LEVETIRACETAM ALTAN 100 mg/ml CONCENTRATE FOR INFUSION SOLUTION

2. What you need to know before you use Levetiracetam Altan

Do not use Levetiracetam Altan

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

Warnings and precautions

Tell your doctor before you start using Levetiracetam Altan

• if you have kidney problems, follow your doctor's instructions, as he/she will decide if you need to adjust the dose.
• if you notice any decrease in your child's growth or an unexpected delay in puberty, contact your doctor.
• a small number of people taking antiepileptics such as Levetiracetam Altan have had thoughts of harming themselves or committing suicide. If you have any symptoms of depression and/or suicidal thoughts, contact your doctor.
• if you have a history of heart rhythm problems (as shown on an electrocardiogram) or if you have a condition or are taking a medicine that may affect the heart rhythm or electrolyte balance.

Tell your doctor or pharmacist if any of the following side effects get worse or last more than a few days:

• abnormal thoughts, feeling irritable or behaving more aggressively than usual or if you or your family and friends notice significant changes in mood or behaviour.
• worsening of epilepsy

Rarely, the seizures may become worse or more frequent, mainly during the first month after the start of treatment or the increase of the dose.

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

If you experience any of these new symptoms while taking Levetiracetam Altan, contact a doctor as soon as possible.

Children and adolescents

• Monotherapy with Levetiracetam Altan is not indicated for children and adolescents under 16 years.

Use of Levetiracetam Altan with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Levetiracetam can only be used during pregnancy if, after a careful evaluation, your doctor considers it necessary.

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

The risk of birth defects for your baby cannot be completely excluded.

Breastfeeding is not recommended during treatment with Levetiracetam Altan.

Driving and using machines

Levetiracetam Altan may affect your ability to drive or use tools or machines, as it may cause drowsiness. This is more likely at the start of treatment or when the dose is increased. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam Altan contains sodium

A single maximum dose of Levetiracetam Altan contains 2.5 mmol (or 57.30 mg) of sodium (0.8 mmol (or 19 mg) of sodium per vial). To be taken into consideration by patients on a controlled sodium diet.

3. How to use Levetiracetam Altan

Levetiracetam Altan will be administered to you by a doctor or a nurse through intravenous infusion.

Levetiracetam Altan should be administered twice daily, once in the morning and once in the evening, approximately at the same time every day.

The intravenous formulation is an alternative to oral administration. You can switch from film-coated tablets or oral solution to the intravenous formulation, or vice versa, directly without dose adjustment. Your total daily dose and frequency of administration should be the same.

Concomitant therapy and monotherapy (from 16 years of age)

Adults (>18 years) and adolescents (from12 to17 years) weighing50 kgor more:

Recommended dose: between 1,000 mg and 3,000 mg per day.

When you first start taking Levetiracetam Altan, your doctor will prescribe you a lower dosefor two weeks before giving you the lowest daily dose.

Dose in children (from4 to11 years) and adolescents (from12 to17 years) weighing less than 50 kg:

Recommended dose: between 20 mg per kg body weight and 60 mg per kg body weight per day.

Method and route of administration:

Levetiracetam Altan is for intravenous use.

The recommended dose must be diluted in at least 100 ml of a compatible diluent and administered by intravenous infusion over 15 minutes.

More detailed information for the correct use of Levetiracetam Altan is provided in section 6 for doctors and nurses.

Duration of treatment:

• There is no experience with the administration of intravenous levetiracetam for a period longer than 4 days.

If you stop treatment with Levetiracetam Altan:

As with other antiepileptic medicines, the discontinuation of treatment with levetiracetam should be done gradually to avoid an increase in seizures. If your doctor decides to stop your treatment with Levetiracetam Altan, he/she will give you the instructions for the gradual withdrawal of Levetiracetam Altan.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Levetiracetam Altan can cause side effects, although not everybody gets them.

Tell your doctor immediately, or go to the casualty department of your nearest hospital if you experience:

• weakness, dizziness or difficulty breathing, as these may be signs of a severe allergic reaction (anaphylaxis)
• swelling of the face, lips, tongue or throat (Quincke's oedema)
• flu-like symptoms and rash on the face followed by a prolonged rash with high fever, elevated liver enzymes in blood tests and an increased number of 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, tiredness, nausea, vomiting, confusion and swelling of legs, arms or feet, as this may be a sign of sudden decrease in kidney function
• a skin rash which may form blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 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, drowsiness (drowsiness), amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered coordination of movements) or other neurological signs including involuntary or uncontrolled movements. These may be symptoms of encephalopathy.

The most frequently reported side effects are nasopharyngitis, somnolence (feeling drowsy), headache, fatigue and dizziness. Side effects such as drowsiness, weakness and dizziness may be more frequent at the start of treatment or when the dose is increased. However, these side effects should decrease over time.

Very common:may affect more than 1 in 10 people

• nasopharyngitis;
• somnolence (feeling drowsy), 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 spinning);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• skin rash;
• asthenia/fatigue (feeling weak).

Uncommon:may affect up to 1 in 100 people

• decreased number of platelets, decreased number of white blood cells;
• weight loss, weight gain;
• suicidal attempt and suicidal thoughts, mental disorders, abnormal behaviour, hallucinations, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (memory loss), memory impairment (memory loss), abnormal coordination/ataxia (altered coordination of movements), paraesthesia (tingling), attention disturbances (lack of concentration);
• diplopia (double vision), blurred vision;
• elevated/abnormal liver enzymes in blood tests;
• hair loss, eczema, itching;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: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 oedema (swelling of face, lips, tongue and throat));
• decrease in sodium levels in the blood;
• suicide, personality disorders (behaviour problems), abnormal thinking (slow thinking, difficulty concentrating);
• delirium;
• encephalopathy (see sub-section "Tell your doctor immediately" for a detailed description of the symptoms);

? seizures may become worse or more frequent;

? 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 failure, hepatitis (inflammation of the liver);

? sudden decrease in kidney function;

? skin rash, which may lead to blisters and may look like targets (central dark spot surrounded by a paler area, with a dark ring on 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 over more than 30% of the body surface (toxic epidermal necrolysis);

? rhabdomyolysis (breakdown of muscle tissue) and increased creatine phosphokinase in the blood. The prevalence is significantly higher in Japanese patients compared to non-Japanese patients;

? limping or difficulty walking;

• combination of fever, muscle stiffness, unstable blood pressure and heart rate, confusion, decreased level of consciousness (may be signs of a condition called neuroleptic 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 urges to do something over and over again (obsessive-compulsive disorder).

Reporting of side effects

If you experience 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 Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Levetiracetam Altan

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 vial and carton after EXP.

The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

6. Container Content and Additional Information

Composition of Levetiracetam Altan

The active ingredient is levetiracetam. Each ml contains 100 mg of levetiracetam. Each 5 ml contains 500 mg of levetiracetam.

The other components are: sodium acetate trihydrate, glacial acetic acid, sodium chloride, water for injectable preparations.

Appearance of the Product and Container Content

Levetiracetam Altan concentrate for solution for infusion (sterile concentrate) is a clear and colorless liquid.

Colorless glass vial, type I with a capacity of 7 ml. Each vial contains 5 ml of concentrate for solution for infusion.

Package sizes: 10 vials.

Marketing Authorization Holder and Manufacturer

Holder:

Altan Pharmaceuticals, S.A.

C/Cólquide Nº 6, Portal 2, 1ª Planta, Oficina F, Edificio Prisma

28230 Las Rozas. Madrid

Spain

Manufacturer

Altan Pharmaceuticals, S.A.

Polígono Industrial de Bernedo, s/n

01118 Bernedo (Álava)

Spain

Or

Altan Pharmaceuticals, S.A.

Avda. de la Constitución, 198-199, Polígono Industrial Monte Boyal, Casarrubios del Monte, 45950 Toledo Spain

Date of the Last Revision of this Prospectus: June 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)http://www.aemps.gob.es

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This information is intended only forhealthcare professionals:

Instructions for the proper use of Levetiracetam Altan are provided in section 3.

A vial of Levetiracetam Altan concentrate contains 500 mg of levetiracetam (5 ml of 100 mg/ml concentrate).

See Table 1 for the recommended preparation and administration of Levetiracetam Altan concentrate to achieve the total daily dose of 500 mg, 1,000 mg, 2,000 mg, or 3,000 mg divided into two doses.

Table 1. Preparation and Administration of Levetiracetam Altan Concentrate

This medication is for single use, so the unused solution must be discarded.

In-use shelf-life: from a microbiological point of view, the product must be used immediately after dilution. If not used immediately, the time and storage conditions prior to the next use are the responsibility of the user and must not exceed 24 hours between 2 and 8°C, unless the dilution has been carried out under validated and controlled aseptic conditions.

It was found that Levetiracetam Altan is physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in PVC bags at a controlled room temperature of 15-25°C.

Diluents:

• Sodium chloride injection solution (0.9%)
• Lactated Ringer's injection solution
• Dextrose 5% injection solution