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Levetiracetam STADA 100 mg / ml oral solution

STADA Arzneimittel GmbH

Standard drug Human
Date of approval10.08.2018
Submission statusDelivery through a (public) pharmacy
Prescription StatusSingle-dose medicinal products based on a doctor's prescription
Pharmacological groupAnti-epileptic drugs

All information

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STADA Arzneimittel GmbH

What is it and what is it used for?

Levetiracetam is an anti-epileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam STADA is used

  • alone, without other medicines for epilepsy (monotherapy), to treat a certain type of epilepsy in adults and adolescents aged 16 years and over who have been diagnosed with epilepsy for the first time. Epilepsy is a condition in which patients have repeated seizures. Levetiracetam is used in the type of epilepsy in which the seizures initially only affect 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 you have.
  • as an add-on treatment to other drugs for epilepsy of:
  • partial seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month of age,

  • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy,
  • primary generalized tonic-clonic seizures (severe seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (the type of epilepsy that appears to be genetic).

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What do you need to consider before use?

Levetiracetam STADA must not be taken

if you are allergic to levetiracetam, pyrrolidone derivatives or any of the other ingredients of this medicine (listed in section 6).

Warnings and Precautions

Talk to your doctor or pharmacist before taking Levetiracetam STADA.

  • If you suffer from kidney problems: In this case, follow the instructions of your doctor. He / she will then decide if your dose needs to be adjusted.
  • If you observe a slowdown in growth in your child or if puberty progresses abnormally, please notify your doctor.
  • A small number of people being treated with anti-epileptic drugs such as Levetiracetam STADA have had thoughts of harming or killing themselves. If you have any signs of depression and / or suicidal thoughts, please notify your doctor.

Tell your doctor or pharmacist if any of the following side effects are serious or last longer than a few days:

Unusual thoughts, irritability, or reactions more aggressive than usual, or when you or your family and friends notice significant changes in mood or behavior.

Children and adolescents

Levetiracetam STADA must not be used on its own (monotherapy) in children and adolescents under 16 years of age.

Other medicines and Levetiracetam STADA

Tell your doctor or pharmacist if you are taking / using, have recently taken / used, or may take / use any other medicines.

You should not use macrogol (a medicine used as a laxative) one hour before and one hour after you take levetiracetam as it may make it less effective.

pregnancy and breast feeding period

Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant.

Levetiracetam should only be used during pregnancy if your doctor considers it necessary after careful consideration.

You should not stop your treatment without talking to your doctor first.

A risk of birth defects to your unborn child cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Ability to drive and Ability to use machines

Warning: This medicine may affect your ability to react and drive.

Levetiracetam STADA can do your Impair your ability to drive or use tools or machines as you may feel sleepy while taking Levetiracetam STADA. This is particularly true at the start of treatment or after increasing the dose. You should not drive or use any tools or machines until it has been found that your ability to perform such activities is not impaired.

Levetiracetam STADA contains methyl 4-hydroxybenzoate, maltitol solution, sodium and benzyl alcohol

Levetiracetam STADA oral solution contains 2.5 mg / ml methyl 4-hydroxybenzoate, which can cause allergic reactions, including late reactions.

Levetiracetam STADA oral solution also contains maltitol solution. Please take this medicine only after consulting your doctor if you know that you suffer from a sugar intolerance.

This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially 'sodium-free'.

This medicinal product contains 0.0016 mg benzyl alcohol per ml. Benzyl alcohol can cause allergic reactions.

Do not use this medicine in young children (under 3 years of age) for more than a week, unless advised by your doctor or pharmacist.

If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice as large amounts of benzyl alcohol can build up in your body and cause side effects (called 'metabolic acidosis').

If you have liver or kidney disease, ask your doctor or pharmacist for advice, as large amounts of benzyl alcohol can build up in your body and cause side effects (called 'metabolic acidosis').

How is it used?

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Levetiracetam STADA must be taken twice a day, once in the morning and once in the evening, at around the same time each day.

Take the oral solution as directed by your doctor.

Monotherapy

Dosage in adults and adolescents (from 16 years):

Measure the appropriate dose with the 10 ml oral syringe that is included in the outer carton for children from 4 years of age, adolescents and adults.

General dose: Levetiracetam STADA must be taken twice a day, divided into two equal doses, which can be between 5 ml (500 mg) and 15 ml (1,500 mg).

When you start treatment with Levetiracetam STADA, your doctor will first prescribe you a lower dose for two weeks before receiving the lowest dose that is suitable for you.

Additional treatment

Dosage in adults and adolescents (12 to 17 years of age):

Measure the appropriate dose with the 10 ml oral syringe that is included in the outer carton for children from 4 years of age, adolescents and adults.

General dose: Levetiracetam STADA must be taken twice a day, divided into two equal doses, which can be between 5 ml (500 mg) and 15 ml (1,500 mg).

Dosage in children from 6 months and older:

Your doctor will prescribe the most suitable dosage form of levetiracetam based on your age, weight and dose required.

For children from 6 months to 4 years of age, measure the appropriate dose with the 3 ml oral syringe provided in the outer carton.

For children from 4 years of age, measure the appropriate dose with the 10 ml oral syringe that is enclosed in the outer carton.

General dose: Levetiracetam STADA must be taken twice a day, divided into two equal doses, which can be between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of body weight of the child (see dosage examples in the table below ).

Dosage in children from 6 months of age:

Body weight Initial dose: 0.1 ml / kg twice a day Maximum dose: 0.3 ml / kg twice a day

body weightStarting dose: 0.1 ml / kg twice a dayMaximum dose: 0.3 ml / kg twice a day
6 kg0.6 ml 2 times a day1.8 ml 2 times a day
8 kg0.8 ml 2 times a day2.4 ml twice a day
10 kg1 ml 2 times a day3 ml twice a day
15 kg1.5 ml 2 times a day4.5 ml twice a day
20 kg2 ml twice a day6 ml twice a day
25 kg2.5 ml twice a day7.5 ml twice a day
from 50 kg5 ml twice a day15 ml twice a day

Dosage in infants (1 month to less than 6 months):

For children from 1 month to less than 6 months, measure the corresponding dose with the 1 ml oral syringe that is enclosed in the outer carton.

General dose: Levetiracetam STADA must be taken twice a day, divided into two equal doses, which can be between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of body weight of the infant (see dosage examples in the following table ).

Dosage in infants (1 month to less than 6 months):

body weightStarting dose: 0.1 ml / kg twice a dayMaximum dose: 0.3 ml / kg twice a day
6 kg0.6 ml twice a day1.8 ml 2 times a day
8 kg0.8 ml 2 times a day2.4 ml twice a day
10 kg1 ml 2 times a day3 ml twice a day
15 kg1.5 ml 2 times a day4.5 ml twice a day
20 kg2 ml twice a day6 ml twice a day
25 kg2.5 ml twice a day7.5 ml twice a day
from 50 kg5 ml twice a day15 ml twice a day

type of application

After the correct dose has been measured with the appropriate oral syringe, Levetiracetam STADA oral solution can be diluted in a glass of water or a baby bottle. You can take Levetiracetam STADA with or without food. Levetiracetam may have a bitter taste after being taken orally.

Instructions for use:

  • To open the bottle: press the screw cap and turn it counterclockwise (Figure 1).
  • Disconnect the adapter from the oral syringe (Figure 2). Insert the adapter into the neck of the bottle. Make sure the adapter is securely in place.
  • Take the oral syringe and insert it into the opening of the adapter. Turn the bottle upside down (Figure 3).
  • Fill the oral syringe with a small amount of solution by pulling out the plunger a little (Figure 4 a). Then push the plunger back in to remove any air bubbles (Figure 4 b). Then pull the plunger out to the milliliter (ml) mark corresponding to the dose your doctor prescribed (Figure 4c).
  • Turn the bottle the right way round. Remove the oral syringe from the adapter.
  • Empty the contents of the oral syringe into a glass of water or into a baby bottle by pushing the plunger into the oral syringe as far as it will go (Figure 5).
  • Completely drink the glass / baby bottle.
  • Close the bottle with the child-resistant cap.
  • Rinse the oral syringe with water only (Figure 6).

Duration of application

  • Levetiracetam STADA is intended for long-term treatment. You have to take Levetiracetam STADA for as long as your doctor has told you to.
  • Do not stop your treatment yourself without talking to your doctor, as this could make your seizures more frequent.

If you take more Levetiracetam STADA than you should

Possible side effects of too high a dose of Levetiracetam STADA are drowsiness, restlessness, aggression, decreased alertness, decreased breathing and coma.

Please notify your doctor if you have taken a larger amount than prescribed. Your doctor will initiate the most appropriate treatment for an overdose.

If you forget to take Levetiracetam STADA

Please notify your doctor if you have forgotten one or more doses. Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam STADA

When stopping treatment, Levetiracetam STADA should be gradually withdrawn to avoid an increase in the frequency of seizures. Should your doctor stop your Levetiracetam STADA treatment, he / she will give you detailed instructions on how to taper the dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

What are the possible side effects?

Like all medicines, this medicine can have side effects, although not everybody gets them.

Talk to your doctor straight away or go to your nearest emergency room at:

  • Weakness, light-headedness or dizziness, or difficulty breathing as these could be signs of a serious 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 a high temperature, increased levels of liver enzymes in blood tests, and increased numbers of a type of white blood cell (eosinophilia) and enlarged lymph nodes (drug eruption with eosinophilia and systemic symptoms [DRESS])
  • Symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling of the legs, ankles or feet as these could be signs of a sudden decrease in kidney function
  • Skin rash that may blister and look like small targets (dark spot in the center surrounded by a paler area surrounded by a dark ring) (erythema multiforme)
  • widespread rash with blisters and peeling skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
  • more severe rash causing skin peeling on more than 30% of the body surface (toxic epidermal necrolysis),
  • Signs of serious mental change or when someone around you experiences signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behavior, or other neurological symptoms including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

The most commonly reported side effects are nasopharyngitis (inflammation of the nose and throat), somnolence (sleepiness), headache, tiredness and dizziness. At the start of treatment or when increasing the dose, side effects such as sleepiness, tiredness and dizziness may occur more frequently. However, over time, these side effects should diminish.

Very common (may affect more than 1 in 10 people):

Common (may affect up to 1 in 10 people):

  • Anorexia (loss of appetite)
  • Depression, hostility or aggression, anxiety, insomnia, nervousness or irritability,
  • Convulsions (spasms), balance disorders, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking),
  • Vertigo,
  • To cough,
  • Abdominal pain, diarrhea, dyspepsia (indigestion), vomiting, nausea,
  • Rash (rash),
  • Asthenia (feeling weak) / tiredness.

Uncommon (may affect up to 1 in 100 people):

  • Decreased number of blood platelets, decreased number of white blood cells,
  • Weight loss, weight gain,
  • Suicide attempt and suicidal ideation, mental disorders, abnormal behavior, hallucination, anger, confusion, panic attack, emotional instability / mood swings, agitation,
  • Amnesia (memory loss), impairment of memory (forgetfulness), coordination disorder / ataxia (lack of coordination of the

Movements), paraesthesia (tingling sensation), disturbance in attention (difficulty concentrating),

  • Diplopia (double vision), blurred vision,
  • increased / abnormal values ​​in liver function tests,
  • Hair loss, eczema, itching,
  • Muscle weakness, myalgia (muscle pain),
  • Injury.

Rare (may affect up to 1 in 1,000 people):

  • Infection,
  • decreased number of all types of blood cells,
  • serious allergic reactions (DRESS, anaphylactic reaction [serious and significant allergic reaction], Quincke's edema [swelling of the face, lips, tongue and throat]),
  • decreased levels of sodium in the blood,
  • Suicide, personality disorders (behavioral problems), thinking abnormal (slow thinking, inability to concentrate),
  • Delirium
  • Encephalopathy (see subsection "Talk to your doctor straight away" for a full description of the symptoms),
  • involuntary and non-suppressible, spasmodic tension in muscles affecting the head, trunk and limbs, difficulty controlling movements, hyperkinesia (overactivity),
  • Pancreatitis (inflammation of the pancreas)
  • Liver failure, hepatitis (inflammation of the liver),
  • sudden decrease in kidney function,
  • Skin rash that may blister and look like small targets (dark spots in the center surrounded by a paler area surrounded by a dark ring) (erythema multiforme), widespread blistered rash and peeling skin, especially around the mouth on the nose, eyes and genital area (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis),
  • Rhabdomyolysis (breakdown of muscle tissue) and associated increased creatine phosphokinase in the blood. The prevalence in Japanese patients is significantly higher than in non-Japanese patients.
  • Limping or difficulty walking.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Federal Office for Safety in Health Care Traisengasse 5

1200 VIENNA AUSTRIA

Fax: + 43 (0) 50 555 36207 Website: http://www.basg.gv.at/

By reporting side effects you can help provide more information on the safety of this medicine.

How should it be stored?

Keep this medicine out of the sight and reach of children.

You may use this medicine after the "use by" or "use by" date on the carton and bottle. by: “Do not use the stated expiry date. The expiry date refers to the last day of the month indicated.

This medicinal product does not require special storage conditions. After first opening: Do not store above 25 ° C.

Do not use the medicine for more than 7 months after first opening the bottle.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. You help to protect our environment.

additional Information

What Levetiracetam STADA 100 mg / ml oral solution contains

The active ingredient is levetiracetam. Each ml of solution contains 100 mg levetiracetam.

The other ingredients are:

Sodium citrate (for pH adjustment), citric acid (for pH adjustment), methyl 4-hydroxybenzoate (E218), glycerol (E422), acesulfame potassium (E950), maltitol solution (E965), raspberry flavor ( contains benzyl alcohol).

What Levetiracetam STADA 100 mg / ml oral solution looks like and contents of the pack

Levetiracetam STADA 100 mg / ml oral solution is a clear liquid.

The 300 ml glass bottle from Levetiracetam STADA (for children from 4 years of age, adolescents and adults) is packed in a cardboard box containing a 10 ml syringe for oral preparations (divided in steps of 0.25 ml) and an adapter for the syringe .

The 150 ml glass bottle of Levetiracetam STADA (for infants and toddlers from 6 months to under 4 years) is packed in a cardboard box containing a 3 ml syringe for oral preparations (divided into 0.1 ml steps) and an adapter for the syringe contains.

The 150 ml glass bottle of Levetiracetam STADA (for infants from 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml syringe for oral preparations (divided in steps of 0.05 ml) and an adapter for the syringe.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Pharmaceutic entrepreneur

STADA Arzneimittel GmbH, 1190 Vienna, Austria

Manufacturer

STADA Arzneimittel GmbH, 1190 Vienna, Austria

STADA Arzneimittel AG, 61118 Bad Vilbel, Germany

Remedica Ltd, 3056 Limassol, Cyprus

Z. No .: 138445

This medicinal product is approved in the member states of the European Economic Area (EEA) under the following names:

Denmark Levetiracetam STADA TBC
Germany Levetiracetam AL 100 mg / ml oral solution
Finland Levetiracetam STADA 100 mg / ml oraaliliuos
France LEVETIRACETAM EG 100 mg / ml, solution buvable
Italy LEVETIRACETAM EUROGENERICI
Iceland Levetiracetam STADA 100 mg / ml mixtúra, lausn
Portugal Levetiracetam Ciclum
Sweden Levetiracetam STADA 100 mg / ml oral solution
Spain Levetiracetam STADA 100 mg / ml solución oral EFG

This leaflet was last revised in January 2021.

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