Prospect: information for the patient

Laurak 100 mg/ml oral solution EFG

Levetiracetam

Read this prospect carefully before you or your child starts taking this medicine, because it contains important information for you.

• Keep this prospect as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1.Laurak solution and its use

2.What you need to know before starting Laurak solution

3.How to take Laurak solution

4.Possible adverse effects

5.Storage of Laurak solution

6.Contents of the package and additional information

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

Laurak solution 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.
• concurrently 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 muscles) 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 Laurak solution

• 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 this medication

• 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 unexpected puberty development, contact your doctor.
• A small number of people taking antiepileptic medications such as levetiracetam have had thoughts of self-harm or suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.

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.

Children and adolescents

• The exclusive treatment with levetiracetam (monotherapy) is not indicated in children and adolescents under 16 years old.

Use of Laurak solution 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) during 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

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

Laurak solution contains methyl parahydroxybenzoate, propyl parahydroxybenzoate, and maltitol

Laurak solution may cause allergic reactions (possibly delayed) because it contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).

This medication contains maltitol. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains 3.4 mg of propylene glycol in each ml.

If the baby is less than 4 weeks old, consult your doctor or pharmacist, especially if the baby has been given other medications containing propylene glycol or alcohol.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Levetiracetam 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

Dose in adults 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.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

When starting to take this medication, your doctor will prescribe a lower dose for two weeks before administering the general lowest 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.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 5 ml (500 mg) and 15 ml (1500 mg).

Dose in children from 6 months of age:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam 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.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.1 ml (10 mg) and 0.3 ml (30 mg) per kilogram of body weight of the child (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.

General dose: levetiracetam is taken twice a day, in two equal doses, each individual dose between 0.07 ml (7 mg) and 0.21 ml (21 mg) per kilogram of body weight of the infant (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, Laurak oral solution can be diluted in a glass of water or in a bottle. You can take Laurak solution with or without food. After oral administration of levetiracetam, its bitter taste may be appreciated.

Instructions for correct administration:

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

• Insert the adapter of the syringe into the neck of the bottle (figure 2). Make sure it is well fixed.
• Take the syringe and insert it into the opening of the adapter (figure 2).

Put the bottle upside down (figure 3).

• Laurak solución se puede tomar con o sin alimentos. Tras la administración oral de levetiracetam se puede apreciar su sabor amargo.

• Fill the syringe with a small amount of solution by lowering the plunger (figure 4A) and then raising it to eliminate any possible bubble (figure 4B). Lower the plunger to the graduation mark corresponding to the dose in milliliters (ml) prescribed by your doctor (figure 4C).

• Put the bottle right side up. Remove the syringe from the adapter.
• Empty the contents of the syringe into a glass of water or a bottle, lowering the plunger to the end of the syringe (figure 5).

• Drink the contents of the glass or bottle entirely.
• Wash the syringe only with water (figure 6).

• Close the bottle with the plastic screw cap.

Duration of treatment:

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

If you take more Laurak solution than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or call the Toxicological Information Service 91 562 04 20 indicating the medication and the amount ingested. The possible adverse effects of a Laurak solution overdose are drowsiness, agitation, aggression, decreased alertness, respiratory inhibition, and coma.

If you forgot to take Laurak solution:

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 the treatment with Laurak solution:

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

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

Like all medicines, this medicine can 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)
• symptoms of the flu 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) and enlarged lymph nodes (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 can 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

• decrease in the number of platelets, decrease in white blood cells;
• weight loss,weight gain;
• suicidal attempt and suicidal thoughts, mental alterations, 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;
• elevated/anomalous values in liver function tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

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

• infection;
• decrease in all types of blood cells;

• severe allergic reactions (DRESS, anaphylactic reaction (severe allergic reaction), Quincke's edema (swelling of the face, lips, tongue, and throat));

• decrease in 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);

• involuntary muscle spasms that affect the head, torso, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
• pancreatitis (inflammation of the pancreas);
• hepatic insufficiency, hepatitis (inflammation of the liver);
• sudden decline in kidney function;
• skin rash, which can 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.

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 the Spanish System for the Vigilance of Medicinal Products for Human Usehttps://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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 6 months of the first opening of the packaging.

This medication does not require special conservation conditions.

Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Composition of Laurak solution

The active substance is levetiracetam.

Each ml contains 100 mg of levetiracetam.

Oral syringe of 1 ml (graduated every 0.05 ml):

Each 0.05 ml contains 5 mg of levetiracetam

Oral syringe of 3 ml (graduated every 0.1 ml):

Each 0.1 ml contains 10 mg of levetiracetam

Oral syringe of 10 ml (graduated every 0.25 ml):

Each 0.25 ml contains 25 mg of levetiracetam

The other components are: sodium citrate, anhydrous citric acid, purified water, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), ammonium glycyrrhizate, glycerol (E422), maltitol (E965), potassium acesulfame (E950), fantasy aroma (includes propylene glycol and menthol), contramarum aroma (includes propylene glycol, triacetin).

Appearance of the product and contents of the package

Laurak solution 100 mg/ml oral solution is a transparent, colorless to slightly brownish liquid.

The 300 ml glass bottle of Laurak solution (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 Laurak solution (for infants and small children from 6 months to less than 4 years of age) is packaged in a cardboard box accompanied by a 3 ml oral syringe (graduated every 0.1 ml) and a syringe adapter.

The 150 ml glass bottle of Laurak solution (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.

150 ml and 300 ml oral solution containers.

Only some sizes of containers may be commercially marketed.

Marketing Authorization Holder and Responsible for Manufacturing

Marketing Authorization Holder

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona

Spain

Responsible for Manufacturing

Neuraxpharm Arzneimittel GmbH

Elisabeth-Selbert-Strasse 23

40764 Langenfeld

Germany

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Portugal:Laurak

Spain:Laurak 100 mg/ml oral solution EFG

Date of the last review of this leaflet:February 2021

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/