250 mg, 500 mg, 750 mg, 1000 mg film-coated tablets
levetiracetam
What Levetiracetam Accord is and what it is used for
Levetiracetam Accord is a medicine used to treat epilepsy (a medicine used to treat epileptic seizures).
Levetiracetam Accord is used:
- 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 medicines for epilepsy to treat:
- partial seizures with or without generalization in adults, adolescents, children and infants from one month 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).
What you need to know before using Levetiracetam Accord
Do not use Levetiracetam Accord
- 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 using Levetiracetam Accord
- 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 that puberty develops in your child unexpectedly, contact your doctor.
- A small number of people who have been treated with antiepileptic drugs , such as Levetiracetam Accord, have also had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and / or suicidal ideation, consult your doctor.
- If you or someone in your family has a history of irregular heartbeat (seen on electrocardiogram , ECG ) or if you have a disease and / or receive treatment that increases the tendency for irregular heartbeat or salt balance disorders.
Tell your doctor or pharmacist if any of the following side effects gets serious or lasts for more than a couple of days:
- Abnormal thoughts, irritability or unusually aggressive reactions, or if you or your family and friends notice significant changes in your mood or behavior.
- Exacerbated epilepsyYour seizures may in rare cases worsen or occur more often, especially during the first month after starting treatment or increasing the dose . See a doctor as soon as possible if you experience any of these new symptoms while taking Levetiracetam Accord.
Children and young people
Levetiracetam Accord should not be used in children and adolescents under 16 years of age alone ( monotherapy ).
Other medicines and Levetiracetam Accord
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
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 Accord may impair your ability to drive or use tools or machines as it 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 Accord 750 mg tablets contain para-orange (E110)
The dye para-orange (E110) may cause allergic reactions. Other strengths of Levetiracetam Accord tablets do not contain this substance.
How to use Levetiracetam Accord
Use for children and adolescents
Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, talk to your doctor or pharmacist.
Take the number of tablets prescribed by your doctor.
Levetiracetam Accord should be taken twice a day, once in the morning and once in the evening, at approximately the same time each day.
Additional treatment and single treatment (from 16 years of age)
- Adults (≥ 18 years) and adolescents (from 12 to 17 years) weighing 50 kg or more:
Usual dose: Between 1000 mg and 3000 mg every day.
When you start taking Levetiracetam Accord, your doctor will prescribe a lower dose for 2 weeks before you receive the lowest standard dose.
Example: If your daily dose is intended to be 1000 mg, your reduced starting dose is 1 250 mg tablet in the morning and 1 250 mg tablet in the evening, after which the dose is gradually increased to 1,000 mg daily after 2 weeks.
- Adolescents (12 to 17 years) weighing 50 kg or less:
Your doctor will prescribe the most suitable formulation of Levetiracetam Accord depending on your weight and dose.
Dose for infants (1 month to 23 months) and children (2 to 11 years) weighing less than 50 kg:
Your doctor will prescribe the most suitable formulation of Levetiracetam Accord depending on your age, weight, and dose.
An oral solution is a dosage form suitable for infants and young children under 6 years, for children and adolescents (6-17 years) weighing less than 50 kg, and when the dosage recommendation can not be achieved with tablets.
Method of administration:
Swallow Levetiracetam Accord tablets with a sufficient amount of liquid (eg a glass of water). You can take Levetiracetam Accord with or without food. Levetiracetam may produce a bitter taste in the mouth.
Processing time:
- Levetiracetam Accord is used as a long-term treatment. You should continue treatment with Levetiracetam Accord for as long as your doctor tells you.
- Do not stop treatment without consulting your doctor, as this may increase the number of seizures
If you use more Levetiracetam Accord than you should
Possible side effects of an overdose with Levetiracetam Accord are drowsiness, agitation, aggression, decreased alertness, respiratory arrest, and coma.
Contact your doctor if you take more tablets than you should. Your doctor will decide on the best treatment for overdose.
If you forget to take a dose of Levetiracetam Accord
Contact your doctor if you have missed one or more doses.
Do not take a double dose to make up for a forgotten tablet.
If you stop using Levetiracetam Accord
If treatment with Levetiracetam Accord 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 Accord, 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: affects more than 1 user in 10
- inflammation of the nose and / or throat
- somnolence (drowsiness), headache
Common: affects 1 to 10 users in 100
- 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: affects 1 to 10 users in 1,000
- decreased platelet count , decreased white blood cell count
- weight loss, weight gain
- suicide attempts, suicidal thoughts, mental disorders, abnormal behavior, hallucinations, anger, confusion, 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: affects 1 to 10 users in 10,000
- infection
- decreased number of all types of blood cell s
- severe allergic 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)
- the attacks may worsen or occur more often
- uncontrollable muscle spasms affecting the head, torso, arms and legs, difficulty controlling movement, hyperkinesia (hyperactivity)
- altered heart rhythm ( electrocardiogram )
- 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 skin detachment 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 Accord
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 blister after EXP. The expiration date is the last day of a specified month.
No special storage instructions.
The medicine should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
No special storage instructions.
Contents of the pack and other information
Content declaration
The active substance is levetiracetam.
Each film-coated tablet contains 250 mg, 500 mg, 750 mg or 1000 mg levetiracetam.
The tablet core contains:
Croscarmellose sodium, povidone K-30, silica colloidal anhydrous, magnesium stearate (E470b).
The film coating contains:
250 mg:
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
500 mg:
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, yellow iron oxide (E172)
750 mg:
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc, red iron oxide (E172), dye para-orange aluminum lacquer (E110)
1000 mg:
Polyvinyl alcohol, titanium dioxide (E171), macrogol, talc
What the medicine looks like and contents of the pack
250 mg:
White to off-white, oval, biconvex, film-coated tablets marked with “L 64” and scored on one side and unmarked on the other side.
500 mg:
Yellow-colored, oval, biconvex, film-coated tablets marked with “L 65” and scored on one side and unmarked on the other side.
750 mg:
Pink oval, biconvex, film-coated tablets marked with “L 66” and scored on one side and unmarked on the other side.
1000 mg:
White to off-white, oval, biconvex film-coated tablets marked with “L 67” and scored on one side and unmarked on the other.
Levetiracetam Accord film-coated tablets 250 mg, 500 mg, 750 mg, and 1000 mg are packaged in PVC-Alu blister packs. The blister packs, together with the package leaflet, are in turn packed in cartons in sizes of 10, 20, 30, 50, 60, 100, and 200 tablets per carton. The tablets are also available as single-dose blisters with 30×1, 60×1, and 100×1 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona, s / n,
Edifici Est 6ª planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Limited
Sage House, 319 Pinner road
North Harrow HA1 4HF
Middlesex
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland