Gabapentin Biion

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language.

Gabapentin BIJON (Gabapentin Rivopharm), 300 mg, hard capsules

Gabapentinum
Gabapentin BIJON and Gabapentin Rivopharm are different trade names for the same medicine.

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Gabapentin BIJON and what is it used for

Gabapentin BIJON 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 Gabapentin BIJON is gabapentin.
Gabapentin BIJON is used to treat:

• -various forms of epilepsy (seizures initially limited to specific areas of the brain, which spread to the rest of the brain or not). The doctor prescribes Gabapentin BIJON as an adjunctive therapy for epilepsy when the previously used treatment does not provide complete control over seizures. Gabapentin BIJON should be taken as an additional medicine in the treatment of epilepsy, unless the doctor advises otherwise. Gabapentin BIJON can also be used as monotherapy in adults and children over 12 years of age.
• peripheral neuropathic pain (long-lasting pain caused by nerve damage). Peripheral (mainly occurring in the lower and/or upper limbs) neuropathic pain is caused by many different diseases, such as diabetes or shingles. Patients describe the pain they feel as burning, stinging, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabapentin BIJON

When not to take Gabapentin BIJON

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

Warnings and precautions

Before starting to take Gabapentin BIJON, the patient should discuss it with their doctor or pharmacist.
if the patient has kidney disease, the doctor may recommend a different dosing schedule,
if the patient is undergoing hemodialysis (to remove waste products from the blood due to kidney failure), they should tell their doctor if they experience pain and/or muscle weakness,
if the patient experiences symptoms such as persistent abdominal pain, nausea, and vomiting, they should contact their doctor immediately, as these may be symptoms of acute pancreatitis,
if the patient has neurological disorders, respiratory disorders, or is over 65 years old; the doctor may recommend a different dose.
There have been reports of abuse and dependence associated with gabapentin after it was introduced to the market. If the patient has a history of drug abuse or dependence, they should tell their doctor.
A small number of people taking antiepileptic drugs containing gabapentin have thought about harming themselves or committing suicide. If the patient ever has such thoughts, they should contact their doctor immediately.

Important information about potential serious side effects

A small number of people taking Gabapentin BIJON have experienced allergic reactions or potentially severe skin reactions, which, if left untreated, can develop into more serious symptoms. The patient should be aware of the possibility of these symptoms occurring while taking Gabapentin BIJON.
Read the description of these symptoms in section 4 of this leaflet"You should contact your doctor immediately if you experience any of the following symptoms after taking this medicine, as they may be serious".
Muscle weakness, tenderness, or pain, especially when accompanied by malaise and high fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney problems. There may be a change in urine color and changes in blood test results (significantly elevated creatine phosphokinase levels in the blood). If such subjective and objective symptoms occur, the patient should contact their doctor immediately.

Gabapentin BIJON and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. In particular, they should tell their doctor (or pharmacist) about all medicines recently or currently used to treat seizures, sleep disorders, depression, anxiety disorders, or any other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patient taking medicines containing opioids (such as morphine) should inform their doctor or pharmacist, as opioids may enhance the effect of Gabapentin BIJON.
Additionally, concomitant use of Gabapentin BIJON and opioids may cause symptoms such as drowsiness and/or shallow breathing.
Antacids
In case of concomitant use of Gabapentin BIJON and antacids containing aluminum and magnesium, the absorption of Gabapentin BIJON from the stomach may be reduced. Therefore, it is recommended to take Gabapentin BIJON at least 2 hours after taking the antacid.
Gabapentin BIJON

• is not expected to interact with other antiepileptic medicines or oral contraceptives.
• may affect the results of some laboratory tests; in case of a urine test, the patient should inform their doctor or hospital about the use of Gabapentin BIJON.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Gabapentin BIJON should not be taken during pregnancy, unless the doctor advises otherwise.
Women of childbearing age must use effective contraception.
Although there are no studies evaluating the use of gabapentin in pregnant women, other antiepileptic drugs have been reported to increase the risk of harm to the developing child, especially when multiple antiepileptic drugs are used. Whenever possible, but only in consultation with the doctor, pregnant women should take only one antiepileptic drug.
The patient should not stop taking this medicine suddenly, as this may cause breakthrough seizures, which can have serious consequences for both the pregnant woman and her child.
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabapentin BIJON, the patient should contact their doctor immediately.
Breastfeeding
Gabapentin, the active substance of Gabapentin BIJON, passes into breast milk. Since it is not known what effect this may have on the breastfed child, breastfeeding is not recommended while taking Gabapentin BIJON.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Gabapentin BIJON may cause dizziness, drowsiness, and fatigue. Before the patient is sure how this medicine affects their ability to drive vehicles, operate complex machines, or perform other potentially hazardous activities, they should avoid doing so.

Gabapentin BIJON, 300 mg, hard capsules contain orange yellow FCF (E 110)

The medicine may cause allergic reactions.

3. How to take Gabapentin BIJON

This medicine should always be taken as directed by the doctor or pharmacist. In case of doubts, the patient should consult their doctor or pharmacist.
The dose suitable for the individual patient is determined by the doctor.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of capsules as directed by their doctor. The dose is usually increased gradually. The usual starting dose is from 300 to 900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, divided into 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).
Children over 6 years of age:
The dose to be given to the child is determined by the doctor based on the child's body weight.
Treatment starts with a small initial dose, which is increased gradually over 3 days. The usual dose of the medicine that controls epilepsy is from 25 to 35 mg/kg body weight per day. The medicine is usually taken in three divided doses, one capsule (or capsules) in the morning, one in the afternoon, and one in the evening.
Gabapentin BIJON is not recommended for use in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
The patient should take the number of capsules as directed by their doctor. The doctor will gradually increase the dose. The usual starting dose is from 300 to 900 mg per day. It can then be gradually increased to a maximum dose of 3600 mg per day, taken as directed by the doctor, in 3 smaller doses (one in the morning, one in the afternoon, and one in the evening).

Use in patients with renal impairment or patients undergoing hemodialysis

In patients with kidney disease or undergoing hemodialysis, the doctor may recommend a different dosing schedule and/or a different dose.
Elderly patients (over 65 years)should take Gabapentin BIJON according to the normally recommended dosing schedule, unless they have kidney disease. In patients with kidney disease, the doctor may recommend a different dosing schedule and/or a different dose.
If the patient feels that the effect of Gabapentin BIJON is too strong or too weak, they should consult their doctor or pharmacist.

Method of administration

Gabapentin BIJON should be taken orally. The capsules should always be swallowed whole, with a large amount of water.
Gabapentin BIJON can be taken with or without food.
Gabapentin BIJON should not be stopped suddenly, unless the doctor advises otherwise.

Taking a higher dose of Gabapentin BIJON than recommended

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhea. If the patient has taken a higher dose of Gabapentin BIJON than recommended, they should contact their doctor or go to the nearest hospital emergency department (ER) immediately. They should bring any remaining capsules, packaging, and leaflet so that the hospital staff knows which medicine was taken.

Missing a dose of Gabapentin BIJON

If a dose is missed, it should be taken as soon as remembered, unless it is time for the next dose. A double dose should not be taken to make up for a missed dose.

Stopping Gabapentin BIJON

Gabapentin BIJON should not be stopped, unless the doctor advises otherwise. The medicine should be discontinued gradually, over a minimum period of 1 week. Stopping Gabapentin BIJON suddenly or without the doctor's advice increases the risk of seizures.
In case of any further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabapentin BIJON can cause side effects, although not everybody gets them.

The patient should contact their doctor immediately if they experience any of the following symptoms after taking this medicine, as they may be serious:

• anaphylactic reactions (severe, potentially life-threatening reactions involving difficulty breathing, swelling of the lips, throat, and tongue, and low blood pressure requiring immediate treatment)
• severe skin reactions requiring immediate medical attention, swelling around the mouth, and face, skin rash, and redness, and (or) hair loss (these may be symptoms of a severe allergic reaction)
• persistent abdominal pain, nausea, and vomiting, as these may be symptoms of acute pancreatitis
• Gabapentin BIJON may cause severe or life-threatening allergic reactions that can affect the skin or other parts of the body, such as the liver or blood cells. During such reactions, a rash may or may not occur. These symptoms may require hospitalization or discontinuation of Gabapentin BIJON. The patient should contact their doctor if they experience any of the following symptoms:
• Rash
• Hives
• Fever
• Swollen lymph nodes that do not go away
• Swelling of the lips and tongue
• Yellowing of the skin or the whites of the eyes (jaundice)
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unusual muscle pain
• Frequent infections
• breathing problems, which in severe cases may require immediate and intensive therapy to restore normal breathing.

The above symptoms may be the first signs of a severe reaction. The doctor should decide whether to continue treatment with Gabapentin BIJON.

If the patient is undergoing hemodialysis, they should tell their doctor if they experience pain and/or muscle weakness.
Other side effects include:

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

• viral infections
• drowsiness, dizziness, lack of coordination
• fatigue, fever

Common (may affect up to 1 in 10 people):

• pneumonia, respiratory tract infections, urinary tract infections, infection, ear infection, or other infections
• decreased white blood cell count
• loss of appetite, increased appetite
• hostility towards others, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• seizures, sudden muscle movements, speech problems, memory loss, tremors, sleep disturbances, headaches, increased sensitivity of the skin, decreased sensation (numbness), coordination problems, abnormal eye movements, exaggerated, decreased, or absent reflexes
• blurred vision, double vision
• dizziness
• high blood pressure, flushing, or vasodilation
• shortness of breath, bronchitis, sore throat, cough, feeling of dryness in the nose
• 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

In addition, in clinical studies in children, aggressive behavior and sudden muscle jerks were frequently reported.

Uncommon (may affect up to 1 in 100 people):

• restlessness (a state of constant restlessness and involuntary, aimless movements)
• allergic reactions, e.g., hives
• decreased mobility
• rapid heartbeat
• swelling, which may involve the face, trunk, and limbs
• abnormal blood test results suggesting liver problems
• psychiatric disorders
• falls
• elevated blood glucose levels (most commonly observed in patients with diabetes)
• difficulty swallowing

Rare (may affect up to 1 in 1000 people):

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

After the medicine was introduced to the market, the following side effects were reported:

• decreased platelet count (cells responsible for blood clotting)
• hallucinations
• abnormal movements, such as twisting of limbs or sudden jerks and stiffness
• ringing in the ears
• a syndrome of side effects that may include swollen lymph nodes (isolated, small, swollen lumps under the skin), fever, rash, and liver inflammation occurring at the same time
• yellowing of the skin and eyes (jaundice), liver inflammation
• acute kidney failure, urinary incontinence
• breast enlargement, breast engorgement
• side effects after sudden discontinuation of gabapentin (anxiety, sleep problems, nausea, pain, excessive sweating), chest pain
• changes in blood glucose levels in patients with diabetes
• muscle fiber breakdown (rhabdomyolysis)
• changes in blood test results (elevated creatine phosphokinase levels)
• sexual function disorders, including inability to achieve orgasm, delayed ejaculation
• low sodium levels in the blood.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Gabapentin BIJON

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the blister and carton after "EXP:". The expiry date refers to the last day of the month.
The medicine should not be stored above 25°C. It should be stored in the original packaging.
The blisters should be stored in the outer packaging.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Gabapentin BIJON contains

• The active substance of Gabapentin BIJON is gabapentin. Each hard capsule contains 300 mg of gabapentin.
• Other ingredients are: Capsule core: talc, cornstarch, Cornstarch Wieczko and capsule body: gelatin, erythrosine (E 127), orange yellow FCF (E 110), titanium dioxide (E 171) Printing ink: shellac, iron oxide black (E 172), propylene glycol
• The capsule core may contain: talc, cornstarch

What Gabapentin BIJON looks like and what the pack contains

Hard gelatin capsule with an orange cap and body, filled with a white or off-white powder in small clusters. The cap and body are printed with the numbers "93" and "39". The pack contains 100 hard capsules.