ZARONTIN SYRUP ethosuximide 250mg/5mL oral liquid bottle

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

ethosuximide, Quantity: 50 mg/mL

Tillgänglig från:

Clinect Pty Ltd

Läkemedelsform:

Oral Liquid, solution

Sammansättning:

Excipient Ingredients: citric acid monohydrate; saccharin sodium; sucrose; glycerol; sodium citrate dihydrate; sodium benzoate; purified water; Flavour

Administreringssätt:

Oral

Enheter i paketet:

200mL

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

ZARONTIN is indicated for the control of petit mal epilepsy.

Produktsammanfattning:

Visual Identification: A clear slightly yellowish to slightly pinkish liquid.; Container Type: Bottle; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Bemyndigande status:

Registered

Tillstånd datum:

2002-06-27

Bipacksedel

ZARONTIN
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
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,

Produktens egenskaper

1
AUSTRALIAN
PRODUCT
INFORMATION
–
ZARONTIN
(ETHOSUXIMIDE)
CAPSULES
AND
SYRUP
1
NAME OF THE 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/5mL.
Excipients with known effect:
ZARONTIN syrup contains benzoates, saccharin and sugars.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ZARONTIN Capsules: Clear medium orange capsules printed P-D 237.
ZARONTIN Syrup: A clear slightly yellowish to slightly pinkish liquid.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ZARONTIN is indicated for the control of petit mal epilepsy.
4.2 DOSE AND METHOD OF ADMINISTRATION
ZARONTIN is administered orally.
Recommended initial daily dose for children and adults is
approximately 20-30 mg/kg administered in two
divided doses. This regimen will frequently achieve plasma levels in
the therapeutic range of 40-100 mg/L
(optimum 75 mg/L). As the dose serum level relationship may be
curvilinear in individual patients dosage
should be increased by small increments.
One useful method is to increase the daily dose by 250 mg every four
to seven days until control is achieved
with minimal side effects. Dosages exceeding 1.5 g daily, in divided
doses should be administered only
under the strictest supervision of the physician. Plasma level
monitoring is recommended. ZARONTIN may
be administered in combination with other anticonvulsants when other
forms of epilepsy coexist with petit
mal.
4.3 CONTRAINDICATIONS
Ethosuximide is contraindicated in patients with hypersensitivity to
succinimides, ethosuximide or any
components of this medication.
2
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_GENERAL _
Ethosuximide, when used alone in mixed types of epilepsy, may increase
the frequency of grand mal
seizures in some patients. As with other anticonvulsants, it is
important to proceed slowly when increasing
or decreasing dosage, as well as whe