Lacosamide Dr Reddys 10 mg/ml solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Lacosamide Dr. Reddys 10 mg/ml solution for infusion EFG

Read the entire leaflet carefully before you start using 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 or pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Package leaflet contents

1. What Lacosamide Dr. Reddy's is and what it is used for
2. What you need to know before using Lacosamide Dr. Reddy's
3. How to use Lacosamide Dr. Reddy's
4. Possible side effects
5. How to store Lacosamide Dr. Reddy's
6. Contents of the pack and other information

1. What Lacosamida Dr. Reddys is and what it is used for

What Lacosamida Dr. Reddys is

Lacosamida Dr. Reddys contains lacosamide, which belongs to a group of medicines called "antiepileptic medicines". These medicines are used to treat epilepsy.

• You have been prescribed this medicine to reduce the number of seizures you experience.

What Lacosamida Dr. Reddys is used for

• Lacosamida is used:

• as monotherapy and in combination with other antiepileptic medicines in adults, adolescents, and children from 2 years of age for the treatment of a certain type of epilepsy characterized by partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they may then spread to larger areas on both sides of the brain;

• in combination with other antiepileptic medicines in adults, adolescents, and children from 4 years of age for the treatment of primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy believed to have a genetic origin).

2. What you need to know before starting to use Lacosamide Dr. Reddy's

Do not use Lacosamide Dr. Reddy's

• if you are allergic to lacosamide or to any of the other ingredients of this medicine (listed in section 6). If you are unsure whether you are allergic, consult your doctor.
• if you have a certain type of heart rhythm problem called second- or third-degree AV block.

Do not use lacosamide if either of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medicine.

Warnings and precautions

Consult your doctor before starting to use lacosamide if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptic medicines such as lacosamide have had thoughts of self-harm or suicide. If at any time you have these types of thoughts, contact your doctor immediately.
• you have a heart condition affecting your heartbeat and often have a pulse that is particularly slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter).
• you have severe heart disease such as heart failure or have had a myocardial infarction.
• you often feel dizzy or fall frequently. Lacosamida may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be cautious until you are accustomed to the effects of this medicine.

If any of the above apply to you (or you are unsure), consult your doctor or pharmacist before starting to use lacosamide.

If you are taking lacosamide, consult your doctor if you experience a new type of seizure or a worsening of existing seizures.

If you are taking lacosamide and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, dyspnea (difficulty breathing), dizziness, or fainting), contact your doctor immediately (see section 4).

Children

Lacosamide is not recommended in children under 2 years of age with epilepsy characterized by partial-onset seizures, and it is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is still unknown whether it is effective and safe in children of these age groups.

Other medicines and Lacosamida Dr. Reddys

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

In particular, inform your doctor or pharmacist if you are taking any of the following medicines that affect the heart, as lacosamide may also affect the heart:

• medicines used to treat heart problems;
• medicines that can increase the “PR interval” on a heart test (ECG or electrocardiogram), such as epilepsy or pain medicines called carbamazepine, lamotrigine, and pregabalin;
• medicines used to treat certain types of arrhythmia or heart failure.

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before starting treatment with Lacosamida Dr. Reddys.

Also inform your doctor or pharmacist if you are taking any of the following medicines, as they may either increase or decrease the effect of Lacosamida Dr. Reddys in your body:

• antifungal medicines such as fluconazole, itraconazole, and ketoconazole;
• an HIV medicine such as ritonavir;
• antibacterial medicines such as clarithromycin and rifampicin;
• a herbal remedy used to treat mild anxiety and depression called St. John’s wort.

If any of the above apply to you (or you are unsure), speak with your doctor or pharmacist before starting treatment with Lacosamida Dr. Reddys.

Use of Lacosamida Dr. Reddy's with alcohol

As a safety precaution, do not use Lacosamida Dr. Reddy's with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraception with their doctor.

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

The use of lacosamide is not recommended during pregnancy, as the effects of lacosamide on pregnancy and the fetus are unknown. Breastfeeding is not recommended while taking lacosamide, because lacosamide passes into breast milk.

Seek immediate advice from your doctor if you are pregnant or planning to become pregnant. Your doctor will help you decide whether or not you should take lacosamide.

Do not stop treatment without first talking to your doctor, as this could increase seizures. Worsening of your condition may also harm the fetus.

Driving and operating machinery

You should not drive, ride a bicycle, or operate machinery until you know whether this medicine affects you. The reason is that lacosamide may cause dizziness or blurred vision.

Lacosamide Dr. Reddy's contains sodium

This medicine contains 59.8 mg of sodium (the main component of table/cooking salt) in each vial. This corresponds to 3% of the maximum daily recommended sodium intake for an adult. You should take this into account if you are on a controlled sodium diet.

3. How to use Lacosamide Dr. Reddy's

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

Use of Lacosamide Dr. Reddy's

• Treatment with lacosamide may be initiated:

• by taking the medicine orally, or

• administered as an intravenous infusion (sometimes referred to as IV infusion), during which your doctor or nurse administers the medicine into a vein. The administration lasts between 15 and 60 minutes.

  • The IV infusion is normally used for a short period of time, when the medicine cannot be taken orally.
  • Your doctor will decide for how many days you will receive infusions. Experience exists with administering lacosamide infusions twice daily for up to 5 days. For longer-term treatment, lacosamide tablets and oral solution are available.

When you switch from infusion to oral administration (or vice versa), the total daily dose and the frequency of administration remain the same.

• Use lacosamide twice daily (approximately 12 hours apart).
• Try to take it at approximately the same times every day.

What amount to use

The following are the recommended normal doses of Lacosamida Dr. Reddys for different age and weight groups. Your doctor may prescribe you a different dose if you have kidney or liver problems.

Adolescents and children weighing 50 kg or more, and adults

When using lacosamide alone:

• The usual starting dose is 50 mg of lacosamide twice a day.
• Treatment with lacosamide may also be initiated with a dose of 100 mg of lacosamide twice a day.

Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 300 mg twice a day.

When using lacosamide with other antiepileptic medicines:

• The usual starting dose is 50 mg of lacosamide twice a day.
• Your doctor may increase your twice-daily dose by 50 mg each week, until reaching a maintenance dose between 100 mg and 200 mg twice a day.
• If you weigh 50 kg or more, your doctor may decide to start lacosamide treatment with a single "loading" dose of 200 mg, followed 12 hours later by the start of your regular maintenance dosing.

Children and adolescents weighing less than 50 kg

• In the treatment of partial-onset seizures: note that lacosamide is not recommended for children under 2 years of age.
• In the treatment of primary generalized tonic-clonic seizures: note that lacosamide is not recommended for children under 4 years of age.

When using lacosamide alone

• Your doctor will determine the lacosamide dose based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), twice daily.
• Your doctor may increase your twice-daily dose by 1 mg (0.1 ml) per kg of body weight each week, until the maintenance dose is reached. The following dosing tables include the maximum recommended dose:
• These doses are for informational purposes only. Your doctor will calculate the correct dose for you:

To be used twice daily, for children from 2 years of age weighing from 10 kg to less than 40 kg

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml	12 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml	15 ml
30 kg	3 ml	6 ml	9 ml	12 ml	15 ml	18 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml	17.5 ml	21 ml

To be used twice daily, for adolescents and children weighing 40 kg to less than 50 kg:

Weight	Week 1 Initial dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
40 kg	4 ml	8 ml	12 ml	16 ml	20 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml	22.5 ml

When using lacosamide with other antiepileptic medicines

• Your doctor will determine the lacosamide dose according to your body weight.
• For children and adolescents weighing from 10 kg to less than 50 kg, the usual initial dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice daily.
• Your doctor may increase your dose by 1 mg (0.1 ml) per kg of body weight, twice daily, each week, until the maintenance dose is reached. The dosing table below includes the maximum recommended dose.
• These doses are for informational purposes only. Your doctor will calculate the correct dose for you.

To be used twice daily, for children from 2 years of age weighing from 10 kg to less than 20 kg

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 0.5 ml/kg	Week 6 Maximum recommended dose: 0.6 ml/kg
10 kg	1 ml	2 ml	3 ml	4 ml	5 ml	6 ml
15 kg	1.5 ml	3 ml	4.5 ml	6 ml	7.5 ml	9 ml

To be used twice daily, for adolescents and children weighing 20 kg to less than 30 kg:

Weight	Week 1 Initial dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 0.4 ml/kg	Week 5 Maximum recommended dose: 0.5 ml/kg
20 kg	2 ml	4 ml	6 ml	8 ml	10 ml
25 kg	2.5 ml	5 ml	7.5 ml	10 ml	12.5 ml

To be used twice daily, for adolescents and children weighing 30 kg to less than 50 kg

Weight	Week 1 Starting dose: 0.1 ml/kg	Week 2 0.2 ml/kg	Week 3 0.3 ml/kg	Week 4 Maximum recommended dose: 0.4 ml/kg
30 kg	3 ml	6 ml	9 ml	12 ml
35 kg	3.5 ml	7 ml	10.5 ml	14 ml
40 kg	4 ml	8 ml	12 ml	16 ml
45 kg	4.5 ml	9 ml	13.5 ml	18 ml

If you interrupt treatment with Lacosamide Dr. Reddy's

If your doctor decides to discontinue your treatment with lacosamide, your dose will be gradually reduced step by step. This is to prevent epilepsy from recurring or worsening.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.

Nervous system effects such as dizziness may be greater after a single "loading" dose.

Tell your doctor or pharmacist if you experience any of the following effects:

Very common: may affect more than 1 in 10 patients

• Headache;
• Feeling dizzy or sick (nausea);
• Double vision (diplopia).

Common: may affect up to 1 in 10 patients

• Brief jerking of a muscle or group of muscles (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems with balance, tremor, tingling (paraesthesia), or muscle spasms, tendency to fall and bruise easily;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Feeling of dizziness (vertigo), sensation of drunkenness;
• Feeling dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhoea;
• Decreased sensation, difficulty articulating words, attention disorder;
• Ringing in the ears such as buzzing or whistling;
• Irritability, difficulty sleeping, depression;
• Drowsiness, tiredness or weakness (asthenia);
• Itching, rash.

Uncommon: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse, or other changes in the heart's electrical activity (conduction disorder);
• Exaggerated feeling of well-being, seeing and/or hearing things that are not real;
• Allergic reaction to taking the medicine, hives;
• Blood tests may show abnormalities in liver function, liver damage;
• Thoughts of self-harm or suicide, or suicide attempt: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts and/or loss of sense of reality;
• Severe allergic reactions causing swelling of the face, throat, hands, feet, ankles, or lower parts of the legs;
• Fainting;
• Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, high temperature, and getting infections more often than normal. Blood tests may show a severe decrease in a specific type of white blood cells (agranulocytosis);
• Serious skin reaction, which may include high temperature and other flu-like symptoms, rash on the face, widespread rash with swollen lymph nodes (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and of a type of white blood cells (eosinophilia);
• 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);
• Seizures.

Other adverse effects of intravenous administration

Local adverse reactions may occur.

Frequent: may affect up to 1 in 10 patients

• Pain or discomfort at the injection site or irritation.

Uncommon: may affect up to 1 in 100 patients

• Redness at the injection site.

Other adverse reactions in children

Additional adverse reactions observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), behavioral changes, not acting as they normally do (abnormal behavior), and lack of energy (lethargy). A feeling of sleepiness (somnolence) is a very common side effect in children and may affect more than 1 in every 10 children.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is an adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Lacosamide Dr. Reddy's

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

Do not use this medicine after the expiry date stated on the carton and on the vial after EXP. The expiry date is the last day of the month indicated.

This medicine does not require any special storage conditions.

Each vial of Lacosamide Dr. Reddy's solution for infusion is for single use only. Any unused solution must be discarded.

Only solutions that are clear, particle-free, and without discoloration should be used.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Lacosamide Dr. Reddy's

• The active substance is lacosamide.

1 ml of Lacosamide Dr. Reddy's solution for infusion contains 10 mg of lacosamide.

1 vial contains 20 ml of Lacosamide Dr. Reddy's solution for infusion, equivalent to 200 mg of lacosamide.

• The other components are: sodium chloride, hydrochloric acid, water for injections.

Appearance of the product and contents of the pack

• Lacosamide Dr. Reddy's 10 mg/ml solution for infusion is a clear, colourless solution presented in a clear glass vial with a grey rubber stopper and sealed with a grey cap.

Lacosamide Dr. Reddy's solution for infusion is available in packs containing 1 vial and 5 vials. Each vial contains 20 ml.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Reddy Pharma Iberia, S.A.

Avda. Josep Tarradellas nº 38

08029 Barcelona

Spain

Manufacturer

betapharm Arzneimittel GmbH

Kobelweg 95

86156 Augsburg

Germany

or

Pharmadox Healthcare Ltd.

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

or

Rual Laboratories SRL

313, Splaiul Unirii, Building H 1st floor, sector 3

Bucuresti, 030138

Romania

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

Member State Name	Medicinal Product Name
Spain	Lacosamida Dr. Reddys 10 mg/ml solution for infusion EFG
Italy	Lacosamide Dr. Reddy’s

Date of the most recent review of this leaflet: January 2024

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

This information is intended for healthcare professionals only:

Each vial of Lacosamida Dr. Reddys solution for infusion must be used only once (single use). Any unused solution must be discarded (see section 3).

Lacosamida Dr. Reddys solution for infusion can be administered without further dilution, or it may be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), or Ringer's lactate solution.

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, storage in use and conditions prior to use are the responsibility of the user and must not exceed 24 hours at a temperature of 2 to 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.

Chemical and physical in-use stability has been demonstrated for 24 hours at temperatures up to 25 °C for diluted products mixed with these diluents and stored in glass or PVC bags.