250 mg, 500 mg, 750 mg, 1000 mg film-coated tablets
levetiracetam
What Levetiracetam 1A Farma is and what it is used for
Levetiracetam 1A Farma is a medicine used to treat epilepsy (a medicine used to treat epileptic seizures).
Levetiracetam 1A Farma 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 1 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).
Levetiracetam contained in Levetiracetam 1A Farma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Levetiracetam 1A Farma
Do not take Levetiracetam 1A Farma
- 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 taking Levetiracetam 1A Farma:
- 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 anti- epileptic drugs such as Levetiracetam 1A Farma has had thoughts of harming itself 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 1A Farma.
Children and young people
- Levetiracetam 1A Farma should not be used in children and adolescents under 16 years of age alone ( monotherapy ).
Other medicines and Levetiracetam 1A Farma
Tell your doctor or pharmacist if you are taking, have recently taken, or might take 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.
Levetiracetam 1A Farm with food, drink and alcohol
You can take Levetiracetam 1A Farma with or without food. As a precautionary measure, do not take Levetiracetam 1A Farma with alcohol.
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 1A Farma 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 1A Farma may impair your ability to drive or use tools or machines as Levetiracetam 1A Farma 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.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Levetiracetam 1A Farma contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per film-coated tablet, ie essentially ‘sodium-free’.
How to take Levetiracetam 1A Farma
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Take the number of tablets prescribed by your doctor.
Levetiracetam 1A Farma should be taken twice a day, once in the morning and once in the evening, at approximately the same time each day.
Alone treatment
Dose for adults and adolescents (from 16 years)
Usual dose: Between 1000 mg and 3000 mg every day.
When you start taking Levetiracetam 1A Farma, your doctor will prescribe a lower dose for 2 weeks before you receive the lowest standard dose.
Example: If your daily dose is 1000 mg, your reduced starting dose is 2 250 mg tablets in the morning and 2 250 mg tablets in the evening.
Additional treatment
- Dose for adults and adolescents (12–17 years) weighing 50 kg or moreUsual dose: Between 1000 mg and 3000 mg every day.Example: if your daily dose is 1,000 mg, you must take 2 tablets á 250 mg in the morning and 2 tablets á 250 mg in the evening.
- Dose for infants (1–23 months), children (2–11 years) and adolescents (12–17 years) weighing less than 50 kgYour doctor will prescribe the most suitable formulation of levetiracetam depending on your age, weight and dose .
Levetiracetam 100 mg/ml oral solution is a dosage form suitable for infants and young children under six years of age and children and adolescents (6-17 years) weighing less than 50 kg and when the dosage recommendation cannot be achieved with tablets.
Method of administration
Swallow Levetiracetam 1A Farma tablets with a sufficient amount of liquid (eg a glass of water). You can take Levetiracetam 1A Farma with or without food.
Levetiracetam may produce a bitter taste in the mouth.
The tablet can be divided into two equal doses.
Treatment time
- Levetiracetam 1A Farma is used as a long-term treatment. You should continue treatment with Levetiracetam 1A Farma 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 take more Levetiracetam 1A Farma than you should
Possible side effects of an overdose with Levetiracetam 1A Farma 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.
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 up to 1 in 10 users
- lost appetite ( anorexia )
- 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 up to 1 in 100 people
- 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 up to 1 in 1,000 users
- 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 rashes 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), 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 1A Farma
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/jar and the blister after EXP. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive.
The opened jar should be used within 100 days.
Medicines 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.
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.
Other ingredients are:
250 mg film-coated tablets: povidone K25, microcrystalline cellulose, croscarmellose sodium, crospovidone (type A), colloidal anhydrous silica, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose, macrogol 6000, titanium dioxide (E 171), talc, indigo carmine (E132) (containing sodium ).
500 mg film-coated tablets: povidone K25, microcrystalline cellulose, croscarmellose sodium, crospovidone (type A), colloidal anhydrous silica, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose, macrogol 6000, titanium dioxide (E171), talc, yellow iron oxide (E172).
750 mg film-coated tablets: povidone K25, microcrystalline cellulose, croscarmellose sodium, crospovidone (type A), colloidal anhydrous silica, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose, macrogol 6000, titanium dioxide (E171), talc, red iron oxide (E172 oxide) E172).
1000 mg film-coated tablets: povidone K25, microcrystalline cellulose, croscarmellose sodium, crospovidone (type A), colloidal anhydrous silica, talc, magnesium stearate, hypromellose, hydroxypropyl cellulose, macrogol 6000, titanium dioxide (E171), talc.
What the medicine looks like and contents of the pack
250 mg film-coated tablets:
Light blue, oval, biconvex film-coated tablets with a notch on both sides and marked with “LVT / 250” on one side.
500 mg film-coated tablets:
Yellow, oval, biconvex film-coated tablets with a notch on both sides and marked with “LVT / 500” on one side.
750 mg film-coated tablets:
Apricot-colored, oval, biconvex film-coated tablets with a notch on both sides and marked with “LVT / 750” on one side.
1000 mg film-coated tablets:
White, oval, biconvex film-coated tablets with a notch on both sides and marked with “LVT / 1000” on one side.
The film-coated tablets are packaged in OPA / Al / PVC-Al blisters or HDPE cans with polypropylene screw caps containing a silica gel wipe. The blisters and jars are packed in cardboard boxes.
Pack sizes:
Levetiracetam 1A Farma 250 mg
Blisters: 10, 20, 28, 30, 50, 50 × 1, 60, 100, 120, 200 film-coated tablets
Jar: 10, 20, 30, 50, 60, 100, 120, 200 film-coated tablets
Levetiracetam 1A Farma 500 mg, 750 mg and 1000 mg
Blisters: 10, 28, 30, 50, 50 × 1, 60, 100, 120, 200 film-coated tablets
Jar: 10, 20, 30, 50, 60, 100, 120, 200 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
1A Farma A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals, dd, Trimline 2 D, 9220 Lendava, Slovenia