LEVETIRACETAM STRIDES 100 MG / ML ORAL SOLUTION - patient leaflet, side effects, dosage

Patient leaflet - LEVETIRACETAM STRIDES 100 MG / ML ORAL SOLUTION

Package Leaflet: Information for the patient

Levetiracetam

Read all of this leaflet carefully before you or your child start taking this medicine because it contains important information for you.

– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Levetiracetam Strides oral solution is and what it is used for
2. What you need to know before you take Levetiracetam Strides oral solution
3. How to take Levetiracetam Strides oral solution
4. Possible side effects
5. How to store Levetiracetam Strides oral solution
6. Contents of the pack and other information

1. what levetiracetam strides oral solution is and what it is used for levetiracetam is an antiepileptic medicine (a medicine used to treat seizures in epilepsy). levetiracetam strides 100 mg/ml oral solution is used:

on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy. Epilepsy is a condition where the patients have repeated fits (seizures). Levetiracetam is used for the epilepsy form in which the fits initially affect only one side of the brain, but could thereafter extend to larger areas on both sides of the brain (partial onset seizure with or without secondary generalization). Levetiracetam has been given to you by your doctor to reduce the number of fits.
as an add-on to other antiepileptic medicines to treat:

o partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age

o 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

o primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

2. what you need to know before you take levetiracetam strides oral solution

Do not take Levetiracetam Strides oral solution

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 before taking Levetiracetam Strides oral solution

If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.
If you notice any slowdown in the growth or unexpected puberty development of your child, please contact your doctor.
A small number of people being treated with anti-epileptics such as Levetiracetam Strides oral solution have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.
If you have a family or medical history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or take a treatment that make(s) you prone to heartbeat irregularities or salt imbalances.

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

Abnormal thoughts, feeling irritable or reacting more aggressively than usually, or if you or your family and friends notice important changes in mood or behaviour.
Aggravation of epilepsy

Your seizures may rarely become worse or happen more often, mainly during the first month after the start of the treatment or increase of the dose. If you experience any of these new symptoms while taking Levetiracetam Strides oral solution, see a doctor as soon as possible.

Children and adolescents

Levetiracetam Strides oral solution is not indicated in children and adolescents below 16 years on it’s own (monotherapy)

3. how to take levetiracetam strides oral solution

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 Strides oral solution must be taken twice a day, once in the morning and once in the evening, at about the same time each day.

Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents from 16 years of age

Measure the appropriate dosage using the 10 ml syringe included in the package for patients 4 years and above.

General dose: Levetiracetam Strides oral solution is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).

When you will first start taking Levetiracetam Strides oral solution, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therap y

Dose in adults and adolescents (12 to 17 years) weighing 50kg or more:

Measure the appropriate dosage using the 10 ml syringe included in the package for patients of 4 years and above.

General dose: Levetiracetam Strides oral solution is taken twice daily, in two equally divided doses, each individual dose being measured between 5 mL (500mg) and 15 mL (1500mg).

Dose in children 6 months and older:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.

For children 6 months to 4 years , measure the appropriate dosage using the 3 ml syringe included in the package.

For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.

General dose: Levetiracetam Strides oral solution is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).

Dose in children 6 months and older

Weight

Starting dose: 0.1 ml/kg twice daily

Maximum dose: 0.3 ml/kg twice daily

6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

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

For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.

General dose: Levetiracetam Strides oral solution is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant. (see table below for dose examples).

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

9075

Weight	Starting dose: 0.07 ml/kg twice daily	Maximum dose: 0.21 ml/kg twice daily
4 kg	0.3 ml twice daily	0.85 ml twice daily
5 kg	0.35 ml twice daily	1.05 ml twice daily
6 kg	0.45 ml twice daily	1.25 ml twice daily
7 kg	0.5 ml twice daily	1.5 ml twice daily

Method of administration:

After measuring the correct dose with an appropriate syringe, Levetiracetam Strides oral solution may be diluted in a glass of water or baby’s bottle. You may take Levetiracetam Strides oral solution with or without food. After oral administration the bitter taste of levetiracetam may be experienced.

Instructions for use:

o Open the bottle: press the cap and turn it anticlockwise (figure 1)

o Separate the adaptor from the syringe (figure 2). Insert the adaptor into the bottle neck (figure 3). Ensure it is well fixed.

o Take the syringe and put it in the adaptor opening (figure 4). Turn the bottle upside down (figure 5).

Dimension: 380 × 310 mm

Front Side

Font: Times New Roman

Font Size: 9 pt

No. of Columns: 3 Columns

o Fill the syringe with a small amount of solution by pulling the piston down (figure 5A), then push the piston upward in order to remove any possible bubble (figure 5B). Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 5C).

o Turn the bottle the right way up (figure 6A). Remove the syringe from the adaptor (figure 6B). _

o Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe (figure 7).

o Drink the whole contents of the glass/baby’s bottle.

o Close the bottle with the plastic screw cap.

o Wash the syringe with water only (figure 8).

Duration of treatment:

Levetiracetam Strides oral solution is used as a chronic treatment. You should continue Levetiracetam Strides oral solution treatment for as long as your doctor has told you.
Do not stop your treatment without your doctor’s advice as this could increase your seizures.

If you take more Levetiracetam Strides oral solution than you should:

The possible side effects of an overdose of Levetiracetam Strides oral solution are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more Levetiracetam Strides oral solution than you should. Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam Strides oral solution:

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam Strides oral solution:

If stopping treatment, Levetiracetam Strides oral solution should be discontinued gradually to avoid an increase of seizures.

Should your doctor decide to stop your Levetiracetam Strides oral solution treatment, he/ she will instruct you about the gradual withdrawal of Levetiracetam Strides oral solution. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. possible side effects

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

Tell your doctor immediately, or go to your nearest emergency department, if you experience:

weakness, feel light-headed or dizzy or have difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction;
swelling of the face, lips, tongue and throat (Quincke’s oedema);
flu like symptoms and a rash on the face followed by an extended rash with a high temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes (Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]);
symptoms such as low urine volume, tiredness, nausea, vomiting, confusion and swelling in the legs, ankles or feet, as this may be a sign of sudden decrease of kidney function;
a skin rash which may 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 widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome);
a more severe form of rash causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
signs of serious mental changes or if someone around you notices signs of confusion, somnolence (sleepiness), amnesia (loss of memory), memory impairment (forgetfulness), abnormal behaviour or other neurological signs including involuntary or uncontrolled movements. These could be symptoms of an encephalopathy.

The most frequently reported adverse reactions were nasopharyngitis, somnolence (sleepiness), headache, fatigue and dizziness. At the beginning of the treatment or at dose increase side effects like sleepiness, tiredness and dizziness may be more common.

These effects should however decrease over time.

Very common: may affect more than 1 in 10 people

nasopharyngitis;
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;
convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy (lack of energy and enthusiasm), tremor (involuntary trembling);
vertigo (sensation of rotation);
cough;
abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
rash;
asthenia/fatigue (tiredness).

Uncommon: may affect up to 1 in 100 people

decreased number of blood platelets, decreased number of white blood cells;
weight decrease, weight increase;
suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
diplopia (double vision), vision blurred;
elevated/abnormal values in a liver function test;
hair loss, eczema, pruritus;
muscle weakness, myalgia (muscle pain);
injury.

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

infection;
decreased number of all blood cell types;
severe allergic reactions (DRESS, anaphylactic reaction [severe and important allergic reaction], Quincke’s oedema [swelling of the face, lips, tongue and throat]);
decreased blood sodium concentration;
suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
delirium
encephalopathy (see sub-section ‘Tell your doctor immediately’ for a detailed description of symptoms);
seizures may become worse or happen more often;
uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
change of the heart rhythm (Electrocardiogram);
pancreatitis;
liver failure, hepatitis;
sudden decrease in kidney function;
skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens- Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
rhabdomyolysis (breakdown of muscle tissue) and associated blood creatine phosphokinase increase. Prevalence is significantly higher in Japanese patients when compared to non-Japanese patients;
limp or difficulty walking.

Reporting of side effects

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store levetiracetam strides oral solution

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 cardboard box and bottle after EXP: The expiry date refers to the last day of the month.

Do not use after 7 months of first opening the bottle.

Store in the original bottle, in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other information

What Levetiracetam Strides oral solution contains

– The active substance is called levetiracetam. Each ml contains 100 mg of levetiracetam.
– The other ingredients are: sodium citrate (E331), citric acid monohydrate (E330), methyl para-hydroxybenzoate (E218), ammonium glycyrrhizate (E958), glycerol (E422), maltitol liquid (E965), acesulfame potassium (E950), flavour natural white grape, purified water.

What Levetiracetam Strides oral solution looks like and contents of the pack

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

Orange colour labelled 300 ml glass bottle of Levetiracetam Strides oral solution (for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a 10 ml oral syringe (graduated every 0.25 ml) and an adaptor for the syringe.
Green colour labelled 150 ml glass bottle of Levetiracetam Strides oral solution (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Blue colour labelled 150 ml glass bottle of Levetiracetam Strides oral solution (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a 1 ml oral syringe (graduated every 0.05 ml) and an adaptor for the syringe.