Consumer medicine information

Zarontin 250 mg/5 mL Syrup

Ethosuximide

BRAND INFORMATION

Brand name

Zarontin

Active ingredient

Ethosuximide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Zarontin 250 mg/5 mL Syrup.

1. Why am I using Zarontin?


Zarontin contains the active ingredient ethosuximide. Zarontin is used to control epilepsy in children and children. Zarontin is used to control petit mal seizures. For more information, see Section 1. Why am I using Zarontin? in the full CMI.

2. What should I know before I use Zarontin?


Do not use if you have ever had an allergic reaction to Zarontin, succinimides or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other allergies, medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use Zarontin? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Zarontin and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Zarontin?

  • Swallow Zarontin capsules while with a full glass of water.
  • For Zarontin syrup, shake the bottle well and accurately pour the dose with a medicine measure before taking it.

More instructions can be found in Section 4. How do I use Zarontin? in the full CMI.

5. What should I know while using Zarontin?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Zarontin.
  • Tell your doctor immediately if you are having thoughts about suicide or self-harm.
  • If you become pregnant while taking Zarontin, tell you doctor.
  • If you are breastfeeding, watch your baby carefully.
Things you should not do
  • Do not stop using this medicine unless your doctor tells you to.
  • Do not give Zarontin to anyone else, even if their symptoms seem similar to yours or they have the same condition as you.
Driving or using machines
  • Zarontin may cause dizziness, light-headedness, tiredness, drowsiness and affect alertness. Make sure you know how you react to Zarontin before you drive a car, operate machinery, or do anything else that could be dangerous if you are affected.
Drinking alcohol
  • Drinking alcohol when taking Zarontin can make you more sleepy, dizzy or lightheaded.
Looking after your medicine
  • Keep your capsules in a cool dry place, where the temperature stays below 30°C.
  • Keep your syrup in a cool dry place, where the temperature stays below 25°C
  • Keep it where children cannot reach it.

For more information, see Section 5. What should I know while using Zarontin? in the full CMI.

6. Are there any side effects?


Speak to your doctor or pharmacist if you have any less serious side effects and they worry you. Tell your doctor as soon as possible if you: have thoughts of suicide or self-harm, notice unusual changes in mood or show signs of depression. Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects: more frequent or severe seizures, severe depression, apparent intentions of suicide, aggressive behaviour, frequent infections, frequent nosebleeds, persistent nausea or vomiting, sudden signs of allergy, severe skin rash. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Zarontin

Active ingredient

Ethosuximide

Schedule

S4

 

1 Name of Medicine

Ethosuximide.

2 Qualitative and Quantitative Composition

Zarontin contains the active component ethosuximide.
Each Zarontin capsule contains 250 mg ethosuximide. Zarontin syrup contains ethosuximide 250 mg/5 mL.
Excipients with known effect. Zarontin syrup contains benzoates, saccharin and sugars.
Zarontin capsules contains hydroxybenzoates and sulfites. Sulfites may be present in residual amounts from the manufacturing process.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Zarontin capsules. Clear oval soft gelatin capsules.
Zarontin syrup. A clear slightly yellowish to slightly pinkish liquid.

4 Clinical Particulars

4.9 Overdose

Symptoms. Acute overdoses may produce nausea, vomiting and CNS depression including coma with respiratory depression. A relationship between ethosuximide toxicity and its plasma levels has not been established. The therapeutic range is 40 microgram/mL to 100 microgram/mL, although levels as high as 150 microgram/mL have been reported without signs of toxicity.
Treatment. Treatment is symptomatic and supportive of respiratory and cardiovascular functions. There is no specific antidote available. Activated charcoal may be used to reduce drug absorption and is most effective when administered within 1 hour of ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via nasogastric tube once the airway is protected.
Haemodialysis may be useful, but forced diuresis and exchange transfusions are ineffective.
Ipecac induced emesis is not recommended because of the potential for CNS depression.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSETHOSU.gif Ethosuximide is chemically described as α-ethyl-α-methylsuccinimide with an empirical formula of C7H11NO2 and a molecular weight of 141.17. The molecular structure of ethosuximide is shown above.
Ethosuximide is a white or almost white powder or waxy solid, freely soluble in water, very soluble in alcohol, in ether and in methylene chloride.
CAS number. 77-67-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ZARONTST.gif