EPIGAPENT 800 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Epigapent, 600 mg, coated tablets
3. Epigapent, 800 mg, coated tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What Epigapent is and what it is used for
   1. Epigapent is indicated for the treatment of:
5. Important information before taking Epigapent
   1. When not to take Epigapent:
   2. Warnings and precautions
   3. Dependence
   4. Important information about potentially serious reactions
   5. Epigapent and other medicines
   6. Epigapent with food
   7. Pregnancy, breastfeeding, and fertility
   8. Driving and using machines
6. How to take Epigapent
   1. Epilepsy, recommended dose
   2. Peripheral neuropathic pain, recommended dose
   3. If you have kidney disease or are undergoing hemodialysis
   4. Method of administration
   5. Taking a higher dose of Epigapent than recommended
   6. Missing a dose of Epigapent
   7. Stopping treatment with Epigapent
7. Possible side effects
   1. Very common (may affect more than 1 in 10 people)
   2. Common (may affect up to 1 in 10 people)
   3. Uncommon (may affect up to 1 in 100 people)
   4. Rare (may affect up to 1 in 1000 people)
   5. Frequency not known: frequency cannot be estimated from the available data
   6. After marketing, the following side effects have been observed:
   7. Reporting side effects
8. How to store Epigapent
9. Contents of the pack and other information
   1. What Epigapent contains
   2. What Epigapent looks like and contents of the pack
   3. Marketing authorization holder
   4. Manufacturer/Importer
   5. For more information about this medicine and its authorized names in the European Economic Area, please contact the representative of the marketing authorization holder:

Package Leaflet: Information for the User

Epigapent, 600 mg, coated tablets

Epigapent, 800 mg, coated tablets

Gabapentin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What Epigapent is and what it is used for
• 2. Important information before taking Epigapent
• 3. How to take Epigapent
• 4. Possible side effects
• 5. How to store Epigapent
• 6. Contents of the pack and other information

1. What Epigapent is and what it is used for

Epigapent belongs to a group of medicines used to treat epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance of Epigapent is gabapentin.

Epigapent is indicated for the treatment of:

• various forms of epilepsy (seizures that initially occur in specific areas of the brain and may or may not spread to other parts of the brain). The doctor prescribes Epigapent to adults and children aged 6 years and older as an adjunctive therapy for epilepsy when previous treatment does not fully prevent seizures. Epigapent should be taken as an adjunctive therapy for epilepsy in adults or children aged 6 years and older, unless the doctor advises otherwise. Epigapent can also be used as a single medicine in adults and children over 12 years of age;
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Many different diseases, such as diabetes or shingles, can cause peripheral neuropathic pain (mainly occurring in the lower and/or upper limbs). Patients describe the pain they experience as burning, tingling, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, feeling of suffering, etc.

2. Important information before taking Epigapent

When not to take Epigapent:

Warnings and precautions

Before starting to take Epigapent, discuss this with your doctor or pharmacist:

• before starting to take this medicine, you should tell your doctor if you have ever abused or been dependent on alcohol, prescription drugs, or illegal drugs; this may mean that the risk of dependence on Epigapent is higher. After the marketing of gabapentin, cases of abuse and dependence have been reported. If you have a history of drug abuse or dependence, you should tell your doctor.

In a small number of patients taking antiepileptic drugs such as gabapentin, thoughts of self-harm or suicide have occurred. If you have ever had such thoughts, you should contact your doctor immediately.

Dependence

In some people, dependence on Epigapent (the need for continuous use of the medicine) may develop. After stopping the use of Epigapent, withdrawal symptoms may occur (see section 3, "How to take Epigapent" and "Stopping Epigapent"). If you are concerned that you may become dependent on Epigapent, it is essential to consult your doctor.
If, while taking Epigapent, you notice any of the following signs, it may indicate the development of dependence.

• You feel that you need to take the medicine for longer than your doctor prescribed
• You feel that you need to take a higher dose than prescribed
• You use the medicine for purposes other than prescribed
• You have made multiple, unsuccessful attempts to stop or control the use of the medicine
• After stopping the medicine, you feel unwell, and after taking it again, you feel better

If you notice any of the above behaviors, you should talk to your doctor to discuss the best course of treatment for you, including determining when it is appropriate to stop taking the medicine and how to do it safely.

Important information about potentially serious reactions

In connection with the use of gabapentin, severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have occurred. If any of the symptoms of severe skin reactions described in section 4 occur, you should stop taking gabapentin and contact your doctor immediately.
You should read the description of these symptoms in section 4 of this leaflet,subsection "You should contact your doctor immediately if you experience any of the following symptoms while taking the medicine, as they may have serious consequences".
Muscle weakness, tenderness, or pain, especially if accompanied by malaise or fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney problems. It may also cause urine discoloration and changes in blood test results (significant increase in creatine phosphokinase activity in the blood). If such symptoms occur, you should contact your doctor immediately.

Epigapent and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as any medicines you plan to take.
You should especially tell your doctor (or pharmacist) about all medicines you have taken recently or are taking to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
If you are taking any medicines containing opioids (such as morphine), you should inform your doctor or pharmacist, as opioids may enhance the effect of Epigapent. Additionally, taking Epigapent and opioids at the same time may cause drowsiness, sedation, shallow breathing, or death.
Antacids for heartburn
Taking Epigapent and antacids containing aluminum and magnesium at the same time may reduce the absorption of Epigapent from the stomach. Therefore, it is recommended to take Epigapent at least two hours after taking an antacid.

• Epigapent does not interact with other antiepileptic medicines or oral contraceptives.
• it may affect the results of some laboratory tests; if a urine test is necessary, you should inform your doctor or hospital about the medicines you are taking.

Epigapent with food

Epigapent can be taken with or without food.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not take Epigapent during pregnancy unless your doctor advises you to do so. Women of childbearing age must use effective contraception.
No studies have been conducted to specifically evaluate the use of gabapentin in pregnant women; however, when other antiepileptic drugs were used, an increased risk of harm to the developing child was reported, especially when multiple antiepileptic drugs were used at the same time. Therefore, whenever possible, you should take only one antiepileptic drug and always in consultation with your doctor.
Taking gabapentin during pregnancy may cause withdrawal symptoms in newborns. This risk may increase when gabapentin is taken with opioid painkillers (drugs used to treat severe pain).
If you become pregnant, think you may be pregnant, or plan to become pregnant while taking Epigapent, you should contact your doctor immediately. You should not stop taking Epigapent suddenly, as this may cause seizures, which can have serious consequences for the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance of Epigapent, is excreted in human milk. As the effect on the child is unknown, breastfeeding is not recommended during treatment with Epigapent.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Epigapent may cause dizziness, drowsiness, and fatigue. You should not drive, operate complex machinery, or perform other potentially hazardous activities until you know whether this medicine affects your ability to perform these activities.

3. How to take Epigapent

This medicine should always be taken exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
Your doctor will determine the dose that is right for you.

Epilepsy, recommended dose

Adults and adolescents:
Take the number of tablets that your doctor has prescribed for you. Usually, your doctor will gradually increase the dose.
The most commonly used initial dose is from 300 mg to 900 mg per day. It can then be increased as instructed by your doctor to a maximum dose of 3600 mg per day, divided into 3 separate doses, e.g., one in the morning, one in the afternoon, and one in the evening.
Children aged 6 years and older:
The dose to be given to the child will be determined by the doctor based on the child's weight. Treatment starts with a small initial dose, which is gradually increased over a period of approximately 3 days.
The commonly used dose of Epigapent for the treatment of epilepsy is from 25 to 35 mg/kg per day. This dose is usually divided into 3 separate doses, and the tablet(s) are given to the child daily, usually one in the morning, one in the afternoon, and one in the evening.
Epigapent should not be used in children below 6 years of age.

Peripheral neuropathic pain, recommended dose

Adults
Take the number of tablets that your doctor has prescribed for you. Usually, your doctor will gradually increase the dose.
The most commonly used initial dose is from 300 mg to 900 mg per day. It can then be increased as instructed by your doctor to a maximum dose of 3600 mg per day, divided into 3 separate doses, e.g., one in the morning, one in the afternoon, and one in the evening.

If you have kidney disease or are undergoing hemodialysis

Your doctor may recommend a different dosing schedule and/or a different dose of Epigapent if you have kidney disease or are undergoing hemodialysis.
If you are elderly (over 65 years of age),you should take the usual recommended dose of Epigapent unless you have kidney disease. If you have kidney disease, your doctor may recommend a different dosing schedule and/or a different dose.
If you think that the effect of Epigapent is too strong or too weak, you should talk to your doctor or pharmacist as soon as possible.

Method of administration

Epigapent is taken orally. The tablets should be swallowed with a large amount of water.
The tablets can be divided into two equal doses.
Epigapent should be taken for as long as your doctor has prescribed.

Taking a higher dose of Epigapent than recommended

Taking higher doses than recommended may cause an increase in side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. If you have taken a higher dose of Epigapent than your doctor prescribed, you should contact your doctor or go to the nearest hospital emergency department immediately. You should also take all the remaining tablets, packaging, and leaflet with you so that the hospital staff can immediately see what medicine has been taken.

Missing a dose of Epigapent

If you miss a dose, take it as soon as possible, unless it is almost time for your next dose. Do not take a double dose to make up for a forgotten dose.

Stopping treatment with Epigapent

Do not stop taking Epigapent suddenly. If you want to stop taking Epigapent, you should first discuss this with your doctor. Your doctor will tell you how to do this. If treatment needs to be stopped, the medicine should be discontinued gradually over a minimum period of 1 week. If the use of Epigapent is stopped suddenly or before your doctor advises you to do so, there is an increased risk of seizures. After stopping short-term or long-term treatment with Epigapent, you should be aware that certain side effects, so-called withdrawal symptoms, may occur. These symptoms may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, feeling abnormal, dizziness, and general malaise. These symptoms usually occur within 48 hours after stopping Epigapent. If you experience withdrawal symptoms, you should contact your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Due to the potential serious health consequences, you should contact your doctor immediately if you experience any of the following symptoms after taking the medicine:

• red, non-raised, plate-like or round patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

Like all medicines, Epigapent can cause side effects, although not everybody gets them.
You should contact your doctor immediatelyif you experience any of the following symptoms while taking the medicine, as they may have serious consequences:

• severe skin reactions requiring immediate medical attention, swelling of the lips and face, skin rash, and hair loss (may be symptoms of a severe allergic reaction);
• persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis;
• breathing difficulties, which, if severe, may require immediate and intensive medical attention to restore normal breathing;
• Epigapent may cause serious or life-threatening allergic reactions, which can affect the skin or other parts of the body, such as the liver or blood cells. An allergic reaction may, but does not always, occur with a rash. Hospitalization or discontinuation of the medicine may be necessary.

Epigapent. You should contact your doctor immediately if you experience any of the following symptoms:

• skin rash
• hives
• fever
• prolonged swelling of the lymph nodes
• swelling of the lips and tongue
• yellowing of the skin or whites of the eyes
• unusual bruising or bleeding
• severe fatigue or weakness
• unusual muscle pain
• frequent infections

These symptoms may be the first sign of a serious allergy. Your doctor should examine you to decide whether to continue taking Epigapent.

• If you are undergoing hemodialysis, you should inform your doctor if you experience muscle pain and/or weakness.

Other side effects include:

Very common (may affect more than 1 in 10 people)

• viral infections
• drowsiness, dizziness, lack of coordination
• feeling tired, fever.

Common (may affect up to 1 in 10 people)

• pneumonia, respiratory tract infections, urinary tract infections, ear infections, or other infections
• decreased white blood cell count
• loss of appetite, increased appetite
• hostility towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking abnormalities
• seizures, sudden muscle movements, speech difficulties, memory loss, tremors, sleep disturbances, headaches, increased sensitivity of the skin, numbness, coordination disorders, abnormal eye movements, increased, decreased, or absent reflexes
• blurred vision, double vision
• dizziness
• high blood pressure, flushing, or vasodilation
• shortness of breath, bronchitis, sore throat, cough, dryness in the nose
• vomiting, nausea, dental problems, gum inflammation, diarrhea, abdominal pain, indigestion, constipation, dry mouth or throat, bloating
• facial swelling, bruising, rash, itching, acne
• joint pain, muscle pain, back pain, muscle tremors
• erectile dysfunction (impotence)
• swelling of the feet and hands, difficulty walking, weakness, pain, malaise, flu-like symptoms
• decreased white blood cell count, weight gain
• accidental injuries, bone fractures, skin abrasions.

Additionally, in clinical studies in children, aggressive behavior and sudden jerky movements were frequently reported.

Uncommon (may affect up to 1 in 100 people)

• restlessness (a state of constant restlessness and unintentional, purposeless movements)
• allergic reactions, e.g., hives
• restricted movement
• rapid heartbeat
• difficulty swallowing
• swelling that includes the face, torso, limbs
• abnormal blood test results indicating liver function disorders
• psychiatric disorders
• falls
• increased blood glucose levels (most commonly observed in patients with diabetes).

Rare (may affect up to 1 in 1000 people)

• low blood glucose levels (most commonly observed in patients with diabetes)
• loss of consciousness
• breathing difficulties, shallow breathing (respiratory depression).

Frequency not known: frequency cannot be estimated from the available data

• development of dependence on Epigapent ("drug dependence")

After stopping short-term or long-term treatment with Epigapent, you should be aware that certain side effects, so-called withdrawal symptoms, may occur (see "Stopping Epigapent").

After marketing, the following side effects have been observed:

• decreased platelet count (blood cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as twisting of limbs, sudden jerky movements, muscle stiffness
• ringing in the ears
• yellowing of the skin and whites of the eyes (jaundice), liver inflammation
• acute kidney failure, urinary incontinence
• growth of breast tissue, breast enlargement
• side effects after sudden stopping of gabapentin (anxiety, difficulty sleeping, nausea, pain, excessive sweating), chest pain
• muscle fiber breakdown (rhabdomyolysis)
• changes in blood test results (increased creatine phosphokinase activity)
• sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• low sodium levels in the blood
• anaphylactic reactions (severe, life-threatening allergic reactions, including difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure, requiring immediate treatment).

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the
Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C, 02-222 Warsaw; phone: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Epigapent

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "EXP" and on the blister after "EXP". The expiry date refers to the last day of that month.
PVC/PVDC blisters: do not store above 25°C.
Aluminum/Aluminum blisters: do not store above 30°C.
HDPE bottle with PP cap: do not store above 30°C.
Store in the original packaging to protect from moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Epigapent contains

The active substance of Epigapent is gabapentin.
Each tablet contains 600 mg or 800 mg of gabapentin.
The other excipients are:
Core: cornstarch, copovidone, poloxamer 407, magnesium stearate
Coating: Ready coating[hypromellose, titanium dioxide (E171), macrogol 400, polysorbate 80], macrogol 8000, talc.

What Epigapent looks like and contents of the pack

Epigapent, 600 mg are white or almost white oval, biconvex, film-coated tablets with a dividing line, with the marking "G" and "31" on one side, approximately 17.40 ± 0.2 mm in length.
The tablet can be divided into equal doses.
Epigapent, 800 mg are white or almost white oval, biconvex, film-coated tablets with a dividing line, with the marking "G" and "13" on one side, approximately 19.10 ± 0.2 mm in length.
The tablet can be divided into equal doses.
Available pack sizes:
100 film-coated tablets in a cardboard box

Marketing authorization holder

neuraxpharm Arzneimittel GmbH
Elisabeth-Selbert-Str. 23
40764 Langenfeld
Germany

Manufacturer/Importer

Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b
140 78 Prague 4
Czech Republic

For more information about this medicine and its authorized names in the European Economic Area, please contact the representative of the marketing authorization holder:

Neuraxpharm Polska Sp. z o.o.
Domaniewska 37
02-672 Warsaw
Date of last revision of the leaflet:01/2023