin capsules.

They are available in packs of 56 capsules.

PL: 15814/1462 POM

Manufactured by Catalent France Beinheim SA, 74, rue Principale, 67930 Beinheim, France.

Procured from within the EU and repackaged by the Product Licence holder: O.P.D. Laboratories Ltd., Unit 6 Colonial Way, Watford, Herts WD24 4PR.

Leaflet revision and issue date (ref.): 21.01.2021.

To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796

Ethosuximide OPD 250 mg Capsules

(ethosuximide)

This medicine is available as the above name but will be referred to as Ethosuximide capsules throughout the following leaflet.

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• 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 only. 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.

What is in this leaflet

• 1. What Ethosuximide capsules are and what they are used for

• 2. What you need to know before you take Ethosuximide capsules

• 3. How to take Ethosuximide capsules

• 4. Possible side effects

• 5. How to store Ethosuximide capsules

• 6. Contents of the pack and other information

• 1. What Ethosuximide capsules are and what they are used for

Ethosuximide capsules contain 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).

2. what you need to know before you take ethosuximide capsules

Do not take Ethosuximide capsules:

• if you are allergic to ethosuximide, other similar medicines called succinimides, or any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to soya oil (see end of this section)
• if you have porphyria (a metabolism disorder which causes abdominal pains and mental disorder).

If any of the above apply to you, speak to your doctor or pharmacist.

Warnings and precautions

Talk to your doctor or pharmacist before taking Ethosuximide capsules:

• if you have liver or kidney disease
• if you 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.

Other medicines and Ethosuximide capsules

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

Some medicines may be affected by ethosuximide or they may affect how well ethosuximide 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 Ethosuximide capsules are to replace your other medicines for epilepsy, your doctor will withdraw these gradually to avoid seizures.

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 for advice before taking this medicine.

Pregnancy

Ethosuximide may affect the unborn baby.

However, it is very important to control your fits while you are pregnant.

If you need to take ethosuximide, your doctor can help you decide whether or not to take it during pregnancy.

Breast-feeding

DO NOT take Ethosuximide capsules if you are breast-feeding, as it can pass into breast milk.

Driving and using machines

Ethosuximide capsules may cause drowsiness. If this occurs do not drive, use machinery, or perform any tasks that may require you to be alert.

Ethosuximide capsules contain sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin

• sodium ethyl hydroxybenzoate and sodium propyl hydroxybenzoate

This medicine contains 0.6 mg sodium ethyl hydroxybenzoate and 0.3 mg sodium propyl hydroxybenzoate in each capsule, which may cause allergic reactions (possibly delayed).

• soya lecithin

This medicine contains traces of soya lecithin. If you are allergic to peanut or soya, do not use this medicinal product.

This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.

3. how to take ethosuximide capsules

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.
• Swallow the capsules whole with a drink of water.
• Take the capsules with or without food, whichever you prefer.

Recommended dose

Adults, elderly and children over 6 years: the usual starting dose is 2 capsules a day.

Your doctor may increase your dose by 1 capsule a day every 5 to 7 days until your epilepsy is well controlled.

A maximum dose of 8 capsules a day, taken in divided doses, may occasionally be necessary.

Do NOT change the dose yourself.

Use in children under 6 years

Children under 6 years and those unable to swallow capsules will be given ethosuximide in liquid form.

Blood tests may be carried out to check the level of ethosuximide in your body.

If you take more Ethosuximide capsules than you should

If you take more capsules than you should, you may feel very drowsy or confused.

• 1. Tell your doctor, pharmacist or nearest hospital casualty department immediately.

• 2. Take the container and any remaining capsules with you so that people can see what you have taken.

• 3. Do this even if you feel well.

If you forget to take Ethosuximide capsules

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 forgotten dose and continue as usual.

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

If you stop taking Ethosuximide capsules

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. Ethosuximide 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 weekend or on holidays.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, this medicine 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 capsules 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.
• dizziness
• hiccough
• skin rash
• weight loss, diarrhoea, abdominal pain
• thickening or enlargement of gum tissue (gum hypertrophy)
• 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.
• 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
• 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 via the Yellow Card Scheme at: 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.

5. how to store ethosuximide capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after Exp. The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the container tightly closed in order to protect from light and moisture. Do not refrigerate.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. If the capsules become discoloured or shows signs of any deterioration, you should seek the advice of your pharmacist.

6. contents of the pack and other information

What Ethosuximide capsules contain

• The active substance is ethosuximide. Each soft capsule contains 250 mg ethosuximide.
• The other ingredients are macrogol 400, gelatin, glycerin, sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate, medium chain triglycerides, soya lecithin and purified water. (See end of Section 2 for further information on sodium ethyl hydroxybenzoate, sodium propyl hydroxybenzoate and soya lecithin).