Gabapentin

Patient Information Leaflet

Gabacol, 100 mg, hard capsules
Gabacol, 300 mg, hard capsules
Gabacol, 400 mg, hard capsules
Gabapentinum
Please read this leaflet carefully before taking this medicine, as it contains important information for you.

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

Leaflet contents:

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

1. What Gabacol is and what it is used for

Gabacol 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 Gabacol is gabapentin.
Gabacol is indicated for the treatment of:

• Various forms of epilepsy (seizures that originate in specific areas of the brain and may or may not spread to the rest of the brain). Gabacol is prescribed for adults and children aged 6 years and older as an add-on therapy in the treatment of epilepsy when current treatment does not fully prevent seizures. Gabacol 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 a doctor. Gabacol may also be used as monotherapy (as the only medicine) in adults and children aged 12 years and older;
• 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, shooting, stabbing, sharp, cramp-like, aching, tingling, numbness, etc.

2. Important information before using Gabacol

When not to use Gabacol:

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

Warnings and precautions
Before starting treatment with Gabacol, talk to your doctor or pharmacist:

• if the patient has kidney disease, the doctor may recommend a different dosing regimen;
• if the patient has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs, inform the doctor, as this may indicate a higher risk of dependence on Gabacol;
• if the patient is undergoing hemodialysis (to remove waste products due to kidney failure), inform the doctor about muscle pain and/or weakness;
• if symptoms such as persistent abdominal pain, nausea, or vomiting occur, 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 a different dosage.

Dependence
Some people may become dependent on Gabacol (a need to continue taking the medicine). After
discontinuing Gabacol, withdrawal symptoms may occur (see section 3 "How to take Gabacol" and
"Stopping Gabacol"). If the patient is concerned about becoming dependent on Gabacol, they should
consult their doctor.
The occurrence of any of the following symptoms during treatment with Gabacol may indicate
dependence:

• The patient feels they need to take the medicine longer than prescribed by the doctor.
• The patient feels they need to take a higher dose than recommended.
• The patient uses the medicine for reasons other than those prescribed.
• The patient has made repeated unsuccessful attempts to stop or control use of the medicine.
• After stopping the medicine, the patient feels unwell and feels better after taking it again.

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best
treatment approach, including when and how to safely stop taking the medicine.
A small number of patients taking antiepileptic medicines such as gabapentin have had thoughts of
self-harm or suicide. If the patient ever experiences such thoughts, they should contact their doctor
immediately.
Important information about 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 gabapentin use.
Gabapentin should be discontinued and immediate medical help sought if any of the symptoms
associated with these serious skin reactions described in section 4 occur.
A description of the symptoms is in section 4 “Stop taking Gabacol and
seek immediate medical help if any of the following symptoms occur.”
Muscle weakness, tenderness, or pain, especially when accompanied by malaise and high fever, may
be due to abnormal breakdown of muscle fibers, which can be life-threatening and lead to kidney
problems. Urine discoloration and changes in blood test results (marked increase in creatine kinase
activity in blood) may occur. If such subjective or objective symptoms occur, contact a doctor
immediately.
Gabacol and other medicines
Tell your 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 to treat seizures, sleep disorders, depression, anxiety, or any
other neurological or psychiatric disorders.
Medicines containing opioids, such as morphine
Patients taking medicines containing opioids (such as morphine) should inform their doctor or
pharmacist, as opioids may enhance the effect of Gabacol.
Additionally, taking Gabacol together with opioids may cause drowsiness, sedation, respiratory
depression, or death.
Medicines that neutralize gastric acid, used for indigestion
When Gabacol is taken together with antacids containing aluminum and magnesium, absorption of
Gabacol from the stomach may be reduced. It is therefore recommended to take Gabacol at least
two hours after taking an antacid.
Gabacol

• does not interact with other antiepileptic medicines or with oral contraceptives;
• may affect the results of certain laboratory tests; if undergoing urine testing, inform the doctor or hospital about currently taken medicines.

Gabacol and food
Gabacol can be taken independently of meals.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a
baby, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Gabacol should not be taken during pregnancy unless otherwise advised by a doctor. Women of
childbearing potential must use effective contraception.
Although specific studies on the use of gabapentin in pregnant women have not been conducted,
there are reports that other antiepileptic medicines increase the risk of harm to the developing baby,
particularly when several antiepileptic medicines are taken together. Whenever possible, but only in
consultation with a doctor, pregnant women should take a single antiepileptic medicine.
If the patient took Gabacol during pregnancy, gabapentin may cause withdrawal symptoms in the
newborn. This risk may be increased when gabapentin is taken together with opioid pain medicines
(medicines used to treat severe pain).
If pregnancy occurs, is suspected, or is planned while taking Gabacol, contact the doctor
immediately. Do not suddenly stop taking Gabacol, as this may lead to withdrawal seizures, which
could have serious consequences for both the pregnant woman and her baby.
Breastfeeding
Gabapentin, the active ingredient in Gabacol, passes into human milk. As it is unknown what effect it
may have on the breastfed infant, breastfeeding is not recommended during treatment with Gabacol.
Fertility
Studies in animals have not shown any effect of the medicine on fertility.
Driving and operating machinery
Gabacol may cause dizziness, drowsiness, and fatigue. Do not drive, operate complex machinery,
or perform other potentially dangerous activities until you are certain how this medicine affects your
ability to perform such tasks.
Gabacol contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, meaning the medicine is
considered "sodium-free".

3. How to use Gabacol

This medicine should always be taken exactly as prescribed by your doctor. If in doubt, consult
your doctor or pharmacist. Do not take more medicine than prescribed.
The dose is 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 mg to 900 mg per day. This may then be
gradually increased according to your doctor's instructions up to a maximum dose of
3600 mg per day, divided into 3 separate doses (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 is 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 about
3 days. The usual effective dose for controlling epilepsy is 25 to 35 mg/kg body weight/day. This
dose is usually administered in three separate doses, i.e. one capsule (or capsules) daily, typically
in the morning, afternoon, and evening.
Gabacol 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. Doses are usually increased
gradually. The most commonly used starting dose is 300 mg 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 (in the morning, afternoon, and evening).
Use in patients with renal impairment or patients undergoing hemodialysis
Your doctor may recommend a different dosing schedule and/or a different dose of Gabacol for
patients with renal impairment or patients undergoing hemodialysis.
Elderly patients (over 65 years)
Elderly patients (over 65 years) should take the normally recommended dose of Gabacol, unless
they have impaired kidney function. In patients with kidney problems, the doctor may recommend
a different dosing schedule and/or a different dose.
If the effect of Gabacol appears too strong or too weak, consult your doctor or pharmacist as soon
as possible.
Method of administration
Gabacol is administered orally. The capsules should be swallowed with plenty of water.
Do not stop taking Gabacol unless your doctor tells you to do so.
Taking more than the recommended dose of Gabacol
Taking more than the recommended dose may increase the risk of adverse effects, including loss
of consciousness, dizziness, double vision, slurred speech, drowsiness, and diarrhoea. If you take
more Gabacol than prescribed, seek immediate medical advice from a doctor or go to the nearest
hospital emergency department (A&E). In such a case, bring all remaining capsules, the
packaging, and the patient information leaflet so that hospital staff can immediately identify the
medicine taken.
Missed dose of Gabacol
If you miss a dose, take it as soon as possible, unless it is almost time for the next dose. Do not
take a double dose to make up for a missed dose.
Stopping Gabacol
Do not stop taking Gabacol suddenly. If you wish to stop taking Gabacol, consult your doctor
to discuss how this should be done. The medicine should be discontinued gradually over a period
of at least 1 week. You should be aware that after stopping short- or long-term treatment with
Gabacol, certain adverse effects, known as withdrawal symptoms, may occur. These may include
seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremor, headache, depression,
dysphoria, dizziness, and general malaise. These symptoms usually occur within 48 hours after
stopping Gabacol. If you experience withdrawal symptoms, contact your doctor.
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 everyone will experience them.
You must stop taking Gabacol and seek immediate medical help if any of the following symptoms occur:

• Red spots resembling a target or circular rash on the trunk, often with central blisters, peeling skin, and ulceration of 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 fever, and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

• Severe skin reactions requiring immediate medical attention, swelling around the lips and face, skin rash and redness and (or) hair loss (these may be signs of a severe allergic reaction)
• 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
• Gabacol may cause serious or life-threatening allergic reactions affecting the skin or other parts of the body, such as the liver or blood cells. Such reactions may include a rash. These reactions may require hospitalization or discontinuation of Gabacol. Contact your doctor immediately if any of the following symptoms occur:
• Skin rash
• Urticaria (hives)
• Fever
• Persistent swelling of lymph nodes
• Swelling of lips 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 sign of a serious reaction. The doctor should examine the patient and decide whether Gabacol treatment should continue.

• In patients undergoing hemodialysis, inform the doctor if muscle pain and (or) weakness occur.

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

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

Common: (may affect up to 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 disturbances
• Seizures, sudden muscle movements, speech difficulties, memory loss, tremor, sleep disturbances, headache, increased skin sensitivity, reduced sensation (numbness), coordination disturbances, 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, 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 flexion of limbs were commonly reported.
Uncommon: (may affect up to 1 in 100 people)

• Restlessness (a state of constant agitation and unintentional, purposeless movements)
• Allergic reactions, e.g., urticaria
• Restricted movement
• Palpitations
• Swelling affecting face, trunk, limbs
• Abnormal blood test results indicating liver function disorders
• Psychiatric disorders
• Falls
• Increased 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 difficulties, shallow breathing (respiratory depression)

Frequency not known: (cannot be estimated from available data)

• Dependence on Gabacol (‘drug dependence’)

Patients should be aware that after discontinuation of short- or long-term treatment with Gabacol, certain adverse reactions may occur, known as withdrawal symptoms (see “Discontinuing Gabacol”).
After Gabacol was introduced to the market, the following adverse reactions have been observed:

• Decreased platelet count (blood cells responsible for blood clotting)
• Suicidal thoughts, hallucinations
• Abnormal movements, such as twisting of limbs or sudden flexion, muscle stiffness
• Tinnitus (ringing in the ears)
• Yellowing of the skin and whites of the eyes (jaundice), hepatitis
• Acute kidney failure, urinary incontinence
• Breast tissue overgrowth, breast enlargement
• Adverse reactions after abrupt discontinuation of gabapentin (anxiety, sleep disturbances, nausea, pain, excessive sweating), chest pain
• Rhabdomyolysis (breakdown of muscle fibers)
• Changes in blood test results (increased creatine kinase levels)
• Sexual dysfunction, including inability to achieve orgasm, delayed ejaculation
• Hyponatremia (low sodium levels in blood)
• 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 the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 responsible entity.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Gabacol
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the stated month.
PVC/PVDC/Aluminum blisters: Do not store above 30°C.
HDPE bottles and Aluminum/Aluminum blisters: No special temperature requirements for storage.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Gabacol contains

• The active substance is gabapentin. Each hard capsule contains 100 mg, 300 mg or 400 mg of gabapentin.
• Other ingredients are: maize starch, copovidone, poloxamer 407, magnesium stearate.
• Capsule shell: gelatin and sodium lauryl sulfate, purified water. The capsule also contains the following colourings: titanium dioxide (E 171), iron oxide red (E 172) (400 mg capsules), iron oxide yellow (E 172) (300 mg and 400 mg capsules). Printing ink components: shellac, propylene glycol, concentrated ammonium hydroxide, indigo carmine (E 132).

What Gabacol looks like and contents of the pack
Gabacol 100 mg hard capsules: two-part, white, opaque, gelatin capsules, size 3, 15.4–16.2 mm in length, with a blue print "G 100" on the cap, containing a white or almost white powder.
Gabacol 300 mg hard capsules: two-part, yellow, opaque, gelatin capsules, size 1, 18.9–19.7 mm in length, with a blue print "G 300" on the cap, containing a white or almost white powder.
Gabacol 400 mg hard capsules: two-part, orange, opaque, gelatin capsules, size 0, 21.0–21.8 mm in length, with a blue print "G 400" on the cap, containing a white or almost white powder.
The capsules are packed in PVC/PVDC/Aluminium blisters, Aluminium/Aluminium blisters or HDPE bottles.
Pack sizes:
PVC/PVDC/Aluminium or Aluminium/Aluminium blisters: 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
HDPE bottle: 100 or 500 capsules.
Marketing Authorisation Holder:
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warszawa
Tel: +48 22 577 28 00
Manufacturer/Importer:
Laboratori Fundacio Dau
C/C, 12-14 Pol. Ind. Zona Franca
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Accord Healthcare B.V.
Winthontlaan 200
3526 KV Utrecht
The Netherlands
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names: