Gabacol

Leaflet accompanying the packaging: patient information

Gabacol, 100 mg, hard capsules

Gabacol, 300 mg, hard capsules

Gabacol, 400 mg, hard capsules

Gabapentin

Read the 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 a specific person. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Gabacol and what is it used for
• 2. Important information before taking Gabacol
• 3. How to take Gabacol
• 4. Possible side effects
• 5. How to store Gabacol
• 6. Package contents and other information

1. What is Gabacol and what is it used for

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

• various forms of epilepsy (seizures that initially occur in specific areas of the brain and then spread to the rest of the brain or not). Gabacol is prescribed to adults and children over 6 years of age as an adjunctive therapy in the treatment of epilepsy when the current treatment does not fully prevent seizures. Gabacol should be taken as an adjunctive therapy in the treatment of epilepsy in adults or children over 6 years of age, unless the doctor advises otherwise. Gabacol can also be used as monotherapy (as the only medicine) 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 various diseases, such as diabetes or shingles. Patients describe the pain they experience as burning, tingling, pulsating, piercing, stabbing, sharp, similar to muscle cramps, as aching, tingling, numbness, etc.

2. Important information before taking Gabacol

When not to take Gabacol:

Warnings and precautions

Before starting to take Gabacol, the patient should talk to their doctor or pharmacist:

• in case of kidney disease, the doctor may recommend a different dosing schedule;
• in case of hemodialysis treatment (to remove metabolic products due to kidney failure), the patient should inform their doctor about any muscle pain and/or weakness;

Dependence

Some people may become dependent on Gabacol (need to continue taking the medicine). After stopping the use of Gabacol, withdrawal symptoms may occur (see section 3 "How to take Gabacol" and "Stopping Gabacol"). If the patient is concerned that they may become dependent on Gabacol, they should consult their doctor.
The occurrence of any of the following symptoms while taking Gabacol may indicate dependence.

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

If the patient notices any of these symptoms, they should talk to their doctor to discuss the best course of treatment, including when to stop taking the medicine and how to do it safely.
A small number of patients taking antiepileptic drugs such as gabapentin have had thoughts of self-harm or suicide. If the patient has ever had such thoughts, they should contact their doctor immediately.

Important information about potentially serious reactions

In connection with the use of gabapentin, severe skin rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash with eosinophilia and systemic symptoms (DRESS), have been reported. The patient should stop taking gabapentin and seek medical help immediately if any of the symptoms associated with these severe skin reactions described in section 4 occur.
See section 4 for a description of the symptoms"Stop taking Gabacol and seek medical help immediately if any of the following symptoms occur”.
Muscle weakness, tenderness, or pain, especially if accompanied by malaise and high fever, may be caused by abnormal muscle fiber breakdown, which can be life-threatening and lead to kidney disorders. There may be a change in urine color and changes in blood test results (significant increase in creatine phosphokinase activity in the blood). If such subjective and objective symptoms occur, the patient should contact their doctor immediately.

Gabacol 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, the patient 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 Gabacol.
Additionally, concomitant use of Gabacol and opioids may cause drowsiness, sedation, shallow breathing, or death.
Antacids, used to treat heartburn
In case of concomitant use of Gabacol and antacids containing aluminum and magnesium, the absorption of Gabacol from the stomach may be limited. Therefore, it is recommended to take Gabacol at least 2 hours after taking an antacid.

• Gabacol does not interact with other antiepileptic medicines or oral contraceptives;
• it may affect the results of some laboratory tests; in case of a urine test, the patient should inform their doctor or hospital about the medicines they are currently taking.

Gabacol with food

Gabacol can be taken with or without food.

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
Gabacol should not be taken during pregnancy, unless the doctor recommends it. Women of childbearing age must use effective contraception.
Although no specific studies have been conducted on the use of gabapentin in pregnant women, there are reports that other antiepileptic drugs increase the risk of harm to the developing child, especially when multiple antiepileptic drugs are used at the same time. Whenever possible, but only in agreement with the doctor, pregnant women should take only one antiepileptic drug.
If the patient took Gabacol during pregnancy, gabapentin may cause withdrawal symptoms in the newborn baby. This risk may be increased if gabapentin is taken with opioid painkillers (medicines used to treat severe pain).
In case of pregnancy, suspected pregnancy, or planning pregnancy while taking Gabacol, the patient should contact their doctor immediately. The patient should not stop taking Gabacol suddenly, as this may lead to the occurrence of withdrawal seizures, which can have serious consequences for both the pregnant woman and her child.
Breastfeeding
Gabapentin, the active substance of Gabacol, passes into breast milk. Since it is not known what effect it has on the breastfed child, breastfeeding is not recommended while taking Gabacol.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Gabacol may cause dizziness, drowsiness, and fatigue. The patient should not drive, operate complex machines, or perform other potentially hazardous activities until they are sure how the medicine affects their ability to perform such activities.

Gabacol contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per capsule, which means the medicine is essentially 'sodium-free'.

3. How to take Gabacol

This medicine should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist. The patient should not take more medicine than prescribed.
The doctor determines the dose.

Epilepsy - recommended dose

Adults and adolescents
The patient should take the number of capsules recommended by their doctor. The dose is usually increased gradually. The most commonly used initial dose is 300 mg to 900 mg per day. It can then be gradually increased according to the doctor's instructions 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 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 gradually increased over a period of about 3 days. The commonly used dose to control epilepsy is 25 to 35 mg/kg body weight per day. This dose is usually divided into 3 separate doses, i.e., one capsule (or capsules) is given daily, usually in the morning, afternoon, and evening.
Gabacol should not be used in children under 6 years of age.

Peripheral neuropathic pain - recommended dose

Adults
The patient should take the number of capsules recommended by their doctor. The dose is usually increased gradually. The most commonly used initial dose is 300 mg 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 (in the morning, afternoon, and evening).

Use in patients with renal impairment or in patients undergoing hemodialysis

The doctor may recommend a different dosing schedule and/or a different dose of Gabacol in patients with renal impairment or in patients undergoing hemodialysis.

Elderly patients (over 65 years of age)

Elderly patients (over 65 years of age) should take the normally recommended dose of Gabacol, unless they have kidney problems. In patients with kidney problems, the doctor may recommend a different dosing schedule and/or a different dose.
If it seems that the effect of Gabacol is too strong or too weak, the patient should talk to their doctor or pharmacist as soon as possible.

Method of administration

Gabacol is taken orally. The capsules should be swallowed with a large amount of water.
Gabacol should not be stopped until the doctor recommends it.

Overdose of Gabacol

Taking higher doses than recommended may cause an increased number of side effects, including loss of consciousness, dizziness, double vision, blurred speech, drowsiness, and diarrhea. In case of taking a higher dose of Gabacol than recommended, the patient should immediately contact their doctor or go to the nearest hospital emergency department (ER).
In such a situation, the patient should also take all remaining capsules, packaging, and leaflet, so that the hospital staff knows which medicine was taken.

Missed dose of Gabacol

In case of a missed dose, the patient should take it as soon as possible, unless it is almost time for the next dose. The patient should not take a double dose to make up for the missed dose.

Stopping Gabacol

Gabacol should not be stopped suddenly. If the patient wants to stop taking Gabacol, they should consult their doctor to discuss how to do it. Stopping the medicine should be done gradually, over a minimum period of 1 week. The patient should be aware that after stopping short-term or long-term treatment with Gabacol, certain side effects may occur, so-called withdrawal symptoms. These effects may include seizures, anxiety, difficulty sleeping, nausea, pain, sweating, tremors, headache, depression, abnormal feelings, dizziness, and general malaise. These effects usually occur within 48 hours after stopping Gabacol. If the patient experiences withdrawal symptoms, they should contact their doctor.
In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Gabacol can cause side effects, although not everybody gets them.
The patient should stop taking Gabacol and seek medical help immediatelyif they experience any of the following symptoms:

• Red spots resembling a target or round spots on the torso, often with central blisters, peeling skin, ulcers in the mouth, throat, nose, genitals, 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).

The patient should seek medical help immediately if they experience any of the following symptoms:

• • severe skin reactions requiring immediate medical attention, swelling around the eyes, face, lips, tongue, or throat, 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 may require immediate and intensive medical attention to restore normal breathing
• • Gabacol may cause serious or life-threatening allergic reactions, which may affect the skin or other parts of the body, such as the liver or blood cells. In such cases, a rash may occur. Such a reaction may require hospitalization or discontinuation of Gabacol. The patient should seek medical help immediately if they experience any of the following symptoms:
• • skin rash
• • hives
• • fever
• • persistent swollen 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
• • 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 to continue taking Gabacol.

• In case of hemodialysis, the patient should inform their doctor about any 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
• fatigue, 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
• irritability towards others, disorientation, mood changes, depression, anxiety, nervousness, thinking disorders
• seizures, sudden muscle movements, speech difficulties, memory loss, tremors, sleep disturbances, headaches, increased skin sensitivity, 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, feeling of 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
• 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 limb flexion were frequently reported.

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

• restlessness (a state of constant restlessness and unintentional, purposeless movements)
• allergic reactions, such as hives
• restricted movement
• palpitations
• swelling affecting 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)
• 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 the available data)

• dependence on Gabacol ("drug dependence")

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

After the marketing of Gabacol, the following side effects have been observed:

• decreased platelet count (blood cells responsible for blood clotting)
• suicidal thoughts, hallucinations
• abnormal movements, such as limb twisting or sudden flexion, muscle stiffness
• ringing in the ears
• yellowing of the skin and whites of the eyes (jaundice), liver inflammation
• acute kidney failure, urinary incontinence
• breast tissue growth, 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 side effects occur, including those not listed in this leaflet, the patient should tell their 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
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: + 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Gabacol

The medicine should be stored out of sight and reach of children.
Gabacol should not be taken after the expiry date stated on the blister and carton after: EXP.
The expiry date refers to the last day of the month stated.
PVC/PVDC/Aluminum blisters: Do not store above 30°C.
HDPE bottle and Aluminum/Aluminum blisters: No special storage precautions.

6. Package contents and other information

What Gabacol contains

• The active substance of Gabacol is gabapentin. Each hard capsule contains 100 mg, 300 mg, or 400 mg of gabapentin.
• Other ingredients are: cornstarch, copovidone, poloxamer 407, magnesium stearate
• Capsule shell: gelatin, sodium lauryl sulfate, purified water. The capsule also contains colorants: titanium dioxide (E 171), iron oxide red (E 172) (400 mg capsules), iron oxide yellow (E 172) (300 mg and 400 mg capsules). The composition of the ink used for printing includes: shellac, propylene glycol, concentrated ammonia, 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, length 15.4-16.2 mm, with blue printing "G 100" on the capsule cap, containing white or almost white powder.
Gabacol, 300 mg, hard capsules: two-part, yellow, opaque, gelatin capsules, size 1, length 18.9-19.7 mm, with blue printing "G 300" on the capsule cap, containing white or almost white powder.
Gabacol, 400 mg, hard capsules: two-part, orange, opaque, gelatin capsules, size 0, length 21.0-21.8 mm, with blue printing "G 400" on the capsule cap, containing white or almost white powder.
The capsules are packaged in PVC/PVDC/Aluminum blisters, Aluminum/Aluminum blisters, or HDPE bottles.
Pack sizes:
PVC/PVDC/Aluminum blisters or Aluminum/Aluminum blisters: 20, 30, 50, 60, 84, 90, 98, 100, 200, 500, 1000 capsules.
HDPE bottle: 100 or 500 capsules

Marketing authorization holder:

Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
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
Netherlands

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of last revision of the leaflet: May 2023