Levetiracetam SUN - Levetiracetam uses, dose and side effects

as the sole treatment in adults and adolescents from the age of 16 with newly diagnosed epilepsy , to treat a certain type of epilepsy . Epilepsy is a condition in which patients have repeated seizures (seizures). Levetiracetam is used for the form of epilepsy where the seizures initially affect only one side of the brain, but can then spread to larger areas on both sides of the brain ( partial seizures with or without secondary generalization). Your doctor has given you levetiracetam to reduce the number of seizures
in addition to other antiepileptic drugs ( adjunctive therapy ) to treat:
- partial seizures with or without generalization in adults, adolescents and children from 4 years of age
- myoclonic seizures (short, sudden twitching of any muscle or muscle group) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy
- primarily generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents from 12 years of age with generalized epilepsy of unknown origin (the type of epilepsy considered hereditary).
Levetiracetam SUN concentrate for solution for infusion may be used when temporary administration of oral levetiracetam is not possible.

What you need to know before you receive Levetiracetam SUN

Do not use Levetiracetam SUN

If you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and cautions

Talk to your doctor before receiving Levetiracetam SUN

If you have kidney problems, follow your doctor’s instructions. He / she decides if your dose needs to be adjusted.
If you notice that growth slows down or if puberty develops in your child unexpectedly, contact your doctor.
A small number of people who have been treated with antiepileptic drugs , such as Levetiracetam SUN, have also had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and / or suicidal ideation, consult your doctor.

Children and young people

Levetiracetam SUN should not be used in children and adolescents under 16 years of age as a single treatment ( monotherapy ).

Other medicines and Levetiracetam SUN

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

Do not take macrogol (a medicine used as a laxative ) one hour before and one hour after taking levetiracetam as it may result in levetiracetam losing its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.

Levetiracetam can be used during pregnancy, but only if the doctor, after careful consideration, considers it necessary. You should not stop your treatment without first discussing this with your doctor. The risk of birth defects in your unborn baby can not be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam SUN may impair your ability to drive or use tools or machines as Levetiracetam SUN may make you drowsy. This is more likely at the beginning of treatment or after a dose increase. You should not drive or use machines until it has been determined that your ability to perform such activities is not affected.

Levetiracetam SUN contains sodium

A maximum single dose of Levetiracetam SUN concentrate contains 2.5 mmol (or 57 mg) sodium (0.8 mmol (or 19 mg) sodium per vial ). This should be considered if you have been prescribed a low-salt diet.

How Levetiracetam SUN is given

A doctor or nurse will give you Levetiracetam SUN as an intravenous infusion.

Levetiracetam SUN should be given twice a day, once in the morning and once in the evening, at approximately the same time each day.

The intravenous formulation is an alternative to the oral formulation. You can be switched from one to the other without changing the dose. Your total daily dose and number of dosing times remain the same.

Alone treatment

Dose for adults and adolescents (from 16 years):

When you start taking Levetiracetam SUN, your doctor will prescribe a lower dose for 2 weeks before adjusting the dose as needed.

Usual dose: Between 1000 mg and 3000 mg every day.

Additional treatment

Dose for adults and adolescents (12 to 17 years) weighing 50 kg or more

Usual dose: between 1000 mg and 3000 mg every day.

Dose for children (4 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Usual dose: Between 20 mg / kg body weight and 60 mg / kg body weight every day.

Method of administration:

Levetiracetam SUN is for intravenous use.

The recommended dose must be diluted in at least 100 ml of compatible diluent and infused over 15 minutes. For more information on the proper use of Levetiracetam SUN for physicians and nurses, see section 6.

Processing time:

There is no experience with the administration of intravenous levetiracetam for a longer period than 4 days.

If you stop using Levetiracetam SUN

If treatment with Levetiracetam SUN is to be stopped, this should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam SUN, he/she will instruct you on how to stop the treatment gradually.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Talk to your doctor immediately or see your nearest emergency department if you experience:

weakness, dizziness or feeling dizzy or having difficulty breathing as this may be a sign of a severe allergic (anaphylactic) reaction
swelling of the face, lips, tongue and throat ( Quincke’s edema )
flu-like symptoms and rash on the face followed by a widespread rash with fever, elevated levels of liver enzymes seen in blood samples, and an increase in the type of white blood cells ( eosinophilia ) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS])
symptoms such as small urine volume, fatigue, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden renal impairment
skin rash that can form blisters and look like small targets (central dark spots surrounded by a paler area with a dark ring around the edge) ( erythema multiforme )
extensive skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome )
a more severe form of skin rash that causes skin detachment on more than 30% of the body surface ( toxic epidermal necrolysis )
signs of severe mental changes or if someone around you detects signs of confusion, drowsiness (drowsiness), amnesia (memory loss), impaired memory (forgetfulness), abnormal behavior or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy .

The most commonly reported side effects are inflammation of the nose and/or throat, somnolence (drowsiness), headache, fatigue, and dizziness. At the beginning of treatment or when increasing the dose, side effects such as drowsiness, fatigue, and dizziness may be more common. However, these side effects should decrease over time.

Very common: may affect more than 1 user in 10

inflammation of the nose and / or throat
somnolence (drowsiness), headache

Common: may affect less than 1 user in 10

anorexia (loss of appetite)
depression, hostility or aggression, anxiety, insomnia, nervousness or irritability
cramps, balance disorders, dizziness (feeling of instability), drowsiness (lack of energy and enthusiasm), tremor (involuntary shaking)
vertigo (feeling of rotation)
cough
abdominal pain, diarrhea, dyspepsia (stomach upset), vomiting, nausea
rash
weakness / fatigue (fatigue)

Uncommon: may affect less than 1 user in 100

decreased platelet count , decreased white blood cell count
weight loss, weight gain
suicide attempts, suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional lability / mood swings, agitation
amnesia (memory loss), impaired memory (forgetfulness), abnormal coordination / ataxia (impaired coordination of movements), paresthesia (tingling), disturbance of attention (impaired ability to concentrate)
diplopia (double vision), blurred vision
elevated / abnormal values on liver function tests
hair loss, eczema , itching
muscle weakness, myalgia (muscle pain)
damage

Rare: may affect less than 1 in 1,000 users

infection
decreased number of all types of blood cell s
severe hypersensitivity reactions (DRESS, anaphylactic reaction [severe and severe allergic reaction ], angioedema [swelling of the face, lips, tongue and throat])
low levels of sodium in the blood
suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, inability to concentrate)
delirium
encephalopathy (see section “Talk to your doctor immediately” for a detailed description of the symptoms)
uncontrollable muscle spasms affecting the head, torso, arms and legs, difficulty controlling movement, hyperkinesia (hyperactivity)
pancreatitis
liver failure, hepatitis
rapidly impaired renal function
skin rash, which can form blisters and look like small targets (central dark spots surrounded by a paler area with a dark ring around the edge) ( erythema multiforme ), a large skin rash with blisters and flaky skin, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes peeling of the skin on more than 30% of the body surface ( toxic epidermal necrolysis )
rhabdomyolysis (degradation of muscle tissue) associated with elevated creatine phosphokinase in the blood. The incidence is significantly higher in Japanese
patients compared to non-Japanese patients.
lame gait or difficulty walking.

How to store Levetiracetam SUN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiration date is the last day of the specified month.

Do not store in the refrigerator or freezer.

Contents of the pack and other information

Content declaration

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
The other ingredients are: Sodium acetate trihydrate, concentrated acetic acid, sodium chloride, water for injections.

What the medicine looks like and contents of the pack

Levetiracetam SUN concentrate for solution for infusion (sterile concentrate) is a clear, colorless liquid.

Levetiracetam SUN concentrates for solution for infusion is packed in cardboard boxes with 10×5 ml vials.

Marketing Authorization Holder and Manufacturer

Sun Pharmaceutical Industries Europe BV

Polarisavenue 87

2132 JH Hoofddorp

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

België / Belgique / Belgien / България / Česká republika / Danmark / Eesti / Ελλάδα / Hrvatska / Ireland / Ísland / Κύπρος / Latvija / Lietuva / Luxembourg / Luxemburg / Magyarország / Malta / Nederland / Norge / Österreich / Portugal / Slovenija / Slovensk Finland / Finland / Sweden