Epigapent

Package leaflet: Information for the user

Epigapent, 600 mg, film-coated tablets
Epigapent, 800 mg, film-coated tablets
Gabapentinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform 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 in the treatment of epilepsy and peripheral neuropathic pain (long-lasting pain caused by nerve damage).
The active substance in Epigapent is gabapentin.
Epigapent is indicated for the treatment of:

• various forms of epilepsy (seizures that initially originate in specific areas of the brain and may or may not spread to other parts of the brain). Your doctor prescribes Epigapent for adults and children aged 6 years and older as an adjunctive treatment for epilepsy when current therapy does not fully prevent seizures. Epigapent should be taken as an additional medicine in the treatment of epilepsy in adults or children aged 6 years and older, unless otherwise directed by your doctor. Epigapent may also be used as the sole treatment in adults and children over 12 years of age;
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Various diseases, such as diabetes or shingles, may cause peripheral neuropathic pain (occurring mainly in the lower and/or upper limbs). Patients describe this pain as burning, stinging, pulsating, stabbing, sharp, cramp-like, aching, tingling, numbness, or a sensation of pins and needles.

2. Important information before using Epigapent

When not to use Epigapent:

• if the patient is allergic (hypersensitive) to gabapentin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Epigapent, discuss the following with your doctor or pharmacist:

• if the patient has kidney disease, the doctor may recommend a different dosing regimen;
• if the patient is undergoing haemodialysis (to remove metabolic waste products due to kidney failure), inform the doctor if muscle pain and/or weakness occur;
• if the patient experiences symptoms such as persistent abdominal pain, nausea, or vomiting, contact the doctor immediately, as these may be signs of acute pancreatitis;
• if the patient has neurological or respiratory disorders or is over 65 years of age; the doctor may recommend an adjusted dosage.
• before starting treatment with this medicine, inform the doctor if the patient has ever misused or been dependent on alcohol, prescription medicines, or illicit drugs; this may mean that the risk of becoming dependent on Epigapent is higher. Cases of misuse and dependence on gabapentin have been reported since the medicine was introduced. If the patient has previously misused or been dependent on drugs, this should be discussed with the doctor.

A small number of patients taking antiepileptic medicines such as gabapentin have experienced thoughts of self-harm or suicide. If such thoughts occur in the patient, contact the doctor immediately.
Dependence
Some individuals may develop dependence on Epigapent (a need to continue taking the medicine). After stopping Epigapent, withdrawal symptoms may occur (see section 3, "How to take Epigapent" and "Stopping treatment with Epigapent"). If the patient is concerned about possibly becoming dependent on Epigapent, it is important to consult the doctor.
If the patient notices any of the following signs while taking Epigapent, this may indicate the development of dependence:

• Feels the need to take the medicine longer than prescribed by the doctor
• Feels the need to take a higher dose than prescribed
• Uses the medicine for purposes other than those prescribed
• Has made multiple unsuccessful attempts to stop or control use of the medicine
• Feels unwell after stopping the medicine, but feels better after taking it again

If the patient notices any of the above behaviours, they should speak with their doctor to discuss the best treatment approach, including when it may be appropriate to stop taking the medicine and how to do so safely.
Important information regarding potentially serious reactions
Serious skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with the use of gabapentin. If any of the symptoms associated with serious skin reactions described in section 4 occur, stop taking gabapentin and contact a doctor immediately.
Please refer to the description of serious symptoms in section 4 of this leaflet, subsection "Contact the doctor immediately if the patient experiences any of the following symptoms during treatment, as they may have serious consequences".
Muscle weakness, tenderness, or pain, especially if accompanied by feeling unwell or having a high temperature, may be due to abnormal breakdown of muscle fibres (rhabdomyolysis), which can be life-threatening and may lead to kidney problems. Changes in urine colour and blood test results (marked increase in blood creatine kinase activity) may also occur. If such symptoms occur, contact the doctor immediately.
Epigapent and other medicines
Inform the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform the doctor (or pharmacist) about all medicines currently or recently used for seizures, sleep disorders, depression, anxiety, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
If the patient is taking any opioid-containing medicines (such as morphine), they should inform the doctor or pharmacist, as opioids may enhance the effect of Epigapent. Additionally, concomitant use of Epigapent and opioids may cause drowsiness, sedation, respiratory depression, or death.
Antacids used for indigestion
Concomitant use of Epigapent and antacids containing aluminium and magnesium 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 with oral contraceptives.
• may affect the results of certain laboratory tests; if a urine test is required, inform the doctor or hospital about all currently taken medicines.

Epigapent and food
Epigapent may be taken with or between meals.
Pregnancy, breastfeeding, and fertility

• If the patient is pregnant or suspects she may be pregnant, contact the doctor immediately to discuss the potential risk to the unborn child associated with taking this medicine.
• Do not stop treatment without discussing it with the doctor.
• If the patient plans to become pregnant, treatment should be discussed with the doctor or pharmacist as early as possible before conception.
• If the patient is breastfeeding or plans to breastfeed, contact the doctor or pharmacist before starting treatment with this medicine.

Pregnancy
Epigapent may be used during the first trimester of pregnancy if clearly needed.
If the patient is planning to become pregnant, is pregnant, or suspects she may be pregnant, she should contact her doctor immediately.
If the patient becomes pregnant and has epilepsy, it is important not to stop taking the medicine without first consulting the doctor, as this could worsen the condition. Seizure exacerbation may pose a risk to both the mother and her unborn child.
In a study involving data from women in Scandinavian countries who took gabapentin during the first three months of pregnancy, no increased risk of congenital malformations or neurodevelopmental disorders (problems with brain development) was observed. However, in children of women who took gabapentin during pregnancy, there was an increased risk of low birth weight and preterm birth.
Use of gabapentin during pregnancy may lead to withdrawal symptoms in newborns. This risk may be increased when gabapentin is taken together with opioid pain medicines (medicines used to treat severe pain).
If the patient becomes pregnant, suspects she is pregnant, or plans a pregnancy while taking Epigapent, she should contact her doctor immediately. Do not suddenly stop taking Epigapent, as this may cause seizures, which could have serious consequences for the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance in Epigapent, is excreted in human milk. As the effect on the infant is unknown, breastfeeding is not recommended during treatment with Epigapent.
Fertility
No effects of the medicine on fertility were observed in animal studies.
Driving and operating machinery
Epigapent may cause dizziness, drowsiness, and fatigue. The patient should not drive, operate complex machinery, or perform other potentially hazardous activities until they know whether the medicine affects their ability to perform these tasks.

3. How to take Epigapent

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure,
you should consult your doctor or pharmacist. Do not take more medicine than prescribed.
Your doctor will determine the dose appropriate for you.

Epilepsy, recommended dose
Adults and adolescents:
Take the number of tablets as prescribed by your doctor. Usually, your doctor will gradually increase the dose.
The most commonly used starting dose is 300 mg to 900 mg per day. This may then be increased according
to your doctor's instructions up to a maximum dose of 3600 mg per day, divided into 3 separate doses, for
example, 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 a child will be determined by the doctor based on the child's body weight. Treatment
is started with a low initial dose, which is gradually increased over a period of approximately 3 days.
The usual dose used in the treatment of epilepsy is 25 to 35 mg/kg per day. This dose is usually divided into
three separate doses, administered daily to the child, typically one in the morning, one in the afternoon, and
one in the evening.

Use of Epigapent is not recommended in children under 6 years of age.

Peripheral neuropathic pain, recommended dose
Adults
Take the number of tablets as prescribed by your doctor. Usually, your doctor will gradually increase the dose.
The most commonly used starting dose is 300 mg to 900 mg per day. This may then be increased according
to your doctor's instructions up to a maximum dose of 3600 mg per day, divided into 3 separate doses, for
example, one in the morning, one in the afternoon, and one in the evening.

If the patient has kidney disease or is undergoing hemodialysis
Your doctor may recommend a different dosing schedule and/or a different dose if you have kidney disease
or are undergoing hemodialysis.

If the patient is elderly (over 65 years of age), they should usually take the recommended dose of Epigapent,
unless the patient has kidney disease. If kidney disease is present, your doctor may recommend a different
dosing schedule and/or a different dose.

If you feel that the effect of Epigapent is too strong or too weak, you should contact your doctor or pharmacist
as soon as possible.

Method of administration
Epigapent is taken orally. Tablets should be swallowed with plenty of water.
Tablets may be divided into halves.
Epigapent should be taken for as long as your doctor recommends continuing treatment.

Taking more Epigapent than prescribed
Taking more than the prescribed dose may increase the risk of adverse effects, including loss of consciousness,
dizziness, double vision, slurred speech, drowsiness, and diarrhea. If you have taken more Epigapent than
prescribed, you should contact your doctor immediately or go to the nearest hospital emergency department.
You should also bring any remaining tablets, the packaging, and the leaflet with you so that hospital staff can
quickly identify which medicine has been taken.

If you miss 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 missed dose.

Stopping Epigapent
Do not stop taking Epigapent suddenly. If you wish to discontinue treatment with Epigapent, you should first
discuss this with your doctor. Your doctor will advise you on how to proceed. If treatment needs to be stopped,
the medicine should be withdrawn gradually over a period of at least 1 week. If Epigapent is stopped suddenly
or before your doctor advises, there is an increased risk of having a seizure. After short-term or long-term
treatment with Epigapent, you should be aware that certain adverse effects, known as withdrawal symptoms,
may occur. These may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremor, headache,
depression, feelings of abnormality, dizziness, and general malaise. These symptoms usually occur within
48 hours after stopping Epigapent. If withdrawal symptoms occur, contact your doctor.

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

4. Possible adverse reactions

Due to possible serious health consequences, you should contact a doctor immediately if any of the following symptoms occur after taking the medicine:

• Reddish, non-elevated, flat or round spots on the trunk, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genital organs and eyes. These severe skin rashes 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 any medicine, this medicine may cause adverse reactions, although not everyone experiences them.
You should contact a doctor immediately if any of the following symptoms occur during treatment, as they may have serious consequences:

• Persistent abdominal pain, nausea and vomiting, as these may be symptoms of acute pancreatitis;
• Breathing difficulties, which may, especially if severe, require immediate and intensive medical care to restore normal breathing;
• The medicine Epigapent may cause serious or life-threatening allergic reactions affecting the skin or other parts of the body, such as the liver or blood cells. An allergic reaction may, but does not necessarily, be accompanied by a rash. Hospitalization or discontinuation of Epigapent may be required. You should contact a doctor immediately if any of the following symptoms occur:
• Skin rash and redness of the skin, and (or) hair loss
• Urticaria (hives)
• Fever
• Prolonged swelling of lymph nodes
• Swelling of lips, face and tongue
• Yellowing of the skin or whites of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected muscle pain
• Frequent infections

These symptoms may be the first signs of serious hypersensitivity. The doctor should examine the patient to decide whether treatment with Epigapent should be continued.

• If the patient is undergoing hemodialysis, they should inform the doctor if muscle pain and (or) weakness occurs.

Other adverse reactions include:
Very common (may occur in more than 1 in 10 people)

• Viral infections
• Drowsiness, dizziness, lack of coordination
• Feeling of fatigue, fever.

Common (may occur in no more than 1 in 10 people)

• Pneumonia, respiratory tract infections, urinary tract infections, ear infection or other infections
• Decreased white blood cell count
• Loss of appetite, increased appetite
• Irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disorders
• Seizures, sudden muscle movements, speech difficulties, memory loss, tremor, sleep disturbances, headaches, increased skin sensitivity, reduced sensation (numbness), coordination disorders, unusual eye movements, increased, decreased or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dry 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 twitching
• Erectile dysfunction (impotence)
• Swelling of legs 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 trials in children, aggressive behavior and sudden jerky movements were commonly reported.
Uncommon (may occur in no more than 1 in 100 people)

• Agitation (a state of constant restlessness and unintentional, purposeless movements)
• Allergic reactions, e.g. urticaria
• Limited mobility
• Palpitations
• Difficulty swallowing
• Swelling affecting face, trunk, limbs
• Abnormal blood test results indicating liver function disorders
• Psychiatric disorders
• Falls
• Increased blood glucose levels (most commonly observed in diabetic patients).

Rare (may occur in no more than 1 in 1000 people)

• Low blood glucose levels (most commonly observed in diabetic patients)
• Loss of consciousness
• Breathing difficulties, shallow breathing (respiratory depression).

Frequency unknown: frequency cannot be determined based on available data

• Development of dependence on Epigapent (‘drug dependence’)

After discontinuation of short-term or long-term treatment with Epigapent, it should be noted that certain adverse reactions, so-called withdrawal symptoms, may occur (see “Discontinuation of Epigapent”).
Adverse reactions observed after marketing authorization:

• Decreased platelet count (blood cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting of limbs, sudden jerking, muscle stiffness
• Tinnitus (ringing in the ears)
• Yellowing of the skin and whites of the eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Tissue overgrowth in the breast area, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep difficulties, nausea, pain, excessive sweating), chest pain
• Rhabdomyolysis (breakdown of muscle fibers)
• Changes in blood test results (increased creatine phosphokinase activity)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low blood sodium levels
• Anaphylactic reactions (severe, potentially life-threatening allergic reactions involving breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring immediate treatment).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw; tel.: +48 22 49 21 301; fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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 cardboard box after "Expiry date (EXP)" and on the blister after the abbreviation "EXP". The expiry date refers to the last day of the stated month.
PVC/PVDC foil blisters: do not store above 25°C.
Aluminium/Aluminium foil 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 must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Epigapent contains
The active substance is gabapentin.
Each tablet contains 600 mg or 800 mg of gabapentin.
The other ingredients are:
Tablet core: maize starch, copovidone, poloxamer 407, magnesium stearate
Coating composition: Ready-made coating [hypromellose, titanium dioxide (E171), polyethylene glycol 400, polysorbate 80],
polyethylene glycol 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 division line, marked with "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 division line, marked with "G" and "13" on one side, approximately 19.10 ± 0.2 mm in length.
The tablet can be divided into equal doses.

Pack sizes available:
100 film-coated tablets in a cardboard box

Marketing Authorisation 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 further information about this medicinal product and its names in the European Economic Area countries, please contact the representative of the Marketing Authorisation Holder:
Neuraxpharm Polska Sp. z o.o.
ul. Poleczki 35
02-822 Warsaw
[email protected]