LACOSAMIDE DR REDDYS 10 mg/ml SOLUTION FOR INFUSION

Introduction

Patient Information Leaflet

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

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Leaflet

1. What is Lacosamida Dr. Reddys and what is it used for
2. What you need to know before taking Lacosamida Dr. Reddys
3. How to take Lacosamida Dr. Reddys
4. Possible side effects
5. Storage of Lacosamida Dr. Reddys
6. Package contents and additional information

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

What is Lacosamida Dr. Reddys

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 is Lacosamida Dr. Reddys used for

• Lacosamida is used:

• alone and with other antiepileptics in adults, adolescents, and children from 2 years of age to treat a certain type of epilepsy characterized by the occurrence of partial-onset seizures with or without secondary generalization. In this type of epilepsy, seizures affect only one side of the brain. However, they can then spread to larger areas on both sides of the brain;
• with other antiepileptics in adults, adolescents, and children from 4 years of age to treat 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 taking Lacosamida Dr. Reddys

Do not take Lacosamida Dr. Reddys

• if you are allergic to lacosamide or any of the other ingredients of this medicine (listed in section 6). If you are not sure, consult your doctor.
• if you have a certain type of heart rhythm problem called second- or third-degree AV block.

Do not take lacosamida if any of the above applies to you. If you are not sure, consult your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Consult your doctor before starting to take lacosamida if:

• you have thoughts of self-harm or suicide. A small number of people taking antiepileptics such as lacosamida have had thoughts of self-harm or suicide. If you have such thoughts at any time, contact your doctor immediately.
• you have a heart problem that affects your heartbeat and your pulse is often 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 heart attack.
• you often feel dizzy or fall. Lacosamida may cause dizziness, which could increase the risk of accidental injury or falls. This means you should be careful until you are used to the effects of this medicine.

If any of the above applies to you (or you are not sure), consult your doctor or pharmacist before starting to take lacosamida.

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

If you are taking lacosamida and experience symptoms of abnormal heartbeat (such as slow, fast, or irregular heartbeat, palpitations, shortness of breath, dizziness, fainting), consult your doctor immediately (see section 4).

Children

Lacosamida is not recommended for children under 2 years of age with epilepsy characterized by partial-onset seizures and is not recommended for children under 4 years of age with primary generalized tonic-clonic seizures. This is because it is not yet known whether it is effective and safe for children in this age group.

Other medicines and Lacosamida Dr. Reddys

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

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

• medicines for heart problems;
• medicines that can increase the “PR interval” in 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 applies to you (or you are not sure), talk to your doctor or pharmacist before starting to take lacosamida.

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

• medicines for fungal infections such as fluconazole, itraconazole, and ketoconazole;
• a medicine for HIV such as ritonavir
• medicines for bacterial infections such as clarithromycin and rifampicin;
• a herbal medicine used to treat mild anxiety and depression called St. John's Wort.

If any of the above applies to you (or you are not sure), talk to your doctor or pharmacist before starting to take Lacosamida Dr. Reddys.

Using Lacosamida Dr. Reddys with alcohol

As a precaution, do not use Lacosamida Dr. Reddys with alcohol.

Pregnancy and breastfeeding

Women of childbearing age should discuss the use of contraceptives 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.

Lacosamida is not recommended if you are pregnant, as its effects on pregnancy and the fetus are not known. It is also not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.

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

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

Driving and using machines

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

Lacosamida Dr. Reddys contains sodium

This medicine contains 59.8 mg of sodium (the main component of cooking/table salt) per vial. This is equivalent to 3% of the maximum recommended daily intake of sodium for an adult. You should be aware of this if you are on a controlled sodium diet.

3. How to take Lacosamida Dr. Reddys

Follow the instructions for administration of this medicine exactly as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

Using Lacosamida Dr. Reddys

• Treatment with lacosamida may be started:

• by taking the medicine orally or
• by administering it as an intravenous infusion (sometimes called IV infusion) with which your doctor or nurse will administer the medicine into a vein. The administration takes 15 to 60 minutes.
• • IV infusion is normally used for a short period, when the medicine cannot be taken orally.
  • Your doctor will decide how many days you will receive infusions. There is experience with the administration of lacosamida infusions twice a day for up to 5 days. For longer-term treatment, lacosamida tablets and syrup are available.

When you switch from infusion to taking the medicine orally (or vice versa), the total amount you take each day and how often you take it remains the same.

• Use lacosamida twice a day (with approximately 12 hours in between).
• Try to use it at approximately the same time every day.

How much to use

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

Adolescents and children weighing 50 kg or more and adults

When using lacosamida alone:

• The usual starting dose is 50 mg twice a day.
• Treatment with lacosamida may also start with a dose of 100 mg of lacosamida twice a day.

Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach a maintenance dose between 100 mg and 300 mg twice a day.

When using lacosamida with other antiepileptic medicines:

• The usual starting dose is 50 mg twice a day.
• Your doctor may increase the dose you take twice a day by 50 mg each week, until you reach 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 treatment with lacosamida with a single “loading dose” of 200 mg. You will then start taking your maintenance dose 12 hours later.

Children and adolescents weighing less than 50 kg

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

When using lacosamida alone

• Your doctor will decide the dose of lacosamida based on your body weight.
• The usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight, each week, until you reach the maintenance dose. The following dosing tables include the maximum recommended dose:
• These doses are for guidance only. Your doctor will calculate the correct dose for you.

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

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

When using lacosamida with other antiepileptic medicines

• Your doctor will decide the dose of lacosamida based on your body weight.
• For children and adolescents weighing 10 kg to less than 50 kg, the usual starting dose is 1 mg (0.1 ml) per kilogram (kg) of body weight, twice a day.
• Your doctor may increase the dose you take twice a day by 1 mg (0.1 ml) per kg of body weight, each week, until you reach the maintenance dose. The following dosing table includes the maximum recommended dose:
• These doses are for guidance only. Your doctor will calculate the correct dose for you.

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

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

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

If you stop taking Lacosamida Dr. Reddys

If your doctor decides to stop your treatment with lacosamida, they will gradually reduce your dose. This is to prevent your epilepsy from coming back or getting worse.

If you have any other 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 all people suffer from them.

Adverse effects on the nervous system, such as dizziness, may be greater after a single "loading" dose.

Inform your doctor or pharmacist if you experience any of the following effects: Very frequent: may affect more than 1 in 10 patients

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

Frequent: may affect up to 1 in 10 patients

• Brief jerks of a muscle or group of muscles (myoclonic seizures);
• Difficulty coordinating movements or walking;
• Problems maintaining balance, agitation (tremor), tingling (paresthesia), or muscle spasms, easy falling and bruising;
• Memory problems, difficulty thinking or finding words, confusion;
• Rapid, uncontrolled eye movements (nystagmus), blurred vision;
• Feeling of dizziness (vertigo), feeling of intoxication;
• Being dizzy (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestine, diarrhea;
• Decreased sensitivity, difficulty articulating words, attention disorder;
• Noise in the ears like buzzing or whistling;
• Irritability, sleep problems, depression;
• Somnolence, fatigue or weakness (asthenia);
• Itching, rash.

Infrequent: may affect up to 1 in 100 patients

• Decreased heart rate, palpitations, irregular pulse or other changes in heart 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 attempted suicide: inform your doctor immediately;
• Feeling angry or agitated;
• Abnormal thoughts and/or loss of sense of reality;
• Severe allergic reactions, which cause swelling of the face, throat, hands, feet, ankles, or lower legs;
• Fainting.
• Abnormal involuntary movements (dyskinesia).

Frequency not known: cannot be estimated from the available data

• Abnormally fast heartbeat (ventricular tachyarrhythmia);
• Sore throat, elevated temperature, and frequent infections. Blood tests may show a severe decrease in a specific class of white blood cells (agranulocytosis);
• Severe skin reaction, which may include elevated temperature and other flu-like symptoms, rash on the face, generalized rash with lymph node swelling (enlarged lymph nodes). Blood tests may show an increase in liver enzyme levels and a type of white blood cell (eosinophilia);
• 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);
• 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.

Infrequent: may affect up to 1 in 100 patients

• Redness at the injection site.

Other Adverse Effects in Children

Additional adverse effects 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). Somnolence is a very frequent side effect in children and may affect more than 1 in 10 children.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Lacosamida Dr. Reddys

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the box and on the vial after CAD. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Each vial of Lacosamida Dr. Reddys solution for infusion should be used only once (single use). The unused solution should be discarded.

Only clear, particle-free, and colorless solutions should be used.

Medicines should not be thrown away through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medicines that are no longer needed. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Lacosamida Dr. Reddys

• The active ingredient is lacosamide.

1 ml of Lacosamida Dr. Reddys solution for infusion contains 10 mg of lacosamide.

1 vial contains 20 ml of Lacosamida Dr. Reddys solution for infusion, equivalent to 200 mg of lacosamide.

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

Product Appearance and Package Contents

• Lacosamida Dr. Reddys 10 mg/ml solution for infusion is a clear, colorless solution, presented in a transparent glass vial with a gray rubber stopper and sealed with a gray cap.

Lacosamida Dr. Reddys solution for infusion is available in packages with 1 vial and 5 vials. Each vial contains 20 ml.

Only some package 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

Bucharest, 030138

Romania

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

Date of the last revision of this leaflet:January 2024

Detailed information about 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 only for doctors or healthcare professionals:

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

Lacosamida Dr. Reddys solution for infusion can be administered without further dilution or can 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 point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to use are the responsibility of the user and should not exceed 24 hours at a temperature between 2 and 8 °C, unless the dilution has taken place in controlled and aseptic validated conditions.

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