Levetiracetam Alter

Patient Information Leaflet

Levetiracetam Alter 250 mg film-coated tablets, 500 mg film-coated tablets, 750 mg film-coated tablets, 1000 mg film-coated tablets

Levetiracetam
Generic medicine
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. 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 their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Levetiracetam Alter is an antiepileptic medicine (a medicine used to treat epileptic seizures).
Levetiracetam Alter is used:

• as monotherapy in adults and adolescents aged 16 years and older with newly diagnosed epilepsy, to treat partial-onset seizures, with or without secondary generalization;
• as add-on therapy to other antiepileptic medicines to treat:
  • partial-onset seizures, with or without secondary generalization, in adults, adolescents and children over 6 years of age;
  • myoclonic seizures in patients aged 12 years and older with juvenile myoclonic epilepsy;
  • primary generalized tonic-clonic seizures in patients aged 12 years and older with idiopathic generalized epilepsy.

2. What you need to know before taking Levetiracetam Alter

Do not take Levetiracetam Alter

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

Warnings and precautions
Talk to your doctor before taking Levetiracetam Alter:

• If you have kidney problems, follow your doctor’s instructions. Your doctor may decide whether your dose needs to be adjusted.
• If you observe slowed growth or unexpected development of puberty in the child, contact your doctor.
• If you notice an increase in seizure severity (e.g., an increase in frequency), contact your doctor.
• A limited number of people taking antiepileptic medicines such as Levetiracetam have experienced suicidal thoughts or self-harming ideation. If you experience any symptoms of depression and/or suicidal thoughts, contact your doctor.

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

• Unusual thoughts, feeling irritable, or more aggressive reactions than usual, or if you or your family and friends notice the onset of significant changes in mood or behaviour.

Other medicines and Levetiracetam Alter
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Levetiracetam Alter with food, drinks and alcohol
You may take Levetiracetam Alter with or without food. As a precautionary safety measure, do not take Levetiracetam Alter with alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine.
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine. Levetiracetam Alter should not be used during pregnancy unless strictly necessary. The potential risk to the foetus is unknown. Levetiracetam has shown adverse reproductive effects in animal studies at dose levels higher than those required to control seizures.
Breastfeeding is not recommended during treatment.
Driving and using machines
Levetiracetam Alter may reduce your ability to drive or operate tools or machinery, as it may cause drowsiness. This is more likely at the beginning of treatment or after an increase in dose. You must not drive or use machines until you are certain that your ability to perform these activities is not impaired.
Levetiracetam Alter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. essentially ‘sodium-free’.

3. How to take Levetiracetam Alter

Take this medicine exactly as directed by your doctor.
If you have any doubts, consult your doctor.
Levetiracetam Alter should be taken twice daily, once in the morning and once in the evening, approximately at the same time each day. Take the number of tablets as instructed by your doctor.

Monotherapy
Dose for adults and adolescents (from 16 years of age):
Typical dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day. When you start taking Levetiracetam Alter for the first time, your doctor will prescribe a lower starting dose for 2 weeks before increasing to the lowest typical dose.
Example: if your daily dose is 1,000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Adjunctive therapy
Dose for adults and adolescents (from 12 to 17 years of age) weighing 50 kg or more:
Typical dose: between 1,000 mg (2 tablets) and 3,000 mg (6 tablets) per day.
Example: if your daily dose is 1,000 mg, you should take 1 tablet in the morning and 1 tablet in the evening.

Dose for children (from 6 to 11 years of age – approximately 25 kg and above) and adolescents (from 12 to 17 years of age) weighing less than 50 kg:
Your doctor will prescribe the most appropriate pharmaceutical form of Levetiracetam Alter based on age, weight, and required dose.
Typical dose: between 20 mg per kg of body weight and 60 mg per kg of body weight per day.
Example: for a typical daily dose of 20 mg per kg of body weight, if the child weighs 25 kg, give 1 tablet in the morning and 1 tablet in the evening.

Method of administration
Swallow the Levetiracetam Alter tablets with a sufficient amount of liquid (e.g. a glass of water).

Duration of treatment

• Levetiracetam Alter is used as a chronic treatment. Treatment with Levetiracetam Alter should continue for as long as prescribed by your doctor.
• Do not stop treatment without consulting your doctor, as this could increase the frequency of seizures. If your doctor decides to discontinue treatment with Levetiracetam Alter, they will provide instructions for gradually tapering off the medication.

If you take more Levetiracetam Alter than you should
Possible adverse effects of an overdose of Levetiracetam Alter include drowsiness, agitation, aggression, decreased attention, respiratory depression, and coma. Contact your doctor immediately if you have taken more tablets than prescribed. Your doctor will determine the best treatment for the overdose.

If you forget to take Levetiracetam Alter
Contact your doctor if you have forgotten to take one or more doses.
Do not take a double dose to make up for a missed dose.

If you stop taking Levetiracetam Alter
If treatment needs to be discontinued, as with any other antiepileptic medicine, Levetiracetam Alter should be withdrawn gradually to avoid an increase in seizures.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Immediately inform your doctor or go to the nearest emergency room if you experience:

• weakness, dizziness or lightheadedness, or if you have difficulty breathing, as these may be signs of a severe allergic reaction (anaphylactic)
• swelling of the face, lips, tongue and throat (angioedema, Quincke's edema)
• flu-like symptoms and facial rash followed by widespread rash with high fever, increased liver enzyme levels observed in blood tests, increased levels of a type of white blood cells (eosinophilia), and swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms [DRESS, Drug Reaction with Eosinophilia and Systemic Symptoms])
• symptoms such as reduced urine volume, fatigue, nausea, vomiting, confusion, and swelling of legs, ankles or feet, as these may indicate sudden worsening of kidney function
• a skin rash that may appear as blisters resembling small targets (dark central spots surrounded by a lighter area, with a dark ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
• a more severe form of rash causing skin peeling affecting more than 30% of the body surface (toxic epidermal necrolysis)
• signs of serious mental disturbances or if someone around you notices confusion, drowsiness, amnesia (memory loss), memory impairment (forgetfulness), abnormal behaviour or other neurological signs, including involuntary or uncontrolled movements. These could be symptoms of encephalopathy.

Inform your doctor if you experience any of the following side effects that concern you.
Some of these side effects, such as drowsiness, fatigue and dizziness, may be more common at the beginning of treatment or when the dose is increased. However, these effects should decrease over time.

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

• nasopharyngitis;
• drowsiness, headache.

Common (may affect from 1 to 10 in 100 people):

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• seizure, balance disorder, dizziness (sensation of unsteadiness), lethargy, tremor (involuntary tremors);
• vertigo (sensation of spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (feeling weak).

Uncommon (may affect from 1 to 10 in 1,000 people):

• decreased number of platelets in the blood, decreased number of white blood cells in the blood;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorder, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional lability/mood changes, agitation;
• amnesia (memory loss), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired motor coordination), paresthesia (tingling), attention disturbance (loss of concentration);
• diplopia (double vision), blurred vision;
• abnormal liver function test;
• hair loss, eczema, pruritus (itching);
• muscle weakness, myalgia (muscle pain);
• injury.

Rare (may affect from 1 to 10 in 10,000 people):

• infection;

• decreased number of all types of blood cells;

• severe hypersensitivity reactions (DRESS);

• decreased concentration of sodium in the blood;

• suicide, personality disorder (behavioural problems), thought disturbances (slowed thinking, inability to concentrate);

• uncontrollable muscle spasms involving the head, trunk and limbs, difficulty controlling movements, hyperkinesia (hyperactivity);

• pancreatitis;

• liver failure, hepatitis;

• sudden decrease in kidney function;

• skin rash with blisters appearing as small targets (dark spots in the center surrounded by a lighter area, which in turn are surrounded by a darker ring) (erythema multiforme); a widespread rash with blisters and skin peeling, especially in the area of the mouth, nose, eyes and genital region (Stevens-Johnson syndrome), 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 increase in blood creatine phosphokinase. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Levetiracetam Alter

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after Exp.
The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Levetiracetam Alter contains

• The active substance is levetiracetam.

Each tablet contains 250 mg of levetiracetam.
Each tablet contains 500 mg of levetiracetam.
Each tablet contains 750 mg of levetiracetam.
Each tablet contains 1000 mg of levetiracetam.

• The other components are: Tablet core: microcrystalline cellulose, croscarmellose sodium, anhydrous colloidal silica, macrogol 6000, magnesium stearate. Coating: hypromellose, titanium dioxide (E171), glycerol triacetate.

Description of the appearance of Levetiracetam Alter and contents of the pack
Levetiracetam Alter 250 mg are white, round, biconvex film-coated tablets with a score line; the tablets are packaged in aluminium/PVC blisters containing 20 and 30 tablets.
Levetiracetam Alter 500 mg are white, oval film-coated tablets with a score line; the tablets are packaged in aluminium/PVC blisters containing 10, 20, 30 and 60 tablets.
Levetiracetam Alter 750 mg are white, oval film-coated tablets with the inscription “750” on the tablet body; the tablets are packaged in aluminium/PVC blisters containing 20 and 30 tablets.
Levetiracetam Alter 1000 mg are white, oval film-coated tablets with a score line; the tablets are packaged in aluminium/PVC blisters containing 10, 20 and 30 tablets.
The break line is intended only to facilitate breaking the tablet for ease of swallowing and is not intended to divide the tablet into equal doses.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Laboratori Alter S.r.l., Via Egadi, 7 – 20144 Milano, Italy

Manufacturer
Laboratorios Alter S.A.
C/Mateo Inurria n. 30, 28036- Madrid, Spain