INTRODUCTION

AMPANEL 4 contains Perampanel which belongs to the group of medicines called Anticonvulsants. It is used in association with other antiepileptic drugs to treat seizures such as partial seizures (fits that affect one part of the brain) with or without secondary generalisation (fits affecting all the brain) in adults, adolescents (12 years and above) and children (4 to 11 years of age).

It is also used to treat generalized seizures (fits that affect all the brain and cause convulsions or starting spells) in adults, adolescents (12 years and above) and children (7 to 11 years of age).

Seizure is a disorder in which nerve cell activity in the brain is disturbed and during seizures person may experience abnormal behaviour, symptoms and sensations including loss of consciousness.

Perampanel blocks certain chemicals that regulate a broad spectrum of processes in the brain, spinal cord, retina and nerves. These chemicals are excessively produced during the sudden disruption of the brain’s normal electrical activity that results in epileptic fits. This inhibitory action enables sufficient control over seizures without substantial impairment of brain function.

AMPANEL 4 is not recommended for use in patients with serious liver problems, moderate or serious kidney problems or patients allergic to perampanel or if you have ever developed a severe skin rash or skin peeling, blistering or mouth sores after taking perampanel. It should be used with caution in patients having a history of substance abuse.

AMPANEL 4 is not recommended for use in pregnant women or women planning for pregnancy and in breastfeeding women. AMPANEL 4 is not recommended for use in children below 4 years of age (for partial seizures) and children below 7 years of age (for generalized seizures). The most common side effects of AMPANEL 4 are dizziness, drowsiness, weight gain, irritable, anxious, or confusion. Talk to your doctor if any of the symptoms get worsen.

USES OF AMPANEL 4

It is used in combination with other antiepileptics to treat certain types of epilepsy:

• Partial seizures (with or without generalized seizures)
• Generalized seizures

HOW AMPANEL 4 WORKS

AMPANEL 4 blocks certain chemicals that regulate a broad spectrum of processes in the brain, spinal cord, retina, and nerves. These chemicals are excessively produced during the sudden disruption of the brain’s normal electrical activity that results in epileptic fits. This inhibitory action enables sufficient control over seizures without substantial impairment of brain function.

DIRECTIONS FOR USE

Take AMPANEL 4 as advised by your physician. Swallow the medicine whole with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF AMPANEL 4

HOW TO MANAGE SIDE EFFECTS

Nausea:

Take this medicine along with, or just after meals. Stick to simple meals and avoid eating oil rich or spicy foods. If the symptom does not improve, contact your doctor.

Headache:

Try to relax and rest yourself. Apply pain balm to the head to ease off the pain. Sip on some hot water or ginger tea. If the symptom does not improve, contact your doctor.

Dizziness:

Sit down or lie down slowly when you are feeling dizziness. Take rest for some time and drink plenty of water. Avoid coffee and other carbonated drinks. If the symptom does not improve, contact your doctor.

Tiredness:

Drink plenty of fluid and eat balanced diet and frequent meals. Do regular minimal exercise and follow regular sleep schedule. If the symptom does not improve, contact your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug - Drug interactions:

Before taking AMPANEL 4, inform your doctor if you are taking any of the following medicine:

• medicines used in the treatment of epilepsy (Ex. carbamazepine, oxcarbazepine, and phenytoin, felbamate, midazolam)
• rifampicin (used in treatment of bacterial infections)
• St. John’s Wort (herbal medicine used in the treatment of mild anxiety)
• ketoconazole (medicine used in treatment of fungal infections)
• hormonal contraceptives such as levonorgestrel including implants, injections, and patches (used to prevent pregnancy)

Overdosage:

If you or anyone else accidentally take too much of AMPANEL 4, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are confusion, agitation, aggressive behaviour, and depressed level of consciousness.

SYNOPSIS

MORE INFORMATION

• Keep AMPANEL 4 out of reach of children
• Store at room temperature

FAQs ABOUT AMPANEL 4

What is AMPANEL 4 used for?

AMPANEL 4 is used in association with other anti-epileptic drugs to treat partial seizures (fits that affect one part of the brain), with or without secondary generalization in patients who are 4 years of age and older, also used to treat generalized seizures (fits that affect the entire brain) in patients who are 12 years of age and older.

What should I avoid while taking AMPANEL 4?

Avoid consuming alcohol while taking AMPANEL 4 because it might make you sleepier and dizzier. You should also avoid driving and using heavy machinery after taking AMPANEL 4 and consult your concern with your doctor before starting to take this medicine.

What will happen if I suddenly stop taking AMPANEL 4?

You should not suddenly stop taking AMPANEL 4. Take as long as your doctor recommends. AMPANEL 4 can cause physical dependence, which means that abruptly discontinuing can result in symptoms such as anxiety, nervousness, irritability, fatigue, weakness, lethargy, mood swings and sleeplessness.

What are the health tips to be followed while taking AMPANEL 4 to prevent seizures?

Take a healthy diet along with regular exercise, practice yoga every day, get enough sleep, limit the use of screen time such as mobile or laptop and remember to take AMPANEL 4 on time. Follow these health tips after consulting your doctor.

Does taking AMPANEL 4 affect my mental health?

Yes, while taking AMPANEL 4 you might experience extreme mood changes, increased aggressive behaviour and suicidal thoughts also might crop up in your mind. If any you experience any of these symptoms, please consult your doctor immediately.

REFERENCES

1. KD. Tripathi. Antiepileptic Drugs. Essentials of medical pharmacology. Eighth edition. 2019. Page – 449.

2. Hansen, Cerine C., Hanna Ljung, Eylert Brodtkorb, and Arne Reimers. "Mechanisms underlying aggressive behaviour induced by antiepileptic drugs: focus on topiramate, levetiracetam, and perampanel." Behavioural neurology. [Revised in November 2018] [Accessed on 21st May 2022] https://doi.org/10.1155/2018/2064027

3. Trinka, Eugen, Simona Lattanzi, Kate Carpenter, Tommaso Corradetti, Bruna Nucera, Fabrizio Rinaldi, Rohit Shankar, and Francesco Brigo. "Exploring the evidence for broad-spectrum effectiveness of perampanel: a systematic review of clinical data in generalised seizures." CNS drugs. [Revised in July 2021] [Accessed on 21st May 2022] https://link.springer.com/article/10.1007/s40263-021-00831-y

4. Eisai Inc. U.S. Food & Drug Administration. [Revised in December 2021] [Accessed on 21st May 2022] https://www.fycompa.com/-/media/Files/Fycompa/Fycompa_Prescribing_Information.pdf

5. Eisai Manufacturing Limited. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 21st May 2022] https://www.medicines.org.uk/emc/files/pil.4276.pdf

USEFUL DIAGNOSTIC TESTS

• Complete blood count (CBC)
• Blood sugar test
• Electrolyte panel
• Kidney function test