Levetiracetam Actavis - 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 specific form of epilepsy . Epilepsy is a condition in which the patient suffers from recurrent seizures. Levetiracetam is used for the form of epilepsy where the seizures initially affect only one side of the brain, but can later spread to larger areas on both sides of the brain ( partial seizures with or without secondary generalization). Levetiracetam has been prescribed for you by your doctor 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, shock-like twitching in a 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 unconsciousness) in adults and adolescents from 12 years of age with generalized epilepsy (a type of epilepsy believed to have a genetic cause)

What you need to know before you use Levetiracetam Actavis

Do not take Levetiracetam Actavis

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 Actavis

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 Actavis, 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 previous medical 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 epilepsyIn rare cases, your seizures may worsen or occur more often, mainly during the first month after starting treatment or by increasing the dose . See a doctor as soon as possible if you experience any of these new symptoms while taking Levetiracetam Actavis.

Children and young people

Levetiracetam Actavis is not indicated for use in children and adolescents under 16 years of age as monotherapy alone ( monotherapy ).

Other medicines and Levetiracetam Actavis

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 or one hour after using levetiracetam, as it may reduce 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 or pharmacist for advice before taking 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 Actavis 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 Actavis contains para-orange (E110)

The dye para-orange (E110) may cause allergic reactions.

How to take Levetiracetam Actavis

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Take the number of tablets your doctor has prescribed.

Levetiracetam Actavis should be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Additional treatment and single treatment (from 16 years of age)

Dose for adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:
Usual dose: Between 1000 mg and 3000 mg daily.
When you start taking Levetiracetam Actavis, 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 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 Actavis depending on your weight and dose .

Dose for infants (1 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 more suitable formulation for infants and children under 6 years of age as well as children and adolescents (from 6 to 17 years) who weigh less than 50 kg and in cases where the tablets do not allow the correct dosage.

Method of administration:

Swallow Levetiracetam Actavis tablets with a sufficient amount of liquid ( eg a glass of water). Levetiracetam Actavis can be taken with or without food. Levetiracetam may produce a bitter taste in the mouth.

Processing time:

Levetiracetam Actavis is used for long-term treatment. You should continue treatment with Levetiracetam Actavis 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 Actavis than you should

Possible side effects of levetiracetam overdose 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 use Levetiracetam Actavis

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 taking Levetiracetam Actavis

If treatment with Levetiracetam Actavis is completed, this should, as with other drugs for epilepsy, be done gradually to avoid an increase of seizures. If your doctor decides to stop your treatment with Levetiracetam Actavis, he/she will instruct you on how to gradually reduce your intake of Levetiracetam Actavis.

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, drowsiness, headache, fatigue, and dizziness. Side effects such as drowsiness, fatigue, and dizziness may be more common at the beginning of treatment or when increasing the dose. However, these side effects should decrease over time.

Very common: may affect more than 1 in 10 people

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

Common: may affect 1 to 10 in 100 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: 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, 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 in liver function tests
hair loss, eczema , itching
muscle weakness, myalgia (muscle pain)
damage

Rare: may affect 1 to 10 in 10,000 people

infection
decreased number of all types of blood cell s
severe hypersensitivity reactions (DRESS, anaphylactic reaction [severe and significant allergic reaction ], Quincke’s edema [swelling of the face, lips, tongue and throat])
decreased concentration 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 Actavis

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, label, or 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.

One tablet of Levetiracetam Actavis 250 mg contains 250 mg of levetiracetam.

One tablet of Levetiracetam Actavis 500 mg contains 500 mg of levetiracetam.

One tablet of Levetiracetam Actavis 750 mg contains 750 mg of levetiracetam.

One tablet of Levetiracetam Actavis 1000 mg contains 1000 mg of levetiracetam.

Other ingredients are:

crospovidone, povidone, colloidal anhydrous silica, magnesium stearate, polyvinyl alcohol partially hydrolyzed, macrogol 4000, talc, titanium dioxide (E171), dyes *.

* The dyes are:

250 mg tablet: indigo carmine (E132)

500 mg tablet: yellow iron oxide (E172), indigo carmine (E132)

750 mg tablet: indigo carmine (E132), para-orange (E110), red iron oxide (E172)

What the medicine looks like and contents of the pack

Levetiracetam Actavis 250 mg film-coated tablets are oval, light blue, 13.6 x 6.4 mm marked with “L” on one side and “250” on the other side.

Levetiracetam Actavis 500 mg film-coated tablets are oval, yellow, 17.1 x 8.1 mm marked with “L” on one side and “500” on the other side.

Levetiracetam Actavis 750 mg film-coated tablets are oval, orange 19.0 x 9.3 mm marked with “L” on one side and “750” on the other side.

Levetiracetam Actavis 1000 mg film-coated tablets are oval, white, 19.0 x 10.0 mm marked with “L” on one side and “1000” on the other side.

Pack sizes

Blisters: 20, 30, 50, 60, 100, 120 and 200 film-coated tablets.

Perforated unit dose blister: 60 x 1 film-coated tablets (only available for 250 mg, 500 mg and 1000 mg tablets).

Tablet jar: 30, 100 and 200 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegur 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Specifar SA

1, 28 Octovriou str., 123 51 Ag. Varvara, Athens, Greece

Teva Operations Poland Sp. z oo

ul. Mogilska 80. 31-546 Krakow, Poland

Tjoapack Netherlands BV

Nieuwe Donk 9, ETTEN-LEUR, 4879AC, The Netherlands