Patient Information Leaflet

Keppra 100 mg/ml Oral Solution

Levetiracetam

Read this leaflet carefully before you or your child start taking this medicine, as it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Keppra and what it is used for

2.What you need to know before starting Keppra

3.How to take Keppra

4.Possible side effects

5.Storage of Keppra

6.Contents of the pack and additional information

Levetiracetam is an antiepileptic medication (a medication for the treatment of seizures in epilepsy).

Keppra is used:

• alone in adults and adolescents 16 years of age or older with recently diagnosed epilepsy to treat a form of epilepsy. Epilepsy is a disease where patients have seizures (crises). Levetiracetam is used for the form of epilepsy in which seizures initially affect only one side of the brain, but may later spread to wider areas in both sides of the brain (partial onset seizures with or without secondary generalization). Your doctor has prescribed levetiracetam to reduce the number of seizures.
• in combination with other antiepileptic medications to treat:

• partial onset seizures with or without generalization in adults, adolescents, children, and infants 1 month of age or older.
• myoclonic seizures (shock-like, short, muscle or group of muscle seizures) in adults and adolescents 12 years of age or older with juvenile myoclonic epilepsy.
• primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age or older with idiopathic generalized epilepsy (a type of epilepsy thought to have a genetic cause).

Do not take Keppra

• If you are allergic to levetiracetam, pyrrolidone derivatives, or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor before starting to take Keppra

• If you have kidney problems, follow your doctor's instructions, who will decide if you need to adjust your dose.
• If you notice any decrease in your child's growth or an unexpected onset of puberty, contact your doctor.
• A small number of people taking antiepileptic medications such as Keppra have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• If you have a medical history or family history of irregular heart rhythm (visible on an electrocardiogram), or if you have a disease and/or are taking a treatment that makes you prone to cardiac arrhythmias or electrolyte imbalances.

Inform your doctor or pharmacist if any of the following adverse effects worsen or last more than a few days:

• Abnormal thoughts, feeling of irritability, or reacting more aggressively than normal, or if you or your family and friends notice significant changes in mood or behavior.
• Worsening of epilepsy:

In rare cases, seizures may worsen or occur more frequently, mainly during the first month after starting treatment or increasing the dose.

In a very rare form of early-onset epilepsy (SCN8A mutation-associated epilepsy) that causes multiple types of seizures and loss of skills, you may notice that seizures persist or worsen during treatment.

If you experience any of these new symptoms while taking Keppra, see a doctor as soon as possible.

Children and adolescents

• Monotherapy with Keppra is not indicated in children and adolescents under 16 years old.

Use of Keppra with other medications

Inform your doctor or pharmacistif you are using, have used recently, or may need to use any other medication.

Do not take macrogol (laxative medication) within one hour before and one hour after taking levetiracetam, as it may reduce its effect.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Levetiracetam can only be used during pregnancy if, after careful evaluation, your doctor considers it necessary.

Do not stop your treatment without discussing it with your doctor first.

The risk of birth defects for the baby cannot be completely ruled out.

Breastfeeding is not recommended during treatment.

Driving and operating machinery

Keppra may affect your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the start of treatment or when increasing the dose. Do not drive or operate machinery until it is confirmed that your ability to perform these activities is not impaired.

Keppra contains parahydroxybenzoic acid methyl ester, parahydroxybenzoic acid propyl ester, and maltitol

Keppra 100 mg/ml oral solution, containing parahydroxybenzoic acid methyl ester (E218) and parahydroxybenzoic acid propyl ester (E216), may cause allergic reactions (possibly delayed).

Keppra oral solution also contains maltitol. If your doctor informs you that you have intolerance to some sugars, contact your doctor before taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Keppra should be taken twice a day, once in the morning and once at night, approximately at the same time each day.

Take the oral solution according to your doctor's instructions.

Monotherapy (from 16 years of age)

Adults (≥18 years) and adolescents (from 16 years of age):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe included in the box.

Recommended dose: Keppra is taken twice a day, in two equal doses, each dose between 5 ml (500 mg) and 15 ml (1 500 mg).

When starting Keppra, your doctor will prescribe a lower dose for two weeks before administering the daily minimum dose.

Concomitant therapy

Dose in adults and adolescents (from 12 to 17 years):

For patients from 4 years of age, measure the appropriate dose using the 10 ml syringe included in the box.

Recommended dose: Keppra is taken twice a day, in two equal doses, each dose between 5 ml (500 mg) and 15 ml (1 500 mg).

Dose in children from 6 months of age:

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

For children from 6 months to 4 years of age, measure the appropriate dose using the 3 ml syringe included in the box.

For children over 4 years of age, measure the appropriate dose using the 10 ml syringe included in the box.

Recommended dose: Keppra is taken twice a day, in two equal doses, each dose individual between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kg of child's body weight (see the following table for dose examples).

Dose in children from 6 months of age :

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

For infants from 1 month to less than 6 months of age, measure the appropriate dose using the 1 ml syringe included in the box.

Recommended dose: Keppra is taken twice a day, in two equal doses, each dose individual between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kg of infant's body weight (see the following table for dose examples).

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

Administration form:

After measuring the correct dose with the appropriate syringe, Keppra oral solution can be diluted in a glass of water or in a bottle. You can take Keppra with or without food. After oral administration of levetiracetam, its bitter taste may be perceived.

Instructions on how to use the syringe:

• Open the bottle: press the cap and unscrew in the opposite direction to the clock hands (figure 1)

• Follow these steps the first time you take Keppra:

• Separate the adapter from the oral syringe (figure 2).
• Place the adapter on the top of the bottle (figure 3). Make sure it is well secured in place. It is not necessary to remove the adapter after use.

• Follow these steps every time you take Keppra:

• Place the oral syringe in the opening of the adapter (figure 4).
• Turn the bottle upside down (figure 5).

• Hold the bottle upside down with one hand and use the other hand to fill the oral syringe.

• Push the plunger down to fill the oral syringe with a small amount of solution (figure 5A).

• Then, press the plunger up to remove any possible air bubbles (figure 5B).

• Lower the plunger to the graduation mark on the oral syringe corresponding to the dose in milliliters (ml) prescribed by your doctor (figure5C). The plunger may return to the cylinder with the first administration. Therefore, make sure the plunger is in position until the syringe is disconnected from the bottle.

• Turn the bottle right side up (figure 6A). Remove the syringe from the adapter (figure 6B).

• Empty the contents of the syringe into a glass of water or a bottle, lowering the plunger to the end of the syringe (figure 7).

• Drink the contents of the glass or bottle entirely.

• Close the bottle with the plastic screw cap (it is not necessary

to remove the adapter).

• To wash the syringe, rinse it only with cold water, moving the plunger several times up and down and expelling the water without separating the two components (figure 8).

• Keep the bottle, syringe, and leaflet in the box.

Treatment duration:

• Keppra is used as a chronic treatment. You must continue treatment with Keppra for the time indicated by your doctor.
• Do not stop treatment without your doctor's recommendation, as seizures may increase.

If you take more Keppra than you should

The possible adverse effects of a Keppra overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

Contact your doctor if you have taken more oral solution than you should. Your doctor will establish the best possible treatment for the overdose.

If you forgot to take Keppra:

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

Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Keppra:

The discontinuation of treatment with

Keppra should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Keppra, they will give you instructions for the gradual withdrawal of Keppra.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, Keppra may cause side effects, although not everyone will experience them.

Inform your doctor immediately, or go to the emergency service of your nearest hospital if you experience:

• weakness, dizziness, or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue, or throat (Quincke's edema)
• flu-like symptoms and a rash on the face followed by a prolonged rash with elevated temperature, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia), enlarged lymph nodes, and the involvement of other organs of the body (drug reaction with eosinophilia and systemic symptoms (DRESS))
• symptoms such as low urine output, fatigue, nausea, vomiting, confusion, and swelling of the legs, arms, or feet, as it may be a sign of sudden kidney function decline
• a skin rash that may form blisters and may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis)
• signs of severe mental changes or if someone around you notices signs of confusion, drowsiness (drowsiness), amnesia (memory loss), memory decline (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, drowsiness (feeling sleepy), headache, fatigue, and dizziness. Side effects such as feeling sleepy, feeling weak, and dizziness may be more frequent when starting treatment or increasing the dose. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• drowsiness (feeling sleepy), headache.

Common:may affect up to 1 in 10 people

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness, or irritability;
• seizures, balance disorder, dizziness (feeling unsteady), lethargy (lack of energy and enthusiasm), tremor (involuntary shaking);
• vertigo (feeling of rotation);
• cough;
• abdominal pain, diarrhea, dyspepsia (heavy digestion, burning, and acidity), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Rare: may affect up to 1 in 100 people

• decreased platelet count, decreased white blood cell count;
• weight loss,weight gain;
• suicidal thoughts and attempts, mental changes, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood changes, agitation;
• amnesia (memory loss), memory decline (forgetfulness), abnormal coordination/ataxia (coordinated movement altered), paresthesia (tingling), attention alterations (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test results;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decreased count of all types of blood cells;
• severe allergic reactions (DRESS, anaphylactic reaction (severe and life-threatening allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));
• decreased sodium concentration in blood;
• suicide, personality disorders (behavior problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see "Inform your doctor immediately" for a detailed description of symptoms);
• seizures may worsen or occur more frequently;
• involuntary and uncontrolled muscle spasms affecting the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• change in heart rhythm (electrocardiogram);
• pancreatitis (inflammation of the pancreas);
• liver insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which may lead to blisters that may appear as small dots (central dark spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme), a generalized rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes skin peeling on more than 30% of the body surface (toxic epidermal necrolysis):
• rhabdomyolysis (muscle tissue breakdown) and elevated creatine phosphokinase associated. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;
• gait disturbance or difficulty walking;
• combination of fever, muscle rigidity, unstable blood pressure, and heart rate, confusion, low level of consciousness (may be signs of a condition calledneuroleptic malignant syndrome). The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Very rare: may affect up to 1 in 10,000 people

• unwanted thoughts or feelings and repeated or the urge to do something over and over (obsessive-compulsive disorder).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD.

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

Do not use after 7 months of opening the container.

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

Medicines should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the containers and the medications that you no longer need. In this way, you will help protect the environment.

Keppra Composition

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

The other components are: sodium citrate, citric acid monohydrate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), liquid maltitol (E965), potassium acesulfame (E950), grape flavor, purified water.

Appearance of the product and contents of the package

Keppra 100 mg/ml oral solution is a transparent liquid.

The 300 ml glass bottle of Keppra (for children from 4 years of age, adolescents, and adults) is packaged in a cardboard box accompanied by a 10 ml oral syringe (graduated every 0.25 ml) and a syringe adapter.

The 150 ml glass bottle of Keppra (for infants and small children from 6 months to less than 4 years of age) is packaged in a cardboard box accompanied by a 5 ml oral syringe (graduated every 0.1 ml from 0.3 ml to 5 ml and every 0.25 ml from 0.25 ml to 5 ml) and a syringe adapter.

The 150 ml glass bottle of Keppra (for infants from 1 month to less than 6 months of age) is packaged in a cardboard box accompanied by a 1 ml oral syringe (graduated every 0.05 ml) and a syringe adapter.

Marketing Authorization Holder

UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgium.

Responsible for manufacturing

NextPharma SAS, 17 Route de Meulan, F-78520 Limay, France

orUCB Pharma SA, Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Last review date of this leaflet:

Other sources of information

The detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu.