GRIFOXINA 500 mg Tabletki Powlekane

Treść ulotki

1. GRIFOXINA 500 mg film-coated tablets, 1000 mg film-coated tablets
   1. WHAT IS GRIFOXINA AND WHAT IT IS USED FOR
   2. BEFORE TAKING GRIFOXINA
   3. HOW TO TAKE GRIFOXINA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE GRIFOXINA
   6. OTHER INFORMATION

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

Levetiracetam
Generic Equivalent

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, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What GRIFOXINA is and what it is used for
• 2. Before taking GRIFOXINA
• 3. How to take GRIFOXINA
• 4. Possible side effects
• 5. How to store GRIFOXINA
• 6. Further information

1. WHAT IS GRIFOXINA 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 seizures).
GRIFOXINA is used:

• alone in patients starting from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures with or without secondary generalization.
• as an addition to other antiepileptic medicines to treat:
• partial-onset seizures, with or without generalization
• myoclonic seizures in adults and adolescents starting from 12 years of age with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures in patients starting from 12 years of age with idiopathic generalized epilepsy.

2. BEFORE TAKING GRIFOXINA

Do not take GRIFOXINA

• If you are allergic (hypersensitive) to levetiracetam or 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 suffer from kidney problems, follow your doctor's instructions. The latter may decide whether the dose needs to be corrected.
• If you notice an increase in the severity of seizures (for example, an increase in the number), contact your doctor.
• A limited number of people treated with antiepileptics such as Levetiracetam have experienced self-harmful thoughts or suicidal ideas. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

Taking GRIFOXINA with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines,
including those without a prescription.

Taking GRIFOXINA with food and drink
You can 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, tell your doctor. GRIFOXINA
should not be used during pregnancy unless strictly necessary. The potential risk to the fetus
is unknown. Levetiracetam has shown undesirable reproductive effects in animal studies with
higher dose levels than those necessary to control seizures.
Breastfeeding is not recommended during treatment.

Driving and using machines
GRIFOXINA may reduce your ability to drive vehicles or use tools or machinery as
GRIFOXINA may cause drowsiness. This is more likely at the beginning of treatment or after an
increase in the dose. You should not drive or use machinery until you have verified that your ability to
perform these activities is not affected.

3. HOW TO TAKE GRIFOXINA

Always take GRIFOXINA exactly as your doctor or pharmacist has told you.
If you have any doubts, ask your doctor.
GRIFOXINA must be taken twice a day, once in the morning and once in the evening, approximately at
the same time each day. Take the number of tablets following your doctor's instructions.

Monotherapy
Dosage 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 start taking
GRIFOXINA for the first time, your doctor will prescribe a lower dosefor 2 weeks before giving you 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.

Add-on therapy
Dosage for adults and adolescents (from 12 to 17 years) 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 and swallow them with a glass of water.
The score line is only to facilitate breaking the tablet to make it easier to swallow and not
to divide it into two equal doses. That is, if the tablet is divided to make swallowing easier, the
two halves must be taken at the same time.

Duration of treatment:

• GRIFOXINA is used as chronic treatment. Treatment with GRIFOXINA should last as long as prescribed by your doctor.
• Do not stop treatment without your doctor's advice as this could increase the number of seizures. If your doctor decides to stop treatment with GRIFOXINA, they will give you instructions regarding the gradual discontinuation of GRIFOXINA.

If you take more GRIFOXINA than you should:
The possible side effects of an overdose of GRIFOXINA are drowsiness, agitation, aggression,
decreased attention, respiratory inhibition and coma. Contact your doctor if you have taken more tablets than
you should. The doctor will determine the best possible 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:
In case of discontinuation of treatment, as with any other antiepileptic drug, GRIFOXINA must
be discontinued gradually to avoid an increase in seizures.
If you have any questions about the use of GRIFOXINA, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, GRIFOXINA can cause side effects, although not everybody gets them.
Tell your doctor if you have any of the following effects that worry you.
Some side effects such as drowsiness, fatigue and dizziness may be more common
at the beginning of treatment or when the dose is increased. These effects should, in any case, decrease
over time.

Very common(affects more than 1 in 10 people):

• nasopharyngitis;
• drowsiness, headache.

Common(affects 1 to 10 people in 100):

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

Uncommon(affects 1 to 10 people in 1,000):

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

Rare(affects 1 to 10 people in 10,000):

• infection;
• decreased number of all types of blood cells;
• suicide, personality disorder (behavioral problems), thought disorders (slowness of thought, 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 that look like small targets (dark spots in the center surrounded by a lighter halo, in turn surrounded by a darker ring) (erythema multiforme);a widespread rash with blisters and skin that tends to exfoliate especially in the area of the mouth, nose, eyes and genital area ( Stevens-Johnson Syndrome), a more severe form causes the skin to peel off in more than 30% of the body surface ( toxic epidermal necrolysis).

If any of these side effects gets worse, or if you notice any side effects

5. HOW TO STORE GRIFOXINA

Keep out of the reach and sight of children.
Do not use GRIFOXINA after the expiry date which is stated on the packaging and blister.
The expiry date refers to the last day of the month.
This medicine does not require any particular storage conditions.
Medicines should 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 ingredient 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.
500 mg tablets are coated with Opadry II yellow 85F32004 containing: partially hydrolyzed polyvinyl alcohol,
titanium dioxide (E171), polyethylene glycol, talc, yellow iron oxide (E172).
1000 mg tablets are coated with Opadry II white 85F18422 containing partially hydrolyzed polyvinyl alcohol,
titanium dioxide (E171), polyethylene glycol, talc.

Description of the appearance of GRIFOXINA and contents of the pack
GRIFOXINA500 mg film-coated tablets are packaged in PVC/Aclar-Al blisters of 60
tablets

GRIFOXINA1000 mg film-coated tablets are packaged in PVC/Aclar-Al blisters of 30
tablets
Not all pack sizes may be marketed.

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

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

This leaflet was last revised on 18 April 2013