Levetiracetam Teva - 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 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 you take Levetiracetam Teva

Do not take Levetiracetam Teva

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 Teva

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 Teva, 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 Teva.

Children and young people

Levetiracetam Teva should not be used in children and adolescents under 16 years of age alone ( monotherapy ).

Other medicines and Levetiracetam Teva

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 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 Teva 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 Teva contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per film-coated tablet, ie essentially ‘sodium-free’.

Levetiracetam Teva 500 mg contains tartrazine

Levetiracetam Teva 500 mg contains the dye tartrazine (E102) which may cause allergic reactions.

Levetiracetam Teva750 mg contains para ‑ orange

Levetiracetam Teva 750 mg contains the dye para ‑ orange (E110) which may cause allergic reactions.

How to take Levetiracetam Teva

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 Teva 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)

Adults (≥18 years) and adolescents (12 to 17 years) weighing 50 kg or more:Usual dose: between 1,000 mg and 3,000 mg daily.When you start taking Levetiracetam Teva, 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 reach 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 Teva 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 Teva tablets with a sufficient amount of liquid (eg a glass of water). You can take Levetiracetam Teva with or without food. Levetiracetam may produce a bitter taste in the mouth.

Treatment time

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

Possible side effects of an overdose with Levetiracetam Teva 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.

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 in 10 people

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

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 the blister after EXP.

The expiration date is the last day of the specified month.

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 Levetiracetam Teva 250, 500, 750, 1,000 mg film-coated tablet contains 250, 500, 750, 1,000 mg levetiracetam.
Other ingredients are:Tablet core: corn starch, povidone, crushed caramel sodium and magnesium treat.
Coating: hypromellose 6 cp, titanium dioxide (E171), macrogol 3350, dyes *

* The dyes are:

250 mg film-coated tablets: brilliant blue FCF (E133) and indigo carmine (E132).

500 mg film-coated tablets: indigo carmine (E132), tartrazine (E102), and yellow iron oxide (E172).

750 mg film-coated tablets: yellow iron oxide (E172), red iron oxide (E172), and para-orange FCF (E110)

What the medicine looks like and contents of the pack

Levetiracetam Teva 250 mg film-coated tablets

Blue, oblong film-coated tablets with a notch on one side and “9” and “3” embossed on each side of the notch. The tablet is marked with “7285” on the other side.

Levetiracetam Teva 500 mg film-coated tablets

Yellow, oblong film-coated tablets with a notch on one side and “9” and “3” embossed on each side of the notch. The tablet is marked with “7286” on the other side.

Levetiracetam Teva 750 mg film-coated tablets

Orange, oblong film-coated tablets with a notch on one side and “9” and “3” embossed on each side of the notch. The tablet is marked with “7287” on the other side.

Levetiracetam Teva 1,000 mg film-coated tablets

White, oblong film-coated tablets with a notch on one side and “9” and “3” embossed on each side of the notch. The tablet is marked with “7493” on the other side.

The breaker is not there to divide the tablet into equal doses, but only to facilitate swallowing.

Levetiracetam Teva is available in packs of 20, 30, 50, 60, 100, 120 and 200 film-coated tablets and 50 x 1 film-coated tablets in PVC / PVdC perforated aluminum single-dose blisters.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Teva BV

Swensen 5

2031GA Haarlem

Netherlands

Manufacturer:
Teva Pharmaceutical Works Private Limited Company

Pallagi út 13

Debrecen U-4042

Hungary

Teva Operations Poland Sp. z oo

ul. Mogilska 80. 31-546

Krakow

Poland

Teva Czech Industries sro

Ostravska 29, cp 305, 74770

Opava-Komarov

Czech Republic

TEVA PHARMA, SLU

C / C, No. 4, Poligono Industrial Malpica

50016 Zaragoza

Spain

Pharmachemie BV