Lacosamida dr reddys 10 mg/ml solucion para perfusion efg
Introduction
Patient Information Leaflet: Lacosamida Dr. Reddys 10 mg/ml Infusion Solution
Lacosamida Dr. Reddys 10 mg/ml Infusion Solution
Read this 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 are unsure about anything, ask your doctor or pharmacist.
- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Table of Contents
- What Lacosamida Dr. Reddys is and what it is used for
- What you need to know before you start using Lacosamida Dr. Reddys
- How to use Lacosamida Dr. Reddys
- Possible side effects
- Storage of Lacosamida Dr. Reddys
- Contents of the pack and additional information
1. What is Lacosamida Dr. Reddys and for what it is used
What is Lacosamida Dr. Reddys
Lacosamida Dr. Reddys contains lacosamida, 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.
For what Lacosamida Dr. Reddys is used
- Lacosamida is used:
- alone and in combination with other antiepileptic medicines in adults, adolescents, and children aged 2 years or older 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 may then spread to larger areas in both sides of the brain;
- in combination with other antiepileptic medicines in adults, adolescents, and children aged 4 years or older to treat primary generalized tonic-clonic seizures (major seizures, with loss of consciousness) in patients with idiopathic generalized epilepsy (a type of epilepsy that is believed to have a genetic origin).
2. What you need to know before starting to use Lacosamide Dr. Reddy's
Do not use Lacosamida Dr. Reddys
- If you are allergic to lacosamida or any of the other ingredients of this medication (listed in section 6). If you are unsure if 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 lacosamida if any of the above applies to you. If you are unsure, consult your doctor or pharmacist before starting to use this medication.
Warnings and precautions
Consult your doctor before starting to use lacosamida if:
- You have thoughts of self-harm or suicide. A small number of people taking antiepileptic medications such as lacosamida have had thoughts of self-harm or suicide. If you ever have these thoughts, contact your doctor immediately.
- You have a heart problem that affects your heartbeat and often your pulse is especially slow, fast, or irregular (such as AV block, atrial fibrillation, or atrial flutter)
- You have a serious heart condition 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 injuries or falls. This means you should be careful until you are used to the effects of this medication.
If any of the above applies to you (or you are unsure), consult your doctor or pharmacist before starting to use 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 heart rhythm (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 with epilepsy characterized by the onset of partial seizures and is not recommended for children under 4 years with primary generalized tonic-clonic seizures. This is because it is not yet known if it is effective and safe for children in this age group.
Other medications and Lacosamida Dr. Reddys
Inform your doctor or pharmacist if you are using or have used recently or may need to use any other medication.
In particular, inform your doctor or pharmacist if you are taking any of the following medications that affect the heart, as lacosamida may also affect the heart:
- Medications to treat heart problems;
- Medications that may increase the "PR interval" in a heart test (ECG or electrocardiogram) such as epilepsy or pain medications called carbamazepine, lamotrigine, and pregabalin;
- Medications used to treat certain types of arrhythmia or heart failure.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use lacosamida.
Also inform your doctor or pharmacist if you are using any of the following medications, as they may also increase or decrease the effect of Lacosamida Dr. Reddys on your body:
- Medications for fungal infections such as fluconazole, itraconazole, and ketoconazole;
- A medication for HIV such as ritonavir
- Medications for bacterial infections such as clarithromycin and rifampicin;
- A medicinal herb used to treat mild anxiety and depression called St. John's Wort.
If any of the above applies to you (or you are unsure), speak with your doctor or pharmacist before starting to use Lacosamida Dr. Reddys.
Use of 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 medication.
Lacosamida is not recommended during pregnancy, as its effects on pregnancy and the fetus are unknown. It is also not recommended to breastfeed while taking lacosamida, as lacosamida passes into breast milk.
Seek advice immediately from your doctor if you are pregnant or plan to become pregnant. They will help you decide if you should take lacosamida or not.
Do not stop treatment without first talking to your doctor, as this may increase seizures (crises). A worsening of your condition may also harm the fetus.
Driving and operating machinery
You should not drive, cycle, or use machines until you know if this medication affects you. The reason is that lacosamida may cause dizziness or blurred vision.
Lacosamida Dr. Reddys contains sodium
This medication contains 59.8 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 3% of the recommended daily maximum sodium intake for an adult. You should be aware of this if you are on a controlled sodium diet.
3. How to use Lacosamida Dr. Reddys
Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.
Use of Lacosamida Dr. Reddys
- The treatment with lacosamida can be initiated:
- by taking the medication by mouth or
- administered as an intravenous infusion (also known as IV infusion) with which your doctor or nurse administers the medication through a vein. The administration lasts from 15 to 60 minutes.
- The IV infusion is usually used for a short period of time, when the medication cannot be taken by mouth.
- Your doctor will decide for 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 medication orally (or vice versa), the total amount you take each day and the frequency with which you take it remain the same.
•Use lacosamida twice a day (with approximately 12 hours of difference).
•Try to use it approximately at the same time every day.
What dose to use
The following are the normal 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 can also begin 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 medications:
- 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 a single "loading" dose of 200 mg. Then you will start taking your continued maintenance dose 12 hours later
Children and adolescents weighing less than 50 kg
- In the treatment of partial onset seizures:Lacosamida is not recommended for children under 2 years old.
- In the treatment of primary generalized tonic-clonic seizures:Lacosamida is not recommended for children under 4 years old.
When using lacosamida alone
- Your doctor will decide the dose of lacosamida according to your body weight.
- The usual starting dose is 1 mg (0.1 ml) per kilogram (kg), 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 dosage tables include the maximum recommended dose:
- These doses are merely informative. Your doctor will calculate the correct dose for you:
To be used twice a day,for children aged 2 years or olderweighing 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 a day,for adolescents and childrenweighing from 40 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 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 lacosamida with other antiepileptic medications
- Your doctor will decide the dose of lacosamida according to your body weight.
- For children and adolescents weighing from 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 dosage tables include the maximum recommended dose.
- These doses are merely informative. Your doctor will calculate the correct dose for you:
To be used twice a day,for children aged 2 years or olderweighing from 10 kg to less than20 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 a day,for adolescents and childrenweighing from 20 kg to less than 30 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 |
20 kg | 2 ml | 4 ml | 6 ml | 8 ml |
25 kg | 2.5 ml | 5 ml | 7.5 ml | 10 ml |
To be used twice a day,for adolescents and childrenweighing from 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 Lacosamida Dr. Reddys
If your doctor decides to stop your treatment with lacosamida, they will gradually reduce your dose. This is to prevent seizures from recurring or worsening.
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 side effects, although not everyone will experience them.
The side effects in the nervous system, such as dizziness, may be more pronounced after a single "loading" dose.
Inform your doctor or pharmacist if you experience any of the following side effects: Very common: may affect more than 1 in 10 patients
- Headache;
- Feeling dizzy or nauseous;
- Diplopia (double vision).
Common: may affect up to 1 in 10 patients
- Sudden brief muscle or muscle group spasms (myoclonic crisis);
- Difficulty coordinating movements or walking;
- Problems maintaining balance, agitation (tremor), paresthesia (tingling) or muscle spasms, easy to fall and bruise;
- Memory problems, difficulty thinking or finding words, confusion;
- Uncontrolled rapid eye movements (nystagmus), blurred vision;
- Sensation of dizziness (vertigo), feeling drunk;
- Feeling nauseous (vomiting), dry mouth, constipation, indigestion, excessive gas in the stomach or intestines, diarrhea;
- Decreased sensitivity, difficulty articulating words, attention disorder;
- Ringing in the ears like buzzing or whistling;
- Irritability, difficulty sleeping, depression;
- Drowsiness, fatigue or weakness (asthenia);
- Itching, rash.
Uncommon: 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 the medication, hives;
- Blood tests may show liver function abnormalities, 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;
- Loss of consciousness.
- Abnormal involuntary movements (dyskinesia).
Frequency not known: cannot be estimated from available data
- Abnormally fast ventricular heart rate (ventricular tachyarrhythmia);
- Sore throat, elevated temperature, and increased frequency of infections. Blood tests may show a severe decrease in a specific type of white blood cell (agranulocytosis);
- Severe skin reaction, which may include elevated temperature and other pseudogripal symptoms, generalized rash with lymph node inflammation (enlarged lymph nodes). Blood tests may show increased levels of liver enzymes and a type of white blood cell (eosinophilia);
- Generalized blistering and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin on more than 30% of the body surface (toxic epidermal necrolysis);
- Seizures.
Other adverse effects of intravenous administration
Local adverse reactions may occur.
Common: 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 effects in children
Additional adverse effects observed in children were fever (pyrexia), runny nose (nasopharyngitis), sore throat (pharyngitis), eating less than usual (decreased appetite), changes in behavior, not acting normally (abnormal behavior), and lack of energy (lethargy). Drowsiness (somnolence) is a very common 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 prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.
By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.
5. Conservation of Lacosamida Dr. Reddys
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.
This medication does not require special conservation conditions.
Each vial of Lacosamida Dr. Reddys infusion solution must be used only once (single use). Unused solution must be discarded.
Only clear solutions, free of particles and without color change should be used.
Medications should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.
6. Contents of the packaging and additional information
Lacosamide Dr. Reddy’s Composition
- The active ingredient is lacosamide.
1 ml of Lacosamide Dr. Reddy’s infusion solution contains 10 mg of lacosamide.
1 vial contains 20 ml of Lacosamide Dr. Reddy’s infusion solution, equivalent to 200 mg of lacosamide.
- The other components are: sodium chloride, hydrochloric acid, water for injection preparations.
Appearance of the product and contents of the package
- Lacosamide Dr. Reddy’s 10 mg/ml infusion solution is a transparent, colorless solution, presented in a transparent glass vial with a grey rubber stopper and sealed with a grey closure.
Lacosamide Dr. Reddy’s infusion solution 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
Responsible for manufacturing
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 medicine is authorized in the member states of the European Economic Area with the following names:
Member state name | Medicine name |
Spain | Lacosamida Dr. Reddys 10 mg/ml infusion solution EFG |
Italy | Lacosamide Dr. Reddy’s |
Last review date of this leaflet:January 2024
The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.
This information is intended solely for doctors or healthcare professionals:
Each vial of Lacosamide Dr. Reddys infusion solution should be used only once (single use). The unused solution should be discarded (see section 3).
Lacosamide Dr. Reddys infusion solution can be administered without additional dilution, or it can be diluted with the following solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%) or Ringer Lactate solution.
From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times in use and the conditions prior to use are the responsibility of the user and should not be greater than 24 hours at a temperature of between 2 and 8 °C, unless the dilution has taken place in validated and controlled conditions and in an aseptic environment.
The chemical and physical stability in use 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.
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