Gabapentin bijon

Package leaflet: Information for the patient

Warning! Keep the leaflet. The information on the immediate packaging is in a foreign language.
Gabapentin BIJON (Gabapentin Rivopharm), 100 mg, hard capsules
Gabapentinum
Gabapentin BIJON and Gabapentin Rivopharm are different trade names for the same medicinal product.
Please read the leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Gabapentin BIJON is and what it is 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 pack and other information

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

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

• various forms of epilepsy (seizures that start in specific areas of the brain and may either spread to the rest of the brain or remain localized). Your doctor prescribes Gabapentin BIJON as an add-on treatment for epilepsy when previous therapy has not provided full control of seizures. Gabapentin BIJON should be taken as an adjunctive therapy in epilepsy, unless otherwise directed by your doctor. Gabapentin BIJON may 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 pain (occurring mainly in the lower and/or upper limbs) is caused by various diseases, such as diabetes or shingles. Patients describe the pain they feel as burning, stinging, pulsating, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before using Gabapentin BIJON

When not to use 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 treatment with Gabapentin BIJON, discuss this 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 pain and/or muscle weakness occur;
if the patient experiences symptoms such as persistent abdominal pain, nausea and
vomiting, contact the doctor immediately, as these may be symptoms of
acute pancreatitis;
if the patient has neurological disorders, respiratory disorders or is over 65 years of age, the doctor may recommend a different dosage.

Cases of misuse and dependence have been reported following post-marketing use of gabapentin. If the patient has a history of drug abuse or dependence, inform the doctor.

A small number of people taking antiepileptic medicines containing gabapentin have had thoughts of harming themselves or of suicide. If such thoughts occur at any time, contact the doctor immediately.

Important information about potentially serious side effects
A small number of people taking Gabapentin BIJON have experienced allergic reactions or potentially severe skin reactions, which, if untreated, may progress to more serious symptoms. The patient should be aware of the possibility of such symptoms occurring during treatment with Gabapentin BIJON.
Please read the description of the above symptoms in section 4 of this leaflet “Contact a doctor immediately if any of the following symptoms occur after taking this medicine, as they may be serious.”

Muscle weakness, tenderness or pain, particularly when accompanied by malaise and high fever, may be caused by abnormal breakdown of muscle fibres (rhabdomyolysis), which may be life-threatening and lead to kidney problems. Changes in urine colour and changes in blood test results (markedly increased blood levels of creatine kinase) may occur. If such subjective or objective symptoms occur, contact the doctor immediately.

Gabapentin BIJON and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 the treatment of seizures, sleep disorders, depression, anxiety disorders or any other neurological or psychiatric disorders.

Medicines containing opioids, such as morphine
If the patient is taking medicines containing opioids (such as morphine), inform the 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 respiratory depression.

Antacids used for indigestion
When Gabapentin BIJON is taken together with antacids containing aluminium and magnesium, absorption of Gabapentin BIJON from the stomach may be reduced. It is therefore recommended to take Gabapentin BIJON at least two hours after taking an antacid.

Gabapentin BIJON

• is not expected to interact with other antiepileptic medicines or with oral contraceptives.
• may affect the results of certain laboratory tests; if urine testing is to be performed, inform the doctor or hospital that the patient is taking this medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Gabapentin BIJON should not be taken during pregnancy unless otherwise advised by the doctor.
Women of childbearing potential must use an effective method of contraception.
Although no studies have evaluated the use of gabapentin in pregnant women, increased risk of harm to the developing foetus has been reported with other antiepileptic medicines, particularly when several antiepileptic medicines are used together. Whenever possible, but only under medical supervision, pregnant women should be treated with a single antiepileptic medicine.
Do not stop taking this medicine suddenly, as this may trigger breakthrough seizures, which may have serious consequences for both the pregnant woman and her unborn child.
If pregnancy occurs, is suspected or is planned while taking Gabapentin BIJON, contact the doctor immediately.

Breastfeeding
Gabapentin – the active substance in Gabapentin BIJON – passes into breast milk. Since its effect on the breastfed infant is unknown, breastfeeding is not recommended during treatment with Gabapentin BIJON.

Fertility
Animal studies have not shown any effect of the medicine on fertility.

Driving and operating machinery
Gabapentin BIJON may cause dizziness, drowsiness and fatigue. Until the patient knows how this medicine affects their ability to drive, operate complex machinery or perform other potentially hazardous activities, such activities should be avoided.

3. How to use Gabapentin BIJON

This medicine should always be taken exactly as directed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.
The dose appropriate for each patient will be determined by the doctor.

Epilepsy – recommended dose
Adults and adolescents
Take the number of capsules as prescribed by your doctor. Doses are usually increased gradually.
The most commonly used starting dose is 300 to 900 mg per day. This may then be gradually increased
up 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 aged 6 years and older:
The dose to be administered to a child will be determined by the doctor based on the child's body weight.
Treatment starts with a low initial dose, which is gradually increased over a period of 3 days. The usual
dose required to control epilepsy is typically between 25 and 35 mg/kg body weight/day. The medicine is
usually taken in three divided doses daily: 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
Take the number of capsules as prescribed by your doctor. Your doctor will gradually increase the dose.
The usual starting dose is 300 to 900 mg per day. This may then be gradually increased up to a maximum
dose of 3600 mg per day, taken as directed by your doctor, in 3 divided doses (one in the morning, one
in the afternoon, and one in the evening).

Use in patients with renal impairment or patients undergoing haemodialysis
For patients with kidney disease or those undergoing haemodialysis, the doctor may recommend a different
dosing schedule and/or a different dose.

Elderly patients (over 65 years of age) should take Gabapentin BIJON according to the normally recommended
dosing schedule, unless they have kidney problems. In patients with kidney disease, the doctor may recommend
a different dosing schedule and/or a different dose.

If you feel that the effect of Gabapentin BIJON is too strong or too weak, consult your doctor or pharmacist.

Method of administration
Gabapentin BIJON should be taken orally. Capsules must always be swallowed whole, with plenty of water.
Gabapentin BIJON may be taken independently of meals.
Do not stop taking Gabapentin BIJON unless instructed to do so by your doctor.

Taking more Gabapentin BIJON 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 diarrhoea. If you have taken more Gabapentin BIJON
than prescribed, contact your doctor immediately or go to the nearest hospital emergency department (A&E).
Take any remaining capsules, the packaging, and the patient information leaflet with you so that hospital staff
can immediately identify the medicine taken.

Missed dose of Gabapentin BIJON
If you miss a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take
a double dose to make up for a missed dose.

Stopping Gabapentin BIJON
Do not stop taking Gabapentin BIJON unless your doctor tells you to. The medicine should be discontinued
gradually over a period of at least 1 week. Stopping Gabapentin BIJON suddenly or before your doctor advises
you to do so increases the risk of seizures.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will get them.
You should contact your doctor immediately if any of the following occur after taking this medicine,
as they may be serious:

• Anaphylactic reactions (severe, potentially life-threatening reactions including breathing difficulties, swelling of lips, throat and tongue, and hypotension requiring immediate treatment)
• Severe skin reactions requiring immediate medical attention, swelling around the mouth and face, 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 affecting 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. The above symptoms may require hospitalization or discontinuation of Gabapentin BIJON treatment. Contact your doctor if any of the following symptoms occur:
  • Rash
  • Urticaria
  • Fever
  • Persistent swelling of lymph nodes
• Swelling of lips and tongue
• Yellowing of the skin or sclera (whites) of the eyes
• Unusual bruising or bleeding
• Severe fatigue or weakness
• Unexpected 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 early signs of a serious reaction. Your doctor should decide whether
treatment with Gabapentin BIJON should be continued.
If you are undergoing hemodialysis, tell your doctor if you experience pain and (or)
muscle weakness.
Other adverse reactions 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, infection, ear infection or other infections
• Decreased white blood cell count
• Loss of appetite, increased appetite
• Irritability, confusion, mood swings, depression, anxiety, nervousness, difficulty thinking
• Seizures, sudden muscle movements, speech problems, memory loss, tremor, sleep disorders, headache, increased skin sensitivity, reduced sensation (numbness), coordination disorders, unusual eye movements, exaggerated, weakened or absent reflexes
• Blurred vision, double vision
• Dizziness
• Hypertension, flushing or dilation of blood vessels
• Shortness of breath, bronchitis, sore throat, cough, dryness in nose
• Vomiting, nausea, dental problems, gingivitis, 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 hands and feet, 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 limb jerking were commonly reported.
Uncommon (may affect up to 1 in 100 people):

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

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

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

Adverse reactions reported after marketing of the medicine:

• Decreased platelet count (cells responsible for blood clotting)
• Hallucinations
• Abnormal movements such as limb twisting, sudden jerking and stiffness
• Tinnitus (ringing in the ears)
• A syndrome of adverse reactions which may include enlarged lymph nodes (isolated, small, swollen lumps under the skin), fever, rash and hepatitis occurring simultaneously
• Yellowing of skin and eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue enlargement, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep problems, nausea, pain, excessive sweating), chest pain
• Changes in blood glucose levels in diabetic patients
• Muscle fiber breakdown (rhabdomyolysis)
• Changes in blood test results (increased creatine phosphokinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Low blood sodium levels (hyponatremia).

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 the Department of Monitoring Adverse Drug Reactions at 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
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Gabapentin BIJON

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton box after "EXP:". The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Keep blisters in the outer packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Gabapentin BIJON contains

• The active substance is gabapentin. Each hard capsule contains 100 mg of gabapentin.
• Other components are:
  Capsule core: talc, pregelatinized starch, corn starch
  Capsule cap and body: gelatin, black iron oxide (E 172), titanium dioxide (E 171)
  Printing ink: shellac, black iron oxide (E 172), propylene glycol

What Gabapentin BIJON looks like and contents of the pack
A hard gelatin capsule with a grey cap and body, filled with white or almost white powder in small aggregates. Numbers "93" and "38" are printed on the cap and body.
The pack contains 100 hard capsules.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Sweden, country of export:
Rivopharm Ltd.
17 Corrig Road
Sandyford, Dublin 18
Ireland
Manufacturer:
Laboratoires BTT
ZI de Krafft
67150 Erstein
France
Holsten Pharma GmbH
Hahnstrasse 31-35
Frankfurt am Main
Hessen, 60528
Germany
Parallel Importer:
BIJON medica, UAB
Jonavos str. 16A
LT-44269 Kaunas
Lithuania
Repackaged in:
UAB “Entafarma”,
Klonėnų vs. 1,
LT-19156 Širvintų r. sav.,
Lithuania
Marketing Authorisation Number in Sweden, country of export: 22045
Parallel Import Licence Number: 1/22
This medicinal product is authorised in the European Economic Area member states under the following names: