NOUMED LEVETIRACETAM levetiracetam 1000 mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 1000 mg

Available from:

NOUMED PHARMACEUTICALS PTY LTD

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: povidone; magnesium stearate; colloidal anhydrous silica; croscarmellose sodium; maize starch; titanium dioxide; hypromellose; macrogol 6000

Administration route:

Oral

Units in package:

10, 100, 60

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation,,Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME), and,Add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).

Product summary:

Visual Identification: White, capsule shaped, biconvex film coated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2022-07-05

Patient Information leaflet

Noumed Levetiracetam
1
NOUMED LEVETIRACETAM
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 NOUMED LEVETIRACETAM?
Noumed Levetiracetam contains the active ingredient levetiracetam.
Noumed Levetiracetam is used to control epilepsy.
For more information, see Section 1. Why am I using Noumed
Levetiracetam? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NOUMED LEVETIRACETAM?
Do not use if you have ever had an allergic reaction to levetiracetam
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more in
formation, see Section 2. What should I know before I use Noumed
Levetiracetam? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Noumed Levetiracetam 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 NOUMED LEVETIRACETAM?
•
For patients 12 years of age and older, the dosage is generally
between 1000 mg and 3000 mg each day, taken in two
doses.
•
For children 4 to 11 years of age the doctor will calculate the dosage
based on the child's weight and tell you how much to
give. The m
edicine is to be given twice daily.
More instructions can be found in Section 4. How do I use Noumed
Levetiracetam? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NOUMED LEVETIRACETAM?
THINGS YOU
SHOULD DO
• Tell your doctor immediately if you notice an increase in
seizures.
• Tell your doctor immediately if you have symptoms of depression or
thoughts of harming yourself.
THINGS YOU
SHOULD NOT DO
• Do not give Noumed Levetiracetam to anyone else, even if their
symptoms seem similar to yours or
they have the same condition as you.
• Do not take Noumed Levetiracetam to treat any other complaints
unl