PACKAGE LEAFLET: INFORMATION FOR THE USER

GRIFOXINA 500 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Generic Medicine
Please read this leaflet carefully before taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What GRIFOXINA is and what it is used for
Before you take GRIFOXINA
How to take GRIFOXINA
Possible side effects
How to store GRIFOXINA
Further information

1. WHAT GRIFOXINA IS AND WHAT IT IS USED FOR

GRIFOXINA 500 mg film-coated tablets
GRIFOXINA 1000 mg film-coated tablets
is an antiepileptic medicine (a medicine used to treat epileptic seizures).
GRIFOXINA is used:

as monotherapy in patients aged 16 years and older with newly diagnosed epilepsy, to treat partial-onset seizures with or without secondary generalization.
as add-on therapy to other antiepileptic medicines to treat:
- partial-onset seizures, with or without generalization
- myoclonic seizures in adults and adolescents aged 12 years and older with juvenile myoclonic epilepsy
- primary generalized tonic-clonic seizures in patients aged 12 years and older with idiopathic generalized epilepsy.

2. BEFORE TAKING GRIFOXINA

Do not take GRIFOXINA

If you are allergic (hypersensitive) to levetiracetam or to any of the excipients of GRIFOXINA (see list in section 6).

Take special care with GRIFOXINA
Talk to your doctor before taking GRIFOXINA

If you have kidney problems, follow your doctor's instructions. Your doctor may decide whether the dose needs to be adjusted.
If you notice an increase in the severity of seizures (for example, an increase in frequency), contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam have experienced self-harming thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking GRIFOXINA with other medicines
Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines,
including those not requiring a prescription.
Taking GRIFOXINA with food and drink
You may take GRIFOXINA with or without food. As a precautionary safety measure, do not take
GRIFOXINA with alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant or think you may be pregnant, inform your doctor. GRIFOXINA
should not be used during pregnancy unless strictly necessary. The potential risk to the fetus
is unknown. Levetiracetam has shown adverse reproductive effects in animal studies at dose levels higher than those required to control seizures.
Breastfeeding is not recommended during treatment.
Driving and using machines
GRIFOXINA may reduce your ability to drive or operate tools or machinery because
GRIFOXINA may cause drowsiness. This is more likely at the beginning of treatment or after a
dose increase. You must not drive or use machinery until you have determined that your ability to perform these activities is not impaired.

3. HOW TO TAKE GRIFOXINA

Always take GRIFOXINA exactly as instructed by your doctor or pharmacist.
If you have any doubts, consult your doctor.
GRIFOXINA should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day. Take the number of tablets as directed by your doctor.

Monotherapy
Dose for adults and adolescents (from 16 years of age):
Typical dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day. When you first start taking GRIFOXINA, your doctor will prescribe a lower dose for 2 weeks before increasing to the lowest typical dose.
Example: if your daily dose is 1,000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more:
Typical dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.
Example: if your daily dose is 1,000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Method of administration:
Take the tablets at the same time each day, swallowing them with a glass of water.
The score line on the tablet is only intended to facilitate swallowing by allowing the tablet to be broken, and is not intended for dividing the tablet into two equal doses. That is, if the tablet is divided to aid swallowing, both halves must be taken at the same time.

Duration of treatment:

GRIFOXINA is used as a chronic treatment. Treatment with GRIFOXINA should last as long as prescribed by your doctor.
Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures. If your doctor decides to discontinue treatment with GRIFOXINA, they will provide instructions for gradually tapering off the medication.

If you take more GRIFOXINA than you should:
Possible adverse effects of an overdose of GRIFOXINA include drowsiness, agitation, aggression, reduced attention, respiratory depression, and coma. Contact your doctor immediately if you have taken more tablets than prescribed. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take GRIFOXINA:
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for the missed tablet.

If you stop taking GRIFOXINA:
As with any other antiepileptic medicine, GRIFOXINA must be discontinued gradually to avoid an increase in seizure frequency.

If you have any questions about the use of GRIFOXINA, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE EFFECTS

Like all medicines, GRIFOXINA may cause adverse effects, although not everyone experiences them.
Inform your doctor if you experience any of the following effects that concern you.
Some adverse effects such as drowsiness, fatigue, and dizziness may be more common at the beginning of treatment or when the dose is increased. However, these effects should decrease over time.
Very common (affects more than 1 in 10 patients):

nasopharyngitis;
drowsiness, headache.

Common (affects from 1 to 10 in 100 patients):

anorexia (loss of appetite);
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
convulsion, balance disorder, dizziness (sensation of instability), lethargy, tremor (involuntary tremors);
vertigo (sensation of spinning);
cough;
abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (feeling weak).

Uncommon (affects from 1 to 10 in 1,000 patients):

decrease in the number of platelets in the blood, decrease in the number of white blood cells in the blood;
weight loss, weight gain;
suicide attempt and suicidal ideation, mental disorder, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
diplopia (double vision), blurred vision;
abnormal liver function test;
hair loss, eczema, pruritus;
muscle weakness, myalgia (muscle pain);
injury.

Rare (affects from 1 to 10 in 10,000 patients):

infection;
decrease in the number of all types of blood cells;
suicide, personality disorder (behavioral problems), thought disturbances (slowed thinking, inability to concentrate);
uncontrollable muscle spasms involving the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
pancreatitis;
liver failure, hepatitis;
skin rash with the appearance of blisters resembling small targets (dark spots in the center surrounded by a lighter ring, which in turn are surrounded by a darker ring) (erythema multiforme); a widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genital area (Stevens-Johnson syndrome); a more severe form causing skin detachment over more than 30% of the body surface (toxic epidermal necrolysis).

If any of the adverse effects worsen, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. HOW TO STORE GRIFOXINA

Keep out of the reach and sight of children.
Do not use GRIFOXINA after the expiry date stated on the packaging and blister.
The expiry date refers to the last day of the month.
This medicinal product does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer use. This will help protect
the environment.

6. OTHER INFORMATION

What GRIFOXINA contains
The active substance is called levetiracetam.
Each 500 mg tablet contains 500 mg of levetiracetam.
Each 1000 mg tablet contains 1000 mg of levetiracetam.
The excipients are:
Tablet core: povidone (K30), croscarmellose sodium, polyethylene glycol, anhydrous colloidal silica,
magnesium stearate.
The 500 mg tablets are coated with Opadry II yellow 85F32004 containing: partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc, yellow iron oxide (E172).
The 1000 mg tablets are coated with Opadry II white 85F18422 containing partially hydrolysed polyvinyl alcohol, titanium dioxide (E171), polyethylene glycol, talc.

Description of the appearance of GRIFOXINA and contents of the pack
GRIFOXINA 500 mg film-coated tablets are packed in PVC/Aclar-Al blisters containing 60 tablets.
GRIFOXINA 1000 mg film-coated tablets are packed in PVC/Aclar-Al blisters containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
PIAM Farmaceutici S.p.A. – Via Padre G. Semeria, 5 – 16131 Genoa, Italy

Responsible producer for batch release
PSI Supply nv
Axxes Business Park - Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium

This leaflet was last approved on April 18, 2013