Levetiracetam Tecnigen 100 mg/ml oral solution EFG: detailed information

Brand name Levetiracetam Tecnigen 100 mg/ml oral solution EFG

Form solution, oral

Active substance / Dosage

LEVETIRACETAM · 100 mg

Prescription type Prescription Only Medicine

ATC code

N03A N03AX N03AX14

Registration number 75780

Manufacturer Tecnimede Espana Industria Farmaceutica S.A.

Levetiracetam Tecnigen 100 mg/ml oral solution EFG solution, oral

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Levetiracetam TecniGen is and what it is used for
2. What you need to know before starting to take Levetiracetam TecniGen
3. How to take Levetiracetam TecniGen
4. Possible adverse effects
5. Storage of Levetiracetam TecniGen
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Levetiracetam TecniGen 100 mg/ml oral solution EFG

Levetiracetam

Read all of this leaflet carefully before you or your child starts taking this medicine because 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, pharmacist or nurse.
This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

What Levetiracetam TecniGen is and what it is used for
What you need to know before taking Levetiracetam TecniGen
How to take Levetiracetam TecniGen
Possible side effects
Storage of Levetiracetam TecniGen
Contents of the pack and other information

1. What Levetiracetam TecniGen is and what it is used for

Levetiracetam TecniGen is an antiepileptic medicine (a medicine used to treat seizures in epilepsy).

Levetiracetam TecniGen is used:

as monotherapy in adults and adolescents 16 years of age and older with newly diagnosed epilepsy, to treat one type of epilepsy. Epilepsy is a condition in which patients experience seizures. Levetiracetam is used for the type of epilepsy in which seizures initially affect only one side of the brain but may subsequently spread to broader areas on 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 medicines to treat:
- partial-onset seizures with or without secondary generalization in adults, adolescents, and children from 1 month of age,
- myoclonic seizures (brief, shock-like jerks of a muscle or group of muscles) in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy,
- primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in adults and adolescents 12 years of age and older with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic cause).

2. What you need to know before starting to take Levetiracetam TecniGen

Do not take Levetiracetam TecniGen

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take Levetiracetam TecniGen:

If you have kidney problems, follow your doctor's instructions. Your doctor will decide whether your dose needs to be adjusted.
If you notice any slowing in your child's growth or unexpected development of puberty, contact your doctor.
A small number of people taking antiepileptic medicines such as Levetiracetam TecniGen have had thoughts of harming themselves or of suicide. If you experience 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 longer than a few days:

Abnormal thoughts, feeling irritable, or reacting more aggressively than usual, or if you or your family and friends notice significant changes in mood or behaviour.

Children and adolescents

Monotherapy treatment with Levetiracetam TecniGen (treatment with this medicine alone) is not indicated in children and adolescents under 16 years of age.

Taking Levetiracetam TecniGen with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Do not take Macrogol (a medicine used as a laxative) within one hour before or one hour after taking levetiracetam, as it may reduce its effectiveness.

Taking Levetiracetam TecniGen with food, drinks, and alcohol

You may take Levetiracetam TecniGen with or without food. As a precaution, do not take Levetiracetam TecniGen with alcohol.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Levetiracetam TecniGen should not be used during pregnancy unless strictly necessary. A risk of birth defects in the baby cannot be completely ruled out. Animal studies have shown that levetiracetam has adverse effects on reproduction at doses higher than those needed to control your seizures.

Breastfeeding is not recommended during treatment.

Driving and using machines

Levetiracetam TecniGen 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. You should not drive or use machinery until you are certain that your ability to perform these activities is not impaired.

Levetiracetam TecniGen contains methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and maltitol

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

This medicine contains liquid maltitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per ml; this is essentially “sodium-free”.

3. How to take Levetiracetam TecniGen

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Levetiracetam TecniGen should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day.

Take the oral solution as directed by your doctor.

Monotherapy

Dosage in adults and adolescents from 16 years of age:

Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of age onwards.

General dose: Levetiracetam TecniGen is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

When you first start taking Levetiracetam TecniGen, your doctor will prescribe a lower dose for two weeks before increasing to the lowest general dose.

Concomitant therapy

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

Measure the appropriate dose using the 10 ml syringe provided in the package for patients from 4 years of age onwards.

General dose: Levetiracetam TecniGen is taken twice daily, divided into two equal doses, each ranging from 5 ml (500 mg) to 15 ml (1,500 mg).

Dosage in children from 6 months of age onwards:

Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam TecniGen based on age, weight, and required dose.

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

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

General dose: Levetiracetam TecniGen is taken twice daily, divided into two equal doses, each ranging from 0.1 ml (10 mg) to 0.3 ml (30 mg) per kg of the child's body weight (see dose examples in the table below).

Dosage in children from 6 months of age onwards:

Weight	Initial 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

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 provided in the package.

General dose: Levetiracetam TecniGen is taken twice daily, divided into two equal doses, each ranging from 0.07 ml (7 mg) to 0.21 ml (21 mg) per kg of the infant's body weight (see dosage examples in the table below):

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

Weight	Initial 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

Administration method:

After measuring the correct dose with an appropriate syringe, Levetiracetam TecniGen may be taken by diluting the oral solution in a glass of water or in a bottle. It may be taken with or without food.

Instructions for correct administration:

Open the bottle: press down on the cap and turn counterclockwise (Figure 1).
Insert the syringe adapter into the neck of the bottle (Figure 2). Make sure it is securely attached.
Place the syringe into the opening of the adapter (Figure 2).
Turn the bottle upside down (Figure 3).

Three steps illustrated: unscrew the cap, insert the

Draw a small amount of solution into the syringe by pulling the plunger downward (Figure 4A), then push the plunger upward to remove any possible air bubbles (Figure 4B). Pull the plunger down to the mark corresponding to the prescribed amount in millilitres (mL) as directed by your doctor (Figure 4C).

Three diagrams show hands holding a syringe with arrows indicating downward movements A, toward the

Turn the bottle back to an upright position. Remove the syringe from the adapter.
Empty the syringe contents into a glass filled with water or into a bottle, pressing the plunger fully to the end of the syringe (Figure 5).
Drink all the contents of the glass/bottle.
Close the bottle with the plastic screw cap.
Wash the syringe with water only (Figure 6).

Technical drawing showing a hand tilting a syringe over a container, with drops of liquid falling above a vertical syringe

Duration of treatment:

Levetiracetam TecniGen is used as a chronic treatment. You must continue Levetiracetam TecniGen treatment for the length of time indicated by your doctor.
Do not stop your treatment without your doctor’s recommendation, as your seizures may increase.

If you take more Levetiracetam TecniGen than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medication and the amount ingested.

Possible adverse effects of a Levetiracetam TecniGen overdose include somnolence, agitation, aggressiveness, decreased alertness, respiratory depression, and coma.

Contact your doctor if you have taken more Levetiracetam TecniGen than prescribed. Your doctor will determine the most appropriate treatment for the overdose.

If you forget to take Levetiracetam TecniGen:

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

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

If you stop treatment with Levetiracetam TecniGen:

Discontinuation of treatment with Levetiracetam TecniGen should be done gradually to avoid an increase in seizures.

If your doctor decides to stop your treatment with Levetiracetam TecniGen, they will provide you with instructions for the gradual withdrawal of Levetiracetam TecniGen.

If you have any further questions about the use of this product, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Levetiracetam TecniGen can cause adverse effects, although not everyone experiences them.

Contact your doctor immediately, or go to the nearest hospital emergency department if you experience:

weakness, dizziness, or difficulty breathing, as these may be signs of a serious allergic (anaphylactic) reaction
swelling of the face, lips, tongue, or throat (angioedema)
flu-like symptoms and facial rash followed by a persistent rash with high fever, elevated liver enzymes in blood tests, an increase in a type of white blood cells (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 of the legs, arms, or feet, as these may indicate a sudden decrease in kidney function
a skin rash that may blister and may appear as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
a more severe form causing skin peeling over 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 (drowsiness), amnesia (memory loss), memory impairment (forgetfulness), abnormal behavior, or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported adverse effects are: nasopharyngitis, somnolence (drowsiness), headache, fatigue (feeling of weakness), and dizziness. These latter adverse effects may be more common when treatment is started or the dose is increased. However, these adverse effects should decrease over time.

Very common (affects more than 1 in 10 patients)

nasopharyngitis;
somnolence (drowsiness), headache.

Common (affects between 1 and 10 in 100 patients)

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

Uncommon (affects between 1 and 10 in 1,000 patients)

decreased platelet count, decreased white blood cells;
weight loss, weight gain;
suicide attempt and suicidal thoughts, mental disturbances, abnormal behavior, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
amnesia (memory loss), memory impairment (memory problems), abnormal coordination/ataxia (impaired movement coordination), paresthesia (tingling), attention disturbances (loss of concentration);
diplopia (double vision), blurred vision;
elevated/abnormal results in liver function tests;
hair loss, eczema, itching;
muscle weakness, myalgia (muscle pain);
injury.
possible symptoms of rhabdomyolysis (breakdown of muscle tissue) and associated increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Rare (affects between 1 and 10 in 10,000 patients)

infection;
decrease in all types of blood cells;
severe allergic reactions (DRESS, anaphylactic reaction (serious and severe allergic reaction), angioedema (swelling of face, lips, tongue, and throat));
decreased concentration of sodium in the blood;
suicide, personality disorders (behavioral problems), abnormal thinking (slow thinking, difficulty concentrating);
uncontrollable muscle spasms affecting the head, trunk, and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);
pancreatitis (inflammation of the pancreas);
liver failure, hepatitis (inflammation of the liver);
skin rash that may lead to blisters appearing as small targets (dark central spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis);
sudden decrease in kidney function.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam TecniGen

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

Do not use this medicine after the expiry date stated on the label or the box after EXP. The expiry date refers to the last day of the month indicated.

Do not use more than 3 months after first opening the bottle.

Store in the original packaging.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Levetiracetam TecniGen

The active substance is levetiracetam. Each ml contains 100 mg of levetiracetam.
The other components are: sodium citrate dihydrate, citric acid monohydrate, methylparahydroxybenzoate (E218), propylparahydroxybenzoate (E216), monoammonium glycyrrhizinate, glycerol, liquid maltitol, potassium acesulfame (E950), flavouring, and purified water.

Nature and contents of the product and pack

Levetiracetam TecniGen 100 mg/ml oral solution is a clear, transparent or slightly yellowish liquid.

The 300 ml glass bottle of Levetiracetam TecniGen (for children from 4 years of age, adolescents and adults) is packaged in a cardboard box and supplied with a 10 ml oral dosing syringe (graduated every 0.25 ml).

For infants and young children from one month to four years of age, an appropriate oral dosing syringe should be used.

Each cardboard box also contains a syringe adapter.