250 mg, 500 mg, 750 mg and 1000 mg film-coated tablets
levetiracetam
What Levetiracetam STADA is and what it is used for
Levetiracetam is a medicine used to treat epilepsy (a medicine used to treat epileptic seizures).
Levetiracetam Stada 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).
Levetiracetam contained in Levetiracetam Stada 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 use Levetiracetam STADA
Do not take Levetiracetam STADA
- 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 Stada
- 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 Stada, has also had thoughts of harming himself 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 epilepsy . Your 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 Stada.
Children and young people
Levetiracetam Stada should not be used in children and adolescents under 16 years of age alone treatment ( monotherapy ).
Other medicines and Levetiracetam STADA
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.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Levetiracetam Stada can be used during pregnancy, but only if your doctor 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 Stada 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.
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 STADA contains para-orange (E110)
Levetiracetam Stada 750 mg tablets contain the dye para-orange (E110) which may cause allergic reactions.
How to use Levetiracetam STADA
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 Stada 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 (12 to 17 years) weighing 50 kg or more:
Usual dose: Between 1000 mg and 3000 mg every day.
When you start taking Levetiracetam Stada, 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 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 depending on your age, weight, and dose.
An oral solution is a dosage form suitable for infants and young children under 6 years of age, for 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 Stada tablets with a sufficient amount of liquid (eg a glass of water). You can take Levetiracetam Stada with or without food. Levetiracetam may produce a bitter taste in the mouth.
Treatment time
- Levetiracetam Stada is used as a long-term treatment. You should continue treatment with Levetiracetam Stada 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 STADA than you should
Possible side effects of an overdose with Levetiracetam Stada are drowsiness, agitation, aggression, decreased alertness, respiratory arrest, and coma.
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 (sleepiness)
- headache.
Common (may affect up to 1 in 10 people):
- 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 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 people):
- 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 seizures 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 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 STADA
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 the specified month.
No special storage instructions.
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.
Levetiracetam STADA 250 mg film-coated tablets
Each film-coated tablet contains 250 mg levetiracetam.
Levetiracetam STADA 500 mg film-coated tablets
Each film-coated tablet contains 500 mg of levetiracetam.
Levetiracetam STADA 750 mg film-coated tablets
Each film-coated tablet contains 750 mg of levetiracetam.
Levetiracetam STADA 1000 mg film-coated tablets
Each film-coated tablet contains 1000 mg of levetiracetam.
Other ingredients are:
Core: Microcrystalline cellulose, crospovidone, anhydrous colloidal silica, magnesium stearate
Film coating
Levetiracetam Stada 250 mg film-coated tablets
Opadry II blue, consisting of polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, indigo carmine (E 132)
Levetiracetam Stada 500 mg film-coated tablets
Opadry II yellow, consisting of polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, yellow iron oxide (E 172)
Levetiracetam Stada 750 mg film-coated tablets
Opadry II orange, consisting of polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc, para-orange (E 110), red iron oxide (E 172)
Levetiracetam Stada 1000 mg film-coated tablets
Opadry II white, consisting of polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc
What the medicine looks like and contents of the pack
Levetiracetam Stada 250 mg film-coated tablets are blue, oblong, biconvex, film-coated tablets with a scoreline on one side approximately 12.8 mm long. The tablet can be divided into two halves.
Levetiracetam Stada 500 mg film-coated tablets are yellow, oblong, biconvex, film-coated tablets with a scoreline on one side approximately 16.4 mm long. The tablet can be divided into two halves.
Levetiracetam Stada 750 mg film-coated tablets are orange, oblong, biconvex, film-coated tablets with a scoreline on one side approximately 18.6 mm long. The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.
Levetiracetam Stada 1000 mg film-coated tablets are white, oblong, biconvex, film-coated tablets with a scoreline on one side approximately 19.1 mm long. The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.
Levetiracetam Stada film-coated tablets are packed in PVC / Aluminum blisters.
Blister pack of Levetiracetam Stada 250 film-coated tablets containing: 10, 20, 30, 50, 60, 100, 150, 180 or 200 tablets.
Blister pack of Levetiracetam Stada 500 film-coated tablets contain: 10, 20, 30, 50, 60, 100, 120, 150, 180 or 200 tablets.
Blister pack of Levetiracetam Stada 750 film-coated tablets contains: 20, 30, 50, 60, 100, 150, 180 or 200 tablets.
Blister pack of Levetiracetam Stada 1000 film-coated tablets contains: 10, 20, 30, 50, 60, 100, 150, 180 or 200 tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany
Other manufacturers
LAMP San Prospero SpA
Via della Pace, 25 / A, 41030 San Prospero (Modena), Italy
STADA Arzneimittel GmbH,
Muthgasse 36, 1190 Vienna, Austria
Clonmel Healthcare Ltd.
Waterford Road, Clonmel, Co. Tipperary, Ireland
Eurogenerics NV,
Heizel Esplanade B22, B-1020 Brussels, Belgium
Sanico NV,
Veedijk 59, B-2300 Turnhout, Belgium
PharmaCoDane ApS, Herlev
Marielundvej 46 A, DK-2730 Herlev, Denmark
Centrafarm Services BV
Etten-Leur, The Netherlands
Local representative
STADA Nordic ApS
Marielundvej 46 A
2730 Herlev
Denmark